Quality management indicators for tissue banks: an operative model from the period of 2002-2007.

AIM

The purpose of this study was to determine a specific indicator model to evaluate the Quality Management System (QMS) in Tissue Banks (TB) for deceased and/or live donors.

METHODS

Quantitative Indicators for Quality Management are considered for deceased donors as the origin of therapeutic tissues. A glossary of definitions was established (also applicable for tissues from live donors): Deceased Therapeutic Real Donors (DTRD), donors that were processed and at least 1 tissue was harvested for a therapeutic purpose; Deceased Effective Donors (DED), DTRD in which 1 or more tissues were validated, stored, and/or grafted; Processed Tissues (PT), number of tissues harvested from a DTRD, which were processed and counted as final product units; Validated Tissues (VT), number of tissues as final product units, which fulfilled quality criteria to be grafted; Grafted Tissues (GT), number of transplanted tissues for therapeutic purposes; and Grafted Patients (GP), number of patients who were grafted with validated tissues. MANAGEMENT QUANTITATIVE INDICATORS: Deceased donors were considered from 2002 to 2007. The total number of tissues was 15,363: Productivity Index (PI), PI = DED/DTRD; Processing Quality Rate (PQR), PQR = VT/PT%; Productivity Efficiency per Donor (PED), PED = VT/DED; Grafted Tissues Coefficient (GTC), GTC = GT/VT; and Grafted Patients Index per Donor (GID), GID = GP/DED.

RESULTS

Results were as follows: PI = 0.80; PQR = 76%; PED = 30.99; GTC = 0.93; and GID = 4. In our study, 80% of DTRD produced VT (PI = 0.80), which represented 76% of PT (average, 31 final products per donor). Also, 93% of the VT were grafted with 5 patients grafted per donor.

CONCLUSIONS

Defined variables resulted in useful tools to evaluate QMS in a TB.