Health Insurance (Accredited Pathology Laboratories Approval) Principles 1999 (Cth)
Health Insurance (Accredited Pathology Laboratories — Approval) Principles 1999
as amended
made under subsection 23DNA (1) of the
Health Insurance Act 1973
This compilation was prepared on 15 October 2001
taking into account amendments up to Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2001 (No. 3)
Prepared by the Office of Legislative Drafting,
Attorney-General’s Department, Canberra
Contents
Page
Part 1 Introductory
1 Name of Principles [see Note 1] 3
2 Commencement 3
3 Revocation of previous principles 3
4 Definitions 3
5 Purpose of principles 3
Part 2 Principles
6 Endorsement of independent body 4
7 Other considerations 5
8 Allocation of categories 5
9 Standards of direction, control etc required 7
10 Other principles 9
11 Period of approval 10
Part 3 Miscellaneous
12 Minister may take expert advice 11
13 Application unsatisfactory — Minister to give notice 11
Schedule 1 NPAAC accreditation materials as in force on 15 October 2001 12
Notes 14
Part 1 Introductory
Name of Principles [see Note 1]
These Principles are the Health Insurance (Accredited Pathology Laboratories — Approval) Principles 1999.
Commencement
These Principles commence on 1 January 2000.
Revocation of previous principles
All principles previously determined under subsection 23DNA (1) of the Act are revoked.
Definitions
In these Principles:
Act means the Health Insurance Act 1973.
applicant premises means premises in relation to which application has been made under subsection 23DN (1) of the Act.
category, in relation to premises, means category of accreditation as a pathology laboratory allocated to the premises.
group of pathology means a group mentioned in the pathology services table.
National Pathology Accreditation Advisory Council means the body so named established under subsection 9 (1) of the National Health Act 1953.
NPAAC accreditation materials means standards, guidelines and other assessment aids published by the National Pathology Accreditation Advisory Council that are mentioned in Schedule 1, as in force on the date mentioned in Schedule 1.
State includes a Territory.
Note Other words and expressions used in this instrument are defined in the Act, including accredited pathology laboratory, pathology service and approved pathology practitioner (see s 3 of Act) and pathologist, scientist and senior scientist (see s 23DNA of Act).
Purpose of principles
These are the principles to be applied by the Minister in exercising his or her powers under subsection 23DN (1) of the Act:
(a) to approve, in principle, premises as an accredited pathology laboratory; or
(b) to refuse approval of premises as an accredited pathology laboratory.
Part 2 Principles
Endorsement of independent body
(1) The Minister must consider, in relation to applicant premises, a report, if any, of an independent body qualified to assess the suitability of the premises to operate as an accredited pathology laboratory.
(2) A report must be in writing and must:
(a) address the NPAAC accreditation materials; and
(b) if the assessment is that the premises are suitable — recommend the category, within the meaning of section 8, to which the laboratory could be allocated.
(3) However, the Minister may ignore subsection (1) if:
(a) a pathology laboratory is operating at the applicant premises and is accredited, in that capacity, with the independent body; and
(b) the Minister is otherwise satisfied that the laboratory is operating in accordance with the applicable NPAAC accreditation materials.
Note The accreditation mentioned in subs (3) is different from approval as an accredited pathology laboratory under the Act.
(4) Also, the Minister may ignore subsection (1) if:
(a) a pathology laboratory is operating at the applicant premises and, at the time the application is made, assessment of the premises by the independent body has been arranged; and
(b) the Minister is otherwise satisfied that:
(i) the premises are appropriately staffed with the persons to carry out, and the persons to direct, control or supervise, the range of pathology services performed; and
(ii) the laboratory is participating in the quality assurance program of an independent body that ensures that the laboratory is operating in accordance with the NPAAC accreditation materials applicable to the group, or groups, of pathology to which approval of the premises will relate; and
Note The independent body mentioned in subpara (4) (b) (ii) could be a different body from the independent body mentioned elsewhere in this section.
(iii) the laboratory operates effective quality control programs for the services given, ensuring that work performed meets acceptable standards; and
(iv) the laboratory could be unreasonably disadvantaged if the Minister cannot make a decision on the application until complying with subsection (1).
Other considerations
(1) This section applies if the State in which applicant premises are located has laws under which pathology laboratories may obtain State accreditation for the performance of pathology services of the kind to which the application relates.
(2) The Minister must consider, in relation to the applicant premises, the following matters:
(a) whether the premises are accredited under the laws of the State;
(b) if the premises are so accredited, the period for which accreditation has been granted;
(c) for premises that are not so accredited, whether that circumstance is because:
(i) accreditation of the premises has been suspended or revoked; or
(ii) accreditation of the premises has been refused; or
(iii) accreditation of the premises has not been sought;
(d) for premises to which subparagraph (c) (i), (ii) or (iii) applies — the reasons for the circumstance mentioned.
Allocation of categories
(1) In deciding, under subsection 23DN (1) of the Act, whether to approve in principle, or to refuse approval, the Minister must allocate the premises concerned to the category appropriate to:
(a) the range of pathology services to be performed on the premises; and
(b) the level of direction, control or supervision under which the services will be performed.
(2) For subsection (1) of this provision, and section 6 of the Health Insurance (Pathology) (Fees) Act 1991, the categories of accreditation are:
Category GX (General)
premises comprising a laboratory, or a number of co‑located laboratories, performing services in 1 or more groups of pathology:
(a) under the direction, control and full-time supervision of a pathologist, or senior scientist, who is expert in the group, or groups, concerned; and
(b) at which the number of working pathologists (whether full-time or part-time) is equivalent to more than 2 full-time pathologists;
Category GY (General)
premises comprising a laboratory, or a number of co-located laboratories, performing services in 1 or more groups of pathology:
(a) under the direction, control and full-time supervision of a pathologist, or senior scientist, who is expert in the group, or groups, concerned; and
(b) at which the number of working pathologists (whether full-time or part-time) is equivalent to not more than 2 full-time pathologists;
Category B (Branch)
premises comprising a laboratory performing services in 1 or more groups of pathology, being a laboratory related, by appropriate arrangement, to an accredited pathology laboratory of category GX or GY, as:
(a) a branch, integral (except in its location) with the category GX or GY laboratory; or
(b) a member of participating laboratories in a regional pathology service;
operating under:
(c) the direction and control of a pathologist, or senior scientist, who is expert in the group, or groups, concerned; and
(d) the supervision of at least a scientist, who is expert in the group, or groups, concerned;
Category M (Medical)
premises comprising a laboratory performing pathology services under the direction, control and supervision of a medical practitioner, being services only for the patients of the medical practice operated by, or that employs, the medical practitioner;
Category S (Specialised)
premises comprising a laboratory performing a limited range of pathology tests under the supervision of a person with special qualifications or skills in the field of those tests, that are tests:
(a) performed for a particular target population or are of a specialised nature; and
(b) are performed in the field of those special qualifications or skills.
(3) In the description of category B premises, appropriate arrangement means a written arrangement that includes provisions for the direction and control of the category B premises by a pathologist, or senior scientist, employed in the related category GX or GY laboratory.
(4)For the purpose of determining the fee payable for an application for accreditation as a particular category of laboratory, the categories mentioned in this section correspond to the categories mentioned in section 6 of the Health Insurance (Pathology) (Fees) Act 1991 as follows:
(a) category GX — paragraph 6 (3) (a);
(b) category GY — paragraph 6 (3) (b);
(c) category B — paragraph 6 (3) (c);
(d) category M — paragraph 6 (3) (d);
(e) category S — paragraph 6 (3) (d).
Standards of direction, control etc required
(1) In deciding, under subsection 23DN (1) of the Act, whether to approve in principle, or to refuse approval, the Minister must consider whether the premises concerned are provided with the standard of direction, control or supervision specified in these Principles for the category applying to the premises.
General standard of direction and control
(2) In all cases, the person directing and in control of a pathology laboratory must:
(a) consider, and approve, the operational practices of the laboratory and the staffing appointments to the laboratory; and
(b) ensure appropriate consultation occurs on medical and scientific issues that arise; and
(c) ensure that the laboratory practices quality control for work performed and participates in externally administered quality assurance programs relevant to the laboratory’s operations; and
(d) ensure that quality control practices and quality assurance methods and data are regularly reviewed, and that all aspects of the laboratory’s performance are discussed with the scientific staff; and
(e) ensure that medical and other scientific and technical support staff participate in relevant continuing education; and
(f) ensure that supervision, as prescribed under section 8 for the category of laboratory, is provided continuously (whether by 1 person, or more); and
(g) if pathology work is performed outside normal working hours and not in the presence of a supervisor prescribed under section 8 for the category of laboratory — ensure that it is performed by staff who, because of their training and experience, are appropriate staff for that work.
Arrangements for categories GX and GY
(3) For a category GX or GY pathology laboratory, a supervising pathologist or senior scientist must usually be present during normal working hours, and available for telephone (or other electronic) consultation at other times.
Arrangements for category B
(4) For a category B pathology laboratory, the pathologist or senior scientist under whose direction and control pathology services are performed must:
(a) be employed in the related category GX or GY laboratory; and
(b) have qualifications and experience relevant to the laboratory’s operations; and
(c) attend the laboratory, in accordance with subsections (5) and (6) (or arrange for the attendance of a scientist under his or her direction and control); and
(d) be available for telephone (or other electronic) consultation when not personally attending the laboratory; and
(e) monitor a system of electronic supervision of the quality of services performed.
(5) The attendance requirement for paragraph (4) (c) is time amounting to, in a year:
(a) if the electronic supervision is effected by way of online reports from the supervised laboratory to the related category GX or GY pathology laboratory — the equivalent of 10 full-time days; or
(b) otherwise — the equivalent of 50 full-time days.
(6) However, attendance at supervised training, or professional development, that is conducted in the related category GX or GY laboratory and is relevant to the supervision of the laboratory is taken to satisfy the laboratory attendance requirement:
(a) if paragraph (5) (a) applies — to the extent of the time so spent, up to the equivalent of 5 full-time days; and
(b) if paragraph (5) (b) applies — to the extent of the time so spent, up to the equivalent of 20 full-time days.
(7) In addition:
(a) externally administered quality assurance programs must be monitored by a pathologist or senior scientist employed at the related category GX or GY pathology laboratory who must endorse, in writing, the reports generated by the programs; and
(b) an internal quality assurance system integrated between the laboratory and the related category GX or GY laboratory must be in place.
Arrangements for category M
(8) For a category M pathology laboratory, the supervising medical practitioner must:
(a) usually be present when a pathology service is performed; and
(b) be available for telephone (or other electronic) consultation when not present; and
(c) have a working knowledge of the procedures for the pathology services performed and an involvement in the resolution of any problem encountered in performing those services; and
(d) ensure that the only services performed are services appropriate for a category M laboratory.
Arrangements for category S
(9) For a category S pathology laboratory, a supervisor prescribed under section 8 for the category of laboratory must:
(a) usually be present when a pathology test is performed, unless, because of the training and experience of medical, scientific or technical support staff present, he or she need not be present; and
(b) be available for telephone (or other electronic) consultation when not present; and
(c) ensure that the only tests performed are tests appropriate for a category S laboratory.
Other principles
In deciding, under subsection 23DN (1) of the Act, whether to approve in principle, or to refuse approval, the Minister must consider whether the premises concerned comply with the following principles:
(a) the premises have sufficient professional and support staff with the training and experience to ensure that pathology services are performed in accordance with relevant NPAAC accreditation materials;
(b) the premises have staff who are competent to advise clinicians on:
(i) the evaluation and interpretation of results of laboratory examinations and tests; and
(ii) the precision and accuracy of methods employed for examinations and tests;
(c) the premises have the space, fittings and facilities necessary for pathology services to be performed satisfactorily;
(d) equipment for the pathology services performed is maintained in good working order;
(e) the premises are subject to effective control of the health and safety of persons working at, or visiting, the premises;
(f) procedures are established at the premises ensuring that:
(i) pathology specimens are labelled with full identification and accompanied by a documented request signed by the requesting medical or dental practitioner or other appropriate person; and
(ii) specimens not complying with subparagraph (i) or of unsatisfactory quality for examination or testing are rejected, and notification given to the requesting practitioner or other person; and
(iii) techniques for long-term identification of specimens are adequate; and
(iv) specimens are maintained for a period that is appropriate, taking account of their nature and origin and the applicable NPAAC accreditation material;
(g) laboratory methods are validated methods, taking account of methods recommended by the professional organisations in Australia relevant to the services performed;
(h) the premises contain appropriate, current manuals for the procedures and methods applicable to the services performed;
(i) a system of reporting results of pathology services is established that ensures:
(i) that the requesting person receives a report as quickly as good patient care allows, identifying the patient, the pathology laboratory, the type of specimen, the date (and, if appropriate, the time) of collection, the qualitative or quantitative results (as appropriate), the units of concentration or activity (as appropriate) and reference range (if any); and
(ii) that an urgent report is given initially by telephone, or a similarly quick method, to the requesting person, or a nominated appropriately qualified substitute person, and subsequently provided in writing to that person;
(j) a system of recording, in a readily accessible form, the results of examinations and tests of specimens and the quality control procedures relied on.
Period of approval
In determining the period for which an approval under subsection 23DN (1) of the Act will have effect, the Minister:
(a) must assess the period for which the proprietor of the applicant premises can ensure compliance with the principles in this Part that apply to the premises concerned; and
(b) should not, unless special considerations apply, determine a period longer than the period, if any, for which the premises are accredited under the laws of the State in which the premises are located, for the performance of pathology services of the kind to which the application for approval relates.
Part 3 Miscellaneous
Minister may take expert advice
(1) In making a decision under subsection 23DN (1) of the Act, the Minister may invite, and accept, information and expert advice relevant to the decision.
(2) For this section, the Minister may convene an advisory panel of persons having relevant expertise.
Application unsatisfactory — Minister to give notice
(1) If the Minister considers that he or she requires more information before applicant premises can be approved under subsection 23DN (1) of the Act, the Minister must give the applicant written notice of that fact as soon as practicable in the circumstances.
(2) If the applicant gives the Minister further written information in support of the application before the end of 28 days after the notice is given, the Minister must consider that information before making a decision to grant or refuse approval of the premises.
Schedule 1 NPAAC accreditation materials as in force on 15 October 2001
(section 4)
|
|
| Publication date |
| 1 | Guidelines for the Preparation of Laboratory Manuals | 1986 |
| 2 | Laboratory Assessment Checklist — Small Laboratory Testing Facilities | 1986 |
| 3 | Guidelines for the Preparation of Manuals for Administrative Instruction and Personnel Procedures for Laboratories | 1987 |
| 4 | Laboratory Assessment Checklist — Clinical Biochemistry Section | 1987 |
| 5 | Laboratory Assessment Checklist — Microbiology Section | 1987 |
| 6 | Laboratory Assessment Checklist — Computer Services Section | 1991 |
| 7 | Laboratory Assessment Checklist — Cytogenetics Section | 1991 |
| 8 | Laboratory Assessment Checklist — General Section | 1991 |
| 9 | Laboratory Assessment Checklist — Cytology Section | 1992 |
| 10 | Laboratory Assessment Checklist — Immunology Section | 1992 |
| 11 | Laboratory Assessment Checklist — Haematology Section | 1992 |
| 12 | Criteria for Assessment of External Quality Assurance Programs: Vol 1 — Clinical Biochemistry, Haematology and Microbiology | 1995 |
| 13 | Criteria for Assessment of External Quality Assurance Programs: Vol 2 — Anatomical Pathology, Cytology and Transfusion Serology | 1996 |
| 14 | Laboratory Assessment Checklist — Blood Banks and Transfusion Services | 1996 |
| 15 | Requirements for Gynaecological (Cervical) Cytology | 1997 |
| 16 | Guidelines for Data Communication | 1998 |
| 17 | Information on Transport of Pathology Specimens | 1998 |
| 18 | Laboratory Assessment Checklist — Anatomical Pathology Section | 1998 |
| 19 | Retention of Laboratory Records and Diagnostic Material | 1998 |
| 20 | Standards for Pathology Laboratories | 1998 |
| 21 | Guidelines for Laboratory Procedures Related to the Processing, Storage, and Infusion of Haemopoietic Stem Cells for Transplantation from Bone Marrow, Mobilised Peripheral Blood and Umbilical Cord Blood | 1999 |
| 22 | Requirements for Supervision of Pathology Laboratories | 1999 |
| 23 | Guidelines for Approved Pathology Collection Centres (APCCs) | 2000 |
| 24 | Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection Techniques | 2000 |
| 25 | Guidelines for Cytogenetics Laboratories | 2001 |
| 26 | Guidelines for Quality Systems in Medical Laboratories | 2001 |
| 27 | Guidelines for Performance of the Pathology Surgical Cutup | 2001 |
| 28 | Guidelines for the Use of Fluid Based Collection Sustems and Automated and Semi-Automated Screening Devices in the Practice of Gynaecological (Cervial) Cytology | 2001 |
Notes to the Health Insurance (Accredited Pathology Laboratories — Approval) Principles 1999
Note 1
The Health Insurance (Accredited Pathology Laboratories — Approval) Principles 1999 (in force under subsection 23DNA (1) of the Health Insurance Act 1973) as shown in this compilation is amended as indicated in the Tables below.
Table of Instruments
| Title | Date of notification | Date of | Application, saving or |
| Health Insurance (Accredited Pathology Laboratories — Approval) Principles 1999 | 22 Dec 1999 (see Gazette 2000, No. GN51) | 1 Jan 2000 | |
| Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2000 (No. 1) | 26 July 2000 (see Gazette 2000, No. GN29) | 1 July 2000 | — |
| Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2000 (No. 2) | 5 Sept 2000 (see Gazette 2000, No. S480) | 1 Jan 2001 | — |
| Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2001 (No. 1) | 28 Mar 2001 (see Gazette 2001, No. GN12) | 1 Apr 2001 | — |
| Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2001 (No. 2) | 24 July 2001 (see Gazette 2001, No. S299) | Ss. 1–3 and Schedule 1: 24 July 2001 Schedule 2: 1 Aug 2001 | — |
| Health Insurance (Accredited Pathology Laboratories — Approval) Amendment Principles 2001 (No. 3) | 22 Aug 2001 (see Gazette 2001, No. GN33) | 15 Oct 2001 | — |
Table of Amendments
| ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted | |
| Provision affected | How affected |
| S. 4.......................................... | am. 2000 No. 1 |
| Heading to Schedule 1........ | rs. 2000 Nos. 1 and 2; 2001 Nos. 2 and 3 |
| Schedule 1............................. | am. 2000 Nos. 1 and 2; 2001 No. 1 |
| rs. 2001 No. 2 | |
| am. 2001 Nos. 2 and 3 | |
0
0
0