Monash IVF Conditions for Registration Under the Assisted Reproductive Treatment Act 2008 (Vic) Updated and effective as at: 24 July 2017

Transcription

1 Monash IVF Conditions for Registration Under the Assisted Reproductive Treatment Act 2008 (Vic) Updated and effective as at: 24 July 2017

2 Contents SECTION 1: Background... 3 SECTION 2: Conditions for Registration Compliance with the Law RTAC Accreditation Provision of Information to the Authority Information required under section 81(2) of the Act Information for annual reporting to Minister Donor Registers Developments in treatment and research Advertising and other published information Notification of Incidents Conditions specific to Monash IVF... 7 SECTION 3: Term, Suspension and Further Conditions... 8 Page 2 of 8

3 SECTION 1: Background The Victorian Assisted Reproductive Treatment Authority (the Authority) is a statutory authority established by the Assisted Reproductive Treatment Act 2008 (Vic) (Act). The Authority has responsibility under the Act for administration of the registration system for Assisted Reproductive Treatment (ART) providers in Victoria, monitoring programs and activities carried out under the Act, public education, promotion of research, management of the donor conception registers (from 1 March 2017) and a number of other matters outlined in the Act. The Authority is also required to advise the Minister regarding any contravention of the Act, regulations or a registration, as well as any developments, whether in Victoria or elsewhere, that the Authority considers of major importance or concern with regard to research relating to infertility and treatment for infertility. Under the Act, a person may only carry out ART if that person is (or is under the supervision and direction of) a doctor who is carrying out the treatment on behalf of an ART provider registered under the Act. An application for registration may be made to the Authority by any provider who holds Reproductive Technology Accreditation Committee (RTAC) accreditation. The Authority may impose conditions on registration if it considers it necessary in the public interest. Any such conditions must not be inconsistent with a condition imposed on the ART provider s RTAC accreditation. Where the requirements of the Act are different to those of RTAC then the requirements of the Act take precedence. The Authority may also, by written notice given to a registered ART provider, suspend the provider's registration, either in whole or part, if it believes the ART provider has contravened a condition of registration or if it is satisfied that there are reasonable grounds for the suspension. Conditions for registration include the responsibility for registered ART providers to ensure that advertising and patient information is not misleading for patients, such as in the publication of comparative success rates. Further clarification about the conditions contained in this document can be sought directly from the Victorian Assisted Reproductive Treatment Authority: Postal address: Level 30, 570 Bourke Street, Melbourne VIC 3000 Phone: (03) Fax: (03) varta@varta.org.au Web: Page 3 of 8

4 SECTION 2: Conditions for Registration Any application for registration must be in the Authority s prescribed form. All registered ART providers must comply with these Conditions for Registration, as amended by the Authority from time to time. 2.1 Compliance with the Law The ART provider must comply with the Act, all regulations issued under the Act and all other applicable Victorian and Commonwealth laws and regulations. The ART provider must have appropriate governance, processes and systems in place to ensure compliance with the Act, these Conditions for Registration and all other applicable laws, regulations and conditions on approvals granted by the Authority and must provide evidence of the same when requested by the Authority. Designated Officers must attest to the following at the end of June each year: I, [name of designated officer], certify that [name of registered ART provider] has processes and systems in place which comply with the Assisted Reproductive Treatment Act 2008 (Vic), its Conditions for Registration and all other applicable laws, regulations and conditions on approvals granted by the Authority. The [name of registered ART provider] reviews these processes and systems annually to ensure that these requirements are met. Written notice has been given to the Authority as required under the Conditions of Registration of any non-compliance or other notifiable incidents which occurred during the past year. 2.2 RTAC Accreditation An ART provider must be accredited by RTAC in order to be registered under the Act. Evidence of accreditation must be provided with the application for registration, together with a copy of the accreditation report from the RTAC Certification Body. An ART provider must notify the Authority forthwith if RTAC accreditation ceases or if RTAC imposes conditions on an accreditation. An ART provider must provide the Authority with a copy of all RTAC accreditation, audit and surveillance reports upon receipt, and any corrective action plans or the like issued by the provider in relation to any nonconformity with the RTAC Code of Practice. Page 4 of 8

5 2.3 Provision of Information to the Authority An ART provider must provide the Authority with any information that the Authority considers relevant to the carrying out of its functions under the Act, including (without limitation): Information required under section 81(2) of the Act a) the registered ART provider's name; b) the address of each premises at which the registered ART provider carries out treatment procedures; c) the period for which the registered ART provider holds RTAC accreditation; d) details of the registered ART provider's internet site, if any; e) any changes to that information as they arise; and Information for annual reporting to Minister An ART provider must provide the information that the Authority requires to report annually to the Minister for Health under section 114 of the Act, including information about treatment programs, participants in treatment procedures conducted, embryos formed, and embryos and gametes stored by the end of by the end of the third week in August or such other date as is notified by the Authority. Designated Officers must provide the following attestation when supplying such information: I, [name of designated officer], certify that [name of registered ART provider] has to the best of my knowledge after due and proper verification provided accurate data for VARTA s annual report. The [name of registered ART provider] critically reviews patient information management processes and systems annually to ensure that annual report data can be provided in a timely and reliable way Donor Registers An ART provider must provide the information and/or copies of original records the Authority requires to verify or update information held on the Central Register or confirm information provided by an applicant to the Central or Voluntary Registers, including the information described in section 51 (1) of the Act Developments in treatment and research An ART provider must notify the Authority where it is proposing to utilise a new treatment procedure or a treatment for infertility that is significantly new to the field of ART. An ART providers must notify the Authority of other developments which, in their opinion, will impact significantly on the practice of ART Advertising and other published information Published claims, comparisons and advertising by an ART provider must comply with section 133 the Health Practitioner Regulation National Law (Victoria) Act 2009 and have due regard to the Australian Health Practitioner Regulation Agency Guidelines for Advertising Regulated Health Services. All advertising, claims and other information published or provided to the public, patients, practitioners of any other third parties must be verifiable and not likely to be misleading or Page 5 of 8

6 deceptive, either directly, or by implication, by use of emphasis, comparison, contrast or omission in whole or in part or in any other manner. An ART provider must, on request, provide the Authority with evidence verifying published claims, comparisons or information. If VARTA considers these published claims, comparisons or information may not have been adequately verified, or may be likely to be misleading or deceptive, the Authority may refer the same to another Australian regulatory authority such as AHPRA and/or the ACCC. Designated Officers must attest to the following at the end of June each year: I, [name of designated officer], certify that [name of registered ART provider] has processes and systems in place to ensure that it complies with section 133 of the Health Practitioner Regulation National Law (Victoria) Act The [name of registered ART provider] critically reviews advertising, claims and information for the general public, patients and others annually, verifying the accuracy of information provided with appropriate senior scientific/medical staff to ensure that the Conditions of Registration are met. 2.4 Notification of Incidents A registered ART provider must give the Authority written notice of: a) any actual or potential contravention of the Act or its regulations; b) any actual or potential breach of its registration conditions or conditions attached to any approval granted by the Authority; c) any notifiable incident that is reported to RTAC as part of accreditation requirements; and d) any contravention of the guiding principles of the Act in carrying out activities regulated by the Act, including any incident which is or is likely to be harmful to the health or wellbeing of patients, gametes or embryos (including, for example, if incorrect gametes are used to form an embryo, an incorrect embryo is transferred to a woman in a treatment procedure, or where a number of gametes or embryos are lost through freezing unit or dry shipper failure); by the registered ART provider or any person carrying out ART on its behalf. Notification of any such incidents must occur as soon as practicable after the registered ART provider becomes aware of the incident. The notification must include the following information: a) the date of the incident; b) a description of the incident (including the type of incident, how it occurred and cause); c) whether there was any damage to or loss of embryos; and f) action taken (including immediate action and corrective action to avoid the incident occurring again); and a copy of any records, documents or information relevant to the incident must be provided on request. Page 6 of 8

7 2.5 Conditions specific to Monash IVF Changes to systems and processes Monash IVF must improve its systems, processes, policies and governance to ensure compliance with the Act, including: a) upgrading its business rules, policies and processes relating to blocking the thawing and use of certain frozen embryos, including ensuring that comprehensive information about blocked-use status and rationale can be checked by staff; b) upgrading Reproductive Information Management System (RIMS) to ensure that clear, comprehensive information about the blocked-use status of all frozen embryos and rationale is displayed to all users of the system who may need to access that information, that appropriate warnings and restrictions ensure that frozen embryos blocked from use cannot be booked for use in a treatment procedure, and that alerts are generated for accessing embryos of different genetic origins; c) the manual system of freeze cards and laboratory frozen embryo transfer (FET) sheets, with a view to digitalise these processes by embedding them into the functions of the RIMS; d) ongoing training of all relevant staff in relation to the requirements of the Act and measures taken by Monash IVF to ensure compliance with those requirements; and e) completion of the foregoing and the changes outlined in Monash IVF s Risk Reduction Action Plan, provided to the Authority in its June 2017 root cause analysis as expeditiously as possible Interim report Monash IVF must provide the Authority with an interim report by the end of August 2017 in relation to the interim measures to be implemented in order to ensure Monash IVF s compliance with the Act while the measures outlined in condition are being put in place Progress reports Monash IVF must provide the Authority with monthly progress reports in relation to changes to systems and processes outlined in condition 2.5.1, commencing 31 July These progress reports must include: a) progress made in relation to each of the measures set out in conditions a) to e) and conditions all inclusive; b) any other rectifications to Monash IVF s systems and processes undertaken; c) initiatives taken to improve patient-centred care by Monash IVF; d) any changes or updates in relation to the information provided to the Authority in its June 2017 root cause analysis; and e) updates in relation to the welfare of the patient and donor(s) impacted by systemic failure, and any significant events related to the patient s pregnancy, birth of a child and provision of information for the Central Register. These progress reports must address issues and developments in the clinical, laboratory and nursing sectors of Monash IVF. Page 7 of 8

8 2.5.4 Final report Upon completion of the measures set out in conditions and Monash IVF must provide the Authority with: a) a final report describing all of the matters and measures undertaken in accordance with conditions and and their impact, including how risks of future adverse incidents are being anticipated and minimised by Monash IVF; b) a demonstration of all measures put in place to ensure compliance with the Act; and c) an attestation by the Monash IVF Designated Officer as follows: I, [name of designated officer], certify that Monash IVF has satisfactorily completed the upgrade of its systems, processes, policies and governance to ensure compliance with Part 3 of the Assisted Reproductive Treatment Act 2008 (Vic), its Conditions for Registration and all other applicable laws, regulations and conditions on approvals granted by the Authority. SECTION 3: Term, Suspension and Further Conditions Once granted, registration of an ART provider shall continue until terminated or suspended in accordance with the Act or the Conditions for Registration. The Authority may impose further conditions on the registration of the ART provider if the Authority considers it necessary in the public interest. These Conditions for Registration are reviewed by the Authority on a regular basis and updated where appropriate. Version history: Date effective 24 July 2017 Superseded version 30 January 2017 Page 8 of 8