Crs SCM Healthannex

SUPPLY CHAIN MANAGEMENT HANDBOOK
Health Annex:
Supporting National Supply Chain Health Systems
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Catholic Relief Services. 2022. Supply Chain Management Handbook: Version 2.0 Health Annex. Baltimore, MD: Catholic
Relief Services.
The Health Annex of the CRS Supply Chain Management Handbook has been prepared by Catholic Relief Services for use
by staff and partners. This annex is intended to be used in conjunction with the CRS Supply Chain Management Handbook.
Cover photo by Jason Florio
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HEALTH ANNEX CONTENTS
HEALTH ANNEX ACRONYMS .................................................................................................. 7
HEALTH ANNEX GLOSSARY .................................................................................................. 10
INTRODUCTION ..................................................................................................................... 8
PART I: DESIGN ...................................................................................................................... 9
Chapter 1.1: Proposal ......................................................................................................... 9
Chapter 1.2: Health Supply Chain Assessment ................................................................. 14
Chapter 1.3: Health Supply Chain Design ......................................................................... 20
Chapter 1.4: Define Procurement and Supply Chain Interventions ................................. 33
Chapter 1.5: Quantification of Health Products ............................................................... 42
Chapter 1.6: Risk Assessment ........................................................................................... 67
PART II: START UP................................................................................................................ 72
Chapter 2.1: Recruitment of the Health Supply Chain Manager ...................................... 73
Chapter 2.2: Supply Chain Strategy and Coordination ..................................................... 76
Chapter 2.3: HR Analysis ................................................................................................... 82
Chapter 2.4: Contracting Warehouse and Distribution Services ...................................... 88
Chapter 2.5: Supply Planning ............................................................................................ 93
Chapter 2.6: Procurement ................................................................................................ 96
PART III. IMPLEMENTATION ................................................................................................. 97
Chapter 3.1: Stock Monitoring.......................................................................................... 97
Chapter 3.2: Financial Reporting of Health Commodities .............................................. 102
Chapter 3.3: Tracking PSM Costs for Global Fund Grants .............................................. 105
Chapter 3.4: QA............................................................................................................... 108
Chapter 3.5: Distribution ................................................................................................ 123
Chapter 3.6: Cold Chain Program ................................................................................... 135
Chapter 3.7: Waste Management .................................................................................. 138
Chapter 3.8: Pharmacovigilance ..................................................................................... 144
Chapter 3.9: HMIS/LMIS Data Comparison .................................................................... 147
Chapter 3.10: PUDR Donor Reporting Requirements (Global Fund) .............................. 151
Chapter 3.11: PQR Donor Reporting Requirements (Global Fund) ................................ 154
Chapter 3.12: Quality Pulse Check Donor Reporting Requirements (Global Fund) ....... 158
Chapter 3.13: Procurement Reporting Requirements for COVID-19 (Global Fund) ...... 160
PART V. CLOSE OUT/TRANSITION ...................................................................................... 162
HEALTH ANNEX REFERENCES ............................................................................................. 163
HEALTH ANNEX ACRONYMS
AIDS Acquired Immunodeficiency Syndrome
API Active Pharmaceutical Ingredient
CAT Capacity Assessment Tool
CIPS Chartered Institute of Procurement and Supply
CMM Capability Maturity Model
CMS Centers for Medicare & Medicaid Services
COVID-19, C19 Coronavirus Disease 2019
CTP Cash Transfer Programming
CV Curriculum Vitae
FBDI File-Based Data Import
FFATA Federal Funding Accountability and Transparency Act
GAVI Global Alliance for Vaccines and Immunization
GDF Global Drug Facility
GDP Good Distribution Practices
GHTF Global Harmonization Task Force
GHSC Global Health Supply Chain
GMP Good Manufacturing Practice
GSCM Global Supply Chain Management
GSP Good Storage Practices
HIV Human Immunodeficiency Virus
HPM Health Product Management
HPMT Health Product Management Template
HR Human Resources
HSS Health System Strengthening
IDA International Dispensary Association (IDA Foundation)
ICT4D Information and Communication Technologies for Development
ITN Insecticide-treated Net
ISO International Organization for Standardization
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CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

JD Job Description
JSI John Snow, Inc.
KPI Key Performance Indicator
LFA Local Fund Agent
LLIN Long-lasting Insecticidal Net
LOE Level of Effort
M&E Monitoring & Evaluation
mg milligram
MOH Ministry of Health
NDRA National Drug Regulatory Authority
NextGen Next Generation
NMRA National Medicines Regulatory Authority
NSCA National Supply Chain Assessment
OOO Out of Office
PEPFAR The United States President’s Emergency Plan for AIDS Relief
PMI President Malaria Initiative
PO Purchase Order
PQR Price Quality Reporting
PSM Procurement and Supply Chain Management
PUDR Progress Update Disbursement Request
QA Quality Assurance
QAT Quantification Analytics Tool
QC Quality Control
RACI Responsible, Accountable, Consulted, and Informed
RDT Rapid Diagnostic Test
RFP Request for Proposal
RFQ Request for Quote
RSSH Resilient and Sustainable Systems for Health
SCM Supply Chain Management
SOP Standard Operating Procedure
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SOW Scope of Work
SRA Stringent Drug Regulatory Authority
STGs Standard Treatment Guidelines
TB Tuberculosis
UNFP United Nations Population Funds
UNICEF United Nations International Children’s Emergency Fund
USAID U.S. Agency for International Development
WHO World Health Organization
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HEALTH ANNEX GLOSSARY
Active Pharmaceutical Ingredient (API): Any Essential Medicines: Satisfy the priority health
substance or combination of substances used in care needs of a population. They are selected
a finished pharmaceutical product, intended to with due regard to disease prevalence and
have a direct effect on the diagnosis, cure, public health relevance, evidence of efficacy
mitigation, treatment, or prevention of disease. and safety, and comparative cost-effectiveness.
Essential medicines are intended to be available
Adverse Drug Reaction: A response to a drug in functioning health systems always, in
that is noxious, unintended, and occurs at appropriate dosage forms, of assured quality,
therapeutic doses for the prophylaxis, and at prices individuals and health systems can
diagnosis, or therapy of disease, or the afford. Every two years, WHO updates a list of
modification of physiological function. finished pharmaceutical products used to treat
HIV/AIDS, TB, malaria and other diseases, and
reproductive health, assessed by WHO and
Capacity Statement: A document with found to be acceptable, in principle, for
information on CRS’ expertise and ability to procurement by UN agencies.
perform functions effectively, efficiently, and
sustainably developed to attract potential
donors. Generic Medicine: A pharmaceutical product
Capacity Assessment Tool (CAT): Assessment usually intended to be interchangeable with the
tool used by the Global Fund to assess the originator brand product, manufactured
principal recipient's readiness. without a license from the originator
manufacturer, and marketed after the expiry of
Central Medical Stores: National or parastatal the patent or other exclusivity rights.
entities in charge of the procurement,
warehousing, and distribution of public health Global Fund Project Dedicated Supply Chain
commodities. Some central medical stores have Manager: Global Fund Project dedicated Supply
decentralized entities, while others are linked Chain Manager, with a Logistics Manager
and used directly. persona in Insight.
Country Program Supply Chain Manager: Good Storage Practices (GSP) and Good
Country Program Supply Chain Manager playing Distribution Practices (GDP): WHO Guidance
the Supply Chain Manager persona for CRS’ describing special measures considered
Enterprise Resource Planning system, known as appropriate for the storage and transportation
Insight. of pharmaceuticals.
COMPASS: The COMPASS website supports CRS Good Manufacturing Practices (GMP): The part
staff in attaining project management of QA that ensures that pharmaceutical
excellence across CRS emergency response and products are consistently produced and
development projects. COMPASS provides step- controlled to the quality standards appropriate
by-step guidance and practical resources that to their intended use and as required by the
support the CRS project management marketing authorization.
standards. Health Supply Chain Manager: Terminology
used to reflect the country focal point, supply
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chain manager, or any other person supporting
the health supply chain section.
Pooled Procurement Mechanism: A Global
Fund strategic initiative that aggregates order
volumes on behalf of grantees to negotiate
Health Products: At CRS, the terminology prices and delivery conditions with
“health products” encompasses all manufacturers.
pharmaceuticals, consumables, vaccines, and
equipment acquired to cure, prevent, diagnose Procurement and Supply Chain Management
diseases, and protect health workers. Health (PSM): Terminology used in Global Fund grants
supplies include pharmaceuticals and vaccines, that refers to procurement and supply chain
other medical products (e.g., nutritional activities.
supplements, bed nets for malaria prevention,
Pulled or Requisition system: A system
test kits, medical and laboratory equipment,
whereby products are supplied based on
and medical and laboratory supplies (e.g.,
gloves, syringes, gauze, and lab reagents). In demand.
most developing country contexts, the health Push or Allocation system: A system whereby
supply chain is managed by the MOH or by products are pushed through the supply chain.
parastatal organizations that receive funding Distribution is based on forecasts.
and oversight from the government.
Health Supply Chain Management: A set of
interlinked players and processes – including Quality Assurance (QA): The totality of the
assessment, planning, procurement, shipping, arrangements to ensure that health products
goods clearance, warehouse and inventory are of the quality required for their intended
management, in-country distribution, use, including quality monitoring.
information management, and monitoring and
evaluation – that ensure that the right Quality Control (QC): The part of quality
quantities of the right supplies are delivered to monitoring that includes all measures taken,
the right locations at the right time, to meet the including the setting of specifications, sampling,
needs of the end-users in the most efficient testing, and analytical clearance, to ensure that
manner possible (definition sourced from the health products conform to established
UNICEF Process Guide and Toolkit for specifications.
Strengthening PUBLIC HEALTH SUPPLY CHAINS
Quality Medicines: Must consistently and safely
through Capacity Development). It also
provide their intended benefit. All functions,
encompasses the reverse flow of supplies
from manufacturing, storing, transporting, and
upstream for waste management and the flow
giving people access to medicines must meet
of finances and information upstream and
quality standards to ensure doses are of the
downstream to support and improve supplies
appropriate strength and free of contamination
management.
and defects.
Quality Monitoring: All activities are
undertaken to ensure that health products
Logistics Assessments: Provide information continue to conform to the manufacturer’s
related to infrastructure and service availability established quality specifications during the
throughout the area of operation. These tactical storage, distribution, and use of such products,
assessments are designed to assist managers in including QC in a laboratory.
identifying elements critical to logistics and the
provision of operational support.
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through a legally binding mutual recognition
agreement including Australia, Norway, Iceland,
Regulatory Authorities of the Founding and Liechtenstein (as may be updated from
Members of the Global Harmonization Task time to time).
Force (GHTF): The regulatory authorities of the
United States, the European Union, Japan,
Canada, and Australia.
World Health Organization (WHO): The United
Nations agency leading global efforts to expand
universal health coverage and protect people
Stringent Drug Regulatory Authority (SRA): A from health emergencies. Universal health
regulatory authority that is (a) a member of the coverage includes improving access to essential
ICH (as specified on its website:); or (b) an ICH medicines and health products as improving
Observer, being the European Free Trade monitoring, data, and information. WHO
Association (EFTA) as represented by Swiss establishes international standards that are
Medic, Health Canada and WHO (as may be integrated by countries, donors, and
updated from time to time); or (c) a regulatory implementing partners.
authority associated with an ICH member
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INTRODUCTION
As a Health Annex to the CRS Supply Chain Management Handbook, this guide intends to describe CRS
processes that govern the PSM of health products using national or third-party systems in public or
private sectors. The goal is to ensure standardization, harmonization, and optimization of the health
supply chain process across the agency and thus building sustainable health supply chain systems across
the agency and in supported countries.
This Health Annex is intended to provide guidance and valuable resources to successfully implement
HPM activities at each phase of the project lifecycle, per international standards and donor
requirements. CRS also recommends using the public health system structure, where possible.
The intended audience of this Health Annex is CRS staff, primarily the CRS health supply chain
workforce. CRS health supply chain staff are organized across the agency into three levels: country
programs, regions, and GSCM.
CRS country programs execute and directly support supply chain activities that are led in the country.
Regions provide direct oversight and technical guidance to country programs to achieve operational
excellence. GSCM teams support regions and country programs for strategic and innovative
interventions, best practices, and advice for quality implementation.
The guide follows the SCM cycle per the figures below and the CRS project management cycle. We have
four main parts: 1) Design, 2) Start-up, 3) Implementation, and 4) Closeout (please refer to COMPASS for
more details). For each specific health supply chain activity, we describe the health process and provide
RACI tables and resources tables.
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PART I: DESIGN
CRS staff use Agency project management standards to design health supply chain projects. The CRS
Supply Chain Management Handbook recommends and provides practical examples and guidance for
successfully developing supply chain projects. This Health Annex includes complementary processes and
tools to strengthen the design of health supply chain projects.
Part I focuses on health supply chain specificity during the design phase. It contains the required
collaboration mechanisms with local partners, the MOH, private sector, and other key partners as well
as the expected cross-discipline collaboration and the different assessments conducted by prominent
donors in health.
CHAPTER 1.1: PROPOSAL
• CRS COMPASS Standards - Design Phase
• Global Fund The Challenging Operating Environments Policy Describes PSM capacities to be selected as a principal
recipient for The Global Fund
• Chemonics SCM
• GAVI Immunisation Supply Chain
• JSI The Supply Chain Manager’s Handbook
• The Global Fund Guide to Policies on PSM of Health Products
• USAID Logistics Handbook for Health Commodities
• USAID PMI Technical Guidance for FY 2023
• WHO QA
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Preparing the capacity statement is one of the most
important first steps of the proposal process. Capacity
statements are tailored to each call for expression of interest
depending on location and focus.
The GSCM Strategic Technical Assistance and Response
Health team develops and regularly updates the
organization's capacity statement to support new proposals.
The capacity statement includes key information
demonstrating CRS expertise in the health supply chain,
including:
• A category of health commodities directly or indirectly procured, stored, transported, and
distributed (e.g., antimalarial, RDTs), cold chain items, and medical equipment)
• Types of activities or services performed (e.g., warehouse and inventory management, technical
assistance, ICT4D for SCM, and innovations)
• Types of partnerships - public and private - implemented
• Geographical areas covered
• Activity implementation type: Direct management or health systems strengthening
• Number of beneficiaries supported
• Success stories and evidence-based solutions
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For new projects with no Health Supply Chain Manager position, the Supply Chain Manager of the
country program is responsible for preparing and providing input to the response.
The design of a health supply proposal requires health supply chain expertise.
If the country program does not have health supply chain expertise, we recommend reaching the SCM
Regional Technical Advisor for technical assistance support.
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
Please note the involvement of other stakeholders in proposals managed at the global
level. For instance, internal stakeholders could be GKIM, The Global Fund Support Unit,
and/or Regional Technical advisors. External stakeholders could be, national programs,
Pharmacy Directorate, and/or international partners
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CHAPTER 1.2: HEALTH SUPPLY CHAIN
ASSESSMENT
• CRS Supply Chain Transformation for Excellence Project Assessment Guidance
• The Global Fund Guidelines for LFAs for Capacity Assessment of Implementers Not addressed to implementers-
but valuable to know how LFAs conduct capacity assessment meetings
• The Global Fund Guidelines on Implementers of Global Fund Grants Includes requirements for assessing
Implementers of Global Fund grants
• The Global Fund Instructions on Implementation Arrangement Mapping Provides practical guidance on how to
map relations and links between entities, provides the symbol list, how to record flows on roles and
responsibilities, funds, commodities, and assets
• The Global Fund Technical Brief: Procurement and Supply Chain Management Helps countries and implementers
define the SCM roadmap in planning, execution, and enablers
• USAID Organization Capacity Assessment Tools
• WHO Essential Medicines Prequalification List
• WHO Electronical Essential Medicines List Provides detailed information on medicines
• WHO Good Storage and Distribution Practices for Medical Products
• WHO Medicines Prequalification
Conducting initial health supply chain and logistics assessments for health projects is essential to guiding
the design process and preparing to respond to donor requirements and reviews. Collecting baseline
data on logistics systems capacity and performance can better inform the design, determine the
resource requirements, and provide monitoring and evaluation data as shown in the figure below.
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A health supply chain assessment is required to identify the strengths and weaknesses of health
systems. However, considering the resources and time needed for that exercise, conducting a detailed
assessment during the design phase may not be feasible. Thus, we recommend collecting information
from previous reviews and requesting the donor perform a future thorough analysis.
The Health Supply Chain Manager needs to coordinate with implementers and stakeholders to conduct
the healthy supply chain assessment. Various supply chain assessment tools exist that are already
developed by well-known actors. Therefore, the available in-country information is leveraged.
Logistics Assessments: For more information, please refer to the Supply Chain Design chapter of the
CRS Supply Chain Management Handbook.
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Health supply chain experts lead health supply chain assessments. Country programs without in-house
expertise at the design phase need to request support from regions.
• CRS Supply Chain Transformation for Excellence Project Assessment Guidance: CRS’ internal
assessment tool, The Supply Chain Transformation for Excellence Project, takes a comprehensive
view of the supply chain opportunities ahead, including Project Insight, the release of the CRS Supply
Chain Management Handbook, CTP, and the HR job standardization project. The goal of this tool is
to transform CRS’ supply chain so that country programs can adapt to these changes. The Supply
Chain Transformation for Excellence Project Assessment Guidance will ensure that country
programs can 1) achieve program objectives, 2) meet global minimum standards, and 3) implement
Project Insight.
• USAID NSCA Toolkit: Funded by USAID is a comprehensive toolkit that can assess the capability and
performance at all levels of a health supply chain or focus on a specific level or site within the
system. CMM and KPIs are the metrics used to assess capability and performance, respectively. The
results of the assessment help supply chain stakeholders develop their strategic, operational, and/or
investment plans and monitor whether activities are achieving desired outcomes.
• UNICEF Supply Chain Maturity Model: This model is a participatory, qualitative, and government-led
supply chain assessment tool that governments and organizations can use to measure the
performance of key supply chain functions across five levels. Level 1 brings evidence of minimum
development, while level 5 reflects best SCM and practices. The maturity model complements other
quantitative supply chain assessments such as the Effective Vaccine Management, NSCA, and
Immunization Supply Chain Process scorecard. In addition, the tool allows for matching shifting
country needs with external partner resources and helps partners with planning and coordination
processes.
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• The Global Fund CAT (LFA template): Before signing a grant agreement with a Principal Recipient,
The Global Fund ensures that the proposed implementation arrangements are sound. To do so, The
Global Fund, through the LFA, assesses whether the systems and capacities of grant implementers
are adequate for effective management of the grant funds. Indeed, The Global Fund’s CAT covers
various aspects of a project from governance, finance, programmatic to procurement, and SCM. The
assessment aims to:
▪ Evaluate the capacity of CRS to implement the program.
▪ Describe and assess the proposed implementation arrangements and systems in four
functional areas: M&E, PSM, Finance, and Governance.
▪ Determine if CRS has adequate capacity and systems in place to fulfill the role assigned in
the program.
▪ Identify critical capacity gaps and determine capacity-building measures to address these in
the short and long term.
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o
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CHAPTER 1.3: HEALTH SUPPLY CHAIN DESIGN
• CRS Supply Chain Management Handbook. Chapter 4: Supply Chain Design
• JSI The Supply Chain Manager's Handbook, Chapter 2: System Design & Strategy Provides an understanding of
the importance of dedicating resources to supply chain design and guidance
• JSI The Supply Chain Manager's Handbook, Chapter 3: Logistics Management Information Systems Provides
further details about how data are used for routine operations, strategic decisions, and monitoring of the
performance of the supply chain
• The Global Fund Instructions on Implementation Arrangements Mapping Provides practical guidance on how
to outline the map, the relations, and links between entities; also provides the symbol list, how to record the
roles, responsibilities, fund and commodity, and asset flows
• Village Reach Supply Chain Design: Options to Address Common Challenges Provides guidance on preparing
supply chain design while using governmental systems
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Public health systems are often defined as all public, private, and voluntary entities that contribute to
delivering essential public health services within a jurisdiction. A public health supply chain is a network
of interconnected organizations or actors that ensures the availability of health commodities to the
people who need them.
The purpose of designing the logistics system is to optimize the flow of commodities and information, as
well as standardize the related business processes.
It is required to conduct optimization exercises based on the supply chain performance analysis and
cost-effectiveness analysis outcomes to identify a more efficient warehousing and distribution
mechanism. Coordination and discussion with stakeholders should be conducted to design a system that
aligns with the national supply chain strategy. Propositions for redesigning the supply chain need to be
aligned with existing national plans, if any (i.e., NSC transformation plans, conclusions of previous
assessments, etc.). Any change in the supply chain design will likely have a cost impact (new contractors,
required training, etc.) that will need to be accounted for in the budget.
The Health Supply Chain Manager should explore the identified 5 Promising Practices to guide
design discussions while using governmental supply chain systems. For example, the following five
promising practices were successful, even for hard-to-reach communities: direct delivery, level
jumping, outsourcing (engaging the private sector), resources sharing, and resupply frequency.
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Country programs may not have the opportunity to conduct the detailed analysis and design
recommended above due to various reasons. The implementation arrangements often align to the
existing health supply chain network. It is required to discuss arrangements with the donor to agree on
the detailed analysis timeline later during the implementation.
It is imperative to collaborate with the MOH and related departments to establish an implementation
arrangement in the health supply chain. Understanding how the existing supply chain works helps
country programs collaborate with implementing partners to define the best health supply chain
network. The design of the health supply chain network can include:
• Leveraging on the existing health supply chain infrastructure.

• CRS directly distributing health products.
• Contracting third-party service.
• Combining various approaches above.
Procurement can be performed through a procurement service agent and/or directly by CRS.
Warehousing and transportation of health products can be performed through Third-Party Logistics
providers from the public sector, i.e., central medical stores, or the private sector. At last-mile delivery
points, health products can be delivered to patients throughout various settings such as health facilities,
directly through temporary distribution points, or via door-to-door advanced strategies.
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
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Product flow charts intend to represent the physical path taken by the products from the port of entry
to the patients or end-users. Having a clear picture of the distribution process from one point to another
helps define how responsibilities and custody are managed and identify strengths and risks in terms of
management as safety of the products and accountability. See the below figure that shows the seasonal
malaria chemo prevention’s product flow chart model.
CRS INT L SUPPLIER PORT CENTRAL REGION DISTRICT HEALTH FACILITY Country side
CRS’ Regional Med Store

(6)
Districts
(38)
Health Facility
(381) South
Programmati
c Order Prep
Procurement Service
Port
Central Med Store
Agent (1)
Responsibilit
y
CRS’ Supply chain
Regional Med Store
(2) responsibility
Districts
(25)
Health Facility
(362)
North
CRS ’supply chain

responsibility to be defined
The product flow chart sketches how products flow throughout the supply chain and defines which
stakeholder has responsibility, custody, and accountability.
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
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Information flow charts represent the logistical information's physical (for paper-based supports) or
virtual (for electronic support) stream. Having a clear picture of how the logistical information flows
between the various points helps define reporting mechanism of key information (i.e., stock levels). The
figure below from Chapter 3 of JSI’s The Supply Chain Manager’s Handbook, A Practical Guide to the
Management of Health Commodities shows a sample of a logistic information and supply flow diagram.
Source: Sample LMIS Information and Supply Flow Diagram, The Supply Chain Manager’s Handbook,
A Practical Guide to the Management of Health Commodities, John Snow, Inc., 2020, p. 27.
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
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Health supply chain projects require partnering with various stakeholders. These stakeholders play key
roles in the importation, transportation, warehouse and inventory management, data management,
distribution, and dispensation. CRS can establish a partnership with the private sector (i.e., Third-party
Logistics) and public sector (i.e., central medical store, national programs, and health facilities) entities.
To implement SCM activities, each party needs to have a common understanding of their roles and
responsibilities. A detailed SOW will need to be developed to define the process, roles, and
responsibilities in the collaboration.
The SOW, payment modalities, and donor guidance will constitute the agreements. More details on the
contracting mechanism are provided later in the contracting chapter. This section covers the
establishment of the process.
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CHAPTER 1.4: DEFINE PROCUREMENT AND
SUPPLY CHAIN INTERVENTIONS
• CRS COMPASS Standard 2

• USAID Vision for HSS 2030
• The Global Fund Modular Framework Handbook

• The Global Fund Resilient and Sustainable Systems for Health
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The procurement and supply chain interventions are defined based on the supply chain assessment
outcomes and align with national supply chain strategies.
At CRS, we recommend including interventions justified by evidence-based needs or gaps and national
stakeholders' early involvement in elaborating the strategy and interventions.
Supply chain interventions can be categorized into two categories:
• Intervention related to the management of commodities for a project: Includes the cost related to
procurement, pre-shipment QC, international transport, warehousing, and in-country distribution.
• Interventions related to strengthening the national procurement and supply chain system:
Includes capacity building for the SCM workforce, digitalization of the health system, system
optimization, supply chain assessment, infrastructure improvement, strengthening the NMRA, and
Pharmacovigilance.
Prominent donors are considerably investing in health supply chain system strengthening. PSM
interventions should be elaborated in light of donors and country supply chain strategies.
• Global Fund refers to RSSH to design all the interventions for strengthening the health system. It
includes improving procurement and supply chain, strengthening data systems and data use,
building stronger community systems and responses, promoting integrated people-centered
health services, and investing in HR. A detailed Global Fund Supply Chain Road Map covering
2023-2025, developed with stakeholders, provides guidance relevant during the design phase.
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• USAID also revised its strategies and implemented the NextGen Global Health Supply Chain with
an emphasis on supply chain segmentation, improving private sector partnership, reinforcing
government stewardship, increasing end-to-end visibility, using performance contracts, and
improving risk management.
The GSCM Strategic Technical Assistance and Response Health team developed a compendium of
generic activities to support The Global Fund health supply chain team. Generic activities are intended
to ensure alignment of in-country support provided by the CRS technical experts for implementing
Global Fund grants and delineate the roles and responsibilities of the CRS supply chain supporting
system: headquarters, regions, and country programs.
Per CRS’ programmatic approach, the country program will implement activities; the SCM Regional
Technical Advisor will provide direct support and technical oversight to the country program; and the
headquarters team will develop strategic orientation, processes, procedures, and materials for capacity
building.
The CRS Detailed List of Health SCM Activities will guide the supply chain manager in the country
program and the SCM Regional Technical Advisor in implementing supply chain activities. The list
describes the type of activities that the country program needs to implement to support the health
supply chain grants.
This detailed list of activities intends to provide the country program and regional technical advisors
with a systematic approach to use across the various grants and to better define the roles and
responsibilities of stakeholders.
The activity list will also provide direction for the SCM Regional Technical Advisor to ensure required
country program support is provided, as well as provide clarity on the GSCM Strategic Technical
Assistance and Response health team activities.
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The CRS Detailed List of Health SCM Activities includes specific activities required during a Global Fund
project's design, start-up, implementation, and close-out. The list has categorized the activities per
intervention to facilitate the navigation per the list below:
1. Strengthening CRS internal health supply chain processes:

a) Readiness assessment support
b) Internal support & collaboration
c) Strategy, policies & procedures/compliance
d) Strong relationships with donor's supply chain division
e) Project implementation support
2. Elevate supply chain effectiveness through innovations:
f) Data management, analysis, and reporting
g) Risk mitigation
3. Reinforcing and institutionalizing the risk-based approach in health SC
4. Reinforce our workforce knowledge in health SC best practice
h) Reinforce and strengthen country program staff (Supply Chain Manager, Programming
Staff) knowledge
i) Capacity building for partners
5. Reinforcing the use of metrics and performance
j) Metrics and performance
In addition to the above categories, we have included specific objectives expected to better guide end-
users.
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After reviewing existing material from the donor, CRS, and outcomes of the supply chain assessment,
the supply chain team will need to prioritize intervention.
o
o
o
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The country program collaborates with national authorities and implementing partners to develop a
clear description of PSM interventions and activities to gain donor approval. PSM interventions and
activities that are new and/or require new technologies, and processes, or include some level of
complexity require a detailed description or visualization to gain acceptance from stakeholders. The
process below describes how to prepare the operational plan as additional resources detailing some of
these activities.
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
Two types of descriptions are required: The PSM operational plan, detailing common PSM operations
(warehousing, transport, procurement, etc.) and narratives or term of reference for more complex
activities.
− For each suggested intervention, a concise description of the activity, with information on the
issue to resolve, the reason for selecting that activity with evidence-based data, number of
beneficiaries, participants, or facilities covered, the indicators to monitor, and the expected
outcomes. See the CRS Model of Budget Narrative.
− The operational plan provides information on the routine distribution and mass campaign
distribution mechanism, logistics arrangements, and roles and responsibilities of the
stakeholders. See the CRS Model of Procurement and Supply Chain Management Plan.
— 38 —

Providing an in-depth description of PSM activities allows to better plan for cost elements and
budgeting. Each donor provides guidance on the elaboration of the budget and cost elements.
o
o
o
o
o
o
o
o
o
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— 39 —

— 40 —

— 41 —

CHAPTER 1.5: QUANTIFICATION OF HEALTH
PRODUCTS

• The Global Fund Procurement Policy

• The Global Fund QA Policy for Diagnostics Products
• The Global Fund QA Policy for Pharmaceutical Products
• JSI The Supply Chain Manager’s Handbook

• The Global Fund Interim QA Requirements for the Procurement of COVID-19 Diagnostic Products
— 42 —

Quantification is the process of estimating the quantities and costs of the products required for a
specific health program (or service) and determining when to deliver the products to ensure an
uninterrupted supply for the program.
Quantification is a major and iterative exercise to ensure accessibility to essential medicines.
For new projects, the capacity assessment process (documentation review and interviews with
leading stakeholders) as the gaps and risk analysis performed at the earlier stage (see Part 1)
should provide the country program with an overview of strengths and improvements needed to
support the quantification exercise.
For renewed grants, lessons learned are crucial to defining areas for improvement.
The guidance provided here describes how the three major steps of preparation, forecasting, and supply
planning, sketched below, should be supported by country programs. The following figure sourced from
Chapter 5 of JSI’s The Supply Chain Manager’s Handbook, A Practical Guide to the Management of
Health Commodities shows key steps in quantification.
— 43 —

Source: Steps in Quantification, The Supply Chain Manager’s Handbook,
A Practical Guide to the Management of Health Commodities, John Snow, Inc., 2020, p. 55.
The preparation stage is critical to a successful forecast.
— 44 —

•
•
•
•
•
•
•
•
•
•
•
•
— 45 —

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o
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— 46 —

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— 47 —


o
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o
Forecasting is the process of estimating the quantities of products that will be dispensed or used to
meet the needs of a targeted population during a future period.
Forecasts are prepared based on historical consumption, services, morbidity, and/or demographic data.
The table below defines types of data, sourced from definitions from JSI’s The Supply Chain Manager’s
Handbook, A Practical Guide to the Management of Health Commodities.
— 48 —

Source of Definitions in the above table: The Supply Chain Manager’s Handbook,
A Practical Guide to the Management of Health Commodities, John Snow, Inc., 2020.
The country’s quantification guidance should define the type of data used. Then, the team needs to
reach a consensus based on data reliability, availability, and informed or calculated extrapolations, if not
available.
Assumptions are made to adjust historical program data for poor quality (incomplete, outdated,
unreliable, or unavailable) and for future program performance. Assumptions may include elements
such as:
— 49 —

• Expected uptake in services (i.e., population migrations).
• Compliance with recommended treatment guidelines (i.e., adoption of WHO’s Electronic
Essential Medicines List).
• Future changes in STGs and introduction of new commodities.
• Impact of changing program policies and strategies on supply and demand.
• Service capacity (infrastructure, HR availability, and capacity).
• Client awareness of and access to services.
• Timing and amount of funding commitments for procurement.
• Seasonality (i.e., rainy periods).
• Geographic variations in disease incidence and prevalence.
• Other factors that may affect demand.
Forecasts completed using services, morbidity, demographic, or program target must be converted from
several patients, visits, and episodes treated into estimates of quantities of products consumed. The
conversion requires assumptions about applying and adherence to STGs, dispensing protocols, testing
algorithms, or lab testing procedures.
— 50 —

Conversion of Data into Product Quantities – Source JSI
CRS uses various tools and software to calculate forecasts:
— 51 —


Quantification exercises fall under the country's leadership or national program leadership. However,
country programs must understand the assumption and process to champion the supply plan and PSM
budget.
— 52 —


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— 53 —

— 54 —

Supply planning is the final output of the quantification process that determines the quantities required
to fill the health product pipeline, related costs, lead times, and shipment dates to ensure optimal
procurement and delivery schedules.
There are various tools and software used to plan shipment:
— 55 —

After health supply implementation arrangements are defined and distributed amongst main
stakeholders and CRS, the supply planning will reflect product to procure and related procurement costs
supported by CRS. For instance, if the QA/QC activity is included in the HSS grant funded by another
recipient than CRS, the supply plan carried out by CRS must not have this activity.
Donors have different supply planning tools to collect information on commodities – costs and delivery
schedule information.
• PEPFAR-funded programs use the Commodities Supply Planning Tool. This Excel-based and
interactive tool enables countries to perform projections within the next 18 months of all
Antiretrovirals (adult, pediatric, infant prophylaxis, Prevention of Mother-to-Child Transmission, and
Pre-exposure Prophylaxis) for Antiretroviral Therapy.
• US PMI projects use the Gap analysis table to collect information on required commodities to be
funded by the donor.
• GAVI-funded programs use the vaccine portfolio template at the funding request stage.
• The Global Fund-funded program uses the HPMT. The following paragraph will focus on how to
complete this tool required by the donor at the CRS level.
The HPMT and the detailed budget template are the final steps for completing The Global Fund’s
funding request process. Both documents include PSM activities and related costs and should be
prepared and completed by country programs.
Both templates are provided by The Global Fund’s country team to principal recipients with a timeline
summarizing the due dates for the first submission, review, and final approval before grant signing.
— 56 —

The HPMT provides detailed information on the health products, PSM costs, and delivery schedule for
Global Fund grants.
The terminology PSM costs are often used in Global Fund grants and refer to all the costs encountered
from sourcing, international transport, QA, in-country distribution, warehousing, and storage.
The table below describes the different types of PSM costs and where to find the reference prices.
— 57 —

The present paragraph focuses on the process to complete and validate the HPMT.
In the following paragraph, “Health Supply Chain Manager” designates any person supporting the roles;
we understand that the position can be vacant during grant-making, and a selected country focal point
can support or temporary technical assistance. The “Health Supply Chain Manager” reminds and
highlights that the work requires expertise in health SCM.
— 58 —


— 59 —

The Global Fund’s funding allocation mechanism differentiates two types of interventions with specific
interventions:
1. Direct supply chain interventions: Come in direct support to achieve program objectives and are
disease specific. Interventions can include HPM functions such as procurement, quality
monitoring, warehousing, transportation, and reporting.
2. RSSH interventions: Aim to build a stronger health system and capacities (including laboratory),
thus, integrating the interventions for the three diseases (Malaria, TB, and HIV) to resolve
systematic issues.
The Global Fund Modular Framework Handbook provides clear guidance on describing and categorizing
the PSM activities, interventions, and modules.
— 60 —


— 61 —


— 62 —


Preparing for negotiations sessions with the donor and the main stakeholder includes
listing and communicating what will be needed from the country program perspective
in terms of support provided by regions and global departments.
Planning ahead will allow other departments to plan, organize, prepare, and
coordinate for support during negotiations with donors.
Supporting evidence-based elements for grant negotiations can be:

• Narratives of activity description.
• Business case presentations for innovative activities.
• LOE analysis for PSM and data analyst staffing.
• JDs.
• Organizational charts and definition of PSM roles and responsibilities support to justify
overheads costs.
• Cost elements justifications (contracts, prices, and invoices).
• Presentation from subject matter experts.
• Studies.
— 63 —


— 64 —

— 65 —

— 66 —

CHAPTER 1.6: RISK ASSESSMENT
• CRS GSCM Operational Risk Register Operational Risk Register Template Draft.xlsm
• The Global Fund Risk Management Policy
• The Global Fund Risk & Assurance Toolbox

• USAID Risk Management for Public Health Supply Chains
Risk management is a formal approach used to identify and mitigate the sources of disruption and
dysfunction within the public health supply chain.
Risk management is an iterative process throughout the grant implementation.
— 67 —

The health supply chain assessment, supply chain design, and the quantification of health products
provide the country program with a good understanding of the activities to implement, and the risks
attached.
Before signing the grant documents, the Agency must re-evaluate the grant risks and establish
mitigation measures.
— 68 —


— 69 —

— 70 —

— 71 —

PART II: START UP
Start-up is the phase between planning and execution. COMPASS provides further information and
guidance on navigating the project start-up journey.
In line with other projects, the health supply chain project requires human and financial resources for
successful implementation.
Pharmaceutical and other health commodities are critical products and sometimes lifesaving, and
therefore, particular attention must be paid to their management to maintain their quality and
uninterrupted supply. Managing the peculiarities of health products requires:
• Recruiting a supply chain manager with an HPM background.
• Have a pharmacist on the team.
• Preparing agreements/contracts with third parties able to comply with good storage and
distribution practices.
• Preparing for procurement activities.
— 72 —

CHAPTER 2.1: RECRUITMENT OF THE HEALTH
SUPPLY CHAIN MANAGER
• CRS COMPASS – Standard 9

• CRS Policy on Recruiting and Selection
• JSI The Supply Chain Manager's Handbook Chapter 10 outlines organizational capacity and workforce
• The Global Fund Guide to Policies on PSM of Health Products Section 2.4 related to QA Systems describes
requirements to manage health products per WHO standards, including recruiting staff to oversee QA
aspects
The processes outlined below describes the recruitment of health supply chain managers with HPM
experience and/or pharmacist backgrounds.
The Supply Chain Manager supporting health grants should demonstrate special abilities in
understanding national health supply chain management, identifying risks, developing technical
arguments, and gathering information that adequately feeds decision-making processes.
Health supply chain management requires a pharmacist or experienced staff in product health
management via national systems to fulfill donor requirements as per The Global Fund Guide to Policies
on PSM of Health Products and WHO Model QA for Procurement Agencies. The pharmacist or
experienced staff in product health management must have the appropriate training to manage
QA, drug use, and pharmaceuticals procurements.
— 73 —


HR departments from country programs manage selection processes based on the

criteria or qualifications of the position advertised. HR selects five to 10 CVs to pass a
written exam and interview.
— 74 —

— 75 —

CHAPTER 2.2: SUPPLY CHAIN STRATEGY AND
COORDINATION
• CIPS Strategic Supply Chain Management

• JSI The Supply Chain Manager's Handbook- Supply Chain Strategy Page 17
The supply chain strategy is the roadmap developed to guide the health supply chain management
optimization. Supply chain strategy in the private sector considers the value that can be derived. This
value is also valid in the public health sector; a cost-efficient supply chain in delivering products to
patients allows better use of the scarce resources in the health system. Moreover, clear objectives and
long-term goals defined in the supply chain strategy contribute to attaining less waste and addressing
recurrent challenges.
Prominent donors recommend establishing a national strategy to facilitate resource mobilization and
coordination among stakeholders.
The development of supply chain strategy can occur at the design, start-up, or implementation phases.
The supply chain strategy is developed in coordination with all stakeholders and led by the entity in the
MOH in charge of health products. In most countries, this entity in charge is the National Pharmaceutical
regulatory authority.
— 76 —

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— 77 —

— 78 —

In health supply chain management, coordination is critical for efficient implementation and good use of
the resources available in countries.
In most of the country program, the main stakeholders are:
− Implementing partners: Central Medical store, international NGOs, national entities, private
service providers, etc.
− National stakeholders: MOH and their subdivision
− Donors: US PMI, USAID
− Suppliers: International and national suppliers
The supply chain technical working group includes representatives of the mentioned entities. However,
variations from countries exist with disease-specific, sub-technical groups, or even decentralized
coordination. Functional decentralized coordination aims to improve reporting rate, promptness, and
data quality.
— 79 —

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— 80 —

— 81 —

CHAPTER 2.3: HR ANALYSIS
Successful health supply chain management requires adequate staffing to run and/or oversight HPM
activities. Two types of approaches can be combined to evaluate SCM's staffing needs:
• Assessment of the volume of transactions (procurement or inventory): The information might
only be available once country programs have the Insight SCM module deployed.
• Analysis of the expected workload per staff includes a three-step methodology:
1. Modeling staff workload includes reviewing LOE and time OOO for each staff position.
2. Analyzing the results by adjusting the allocated work as JDs and calculating appropriate
staffing levels.
3. Advocating for additional staff.
Staffing analysis should be conducted at the early stages of the start-up phase, annually during the
implementation phase, and during the reprogramming stages. Evidence-based results of the analysis
facilitate discussions and negotiations with donors and CRS leadership on staffing needs.
— 82 —


The CRS Model for SCM HR Analysis can include justifications for change management as shown in the
below table.
— 83 —

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— 84 —

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o
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In the case of Nigeria, the five staff work 40-hour weeks. The total time required to complete all tasks
was 280 hours, but the five staff members only have 200 hours. Therefore, the analysis suggests that the
program needs at least two more staff members at 40 hours each to cover the remaining work.
However, note that the LOE calculation does not consider staff OOO time.
A totaled number of days each staff member would be out of the office running activities outside of the
office. The calculation did not include travel time to the field. The Nigerian PSM staff JDs include the
— 85 —

amount of expected travel (ranging from 40-75%), and the OOO was compared to the amount of
expected travel. The totals differed by 137%. This indicates the need for two or three additional staff.
The LOE nor the OOO calculations cover planned activities. Unplanned activities, such as a flood (e.g.,
Taraba, 2019) will increase the workload and the OOO requirement. If the donor adds additional
deliverables to the grant (e.g., adding service to IDPs in Taraba), both the LOE and the OOO calculations
should be reviewed.
Whenever the analysis results show discrepancies between existing JDs, workload, exceeding level of
efforts, then the Health Supply Chain Manager or for new grants, the SCM Regional Technical Advisor, or
the country program Supply Chain Manager should advocate for additional staffing.
— 86 —

— 87 —

CHAPTER 2.4: CONTRACTING WAREHOUSE AND
DISTRIBUTION SERVICES
• JSI The Supply Chain Manager's Handbook Chapter 8 provides useful information related to warehousing
and distribution
— 88 —

Health grants often build on existing national health supply chain networks. Global Fund, USAID, and
GAVI-funded projects encourage that approach to ensure sustainability and strengthening of national
health systems. In alignment with this view, CRS should establish agreements with national entities
and/or service providers from the public and private sectors to manage SCM services, including
performance-based contracts with KPIs. Agreements can cover warehousing, transportation, clearance,
or other services related to SCM and logistics management information. Agreements can reflect various
dynamics between donors, service providers, Principal Recipients from other grants, and CRS.
It is fundamental to plan provisions for reviewing agreement terms and include lessons learned after
annual reviews.
The SOW should be aligned with in-country partners using the services of the CMS or third-party, using
the in-country coordination mechanism. It is also recommended to conduct an annual review of the
contracts for existing programs or new country programs include lessons learned.
— 89 —

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— 90 —

— 91 —

Contracting Warehousing and services
The SCMgr regularly

organize quarterly The SCMgr tracks
SCMgr regularly
warehouse visit, the implementation
reports to
quarterly monitoring of identified
stakeholders the
of the performance recommendation to
SCM performance
and the annual improve the SCM
physical inventory
CP
Start
The SCMgr fill the The HoOPs review

CRS template and the contracts and
Contracts and
The SCMgr seek The SCMgr finalize the SOW submit for CRS
service level End
support from the prepare the SOW and submit to the internal approbation
agreement signed
the RTAs and GFSU and fill the HoOPs and CoP for per APP policy and
for the contract contracts their input procedure
development. questionnaires
The RTA SCM RTA SCM collect on

review the national
Region -RTA
a regular basis
The RTAs SCM service level information on the
reviews technically agrement the SOW SCM performance
the SOW and the and check the and suggest
inclusion of inclusion of KPIs, improvement
performance Insurance, and actions
management clause monitoring plans
yes
STAR Health team

The RTA SCM suggest
informs and seek improvement
Health STAR team actions and leverage
No support on on the lessons
challenges reported learned to develop
HQ
The GFSU provide the by the SCMgr capacity building

contract questionnaire Legal team review Use CRS contracts or material
to the SCMgr to and suggest the National template for
identify the appropriate contract Service level agreement
appropriate contracts
Mechanism
— 92 —

CHAPTER 2.5: SUPPLY PLANNING
Supply planning determines the required quantities per period from the annual forecast of health
products after considering stock in countries and projected consumption to ensure inventory stock
levels remain between minimum and maximum range levels.
• GDF Category and Product-level Procurement and Delivery Planning Guide (TB) (2022)
• GDF Resources
• The Global Fund Category and Product-level Procurement and Delivery Planning Guide – Health and Non-health
Products
The Health Supply Chain Manager develops the supply plan based on forecasted quantities (refer to the
HPMT for Global Fund grants). The supply plan must include the list of items procured via Pooled
Procurement Mechanism and/or direct procurements. The supply plan can be prepared using software
such as the PipeLine, or using an Excel spreadsheet including the following information:
• The type of commodities and detailed specifications.

• The quantities of health products expected per shipment.
• Delivery dates (estimated time of arrival).
• Status of the shipment expected and if the orders were confirmed or not.
• The stock on hand at all levels at a specific period. For example, information collected during the
last reporting period.
• The national established maximum and minimum levels of inventory.
• The estimate of the Months of Stocks.
• The expiration date of the health products.
• The consumption data (if not available, use the forecasted quantities).
At the end of the supply planning exercise, the supply plan report should be issued.
When CRS implements a new Global Fund grant as the primary recipient (PR), the stocks of previous PR
must be formally transferred to CRS. This stock transfer should be considered during supply planning.
— 93 —

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— 94 —

— 95 —

CHAPTER 2.6: PROCUREMENT
Procurement of health products can be performed directly by CRS or using donors 'procurement
mechanism, systems, or solutions.
For example, Global Fund grants recommend the use of the Pooled Procurement Mechanism for Malaria
and HIV products and GDF for Tuberculosis products. GAVI will recommend the use of UNICEF and WHO
OPS. USAID identifies procurement solutions for each product
• CRS Policy on Consultants

• CRS Procurement Approvals Policy
• CRS Procurement Contracts Policy
• CRS Procurement Policy
• CRS Purchase of Program Property Policy
• CRS SCM Offline Transactions and Approvals Policy
• CRS Selection and Purchase of CRS Vehicles Policy
• CRS Supplier Master Policy and Procedure
• CRS Supply Chain Records Management Policy
• The Global Fund Guidelines for Grant Budgeting Section 7 related to specific budgeting and costing guidance
• WHO Model QA System for Procurement Agencies
Please refer to the Procurement chapter of the CRS Supply Chain Management Handbook for the best
guidance related to the procurement of health products.
— 96 —

PART III. IMPLEMENTATION
With the approval of the grants, the implementation of supply chain activities can start as per the
established detailed implementation plan.
In this part, we will discuss the critical process required in the supply chain of health products.
CHAPTER 3.1: STOCK MONITORING
• JSI The Supply Chain Manager's Handbook Chapter 7 provides further information on Inventory Planning
• The Global Fund Principal Recipient Progress Update and Disbursement Request Section 3 of the
procurement and supply management reporting chapter describes minimum requirements to conduct
stock and expiry dates analysis
• USAID Pipeline Software Database Administrator’s Guide
• WHO Harmonized Monitoring and Evaluation Indicators for Procurement and Supply Management
Systems
Health supply chain practitioners thrive on reducing the amount of stock held while endeavoring not to
run out of stock or end up with expired products. This is achieved by monitoring the stock levels.
Stock monitoring in health grants involves collaboration with national health information systems,
specifically the LMIS. Some countries have well-established LMIS systems with paper and electronic-
based systems, while others are still building the system.
In some countries, logistics coordinating entities named the Logistic Management unit, oversee and
coordinate logistics activities hosted by the MOH.
Thus, the LMIS reports are collected from decentralized teams and aggregated at the district/states and
later at the central level. Therefore, the Supply Chain Manager, in collaboration with the program,
should liaise with that unit to access the LMIS data.
— 97 —

— 98 —


— 99 —

A quarterly supply planning review is required to allow an on-time replenishment of health
commodities.
Different tools and software are used. For example, The PipeLine Monitoring and Procurement Planning
System (PipeLine) was designed to enable program managers to plan optimal procurement and
shipment schedules for health commodities and monitor the stock status of health products.
Under GHSC-PSM, the tool is being upgraded to the new online QAT. This tool will have a
comprehensive forecasting and supply planning solution with an enhanced user interface, automated
and integrative analytics, and interoperability opportunities with external systems. The introduction and
use of QAT will be conducted in a phased approach with countries.
— 100 —


— 101 —

CHAPTER 3.2: FINANCIAL REPORTING OF
HEALTH COMMODITIES

• CRS FFATA Reporting Procedure
• CRS Insight Inventory Management Reference Guide
• The Global Fund Guidelines Principal Recipient Progress Update and Disbursement Request. Section 6 describes
donor requirements
The ability to demonstrate that funding spent aligns with agreements in a transparent manner showing
accountability is fundamental.
— 102 —


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— 103 —

— 104 —

CHAPTER 3.3: TRACKING PSM COSTS FOR
GLOBAL FUND GRANTS
• The Global Fund Operational Policy Manual Section 2 includes operational procedures on annual funding decisions
and disbursements and Pooled Procurement Mechanism
• The Global Fund Guidelines Principal Recipient Progress Update and Disbursement Request Section 6 describes
donor requirements related to price and quality reporting
PSM costs disbursed directly by The Global Fund country team to the procurement agencies need to be
tracked for the inclusion in CRS financial reporting mechanism. The Global Fund country team shares
disbursement notification to the Chief of Party, Country Representative, and the PR. Therefore, the
Supply Chain Manager must collect that information to support reporting. In addition to the
disbursement notification, the information is available on the Wambo.org platform. The Pooled
Procurement Mechanism agencies also provide the quarterly financial report with the detailed cost
incurred by the project.
— 105 —


— 106 —

— 107 —

CHAPTER 3.4: QA

• CRS Inventory Counts Policy
• The Global Fund Operational Manual Policy

• The Global Fund QA Policy for Diagnostic Products
• The Global Fund QA Policy for Pharmaceutical Products
• JSI Guidelines for Warehousing Health Commodities Appendix 1 includes a list of relevant questions to ask
during the assessment.
• The Global Fund Guide to Policies on PSM of Health
• The Global Fund In-country Monitoring of Pharmaceutical Products in Global Fund-supported Programs
• WHO Assessment Tool Based on the Model QA System for Procurement Agencies: Aide-Memoire for
Inspection
• WHO Guidelines for Sampling of Pharmaceutical Products
• WHO List of Prequalified In Vitro Diagnostic Products
• WHO QA Policy for the Procurements of Essential Medicines and Other Health Products
— 108 —

QA is a wide-ranging concept covering all matters that individually or collectively influence the quality of
a product. It is the totality of the arrangements made to ensure that pharmaceutical products are of the
quality required for their intended use.
NMRAs are legally responsible for overseeing the quality of pharmaceutical products in countries.
All parties involved in the distribution of pharmaceutical products are responsible for the quality and
integrity of pharmaceutical products. The responsibility remains throughout the distribution process
from the manufacturer's site to the entity dispensing or providing the product to the patient.
The table below shows the minimum required quality standards to source and procure health products.
— 109 —

For additional verification of compliance with The Global Fund QA policy, it is recommended to use the
Global Fund eligible products lists (available on The Global Fund website, QA section) to ensure that the
products to procure are listed.
Please refer to the Procurement chapter in the CRS Supply Chain Management Handbook for more
guidance on sourcing and procuring health products including medicines, Rapid Diagnostic Products, and
bed nets.
GDP and GSP for Pharmaceuticals apply to manufacturers, pharmaceutical importers, contractors,
wholesalers, communities, and hospital pharmacies. Each guidance gathers the minimum and standard
requirements to maintain pharmaceuticals of good quality for human use and should be incorporated
into national regulations.
Donors funding projects, including the distribution of health products, require that patients or end users
have access to good quality products. Therefore, as Principal Recipient, CRS needs to ensure that the
quality of products is kept along the supply chain even while warehousing and transportation services
are externalized to Third-party Logistics.
The main elements of QA in grant-supported programs are:
• Sourcing of products per Procure-to-pay and in compliance with donor's QA policies.

• Appropriate temperature conditions during international freight.
• Appropriate storage conditions at all levels of the in-country supply chain.
• Secured distribution systems.
— 110 —

• Batch traceability system throughout the supply chain.

o
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o
— 111 —

The SCM Regional Technical Advisor and Health Supply Chain Manager review the table below to guide
the regular assessment:
— 112 —

— 113 —

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— 114 —


— 115 —

QC testing will enable country programs to:
• Monitor the quality of the medicines procured and distributed by CRS and partners along the
supply chain.
• Provide evidence that medicines reaching patients meet specifications.
• Identify products or batches not meeting specifications and remove them from the supply chain.
• Obtain information to support gap analysis and risk management in the supply chain.
— 116 —


o
o
— 117 —

Sampling plans include lists of products that will be tested, collection date, and the testing method as
the criteria to define acceptance. In addition, sampling plans should consider supply chain-related risks
as well as product-related risks.
√
√
√
√
√
√
√
√
√
√
√
√ ○
√
√
√
√
√
√
√
√
√
√
√
√
— 118 —


For each product to be sampled, it is important to know in advance how many units
(I.e., number of tablets, number of bottles) need to be collected. This information
comes from the selected QC Laboratory.
— 119 —



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— 120 —

— 121 —

— 122 —

CHAPTER 3.5: DISTRIBUTION

• CRS Digitizing Health Campaigns Improves Outcomes
• CRS In-Country Management and Distribution of Long Lasting Insecticide-Treated Nets
• CRS Inventory Counts Policy
• WHO Model QA System for Procurement Agencies

• The Alliance for Malaria Prevention Toolkit 2.0
• The Task Force for Global Health Decision Toolkit on Health Campaign Integration Designed to assist
officials and stakeholders at the country and global levels to identify and collect information on potential
opportunities for health campaign integration
Distribution consists of moving products down the pipeline from the national central warehouse until
they are dispensed to patients or made available to end users.
The most common in-country distribution system is a system where products flow from central medical
stores to regions and or districts and ultimately to Service Delivery Points. Distribution networks need to
consider what is the ideal distribution network that will provide a satisfactory level without stock outs at
dispensing facilities.
— 123 —

Routine distribution, as opposed to mass campaign distribution, aims to maintain a constant supply of
products as per cycles defined by national guidance. For instance, national schemes can have
established that Service Delivery Points are supplied monthly, district pharmacies every quarter,
regional warehouses every semester, and central medical stores annually. Distribution can be based on
a pull system (requisition), push system (allocation), or hybrid approach combining pulling and pushing
systems.
Implementing successful distributions depends on establishing a solid collaborative partnership with

main stakeholders to ensure that the right products are delivered at the right locations, right time, and
in the right quantities. Modeling, organizing transportation, and planning to deliver the right quantities
before needed is key.
— 124 —


o
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— 125 —


— 126 —

— 127 —

Mass distribution campaigns aim to reach an important number of beneficiaries to prevent diseases.
Distribution for mass campaigns can be organized through door-to-door or fixed-point deliveries.
Health mass campaign distribution activities are organized to reach many beneficiaries for a given
period. Mass campaign distribution is used for various health interventions to reach higher coverage.
The types of products used varies from vaccines, ITNs, Nutrition (Vitamin A), drugs for Seasonal Malaria
Chemoprophylaxis, and Neglected Tropical Diseases.
For a successful mass campaign, many complex and disparate activities are performed, such as:
• Macroplanning: Include the planning process with the development of an action plan, timeline,
and the elaboration of the Macro budget managed at the central level.
• Procurement: Health products and services providers for transport, storage, printing tools, and
vouchers.
• Coordination: A coordination mechanism with clear roles and responsibilities at all national
system levels.
• Microplanning: Engaging the operational level to gather bottom-up critical information for
logistics and detailed budget.
• Behavioral change activities: To sensitize the community at all levels on the benefits of the
health interventions.
• Household mobilization: To enumerate the number of beneficiaries in each household either
using technologies or a paper-based system.
• Training the practitioners on the distribution activities, household mobilization, and
supervision.
• Supervision and monitoring of activities.
• Distribution activities.
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• Payment of services providers.
• Reverse logistics and waste management.
For more details on the above, see the AMP Tool Kits Chapter 7 on implementation.
The following explanations of full integration and partial integration are sourced from The Task Force for
Global Health, Technical Brief on the Integration Between Health Campaigns: Intervention Co-delivery
and Collaboration.
Full integration involves coordinating most or all typical campaign components (microplanning,
registration, logistics, implementation, and evaluation) to allow co-delivery or simultaneous delivery of
two or more health interventions at the point of service delivery.
Partial integration involves collaboration or sharing of specific campaign components between vertical
health programs to improve efficiency and effectiveness of multiple campaigns but without co-delivery
of interventions.
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CHAPTER 3.6: COLD CHAIN PROGRAM
• WHO-UNICEF Temperature-sensitive Health Products in the Expanded Program on Immunization Cold Chain
The “cold chain” is a system for storing and transporting temperature-sensitive products at
recommended temperatures from the point of manufacture to the point of use. Effective management
of the cold chain is key to maintaining the safety and potency of vaccines and temperature-sensitive
pharmaceuticals during storage, transport, and service delivery.
To ensure efficacy and quality of care, health systems must find ways to ensure all cold chain medical
products are properly managed from the manufacturer, through the entire supply chain, to the point of
use.
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CHAPTER 3.7: WASTE MANAGEMENT
• The Global Fund Guide to Policies on PSM of Health Products Section 10 describes donor requirements
• WHO Guidelines for Safe Disposal of Unwanted Pharmaceuticals in and After Emergencies
• WHO Safe Management of Wastes from Health-care Activities
In this section, health waste products are those pharmaceuticals and RDTs expired, with quality issues,
damaged, etc.
Waste management requires increased attention and diligence to avoid adverse health outcomes
associated with poor practice, including exposure to infectious agents and toxic substances. WHO
considers waste management as part of the supply chain.
The following are considered pharmaceutical waste (“unusable” products): expired products, unsealed
syrups and eyedrops, breakage (I.e., vials), products with confirmed quality issues. They must be
disposed of safely and with minimal environmental impact, per the national regulations.
There are two aspects to waste management:
• Health systems strengthening: The strengthening of the national waste management systems
(policies, operations, funding, HR, infrastructure, and equipment).
• Operational: When CRS manages a health project, unusable products must be collected,
inventoried, and safely disposed of regularly.
Waste management traditionally falls under HSS grants.
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CHAPTER 3.8: PHARMACOVIGILANCE
• The Global Fund Guide to Policies on PSM of Health Products Section 4.6 describes donor requirements for
managing adherence to treatment protocols, drug resistance, and adverse effects
• WHO Pharmacovigilance Indicators: A Practical Manual for the Assessment of Pharmacovigilance Systems
Pharmacovigilance is the science and activities relating to detecting, assessing, understanding, and
preventing adverse effects or any other medicine/vaccine-related problem. An adverse drug reaction is
a harmful response caused by the medicine after it was given to the patient in the recommended
manner (dose, frequency, route, and administration technique). All medicines and vaccines undergo
rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
The objective of pharmacovigilance is to identify adverse drug reactions or effects, misuse of medicines
and drug interactions, detect substandard and falsified medicines, medication errors, lack of efficacy of
medicines, the interaction between medicines, safety, and tolerability of medicines.
Pharmacovigilance will thus improve patient care and safety, promote the rational and safe use of
medicines, and educate patients on matters related to medicine safety.
Pharmacovigilance falls under the NMRA’s functions. Therefore, pharmacovigilance should be part of an
integrated approach and reflected in HSS grants. However, in some contexts, donors may accept the
inclusion of pharmacovigilance activities in disease-specific related grants.
As part of CRS’ efforts to strengthen national systems, pharmacovigilance can be an area of support, if
identified as a priority by the NMRA.
Pharmacovigilance-related activities can be directly undertaken by the Health Supply Chain Manager
whenever capacity and availability allow, or these activities can be managed through technical
assistance contracts. In the latter, the Health Supply Chain Manager, supported by the SCM Regional
Technical Advisor, will need to provide oversight and validate deliverables.
The activities that CRS can support in pharmacovigilance include:
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• Assessment of the national PV system.
• Technical training for the PV unit staff.
• Support the adhesion of WHO Uppsala Monitoring Centre (UMC) and its global reporting
system.
• Support to the design, distribution of national Adverse Reactions Forms, as well as related
trainings for use of the forms.
• Support to the NMRA Pharmacovigilance IT system or database (for collection, transmission, and
analysis of PV reports).
Spontaneous reporting systems form the basis of global pharmacovigilance. Other mechanisms and
tools can be used as drug registries and electronic health records. The functionality of the
pharmacovigilance system involves systematic collection and analysis of reports of suspected ADR to
enable the detection of signals, their communication, and risk management.
o
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o
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CHAPTER 3.9: HMIS/LMIS DATA COMPARISON
The data collected in HMIS tools mainly focus on service delivery, but usually includes indicators related
to drug or vaccine supply such as duration of stock outs.
LMIS data are collected and used for primarily operational supply chain decisions but are also used to
generate performance indicators. Comparing HMIS/LMIS data has various benefits including improved
monitoring and evaluation, reduced data duplication, availability of additional data sets for
quantifications, etc. It also provides coherence and justifies consumption.
The overall objectives are to:
• Ensure that health/service data tally with commodity consumption data.

• Promote data use culture at the facility level and build the capacity of health staff.
• Ensure data registers are completed.
Specific forms are needed to conduct this exercise. See the Health Facility Monthly Data Triangulation
Form and the User Guide on the Health Facility Monthly Data Triangulation Form.
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CHAPTER 3.10: PUDR DONOR REPORTING
REQUIREMENTS (GLOBAL FUND)
• The Global Fund Principal Recipient Progress Update and Disbursement Request
The PUDR is both a progress update on the latest completed period of program implementation and a
request for funds for the following execution and buffer period. The PUDR Tool includes a PSM part
(worksheet “Health Products – PSCM 8”) that must be completed and reviewed twice a year.
There are three main sections to be completed in the health products worksheet: PQR reporting, risk of
stockout and expiry, and additional information.
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• PQR Reporting: Indicate whether the PQR is up to date. It is important to record all the
receptions of products during the semester covered by the PU in the PQR.
• Risk of Stockout and Expiry: For the key categories of products listed in the table, indicate
whether there is any risk of stockout or expiry during the next reporting period. It is essential to
perform a stock analysis at the end of the reported period to determine whether there are such
risks (key date needed to perform the analysis: stock-on-hand with expiry dates central only?
national?), average monthly consumptions (or distribution if AMC not available), quantities in
the pipeline.
• Additional information: Indicate important additional information relevant to health products
management (any challenges, progresses made with HSS activities, training conducted, etc.).
The PUDR must be properly filled with relevant, sufficient, and quality information including a clear level
of writing (coherent and complete sentences, without typos).
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CHAPTER 3.11: PQR DONOR REPORTING
REQUIREMENTS (GLOBAL FUND)
• A Quick Guide to The Global Fund’s PQR
The PQR is the Global Fund online database to record prices and PSM costs of some key categories of
health products procured by their Principal Recipients. When CRS is PR of a Global Fund grant, it is the
responsibility of CRS to update regularly the PQR database. Only the following categories of products
must be entered in the PQR:
• Antiretrovirals, anti-malarial, anti-TB, and anti-hepatitis pharmaceutical products.
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• LLIN and insecticides for indoor residual spraying activities.
• Diagnostic tests for HIV, TB, malaria, and co-infections such as syphilis, hepatitis B, and hepatitis
C.
• COVID-related products (surgical and non-surgical masks, respirators, class C and class D medical
devices such as lung ventilators, pulse oximeters, etc.).
Regularly updating the PQR database provides The Global Fund with updated and accurate information
on consignments of health products received in the country (products, quantities, prices, and PSM costs,
manufacturer, supplier, etc.).
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
At the end of each calendar semester, the Health Supply Chain Manager compares
the procurement tracking table (containing information on PO numbers, invoice
references, products, and corresponding EXW amount, and delivery dates) with the
PQR entries to confirm there are no missing entries.
For this purpose, the Health Supply Chain Manager can request the financial
reconciliation of expenses from the Finance Department and needs to maintain
records of invoices and delivery notes from the Procurement Service Agent or other
suppliers. This verification is very important as the LFA, and The Global Fund do verify
completeness and accuracy of PQR during each PU/DR review.
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— 157 —

CHAPTER 3.12: QUALITY PULSE CHECK DONOR
REPORTING REQUIREMENTS (GLOBAL FUND)
• Completing and Submitting Pulse Checks – Guide to Principal Recipients
The Pulse Check is a quarterly tool that provides visibility into HIV, TB, malaria, RSSH, and COVID-19
Response Mechanism investments to report to the Global Fund Board and support timely identification
of emerging risks and issues to enable more agile course correction.
The purpose of the pulse check is to update The Global Fund on ongoing activities and identification or
anticipation of any potential bottlenecks.
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CHAPTER 3.13: PROCUREMENT REPORTING
REQUIREMENTS FOR COVID-19 (GLOBAL FUND)
• The Global Fund COVID-19 Response Mechanism Guidelines

• The Global Fund C19 RM Procurement Progress Reporting Template
The purpose of the template is to capture information on the award of contracts by implementers and
fulfillment of deliveries by suppliers under these purchased orders.
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— 161 —

PART V. CLOSE OUT/TRANSITION
Close out of a health project is not significantly different from closing out other types of projects. Refer
to the Close Out chapter in the CRS Supply Chain Management Handbook.
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HEALTH ANNEX REFERENCES
Bhatnagar B, Gittelman D, for the Health Campaign Effectiveness Coalition. Integration between health
campaigns: intervention co-delivery and collaboration. Decatur, GA: Task Force for Global Health, 2020.
(https://campaigneffectiveness.org/wp-content/uploads/2020/08/Health-Campaign-
Integration_Technical-Brief_14AUG2020-1.pdf)
John Snow, Inc. 2020. The Supply Chain Manager’s Handbook, A Practical Guide to the Management of
Health Commodities. Arlington, Va.: John Snow, Inc.
John Snow, Inc. 2020. Sample LMIS Information and Supply Flow Diagram, The Supply Chain Manager’s
Handbook, A Practical Guide to the Management of Health Commodities. Arlington, Va.: John Snow, Inc.,
2020, p. 27.
John Snow, Inc. 2020. Steps in Quantification, The Supply Chain Manager’s Handbook, A Practical Guide
to the Management of Health Commodities. Arlington, Va.: John Snow, Inc., 2020, p. 55.
UNICEF, 2016. A Process Guide and Toolkit for Strengthening Public Health Supply Chains through
Capacity Development. Copenhagen, Denmark: United Nations Children’s Fund (UNICEF).
USAID. “The PipeLine Monitoring and Procurement Planning System.” USAID Global Health Supply Chain
Program, https://www.ghsupplychain.org/pipeline-monitoring-and-procurement-planning-system
USAID. “Quantification Analytics Tool.” USAID Global Health Supply Chain Program,
https://www.ghsupplychain.org/quantificationanalyticstool
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SUPPLY CHAIN MANAGEMENT HANDBOOK

Cover photo by Jason Florio

©2022 Catholic Relief Services. All Rights Reserved. 21MK-328766M

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CHAPTER 1.1: PROPOSAL

• CRS COMPASS Standards - Design Phase

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

• CRS Supply Chain Transformation for Excellence Project Assessment Guidance

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

• CRS Supply Chain Management Handbook. Chapter 4: Supply Chain Design

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

• Leveraging on the existing health supply chain infrastructure.

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS’ Regional Med Store

CRS ’supply chain

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

• CRS COMPASS Standard 2

• USAID Vision for HSS 2030

• The Global Fund Modular Framework Handbook

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

1. Strengthening CRS internal health supply chain processes:

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

• CRS COMPASS Standard 3

• The Global Fund Procurement Policy

• JSI The Supply Chain Manager’s Handbook

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX

CRS SUPPLY CHAIN MANAGEMENT HANDBOOK – HEALTH ANNEX