GOVERNANCE OF SERVICE, CERTIFICATION AND PROCESSES
Qualifications, skills and competencies for Clinical Governance Officer
7.—(1) For the purposes of section 24(3)(b) of the Act, an individual is suitably qualified to be appointed a Clinical Governance Officer for an assisted reproduction service if the individual —
(a)
is registered under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner;
(b)
holds a valid practising certificate under the Medical Registration Act 1997;
(c)
is registered under section 22 of the Medical Registration Act 1997 as a specialist in obstetrics and gynaecology;
(d)
has work experience in the provision of a relevant assisted reproduction service, which includes performing oocyte collections or oocyte or embryo transfers for a period of 3 years within a period of 5 years, of which one year must be immediately before the individual’s appointment; and
(e)
whose work experience in performing oocyte collections or oocyte or embryo transfers mentioned in sub‑paragraph (d) includes independently performing —
(i)
at least 250 oocyte collections or oocyte or embryo transfers within a period of 3 years; or
(ii)
at least 350 oocyte collections or oocyte or embryo transfers within a period of 5 years.
(2) For the purposes of paragraph (1)(e), an individual independently performs a procedure where there is no other medical practitioner supervising the individual’s performance of the procedure.
Additional duties and responsibilities of Clinical Governance Officer
8. In addition to regulation 15 of the General Regulations, a Clinical Governance Officer of a licensee must ensure that proper arrangements are in place for the storage and disposal of all reproductive cells and embryos handled in the provision of the assisted reproduction service by the licensee.
Licensee must be certified
9. A licensee must, for the duration of the licensee’s licence, have a valid certification of conformity to the Code of Practice for Assisted Reproductive Technology Units issued by a certifying body recognised by the Reproductive Technology Accreditation Committee established by the Fertility Society of Australia and New Zealand.
Quality management system
10.—(1) A licensee must establish and implement a quality management system in accordance with this regulation to ensure —
(a)
the safety and welfare of patients, husbands of patients and donors;
(b)
the safety, quality and viability of any reproductive cell and embryo collected, tested, processed, stored and distributed by the licensee;
(c)
the proper collection, testing, processing, storage and distribution of reproductive cells and embryos; and
(d)
the objective and systematic monitoring, evaluation, identification of problems in laboratory, clinical and counselling practices and actions to improve the level and appropriateness of care.
(2) Without limiting paragraph (1), the quality management system mentioned in that paragraph must provide for all of the following:
(a)
a system for regular review of the performance and complications (if any) of every assisted reproduction cycle carried out with the aim to improve the quality of care and ensure the safety of patients;
(b)
the investigation of any occurrence or complaint that discloses or may disclose any weakness or inadequacy affecting the quality of the assisted reproduction service;
(c)
the identification and implementation of appropriate and effective actions to address any weakness or inadequacy mentioned in sub‑paragraph (b) and prevent a recurrence;
(d)
the maintenance of adequate and appropriate documentation on the clinical outcomes of any assisted reproduction procedure performed or clinical use of any reproductive cells or embryos by the licensee, including any event that affects or may affect any patient that relates to or is the result of an assisted reproduction procedure;
(e)
quality control measures for equipment used in the provision of the assisted reproduction service, including quality control tests and regular monitoring of equipment performance;
(f)
a system to ensure the appropriate and adequate documentation of the licensee’s policies and processes, including —
(i)
creating, reviewing and updating documentation for the applicable licensee’s quality assurance measures and the compliance of the licensee’s personnel with those measures; and
(ii)
ensuring proper document control of all documentation mentioned in sub‑paragraph (i);
(g)
the availability of all policies and procedures on laboratory safety to all personnel who work in the licensee’s embryology laboratory, and measures to ensure that all such personnel take appropriate infection control measures within the embryology laboratory;
(h)
the documentation of the quality control programme for the embryology laboratory, which must include the goals of the programme, the applicable policies and procedures to meet those goals, and the corrective actions taken where the goals are not met;
(i)
the establishment of written procedures for —
(i)
the risk management of potential cross‑contamination of reproductive cells or embryos stored by the licensee; and
(ii)
where the suitability of any reproductive cell or embryo for its intended use is, or is believed to have been, adversely affected for any reason —
(A)
where the oocyte or embryo has been transferred into the body of an individual — the notification of any person who receives or has received the oocyte or embryo; and
(B)
in any other case — the recall of the reproductive cell or embryo;
(j)
the implementation of quality control measures for all activities relating to the storage of reproductive cells and embryos, including measures pertaining to the safety, quality and viability of the reproductive cells and embryos in relation to —
(i)
the recruitment of donors;
(ii)
the collection and transport of the reproductive cells and embryos;
(iii)
the processing and testing of the reproductive cells and embryos;
(iv)
the quarantine of the reproductive cells and embryos; and
(v)
the storage and distribution of the reproductive cells and embryos;
(k)
a system for appropriate accountability, roles, responsibilities and continuing educational programmes for quality management;
(l)
documentation of the organisational reporting relationships, responsibilities and accountability of each personnel;
(m)
the identification of key performance indicators for assessing performance outcomes of the storage of reproductive cells and embryos, including mechanisms for periodic monitoring and evaluation of these indicators.
(3) A licensee must —
(a)
conduct regular reviews of the quality management system mentioned in paragraph (1);
(b)
make and maintain accurate reports of all reviews conducted under sub‑paragraph (a); and
(c)
update the quality management system as may be necessary, including in response to the findings of any review conducted under sub‑paragraph (a).
(4) A second or subsequent review of the quality management system mentioned in paragraph (1) must be conducted during the twelfth month after the month in which the licensee conducted the immediately preceding review.
(5) In addition, a licensee must —
(a)
participate in and perform satisfactorily for the relevant external quality assessment programme for every test provided by the licensee; and
(b)
ensure that a Clinical Governance Officer or another suitably qualified personnel designated by a Clinical Governance Officer reviews the results of every quality assessment programme mentioned in sub‑paragraph (a) and implements appropriate and effective actions to address any weakness or inadequacy in the provision of the assisted reproduction service.
