The UniTed RepUblic of Tanzania

MinisTRy of healTh, coMMUniTy developMenT, GendeR, eldeRly and childRen.

NatioNal GuideliNe For laboratory

Sample reFerral SyStem

aUGUsT 2019
 The United Republic of Tanzania

Ministry of Health, Community Development,

Gender, Elderly and Children.

National Guideline For Laboratory

Sample Referral System

AUGUST 2019
National Guideline For Laboratory Sample Referral System

Published in 2019
©MOHCDGEC,
Ministry of Health, Community Development, Gender, Elderly and Children,
Government City- Mitumba,
Afya Road,
PO Box 743,
Dodoma, Tanzania.
Tel: +255 (0)26 232 3267
E-mail: [email protected]
Website: www.moh.go.tz

First Edition 2019

Any part of this National Guideline For Laboratory Sample Referral System can be used provided
that the source, which is the Ministry of Health, Community Development, Gender, Elderly and
Children and Management Development for Health are acknowledged.
 Contents

contents .............................................................................................................. i
Abbreviations and acronyms .............................................................................. iv
Foreword .......................................................................................................... vi
Acknowledgment ............................................................................................. viii
Definition of Terms ........................................................................................... ix

1. Introduction .......................................................................................... 1
1.1. Background .................................................................................. 1
1.2. Justification ................................................................................... 3
1.3. Goal ................................................................................................ 4
1.4. Objectives ...................................................................................... 4
1.5. Users of this Guideline ................................................................... 4
1.6. Type of Samples .............................................................................. 5

2. Structure, Organization and Management of SRS .................................... 6

2.1. Key System Components ............................................................... 6
2.2. Roles and Responsibilities ............................................................. 7
2.2.1. Roles of Spoke ..................................................................... 7
2.2.2. Roles of Hub ........................................................................ 7
2.2.3. Hub Management Team ...................................................... 8
2.2.4. Roles of Referral Testing Laboratory .................................... 9
2.2.5. Roles of Courier Services Provider ....................................... 9
2.2.5. Roles of the Council’s Health Management Team ................ 10
2.2.5.1. Roles of DLT ............................................................ 10
2.2.5.2. Roles of DTLC, DACC and DRCH-Co ..................... 11
2.2.6. The Roles of Regional Health Management Team ................ 11
2.2.6.1. The Roles of RLT ..................................................... 12
2.2.6.2. The Roles of RTLC, RLT, RACC and RRCHco ........ 12
2.2.7. Roles at the National Level ................................................... 13
2.2.7.1. Management and Leadership Roles ....................... 13
2.2.8.2 Leadership and management roles of DPS ............ 13

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3. Operation and implementation ............................................................... 14
3.1. Sample management ..................................................................... 14
3.1.1. Sample Collection ................................................................ 14
3.1.2. Sample Packaging ............................................................... 14
3.1.3. Maintaining Sample Quality and Integrity ............................. 15
3.1.4. Standard Operating Procedures ......................................... 16
3.2. Biosafety and Biosecurity regulations ............................................... 16
3.3. Sample transportation process ......................................................... 17
3.4. Laboratory information management system ................................... 18
3.4.1. Electronic sample referral system ........................................ 18
3.4.2. Paper-based laboratory information system ....................... 19
3.4.3. Management of Laboratory Information system
implementation .................................................................... 19
3.4.4. Use of LIMS for sample referral ........................................... 19
3.5. Mentorship support ..................................................................... 20
3.6 Coordination of the Laboratory Sample Referral System ............... 20
3.6.1. National Level ...................................................................... 20
3.6.2. Regional Level ..................................................................... 21
3.6.3. District Level ......................................................................... 21
3.6.4. Hub Level .......................................................................... 22
3.6.5. Testing Laboratory .................................................................. 22
3.7. Financing and Human Resources .................................................. 22
3.7.1. Financing ........................................................................... 22
3.7.2. Potential Funding Sources .................................................. 23
3.7.3. Human Resources .............................................................. 23

4. Monitoring and Evaluation ................................................................... 24

4.1. Key components of Monitoring and Evaluation .............................. 24
4.1.1. Data recording ..................................................................... 24
4.1.2. Data Storage ...................................................................... 25
4.1.3. Data reporting ..................................................................... 25
4.1.4. Data Dissemination and Use ................................................. 25
4.1.5. Document and Records Archiving ......................................... 26
4.2. Monitoring of Sample Referral System ........................................... 26

Bibliography ................................................................................................... 28

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list of table
Table 1: Log Frame for Sample Referral System ......................................... 30
Table 2: M&E Matrix for Sample Referral Indicators ................................ 35
Table 3: List of Participants who developed the Guideline .......................... 66

list of Annex
Annex 1: Hiv Viral Load Sample and Results Register .............................. 44
Annex 2: Hvl High Viral Load Register ...................................................... 45
Annex 3: Facility Heid Register ..................................................................... 46
Annex 4: Tb Laboratory Register ................................................................. 47
Annex 5: Hvl Hub Sample and Result Register ..................................... 48
Annex 6: Tb Hub Sample and Result Register .............................................. 49
Annex 7: Heid Hub Sample and Results Register ........................................ 50
Annex 8: Sample Manifest ........................................................................... 51
Annex 9: Samples Rejection Log ................................................................ 52
Annex 10: Spoke and Hub Standard Operating Procedures - Master List .. 53
Annex 11: Indicators Performance for Sample Referral System .................... 54
Annex 12: Srs Monthly Monitoring Form .................................................... 55
Annex 13: Hub Quarterly Assessment and Supervision Checklist ................. 56
Annex 14: Hub Laboratory Information System - Quarter Assement Tool ..... 58
Annex 15: Hiv Viral Load Turn around Time ................................................... 59
Annex 16: Heid Turn around Time (Conventional) ........................................ 60
Annex 17: Xpert Mtb/Rif Testing Turn around Time ................................... 61
Annex 18: Line Probe Asssay Turn around Time ....................................... 62
Annex 19: Heid Poc Turn around Time .......................................................... 63
Annex 20: Heid Poc Implementation Checklist ............................................ 64

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Abbreviations and acronyms

AIDS Acquired Immunodeficiency Syndrome

ART Anti-Retroviral Therapy
BMC Bugando Medical Center
CCHP Council Comprehensive Health Plans
CHMT Council Health Management Team
CTC Care and Treatment Centre
CTRL Central Tuberculosis Reference Laboratory
DACC District AIDS Control Coordinator
DBS Dried Blood Spot
DCS Director of Curative Services
DHIS District Health Information System
DHSWNS Department of Health Services, Social and Nutrition Services
DLT District Laboratory Technologist
DNA Deoxyribonucleic Acid
DPS Director of Preventive Services
DSS Diagnostic Services Section
DST Drug Susceptibility Testing
DTLC District Tuberculosis and Leprosy Coordinator
DTN Drones Transport Network
EMS Expedited Mail Services
EQA External Quality Assessment
ESRS Electronic Sample referral and Results feedback System
eTL Electronic Tuberculosis and Leprosy Register
GIS Geographic Information Systems
HC Health Center
HCWs Health Care Workers
HEID HIV Early Infant Diagnosis
HF Health Facility
HIV Human Immunodeficiency Virus
HIVDR HIV Drug Resistance
HSHSPIV Health Sector HIV Strategic Plan IV (2018-2022)
HVL HIV Viral Load
IATA International Air Transportation Association
IP Implementing Partner
ISRN Integrated Sample Referral Network

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KCMC Kilimanjaro Christian Medical Centre
Km Kilometre
KNCV Koninklijke Nederlandse Chemische Vereniging (Royal Dutch
Chemical Association)
LPA Line Probe Assay
M&E Monitoring and Evaluation
MDH Management and Development for Health
MNH Muhimbili National Hospital
MOHCDGEC Ministry of Health, Community Development, Gender, Elderly and
Children
MTB Mycobacterium tuberculosis
MZRH Mbeya Zonal Referral Hospital
NACP National AIDS Control Programme
NOPS-VL National Operational Plan for Scaling up Viral Load Testing
NTLP National Tuberculosis and Leprosy Programme
NTLSP National Tuberculosis Laboratory Strategic Plan
PCR Polymerase Chain Reaction
PLHIV People Living with HIV
PO-RALG President’s Office Regional Administration and Local Government
POC Point of Care
RHMT Regional Health Management Team
RIF Rifampicin
RIP Rest in Peace
RLT Regional Laboratory Technologist
RTLC Regional Tuberculosis and Leprosy Coordinator
SOP Standard Operating Procedure
SRS Sample referral and Results feedback System
TAT Turn Around Time
TB Tuberculosis
TCAA Tanzania Civil Aviation Authority
THIS Tanzania HIV Impact Survey
THMIS Tanzania HIV and Malaria Indicator Survey
UN United Nations
UNAIDS Joint United Nations Programme of HIV/AIDS
WHO World Health Organization

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Foreword

On behalf of the MOHCDGEC, I would like to take this opportunity to thank the
Management Development for Health (MDH) for their technical and funding support
towards the development of this integrated TB and HIV samples referral and results
feedback guideline. Tanzania, like many low-income countries, is faced with many
challenges in the deliverance of quality health care to its people. Quality health care
delivery includes many aspects, among which is sample referral to higher laboratory
levels for further testing, either in-country and/or referral abroad. Clearly, without quality
samples submitted for testing, patient /client management is compromised, resulting
to harm or death, and loss or wastage of limited resources and personnel time.

Whereas, it is in the interest of the government to bring advanced technologies in health

care services close to the communities, some technologies cannot only have value
for money at higher level testing laboratories at zonal or national levels, but can also
significant impact in diagnostic services. In this regard, I would like to acknowledge
the support the MOHCDGEC received from the US Government through Development
Partners in mapping and developing national TB and HIV samples referral system. This
will allow efficient laboratory sample transportation to the testing laboratory, and results
back to the testing facility. This is a hub-based system, in which a number of health
facilities in a particular catchment area (spokes) send samples to a sample collection
facility (hub), where they are well packed and transported to testing laboratory for
analysis.

The development of TB and HIV samples referral guideline is yet another endeavour
by the MOHCDGEC to ensure intervention programmes are integrated for efficient
utilization of available resources to improve the quality of care. By integrating TB
samples referral into the existing HIV samples referral system, it will streamline service
delivery, improve diagnosis through referrals, and minimize costs, while achieving the
desired objectives.

This guideline has the following sections: Introduction ,which gives a brief account
of HIV and TB situation in Tanzania and the rationale for developing this Guidelines;
Structure, organization and management of SRS, which gives an overview necessary
for proper management of sample referrals; Operation and Implementation, which
describes sample collection, handling (initial processing and temporary storage),
packaging and transportation in optimum conditions, suitable for the kind of testing

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required; and Monitoring and evaluation which describes how the National Laboratory
Samples Referral Systems will be monitored and evaluated to ensure compliance with
available regulations and its impact in the intervention programmes, hence ultimate
goal of providing quality results and appropriate patient care and management.

Having this Guideline in place will help to support other future intervention programmes
that require samples to be referred and/or transported safely to a testing point; and
also, guarantees timely delivery of test results for patient management or informed
decision.

Although, these National Guidelines Laboratory SRS were developed to target sample
referrals systems for HIV and TB testing, they are not by any means limited to only
these two programmes.

Other pathological samples from disease programmes such Malaria, NCD, Research
including, clinical trials, epidemic prone diseases and future health intervention
programmes, planning to refer samples for testing across and to higher level testing
laboratories, are encouraged to integrate and use this SRS Guideline. As and when this
document is reviewed, new intervention programmes will be incorporated.

Lastly, the MOHCDGEC welcomes views and comments, which will provide valuable
inputs in the updating and preparation of the subsequent edition of the TB and HIV
samples referral and results feedback guideline in Tanzania.

Dr. Zainab A.S. Chaula

Permanent Secretary (Health)

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Acknowledgment

This Guideline for TB and HIV Laboratory Samples Referral System is a product of
dedicated efforts and contributions of Government, Implementing Partners, Non-
Government Organizations, Institutions, Health related intervention programmes
and individuals. The Ministry of Health, Community Development, Gender, Elderly
and Children (MOHCDGEC) is very grateful for their financial support and technical
assistance towards revising and reviewing this Guideline.

The MOHCDGEC through the Department of Curative Services (DCS), and the
Diagnostic Services Section (DSS) would like to acknowledge all Implementing Partners
and stakeholders who in one way or another have contributed to the development
of this guideline. In particular, the MOHCDGEC would like to thank Management
Development for Health (MDH) for the financial and individual technical experts (TABLE
3) for their active participation and constructive input and comments provided in
developing this guideline.

I would like to express my sincere gratitude to the task force which include the National
AIDS Control Programme (NACP), National Tuberculosis and Leprosy programme
(NTLP) and the Central Tuberculosis and Reference Laboratory (CTRL) for the technical
support for developing this important document. Furthermore, we appreciate the
technical guidance provided by WHO Tanzania experts and through referencing from
their standard guidelines.

Finally, the MOHCDGEC would like to acknowledge the technical officers and support
staff from the DSS for their teamwork, spirit and commitment.

Prof. Muhammad B. Kambi

Chief Medical Officer

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Definition of Terms

The following definitions apply to the terms used in this Guideline

Biological Substance, An infectious substance, which is in a form that, when

Category A exposure to it occurs, it is capable of causing permanent
disability, life-threatening or fatal disease in an otherwise
healthy human or animal. When transporting diagnostic
sample Category A, it must be assigned to UN2814.

Biological Substance, An infectious substance, which does not meet the criteria
Category B for inclusion in Category A. When transporting diagnostic
sample Category B for only purpose of diagnosis or
investigation, it must be assigned to UN3373.

Hub Is a designated health facility with capacity to:-

a) gather samples (HVL, TB, HEID, HIVDR) from specific
sites within 30-40 km radius, for initial processing,
temporally storage and transportation of the samples
to the testing laboratory as per testing requirements.
b) receiving and testing samples (TB and HEID) from
spokes using near to Point of Care (POC) equipment
such as GeneXpert. .

Spoke Is the first level facility or TB diagnostic centre which

a) collects and refers samples to the hub for initial pro-
cessing, temporary storage and transportation to high
level testing such HVL testing and TB culture.

b) collects and refers samples (TB and HEID) to the hub

for testing using near Point of Care (POC) such as
GeneXpert.
a) Multiple spokes are centrally connected to the “hub”.

Hub-spoke model Hub and Spoke model for healthcare, is where the “hub” is

a central health facility that is identified to serve as a central
sample collection point for samples coming from multiple
referring sites, termed as “spokes.”

DBS Is blood sample collected on a special filter paper card and

dried.

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Diagnostic Sample Are materials collected directly from the patient/client
including, but not limited to; excreta, secretions, blood and
its components, tissue and tissue fluid and body parts being
collected and transported for purposes such as research,
diagnosis, investigational activities, disease treatment,
prevention and control

Plasma Is the clear fluid separated from whole blood collected in a

tube containing anticoagulant.

Injury An event that results in physical harm to an employee or

client.

HIV Viral Load Is the amount of virus in a patient’s blood sample measured
in copies per millilitre (Copies/ml).

Sputum Mater expectorated from the respiratory system, and

especially the lungs that is composed of mucus but may
contain pus, blood, fibrin, or microorganisms (such as
bacteria) in diseases states.

Health Facility Is a place that provides health care, which includes hospitals,

Health care centres and dispensaries.

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1. Introduction

1.1. Background

The prevalence of HIV among adults in Tanzania is 4.7% (Tanzania HIV Impact Survey-
THIS, 2018), whereby current prevalence of TB is 295/100,000 population (National
TB prevalence survey, 2012). The overlap between the pandemic is substantial, an
estimated 36% of TB cases in Tanzania are co-infected with HIV. Additionally, WHO
indicates the incidence of TB, including TB/HIV at 269/100,000 (WHO Global TB
Report, 2018).

In an endeavour to accelerate HIV/AIDS control by 2020 i.e., achieving an HIV/AIDS

free generation, the Joint United Nations Programme of HIV/AIDS (UNAIDS) came up
with the global goal of the 90-90-90 target. The target calls upon its member states/
partners to ensure 90% of HIV infected individuals know their HIV status, provide life-
saving ART to 90% of those diagnosed, and achieve viral suppression for 90% of those
on treatment. Comprehensive but adequate laboratory services of sample collection,
processing, transportation, storage and testing are critical/vital towards the attainment
of this Global goal of 90-90-90 target, especially the third ‘90’, which requires improved
access to Viral Load testing by people living with HIV (PLHIV) and adequate utilization
of test results by healthcare provides for effective VL monitoring. To increase access
to VL testing, the World Health Organization (WHO) consolidated guidelines for ART,
reinforced the need for a dedicated, efficient, safe and cost-effective sample referral
system, (WHO ART Guideline, 2016).

Similarly, the Global End TB Strategy, approved by the World Health Organization
assembly in 2014, calls for a 95% reduction in TB deaths, and 90% reduction in new
TB cases by 2035 (The WHO End TB Strategy). Achieving these goals depends on
early and accurate detection of TB, including drug-susceptibility testing (DST). The End
TB Strategy has emphasized the important role of a quality-assured laboratory network
equipped with rapid diagnostics.

In response to this global call, the Tanzanian Ministry of Health, Community

Development, Gender, Elderly and Children (MOHCDGEC), through the National AIDS
Control Programme (NACP), included key strategies in its Health Sector HIV Strategic
Plan IV (2018-2022) to highlight on the importance of HIV Viral Load in monitoring the
efficiency of ART regimen used by PLHIV. This HSHSPIII provided guidance to ensure

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appropriate mitigations are implemented to institute rapid HVL scale-up country-wise,
to meet the national goal of providing routine HVL monitoring to at least 50% of all
PLHIV on ART by 2017.

During the early stages of implementation in 2016, strategies outlined in the National
Operational Plan for Scaling up Viral load (NOPS-VL, 2015) envisaged on maximizing the
resources/testing capacity at hand i.e., the pre-existing HIV DNA PCR and HVL testing
at Muhimbili National Hospital (MNH), National Health Laboratory (NHLQATC), Mbeya
Zonal Referral Hospital (MZRH), Kilimanjaro Christian Medical Centre (KCMC), Bugando
Medical Center (BMC) as well as MDH Temeke Laboratory. In an effort to address this,
the MOHCDGEC in collaboration with the Center for Diseases Control (CDC) through
NACP developed and set up a national systematic sample referral network, which
allows for efficient laboratory sample transportation to a referral laboratory and results
feedback to the testing facility. This network is based on a hub-and-spoke model, in
which a number of health facilities (10-25) - “spokes” sampled within a catchment
area of about 30 to 40 kilometres send samples to a collection point - “Hub”, where
samples are aggregated before transportation to the testing laboratory. By early 2017,
approximately 7,239 health facilities have been mapped to 17 HIV DNA PCR and HVL
testing laboratories countrywide via 309 collection hubs. (National Laboratory Sample
Referral Atlas, 2017). There are about two to three hubs per district, for 309 hubs
covering the 7,239 health facilities (National Laboratory Sample Referral Atlas, 2017).
These 309 hubs submit samples to 17 HVL testing laboratories across the country.
Although sample referral is operational, a number of challenges have been impairing
the referral network’s accountability and contributes to some samples arriving in poor
quality, delayed TATs and lost results.

In pursuit of meeting the global target to end TB (The WHO End TB Strategy),
MOHCDGEC has coordinated efforts to scale up near point of care (POC) testing for
TB across Tanzania. In addition, the MOHCDGEC through the National Tuberculosis
and Leprosy Programme provides a network of TB laboratory services throughout the
country. TB laboratory network in Tanzania is organized into five main levels according
to the type of services provided. These levels include: 1) the Central Tuberculosis
Reference Laboratory (CTRL), 2) Five Zonal TB culture laboratories, 3) Thirty-one regional
referral hospital laboratories, 4) 169 district hospital laboratories and 5) laboratories in
peripheral health centres and dispensaries (National Tuberculosis Laboratory Strategic
Plan 2013). There are 1200 TB microscopy diagnostic centres at different levels of the

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health system. Health centres, hospitals, and laboratory facilities within the National
Tuberculosis Leprosy Programme (NTLP) laboratory network routinely collect and test
samples. Samples that require further testing (i.e., culture and/or drug susceptibility
testing [DST]) are referred to appropriately designated referral laboratories by the
National Postal Services through Expedited Mail Service (EMS). However, due to
several limitations in the current sample referral system, laboratory diagnostic services
are underutilized.

1.2. Justification

Currently, there are two parallel systems for TB and HIV sample referral (NTLSP,
2013 and NOPS-VL, 2015). However, despite being operational across the country,
these systems have no standard national guideline that assures their enforcement
and sustainability. Unavailability of such guidelines has led to the un-harmonized
and ineffective implementation of sample referrals and result feedbacks, resulting to
duplication of efforts and wastage of limited resources.

To address this challenge, MOHCDGEC has decided to formulate a guideline for

nationally integrated sample referral and results feedback system that will address
HIV, TB, and any other future interventions that will require the system. This national
guideline envisages implementation of a well-organized sample referral and result
feedback system (hub-spoke model) for HIV and TB to increase access and ensure
quality, sustainability, efficiency and cost-effectiveness. It is anticipated that a quality-
assured sample referral and result feedback system with national coverage will:
a. Improve the quality and integrity of transported samples and reduce the number
of rejected samples by upgrading packaging and transportation conditions;
b. Advance the sample and results tracking mechanisms using tools such as
sample collection and rejection logs, chain of custody and electronic sample
and results referral system;
c. Build capacity for hubs to reach out spokes for sample collection instead of the
other way around - to ensure samples reach the hub within the specified time;
d. Establish even distribution of sample/workload across a laboratory testing
network;
e. Stop delays caused by waiting for certain sample batch size to be transported or
processed.

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Overall, patients and health providers will have an improved access to HIV/TB sample
testing and will be able to pursue appropriate treatment in a timely manner, which
results in better health outcomes and ultimately, a decrease in disease burden.

1.3. Goal

Efficient and integrated sample referral and results feedback network in Tanzania.

1.4. Objectives

a. To increase access and utilisation of laboratory services in diagnosis and

management of HIV, TB and other diseases in Tanzania, 

b. To harmonise standardised procedure for sample referral and results feedback,
c. To improve mechanisms for HIV and TB sample referral and results tracking,
d. To have an effective biosafety and biosecurity measures during sample referrals,
e. To establish a cost-effective sample referral system for HIV and TB samples,
f. To achieve the targeted national turn-around-times for HIV and TB,
g. To improve laboratory data management and utilization.

1.5. Users of this Guideline

The guideline targets a scope of laboratory users, consumers, and stakeholders who
are involved in supporting the referral system. These users include the following:
a. Laboratory personnel and other HCWs at the facilities (spokes), Hub and Testing
Laboratory, to be guided in sample referral processes,
b. Clinicians as key consumers of HIV and TB laboratory tests for collaboration and
creating demand for sample referral system,
c. Couriers involved in sample transportation to be guided in sample handling and
transportation,
d. RHMTs and CHMTs for ensuring proper coordination in planning, budgeting, and
implementation of sample referral and result feedback system,
e. MOHCDGEC (NACP and NTLP) and PO-RALGfor planning and coordination,
and ensuring funding and other support is provided to maintain and sustain an
effective sample referral system,

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f. Donors and Implementing Partners (IPs) for supporting sample referral system,
g. NACP and NTLP for helping in the development and reviewing of training
curricula,
h.) Any health intervention that requires the use of sample referral and result
feedback system.

1.6. Type of Samples

Referred samples are dried blood spots (DBS), whole blood or plasma for HIV testing
parameters for staging and monitoring antiretroviral therapy (ART) and monitoring
treatment of DR-TB; Sputum for TB diagnosis and serum for monitoring treatment of
DR-TB patients. Any other specified pathological sample that will require referral.

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2. Structure, Organization and Management of SRS

2.1. Key System Components

Laboratory sample referral consists of the transportation of a sample from one facility
to another, with laboratory diagnostic capacity for investigative purposes and send the
results back. The organizational structure of the Sample Referral System (SRS) shall
follow the hub and spoke model.

As shown in Figure 1, the SRS network shall have:

a) A spoke, is the first level health care delivery facility, which collets and refers
samples to the Hub for intial processing and sotrage or for near POC testing
such MTB/Rif testing .
b) A hub is a designated health care delivery facility, that receives samples from
referring facilities (Spokes);
c) Testing laboratory, is the third level facility to which samples are sent for advance
testing.

The three key components of the system (spoke, hub and referral testing laboratories)
will be linked with the designated couriers for samples and hardcopy test results
transportation.

FIGURE 1: HIV AND TB SPOKE, HUB AND MODEL

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Health facilities (spokes) within the catchment area of 40-km radius has been mapped
using GIS and courier routes designed to allow each spoke to be visited at least twice
a week by the courier. The hub is responsible for collecting samples from each spoke
in the catchment area and arranging transportation to the referral testing laboratory.
The courier is responsible for shipping samples to the referral testing laboratory and
returning the hardcopy of the results to the spoke. An electronic sample management
system is used to transmit test results to the hub. The SRS recommended the use of
local available courier service.

2.2. Roles and Responsibilities

For the referral system to function effectively and efficiently, the roles and responsibilities
of each component must be clearly defined as follows:

2.2.1. Roles of Spoke

a) Collection of samples;
b) Initial preparation of samples when essential resources are available;
c) Ensuring proper sample packaging for safe transportation to the hub;
d) Ensuring timely dispatch of the collected samples and the necessary
documentation as scheduled;
e) Creating demand for sample referral system and their clinical utility;
f) Laboratory personnel and/or designated HCW in health facilities (spoke) will be
the main contact for sample referral system;
g) To receive and deliver test results to the clinicians and clients.

2.2.2. Roles of Hub

a) Performing initial sample processing, if required, acting as temporary/ontransit

storage centre and making transportation arrangement to the referral testing
laboratory;
b) Performing diagnostic test for TB and HEID using near to POC equipment (if
available);
c) Ensuring proper documentation of sample, processes and providing data that
can be used to monitor quality as well as the efficiency and effectiveness of the
system;

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d) Responsible for completeness and validity of client information and data entry in
the electronic sample referral and results feedback system;
e) Ensuring registration of all sample in ESRS
f) Ensuring all available electronic results from e-SRS are printed and distributed to
its spokes;
g) Expediting transportation of results received from testing laboratories to its
spokes;
h) Coordination shall be done by a designated hub focal person, whose contact
information should be available to all respective spokes and testing laboratories;
i) Monitoring the functionality of the sample referral network using the national
sample referral indicators (M&E Section 4, Tables 1 and 2 refers);
j) Providing mentorship and support to spokes when necessary, to strengthen and
improve sample referral system..
k) Ensuring proper waste management generated from near to POC equipment;
l) Preparing and submitting regular reports of sample referral functions to relevant
authority (CHMT) on monthly basis.

2.2.3. Hub Management Team

Health Facility Management Team (HFMT) of the facility hosting a hub shall provide
immediate oversight on the operations of the hub, and shall report to the council
management committee. The hub focal person and the lab manager at the hubs shall
implement the activities of the hub.

Below are the roles and responsibilities:

a) Providing overall supervision/oversight of the hub and related activities.
b) Supporting the laboratory staff, HEID staff, TB staff, ART clinic staff, hub
coordinator and sample transporter in executing their duties.
c) Identifying potential candidates for positions of hub focal person.
d) Coordinating other stakeholders in planning for hub activities.
e) Supporting the laboratory in-charge in ensuring the hub conducts near POC
tests (if available) for referred samples that can be analyzed at the hub.
f) Supporting the laboratory in-charge in ensuring the hub perfom initial processing,
storage and arrangement of transport samples that cannot be analyzed at the
hub level.

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g) Ensuring adequate laboratory staff numbers with the right qualifications are
available at official working hours.
h) Ensuring adequate Stocks of reagents and consumables for all diagnostic
equipment.
i) Ensuring adequate storage space for reagents and consumables.
j) Ensuring optimal and timely utilization of electronic sample referral system
(ESRS) and other paper-based laboratory information tools.

2.2.4. Roles of Referral Testing Laboratory

The testing laboratory shall have the following duties and responsibilities:
a) Receiving and evaluating sample from the Hubs as per SOP prior to testing;
b) Managing and testing samples according to the SOPs;
c) Ensuring timely delivery of results using available methods, primarily through the
established courier system or via electronic sample referral and results feedback
system;
d) Providing mentorship and support to hubs when necessary, to strengthen and
improve sample referral system.

2.2.5. Roles of Courier Services Provider

The courier service may be operated by the MoHCDGEC/PORALG or outsourced to

another government entity, implementing partner, non-governmental organization, or
private company. The courier staff should be trained on bio-safety and bio-security
and quality measures, including how to deal with spillages during transportation, as
well as documentation requirements for the referral chain. Job aids shall be developed
to reinforce the training. A spill kit with the recommended contents shall be provided
to manage spillages. Any contracted courier services provider shall abide by this
guideline.

Below are the roles and responsibilities:

a) Follow daily and weekly schedule of visits to the spoke, hub, and testing
laboratories;
b) Transport the sample(s) properly and safely from spoke to referral laboratories
via hub and return hardcopy results back to spoke in a timely manner;

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c) Ensuring the quality and/or safety of the sample, environment and all parties
involved in the transportation process including keeping bio-safety and bio-
security;
d) Ensure that their personnel are trained on bio-safety and bio-security, spill
management, confidentiality
e) and documentation requirement for sample referral;
f) Ensuring that the required documentation is available and maintained;
g) Maintaining records of samples and commodities transported;
h) Maintaining communication with spoke, hub and testing laboratories;
i) Report any incident occurred during transportation to responsible authority;
j) Preparing and submitting monthly report to CMHT, RHMT and national HVL/
HEID/sample referral coordinators.

2.2.5. Roles of the Council’s Health Management Team

Members of CHMT are responsible for sample transportation (DLT, DACC and DTLC)
and provide oversight for the sample collection, packaging, transportation and results
feedback.

2.2.5.1. Roles of DLT

a) Coordinating all sample collection, packaging and transportation according to

the SRS-SOPs within the district;
b) Managing laboratory consumables and supplies required for sample
transportation;
c) Making sure the entire SOP and guidelines are available to the hubs and spokes;
d) Leading the implementation of the council’s laboratory sample referral networks;
e) Coordination of the council’s supply of laboratory commodities in respect to
sample referral system;
f) Advocating for the council’s budgetary provisions to support regional sample
referral system;
g) Monitoring performance of the council’s sample referral networks and ensuring
accurate and timely reporting of network function data to the council’s health
management meeting;

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h) Managing the implementation of electronic sample referral system and Sample
and other laboratory information tools for HVL, HEID and TB;
i) Coordination of the council’s implementing partner activities in support of the
sample referral system.

2.2.5.2. Roles of DTLC, DACC and DRCH-Co

DTLC, DACC and DRCH-Co in collaboration with DLT shall coordinate all TB, HIV VL,
HEID sample collection packaging and transportation within the district and manage
laboratory consumables and supplies required for sample transportation. Furthermore,
in collaboration with DLT shall make sure guidelines and SOP are available and used
accordingly.

The roles shall include, but not limited to:

a) Coordinating implementation of the council’s laboratory TB, HVL/HEID sample
management through referral networks;
b) Coordination of the council’s supply of TB, HVL/HEID laboratory commodities in
respect to sample transfer;
c) Advocating for the council’s budgetary provisions to support district TB, HVL/
HEID sample referral networks;
d) Monitoring performance of TB, HVL/HEID sample referral networks and ensuring
timely delivery of results to clinicians, as well as accurate and timely reporting of
network function data to regional health management team (RHMT);
e) Managing the implementation of DHIS2;
f) Coordination of implementing partner activities supporting sample referral
system.

2.2.6. The Roles of Regional Health Management Team

Members of RHMT are responsible for coordination of the sample referral system
(RTLC, RLT, RACC and RRCH co) activities in the region. This includes reinforcement
implementation of guidelines and SOPs at different levels in the region (spoke, hub and
testing laboratory).

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2.2.6.1. The Roles of RLT

Regional Laboratory Technologist (RLT), a member of the Regional Health Management

Team (RHMT), shall oversee sample referral system within the region, including
monitoring and evaluation. The RLT roles shall include:
a) Leading the implementation of regional laboratory sample referral networks;
b) Coordination of regional supply of laboratory commodities in respect to sample
transfer;
c) Advocating for regional budgetary provisions to support regional sample referral
networks;
d) Monitoring performance of regional sample referral networks and ensuring
timely delivery of results to clinicians, as well as accurate and timely reporting of
network function data to the MOHCDGEC;
e) Managing the implementation of tracking paper-based laboratory information
tools and electronic sample referral system for TB and HVL/HEID sample
registration and result feedback;
f) Coordination of regional implementing partner activities in support of the sample
referral networks.

2.2.6.2. The Roles of RTLC, RLT, RACC and RRCHco

RTLC, RLT, RACC and RRCHco in collaboration with RLT shall oversee the sample
referral system within the region, including monitoring and evaluation. The roles shall
include:
a) Coordinating implementation of regional laboratory sample management through
referral networks;
b) Coordination of regional supply of laboratory commodities in respect to sample
transfer;
c) Advocating for regional budgetary provisions to support regional sample referral
networks;
d) Monitoring performance of the regional laboratory sample referral networks and
ensuring timely delivery of results to clinicians, as well as accurate and timely
reporting of network function data to the MOHCDGEC;
e) Coordination of the regional implementing partner activities in support of the
laboratory sample referral system.

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2.2.7. Roles at the National Level

At the MOHCDGEC, guidance will be provided by the Directorate of Curative Services

(DCS) as well as the Directorate of Preventive Services (DPS), through the DSS, NTLP
and NACP. At PORALG it will be provided through the Department of Health Services,
Social and Nutrition Services (DHSWNS). They shall, therefore, have both management
and leadership roles, as described below.

2.2.7.1. Management and Leadership Roles

The DCS through the Diagnostic Services Section will be implemented through:
a) Developing policies and guidance for National laboratory sample referral and
results feedback system, in support of priority diseases such as HIV and TB as
part of laboratory service delivery strategy;
b) Guiding the integration of laboratory sample referral within vertical programmes;
c) Advocacy for budgetary provisions and mobilization of resources to support
national sample referral system;
d) Putting in place systems to ensure allocated funds for sample referral are utilised
for the intended purpose;
e) Developing the M&E framework for monitoring the performance of sample referral
system;
f) Maintaining and regularly updating the National Laboratory Sample Referral
Atlas (2017).

2.2.8.2. Leadership and management roles of DPS

The DPS through the NACP, NTLP and RCHS shall:

a) Coordinate national implementing partner activities in support of sample referral
networks;
b) Perform quarterly monitoring and evaluation of the system;
c) Forecast and quantify the national commodity requirements for sample and
results transfer;
d) Monitor the quality standards of samples in the referral system, such as
establishing and overseeing TAT and conducting regular review to the sample
referral system.

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3. Operation and implementation

3.1. Sample management

Sample management is a critical process control and an essential part of quality

management system (QMS) in the laboratory. The quality of work the laboratory produces
is only as good as the quality of sample used for the test. Sample management starts
from collection, throughout packaging, transportation and eventual testing.

3.1.1. Sample Collection

During sample collection, it is important to ensure that obtained sample meets the
required quality standards by observing the following: -
a) SOPs for Sample management meeting ISO standards shall be developed and
distributed to users for implementation.
b) All personnel responsible for sample collection, packaging and transportation
shall receive basic training to ensure their competency.

3.1.2. Sample Packaging

Comprehensive training on proper procedures for packaging and shipping dangerous

goods will be provided to HCWs by IPs supporting the region. Hub focal personnel will
be certified and Job aids shall be developed and distributed to all HFs to reinforce the
training.

The packaging of sample for referral must adhere to the following:

a) Blood and sputum samples shall be packaged using the triple packaging
system in accordance with the International Air Transport Association (IATA).
Instruction_650 on Diagnostic Samples (reference) as shown in FIGURE 2 refers.

NOTE: APPROPRIATE PACKAGING MATERIALS AND BIO-HAZARD LABELS

SHOULD BE PROVIDED.

b) The triple Packaging system consists of 3 layers: first layer or primary container,
second layer or secondary container and the third layer or tertiary container.
c) All the required documentations must be incorporated into the triple package.
These include laboratory request forms, sample tracking logs/sample manifest.

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 Accompanying documents shall be packed in accordance with the transportation
SOP.

FIGURE 2: TRIPLE-PACK CONTAINER FOR LABORATORY SAMPLE

TRANSPORTATION

Source: WHO Laboratory Biosafety Manual, Third Edition, page 96.

3.1.3. Maintaining Sample Quality and Integrity

The National Sample Referral and Results Feedback System aims to maintain sample
quality and integrity for samples that are being transported to laboratories for testing.
The sample quality and integrity shall be maintained from Spoke, Hub to the Testing
Laboratory. Sample collection sites shall ensure the collected samples are of acceptable
quality before dispatching to hubs. All sample transportation modalities shall maintain
sample integrity throughout the transportation routes and shall comply with governing
biosafety rules and regulations.

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Samples from Spoke to hub shall be accepted/rejected based on the sample rejection
/acceptance criteria which include:
a) Rejection at the hub level, following an approved sample rejection criterion
(ANNEX 9 refers (Sample Rejection Log);
b) Sample storage temperature monitoring, to make sure samples are stored in
the required temperature. (Refer to Sample Handling, Packaging and Transport
SOP);
c) Sample Packaging using triple packaging to maintain both safety and sample
integrity;
d) Completeness of request forms.

3.1.4. Standard Operating Procedures

To ensure consistency, SOPs shall be developed and applied to all stages of the referral
network from sample collection, processing, storage, packaging and transportation.
For these to be achieved, the following should be implemented:
a) HCWs at the Hubs and Spokes shall be required to have all the necessary SOPs
(ANNEX 10) available and in use in their respective areas;
b) All HCWs shall be required to be familiar with adapted SOPs via on-site/on-job
training and orientation;
k) Competency assessment on the operation of SOPs shall be conducted to all
responsible HCWs and couriers. Only competent HCWs and courier shall be
responsible for sample management and transportation respectively.

3.2. Biosafety and Biosecurity regulations

Samples transported via sample referral networks potentially pose a risk of infection
to both the sample handlers and the environment. Thus, safety measures should
be applied in sample referral networks. These biosafety measures should include
application of universal safety precautions and waste management. Therefore, every
component of sample referral network shall ensure the following:
a) Staff are trained on bio-safety and bio-security regulations covering Infection
Prevention Control (IPC), risk assessment and mitigation, physical security,
material control and accountability, transport and transportation security, incident
response and information security;

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b) Bio-safety guidelines, laboratory safety handbooks, material safety data sheets
(MSDS) and SOPs relevant to safety shall be developed and or adopted by
MOHCDGEC and made available and utilized by all personnel or staff involved in
sample transportation network;
c) Safety measures such as use of personal protective equipment (PPE), triple
packaging material and SOPs shall be in place to protect the laboratory personnel,
products and environment from contamination and infection;
d) Biological spill kits that incorporate universal precaution shall be accessible
throughout the sample referral cascade;
e) Bio-security measures shall be in place to prevent the malicious use of biohazard
materials to cause harm.

3.3. Sample transportation process

There shall be a coordination between the spokes, hub and the designated courier
and the receiver (testing laboratory), to ensure that samples are transported safely and
arrive on time and in good condition. Logistical support shall be provided by CHMT/
RHMT in collaboration with IPs, to maintain the agreed processes for national sample
referral system, whilst maintaining sample quality, biosafety and biosecurity, and client/
patient confidentiality throughout.
l) Hubs should be reaching out to the spokes using designated courier services or
transportation means provided by district councils or regional IP. Note: Spokes
reaching out to the hubs to bring their samples using health workers must
be avoided.
m) Once testing is complete and results have been recorded at the testing laboratory,
the results shall be returned immediately to the respective health facilities. Means
for results feedback shall include the following:
i. Using a national approved and secured electronic sample referral system,
which allows the Hub to access results remotely and print them out for
couriers to collect as they bring in samples for referral.
ii. If the electronic system is not available or faulty, hardcopies of results
should be dispatched by the testing laboratory using the same designated
courier during sample delivering at the laboratory. The courier shall return
to the Hub, a hard copy of results and eventually to the spoke, via the
same route the sample was referred. As with the samples, there should

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17
 be a chain of custody or transport logs that tracks the results back to
the health facility. These registers should be signed by both sending and
receiving parties, including transporters, along with every change of hands
to create a tracking system.

NB: Spoke, hub and testing laboratory shall have a well-defined mechanism for
communicating on matters including pending and received results, rejects and
failures.

3.4. Laboratory information management system

The laboratory information management system (LIMS) serves to store and achieve
essential laboratory data and information for immediate use and later reference, in
an appropriate medium. The system shall ensure proper data management in data
security, integrity, confidentiality, long term storage and archiving. The system may be
in hard (paper-based) or soft (electronic sample referral system) copy.

The requisition form shall be the key data source that should be used to link the data
between HF, Hub and Testing laboratories.

3.4.1. Electronic sample referral system

There should be an electronic sample referral system, computer-based laboratory

management systems that enable hubs to log and register samples at the hub/facility
level onto the Laboratory information management system (LIMS) at the testing, monitor
testing progress, view results and retrieve historical results. The information captured
in the request forms shall be entered into the electronic sample referral system.
The system shall enable data entry from the hubs to reduce transcription errors hence
ensuring faster delivery of data to testing laboratories and reduced turnaround times.
The testing laboratories shall be responsible for ensuring integration between ESRS-
LIMS is effectively utilized to ensure electronic results feedback to reduce TAT. Hub
will be responsible for printing results from ESRS and distribute them to its respective
facility (spokes).

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3.4.2. Paper-based laboratory information system

There shall be HF and Hub HVL sample registers to manage HVL sample collection
and return of results to the HF, placed at the HF and Hub respectively. The HF and
Hub HVL sample register should be completed using the requisition form from the HF
and the results form received from the laboratory. The HF and Hub sample register is
designed to allow for longitudinal follow-up of each sample and result, in particular so
that turnaround time can be monitored.

3.4.3. Management of Laboratory Information system implementation

District councils’ ITs and testing laboratories’ ITs shall:

a) Provide support for computer hardware, software and ESRS at the hubs within
their catchment area.
b) Ensure functionality and security of the computer systems.
c) Provide back-up for data.

Hub laboratory manager shall:

• Establish criteria for proper receipt and handling of information.
• Use up-to-date data collection tools.
• Ensure Good laboratory documentation practice is maintained for paper-based
LIMS.
• Validate the ESRS to ensure it is appropriate for the purpose.
• Provide overall supervision of the ESRS utilization.
• Maintain confidentiality while handling client/patient information.
• Ensure sufficient and secure data storage and archiving facilities.

3.4.4. Use of LIMS for sample referral

The LIMS shall be used for the following purposes:

• Collecting and store useful and appropriate information and data on sample
referral.
• Preliminary analysis and use of results at every component of sample referral.
• Periodic reporting (monthly and quarterly) on sample referral.
• Analysis and use of sample referral data at high levels.
• Achieving and retrieving sample referral information and data.

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3.5. Mentorship support

There shall be a documented mentorship support framework across all hubs in the
sample referral system. This framework should include an integrated tool and the plan
for mentorship visits (Annex 13; 14). The hubs shall receive at least one supportive
visit each quarter. Supportive mentorship visits will be a part of essential components
of continual follow-up of trained personnel and on-the-job performance training of the
staff. Mentorship support shall aim at ensuring that the SOPs for documentation,
laboratory data management and analysis are followed in all hubs. Skill gaps shall
be identified for targeted capacity building of the hub staff. Testing laboratories shall
provide adequate mentorship support to staff at hubs in their catchment areas and
they in turn will be supported by NHLQATC. Such mentorship and updates will enable
testing laboratories to pass on new information and changes in laboratory techniques
on a regular basis to the hubs.

3.6. Coordination of the Laboratory Sample Referral System

A mechanism to provide oversight to the network and monitor performance in a timely

manner to ensure sustainability of the sample referral system shall be in place. This
organization shall involve the national level throughout regional level to the district level
and eventual HCFs.

3.6.1. National Level

There shall be a task force with members from interested programs in the DCS and
DPS Directorates as well as Implementing partners. The task force shall coordinate the
management of the sample referral system and make recommendations to the existing
national laboratory TWGs. The task force shall carry out the following functions:
a) Provide policy guidance and related support;
b) Review and update the national laboratory sample referral mapping;
c) Coordinate training and scale-up best practices for optimizing the sample referral
system;
d) Enforce optimal utilisation of the sample referral and results feedback systems;
e) Mobilize resources.

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3.6.2. Regional Level

The regional health management team, including RLT, RACC and RTLC shall provide
oversight management of the referral networks in their respective regions by ensuring
the following:
a) Advising and making recommendations to the task force on matters related to
laboratory sample referral and results feedback networks;
b) Overseeing the quality, safety standards and bio-security of sample during
handling, packaging and transportation;
c) Conducting supportive supervision at specified sites to ensure that the program
functions properly, in collaboration with the councils’ health management teams
and implementing partners.
d) Working with IPs to define uniform and the most sustainable logistics system for
sample transportation;
e) Developing or revising policies and guidelines to improve the national sample
referral system in the same way to ensure the stability of the system;
f) Providing training to all parties involved in the sample referral system and ensure
their competency;
g) Regularly reviewing the performance of the existing laboratory sample referral
system and making recommendations to the task force;
h) Ensuring the sustainability of the system.

3.6.3. District Level

The district health management team including DLTs, DACCs and DTLCs shall
coordinate the referral networks in their respective Councils. They shall advise and
make recommendations to the RHMT and IPs on matters related to laboratory sample
referral and results feedback networks. Their support shall include, but not limited to
the following:
a) Ensure that the sample transportation network operates properly;
b) Ensure that the referral linkages are integrated for all diseases to maximize use
of limited resources;
c) In collaboration with the IPs to oversee the proper utilization of resources and the
implementation of the programme;
d) Regularly review the performance of the existing laboratory sample referral
system;
e) Ensure the sustainability of the system.

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3.6.4. Hub Level

The hub management shall be responsible for organizing and coordinating the referral
mechanisms and the network it serves. There shall be effective communication
throughout the network to ensure prompt relay of information to spokes within the
shortest possible turnaround times. Such information includes:
a) Rejected samples and corrective measures to minimize recurrences,
b) Testing service interruptions or delays (breakdowns of service) and resumption,
c) Alteration in the examination schedules for specific tests, changes in examination
methods and referral mechanisms,
d) Providing monthly and quarterly reports on laboratory and referral networks
performance to CHMT for decision making. (ANNEXES 12).

3.6.5. Testing Laboratory

Testing laboratory shall provide information on the following:

a) Provide comprehensive reports on total number of samples received, rejected
and results returned to the council/district coordinators on a monthly/quarterly
basis,
b) Service interruptions or delays (breakdowns of service, backlogs),
c) Changes in the examination schedules for specific tests, changes of examination
methods, or changes to reference values,
d) Maintaining early notification and proper communication with referring
laboratories and couriers.

3.7. Financing and Human Resources

3.7.1. Financing

There should be sustainable plan at all levels of SRS implementation to ensure funding
availability and support. The plan shall be drawn and presented for budgeting annually.
Establishment of SRS shall be done using dedicated resources from Councils’
Comprehensive Health Plans (CCHP), with support from the medical laboratory
related professionals for example laboratory technicians, laboratory technologists,
laboratory advisors and laboratory scientists.

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The budget to finance SRS will be under PO-RALG, which are prepared annually based
on inputs from the Council levels. Therefore, finance planning for SRS activities shall
start from lower levels to ensure integration into the CCHP and national budgets.
Moreover, funds from implementing partners and stakeholders may be utilized to
finance and manage SRS.

3.7.2. Potential Funding Sources

a) Cost Sharing

After sensitization of the importance of the sample referral system, the budget
will be developed, approved and shared with government institutions involved
in the health sector for different activities (HIV, TB, Malaria, Epidemic prone
diseases, research), implementing partners, programmes and private.

b) External Funding

In the interim, funds shall be provided by implementing partners supporting TB

and ART partners, and through the Laboratory Support Programme within the
DSS and/or stakeholders interested in the SRS activity. However, in order to have
a sustainable system, at the national level, the budget line for SRS activities will
be determined and shared for incorporation into the CCHP budgets to implement
a sustainable system at all levels.

3.7.3. Human Resources

These shall be trained and dedicated Hub (SRS) Focal persons whose roles and
responsibilities include oversight in SRS activity implementation at all levels. They will
ensure activities are implemented against approved plans and budgets.  Hub (SRS)
Focal persons supported by CHMT will ensure optimal use of the courier system at
every hub and spoke for sample collection and transportation including feedback and
response to challenges, whenever required. Roles and responsibilities of personnel
involved in SRS should be defined to avoid duplication of efforts. At the hub level, there
shall be a trained hub focal person. 

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4. Monitoring and Evaluation
There shall be a Monitoring and Evaluation system of this guideline to guide the Ministry
through the respective programs and other HIV and TB stakeholders and implementing
partners to track and assess the sample referral activities.

The M&E intends to facilitate performance monitoring against the set targets and
provide a guide on interpretation and dissemination of the information for programs
improvement at all levels. It also aims to ensure consistency of recording and reporting
systems across all the partners and stakeholders involved and guide on evaluation of
the sample referral system.

HSPs should strive to produce data of high quality. In order for the HFs to pro­duce high
quality data, Data Quality Assessments (DQAs) should routinely be conducted at all
levels by using DQA tools that are approved by the MOHCDGEC.

4.1. Key components of Monitoring and Evaluation

4.1.1. Data recording

Collection of data on HIV, TB and other interventions shall be done by HSPs at the HF
using standardized tools coordinated by R/CHMT. Reporting shall be done on quarterly
basis, from HF levels to the Council level where it is posted to the DHIS2. From the
DHIS2, different authori­ties can access data without necessarily contacting the national
level. The national level, through the MoHCDGEC shall compile HF and Coun­cil data,
which shall then be reported and disseminated to relevant stakeholders.

M&E tools shall be used to capture information collected throughout the sample referral
systems. Recording of the data for HVL, HEID and TB services shall use the following
tools:
a) HVL request form;
b) TB Laboratory request form;
c) Culture and DTS request form;
d) DBS collection form;
e) High Viral Load register;
f) TB Laboratory register (TB05);

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24
g) TB Presumptive register;
h) MC Cohort register;
i) HVL Hub sample and results register book;
j) TB Hub sample and results register book;
k) TB Hub sample and results register book;
l) Sample manifest form;
m) Sample rejection Log
n) SRS monthly monitoring form
o) Electronic Sample Referral System (ESRS)
p) Hub quarter assessment and supervision checklist
q) Hub-LIS quarter assessment tool
r) HEID POC implementation checklist

4.1.2. Data Storage

Data from samples collected shall be stored either electronically through the CTC2,
ETL, laboratory information system (LIS), electronic sample referral system, GxAlert
System or at the National laboratory data repository (OpenLDR), or on hard copies
of the tools used for data col­lecting purposes. The electronic means of data storage
must be secured by passwords, while hard copies must be kept in rooms where
confidentiality will be ensured in accordance with Statistical Act2015.

4.1.3. Data reporting

Reporting of data shall be done on monthly and quarterly basis. HFs reports shall
be submitted to the office of the DMO by the 7thday of the following month. Data are
reported from HFs to the Council, region and finally to the national level.

4.1.4. Data Dissemination and Use

Data dissemination and use shall follow approved format for presentation at national
and international level. Data shall be reported and disseminated on specified period.
Data shall be used at different levels by stakeholders for the purposes of planning and
decision making for improvement of service delivery.

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4.1.5. Document and Records Archiving

All documents and records related to sample and results management throughout all
components of referral system, must be maintained and controlled in a retrievable
and legible manner. It is the responsibility of the components of the referral system to
archive old documents related to sample and results management within the referral
network and make sure that they are stored in the old documents file within the facility
and are reviewed when needed. Out-dated laboratory registers and other records of
samples received by all components of referral system shall be kept for at least five
years.

4.2. Monitoring of Sample Referral System

i. The operation of the sample referral system shall be monitored and evaluated to
ensure the planned activities are being implemented effectively and efficiently.
Indicators shall be used to track and assess sample referral system performance
guided by the following questions: Is the sample referral system effective?
• Network effectiveness:
• number of samples received from spokes,
• number of samples sent to the testing laboratory,
• Average number of samples transported in a specified time,
• Number of samples with results in a specified time.

ii. Is the Network efficient?

• Reduced turnaround time,
• Reduced costs for sample referral services,
• Overall TAT (from sample collection to results available to client/requesting
facility. (Annex 15;16;17;18;19)

iii. Is the Quality of referred samples assured?

• Proportion of sample rejection rate,
• Reduced sample failure,
• Time taken from collection point (Spoke and Hub) to testing laboratory,
• Time taken for intial sample processing,

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 • Time taken to return results from the testing laboratory to the hub,
• Time to return results from Hub to spokes.

Hub functionality - Capacity of the hub to serve respective spokes.

Mechanisms shall be in place to review the M&E system and use of identified gaps for
performance and quality improvement of the network and its referral system. The hub
staff and laboratory managers shall be trained on core referral system indicators and
the methods of documentation, data retrieval, analysis and dissemination of data for
interpretation and decision-making.

The MOHCDGEC through the programmes in collaboration with partners shall facilitate
the M&E of sample referral system. Monitoring of data should be done in specified
period, and report from HFs sent to CHMT, RHMT and relevant authorities. The
MOHCDGEC through programme shall conduct annual performance evaluation and
update the sample referral system, Tables 1 and 2: Log frame and Indicator matrix
refers.

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27
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International Air Transport ... Page 1 of 3. 2015:2-4.
12. World Health Organization. Guidance on regulations for the transport of infectious
substances 2013-2014. World Heal Organ. 2014; (WHO/HSE/2012.12):

National Sample Referral System Guidelines

28
13. Tanzania Health Impact Survey, 2017.
14. Interim Technical Update: Technical operational considerations for implementing
HIV Viral Load Testing; Access to diagnosis, WHO July 2014

National Sample Referral System Guidelines

29
 TABLE 1: LOG FRAME FOR SAMPLE REFERRAL SYSTEM

30
Goal Indicator Source Means of Frequency Assumption
Verification

Efficient and Proportion of TB presumptive Annual DHIS2-ETL, Annually Natural calamities

integrated sample cases tested using GeneXpert assessment, NTLP Central Database and availability of
referral and results DHIS2-ETL Repository resource
feedback network
in Tanzania. Proportion of clients who have CTC2 Database CTC3 Marco Annually Natural calamities
been tested for HVL and HEID Database, CTC3 and availability of
Dashboard resource

Proportion of sample NBS NBS, Central Annually Natural calamities

collected, transported, Database and availability of
tested and resulted for other Repository resource
diseases

Objective 1          

To increase access Number of samples collected HVL register/CTC CTC2 Database, Quarterly Natural calamities
and utilisation of 2 database/MC CTC3 Macro and availability of
laboratory services cohort register/TB database, resource
in diagnosis and Laboratory register Central Database
management (TB05)/DHIS2-ETL Repository, DHIS2-
of HIV, TB, and ETL, DHIS2
other diseases in
Tanzania. Percentage of samples HVL Sample Electronic Sample Quarterly Natural calamities
transported manifest, HEID Referral System, and availability of
sample manifest, Central Database resource
TB Laboratory Repository, DHIS2-
register (TB05), ETL, DHIS3
DHIS2-ETL

National Sample Referral System Guidelines

 Goal Indicator Source Means of Frequency Assumption
Verification

Percentage of results returned HVL register/CTC Electronic Sample Quarterly Natural calamities
within targeted national TAT 2 database/MC Referral System, and availability of
cohort register/ Central Database resource
TB presumptive Repository, DHIS2-
register/DHIS2-ETL ETL, DHIS2

Percentage of referred Hub HVL Sample Electronic Sample Quarterly Natural calamities
samples of which results were manifest, HEID Referral System, and availability of
returned sample manifest, DHIS2-ETL, resource
TB presumptive Laboratory LIS

National Sample Referral System Guidelines

register, DHIS2-
ETL

Objective 2          

To harmonise Sample referral guidelines in Workshop reports, Workshop reports Once  Natural calamities
standardised place Distribution reports and availability of
procedure for resource
sample referral and
results feedback Number of HFs with Sample Workshop reports, Workshop reports Once  Natural calamities
referral SOP in place Supervision reports and availability of
resource

Objective 3          

To improve Percentage of hubs with DHIS2-ETL, e-SRS Electronic Sample Quarterly Natural calamities
mechanisms for functional electronic sample Referral System, and availability of
TB and HIV sample referral and result tracking DHIS2-ETL, resource
referral and results system Laboratory LIS
tracking

31
32
Goal Indicator Source Means of Frequency Assumption
Verification

Objective 4          

To ensure an Number of health care Training reports Training reports Once  Natural calamities
effective biosafety workers trained on biosafety and availability of
and biosecurity and biosecurity measures at resource
measures during the hubs
sample referrals.

Number of non-health care Training reports Training reports  Once  Natural calamities
workers involved in SRS and availability of
trained in biosafety and resource
biosecurity measures.

Integrated biosafety and Workshop reports Workshop reports Once  Natural calamities
biosecurity guideline in place and availability of
resource

Number of HFs with biosafety Supervision report Site Visit reports Once  
and biosecurity SOPs.

Objective 5          

To establish a cost- Cost- effective sample Assessment report Assessment report Once  Natural calamities
effective sample transportation model identified and availability of
referral system and implemented resource
for HIV and TB
samples

National Sample Referral System Guidelines

 Goal Indicator Source Means of Frequency Assumption
Verification

Objective 6          

To ensure quality of Percentage of TB samples for TB Laboratory DHIS2-ETL, Quarterly Natural calamities
referral samples culture referred to the testing registers, Hub Central Database and availability of
laboratories within required/ Sample and Repository, resource
targeted time Results register Electronic Sample
Referral System

Percentage of HVL samples Hub Sample Electronic Sample Quarterly Natural calamities
referred to the testing manifest, Hub Referral System, and availability of

National Sample Referral System Guidelines

laboratories within required/ Sample and DHIS2-ETL, resource
targeted time Results register Laboratory LIS

Percentage of HEID samples Hub sample Electronic Sample Quarterly Natural calamities
referred to the testing manifest, Hub Referral System, and availability of
laboratories within required/ Sample and DHIS2-ETL, resource
targeted time Results register Laboratory LIS

Proportion of samples rejected Rejection log  Electronic Sample Quarterly Natural calamities
Referral System, and availability of
resource

Percentage of referred TB Laboratory DHIS2-ETL, Quarterly Natural calamities

TB samples tested within registers, Hub Central Database and availability of
national TAT Sample and Repository, resource
Results register TB Electronic Sample
hub sample and Referral System
results registers,

33
34
Goal Indicator Source Means of Frequency Assumption
Verification

Objective 7          

To improve Recording and reporting Workshop reports Workshop reports Once Natural disaster
integrated sample integrated transport referral and availability of
referral data data collection tool in place resource
management and
utilization
Number of sample requests electronic Sample Monthly Reports Monthly Natural disaster
entered in the sample referral referral system and availability of
system and accepted at resource
testing Laboratory

Objective 8          

To utilize TB/HIV Number of other pathological Laboratory Central repository Quarterly Natural calamities
sample referral samples transported using TB/ information system, system and availability of
system for other HIV sample referral system manifest form, resource
pathological laboratory sample
samples log/book

Percentage of results of other Laboratory Central repository Quarterly Natural calamities

pathological samples returned information system, laboratory and availability of
through TB/HIV sample system/result result dispatch resource
referral system tracking form book

National Sample Referral System Guidelines

 TABLE 2: M&E MATRIX FOR SAMPLE REFERRAL INDICATORS

Level of Reporting Indicator

S/N Indicator Numerator Denominator Disaggregation Frequency Source of data
priority level description

SPOKES LEVEL INDICATORS

1 Number of Medium Facility & To monitor Number N/A Testing Monthly HVL register/CTC
samples District the number of sample category (TB/ 2 data base/MC
collected at the of samples collected at HEID/HVL) cohort register/
spoke collected at the the spoke TB Laboratory
spoke register (TB 05)

National Sample Referral System Guidelines

2 Percentage High Facility, To monitor Number Total number Testing Monthly HVL Sample
of samples District total number of samples of samples category (TB/ manifest, HEID
transported to of samples transported collected at the HEID/HVL) sample manifest,
the hub transported to to the hub spoke TB Sample
the hub and manifest
total number
of samples
collected

3 Turnaround High Facility, To monitor Average/ N/A Testing Monthly HVL register/CTC
time for results District & time from date Median category (TB/ 2 data base/MC
at the spoke National of sample time taken HEID/HVL) cohort register/
collection to between TB Laboratory
date results sample register
received at the collection to
spoke result receipt
at the spoke

35
36
Level of Reporting Indicator
S/N Indicator Numerator Denominator Disaggregation Frequency Source of data
priority level description

4 Percentage of High Facility, To monitor Total Total number of Testing Monthly HVL register/CTC
results returned District results number of results returned category (TB/ 2 database/MC
within targeted returned test results at the spoke HEID/HVL) cohort register/
national TAT within targeted returned at TB Laboratory
time to the the facility Register and
total number within Spoke Level
of results specified Sample referral
returned turnaround integrated register
time

HUB LEVEL INDICATORS

5 Number of High Hub, · To monitor total number N/A Testing Monthly HVL/HEID/
samples District & total number of sample category (TB/ TB Laboratory
collected from National of sample collected HEID/HVL) Register, Hub
collected
spokes from sample and result
from the
spokes designated register
· To monitor spokes
hub
performance

6 Percentage High Hub, Monitor Total number Total number Testing Monthly Hub HVL Sample
of samples District performance of samples of samples category (TB/ manifest, HEID
referred to of Hub and transported received at the HEID/HVL)/ sample manifest,
the testing sample referral from the Hub from the result system
laboratories mechanism Hub to spokes (Hardcopy/
within required/ the testing electronic
targeted time Laboratory

National Sample Referral System Guidelines

 Level of Reporting Indicator
S/N Indicator Numerator Denominator Disaggregation Frequency Source of data
priority level description

7 Percentage High Hub, To monitor the Total number Total number Testing Monthly Hub HVL Sample
of referred District performance of results of samples category (TB/ manifest, HEID
samples for of Hub and returned transported HEID/HVL)/ sample manifest,
which results result feedback to the Hub from the Hub result system
were returned mechanism from testing to the testing (Hardcopy/
Laboratory Laboratory electronic
in particular
reporting
period

8 Percentage of Medium Hub, To monitor the Total Total number of Testing Monthly Hub HVL Sample

National Sample Referral System Guidelines

results returned District overall sample number of results received category (TB/ manifest, HEID
within specified referral system test results from the testing HEID/HVL)/ sample manifest,
hub TAT between returned Laboratory result system
sample within (Hardcopy/
dispatch and specified electronic
result receipt at hub TAT
Hub

9 Percentage Medium Hub/ To monitor Total number Total number Facility testing Semi- Hub HVL/TB
of spokes District coverage of of active of spokes category Annually Sample manifest,
submitting sample referral spokes mapped to the (CTC/PMTCT/ HEID sample
samples at the system submitting designated TB) manifest,
hub. samples to Hub
the Hub

10 Percentage of High Hub/ To monitor Total number Total number of Testing Monthly Hub sample
sample rejected District/ the quality of samples sample receipt category (TB/ register/Hub
National of sample rejected at and registered HEID/HVL)/ rejection log
received from the Hub at the Hub Rejections register
the spokes reasons

37
 Level of Reporting Indicator

38
S/N Indicator Numerator Denominator Disaggregation Frequency Source of data
priority level description

LABORATORY INDICATORS

11 Number of High Laboratory/ To monitor the Total number N/A Testing Monthly TB and HIV
samples Regional/ performance of samples category (TB/ Laboratory sample
received from National and workload received HEID/HVL) reception register/
the hubs of the at the Laboratory
Laboratory Laboratory information
from Hub systems(TB LIS,
and few DHIS2-ETL)
spokes
submitting
samples
directly
to the
Laboratory

12 Percentage Medium Laboratory To monitor the Number of Total Number Testing Quarterly Laboratory sample
of samples overall sample samples of samples category (TB/ reception register/
received within referral system received received at HEID/HVL) Laboratory
between
required time. within the testing information
sample
collection(hub) required Laboratory. system (TB LIS,
and sample time. DHIS2-ETL)
receipt at
the testing
Laboratory

13 Percentage High Laboratory/ To monitor Number Total number Testing Monthly Laboratory
of samples National the quality of samples of sample category (TB/ sample reception/
rejected of sample rejected receipt and HEID/HVL)/ rejection register/
received from at the registered at Rejections Laboratory
the hub Laboratory the Laboratory reasons information
system;(TB LIS,
DHIS2-ETL)

National Sample Referral System Guidelines

 Level of Reporting Indicator
S/N Indicator Numerator Denominator Disaggregation Frequency Source of data
priority level description

14 Percentage of High Laboratory/ To monitor the Number Total number Testing Monthly Laboratory sample
samples tested. National performance of samples of sample category (TB/ reception register/
and workload tested at the receipt and HEID/HVL) Laboratory
at the Laboratory registered at information
Laboratory the Laboratory system

15 Percentage High Laboratory/ · To monitor Number of Total Number Testing Monthly Laboratory result
of results National number valid results of samples category (TB/ dispatch register/
dispatched of result dispatched tested at the HEID/HVL) Laboratory
from tested

National Sample Referral System Guidelines

to the Hub/ Laboratory information
samples
returned to spokes system (TB LIS,
the specific from the DHIS2-ETL)
hub/spoke Laboratory
· To monitor
the
performance
and
workload
of the
Laboratory

16 Percentage High Laboratory/ Monitor the Number Total Number Testing Monthly Laboratory result
of results National performance of results of results category (TB/ dispatch register/
dispatched and workload dispatched dispatched HEID/HVL) Laboratory
within required of the within to the Hub/ information
Laboratory TAT Laboratory required spokes from system
time form the Laboratory
the testing
Laboratory

39
40
Level of Reporting Indicator
S/N Indicator Numerator Denominator Disaggregation Frequency Source of data
priority level description

COUNCIL LEVEL INDICATORS

17 Percentage of High District/ Monitor Number of Total number of N/A Semi- sample referral
functional hubs National the Hub functional mapped Hubs. Annually atlas/ supervision
functionality Hubs. report
and coverage
of sample
referral system

18 Percentage of Medium District/ Monitor the Number Total number Testing Semi- sample referral
active spokes National coverage of of active of mapped category Annually atlas/ supervision
sample referral spokes. spokes. (HEID/HVL/TB) report/ Hub
system sample register

19 Percentage Medium District/ To monitor Number of Total number Type of Semi- Supervision
of hubs with National the utilization functional of Functional electronic Annually reports/ electronic
functional of electronic Hub with Hubs. sample referral sample referral
electronic sample referral functional system system
sample referral system at the electronic
and result hub(s) sample
tracking system referral
system

National Sample Referral System Guidelines

 Level of Reporting Indicator
S/N Indicator Numerator Denominator Disaggregation Frequency Source of data
priority level description

NATIONAL LEVEL INDICATORS

20 Percentage of High National To monitor Number of Total number of Region/Zonal Semi- National
functional hubs coverage of functional mapped Hubs Annually laboratory sample
hubs nationally Hubs in in country referral atlas/
country supervision report

21 Percentage of Medium National To monitor Number Total number Region/Zonal Semi- National
active spokes coverage of active of mapped Annually laboratory sample
of spokes spokes in spokes in referral atlas /
nationally country country supervision report/

National Sample Referral System Guidelines

Hub sample
register

22 Percentage Medium National To monitor Number of Total number Region/Zonal Semi- Supervision
of hubs with the utilization functional of Functional Annually reports/ electronic
functional of electronic Hub with Hubs in country sample referral
electronic sample referral functional system
sample system at electronic
referral and the hub(s) sample
result tracking nationally referral
system. system in
country

23 Average TAT High National To monitor Average/ N/A Testing Quarterly District & Regional
the overall Median category (TB/ reports/LIS:
turnaround time taken HEID/HVL) TBLIS, DHIS2-ETL
time for the between
sample referral sample
system. collection
to result
receipt.

41
42
Level of Reporting Indicator
S/N Indicator Numerator Denominator Disaggregation Frequency Source of data
priority level description

GENERAL INDICATORS

24 Number High Spoke / To monitor Number N/A Testing Quarterly Laboratory

of other hub the number of other category information
pathological of other pathological (other system, manifest
samples pathological sample pathological form, laboratory
transported to samples transported samples) sample log/book
Hub /testing transported to Hub/
Laboratory using TB/ testing
using TB/HIV HIV sample laboratory
sample referral referral system
system to hub/testing
laboratory

25 Percentage of High Spoke / To monitor Number Total number Testing Quarterly ESRS, result
results of other hub percentage of of results of other category tracking form,
pathological results of other of other pathological (other laboratory result
samples pathological pathological samples pathological dispatch book
returned samples samples transported to samples)
through TB/HIV returned to the returned to Hub/testing
sample referral facility through the facility laboratory
system TB/HIV sample through TB/ using TB/HIV
referral system HIV sample sample referral
referral system

National Sample Referral System Guidelines

 Level of Reporting Indicator
S/N Indicator Numerator Denominator Disaggregation Frequency Source of data
priority level description

26 Number of Medium National/R/ To increase Number of N/A   Annually Training reports

health care CHMT number HCW trained
workers trained of HCW
on biosafety involvement in
and biosecurity biosafety and
measures biosecurity
measures
for sample
handling in
laboratories

National Sample Referral System Guidelines

27 Number of Medium National/R/ To increase Number of N/A   Annually Training reports
non-health CHMT number of non HCW
care workers non HCW trained
involved in involvement in
SRS trained in biosafety and
biosafety and biosecurity
biosecurity measures
measures. for sample
handling in
laboratories

43
 ANNEX 1: HIV VIRAL LOAD SAMPLE AND RESULTS REGISTER

44
Ministry of Health, Community Development, Gender, Elderly and Children.

FACILITY HIV VIRAL LOAD REGISTER

Pregnant/ Quality of the sample
Breast collected (tick below) Results
Clients’ CTC ID feeding Date Time
Date of Time Name of the Person Date
(RR-DD-FFFF- Sex Woman Sample Sample Sample TAT Name of the Person
S/N Age Sample sample who collected the results Copies/ml Log 10 Signature Remarks
PPPPPP) (M/F) (YES/NO) type transported transported (Days) who received the results
collected collected sample received
(tick below) to Hub to Hub
ACCEPTABLE NOT
YES NO ACCEPTABLE

National Sample Referral System Guidelines

 ANNEX 2 HVL HIGH VIRAL LOAD REGISTER
Ministry of Health, Community Development, Gender, Elderly and Children.

HIGH HIV VIRAL LOAD REGISTER

Pregnant Breest-
women feeding Date HVL
Date Date Date of Date of Date of
(YES/NO) (YES/NO) sample HVL results HVL Results
Clients’ CTC ID Sex First HVL HVL results Results HVL First Second Third Additional
S/N Age Current Regimen (tick (tick taken after after EAC after EAC Remarks
(RR-DD-FFFF-PPPPPP) (M/F) sample (Copies/ml) (Log 10) results EAC EAC EAC EAC session
below) below) completing (Copies/ml) (Log 10)
taken received session session session
EAC
YES NO YES NO

National Sample Referral System Guidelines

45
 ANNEX 3: FACILITY HEID REGISTER

46
THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

FACILITY EID REGISTER

Date of Date
Sample Sample Date Results
Date of Results
Mother's/ Collection Collected Sent To Results Results Given to
Facility Birth (DD- Sex Sample Collection Sent by (P/N/In TAT
SN HEI Number ( _ _-_ _-_ _ _ _-_ _ _ _ _ _.C _ _ ) Age* Caregiver' Date (DD- By Hub/Labo Received Received Mother/C Initials Remarks
Name MM- (M/F) Time ( _ _:_ _ ) (Name) determin (Days)
s Address MM- (Name) ratory (DD-MM- By(Name) aregiver(
YYYY) ant)
YYYY) (DD-MM- YYYY) DD-MM-
YYYY) YYYY)

National Sample Referral System Guidelines

 ANNEX 4: TB LABORATORY REGISTER

THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

National Sample Referral System Guidelines

Patient Name Comments

47
 ANNEX 5: HVL HUB SAMPLE AND RESULT REGISTER

48
THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

HIV VIRAL LOAD-HUB SAMPLE REGISTER
Date Date Results
Name of the Quality of the sample collected (tick TAT
Time Sample Results Viral load Results dispatched to Comments
Referring Date of Date Type of Sample below) (Days)
CTC ID. collected at Time Sample received Health Facility
S/N Age Sex (M/F) Health Sample Sample (Whole Blood,
(RR-DD-FFFF-PPPPPP) the facility received
Facility collection received Plasma, DBS)
(Spoke)
(Spoke)
ACCEPTABLE NOT ACCEPTABLE Copies/ml Log10

National Sample Referral System Guidelines

 ANNEX 6: TB HUB SAMPLE AND RESULT REGISTER

THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

TB HUB SAMPLE REGISTER

Date Results
Date sample
dispatched to
Quality of the sample collected tested/ Date Results TAT
Type of Sample received (tick below) TB test results the referring Comments
Name of the Time Sample (tick below) transported to out/ received (Days)
Date Health Facility

National Sample Referral System Guidelines

Referring Date of collected at zonal Lab
Sex Sample (Spoke)
S/N Patient name Lab No. Age Health Sample the Referring
(M/F) received at
Facility collection Health Sputum for
the hub Sputum to Xpert
(Spoke) (Spoke) Xpert Fixed NOT Fixed
be referred ACCEPTABLE MTB/RIF Culture
MTB/RIF smear ACCEPTABLE smear
for Culture testing
testing

49
 ANNEX 7: HEID HUB SAMPLE AND RESULTS REGISTER

50
THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

EARLY INFANT DIAGNOSIS-HUB SAMPLE REGISTER

Date sample
Name of the
Time Sample Quality of the sample Name of the tested using DBS Results Date Results Name of the
Referring Date of Date Date
HEI No. Sex collected at collected (tick below) person who near POC or TAT (Positive/ dispatched person
S/N Name of the client Age Health Sample Sample Results out/ Comments
(RR-DD-FFFF-PPPPPP-CC) (M/F) the facility received the transported to (Days) Negative/ to Health dispatching
Facility collection received received
(Spoke) NOT sample EID testing Indeterminant) Facility results
(Spoke) ACCEPTABLE
ACCEPTABLE laboratory

National Sample Referral System Guidelines

ANNEX 8: SAMPLE MANIFEST

THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

SAMPLE MANIFEST
Facility Name
District Region
Facility Contact

Sample Quality
Pateint name (for TB Sputum(tick below)
CTC ID./HEID No. Date of Sample (tick below)
S/N and other pathological
(/for HIV samples ) Collection Whole
samples)
HVL Sputum HEID/DBS Good Satifactory
Blood

Time pick up time After 2 Hrs After 4 Hrs After 6 Hrs After 8 Hrs After 10 On Arrival

Temperature

Samples sent by Signature Date Time

Samples delivered by Signature Date Time

Samples received by Signature Date Time

National Sample Referral System Guidelines

51
ANNEX 9: SAMPLES REJECTION LOG

THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

National Sample Referral System Guidelines

52
ANNEX 10: SPOKE AND HUB STANDARD OPERATING PROCEDURES -
MASTER LIST

1. Instructions for filling out HIV Viral Load request form

2. SOP for whole blood sample collection
3. SOP for separating whole blood into plasma
4. SOP for sputum collection for AFB staining, GeneXpert , Hain assay and Culture
5. SOP for DBS collection for HEID
6. SOP for DBS collection for HVL
7. SOP for sample collection for POC-EID GeneXpert
8. SOP for sample storage, packaging and transportation
9. SOP for decontamination of cooler boxes
10. SOP for accurate requisition form completion
11. SOP for chain of custody
12. SOP for sample reception
13. SOP for POC-MTB/RIF GeneXpert testing
14. SOP for POC-HEID GeneXpert testing
15. SOP for result pick up at laboratory
16. SOP for barcoding samples
17. SOP for rejecting poor sample(s)
18. SOP for rejected sample(s) notification
19. SOP for test result return from the Hub to facilities(Spokes)
20. SOP for handling results after return from the laboratory (recording results into
the logbook, separating results, patient chart logging, filling out of register)
21. SOP for handling outstanding results identified from the sample(s) daily log
22. SOP for remote login into ESRS and general ESRS utilisation
23. SOP for communication between Hub and the testing Laboratory
24. SOP for e-SRS validation and quality check
25. SOP for POC waste management
26. SOP for Hub Mentorship
27. Sop for Hub supportive supervision

National Sample Referral System Guidelines

53
ANNEX 11: INDICATORS PERFORMANCE FOR SAMPLE REFERRAL SYSTEM
1. Key performance indicators for a sample referral system at spoke level:
1.1. Total number of samples collected at the spoke;
1.2. Total number of samples transported to the hub;
1.3. Turnaround time from sample taken/collected to return of result at the
spoke;
1.4. Percentage of results returned within national TAT.
2. Key performance indicators for a sample referral system at hub level:
2.1. Total number of samples collected (delivered) from spokes;
2.2. Percentage of samples referred to the testing laboratories with specified
time;
2.3. Percentage of referred samples for which results were returned;
2.4. Percentage of results returned electronically through ESRS;
2.5. Number of samples referred for testing/ Number of samples transported;
2.6. Percentage of results returned within specified hub TAT;
2.7. Percentage of spokes submitting samples at the hub;
2.8. Percentage of samples rejected.
3. Key performance indicators for a sample referral system at the testing laboratory:
3.1. Total number of samples received;
3.2. Percentage of samples recived within specified time;
3.3. Percentage of samples rejected;
3.4. Percentage of samples tested;
3.5. Percentage of results dispatched;
3.6. Percentage of results dispatched within required laboratory TAT.
4. Key performance indicators for a sample referral system at Council level:
4.1. Percentage of functional hubs;
4.2. Percentage of active spokes;
4.3. Percentage of hubs with functional electronic sample referral and result
tracking system (eSRS).
5. Key performance indicators for a sample referral system at National level:
5.1. Percentage of functional hubs;
5.2. Percentage of active spokes;
5.3. Avarage overall TAT;
5.4. Percentage of hubs with functional electronic sample referral and result
tracking system (eSRS).

National Sample Referral System Guidelines

54
ANNEX 12: SRS MONTHLY MONITORING FORM

THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

National Sample Referral System Guidelines

55
ANNEX 13: HUB QUARTERLY ASSESSMENT AND SUPERVISION CHECKLIST

THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

SAMPLE REFERRAL QUARTER ASSESSMENT TOOL

National Sample Referral System Guidelines

56
National Sample Referral System Guidelines
57
ANNEX 14: HUB LABORATORY INFORMATION SYSTEM –QUARTER ASSEMENT
TOOL

THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

LABORATORY INFORMATION MANAGEMENT SYSTEM- HUB QUARTER ASSESSMENT TOOL

Name of the Health Facility
Health District Regional
Dispesary Hospital
Level of health Faclity Centre Hospital Hospital

Govement Faith Based Organization Private

Facility Affiliation
District

Region
Name Signature Date
Facility In-charge/Manager/Director
Name Signaure Date
Laboratory in-charge/Manager

HVL TB EID
S/N Tool Correctly filled Correctly Correctly
Available Complete Available Complete Available Complete
filled filled

1 Lab request and report forms

2 Hub register

3 Sample Manifest/Tracking tool

4 Rejection log

5 Referral register data monthly summary report form

HVL TB EID
YES NO YES NO YES NO

6 Does the hub record your specimen/clients information in the authorized laboratory register upon receipt? (Check the reception

7 Are the specimens received accompanied by the recommended laboratory request forms?

8 Do the requests contain relevant data?

9 Does the hub cross check request forms complete and accurately filled?

10 Are unique laboratory numbers assigned for every specimen received?

11 Does record results received from HVL/EID/ TB Culture and Line probe testing laboratories?

12 Does the lab have an officer assigned to compile the Hub reports?

13 Does the lab send reports to higher levels according to the recommended reporting period?

14 Are the specimens received accompanied by the recommended lab request forms?

15 Do the requests contain relevant data?

16 Are the request forms complete and accurately filled?

17 Are unique laboratory numbers/barcode label assigned for every specimen received?

18 Does the Hub retain and file duplicate copies of the original results?

19 Does the Hub send reports to higher levels according to the recommended reporting period?

20 Are there copies of recent Hub Monthly data reports sent to relevant authorities?(Verify)

21 Does the hub receive feedback after sending reports?

22 Does the hub have a designated mode of sending reports?

23 Does the hub have a computer where you log in the lab information?

24 Are there functional equipment for Laboratory Information System/electronic sample tracking and results return system (i.e eTL

26 Is Laboratory information /electronic Sample Referral and Result system(LIMS/ESRS) functional?

No Printer/ Printer
27 If LIMS/ESR NOT functional, tick what is the reason ? No Internet not functional Staff Not well LIMS/ESRS

If LIMS/ESRS is functional, HVL TB EID

YES NO YES NO YES NO

28 Does th hub uses the LIMS/ESRS to register/remote log in samples ?

29 Does th hub uses the LIMS/ESRS to register/remote log in rejected samples ?

30 Does th hub receive results electonically through LIMS/ESRS ?

31 Does the hub uses theLIMS/ESRS to produce monthly report?

HVL TB EID

32 Total Number of sample entered/remote logged at the hubs in a quarter

33 Total Number of results received electronically in a quarter

34 Total number of rejected samples registered at the hubs in a quarter

35 Average TAT for results received electonically

YES NO YES NO YES NO

36 Does the lab have measures to ensure data security?

National Sample Referral System Guidelines

58
ANNEX 15: HIV VIRAL LOAD TURN AROUND TIME

TAT between steps:

1. TAT1: Whole blood should reach a hub and be processed for plasma separation
within six hours of sample collection.
2. TAT 2: Plasma should be transported from the hub and reach the testing
laboratory within 96 (4 days) hours of sample collection.
3. TAT3: Time taken from sample received at laboratory to result released for pick
up shall be 72 hours (3 days).
4. TAT4: The signed hard copy of the results should reach the hub within 72 hours
(3 days) of testing of the sample
5. TAT5: The signed hard or approved soft copy of the results should reach Spokes/
CTCs from the hub within 48 hours (2 days) of testing of the sample.

Overall TAT: The Turnaround Time (TAT) for reporting of results to the Spoke/CTC is 14
days from the time of sample collection.

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ANNEX 16: HEID TURN AROUND TIME (CONVENTIONAL)

TAT between steps:

1. TAT1: DBS should reach a hub within 24 hours of sample collection.
2. TAT 2: DBS should be transported from the hub and reach the testing laboratory
within 72 (3 days) hours of sample collection.
3. TAT3: Time taken from sample received at laboratory to result released for pick
up shall be 72 hours (3 days).
4. TAT4: The signed hard copy of the results should reach the hub within 72 hours
(3 days) of testing of the sample.
5. TAT5: The signed hard or approved soft copy of the results should reach Spokes/
RCHs from the hub within 48 hours (2 days) of testing of the sample.

Overall TAT: The Turnaround Time (TAT) for reporting of results to the Spoke/RCHs is
14 days from the time of sample collection

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ANNEX 17: XPERT MTB/RIF TESTING TURN AROUND TIME

TAT between steps:

1. TAT1: Sputum collection should reach the hub testing Centre within 24 hours
of sample collection.
2. TAT2: Time taken from sample received at the hub testing centre to result
released for pick up shall be 48 hours (2 days)
3. TAT3: The signed hard or approved soft copy of the results should reach the
hub within 24 hours (1 day) of testing of the sample.
n) Overall TAT: The Turnaround Time (TAT) for reporting of results to the spoke/TB
diagnostic centre is 96 hours (4 days) from the time of sample collection

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ANNEX 18: LINE PROBE ASSSAY TURN AROUND TIME

TAT between steps:

1. TAT1: Sputum should reach the hub within 24 hours of sample collection.
2. TAT 2: Sputum should be transported from the hub and reach the testing
laboratory within 48 (2 days) hours of sample collection.
3. TAT3: Time taken from the sample received at laboratory to result released for
pick up shall be 5 days
4. TAT4: The signed hard copy of the results should reach the hub within 48 hours
(2 days) of testing of the sample.
5. TAT5: The signed hard or approved soft copy of the results should reach Spokes/
TB diagnostics from the hub within 24 hours (1 day) of testing of the sample.

Overall TAT: The Turnaround Time (TAT) for reporting of results to the Spoke/TB
diagnostic centre is 10 days from the time of sample collection.

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ANNEX 19: HEID POC TURN AROUND TIME

TAT between steps:

1. TAT1: DBS collection should reach the hub testing Centre within 24 hours of
sample collection.
2. TAT2: Time taken from sample received at the hub testing centre to result
released for pick up shall be 24 hours (1 day)
3. TAT3: The signed hard or approved soft copy of the results should reach the
hub within 24 hours (1 day) of testing of the sample.
o) Overall TAT: The Turnaround Time (TAT) for reporting of results to the spoke/TB
diagnostic centre is 72 hours (3 days) from the time of sample collection

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ANNEX 20: HEID POC IMPLEMENTATION CHECKLIST

THE UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community Development, Gender, Elderly and Children.

POC HEID Implementation Site Monitoring Checklist:
Hub Testing Site
1 Facility name:
2 Name(s) of trained instrument operators/end users:
3 Date of monitoring visit:
4 Name(s) of monitors or supervisors:
Observe and ask about the activities in the table below. For each activity, check the appropriate box to indicate if the
activity is being done (Yes), partially done (Partial) or not being done (No). If an activity is partially or not done, write a
brief explanation and describe the assistance or mentoring provided. If possible, observe at least one instrument operator
performing a test. Provide assistance and mentoring as needed or requested. Enter additional information as required,
such as the number of POC EID/DBS Testing Forms collected.

SECTION A-SOPs, Job Aids and Documentation

SOPs, job aids, registers, tracking logs, electronic sample referral system and testing Yes (100%) Partial(%) No COMMENTS
forms: (NOTE: Observe the facility, discuss with staff, and review error logs and
1.1 SOPs and job aids are available in the appropriate language.
1.2 SOPs and job aids are available and visible to staff (e.g. job aids are hung on the
wall, training manuals are near the testing platform).
1.2 SOPs and job aids are used and adhered to by all staff.
1.4 ANC, PMTCT and ART Initiation registers from the previous three months are
properly and completely filled out.
1.5 An Error and Specimen Rejection Log and sections from the training manual
describing the meaning of error codes are placed
next to the instrument.
1.6 The Error and Specimen Rejection Log is up to date and properly
filled in.
1.7 HEID requesting Forms from the previous three months are
properly and completely filled out.
1.8 HEID request forms were collected during the monitoring visit
for data entry.
SECTION B-Operator Training and Performance
Training and competency of instrument operators/end-users: (NOTE: Discuss with Yes (100%) Partial (%) No COMMENTS
facility staff and platform end users)
2.1 All staff performing POC testing received initial instrument training from a
certified trainer.
2.2 All staff performing POC testing have passed a competency
assessment.
Observation of operator(s)/end user(s): (NOTE: If possible observe at least one
Yes ( 100%) Partial (%) No COMMENTS
instrument operator/end user
3.1 Before the sample is drawn, the POC instrument is switched on
and ready.
3.2 The operator correctly: (a) handles and fills the cartridge; (b)
checks the sample; and (c) closes the cartridge.
3.3 Before running the test in the POC instrument, the infant’s name is verified.

3.4 The operator correctly inserts the cartridge into the instrument.
3.5 The operator correctly enters the User ID and Sample ID into the
device.
3.6 The operator adheres to universal safety precautions for the
handling of human blood (e.g. wears gloves and protective
clothing, washes hands, disposes of lancets in puncture resistant
containers, changes gloves after each specimen).
SECTION C-Inventory and Waste Management
Yes (100%) Partial (%) No COMMENTS
Reagents and Supplies: (NOTE: Observe and discuss with facility staff)

All supplies needed to perform POC testing are available at the

facility (e.g. cartridges, gloves, lancets, alcohol wipes, gauze, and
4.1 thermal paper).
The area where POC testing supplies are stored is clean and well
4.2 organized.
There is a thermometer in the area where testing cartridges (i.e.
4.3 reagents) are stored.
Testing cartridges (i.e. reagents) are stored at the required
4.4 temperature of 2 to 30° degrees Celsius.
Stock cards for POC supplies are used and kept up to date. (NOTE:
For each individual product, stock cards should indicate the
quantity of stock received, on hand, and lost/expired as well as
4.5 adjustments, such as transfers of stock to another facility).
In the last 90 days, there have been stock outs of supplies needed
to perform POC testing. (NOTE: If yes, the reason for stock outs in
4.6 the comments box.)
a If yes, which products were not available?
b Approximately how long did the stock out last (in days)?

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 A physical count of POC HEID cartridges was completed within the last four (4)
4.7 weeks.
If yes: what was the date of last physical count: DD MM YY
a
b How many cartridges were reported on that date:
If there is any concern about inventory management, and time
permits, conduct a physical inventory of POC supplies and cross
check the quantities available against those written in the stock
4.8 cards. Do the quantities match those indicated in the stock cards?
Waste management: (NOTE: Observe and discuss with facility staff)
5.1 Cepheid cartridges are used at this location.
If yes, Cepheid HEID and Viral Load cartridges are disposed of using a high-
5.2 temperature incinerator (>1000 °C)

SECTION D-Receiving samples from spoke sites (for hub sites only)
Yes (100%) Partial(%) No COMMENTS

6.1 There is a log book for sample reception from spoke sites.
a. If yes, the log book is properly filled out.
6.2
Samples are received from spokes sites within 24 hours of sample collection (if
kept at room temperature) or within 72 hours of collection (if kept at 4 degrees C).

6.3 Samples are transported in appropriate conditions (e.g. in cool boxif kept at 4
degrees C)
6.4 All samples arrive with HEID request forms appropriately filled out and with
linked sample.
6.5 Samples from spokes sites are tested as soon as they arrive and withing 48 hours.
a. If samples are not tested immediately, how many hours ypically elapse between
the time when samples are delivered to the hub site and when they are tested?

SECTION E-Linkage to Care

Yes (100%) Partial (%) No COMMENTS

7.1 All HEID test results are conveyed to caregivers on the same day as the sample
tested
7.2 All infants who have a positive initial result have a second POC
sample run for confirmation within 48 hours.
7.3 All infants who have a positive initial POC result are initiated on
ART with 24 hours.
7.4 For all infants who have a positive initial POC test result, but a
negative second POC test result (i.e. discordant result), a DBS
sample is sent to a conventional lab, and contact information is
collected from the patient for follow up.
7.5 In the previous three (3) months, all infants diagnosed as HIVpositive were
successfully linked to ART services (NOTE: If possible, cross check positive cases in
POC HEID/DBS Request Forms/HEID Hub register or logbooks against the facility’s
ART register)

SECTION F-Mentoring, Training, and Information Sharing

Yes (100%) Partial (%) No COMMENTS

8.1 List the topics covered and the recipients of mentoring, training and information sharing.

8.2 List recommendations or plans for future training, mentoring or information sharing.

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 TABLE 3: LIST OF PARTICIPANTS WHO DEVELOPED THE GUIDELINE

66
Name of participants Title Organisation Contact
1. Dr. Alex Magesa ADDS MoHCDGEC [email protected]
2. Mr. Peter Torokaa HLS MoHCDGEC [email protected]
3. Dr. Charles G. Massambu Pathologist Consultant DODOMA REGIONAL [email protected]
REFERRAL HOSPITAL
4. Mr. Dickson M. Majige Principle laboratory technologist DODOMA REGIONAL [email protected]
REFERRAL HOSPITAL
5. Ms. Bahati Mfaki Laboratory program officer NACP [email protected]
6. Ms. Basra Douglas Head of CTRL NTLP [email protected]
7. Mr. Richard O. Buretta Sample Referral coordinator MDH [email protected]
8. Mr. Edgar Luhanga Senior laboratory Advisor KNCV [email protected]
9. Mr. Haji Msuya Senior Laboratory advisor UMB [email protected]
10. Mr. Junior Alphey Shao HIV Viral Load &HEID Coordinator HJFMRI [email protected]
11. Mr.Timothy M. Chonde (RIP) Facilitator Freelance [email protected]
12. Mr. Mura Ngoi National Professional Officer (NPO) – WHO [email protected]
Laboratory
13. Dr. Solomon Mwaigwisya Senior Laboratory Advisor-Blood Safety MDH [email protected]
14. Mr. David M. Ocheng Facilitator Freelance [email protected]
15. Dr Liberate Mleoh Deputy Programme Manager NTLP [email protected]
16. Dr. Johnson Lyimo MDR Coordinator NTLP [email protected]
17. Dr. Zuwena Kondo M&E Coordinator NTLP [email protected]
18. Mr. Amri Kingalu Laboratory Manager NTLP/CTRL [email protected]
19. Mr. Elibariki Akyoo M&E Manager THPS [email protected]
20. Mr. Mussa Maganga Senior Advisor- Laboratory Services BORESHA AFYA SOUTHERN [email protected]
HIGHLAND

National Sample Referral System Guidelines

 FOR FURTHER INFORMATION, CONTACT:
PERMANENT SECRETARY (HEALTH),

Ministry of Health, Community Development, Gender, Elderly and Children,

Government City- Mitumba, Afya Road,
PO Box 743, Dodoma, Tanzania.
Tel: +255 (0)26 232 3267
E-mail: [email protected]
Website: www.moh.go.tz