Guidelines to implement quality management systems in microbiology laboratories for tissue banking. 2009

W Vicentino, and G Rodríguez, and M Saldías, and I Alvarez
Instituto Nacional de Donación y Trasplante de Células, Tejidos y Organos, Av. Italia s/n - Hospital de Clínicas 4 degrees Floor, Montevideo, Uruguay. indt@hc.edu.uy

Human tissues for implants are a biomedical product that is being used more frequently by many medical disciplines. There are infections in the patients related to the implanted tissues. The early detection of infections transmitted by blood and the microbiological study of tissues before their clinical use are strategies in tissue banks to prevent these situations. This work sought to contribute to establish the bases for the operation of a laboratory applied to the microbiological quality control of tissues. Based on classical microbiological principles, we defined the operation of microbiological control and tissues sterilization since 2003. We determine lists of acceptable microorganisms for every tissue, criteria for the interpretation of results, and a diagnostic algorithm of microbiological quality. We observed that the circumstances of donor death can be a determinant of the quality. The environment and the operator should be investigated as probable sources of contamination in outbreaks. The criteria of work based on a solid methodology must help to avoid the transmission of infections between donor and recipient. This is a critical point in the quality management of a tissue bank.

UI MeSH Term Description Entries
D007753 Laboratories Facilities equipped to carry out investigative procedures. Laboratory
D008829 Microbiology The study of microorganisms such as fungi, bacteria, algae, archaea, and viruses.
D011786 Quality Control A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed) Control, Quality,Controls, Quality,Quality Controls
D002102 Cadaver A dead body, usually a human body. Corpse,Cadavers,Corpses
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000465 Algorithms A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task. Algorithm
D001419 Bacteria One of the three domains of life (the others being Eukarya and ARCHAEA), also called Eubacteria. They are unicellular prokaryotic microorganisms which generally possess rigid cell walls, multiply by cell division, and exhibit three principal forms: round or coccal, rodlike or bacillary, and spiral or spirochetal. Bacteria can be classified by their response to OXYGEN: aerobic, anaerobic, or facultatively anaerobic; by the mode by which they obtain their energy: chemotrophy (via chemical reaction) or PHOTOTROPHY (via light reaction); for chemotrophs by their source of chemical energy: CHEMOLITHOTROPHY (from inorganic compounds) or chemoorganotrophy (from organic compounds); and by their source for CARBON; NITROGEN; etc.; HETEROTROPHY (from organic sources) or AUTOTROPHY (from CARBON DIOXIDE). They can also be classified by whether or not they stain (based on the structure of their CELL WALLS) with CRYSTAL VIOLET dye: gram-negative or gram-positive. Eubacteria
D001424 Bacterial Infections Infections by bacteria, general or unspecified. Bacterial Disease,Bacterial Infection,Infection, Bacterial,Infections, Bacterial,Bacterial Diseases
D014015 Tissue Banks Centers for acquiring, characterizing, and storing organs or tissue for future use. Tissue Banking,Bank, Tissue,Banking, Tissue,Banks, Tissue,Tissue Bank
D014019 Tissue Donors Individuals supplying living tissue, organs, cells, blood or blood components for transfer or transplantation to histocompatible recipients. Organ Donors,Donors,Ovum Donors,Semen Donors,Transplant Donors,Donor,Donor, Organ,Donor, Ovum,Donor, Semen,Donor, Tissue,Donor, Transplant,Donors, Organ,Donors, Ovum,Donors, Semen,Donors, Tissue,Donors, Transplant,Organ Donor,Ovum Donor,Semen Donor,Tissue Donor,Transplant Donor

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