Procurement planning in a hematology lab

Selection and procurement of diagnostic analyzers in hematology lab have to be tailored to the end-user. Hence, procedures may differ between the types and levels of labs.

All organizations, whether governmental, nongovern­mental, or private, have limited resources that must be utilized in the most efficient manner possible. The importance of good advance planning must never be underestimated as it provides critical information management requires to allocate resources that will enable the organization to reach its objectives. The procurement planning process can be described in several stages ranging from a preliminary needs assessment through key communication and decision-making stages to the actual development of a written plan. The final stages include the selection and quantification of products. Planning is an iterative process that requires continuous review and input from key stakeholders, good communication between parties, and flexibility in approach.

Approval processes should rely on manufacturer claims for performance and operational characteristics. Verification of performance through regulatory assessment or other national studies may provide independent verification of these claims. Minimum criteria should be discussed and agreed for each product category used at each level of the laboratory network, and take into consideration the following aspects.

Minimum acceptable performance criteria must be agreed and the following characteristics included, as appropriate for a particular product category – clinical sensitivity, analytical sensitivity, clinical specificity, invalid rate/non-reportable results, inter-reader variability, if subjectively read, bias, for quantitative method.

The operational aspects of diagnostics are equally as important as the performance characteristics, and thus both must be included within product specifications. The WHO Prequalification of Diagnostics Program provides an independent assessment of the operational characteristics of diagnostics. Consideration should be given to the instrument/platform, costs and logistics required to perform the assay, including but not limited to: test format, specimen type, detection type (including subtype detection), time to result, endpoint stability, through-out per hour per instrument per operator, equipment/consumables required but not provided in the test kit, such as specimen collection accessories, ease of use, required technical skills of staff conducting testing (including phlebotomy), laboratory infrastructure required, environmental conditions required for shipping, storage and operation, availability of test kit controls, such as internal test device controls and test kit controls for QC, and compatibility with QC materials, compatibility with EQAS/proficiency-testing programs, shelf life upon manufacture (and guaranteed shelf life upon delivery), and expected life span of equipment/instrument.

All contracts related to equipment installation, training, and maintenance must be considered as part of the procurement process. There must be an explicit provision in the procurement contract for preventive and corrective maintenance schedules for the expected life of the equipment. Contracts should cover a minimum of two years post the one-year manufacturer’s warranty, but preferably be longer. The initial contract should be made at the time of procurement (as part of vendor requirements and detailed specifications). Contract extensions beyond the initial time period should be made well in advance and ensure manufacturer-approved service personnel are used. Preventive maintenance should be scheduled on a daily, monthly, quarterly, and annual basis, depending on the type of equipment.

Quantification is the process by which requirements for laboratory equipment, reagents, consumables, and durables are made. The quantification process requires significant preparation to ascertain the current scope and demand for products. A significant part of the quantification process is dedicated to the development and adjustment of forecasting models.

To conclude, procurement planning is very critical in a lab set-up and requires meticulous planning and implementation for the desired output.