The quality management system employed by the Microbiology department is directed by ISO standards provided by UKAS (United Kingdom Accreditation Service) and SMIs Q 1 and Q 2 (Standards for Microbiological Investigation). A comprehensive quality assurance programme is an integral part of the procedures of a diagnostic infection sciences laboratory and is necessary for compliance with accreditation standards (ISO 15189:2012).
The use of a quality management system and associated quality monitoring is designed to increase confidence in the overall processing of the sample from receipt to report including handling and testing of a specimen, the validity of the assay results, and the final report providing quality assurance. However, a laboratory-based quality assurance scheme may only monitor the procedures over which the laboratory has control. Joint audits are conducted to monitor all processes associated with the diagnosis of infections.
All tests performed within the department undergo evaluation prior to being put into use. This information surrounding validation and verification of tests is not published to the general public, however, if information surrounding test evaluation is required a freedom of information request can be made to South Tees NHS Foundation Trust.
The microbiology service is a UKAS (United Kingdom Accreditation Service) accredited medical laboratory (No. 9210) to the ISO 15189:2012 standards for medical laboratories. The accreditation is limited to those activities described on our UKAS schedule of accreditation and complies with regulations set out in the Human Tissue Act.
Protection of personal information:
The Microbiology laboratory follows Trust policy for information governance. This covers and complies with:
- Information governance management
- Confidentiality and data protection assurance
- Freedom Of Information Act 2000
- Information security assurance
- Clinical information assurance
- Secondary use assurance
- Corporate information assurance
For further information, please visit: https://www.southtees.nhs.uk/about/performance/governance/.