Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2006 (No. 2) (Cth)

Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2006 (No. 2)

Health Insurance Act 1973

I, CHARLES ANDREW MASKELL-KNIGHT, Acting First Assistant Secretary, Acute Care Division, Department of Health and Ageing, make these Principles under subsection 23DNA (1) of the Health Insurance Act 1973.

Dated 23 May 2006

CHARLES MASKELL–KNIGHT

Acting First Assistant Secretary, Acute Care Division, Department of Health and Ageing

1. Name of Principles

These Principles are the Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2006 (No. 2).

1. Commencement

These Principles commence as follows:

(a)    on 3 July 2006 — sections 1 to 3 and Schedule 1;

(b)    on 1 August 2006 — Schedule 2.

1. Amendment of Health Insurance (Accredited Pathology Laboratories — Approval) Principles 2002

(1)   Schedule 1 amends the Health Insurance (Accredited Pathology Laboratories — Approval) Principles 2002.

(2)   Schedule 2 amends the Health Insurance (Accredited Pathology Laboratories — Approval) Principles 2002, as amended by the Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2006 (No. 1).

Schedule 1        Amendment commencing on 3 July 2006

(subsection 3 (1))

[1]           Schedule 1

substitute

Schedule 1        Accreditation materials

(section 5)

Part 1          NPAAC materials

Item	Material	Publication date
1	Guidelines for Data Communication	1998
2	Information on Transport of Pathology Specimens	1998
3	Guidelines for Approved Pathology Collection Centres (APCCs)	2000
4	Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection Techniques	2000
5	Guidelines for Cytogenetics Laboratories	2001
6	Guidelines for Quality Systems in Medical Laboratories	2001
7	Guidelines for Performance of the Pathology Surgical Cutup	2001
8	Guidelines for Retention of Laboratory Records and Diagnostic Material	2002
9	Standards for Pathology Laboratories	2002
10	Guidelines for the Facilities and Operation of Hospital and Forensic Mortuaries	2004
11	Standards for Pathology Laboratory Participation in External Proficiency Testing Programs	2004
12	Guidelines for Laboratory Procedures Related to the Processing, Storage and Infusion of Cells for Transplantation or Cell Therapy	2004
13	Requirements for the Validation of In-House In Vitro Diagnostic Devices (IVDs)	2004
14	Requirements for Gynaecological (Cervical) Cytology	2006
15	Performance Measures for Australian Laboratories Reporting Cervical Cytology	2006
16	Requirements for Supervision of Pathology Laboratories	2006
17	Guidelines for the Use of Liquid Based Collection Systems and Semi-Automated Screening Devices in the Practice of Gynaecological (Cervical) Cytology	2006

Part 2          Other materials

ISO/IEC 17025 Application Document, Supplementary Requirements

Accreditation in the Field of Medical Testing, 2002, version 1

Schedule 2        Amendment commencing on 1 August 2006

(subsection 3 (2))

[1]           Schedule 1, Parts 1 and 2

substitute

Part 1          NPAAC materials

Item	Material	Publication date
1	Guidelines for Data Communication	1998
2	Information on Transport of Pathology Specimens	1998
3	Guidelines for Cytogenetics Laboratories	2001
4	Guidelines for Quality Systems in Medical Laboratories	2001
5	Guidelines for Retention of Laboratory Records and Diagnostic Material	2002
6	Standards for Pathology Laboratories	2002
7	Guidelines for the Facilities and Operation of Hospital and Forensic Mortuaries	2004
8	Standards for Pathology Laboratory Participation in External Proficiency Testing Programs	2004
9	Guidelines for Laboratory Procedures Related to the Processing, Storage and Infusion of Cells for Transplantation or Cell Therapy	2004
10	Requirements for the Validation of In-House In Vitro Diagnostic Devices (IVDs)	2004
11	Requirements for Gynaecological (Cervical) Cytology	2006
12	Performance Measures for Australian Laboratories Reporting Cervical Cytology	2006
13	Requirements for Supervision of Pathology Laboratories	2006
14	Guidelines for Approved Pathology Collection Centres (APCCs)	2006
15	Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection Techniques	2006
16	Guidelines for Performance of the Pathology Surgical Cutup	2006
17	Guidelines for the Use of Liquid Based Collection Systems and Semi-Automated Screening Devices in the Practice of Gynaecological (Cervical) Cytology	2006
18	Standards and Guidelines for Laboratory Testing of Antibodies to the Human Immunodeficiency Virus (HIV) and the Hepatitis C Virus	2006

Part 2          Other materials

National Association of Testing Authorities NATA AS 4633 (ISO 15189) Application Document — Supplementary Requirements for Accreditation in the Field of Medical Testing