Guideline
Subject:
Approval Date:
Review Date:
Review by:
Number:
Tests that may be performed in Category M & S Laboratories
August 2012
August 2015
BPPQ
3/2012
The following is a Guideline as to the type of tests that are suitable to be performed by the
following categories of laboratories:
Category M (medical) being a laboratory in which pathology tests are provided by or under the
supervision of a medical practitioner for patients only of the medical practice in which that
practitioner works; and,
Category S (specialised) being a laboratory which performs a limited range of pathology tests
where those services are either performed on a particular target population or 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.
Pathology is an increasingly specialised field of medicine with many tests that should not be
performed without the supervision of a pathologist. Pathologists are trained in conducting the
complex analyses and interpretations of a myriad of technologies, many crossing the disciplines
of anatomical pathology, haematology, genetics, microbiology immunopathology etc. Care should
be taken by medical practitioners operating Category M and S laboratories that they do not
practise beyond their credentials and scope of practice. A list of examples of tests that should not
be performed without pathologist supervision is given at the end of this Guideline. The tests listed
are indicative but not exhaustive. The College should provide further guidance to individual medical
practitioners who are not pathologists on the risks of providing tests outside their scope of
practice.
Example of tests that may be performed without pathologist supervision
1. Point of Care Testing (POCT) M Laboratory:
- Any validated POCT assay except those that require high complexity interpretation eg.
HIV
2. Other M Laboratory:
- As for POCT plus simple card/cartridge tests (eg. hCG) but not HIV
3. Artificial Reproductive Technology/ In-vitro Fertilisation Category S Laboratory:
- Generally, tests that fall into the scope of practice for interpretation by an
Obstetrician/Gynaecologist: ie P8 tests (semen analysis, huhners test, hCG);
Luteinising Hormone; Progesterone; Oestradiol; Prolactin; Follicle Stimulating
Hormone; Testosterone.
4. Blood Gas Category S Laboratory:
- Generally, tests that fall into the scope of practice for interpretation by an Intensive
Care Specialist/ Anaesthetist that are obtained from blood gas analysing machine: ie
arterial and venous blood gases; lactate; INR; glucose.
5. Other Category S Laboratory (eg. Endocrine)
- Only tests that fall into the interpretative range of the supervising medical specialist
Examples of tests that should not be performed without pathologist supervision
1. Chemical Pathology
Vitamin D
Tumor Markers
Fe Studies
B12 / Folate
Thyroid Hormones
2. Haematology
Haematology Morphology
Complex coagulation (other than INR)
Flow Cytometry
Transfusion
Blood Group & Antibodies
3. Microbiology
Viral Serology (including HIV, Hep B & C)
PCR Testing
Microbiology Cultures
4. Immunopathology
Auto Antibody Testing
Investigation of Immunodeficiency
5. Anatomical Pathology
All Histology and Cytology
Immunochemistry
6. Genetics
All Genetic tests