General Project Information
Proposed Title:
Purchasing and Inventory: Management of Laboratory Supplies and Suppliers
Anticipated product will be (check one)
Consensus standard
X Consensus guideline
Other (describe)
Level of intended user
X Novice
X
Development Track
X Track 1 (no more than 14 months)
Intermediate
Report
Advanced
Track 2 (no more than 19 months)
Is this document intended to provide guidance for meeting a regulatory or accreditation requirement(s)?
X Yes
No
Project Description
Rationale for the Project
The CLSI Standing Subcommittee on Quality Management Systems has a goal to develop and maintain one
or more guidelines that support each QSE. There is currently no general CLSI guideline that presents
policies, processes, and procedures to fulfill requirements for QSE Purchasing and Inventory.
NCCLS guideline GP06-A was published in 1994 and is no longer available. In addition, the content is no
longer relevant in today’s electronic environment.
This guideline will describe regulatory and accreditation requirements for QSE Purchasing and Inventory,
and offer ideas on how to fulfill them. When laboratories have an organized approach to acquiring and
managing reagents and other materials and services needed for preexamination, examination, and
postexamination processes, they can use fewer resources and sustain higher quality.
Proposed Scope
This guideline is applicable to medical laboratories of any size, complexity, or specialty, including pointof-care testing. However, as the concepts behind the requirements for purchasing and inventory are
generic, other types of laboratories, such as public health, research, food, environmental, and veterinary
laboratories, can also use this guideline.
This guideline will not provide detailed (“how to”) instructions for implementing an inventory management
system. This guideline does not cover management of human tissues and blood products.
Page 3 of 11
Project Description (Continued)
Process flow chart. The process flow chart helps define the order of the text sections in the document.
Start
Supplier is selected
Supplier is qualified
Materials/services are
purchased
Supplier is evaluated
Received materials are
inspected and verified
Are materials
approved for use?
Yes
Materials are stored
Inventory is managed
Page 4 of 11
No
Project Description (Continued)
Chapter Outline
Chapter 1: Introduction
Scope
Background
Definitions
Abbreviations and Acronyms
Chapter 2: Purchasing and Inventory Process
2.1 Selection and qualification of suppliers of products and services, based on their ability to meet
laboratory expectations
2.1.1 Process to select suppliers, contractors, and consultants
2.1.2 Means to qualify suppliers, contractors, and services for the approved supplier list
2.2 Purchase of materials or services
2.2.1 Defining, documenting, periodically reviewing, and making changes to purchasing agreements
2.2.2 Processes for laboratory purchasing or collaborating with purchasing authority
2.3 Supplier, contractor, and consultant qualification and evaluation
2.3.1 Providing feedback to suppliers on whether they met the laboratory’s expectations
2.3.2 Handling nonconforming suppliers
2.4 Inspection and verification of received materials
2.4.1 Receiving materials into the laboratory
2.4.2 Verifying performance, as necessary
2.5 Storage and handling of materials
2.5.1 Process for storing materials per the manufacturer’s instructions
2.5.2 Provision of needed storage environments
2.5.3 Disposal of expired/outdated materials
2.6 Inventory management
2.6.1 Retrieval, use, and evaluation of laboratory reagents and supplies
2.6.2 Maintenance of an inventory management system
2.6.3 Application of Lean principles for waste reduction and inventory management
2.6.4 Handling nonconforming materials and supplies
2.7 Identification and tracing of critical materials and services
2.7.1 Connecting materials to involved patients, activities, or records
Chapter 3: Important aspects of each QSE are discussed as applicable.
Chapter 4: Conclusion
Chapter 5: Supplemental Information
References
Sample processes, procedures, and forms for:
• Defining criteria for supplies and services to be purchased
• Maintaining and distributing an approved supplier listing
• Evaluating a supplier’s materials and services
• Receiving, inspecting, testing where needed, and storing incoming materials
• Assessing and maintaining inventory
• Tracing supplies to individual patients
Page 5 of 11