An audit is used to check and assure that the processes and methods used in a clinical laboratory comply with the required standards and to persistently improve the service provided for the service users.
The International Organization for Standardization – ISO9001 – defines an audit as “A systematic and independent examination whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives”.1
Audits are therefore an essential part of the Quality Management System and are a requirement by the Clinical Pathology Accreditation (CPA).
The aim of an audit is to collect information by means of observation, discussions and sampling to recognize areas where improvements can or needs to be made to improve the standards of the laboratory. An audit doesn’t only pick up on the poorer processes in the laboratory but also identifies those that are working well, giving an opportunity for the staff to learn from good practice and to allow there knowledge to be transferred to other processes.
Moreover, an audit allows organizations to assess their methods, determine any problems, and to produce cost effective and efficient solutions to fix them.
Audits are used to check practices against procedures and to carefully document any differences that may occur in detail. However, audits are only sampling exercises, so they cannot confirm that all aspects of a method are being obeyed with at all times.
There are 4 main types of audits:
1. Vertical Audit
2. Horizontal Audit
3. Witness or examination Audit
4. Self-assessment Audit
A vertical audit observes a single item, following it from start to finish. For example, the process a single clinical sample takes once it has been received by specimen reception to the results of the tests performed on the analyser and then it being issued to the relevant clinician.
A horizontal audit examines one component in a...