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 to provide for the amendment and formulation of documents used in the accreditation of pathology laboratories and to make some minor drafting corrections.
Administered by: Health
Registered 09 Feb 2007
Tabling HistoryDate
Tabled HR14-Feb-2007
Tabled Senate26-Feb-2007
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

I, ANTONY CHARLES KINGDON, Acting 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 22 January 2007

ANTONY KINGDON


  

  

1              Name of Principles

                These Principles are the Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2007 (No. 1).

2              Commencement

                These Principles commence on 1 July 2007.

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]           Subsection 5 (1), definition of accreditation materials

substitute

accreditation materials means each document mentioned in Schedule 1, published in the year mentioned for the document.

[2]           Subparagraph 11 (1) (a) (ii)

omit

for

[3]           Paragraph 11 (4) (b)

omit

for

[4]           Paragraph 12 (3) (a)

before

a representative

insert

that

[5]           Paragraphs 12 (3) (b) and (c)

before

the independent body

insert

that

[6]           Paragraph 12 (3) (c)

omit

confidence

insert

confidence,

[7]           Subparagraph 12 (3) (c) (ii)

substitute

                         (ii)    the premises are, or will be, appropriately staffed with persons to carry out, and persons to direct, control and supervise, the pathology services to be performed at the premises; and

[8]           Paragraph 15 (1) (a)

omit

covered by the approval,

insert

covered by the approval

[9]           Schedule 1

substitute

Schedule 1        Accreditation materials

(section 5)

Part 1          NPAAC materials

Item

Material

Publication year

1

Guidelines for Data Communication

1998

2

Information on the Transport of Pathology Specimens

1998

3

Guidelines for Cytogenetics Laboratories

2001

4

Retention of Laboratory Records and Diagnostic Material

2002

5

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

2004

6

Guidelines for the Facilities and Operation of Hospital and Forensic Mortuaries

2004

7

Standards for Pathology Laboratory Participation in External Proficiency Testing Programs

2004

8

Guidelines for Approved Pathology Collection Centres

2006

9

Guidelines for the Performance of the Pathology Surgical Cut‑up

2006

10

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

2006

11

Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis

2006

12

Performance Measures for Australian Laboratories Reporting Cervical Cytology

2006

13

Requirements for Gynaecological (Cervical) Cytology

2006

14

Requirements for Supervision of Pathology Laboratories

2006

15

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

2006

16

Guidelines for Quality Management in Medical Laboratories

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

Note   The documents mentioned in Part 1 are available on the Internet — see 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 www.nata.asn.au.