Quantification of Laboratory Commodities
Laboratory services are vital to the success of any comprehensive HIV/AIDS program.
Historically, laboratory services have received little attention from ministries of health or international donors and have been under-funded and neglected. With the onset of comprehensive HIV/AIDS programs, laboratory services are now receiving increased resources.
Successful laboratory services depend on reliable test results. One of the first steps to ensuring reliable results is to ensure that the laboratory is supplied with quality products when the products are needed.
It has been DELIVER’s experience that most laboratories collect data on the number of tests conducted at each facility. Therefore, this guide addresses the steps for conducting a forecast/quantification using service statistics (test numbers). Please be advised when more accurate logistics data on laboratory supplies become available, DELIVER recommends a consumption-based methodology. See The Contraceptive Forecasting
Handbook for Family Planning and HIV/AIDS Prevention Programs
1
(referred to as The
Forecasting Handbook henceforth) for more information about other forecasting methods.
A.
Define Scope and Purpose of the Quantification
Laboratory services, in the context of HIV/AIDS programs, include diagnostic, baseline and monitoring services for HIV and opportunistic infections (OI). The WHO and CDC recommend the following types of tests for a comprehensive HIV program
2
:
Table 1: Recommended HIV-related tests by level
Central Laboratories Intermediate Laboratories Peripheral Laboratories
HIV rapid & ELISA testing HIV rapid & ELISA testing HIV rapid & ELISA testing
CD4 (high-end flow CD4 (flow cytometry) CD4 manual counts
3 cytometry)
Western blot Hemoglobin Hemoglobin
Viral load
Hemoglobin
Pregnancy test
Urinalysis
CBC and differential
Pregnancy test
Urinalysis
CBC and differential
Platelet count
Coagulation test
Urinalysis
Complete blood count
(CBC) and differential
Creatinine
Potassium
Syphilis serology – RPR
1 Family Planning Logistics Management (FPLM). 2000. Contraceptive Forecasting Handbook for Family
Planning and HIV/AIDS Prevention Programs . Arlington, VA: FPLM/John Snow, Inc. for the U.S. Agency for International Development. www.deliver.jsi.com
2 Centers for Disease Control and Prevention. Building Laboratory Capacity in Support of HIV/AIDS Care
Programs in Resource-limited Countries. Report from a Global AIDS Program Meeting. December 16 &
17, 2003, Atlanta, GA.
3 Alternatively, the specimen or patient can be transported to an intermediate laboratory.
1

Central Laboratories
Platelet count
Coagulation test
Creatinine
Intermediate Laboratories Peripheral Laboratories
Creatinine Sputum collection
Potassium Smear microscopy
Microscopy: wet mount, gram stain, Tzanck, giemsa, malaria, TB
ALT
Potassium
Full serum chemistries
Mycobacterium tuberculosis culture
Syphilis rapid tests and
TPPA/TPHA
ALT Culture and susceptibility testing
Mycobacterium tuberculosis culture
Microscopy: wet mount, stool, gram stain, malaria,
TB
Quantitative RPR
GC culture
ALT
These categories include diagnosis of HIV, OIs, sexually transmitted infections (STI) and tuberculosis (TB). Additionally, the tests listed above include baseline tests to determine eligibility for ART, monitor response to treatment and detect toxicity.
The first step in quantification is to develop a realistic scope of work. Discussed below are some questions that should be considered and researched before conducting quantification.

What types of tests will be quantified for? Will the quantification be limited to HIVrelated tests? If it is only for tests related to HIV, which tests are included in this classification?
It is important to recognize that the HIV-related tests listed above can include more than
40 different tests. If the scope of the quantification includes commodities for all of these tests at every level, the number of laboratory supplies needed could total more than 400 commodities. Laboratories at different levels in the system may use different techniques for these tests, requiring different commodities. As a result, the commodities required to conduct the full menu of tests could more than double. This is significant because financial resources may not be adequate for procurement of all required commodities in full supply.

How many laboratories will be included in this quantification? Will the quantification include all laboratories throughout the system or only certain target laboratories? Will the quantification include all levels of laboratories in the system, i.e., regional/provincial/zonal, district, health center?
2

The number and level of the laboratories will become an important issue in the quantification process. Procuring a full supply of laboratory commodities for all laboratories in a country is a significant financial undertaking.

Which programs are you quantifying for and how will the test results be used? Is it a forecast of projected needs for program planning and advocacy/resource mobilization? Or, is it a quantification of requirements for immediate term procurement planning and shipment delivery based on funding available?
.
B.
Determine the Period of the Forecast
DELIVER recommends a medium-term forecast of laboratory commodity needs for two to five years to assist in program planning and mobilization of financial resources for procurement of laboratory supplies. Quantification and costing of commodity requirements for procurement purposes should be developed for the next one year period and should include specific quantities of each product to procure and a shipment delivery schedule for the year. For more information about short- verses long-term forecasting, see
The Forecasting Handbook .
C.
Define the Specific Commodities to be Forecasted/Quantified
As mentioned above, quantification of laboratory supplies depends on the types of tests that will be included in the forecast. For each type of test, there are usually different techniques used to obtain a test result. Each test technique requires commodities specific to that technique which are required to conduct the test. For example, there are approximately eight different manual techniques that could be used to do a hemoglobin test. For each technique different commodities are required as described in Table 2. If the forecast were to include all eight manual techniques, nine reagents, 14 consumables and
22 durables or equipment would be needed
4
. See section E for more information about policies regarding testing techniques.
NOTE: In order to accurately forecast the needed commodities, the advisor must identify the test technique and all associated supplies.
4 Note that these test techniques are exemplary and additional commodities may be required for slightly different operating procedures. Additionally, automated hemoglobin estimation techniques were not analyzed.
3

Table 2: Manual Hemoglobin tests and laboratory supplies needed
Test Technique
Filter Paper Comparison
Copper Sulfate Method
Hematocrit by Centrifuge
Lovibond Comparator
Grey Wedge (BMS)
Photometer
Reagents
-copper sulfate
-ammonia
OR
-potassium ferricyanide
-potassium cyanide
-potassium dihydrogen phosphate
-surfactant
-saponin powder
-EDTA powder
Consumables
-filter/blotting paper
-sterile lancet
-70% alcohol
-cotton wool
-graduated transfer pipette
-capillary tube
-sterile lancet
-70% alcohol
-cotton wool
-capillary tube
-graph paper
-sterile lancet
-blood pipette
-sterile lancet
-70% alcohol
-cotton wool
-parafilm or foil
-70% alcohol
-cotton wool
Sahli Method
HemoCue
Colorimetry-
Hemiglobincyanide Method
-hydrochloric acid
-potassium ferricyanide
-potassium cyanide
-potassium dihydrogen phosphate
-surfactant
-toothpicks
-sterile lancet
-70% alcohol
-cotton wool
-sterile lancet
-70% alcohol
-cotton wool
-cuvettes
-standard cuvettes
-sterile lancet
-70% alcohol
-cotton wool
-standard solution of hemoglobin
-graph paper
-tube labels
TOTAL NUMBER: 9 14
Durables/Equipment
-color comparison chart
-flasks
-weighing scale
-amber tinted bottles
-Microhematocrit centrifuge
-glass tubes
-Lovibond comparator
-colored glass standards
-BMS grey wedge photometer
-glass chamber for blood sample
-calibrating glass standard
-batteries (1.5 volt)
-Sahli hemoglobinometer
-Sahli blood pipette
-dropper
-HemoCue instrument
-batteries
-photoelectric colorimeter
-cuvettes
-test tubes
-watch or timer
-calibrated pipettes
22
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D.
Standardization of Laboratory Practices and Policies
In DELIVER’s experience, standardization of test menus and techniques is an issue that requires attention prior to conducting a forecast/quantification. Most developing countries have a draft national laboratory policy, but the policy may not provide the level of detail needed to calculate an accurate forecast or to sustain a quality laboratory program. The following three areas must be determined by the key stakeholders from all levels in the laboratory services system:
 test menus by level
 test techniques by level
 technical standard operating procedures (SOPs) that instruct staff how to conduct each test
Standardization is not only necessary to make the forecasting and quantification process simpler, but it also enables quality testing throughout the system and simplifies the supply chain for laboratory commodities. Some benefits of standardization include:

Quality, reliable and consistent test results at all facilities

Reduction in number of laboratory products

Manageable supply chain for laboratory commodities

Accurate forecast/quantification results (when using the service statistics method)
Standardization is necessary in order to provide the most accurate estimate of laboratory commodity needs. To understand the importance of standardization, refer back to the hemoglobin example in Table 2. For a single test, there are eight different techniques that could be employed. If there were eight provincial laboratories and each laboratory was using a different technique, the forecast would need to include 43 commodities for one test at one level in the system. The forecast would therefore need to be specific to each laboratory and the commodities required. Now, if these eight laboratories offer 50 different tests with varying techniques, the number of commodities needed for all eight laboratories could increase from 300 to 1000. If this forecast/quantification were to include non-standardized laboratories at another level, for example district or health center, the number of commodities for the entire system could grow even larger.
E.
Laboratory Commodities
Before proceeding with the forecast/quantification process for laboratory commodities, the advisor and counterparts must define what these commodities are and understand the impact of the different categories on the forecasting process. Laboratory commodities can roughly be separated into three categories: reagents, consumables and durables. For the purposes of forecasting and quantification, these categories usually need to be separated even further.
Reagents
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Definition: Reagents are the chemicals used in laboratory testing for detecting or measuring an analyte. They vary widely on cost, stability, cold/cool chain requirements and hazards associated with them.
Considerations for Forecast/Quantification: The reagents and the amount consumed for each technique are very well defined. If you are entering into a system that requires standardization, it may be necessary to consider characteristics of the reagents such as cold chain requirements, stability and shelf life. Standardization can aid in rational and appropriate product selection. For example, if there is a choice between two techniques and both are equally acceptable for the associated laboratory level, the technique that uses reagents with fewer supply chain constraints is preferred.
Consumables
Definition: Consumables are items that are used once while performing a test and are not reused. For the purpose of quantification, there are multiple categories of consumables.
Consumables can include such test-specific items as microscope slides and cover slips.
Other consumables cut across all testing services and are classified as general laboratory consumables, such as bleach, alcohol and gloves.
Considerations for Forecast/Quantification: The test-specific consumables should be counted per test. If a consumable is used each time a test is conducted and that commodity is not reusable, the quantity needed must correlate with the number of tests requiring this consumable.
The general laboratory consumables are not usually quantifiable per test. For these commodities, it is more appropriate to estimate the daily, monthly or annual usage because they are not associated with a certain test, but are associated with functionality of the laboratory. See Annex B for an example list of general and test-specific consumables.
Durables
Definition: Durables are items that can be reused for multiple tests. These include some glassware which can be washed, sterilized and reused. For the purpose of this guide, this category also includes the equipment and instruments used for testing.
Considerations for Forecast/Quantification: Durables also have multiple categories. There are more frequently used items that are durable for a set length of time. For example, the average usage length of a test tube is approximately one year since some test tubes will break. Equipment, such as a CD4 machine, have a much longer usage life.
When forecasting for durables, it is important to look at the usage in the laboratories by level of the system. The laboratory staff should be able to estimate their annual usage for these items.
6

Instrumentation at each level must be considered at the start of a forecast/quantification.
If the system is not standardized, different instruments will most likely be used at the same level in the system for the same test. This means that different reagents associated with the instruments will need to be forecast. If the technical assistance is to include a standardization workshop, the forecast may need to include procurement of instruments so that all laboratories at each level are using the same equipment and technique.
F.
Identify Stakeholders and Collect Required Data
Before forecasted demand for laboratory commodities can be estimated, there are some important data items that must be reviewed and/or gathered.
1.
Conduct assessment of supply chain and service delivery capacity
The forecast/quantification provide numbers of commodities that are needed, but often the reality in-country is that the supply chain can not handle the number of supplies forecasted and adequate staff are not available or not trained to conduct the number and types of tests forecasted. This is particularly evident in laboratory programs where the staff numbers may be limited or the staff may not be trained on the necessary testing techniques or good laboratory practices (GLP).
NOTE: Some key areas to look for when assessing the supply chain capacity include cold chain capability, storage capacity, transportation availability, etc. More information on assessing laboratories can be found in The Assessment Tool for Laboratory Services,
(ATLAS)
5
.
2.
Identify key stakeholders and inputs for commodity procurement
Who are all of the stakeholders involved in the procurement of laboratory supplies? A useful tool is to create a diagram to track funding sources, procurement agents and distribution of the commodities being forecasted/quantified. DELIVER has found that the key stakeholders for procurement of laboratory supplies vary from country to country.
Usually, laboratory services are managed by the national public health laboratory services
(NPHLS) within the diagnostics division of the Ministry of Health (MOH), the central medical stores, or the central level referral laboratory.
Different donors and/or government divisions often have varying restrictions about what and how much they will procure. For laboratory supplies, government officials often include representatives from the NPHLS, the HIV/AIDS control program, the TB program, and blood safety. Different funders and/or programs may be restricted to providing certain supplies. For example, one donor may procure laboratory equipment,
5 John Snow, Inc./DELIVER. 2005. Assessment Tool for Laboratory Services (ATLAS) 2005 . Arlington,
Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. www.deliver.jsi.com
7

but will not provide funding for reagents or consumables. Other donors may be only interested in one type of test or in providing commodities to certain target laboratories.
After the forecasted demand is prepared, the map of funding commitments will be compared with the demand to show funding gaps to facilitate resource mobilization and to harmonize supplies to equipment.
3.
Identify all stakeholders and implementers involved in program
The forecasting/quantification process needs to include input from the service delivery personnel and from the program managers. These key stakeholders will have the answers to many questions that will arise during the forecasting/quantification exercise. For laboratory supplies, this includes representatives from the laboratories at all levels in the system, storekeepers handling laboratory supplies, and laboratory program managers. As mentioned above, this will also likely include representatives from the NPHLS, the
HIV/AIDS control program, laboratory educators, the TB program, and blood safety.
4.
Obtain relevant laboratory policies and procedures
As mentioned earlier, in order to provide an accurate national forecast, development of a standard test menu, technique and operating procedures is necessary. The team will need to following documents, if they exist, before beginning the forecast
6
:

National laboratory policies

Test menu and technique by level

Laboratory SOPs by level
5.
Verify information from laboratory policies and procedures
If the national policies and procedures are developed and available, they need to be verified with key stakeholders. This will require confirmation that the test menus and techniques identified in the policies and procedures are current and practiced. If these guidelines are outdated, unclear or inappropriate, changes to the documented procedures and guidelines may need to be made through consultation and consensus with key stakeholders and informants. Any agreed changes need to be documented in the assumptions (see section H for more information about documenting assumptions). If the guidelines are outdated, unclear or inappropriate, the advisor should strongly advocate for an official review and revision of these guidelines.
Some key considerations that the advisor should note when advocating for review and revision of the policies are:
6 If these documents are not available because they have not been developed, a standard will need to be developed in collaboration with key stakeholders. If the stakeholders opt not to standardize, the forecast will need to be prepared on a facility-by-facility basis.
8


Laboratory technologies are rapidly changing, especially in the wake of HIV/AIDS.
The guidelines need to be kept current with the most appropriate and accurate tests and techniques to maintain a quality laboratory program.

Coordination of laboratory efforts at a national level reduces inefficiencies and wastage of resources in the laboratory system by controlling inputs to follow standardization.

The forecast/quantification for laboratory products and quantities depends on test menus and/or test techniques that are reflective of the reality at the laboratories in the system. Outdated, unclear or inappropriate standards could result in procurement of the wrong supplies.
6.
Verify product registration and importation requirements
Some governments require that laboratory supplies be registered in-country by a national regulatory authority. Before beginning the forecast, the advisor needs to be informed about this process and obtain a list of approved laboratory commodities, if available.
7.
Collect service statistics and stock/inventory status
The following sections will expand on the needed data, but at a minimum, the following data items are required to forecast the demand for laboratory supplies.

Average test numbers for each test technique by level

Current inventory of equipment at each facility (only necessary if forecast/quantification includes procurement of equipment)

Current stock status of all laboratory commodities throughout the system

Anticipated shipments and inputs of laboratory commodities
G.
Forecast Demand of Laboratory Commodities
Assuming a standardized system, each of the following steps should be taken for each level of the system (i.e. for all regional, district, or health center level laboratories).
Given constraints in the type and quality of data available, multiple assumptions will be required about specific tests and techniques by level, capacity and quality of service delivery, procurement and supplier lead times, and status of the in-country supply pipeline. A consultative process with laboratory stakeholders will enhance accuracy and ensure that the final quantities to order have been developed with input from a wide range of laboratory service implementers. It is important to document the sources of information and input from key informants used to inform the assumptions for the quantification. The quantification should be reviewed and updated at least every six months and when any of the major assumptions change.
Examples of the types of assumptions that may need to be made include:

Application of testing protocols
9


Validity of test numbers per level

Quantity of each commodity required per test

Changes to agreed specifications

Forecasted demand for any commodities that do not associate directly with test numbers

Capacity of the supply chain to manage laboratory supplies

Human resources capacity
See Annex C for additional sample assumptions.
Different laboratory commodities require different data and methodology to obtain a forecasted demand. The following steps are for three types of commodities:

Commodities that are used per test

Commodities that are regularly consumed in a laboratory but are not associated with any particular test

Commodities that are durable

Forecasting demand for reagents and consumables that are used per test
1.
List the test techniques by level
Each test can be done differently depending on the level of the system, staff capacity, availability of resources, preferences, etc. A test can be done manually at the lower level, semi-automated at the intermediate level and fully automated at the higher level.
Furthermore, the same testing method can have multiple techniques and/or can use different equipment for the same technique, as shown in Table 2.
The list of tests and techniques is usually found in the national level policy document on testing procedures. If this has not been developed, it may be necessary to have a workshop with key stakeholders from the laboratory system to standardize the test menus and techniques by level. See Section E for more information on standardization.
As mentioned before, where guidelines are outdated, unclear or inappropriate, it is necessary to document in the assumptions any changes in the guidelines agreed to by stakeholders and informants.
2.
Identify commodities associated with each test
One or more products are often needed to conduct one laboratory test: reagents, consumables, durables, etc. Each testing technique uses different commodities. For example, to do a Gram stain blood smear test for bacterial infections, the commodities needed are:
 crystal violet stain
 potassium iodide
 iodine
10

 acetone
 neutral red
 microscope slides
3.
Specify each commodity
Once the product is identified, it needs to be specified
7
in consultation with laboratory managers and implementers. Product specifications include:

Nature (liquid, powder, glass, plastic, etc.)

Grade (analytic, general purpose, etc.)

Size or measurement (21 gauge needle, 5 ml flask, etc.)
Using the above example of crystal violet stain, one specification would be: crystal violet stain powder general purpose reagent (GPR).
The next step in listing the commodities is to list the basic unit of the commodity. The crystal violet stain powder GPR has a basic unit of 1 gram.
4.
Determine appropriate packaging size
The packaging size must be appropriate for each level in the system. The appropriate packaging size of a powder reagent at the health center level may be different than that of the regional level because of the volume of tests. Therefore input from all level of the system should be considered when determining the packaging size.
NOTE: Commodities may not be sold in the optimal packaging size. It is important to be familiar with the typical packaging sizes offered.
In the above example, the packaging size of the crystal violet stain, stain powder GPR at the district level is a 25 gram bottle.
5.
List amount of each commodity needed for one test using this technique
Each test technique uses a certain quantity of a product for the test. The amount of each commodity needed per test can be found in the SOPs, when available.
Determining the quantity needed per test can be particularly challenging with reagents. In the example above, crystal violet stain is supplied in a powder form. To use this stain, it must be reconstituted into a liquid form, changing the basic unit from grams to milliliters
(ml), in this case. The SOPs will likely require a certain amount of the liquid in ml for each test. In order to do determine the amount needed in grams per test, the ml quantity
7 Specifications provide the detail that a procurement agent requires to procure the exact product needed for the test requirements.
11

will have to be converted to grams. Using the example of crystal violet stain, the following logic can be followed:

1 g is used per 50 ml of distilled water

50 ml of solution last for 40 tests

Therefore, 1 g of powder is used for 40 tests

1 test uses 1g/40tests = 0.025g/test
It is vital that formulas such as these be noted in the assumptions. If there are a large number of formulas, it is advisable to note these formulas at the same place as the quantity needed per test. If using an Excel spreadsheet for this process, note this formula in comments attached to the cell containing the formula. If using a quantification software, note the formula in the appropriate notes area.
6.
Determine average number of each test done per facility level in a set period of time
This information can be gathered from different sources. The data may be readily available in a central level health management information system (HMIS). Or, it may be necessary to sample a set of laboratories to obtain the data. Another possibility is to do conduct a mini survey on multiple laboratories. If data is not available or is not reliable in the public sector, the NGO or private sector could be used as an indicator for this information.
Once the information is collected, it is essential to analyze the data for consistency. Some key areas to consider are:

When setting up the quantification spreadsheet, it is important to adjust data collected for the same time period. The number of a particular test performed could be reported over weeks, months, quarters, etc. Therefore, all figures should be adjusted to a predefined time period, i.e., monthly, yearly, etc.

Adjust for any missing data; for instance if one facility did not report or another facility was missing data on a particular test. The advisor will need to work with key informants to understand why any data are incomplete and to make an informed adjustment. These adjustments should be documented in the assumptions.
Adjustments for missing or incomplete data should be done using standard logistics principles for adjusting data (see The Forecasting Handbook for more details about making adjustments).

Identify outlaying test numbers. If discrepancies in the reported test numbers across the facilities at the same level are identified, the reason for these differences needs to be analyzed and the final figure adjusted, if necessary. The reason for these outlaying figures could include stockouts of common reagents, lack of staff to conduct the test, a mistake in recording the test numbers, etc. General logistics principles should be followed to adjust this data (see The Forecasting Handbook for more details about making adjustments).
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NOTE: Depending on the purpose of the forecast/quantification, it may be necessary to do multiple forecasts for different situations. For example, it may be important to show the forecast of laboratory supplies for the current usage rate verses the forecast if laboratory services are scaled up.
7.
Calculate the quantity of each commodity needed per test per facility
It is important to determine this quantity by level in the system because the average test numbers may differ greatly by level.
Table 3: Example of Gram stain technique to test for bacteria at the provincial level
GRAM STAIN
Basic Unit
Quantity needed per test
No. of tests/month
Quantity needed per month
Quantity needed per year
123
Reagents
Crystal violet stain 1 g 0.025 3.075
Potassium iodide 1 g 0.02 2.46
Iodine
1 g 0.01 1.23
Acetone
Neutral red
1 l
1 g
0.0004
0.0005
0.0492
0.0615
Consumables
Microscope slides
1 slide 1 123
If the forecast period is for more than one year, it will be important to determine the change factor (increase or decrease) on the future number of tests to project for future use. This factor could be determined by historical data, projections, program scale-up plans, etc. For more information on estimating consumption based on future trends see
The Forecasting Handbook .
36.9
29.52
14.76
0.5904
0.738
1476
NOTE: Some commodities are not quantifiable per test because there is no correlation between the test numbers and the quantity of the commodity used. It may be necessary to make a decision about how many of these commodities to supply using input from laboratory managers and personnel. Be sure to document the rationale in the assumptions.
For example, antibiotic sensitivity testing is used to determine which antibiotic will kill a particular organism identified in a culture. There are more than 20 antibiotic sensitivity disks which are regularly used to determine sensitivity in organisms, but only an average of 8 disks are used per test depending on the source of the specimen and organism identified with the culture. An additional complication to link the number of disks to the number of tests is that not every culture requires an antibiotic sensitivity test; only cultures with isolated pathogenic bacteria would need the sensitivity test. Without accurate historical data on the discs used, there is no accurate way to determine the amount of each disk used from the number of sensitivity tests or cultures performed.
8.
Sum total forecasted need by commodity, not by test
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Some commodities are used in many tests. For example, microscope slides are not exclusively needed for Gram stains, but are also used in other tests such as India ink staining. Additionally, some reagents are used for multiple tests. Crystal violet stain, for example, is used for Gram stains for high vaginal swab (HVS) microscopy and cerebrospinal fluid (CSF) analysis.
NOTE: The commodities need to be added together before finalizing the requirements estimation to ensure that the appropriate numbers of packaging sizes are forecasted per facility, not per test. If these commodities are forecasted per test, when you proceed to requirements estimation and round the forecasted demand up to the next packaging size, the forecast may have a duplication of supplies.
NOTE: It is important to distinguish the commodities that are reused from the consumables that are used only once. If the microscope slides are washed and reused, the demand for these commodities will be forecasted using the methodology for durables and equipment mentioned below.

Forecasting demand for regularly consumed laboratory commodities, not associated with a particular test
Some commodities needed in the laboratory are not associated with any particular test, such as gloves and alcohol, and can be used outside of the laboratory (i.e., in the hospital). Additional examples can be found in Annex B under general consumables.
These commodities are necessary to run a laboratory and must be included in the forecast.
1.
List commodity needs by level
As with commodities forecasted per test, the specifications, basic unit and packaging size are required.
2.
Calculate quantity of each commodity needed per facility
If possible, past consumption data should be gathered from the logistics management information system (LMIS). If this information is not available from the LMIS, the best informants for regular consumption are the laboratory technologists or laboratory technicians. DELIVER advises determining the commodity demand by level because usage usually varies by level.
The time period for estimating forecasted demand for these commodities may differ by product. The time period may be the day, month or year. It is important to make sure that all the products are adjusted to represent the annual demand.
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
Forecasting Demand for Durables
NOTE: Many forecasts may not include the demand for durables. It is necessary for this to be defined in the scope of the forecast/quantification.
1.
List durables needed per facility
There are two levels to this step of the forecast: durable supplies and equipment. As discussed in section F, Laboratory Commodities , durables are items that can be reused in a laboratory. Durables supplies include items such as:

Washables: glassware (bijou bottles, centrifuge tubes, Erlenmeyer flasks, etc.), plastic containers (measuring containers, etc.). etc.

Minor equipment: staining rack, wire loop holders, etc.
If the laboratory system is fully standardized, it is possible to define the durable equipment by level. If this is the case, it will be simple to compare a list of what should be at a laboratory with what is available at a laboratory and develop with a list of equipment needed per facility.
If the instrumentation is not standardized, defining the equipment needs may be more difficult. In the case of a non-standardized system, laboratories at the same level in the system often have different equipment. Assuming that the different equipment is functioning, it may be difficult come to a consensus about which equipment to set as the standard in the system. Additionally, it is important to note that the equipment and corresponding reagents and consumables must match in order to successfully run the test.
This portion of the forecasted demand will need to be done per facility since it will be necessary to review the specific inventory and compare it with the national standards by level.
As with other laboratory commodities forecasted, the specifications are required. Table 4 shows a few examples of durable supplies and equipment specifications.
Table 4: Specifications for sample durable supplies
Product Specification
Anaerobic jar Autoclavable, 2.5 liters with mounted manometer for both anaerobic and microaerofilic indication
Bijou bottle Screw cap, glass, 5 ml
Serological Pipette 10 ml, graduated with permanent amber marking, bulk packaging
2.
List amount of each commodity needed per facility
3.
Sum total forecasted need by commodity, not by facility
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H.
Requirements Estimation
At this step in the quantification, an assessment of the supply status in-country is needed in order to calculate the quantities of each laboratory commodity to be ordered that can reasonably be expected to be stored, distributed and used. The quantity to order should include the quantities of laboratory commodities required to meet the forecast of demand and fill the pipeline to ensure continuous supply. The quantity to order must be adjusted for quantities already in the system (stock on hand) and quantities already ordered but not yet received (quantity on order) to meet desired stock levels. To arrive at quantity to order for the next one year procurement period, adjustments will need to be made to account for lead time, losses/adjustments, buffer stock, stock on hand, and quantity on order. (Note: The adjusted quantity to order may be greater or less than the quantity required depending on current stock on hand and expected consumption rates). The quantity to order may also need to be further adjusted to reflect current storage and distribution capacity, especially for products that may require refrigeration.
1.
Enter total forecasted demand of each laboratory commodity
Using Excel spreadsheets or other software designed to calculate the quantity to order of each laboratory commodity, enter the total quantity of each laboratory commodity required at all levels of the system for the next one year period (if that is the forecast period).
2.
Increase forecasted demand of all items to include damages, wastage and quantity used for laboratory controls, quality testing and training
Since the method described in this guide is based on service statistics, it is important to account for commodities that are removed from the inventory but are not used for testing
(due to damage, wastage or other losses/adjustments). Before training in GLP, loss/wastage rates are assumed to be 10% of total quantity required. After training, loss/wastage rates can drop as low as 2.5% of the total quantity required.
Each country should have a defined quality control/quality assurance (QC/QA) program.
There are many schemes for internal and external QC/QA. Some of them include using supplies to retest a set percentage of the tests either internally (e.g., by a laboratory technologist) or externally. This QC/QA scheme should be clearly defined in the policy documents and the percentage of tests that are rerun needs to be included in the forecasted demand. If this policy has not been developed, the advisor should strongly advocate to the laboratory program managers that they develop and implement a QC/QA program.
If the forecast/quantification includes durables, the forecasted demand will need to include a quantity for damage of the durables (e.g., broken test tubes).
For equipment, the forecast should always include spare parts that are likely to be needed during the forecast period. Generally this depends on a number of factors, including:
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
Does the forecast include equipment?

Do manufacturers include spare parts in the equipment contract?

Do the facilities have access to spare parts locally? If so, are there funds available to procure these spare parts?
Table 5 provides a general list of regularly required spare parts in the laboratory.
Table 5: Regularly required laboratory spare parts
Major Equipment
Spares kits for each instrument
Minor Equipment
Microscope bulbs
Maintenance tools
Fuses for instruments
Filters for water purifier
3.
Calculate buffer stock needed per facility per level
If the purpose of the forecast/quantification is to estimate the needs requirement for a certain period of time, it is critical to not only determine the quantities needed for that period, but also to include a buffer stock. To do this, divide the total annual quantity required of each laboratory commodity by 12 to determine the Average Monthly Quantity
Required (AMQR).
For each laboratory commodity, multiply the AMQR by the number of months of buffer stock that will be required to cover the lead time. Lead time, expressed in months, should include the time required for preparation of the quantification, allocation and disbursement of funding, contracting of suppliers, procurement, shipment delivery, customs clearance, inspection and reception of products into the central warehouse.
NOTE: It is very important to involve the in-country counterparts when setting the buffer stock.
Add the calculated buffer stock to the total forecasted demand from step 2.
4.
Round up forecasted commodity demand to packaging size by level
NOTE: This step is only necessary for durable commodities that are not typically procured individually.
Table 6: Example of crystal violet stain demand for one year in packaging size for one provincial laboratory
Packaging
Size
Crystal violet stain 25 g
Quantity needed per year
71.1 g
Quantity rounded up to packing size
75 g
No. of packing units required per year
3 bottles
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NOTE: It is important to only round up. If the quantity of crystal violet stain needed per year was 26 g, the quantity would have to be rounded up to 50 g and result in two bottles to avoid undersupply.
5.
Multiply commodity packaging units forecasted by the number of facilities per level
Table 7: Example of crystal violet stain demand for one year in packaging size for provincial laboratories
Crystal violet stain
No. of packing units required per year per facility
3 bottles
No. of provincial laboratories
8
Total no. of commodity for provincial level
24 bottles
Table 8: Example of crystal violet stain demand for one year in packaging size for district laboratories
No. of packing units required per year per facility
Crystal violet stain 1 bottle
No. of district laboratories
29
Total no. of commodity for district level
29 bottles
6.
Subtract stock on hand at the beginning of the forecast period
In order to have an accurate quantity to order, the expected stock on hand (SOH) at the beginning of the forecast period must be included. Calculate this using the following formula:
SOH at beginning of forecast period
=
Current
SOH
+
Anticipated shipments -
Estimated usage +/-
Estimated future losses & adjustments
NOTE: The current SOH includes the stock in each of the laboratories included in the forecast/quantification as well as any stock stored at central or intermediate level storage facilities.
For more details on step 6, see The Forecasting Handbook .
Subtract the SOH at the beginning of the forecast period from the estimated demand calculated in step 5. The resulting annual quantity to order is the quantity of each laboratory commodity needed to ensure full supply at laboratories for the year of the forecast.
Additional adjustments in the quantity to order may be required at this point in the quantification to reflect the volume of product that can be adequately stored and distributed to ensure the quality and security of the laboratory commodities. Using sources of information on packaging and shipment sizes, the packaging dimensions of laboratory commodities on the market may be used to calculate the volume of incoming shipments and compared to actual storage space available in-country. The estimates of
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shipment volume and storage capacity are particularly important for reagents which may require refrigeration.
NOTE: If a maximum/minimum inventory control system has not been designed to ensure full supply of laboratory supplies and logistics data on SOH and usage of laboratory supplies will not be available at the time the quantification is conducted, assumptions may need to be made about national and facility stock levels, lead times for funding disbursement and procurement actions, recommended buffer stocks, and supplier delivery schedules and lead times.
I.
Calculate Financial Requirements
Updated sources of information on reagents and laboratory consumable prices, supplier rates, preferential pricing, and eligibility for donation programs will be needed to estimate the cost of the quantities of each laboratory commodity to be ordered. In addition, information on the cost of insurance and freight, customs clearance and duties, and in-country storage and distribution costs may need to be added to the cost of the quantities of laboratory supplies to be procured if not included in supplier rates or budgeted for through other mechanisms or waiver agreements.
Using Excel spreadsheets or other software designed to calculate the cost of the quantity to order of each laboratory supply, enter the quantity to order as the total number of packing units to be ordered for the year of the forecast.
Using the cost per pack as the unit of measure for calculating the total cost estimate of the laboratory supplies to be ordered, multiply the quantity to order of each commodity by the cost per pack to arrive at the total cost for the year of the forecast.
Depending on the purpose of the quantification and the available sources of financing for procurement of laboratory supplies, additional cost comparisons between suppliers may be required. Using the same Excel spreadsheet or other software for calculating the cost of the quantity to order for each laboratory commodity, different supplier rates and costs per pack may be applied to arrive at alternate total cost scenarios to be considered when making decisions on funding sources and allocations for procurement.
J.
Reconcile Available Funding and Quantities Required
The final decision on the quantities to procure will be determined by the amount of funding available for procurement of laboratory supplies. Where sufficient funding is available, the final quantity to procure of each laboratory commodity will be the same as the quantity to order resulting from the quantification. In the current environment of increasing financial resources for laboratory supply procurement, funding may be adequate to ensure full supply for targeted tests for the period of the forecast where service delivery and supply chain capacity exist. In other situations, the purpose of the quantification may be to determine how many laboratory tests can be provided in a year
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given a specific amount of funding available. Use the map of funding commitments described in Section G should to compare forecasted demand with available funding.
Once the annual quantity to procure has been determined, whether for full supply or nonfull supply, DELIVER recommends flexible regular shipments in which shipment quantities can be adjusted to respond to uptake in testing services, changes in testing demand, existing stock levels and rates of consumption of laboratory supplies.
Agreements with suppliers may also need to include flexibility in delaying shipments of the annual quantities procured into the year following the year of the forecast if uptake of services does not meet expected demand.
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ANNEX A: Test menu and technique by level
Tests Performed at Health Center Laboratory
Laboratory Test

Hemoglobin estimation

Blood slide for haemoparasites

Stool microscopy for parasites

Sputum for AFB

Skin slit for AFB

Urine sediment microscopy

Urine protein, sugar

Syphilis screening

Sickle cell screen

Genito-urinary tract specimens

Pus swabs

Bubo aspirate (plague)

HIV screening

Blood grouping

Rhesus typing

Total white cell count

Differential white cell count

Cerebrospinal fluid microscopy

Cerebrospinal fluid chemistry
Standard Technique

Oxyhemoglobin, lovibond comparator

Cyanmethemoglobin, Sahli

Field stain

Direct saline, iodine

ZN stain

ZN stain

Direct microscopy

Uristix

RPR/VDRL carbon antigen

Sodium metabisulphite

Wet prep/ Gram stain/ KOH

Gram stain

Wayson staining

Rapid screening kits

Tube method

Tube

Manual, Hemocytometer using Turks fluid

Manual, using stained thin film

Gram/Leishman/Turks fluid

Turbidimetric
Additional Tests Performed at District Hospital Laboratory
 Concentration technique
 Blood
 Stool
 Buffy coat (knotts)
 Formal ether
 Uristix  Urine qualitative chemistry (protein, sugar, ketones, blood bilirubin, urobilinogen)
 Skin snip for microfilaria
 Collection and fixation of cytological smears
 Saline direct
 Formalin
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 Collection and fixation of histological specimens
 Formalin
Tests Performed at the Regional Hospital Laboratory
 Hemoglobin estimation
 Total white cell count
 Differential blood counts
 Hematology analyzer
 Platelet count
 Reticulocyte count
 Blood indices
 CD4/CD8 count
 Hematology analyzer










Viral load
Sickle cell screening test
Blood slide examination for parasites
Film comment
Stool microscopy
HIV screening
Hb types
Serum proteins
Hepatitis B screening
Syphilis screening
 Serum bilirubin
 SGOT (serum)
 SGPT (serum)
 Alkaline phosphatase (serum)
 Renal function tests
 Blood glucose
 Serum electrolytes
 Total protein
 Flow cytometer
 Non-cytofluorimetric
 Manual
 HIV RNA
 Real Time PCR
 Heat Dissociated p24 antigen
 Cavidi RT
 Sodium metabisulphite
 Manual microscopy (field)
 Concentration
 Manual microscopy- Romanosky
 Direct saline/ iodine concentration
 Rapid screening kits
 Electrophoresis
 Electrophoresis
 Rapid ELISA
 RPR/VDRL carbon antigen
 Chemistry auto-analyzer(or Manual
Photometer)
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 Examination of CSF for yeast
 Examination of CSF, pus, deposit, etc., micro-organisms
 Negative staining-India ink
 Gram stain
 Culture
 Drug sensitivity
 Microscopy for plague
 Processing biopsy
 Semen analysis
 Cytology
 Sputum for TB
 Urine sediment microscopy
 Urine chemistry
 Genito-urinary track specimens
 Aerobic,
 Anaerobic
 CO2
 Disc diffusion
 Wayson staining
 Haematoxylin and eosin
 Microscopy
 Microscopy
 Pulp smear
 ZN stain
 Direct microscopy
 Uristix
 Wet prep
 Gram
 KOH
 Blood group, type and cross matching  Tube method
 Skin snip for microfilaria  Saline direct
 Examination for fungi  KOH
 TPHA  Confirmatory test for syphilis
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24

Annex B: Examples of laboratory consumables
Consumables by test
General Consumables
Anaerobic sachets Alcohol
Bijou bottles
Blood culture bottles
Blood lancets
Blotting paper
Capillary tubes
Centrifuge tubes
Cotton swabs
Cover slips
Gauze mesh
Heparinized capillary tubes
Immersion oil
Khan tubes
Lancet
Microaerophilic sachets
Microscope slide
Microtainer
Microtitre plates
Pipette tips
Pipette tips (filtered)
Prepacked iodine swabs
Printer Paper for CBD machine
Printer paper for CD4/CD8 machine
Sputum container
Stool Container
Test tubes
Universal containers
Vacutainer, red top
Vacutainer, grey top
Vacutainer, EDTA
Vacutainer needles
Vacutainer needle holder
Applicator stick
Autoclave tape
Cotton Wool
Face masks
Filter paper
Gloves
Immersion oil
Lens Tissue
Lysol
Methylated Spirit
Petri dish (if these are disposable) pH paper
Printed labels
Soap
Sodium Hypochlorite
Xylene
25

26

Annex C: Sample assumptions for laboratory supplies quantification
Assumptions for Commodity Quantification
1. The forecasting/quantification exercise is conducted only for the 16 laboratories (7 provincial hospitals, 7 district hospitals, 2 mission hospitals).
2. Representatives from 15 of the laboratories participated in the workshop, along with 2 representatives from the national NPHLS.
3. Due to the comprehensiveness of the test menu proposed at the provincial and districts levels, the team decided to give priority to the WHO/GFATM recommended test menu to support ART programs (summarized in Building Laboratory Capacity in Support of
HIV/AIDS Care Programs in Resource-limited Countries ). Any tests that were not considered HIV-related were cut from this spreadsheet.
4. Prior to the arrival of these commodities, lab in-charges will have been trained in procedures and testing SOPs.
5. The central warehouse will have the capacity to receive and manage these supplies.
6. Microbiology glass Petri dishes, blood culture bottles, and bijou bottles are reusable.
7. Glass Petri dishes were procured because of the funding will not be sustained and these will be more appropriate for long term use.
8. P24 Antigen testing was not considered because not all facilities have long ELISA machines.
9. Antibiotic sensitivity discs can not be quantified currently because there is not a link between the number of cultures and the number of sensitivities. There is also not a link between which drug combination was used per sensitivity test. Therefore, it was the recommendation of the workshop that starter packages of 10 cartridges (500 discs) be provided to each facility until appropriate logistics data is available for quantifying the usage.
10. The workshop recommended that reagent packs be used for the chemistry tests because these will be less expensive, provide high quality and simplify the supply chain.
11. The Coagulase latex kit was deleted because control plasma is considered a cheaper substitute.
12. Modified Thayer-Martin agar was deleted because it is made from products already on the list (Columbia agar, horse red cells, and VCN supplement).
13. The reagents and consumables required for CD4 testing were specifically selected for the FACSCount machine because the majority of the facilities use this machine. Only 3 facilities do not have FACSCount CD4 machines.
Assumptions for Current, Projected and Adjusted Testing Numbers
1. The test numbers did not all come from the same months or reporting periods (ex. some participants reported numbers from April-June while others from Feb.-May).
2. The current number of tests performed over a period of time may be low because of stockouts.
3. If it was noted that reagents were stocked out, the data was not averaged. If there was noted no tests were conducted (i.e., usage = 0), it was assumed that there were reagents, but no demand for the test.
4. The adjusted projection for Gram stains is the total number of all projected cultures.
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5. Viral load test numbers only include the facilities that currently have a viral load machine (8 laboratories). It is assumed that if additional viral load machines are procured for other facilities, the first year of reagents will be procured.
6. The 2 mission hospitals were considered district hospitals.
7. Test numbers were adjusted for facilities that did not report test. Adjustments were also made for facilities that reported significantly lower test numbers. The following methodology was used:

If no test numbers were reported, the average was divided only by the number of facilities that reported.

If the number of tests reported was significantly lower than the numbers of other facilities, the projected consumption was discarded and replaced by the average of all other facilities at that level.

If it was noted that there were no tests requested, this zero was included in the average.
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