Yale Pathology Tissue Services (YPTS)

• A Pathology-based Central Tissue Resource Lab providing comprehensive tissue related services and material for investigators at Yale and beyond
• Providing services as Critical Technologies for Tissue Services (CTTS), a shared resource of the Yale Cancer Center Providing services as a Yale Skin SPORE core facility

Mission

To provide the maximum amount and quality of human tissue for research at Yale University without impacting diagnostic quality, accuracy and safety in anatomic pathology.

Executive Summary

Human tissue, collected by physicians for diagnostic purposes, is an extremely valuable resource for translational research. However, this resource is limited in amount and constricted in scope of use by the fact that it initially belongs to the patient from whom it was taken, and once collected, is an asset of the institution. Its diagnostic usage supersedes all other uses. There are now a proposed set of policies and standard operating procedures that will provide for optimal management of pathology resources including fresh, frozen, and fixed tissue, included tissue from the Yale Pathology Departmental Archives. The program is the successor to the previous center at Yale (known as Critical Technologies) for archived material, but differs from the previous mechanism in the handling of fresh and frozen tissue. In place of the traditional comprehensive tissue-banking model, this service maintains a limited pilot-type banking activity, and primarily relies upon prospectively acquired tissue and a distributive model of banking. The organizational structure and details are shown in the poster.

Underlying Premises

• All tissue must be handled in strict compliance with HIPAA regulations, University research policies, diagnostic requirements and Hospital by-laws.
• Barriers to tissue use for research should be minimized as much as possible to promote translational research at Yale.
• Tissue used for research should be made available as broadly as possible, but users must recognize and be prepared to assume the responsibilities and costs associated with all aspects of tissue procurement and management.
• Due to the scarcity of the resource, the distribution should be overseen by an inter-department committee that would approve policy; recommend cost recovery policy, and adjudicate disputes related to allocations of scare resources.
• Due to the importance of tissue related information, the information delivery from pathology data archives are also included in this distribution structure.

Definitions

• Diagnostic Tissue: This is the actual material used to render the diagnosis. This generally represents a single or series of tissue blocks. It is generally formalin-fixed and paraffin embedded material. It also includes the “frozen section control” or material that is fixed and processed after the completion of the frozen section procedure.
• Excess Tissue: This refers to tissue received in the surgical pathology suite that is deemed by the resident, PA and/or attending pathologist to be unnecessary for the rendering of a diagnosis. This tissue will be either discarded or may be captured for research purposes.
• Protocol-Defined Tissue: This refers to tissue specifically taken for clinical trial protocols or other clinical studies that are previously approved by the Yale Human Investigation Committee (HIC). This tissue is managed in a manner stipulated by the protocol with over-sight by pathology as prescribed.
• Tissue derived products: This term refers to DNA, RNA or protein made from tissue samples.