The Use of Microbiological Quality Control Techniques Adopted in a Human Tissue Bank

ABSTRACT

The Brazilian Ministry of Health’s Consolidation Ordinance No. 4 of September 28, 2017, provides the requisites for the evaluation of services for human tissue banks (bancos de tecidos humanos [BTH]) in terms of the microbiological control of environments (ISO 5 classification processing room) and products (culture for aerobic, anaerobic, and fungal pathogens), with a view to guaranteeing harmlessness in tissue transplants.

Objectives:  To highlight the techniques for microbiological control of distributed tissues adopted by a BTH over 5 years, as well as the results obtained from the application and use of these techniques.

Methods:  Using standard operating procedures (SOPs), the methodology, and frequency of collections, tests and room cleaning were established in advance. Microbiological cultures were taken from the tissues during all the collections and processing. During tissue processing, fingerprint samples on the processor’s gloves and in the processing room were seeded on blood agar plates. The processing room was cleaned weekly with biguanide and quaternary ammonium. The processing bench was sanitized with sterile 70% alcohol and the microbiological environmental control was carried out every 6 months by a qualified outsourced company.

Results:  In the period analyzed, the techniques proved effective in 46 (96%) cases, with contamination identified in only two (4%) processed and collected samples. The effectiveness and results were documented.

Conclusion:  Effective biological quality control methods are legitimately required, but they can be improved, raising the need to develop safe protocols for the quality of services and the safety of transplanted tissues.

Descriptors Tissue Donation; Tissue Transplantation; Biological Quality Control; Innocuous Products; Human Tissue Bank