Requirements for the supervision of pathology laboratories (2007 Edition)

Laboratory categories

The National Pathology Accreditation Advisory Council (NPAAC) was established in 1979 to consider and make recommendations to the Australian, state and territory governments on matters related to the accreditation of pathology laboratories and the introduction and maintenance of uniform standards of practice in pathology laboratories throughout Australia.

Page last updated: 10 February 2014

Introduction

There are five laboratory categories, as specified in Section 17 of the Health Insurance (Accredited Pathology Laboratory – Approval) Principles 2002: The different categories are described in detail below. Standard 1 of this document outlines the staffing and supervision requirements for each of the five categories; Standard 2 outlines the consultation requirements. The range of tests performed in each category of laboratory must be approved by the accrediting agency.

Categories GX and GY (General)

These categories are used for both large and small multidiscipline or general laboratories providing comprehensive services. They are also used for limited or single discipline laboratories.

A Category GX laboratory comprises of a laboratory, or a number of co-located laboratories, performing services in 1 or more groups of pathology:
(a) under the direction, control and full-time supervision of a supervising pathologist or senior scientist who is expert in the group, or groups, concerned; and
(b) at which the number of working pathologists (whether full-time or part-time) is equivalent to more than 2 full-time pathologists.


A Category GY laboratory comprises of a laboratory, or a number of co-located laboratories, performing services in 1 or more groups of pathology:
(a) under the direction, control and full-time supervision of a supervising pathologist or senior scientist who is expert in the group, or groups, concerned; and
(b) at which the number of working pathologists (whether full-time or part-time) is equivalent to not more than 2 full-time pathologists.


Where a laboratory is operating for less than a full-time equivalent working week then the requirements for supervision in these categories must apply for the hours of operation of that laboratory.
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Category B (Branch)

This category is used for a laboratory that is either:
a) an integral part of a Category GX or GY laboratory, apart from its geographic location
or
b) a part of a regional pathology service.


A Category B laboratory shall have a documented agreement with a Category GX or GY laboratory to ensure that the range of pathology tests provided and the standard of work in the laboratory is under the direction and control of a designated supervising pathologist or senior scientist of an accredited Category GX or GY laboratory.

Category M (Medical practice)

This category is used for a laboratory based in a medical practice, which is under the supervision of a registered medical practitioner of that medical practice. It provides a limited range of approved tests, only for the patients of the medical practice at which the laboratory is situated. A laboratory in this category shall not provide tests on patients referred from other medical practices or from medical practitioners other than those of the medical practice at which the laboratory is sited.

Category S (Specialised)

This category is used for either:
a) a laboratory in which a limited range of tests is performed on a particular patient population
or
b) a laboratory in which a limited range of tests (services) is performed, that are of a specialised nature and are performed under the supervision of a person having special qualifications or skills in the field of those services.


Where the supervisor is a medical practitioner, approved pathology services may be provided for patients of the supervising practitioner and for those referred by other practitioners.