Pathology services work in a highly regulated environment that aims to ensure that laboratories provide a safe working environment for staff and are capable of delivering a consistent, accurate and safe service to patients.

Although the UK Accreditation Service (UKAS) is the main vehicle for accreditation, the Medicines and Healthcare products Regulatory Authority (MHRA), Health and Safety Executive (HSE) and Human Tissue Authority (HTA) impact on laboratory work, with professional guidance provided by The Royal College of Pathologists (RCPath), Association for Clinical Biochemistry and Laboratory Medicine (ACB), British Society for Haematology (BSH), British Infection Association (BIA) and others. They do this through key performance indicators (KPIs), key assurance indicators (KAIs) and formal guidance documents. NHS Improvement (NHSI) is seeking to quantify some aspects of laboratory performance to provide to patients and commissioners with assurance on the clinical value of the services, e.g. Pathology Quality Assurance Dashboard (PQAD) and Getting It Right First Time (GIRFT). 

This document provides an overview of the main regulatory organisations impacting on pathology services, seeking to clarify where there are areas of overlap and synergy.