Notice Type
Notice Title

Designation of Auditing Agency

Pursuant to section 32 of the Health and Disability Services (Safety) Act 2001 (“Act”), I, Don Mackie, Chief Medical Officer, Ministry of Health (“Ministry”) under delegation from the Director-General of Health, designate Global-Mark Pty Limited to audit the provision or likely future provision of the following health care service:

  • New Zealand Fertility Services

This designation is subject to the following conditions:

  1. The Designated Auditing Agency (“DAA”) must comply with the requirements of the DAA Handbook issued by the Ministry and updated from time to time.
  2. Promptly after giving a certified provider or prospective provider an audit report, the DAA must:
    • complete the Ministry of Health Audit Report Tool and provide an electronic copy to the Ministry; and
    • provide a summary of the audit report to the Ministry (refer to condition 9).
  3. The DAA must provide any information about the auditing of health care services pursuant to the Act if requested in writing by the Ministry.
  4. During the term of the DAA’s designation the DAA will allow the Ministry to audit or to commission the undertaking of audits or reviews of the DAA. This could also include attending audits being undertaken by the DAA. The Ministry may or may not notify the DAA of any audit or review.
  5. The DAA must immediately notify the Ministry in writing of any significant change to the DAA, including but not restricted to:
    • any change in ownership and/or control of the legal entity;
    • any change in management personnel;
    • any change to the Auditor Register (refer to condition 8); and
    • any change in the status of any third party accreditation the DAA may hold, including evidence of such accreditation and copies of any Third Party Accreditation Audit Reports or notifications in respect of their accreditation.
  6. The DAA must conduct as a minimum at least one annual:
    • internal audit that focuses on the DAA’s auditing activities undertaken pursuant to the Act, together with a compliance audit against the requirements of the DAA as set out in the Act; and
    • management review in respect of the DAA’s programmes operated pursuant to the Act.
  7. The DAA shall at all times operate an internal appeals system which is documented and conveyed in writing to all clients. Auditable records of the facts and outcomes of all client appeals shall be maintained by the DAA. The DAA must provide these records to the Ministry when requested in writing by the Ministry.
  8. The DAA must provide in a timely manner, when requested by the Ministry in writing, the details of the name, auditing qualifications and experience and, if relevant, the area of clinical or service competency of each auditor or technical expert approved by the DAA to undertake audits pursuant to the Act.
  9. The DAA must provide all documentation to the Ministry in the form prescribed by the Ministry.
  10. The DAA must hold third party accreditation with a Ministry approved third party accreditation body.

Dated at Wellington this 11th day of April 2016.

PHIL KNIPE, Acting Director, Protection Regulation and Assurance, Ministry of Health.