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

Health Insurance Act 1973

I, CHARLES ANDREW MASKELLKNIGHT, 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).

2 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.

3 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 InHouse 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 SemiAutomated 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 InHouse 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 SemiAutomated 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