Tissue Acquisition Specific SOP

It is essential to perform optimal management of pathology resources including fresh, frozen and formalin-fixed specimen regarding the requests of human specimens for research purpose. All human tissues must be handled in strict compliance with HIPAA regulations, University HIC policies, and diagnostic requirements. All users must recognize and be prepared to assume the responsibilities associated with all aspects of tissue procurement and management. For each request, a standard operating procedure (SOP) must be drawn up by the requesting investigator and TPD director. The detailed condition and specific guideline of specimen grossing required should be defined by requesting investigator and attending pathologist in an effect to standardize operating and to keep research tissue sampling under management without jeopardizing diagnosis tissue submission. Personnel from YTPDF will help interested investigators design and optimize SOPs. Terms for specific requests of specimens will be discussed depending on demand, specimen site, and the amount of Pathology participation and manpower required. Negotiations will be conducted by the director of Yale Pathology Tissue Services and overseen and approved by the Tissue Resource Oversight Committee (TROC).

For investigators whose research projects are not claimed to involve Human Subject, based on institutional HIC guideline, limited information associated with samples will be provided including age range, sex, diagnosis and pathological status (Tumor or Normal). YTPDF party will assign a new identifier for each SOP specific sample, in the manner that it would not be possible for investigators to identify the corresponding patient-subject directly. For linked tissues, investigators are required to have HIC approval and signed patient consent.

Prior to implementation, drafted SOP must be reviewed and approved by the directors of Pathology service and other appropriate individuals including attending pathologist who supervising specified tissue collection. Implementation date should be recorded for all procedures.

All data related to tissue collection must be entered into the YTPDF database, which will allow YPTS to manage, keep track of YPTS fresh and frozen tissue biorepositories, and to oversight and coordinate inventories in the distributed banks.

YTPDF SOP format

A. Purpose or clinical significance:

B. Forms and Records:

C. Conditions for Patient Preparation:

D. Step-by-Step Details of the Procedure (detailed and specific):

    1. Collection personnel’s
    2. Collection site
    3. Collection logistics
    4. Exclusion and inclusion criteria for potentially legitimate specimens
    5. Grossing guideline for both tumorous and normal specimen sampling
    6. Anticipated ischemic time
    7. Minimal number of tissue unit required
    8. Minimal size (mm) required for each tissue unit
    9. Tissue Processing
    10. Subjectivity to embargo period
    11. Tissue distribution

E. Equipment, reagents, supplies and personnel

F. Hazardous Materials MSDS:

G. Distribution and Location of SOP