Federal Register of Legislation - Australian Government

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Principles as made
This instrument amends the Health Insurance (Accredited Pathology Laboratories - Approval) Principles 2002 (the Principles) to apply the Minister's power to revoke or approve an application for premises as an accredited pathology laboratory under section 23DNA of the Health Insurance Act 1973, which includes amendments to documemts included in Schedule 1 of the Principles.
Administered by: Health
Registered 12 Sep 2007
Tabling HistoryDate
Tabled HR13-Sep-2007
Tabled Senate13-Sep-2007
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

I, MEGAN PHILOMENA MORRIS, First Assistant Secretary, Medical Benefits Division, Department of Health and Ageing, determine these Principles under subsection 23DNA (1) of the Health Insurance Act 1973.

Dated 3 September 2007

MEGAN MORRIS


  

  

1              Name of Principles

                These Principles are the Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2007 (No. 2).

2              Commencement

                These Principles commence on 1 January 2008.

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

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


Schedule 1        Amendments

(section 3)

  

[1]           Section 3, note

substitute

Note   See also subsection 23DN (3) of the Act.

[2]           Section 5, note

substitute

Note 1   Several other words and expressions used in these Principles have the meaning given by section 3 of the Act. For example:

·      accredited pathology laboratory

·      approved pathology practitioner

·      pathology service

·      pathology services table.

Note 2   Several other words and expressions have the meaning given by section 23DNA of the Act. For example:

·      pathologist

·      scientist

·      senior scientist.

[3]           Section 14, note

substitute

Note   See also paragraph 23DN (2A) (c) of the Act.

[4]           Schedule 1

substitute

Schedule 1        Accreditation materials

(section 5)

Part 1          NPAAC materials

Item

Material

Publication year

1

Guidelines for Laboratory Procedures Related to the Processing, Storage and Infusion of Cells for Transplantation or Cell Therapy

2004

2

Guidelines for the Facilities and Operation of Hospital and Forensic Mortuaries

2004

3

Standards for Pathology Laboratory Participation in External Proficiency Testing Programs

2004

4

Guidelines for Approved Pathology Collection Centres

2006

5

Guidelines for the Performance of the Pathology Surgical Cut-up

2006

6

Guidelines for the use of Liquid Based Collection Systems and Semi-Automated Screening Devices in the Practice of Gynaecological (Cervical) Cytology

2006

7

Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis

2006

8

Performance Measures for Australian Laboratories Reporting Cervical Cytology

2006

9

Requirements for Gynaecological (Cervical) Cytology

2006

10

Requirements for Supervision of Pathology Laboratories

2006

11

Standards and Guidelines for Laboratory Testing of Antibodies to the Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)

2006

12

Classification of Human Genetic Testing

2007

13

Requirements for Quality Management in Medical Laboratories

2007

14

Requirements for Cytogenetic Testing

2007

15

Requirements for Information Communication

2007

16

Requirements for the Packaging and Transport of Pathology Specimens and Associated Materials

2007

17

Requirements for Pathology Laboratories

2007

18

Requirements for the Development and Use of In-house In Vitro Diagnostic Devices (IVDs)

2007

19

Requirements for the Estimation of Measurement Uncertainty

2007

20

Requirements for the Retention of Laboratory Records and Diagnostic Material

2007

Note   The documents mentioned in Part 1 are available on the Internet — see http://www.health.gov.au/npaac.

Part 2          Other materials

       1.       National Association of Testing Authorities NATA AS 4633 (ISO 15189) Application Document — Supplementary Requirements for Accreditation in the Field of Medical Testing, published in 2005.

Note   The document mentioned in item 1 is available from the National Association of Testing Authorities — see http://www.nata.asn.au.