Medtest Pty Ltd and Minister for Health and Ageing

Case

[2002] AATA 566

10 July 2002


DECISION AND REASONS FOR DECISION [2002] AATA 566

ADMINISTRATIVE APPEALS TRIBUNAL      )

)N2002/581

N2002/582

GENERAL ADMINISTRATIVE  DIVISION       )          
           Re      Medtest Pty Ltd   
  Applicant
           And    Minister for Health and Ageing            
  Respondent

DECISION

Tribunal       Mr RP Handley Dr MEC Thorpe  

Date10 July 2002

PlaceSydney

Decision      N2002/581 The Tribunal affirms the decision of the Respondent made on 30 April 2002 refusing to vary the Applicant's approval as an accredited pathology laboratory.  The Stay Order granted by the Tribunal in respect of this decision on 1 May 2002, terminates on 10 July 2002.  N2002/582 The Tribunal sets aside the decision of the Respondent made on 30 April 2002 to refuse approval of the Applicant's premises as an accredited pathology laboratory pursuant to s 23DN(1) of the Health Insurance Act 1973 and substitutes a new decision approving the Applicant's premises in principle as an accredited pathology laboratory for a period of 12 months commencing on 10 July 2002 and expiring at midnight on 9 July 2003.

..............................................
  R P Handley
  Deputy President
CATCHWORDS
HEALTH INSURANCE ACT 1973 - Approval as an Accredited Pathology Laboratory under s23DN of the Act – necessity to comply with NATA standards and by-laws - necessity to comply with the Health Insurance Principles – examination of the laboratory's past history of accreditation – examination of any risk to public health and safety – held that the Applicant should be approved as an Accredited Pathology Laboratory for a period of 12 months with NATA reassessments at six and 12 months sufficient to ensure compliance with NATA standards.
Health Insurance Act 1973 ss 23DN, 23DNA(1)
Health Insurance (Accredited Pathology Laboratories – Approval) Principles 1999 Principles 1, 6, 11
Memorandum of Understanding – Commonwealth of Australia and the National Association of Testing Authorities
National Association of Testing Authorities By-laws

REASONS FOR DECISION

10 July 2002                Mr RP Handley     Dr MEC Thorpe   

  1. This matter involves two applications by Medtest Pty Ltd ("the Applicant"):

  • N2002/581, an application for a review of a decision of a delegate of the Minister for Health and Ageing ("the Respondent") made on 30 April 2002 refusing to vary the Applicant's approval as an accredited pathology laboratory ("APL") by extending that approval, pursuant to section 23DN of the Health Insurance Act 1973 ('the Act");

  • N2002/582, an application for a review of a decision of a delegate of the Respondent made on 30 April 2002 refusing to approve the Applicant's premises as an APL under s 23DN of the Act.

  1. Before the ultimate hearing in this matter, there were numerous interlocutory proceedings and ongoing negotiations between the parties with the result that the parties agreed finally that the only substantive issue for the Tribunal to determine is the period of time for which the Applicant's premises should be approved as an APL. At the hearing in relation to this issue, which took place on 4 July 2002, Peter Dwyer, of Counsel, appeared for the Applicant and Francois Kunc, of Counsel, appeared for the Respondent. The documents before the Tribunal comprised the documents produced pursuant to s 37 of the Administrative Appeals Tribunal Act 1975 ("the T Documents") together with the other documents tendered by the parties at the hearing and at previous hearings relating to the interlocutory proceedings. The Applicant and a number of expert witnesses gave evidence at the interlocutory proceedings, but no witnesses were called at the ultimate hearing.
    Background

  2. In 1985, the Applicant established a pathology laboratory at Unit 1/214 The Boulevard, Fairfield Heights, New South Wales.  Mr Gary Nicholas has been the Laboratory Manager and Co-ordinator since the laboratory was first established.  The Applicant provides a range of services including haematology, chemical analysis, microbiology, immunology, tissue pathology, cytology and infertility. The Applicant's patient population comes predominantly from the western and south-western suburbs of Sydney.

  3. The Applicant's business is relatively small when compared to some operators.  It employs a staff of 22 comprising 2 pathologists, 8 scientists and technicians, 2 trainee scientists, 5 venepuncturists, 3 clerks and 2 couriers (Affidavit of Gary Nicholas dated 15 March 2002).  A number of these staff are part-time.

  4. The Applicant was first accredited by the National Association of Testing Authorities ("NATA") in 1990 as an APL Category 3 laboratory.  The first routine NATA assessment of the laboratory was undertaken on 6 June 1994 with a report issued on 9 January 1995.  The Applicant was given until 24 February 1995 to respond to the matters raised.  A follow-up assessment was conducted on 13 July 1995.  A response to the matters raised was required by 5 September 1995.  A second routine NATA assessment was undertaken on 6 August 1996 with a report issued on 28 January 1997 requiring the matters raised to be addressed by 3 March 1997.  A follow-up assessment was conducted on 28 April 1997 with the report issued on 25 September 1997 requiring that the Applicant address the matters raised by 17 October 1997.  The Category 3 accreditation continued through this period.

  5. The third routine NATA assessment was undertaken on 16 December 1999 with the report issued on 27 March 2000 requiring that the Applicant address the matters raised by 28 April 2000.  A follow-up assessment was conducted on 18 August 2000.  The laboratory was found to be deficient in a number of areas and did "not meet the NATA/RCPA [Royal College of Pathologists of Australasia] requirements for accreditation".  Accordingly, NATA accreditation was made "inoperative" on 13 August 2000 until such time as the laboratory could demonstrate compliance with the accreditation requirements.

  6. The conditions which must be met for NATA accreditation and continuance of accreditation are set out in its By-laws (T7).  Article 52 of the NATA Articles of Association provides that an APL which fails to comply with any condition for continuance of its accreditation may be suspended by the NATA Board.  The APL may, within 28 days of notification, appeal against that decision to a Review Committee constituted and operated in accordance with the by-laws.

  7. On 23 March 2001, a follow-up NATA assessment was conducted. While the report dated 23 April 2001 found that some matters raised had been addressed, "a large number are still outstanding". On 1 May 2001, NATA suspended the Applicant's accreditation. On 29 May 2001, the Applicant appealed against that suspension. On 20 August 2001, the NATA Board decided to cancel the Applicant's accreditation. On 14 September 2001, the Applicant appealed against that decision. However, the Review Committee seems not to have been constituted and any review process was overtaken by events related to Ministerial approval under s 23DN of the Act.

  8. The T Documents contain details of Ministerial approvals under s 23DN(1) since 1987. From 1987 to 2000, approvals were mostly for a period of 12 months, with some variations. In 2000, a new regime for the categorisation of laboratories was introduced and the Applicant's categorisation was changed from Category 3 to Category G and then to Category GY from 1 August 2000. On 20 October 2000, the Health Insurance Commission sent the first of a number of letters to the Applicant requesting that the Applicant "show cause" why Ministerial approval should not be revoked as a result of it being "ruled inoperative by NATA". Ultimately, approval was given for the period 1 August 2000 to 30 September 2001.

  9. On 7 September 2001, the Health Insurance Commission sent the Applicant a follow-up "show cause" letter requiring a response within 14 days. Thereafter, there followed correspondence between the Commission, the Applicant and their solicitors concerning Ministerial approval, with a series of extensions of that approval being granted of between two and eight weeks through until 30 April 2002. Finally, on 14 March 2002, the delegate of the Respondent revoked approval of the Applicant as an accreditated laboratory under s 23DN of the Act.

  10. On 15 March 2002, the Applicant applied to the Tribunal for a stay of that decision, pending the hearing of the Applicant's application for a review of the delegate's decision of 14 March 2002. The Tribunal, exercising its power under s 41(2) of the Administrative Appeals Tribunal Act 1975, granted the stay. On 16 April 2002, the Applicant requested that Ministerial approval be varied by extending the period of the approval beyond 30 April 2002. On 30 April 2002, the delegate refused to vary the approval and, on that day, the Applicant sought a stay of that decision. The Tribunal granted the stay.

  11. By letter dated 16 April 2002, the Applicant applied to the Minister for approval of its laboratory premises as an APL.  On 30 April 2002, the delegate of the Minister refused that approval and, on that day, the Applicant sought a review of that decision.

  12. On 16 May 2002, the Medical Testing Accreditation Advisory Committee ("MTAA Committee") of NATA conducted an inspection of the Applicant's laboratory.  A report on that inspection was issued on 24 May 2002.  The report listed 12 matters "which must be addressed prior to a recommendation for accreditation being made."  The Applicant lodged a written response to those matters, as required, by 7 June 2002. On 20 June 2002, the MTAA Committee assessment team reviewed that response and, on 21 June 2002, reported to be NATA Board on the response.  On 26 June 2002, the NATA Board met to consider the MTAA Committee's recommendations.

  13. On 30 May 2002, the Tribunal dismissed the Applicant's application for a review of a decision of 14 March 2002 by consent of the parties (File No N2002/375).

  14. On 27 June 2002, the Applicant was granted NATA accreditation for a period of three years from that date.  However, its accreditation is dependent on the laboratory complying with the requirements set out in the NATA By-laws and in the publications AS ISO/IEC 17025 – 1999 General requirements for the competence of testing and calibration laboratories and ISO/IEC 17025 Application Document – Supplementary requirements for accreditation in the field of Medical Testing (2000), and conditional upon reassessments being conducted within six months and 12 months of the date of accreditation.  The laboratory is accredited as Category GY (General).

  15. At a telephone directions hearing on 1 July 2002, Counsel for the Respondent informed the Tribunal that the only issue requiring determination by the Tribunal is the period for which the Applicant's premises will be approved as an APL.  The Tribunal heard the parties' submissions on this issue on 4 July 2002.  At the hearing, Counsel for the Applicant agreed with Counsel for the Respondent that the first of the two applications under review, N2002/581, an application for a review of the decision of the delegate of the Respondent made on 30 April 2002 refusing to vary the Applicant's approval as an APL by extending that approval, should be affirmed.  The parties agreed that the Tribunal's Stay Order of 1 May 2002 should terminate on the day of this decision.

  16. Thus, it is the second of the two applications under review, N2002/582, an application for a review of the decision of the delegate of the Respondent made on 30 April 2002 refusing to approve the Applicant's premises as an APL under s 23DN of the Act, which is the focus of this decision but only with respect to the period for which the approval of the Applicant's premises as an APL should be granted.
    The Relevant Law

  17. Section 23DN of the Act provides for the approval of premises as an APL:
    23DN Accredited pathology laboratories

(1)Where a person (in this section called the applicant ) makes an application, in writing in the approved form, to the Minister for the approval of premises as an accredited pathology laboratory, the Minister may, in writing:

(a) approve in principle the premises as an accredited pathology laboratory; or

(b)      refuse to approve the premises as an accredited pathology laboratory.

(2)      Where:

(a)        the Minister approves in principle premises under subsection (1); and

(b) the applicant pays the accreditation fee in respect of the approval of the premises;

the Minister must:

(c) approve, in writing, the premises as an accredited pathology laboratory; and

(d)      give a copy of the approval to the applicant.

(2A) An approval in principle under subsection (1), and an approval under subsection (2), of premises as an accredited pathology laboratory must specify:

(a) the kind of pathology services in respect of which the premises are approved for the purposes of this Act; and

(b)      the category of accreditation allocated to the premises; and

(c) the period (not exceeding 3 years) for which the approval is to have effect.

(3) The Minister shall, in exercising the Minister's powers under this section at a particular time, apply the principles determined under section 23DNA that are in force at that time.

(4)      An approval under subsection (2):

(a) subject to section 23DNAAA, takes effect on the day on which the approval is given or on such day (not being a day earlier than the day on which the application for the approval was received by the Minister) as is specified in the approval; and

(b)      ceases to have effect upon:

(i)       the revocation of the approval; or

(ii) the expiration of the period specified in the approval as the period for which the approval is to have effect;

whichever first occurs.

(5) Where the Minister makes a decision under subsection (1) approving in principle or refusing to approve premises as an accredited pathology laboratory, the Minister shall give notice in writing of the decision to the person who applied for the approval.

(6)      Where the Minister varies or revokes an approval given under subsection

(2) in relation to premises, the Minister shall give notice in writing of the variation or revocation to the proprietor of the premises.

(7) A notice under subsection (5) or (6) shall include a statement to the effect that, subject to the Administrative Appeals TribunalAct 1975, application may be made to the Administrative Appeals Tribunal for review of the decision to which the notice relates by or on behalf of a person whose interests are affected by the decision.

(7A) Where the Minister revokes the approval of premises as an accredited pathology laboratory otherwise than at the request of the proprietor of the premises, the Minister may:

(a) cause a copy of the notice of revocation given under subsection (6) to be published:

(i)       in the Gazette ; or

(ii) by such other means as the Minister in the circumstances thinks appropriate; and

(b) cause a copy of the notice to be laid before each House of the Parliament within 15 sitting days of that House after the notice has been given by the Minister.

(13) Any failure to comply with the requirements of subsection (7) in relation to a decision does not affect the validity of the decision.

Section 23DNA(1) states:

(1)The Minister may, in writing, determine the principles that are to be applied in the exercise of his or her powers under subsection 23DN(1).

The principles referred to, the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 1999 ("the Principles") were made on 9 December 1999. The relevant Principles are as follows:

6.        Endorsement of independent body

(1)The  Minister must consider, in relation to applicant premises, a report, if any, of 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 sub(3) is different from approval as an accredited pathology laboratory under the Act.
(The NPAAC [National Pathology Accreditation Advisory Council)] accreditation materials are set out in Schedule 1).

11.      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.

  1. NATA exercises functions as an expert body delegated to it pursuant to a Memorandum of Understanding between it and the Commonwealth of Australia dated 25 February 1998 (T6). NATA's MTAA Committee conducts assessments of laboratories for the purpose of accreditation as APLs. The Minister, or his or her delegate, exercising the power under s 23DN(1), must, in accordance with Principle 11(a), consider a relevant NATA assessment report in assessing the suitability of premises to operate as an APL.

  2. Accreditation by NATA is different from approval of premises as an APL by the Minister. An important consequence of approval of premises by the Minister as an APL is that Medicare Benefits are payable in respect of services rendered in that APL (s 16A of the Act).
    SUBMISSIONS
    Applicant

  3. Mr Dwyer, for the Applicant, said that the NATA accreditation dated 27 June 2002 for a period of three years is dependent upon continuing compliance with the accreditation requirements, such compliance to be reassessed within 6 months and 12 months of the date of accreditation.  Mr Dwyer contended that NATA accreditation is the major factor to be taken into account by the Minister's delegate in making his or her decision.

  4. Mr Dwyer said that the history of the Applicant's recent compliance with NATA accreditation requirements is addressed by the reassessments within six and 12 months. He contended that Ministerial approval should not add any further burden. Public health and safety issues are addressed by the reassessments. However, in any event, By-law 54(1) of the NATA Rules permits the Chief Executive of NATA, when authorised by the Chair of the Board or, in the Chair's absence, by two other Board members, to conduct a reassessment of an APL, without notice, to ascertain whether the APL is complying with the conditions for continuation of its accreditation. Moreover, the Chief Commonwealth Medical Officer has authority to authorise the entry into and inspection of an approved laboratory at any reasonable time under the terms of the undertaking provided by the laboratory to the Health Insurance Commission (T68). Ultimately, the Minister has power under s 23DN of the Act to revoke an approval.

  5. Mr Dwyer noted that there were 11 extensions of the Applicant's Ministerial approval before the revocation on 14 March 2002.  No question of a risk to public health and safety was raised in relation to those extensions.  The results from the Applicant's testing are not in issue.  The 11 extensions were essentially to allow the cumbersome NATA processes to be completed.  The revocation of the Applicant's approval occurred because of a public health scare.  The Applicant submits that the six and 12 month reassessments required as conditions of the NATA accreditation, together with the other NATA reassessment powers and the powers of the Chief Commonwealth Medical Officer, are more than adequate for the protection of public health and safety.  Mr Dwyer noted that the Applicant has now agreed a timetable with NATA for the reassessment and to the same assessors as those who conducted the assessment on 16 May 2002 conducting the reassessment.  The Tribunal has subsequently been notified that Dr AM Saville, who was a member of the assessment team on 16 May 2002 will be unavailable and it is proposed that he be replaced by Dr SK Tang. The inspection was planned for 18 October 2002 (Gadens' letter to NATA dated 4 July 2002 – A1), but has subsequently been changed to 3 October 2002.    Mr Dwyer said the Applicant's working with NATA to agree a timetable is an indication that, obviously, it wants to avoid protracted proceedings in relation to accreditation in the future.

  1. Mr Dwyer said the Applicant is a small laboratory by comparison to many others.  The costs involved in each NATA assessment ($6000) and each application fee for Ministerial approval ($2000) are substantial.  The costs in relation to the present proceedings have also been very substantial as has the hurt and damage to reputation caused to the Applicant, to Mr Nicholas and his family, to the Applicant's staff, referring doctors and patients.

  2. Mr Dwyer submitted that the Tribunal should now look prospectively in making its decision. He submitted that the seven months approval proposed by the Respondent does not permit sufficient time for the review process provided for in s 23DN(7), and that the Tribunal should grant approval for at least 12 months.
    Respondent

  3. Mr Kunc, for the Respondent, referred the Tribunal to the matters identified in the MTAA Committee's inspection report on the Applicant's premises dated 24 May 2002, and the affidavit of Dr Michael Harrison, the Chair of the MTAA Committee, dated 1 May 2002.  At paragraph 57 of his affidavit, Dr Harrison stated:

    It is my view that Pathology laboratories which do well in the NATA/RCPA assessment processes are likely to provide reliable results which support the diagnosis and treatment of disease and illness and thus support treatment of patients.

At paragraph 63 he stated:

The key aspects of the NATA/RCPA assessment process are to identify whether the stated procedures to be followed in the laboratory are appropriate and then to review records to confirm that practice in the laboratory in fact conforms with the procedure.

  1. By contrast, in his statement of 29 May 2002 (A2), Professor Jeffrey Searle said of the 12 matters to be addressed as set out in the NATA inspection report:

    In my opinion all 12 requirements are procedural matters that the laboratory is in a good position to address.  None of them relates to the quality of the tests performed, and as such they do not raise any issues of public health and safety.

  2. At paragraph 81 of his affidavit, Dr Harrison said that it is common with the assessment of new laboratories for a number of areas requiring improvement to be identified.  However, in the case of the Applicant, similar problems have recurred over a period of about 10 years.

  3. Mr Kunc referred to the affidavit of Paul Fenton-Menzies, General Counsel with the Legal Services Branch of the Health Insurance Commission, dated 2 July 2002.  Mr Fenton-Menzies stated:

    There are no currently approved pathology laboratories operating as Category GY facilities which have been approved for a period longer than 12 months.

  4. Mr Kunc noted that Applicant's assessment history is set out in the affidavit of Victoria Hauke, the Manager, Medical Testing of NATA, dated 1 May 2002.  The attachments to Ms Hauke's affidavit show that, in each assessment, deficiencies in the Applicant's operations were identified and some of those deficiencies continued to recur in later assessment reports.  For example, in the assessment report dated 27 March 2000, 20 deficiencies were identified, many of these matters raised in earlier reports.  Paragraph 2 of the Summary contained in the Assessment Report dated 9 October 2000 makes reference to this.  The Assessment Report dated 23 April 2001 contains the following statement at paragraph 3 of the Summary:

    The assessment conducted on 23 March 2001 revealed that, although some efforts have been made to address the requirements, a large number are still outstanding.  The history of the laboratory is such that, although we have been given assurances that the requirements have been met, this has not been confirmed by subsequent assessment.  We are not confident, given the history of the laboratory, that outstanding requirements will be met and that the laboratory could maintain an acceptable standard of operations.

  5. Mr Kunc noted that the MTAA Committee, in its report to the NATA Board dated 21 June 2002, recommended that the Applicant's laboratory should be accredited on the basis that the laboratory is reassessed in six months.  The Board adopted this recommendation, making accreditation conditional upon reassessments being conducted within six months and 12 months of the date of accreditation.

  6. Mr Kunc emphasised that Principle 11(a) requires the Minister, in assessing the period for which an approval under s 23DN of the Act will have effect, to assess the period for which the proprietor of the applicant premises can ensure compliance with the NATA standards. Having regard to the Applicant's history and the fact that a NATA assessment will occur in six months, the Respondent contends that seven months is the appropriate period, which will permit the NATA assessment to be undertaken, a report to be issued and an application to the Minister to be considered. While NATA clearly has a significant role, s 23DN(1)(a) and Principle 11 indicate that the discretion to grant approval resides in the Minister alone.

  7. Mr Kunc said NATA is obviously concerned about accrediting the Applicant's laboratory – hence the condition requiring assessments within six and 12 months.  To grant Ministerial approval for seven months rather than the 12 months advocated by the Applicant, requires, at most, that the Applicant pay one more application fee. The alternative, if the six month reassessment proves unsatisfactory, is that the onus would be on NATA to suspend the Applicant's accreditation.  In the circumstances, the Respondent submits that it is not appropriate to place such an onus on NATA.  Mr Kunc noted that the agreed timetable for the six month NATA assessment (A1) is unenforceable.
    Application of the Law and Findings

  8. The parties agree that the only issue for determination by the Tribunal is the period for which the Minister grants approval pursuant to s 23DN(1)(a) of the Act. Pursuant to s 23DN(2A)(c), that period must not exceed three years. Principle 11(a) requires that in determining the period of approval, the Minister must assess the period for which the proprietor of the applicant premises can ensure compliance with the NATA standards.

  9. In his affidavit dated 2 July 2002, Mr Fenton-Menzies stated there are no approved pathology laboratories operating in the same category as the Applicant which have been approved for a period longer than 12 months.  In the light of the Applicant's history of assessments, the Tribunal considers that it would not be appropriate to grant approval for more than 12 months, which the Applicant appeared to concede at the hearing.  The Respondent submitted that approval for seven months was appropriate.  The Applicant submitted that for the Applicant to have to reapply for approval after seven months was unduly burdensome and that the requirement for reassessments within six and 12 months of NATA accreditation, when considered in the context of the powers of NATA, the Chief Commonwealth Medical Officer and the Minister, provided adequate protection for public heath and safety.

  10. It is obvious that a very significant amount of time, energy and money - over many months – has been committed by the Applicant in attempting to resolve the matters raised by NATA.  The Tribunal notes the comment made by Professor Searle in his statement of 29 May 2002 (A2), that the 12 matters raised in the MTAA Committee assessment report of 24 May 2002 are procedural and that none of them raise any issues of public health and safety.  However, as Dr Harrison, Chair of the MTAA Committee, recognised in his affidavit of 1 May 2002, laboratories that have proper procedures in place are likely to produce reliable results.

  11. The Applicant has agreed a timetable (A1) with NATA for the assessments within six and 12 months of the NATA accreditation upon which the accreditation is conditional.  While, as the Respondent points out, the timetable is unenforceable, nevertheless, it is an indication of the Applicant's commitment to compliance.

  12. None of the evidence before the Tribunal indicates that public health and safety have been jeopardised, and the Respondent did not contend this.  Essentially what the Respondent did contend was that the history of the NATA inspections of the Applicant's premises and the matters raised by NATA as a result of those inspections, are sufficient to raise concerns over the Applicant's ability to comply with the NATA standards.  Thus, the Respondent submitted, Ministerial approval of the Applicant's premises should be limited to seven months which would permit the first six month reassessment to be undertaken, a NATA report to be issued and the Applicant's application to the Minister for a further approval to be considered.

  13. The Tribunal notes that the report by the MTAA Committee to the NATA Board dated 21 June 2002 setting out the action taken by the Applicant in response to the matters raised in the Committee's report dated 24 May 2002, stated:

    The action taken is considered satisfactory and the laboratory now meets the requirements for NATA/RCPA accreditation

NATA has proposed and the Applicant has agreed that the team who will conduct the follow-up assessment in October 2002 will be the same team that conducted the assessment on 16 May 2002. There has subsequently been one change to the team as mentioned above.

  1. In the Tribunals' view, the two reassessments, within six and 12 months of the NATA accreditation, are sufficient to ensure compliance with the NATA standards and to protect public health and safety. NATA has power under its Articles to suspend accreditation and, pursuant to By-law 54, to conduct a re-examination of an accredited facility without notice. The Chief Commonwealth Medical Officer may authorise entry into and inspection of an approved laboratory at any reasonable time under the terms of an undertaking provided by the laboratory to the Health Insurance Commission. Ultimately, the Minister has the power under s 23DN of the Act to revoke an approval, as happened in this case on 14 March 2002.

  2. For the Applicant to have to reapply for approval within seven months, bearing in mind the reassessment process, the lack of any immediate risk to public health and safety, and the powers available to NATA, the Chief Commonwealth Medical Officer and the Minister, would, in the Tribunal's view, be unduly burdensome.  The Tribunal therefore determines that the period of approval of the Applicant as an APL shall be 12 months to commence on the date of this decision, that is 10 July 2002, expiring at midnight on 9 July 2003.  The Tribunal, therefore also determines that the Stay Order granted on 1 May 2002, terminates on the date of this decision, ie 10 July 2002.

I certify that the 41 preceding paragraphs are a true copy of the reasons for the decision herein of Deputy President RP Handley.

Signed:         .....................................................................................
  Associate

Date/s of Hearing  4 July 2002   
Date of Decision  10 July 2002
Counsel for the Applicant  Mr P Dwyer
Counsel for the Respondent  Mr F Kunc

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