SMILE Johns Hopkins University Baltimore, MD USA QSE 5: Purchasing and Inventory - Policy Purchasing and Inventory Policy Approval Signature: Laboratory Director Policy Number Doc10-14AppE Effective Date 30-Jul-08 Last Review 27 July 2010 Supersedes New SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE Policy The laboratory purchases and maintains an inventory of equipment, supplies, and reagents used in the path of the laboratory workflow. Purpose This policy provides direction for the processes and procedures to effectively work with the Purchasing Department to manage purchase and inventory processes. Responsibility The Purchasing Department is responsible for vendor payment and delivery arrangements. The Laboratory Director reviews and approves contract of services to referral laboratories and other services or facilities. The Laboratory Supervisor is responsible for vendor identification and selection and order processes. The Lead Technologists are responsible for inventory maintenance. The Laboratory Supply Manager is responsible for receiving and storage of inventory. Selection and Use of Referral Laboratory Services The laboratory has an established procedure for evaluating and selecting referral laboratories. Vendor Selection The laboratory has a system for selecting vendors of equipment, supplies, and services. Purchasing Supplies and Reagents The laboratory works with the Purchasing Department to purchase supplies and reagents. Receiving, Inspecting, Storing, and Managing Supplies and Reagents. The laboratory has processes and procedures for receiving, inspecting, storing, and managing the inventory of supplies and reagents used in the path of workflow. Supporting Documents The following processes support this policy: Use of Referral Laboratory Services Identifying and Selecting Vendors Purchasing Supplies and Reagents Handling Supplies and Reagents 106738225 Version#: 1.0 Page 1 of 5 SMILE Johns Hopkins University Baltimore, MD USA Use of Referral Laboratory Services - Process Process for Use of Referral Laboratory Services Who’s Responsible What Happens Laboratory Director Laboratory Supervisor Purchasing Department The laboratory has processes to ensure that the referral laboratory’s performance meets all required regulations and standards. The laboratory enters into contract with a referral laboratory Procedures Use of Referral Laboratories Referral Laboratory Test Menu Referral Laboratory Representatives Laboratory Test Menu Laboratory Supervisor Use of Referral Laboratories Laboratory Director Laboratory Supervisor Use of Referral Laboratories Purchasing Department Completing Purchase Orders Referral Laboratory Representatives The laboratory maintains a listing of all referral laboratories it uses Laboratory Supervisor Use of Referral Laboratories The laboratory maintains a log of all samples sent out to referral laboratories and a record of all tests conducted on each Laboratory Supervisor Technicians/Technologists Use of Referral Laboratories Specimen Tracking and Handling Result reports include the name and address of the referral laboratory and all of the essential elements of the referral laboratory’s report without alterations that may impact clinical interpretations Laboratory Supervisor Technicians/Technologists Use of Referral Laboratories Result Reporting The laboratory has processes for evaluating and selecting referral laboratories 106738225 Version#: 1.0 Page 2 of 5 SMILE Johns Hopkins University Baltimore, MD USA Identifying and Selecting Vendors - Process Process for Identifying and Selecting Vendors for Supplies and Reagents Who’s Responsible What Happens Inventory lists are created from equipment/methods in use Possible vendors are identified and evaluated Vendors are selected 106738225 Lead Technologist Purchasing Department Laboratory Supervisor Laboratory Supervisor Quality Manager Lead Technologists Purchasing Department Version#: 1.0 Procedures Test-Specific SOPs Test Menu Equipment-Specific Operating Manuals Purchasing Department Policies and Procedures List of Approved Vendors Purchasing Department Policies and Procedures List of Approved Vendors Page 3 of 5 SMILE Johns Hopkins University Baltimore, MD USA Purchasing Supplies and Reagents - Process Process for Purchasing Supplies and Reagents Who’s Responsible What Happens Need for purchase of supplies or reagents is identified using inventory lists Lead Technologist Laboratory Supply Manager Purchase order is completed Purchase order is submitted and processed 106738225 Procedures Inventory of Supplies and Reagents Lead Technologist Laboratory Supply Manager Inventory of Supplies and Reagents Completing Purchase Orders Laboratory Supervisor Lead Technologist Completing Purchase Orders Laboratory Supply Manager Purchasing Department Procedures Purchasing Department Inventory of Supplies and Reagents Version#: 1.0 Page 4 of 5 SMILE Johns Hopkins University Baltimore, MD USA Handling Supplies and Reagents- Process Process for Handling Supplies and Reagents Who’s Responsible What Happens Procedures Supplies and reagents are received in the facility Facility Receiving Department Facility Receiving Department Procedures Supplies and reagents are received in the laboratory Quality Manager Laboratory Supply Manager Receiving Supplies and Reagents in the Laboratory Received supplies/reagents are documented on inventory Laboratory Supply Manager Receiving Supplies and Reagents in the Laboratory Inventory of Supplies/Reagents Receiving Supplies and Reagents in the Laboratory Acceptability of reagents/supplies is determined Unacceptable reagents/supplies are handled Acceptable supplies and reagents are labeled and stored for future use Supplies and reagents are put in use 106738225 Laboratory Supervisor Quality Manager Laboratory Supply Manager Quality Control of Supplies and Reagents Technicians/Technologists Parallel Testing Laboratory Supervisor Quality Manager Receiving Supplies and Reagents in the Laboratory Laboratory Supply Manager Quality Control of Supplies and Reagents Technicians/Technologists Quality Manager Laboratory Supply Manager Receiving Supplies and Reagents in the Laboratory Technicians/Technologists Inventory of Supplies/Reagents Quality Manager Laboratory Supply Manager Receiving Supplies and Reagents in the Laboratory Technicians/Technologists Inventory of Supplies/Reagents Test-Specific SOPs Version#: 1.0 Page 5 of 5