Current reasoning holds that Pathology Departments in general abound with potential for development of comprehensive tissue banks as critical resources for investigative research and clinical trials. However, concise program implementation is necessary to provide the most cost-effective, research-oriented, comprehensive bank possible.

The Western Pennsylvania Genitourinary Tissue Bank has constructed a general structural plan for developing and implementing Tissue Banking modules which has proved to be a useful framework and model. This developmental plan occurs in 5 distinct phases. Each phase serves to progressively build towards a fully-functional, self-standing modules of a Tissue Bank.

Phase I: Development of a Tissue Bank Module includes the identification of research potential and recruitment of interested investigators. It is during this phase that a basic outline of tissue needs, harvesting protocols, and the organ/organ-system of interest is identified. Additionally, potential sources of specimens and tissue are identified from UPM C-affiliate and non-affiliate sources
Phase II: Testing of harvesting procedures at the UPMC core hospitals to ensure, since the primary when handling clinical patient samples is maintaining adequate tissue for diagnostic value, that harvesting procedures in no way interfere with the standard sampling for routine surgical pathology and diagnosis. It is also in this phase that refinement of current pathology procedures is made to account for bankin~ and re-design of harvest methods is often required. Many times, banking procedures we have developed have actually improved on the routine pathologic examination, thus increasing levels of patient care.
Phase III: Occurring when banking procedures are implemented to fulfill tissue requests from a select group of ~ Quality assurance measure are already in place, and requests are made based on numbers of cases required by investigators. Only a small portion ofpotentially bankable tissue is actually banked, as most is distributed directly to requesting researchers. Tracking of tissue collection and disbursement is done through a simple database, which includes basic elements ofpatient age, race, primary diagnosis, tissue collected, tissue diagnosis, and disbursement. Office of Research and Institutional Review Board approval at this phase of development most often falls under the 'expedited' category. This simplifies the banking protocol, as patient identifiers are not utilized, and thus consent is not required. As initial researchers progress and patient follow-up or clinical history is needed, the banking module moves to Phase IV.
Phase IV: Module development requires revision of the protocol so that full-board IRB approval is obtained in order for patient clinical follow-up, history, and progression information to be obtained. This revision necessitates the need for patient consent, and it is also at this stage that banking of serum, white cells, and whole blood begins as the issue of patient consent comes on-line'. Phase 4 also includes expansion of the protocol to previously identified affiliated and non-affiliated institutions, and expansion of database activities to incorporate collection of new patient information. However, the database is still PC-confined, and is not mainframe networked.
Phase V: An ambitious phase that has emerged from the constant explosion of technological advances in the field of medical informatics. It is the goal of this phase to transfer the existing database to a mainframed system which communicates with existing clinical mainframes to auto-gather database fields, and to create a dynamic-reporting system inclusive of digital images, radiology images, and demographic profiles ofprevious clinical experiences to be reported on all patient pathology reports. It is also at this phase that determination of a need for a 'warm-autopsy' harvesting program is done, in which collection of metastatic disease tissue from terminal patients at the time of death is pursued.

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