Introduction

This document, Requirements for the Supervision of Pathology Laboratories, details the National Pathology Accreditation Advisory Council (NPAAC) standards used to assure the safety, quality and efficacy of pathology testing through effective supervision.

For the application of the Health Insurance (Accredited Pathology Laboratory - Approval) Principles 1999 (or equivalent), laboratories have been categorised into groups to facilitate the definition of appropriate levels of supervision for particular types of laboratories.

The principles for the approval of premises as an accredited pathology laboratory were first determined in 1987. There were eight categories to which laboratories could be assigned for accreditation purposes, depending on the location of the premises and who is responsible for day-to-day supervision. These categories and definitions were reviewed in 1993 and it was agreed that, for the purposes of accreditation, laboratories be divided into five categories, defined by who is responsible for the day-to-day supervision.

In 2004, NPAAC again reviewed the changes that have taken place within pathology laboratories, in laboratory technology, information technology, electronic supervision and current laboratory work practices.

In each section of this document, points deemed important for practice are identified as either ‘standards’ or ‘guidelines’.

• A standard is the minimum requirement for a procedure, method, staffing resource or laboratory facility that is required before a laboratory can attain accreditation — standards are printed in bold type and prefaced with an ‘S’ (e.g. S2.2). The use of the verbs ‘shall’ and ‘must’ in each standard within this document indicates a mandatory requirement for pathology practice.
• A guideline is a consensus recommendation for best practice and should be used if a higher standard of practice is appropriate, particularly when setting up or modifying a laboratory test, or when contamination problems have occurred — guidelines are prefaced with a ‘G’ (e.g. G2.2) and are numbered to correspond with their associated standard. ‘Should’ is used to indicate guidelines or recommendations where compliance would be expected for good laboratory practice.
• A commentary is provided to give clarification to the standards and guidelines as well as to provide examples and guidance on interpretation. Commentaries are placed where they add the most value, and may be normative or informative depending on both the content and the context of whether they are associated with a Standard or a Guideline. Note that when Comments are expanding on a Standard or referring to other legislation, they assume the same status and importance as the Standards to which they are attached.

While this document is for use in the accreditation process, comment from users would be appreciated and can be directed to:

The Secretary NPAAC
Department of Health
GPO Box 9848
CANBERRA ACT 2601
Phone: (02) 6289 4017
Fax: (02) 6289 8509
Email: The Department