GHP December 2015

ghp December 2015 | 23 regulation & policy Public Health England (PHE) acts as custodian of SMIs and review the documents which are in use every three to five years. They are currently in the consulting stages of developing a guide to good laboratory practice when undertaking serology assays for infectious diseases. SMIs are algorithms and procedures for clinical mi- crobiology, developed through consultation. Patients, public and partner organisations can comment on any open consultations, allowing them the chance to make suggestions on how the standards could be improved. SMI Q 7: Good laboratory practice in serology assays for infectious diseases describes the essential components of a good microbial serology service. A broad definition of serology is used in this document to include both antibody and antigen tests that are performed, usually on blood samples, to detect infection or immunity. Conventionally, microbiology and virology laboratories perform microbial serology assays. In an increasing number of laboratories some tests are performed using analysers on automated blood sciences tracks. It is important to recognise those critical pre-analytical, an- alytical and post-analytical steps and procedures which are essential to the delivery of a high quality service. The principles described in this new document are also relevant to nucleic acid amplification tests (NAATs) performed on blood samples, especially where microbial serology and NAATs are available for the same infection and may be listed together in order entry systems. In these circumstances there should be an experienced assessment of the appropriateness of performing serol- ogy tests or NAATs as part of a unified process that may include changing the request from a NAAT to a serology test, or vice versa. Good laboratory practice, which is what this SMI documents outline within the field of serology assays for infectious diseases, is referred to as “a set of principles that provides a framework within which laboratory stud- ies are planned, performed, monitored, recorded, report- ed and archived”. The aim of good laboratory practice is to promote the development of quality test data as well as to provide a tool to ensure a sound approach to the management of laboratory testing, including conduct, reporting and archiving. Public Health England develop these standards together with partner organisations, Public Health Wales, rep- resentatives from Scotland and Northern Ireland, NHS and the Royal College of Pathologists which display their logos on the SMIs. An organisation’s logo in an SMI indicates the society participated in equal partnership and support for the objectives and process of preparing SMIs. Nominees of professional societies are members of the steering committee and working groups that develop SMIs. The nominees participate in the development of the SMIs although their views cannot be rigorously representative of the members of the partner organi- sation nor the corporate view of the organisation, with nominees also acting as conduits for two way reporting and dialogue. Each of the devolved administrations endorses SMIs. Public Health Wales bases its own All-Wales SOPs on the SMIs. The Welsh Microbiological Association, the Scottish Microbiology and Virology Network, the Scottish Microbiology Association and the Northern Ireland Microbiology Forum and Audit Group also endorse the standards. UK Standards for Microbiology Investigations include: • syndromic algorithms, that are the overarching framework that connect other SMIs, and describe the investigations chosen at the pre-analytical (clini- cal syndrome) stage • recommended investigations for microbiology • minimum testing algorithms for virology (analytical and post analytical) • clinical guidance that covers the clinical back- ground, differential diagnosis, and appropriate investigation of particular clinical conditions • quality guidance that describes laboratory meth- odologies to ensure quality, like assay validation, quality assurance and understanding uncertainty of measurement. There are three groups of users who find SMIs relevant to their work, the first being practicing laboratory medicine professionals in the UK who use the SMIs as a general resource. Additionally, clinicians use SMIs to learn about the standard of laboratory services they can expect for their patients. SMIs can help them order the appropriate tests electronically from hospital wards. The final principal user of SMIs is commissioners of healthcare services, who use SMIs to find the standard of microbiology investigations they can seek as part of the clinical and public health care package for their population. Within the consulting process for SMIs, members of any of these three groups are able to add their views on the document and how it could be improved. All SMIs are developed, reviewed and updated through this consulta- tion process. The standards unit updates and reviews SMIs by con- sultation using the opinions of many other stakeholders, including members of the public, partners and specialist groups. This includes microbiology professionals and doctors. The resulting documents reflect the majority view of contributors, which insures that the document is democratically produced and reflects the needs of every- one who will be affected by the document. The full consultation, which is open until 2nd November 2015, is available to view here. Public Health England is in the final stages of creating UK SMI Q 7, which is designed to provide advice on good laboratory prac- tice when undertaking serology assays for infectious diseases.