RTAC/governance

Question 1

Reproductive technology accreditation committee (RTAC) Code of practice- purpose and scope

Answer 1

Sits under Fertility Society of ANZ. Reports to FSANZ.
Promotes continous improvement in the quality of care offered to people accessing fertility treatment.
Provides a framework and set criteria for the auditing process that leads to acceditation of organisations that deliver fertility services
Ensure the auditing process is carried out in an independent, non-adversarial way and constructive manner.

Question 2

Code of practice Critical criteria (14) - audited annually

Answer 2

Compliance - legislation and regulation requirements
Key personnel - copies of qualifications and CVs.
Stakeholder feedback - complaints management - evidence of written policies, formal processes, corrective actions, audits.
Disaster management
Valid consent
Management and infection risk
Identification and traceability - unique in ART, three identifiers required
Donor and surrogacy requirements
Cryostorage of gametes and embryos
Medical and surgical risks and reporting - in particular OHSS
Adverse event reporting
Multiple pregnancy
Data monitoring - evidence of unit specific methods and data, acceptable ranges, benchmarking against ANZARD report.
Data reporting - evidence of compliance with ANZARD requirements.

Question 3

Key personnel (CC)

Answer 3

Commitment to adequate staffing, training, ongoing education.
Medical director - (FRANZCOG, FSANZ, CREI (ideally))
Scientific director - (FSANZ, SIRT)
Nurse manager (FSANZ, FNA)
Senior counsellor - (ANZICA)

Question 4

Disaster management (CC)

Answer 4

minimise the risk of serious adverse outcomes following a disaster
- Contingency plans, that address potential scenarios (including those unique to location)
- Ensure access to emergency equipment, power, gas
- Show documented evidence of working through scenarios
- Identify the principal components of the plans
- Show regular review of these plans.

Question 5

Identification and traceability (CC)

Answer 5

Must ensure gametes, embryos, patients are correctly identified and matched at all times and in particular, ensure that men providing semen samples confirm in writing on each occassion that the specimin is theirs.
3 unique identifiers required.
Regular audit of this process (at least once a year)

Question 6

Compliance (CC)

Answer 6

Must comply with statutory and regulatory requirements and provide evidence of such.
Compliant with
- HART act
- NZ health and disability act
- RTAC code of rpactice
- Research (HDEC/ECART and locality approval)
- Compliance with guidelines and advice of ACART (issued to ECART)

Provide evidence of how these are incorporated into clinic policies and how dissemination of changes would occur.

Question 7

Stakeholder feedback (CC)

Answer 7

The ART Unit must undertake regular stakeholder feedback. It must provide evidence of implementation and review of policies and procedures to collect, analyse, review and take relevant
action on stakeholder feedback including patient stakeholders.
The ART Unit must acknowledge and investigate complaints, and provide evidence of implementation and review of policies and procedures which include:
a) Information on how patients make a complaint and how they receive feedback
b) Acknowledgement and investigation of complaints
c) Systematic recording, review and corrective action of complaints

Stakeholders must be provided with avenues that allow the escalation of a complaint to persons or Organisations outside of the ART Unit.

Question 8

Valid consent (CC)

Answer 8

Treatment only occurs with valid consent (issued guideline by ACART)
Written, signed and dated
Consent obtained for deidentified information to be supplied to ANZARD
Interpreter must be health care interpreter.

Question 9

Management of infection risk (CC)

Answer 9

• between donors and recipients or surrogates
• between partners in serodiscordant couples,
• for staff handling material
• policies for reuse of medical devices
• address hand hygience practice

Question 10

Donor and surrogacy requirements (CC)

Answer 10

Ensure gametes, embryos, tissues are safe for donation and use in surrogacy arrangements, and appropriate counselling has been provided.
Surrogacy arrangements - counselling is mandatory for the donors, partners, recipients, surrogates and their partners.
Known donations - further joint counselling with all parties required

Question 11

Cryostorage of gametes and embryos (CC)

Answer 11

ART unit has to provide evidence of implementation and review of policies and procedures to ensure the safe management of cryopreserved gametes, embryos, and tissues.
- clear identification of storage container in storage vessel,
- records kept of temperature movements within the vessel that may affect viability
- must have a documented policy that deals with a request for cryostored gametes or embryos to be transported to a clinic in an international destination

Question 12

Medical and surgical risks (CC)

Answer 12

For ART procedures these risks include but are not limited to ovarian hyperstimulation syndrome (OHSS), postoperative bleeding,
postoperative infection and ovarian torsion. The ART Unit must minimise the incidence of these risks. It must provide evidence of implementation and review of policies and procedures that:
a) Enable identification and management of patients at risk
b) Measure and attempt to minimise the incidence of these risks
c) Ensure patients receive information on these risks, their symptoms and their management
d) Ensure patients receive information on how to access help, advice or care out of normal hours or in the event of a medical emergency
e) Ensure that all cases which involve re-hospitalisation that can be attributed directly to the ART procedure are reported to RTAC and the certifying body as a serious notifiable adverse event.
f) Ensure that all cases of OHSS requiring hospitalisation are reported to ANZARD

Question 13

Adverse event reporting (CC)

Answer 13

Not all serious adverse events are reportable to RTAC.
Must have a review process for all SAEs.
Reporting to RTAC -
as soon as possible, must be within 6 weeks
within 2 weeks for a potential or actual breach of legislation
within 48hours for a sentinal event - death

• hospitalisation
• did or could have resulted in spread of communicable disease
• breach of legislation
• embryo or gamete ID mix up
• causes a loss of viable embryos or gametes, or suspected deterioration
• arises from a systemic failure in validation/verification or a diagnositc test that has resulted in misdiagnosis and/or significant harm or loss to patients, their gametes or embryos

Medical AE
- OHSS - severe/critical, hospital admission >24hours, paracentesis or pleurocentesesis, thrombosis
- confirmed pelvic infection (admission to hopsital and IVAB, within 4 weeks)
- complication at oocyte retrieval (if admission to hospital required)
- ovarian torsion (during stimulation or within 4 weeks of OPU and required >24hour hospital admission)
- complications of a sperm retrieval procedure that required hospitalisation
- severe mental health event that required hospitalisation
- death
- direct (directly caused by ART treatmetn)
- indirect (death for which the direct cause of death was not due to ART tx but the tx had a contributory effect)
- conicidental death - deaths from unrelated causes that happen during the course of an IVF treatment cycle
- maternal death from an IVF pateint is not included (captured in obstetric reporting)

Question 14

Multiple pregnancy (CC)

Answer 14

Minimise the incidence of multiple pregnancies. Provide evidence of implementation and review of policies and procedures that:
- annual audit of MPR and corrective actions to reduce MPR in all tx cycles
- no more than one oocyte transfered in first cycle if <35yo oocyte
- no more than 2 embryos are transferred in any one tx cycle in a women under 40 (oocyte collection)
- single embryo transfer for surrogates
- patient must receive risks of multiple pregnancies

Question 15

Data monitoring (CC)

Answer 15

The Organisations/ART Unit must undertake regular reviews of treatment outcomes. It must provide evidence of implementation and review of policies and procedures to:
a) Identify, collect, analyse and review data to monitor treatment procedures and practices and treatment outcomes at least annually.
b) Benchmark the Organisations/ART Unit’s clinical outcomes against the most recent ANZARD Feedback Report and identify areas and opportunities for improvement. Where clinical outcomes fall below the 25th percentile, the unit is required to undertake a root
cause analysis as to why its results fall in this range and provide a corrective action plan or provide a rationale for not doing so.

Question 16

Data reporting (CC)

Answer 16

The Organisations/ART Unit must (a) provide the Australian and New Zealand Assisted Reproduction Database (ANZARD) with required data in the stipulated timeframe, and (b) inform patients of the uses to which their medical information may be put. It must provide evidence of:
a) Compliance with the relevant ANZARD Data Dictionary
b) Accuracy of ANZARD data, including the definition of pregnancy outcome as specified in the current ANZARD data dictionary, through an internal audit before submission to the agency collecting the data

Question 17

Good practice criteria (audited 3 yearly)

Answer 17

Quality management system
Medical management
Information
Medication management
Emergency care

Question 18

Quality management system (QMS) (GPC)

Answer 18

QMS system must have:
1. QM policy
2. QM review at planned intervals to ensure relevance updated
3. ‘Records’ management - compliance with regulations (HART ACART), document control system, systems of internal communication
4. Personnel training and competency
5. Buildings and facilities - adequate facilities and equipment, security
6. Risk management - assessment, review, incident reporting and response, corrective and preventative actions
7. Health and safety
8. Auditing

Question 19

Medical management (GPC)

Answer 19

Must meet the reporductive health needs of the patients and partners under its care.
Appropriate clinical evaluation of women and men
Referral pathways for endocrinology, andrology, psychological expertise
Preconception advice must be provided

Question 20

Information (GPC)

Answer 20

Patient information - accurate, timely, formats and languages appropriate to patient.
OPEN DISCLOSURE
Public domain information - presented in lay language, conclusions aren’t misleading

Succes rates must be
divided by age
specifty LBR for fresh and frozen separately
Accompanied by clarifying information - period during which advertised data collected, unambigious details of population group
Accompanied by qualifying statement of broad factors that affect success rates
Accompanied by a statement that not every treatment cycle will result in an egg collection, embryo transfer or embryo cryopreservation.

Shouldn’t reference other clinics data

Question 21

Medication management (GPC)

Answer 21

When issues medications without pharmacy involvement the unit must provide evidence of implementation and review of policies and procedures to ensure the safe management of medication

Question 22

How is NZ legislated

Answer 22

HART Act 2004
Nga Parewa 8134 (requires annual audit), done at the same time as RTAC (must be able to demonstrate we are culturally diverse and responsive)
ECART/ACART

Question 23

Donor conceived offspring rights

Answer 23

At 18 years donor conceived person can get information on donor (after 2005 unless donor before then has approached donor registry)

Question 24

Governance - what is it

Answer 24

Systems, processes and regulations put in place to ensure the safe, ethical and effective delivery of fertility treatments and services.
1. Regulatory compliance (RTAC) Nga Parewa
2. Ethical guidelines (ECART)
3. Clinical protocls and best practice
4. Patient safety and quality assurance
5. Data management and privacy
6. financial and legal compliance
7. Multidisciplinary collaboration
8. Patient advocacy and support

Question 25

Technical bulletin RTAC - transport of cryopreserved gametes and embryos

Answer 25

1. Undertake due diligence of the carrier, consider a service agreement that covers aspects such as training of couriers, handling of dry shippers, responsibilities of the carrier and unit, level of tracking during the shipment. If the carrier provides the dry shipper - service agreement should include max holding time, methodolofy for priming and checking inregrity before each trip, annual revalidation of holding time as moisture can build up in tanks and artificially increase their weight.
2. Factor in time zone changes when using electronic tracking systems.
3. Data logger should be included in all shipments
4. There must be a discussion with patients about the risks involved in shipping embryos and gametes and this discussion must be documented, conversation should include the splitting of shipments further reducing the risk of loss.

Question 26

Technical bulletin RTAC - use of adjuvants in ART

Answer 26

A therapy undertaken in addition to recognised standard ART treatment regimens.

Adjuvants tend to be:
Treatments which are purported to improve outcomes, but for which there may be little or no supportive evidence.
Treatments for which extra cost is charged.
Treatments for which there may be known or unknown side effects and other harms.

Recommendation:
In order to minimise any risk, RTAC and the Fertility Society of Australia recommends that all ART Units should:
1. Provide patient access to a list of all adjuvant therapies offered at the ART unit.
2. Provide appropriate and accurate information regarding:
a. the effectiveness, including the strength of the evidence,
b. the risks, if known and if not known, advise patients of the uncertainty of the risk and
c. the costs of the any adjuvant therapies.
3. The ART unit should ensure written informed consent is obtained for all adjuvants administered.

Question 27

Technical bulletin RTAC - Disaster management

Answer 27

In order to minimise the risk of serious adverse outcomes following a disaster, RTAC and the Fertility Society of Australia recommends that:
a) ART Units certified and accredited against the respective RTAC Codes of Practice should have contingency plans that address potential disaster scenarios including those unique to their location.

b) The Unit should show evidence of working through scenarios, identify the principle components of the plans, and show them to be feasible and to work.

c) These contingency plans should consider scenarios including but not limited to:
a. power loss to the laboratory and during a clinical procedure, and the capacity of back-up systems.
b. power loss outside of clinic opening hours, and for longer than 1 day, including the function of remote alarm systems.
c. key equipment malfunction (eg. Gas changeover malfunction or gas pipe fracture so the contents of all the gas cylinders connected to the incubators are lost, and integrity of liquid nitrogen dewars is compromised)
d. non-delivery of key reagents (eg. culture medium), consumables (eg. liquid nitrogen, embryo transfer catheters), and medications for longer than stores will last.
e. air conditioning failure in locations with a high ambient temperature
f. physical stability of equipment in earthquake prone locations.
g. fire, floods and water damage.

d) The ART unit should have a policy of open disclosure concerning adverse events. In line with the document Australian Open Disclosure Framework produced by the Australian Commission on Safety and Quality in Health Care, the elements of open disclosure should include:
a. an apology or expression of regret.
b. a factual explanation of what happened.
c. an opportunity for the patient and their family to relate their experience (eg with the clinic’s counsellor).
d. a discussion of the potential consequences of the adverse event.
e. an explanation of the steps being taken to manage the adverse event and prevent recurrence.

Question 28

Technical bulletin RTAC - SAE reporting

Answer 28

A Serious Adverse Event is any event associated with ART treatment:
 which causes or potentially causes harm, loss or damage to patients or their reproductive tissues - which results in hospitalisation following, and as a result of, the treatment.
Serious adverse events must be investigated, fully documented, and corrective actions put in place for review by the Certifying Body at the next scheduled inspection
A Serious Notifiable Adverse Event is an abnormal unintended outcome associated with ART treatment which:
 might result in the transmission of a communicable disease
 might result in death or a life-threatening, disabling, or incapacitating condition
 arises from a gamete or embryo identification error or mix-up.
Serious Reportable Adverse Events must be reported immediately to RTAC and the Certifying Body, along with a summary of investigation of the event and any actions taken. This report should be in the format of the Organisation’s investigation of non-conformances, including details of the event and its outcome, analysis of potential causes, and corrective and
preventive actions put in place.

Question 29

Technical bulletin RTAC - donor issues

Answer 29

Donors must be indentifiable to thier donor offspring - donors recruited now must consent to release of identifying information to offspring or their parents
Comprehensive non-identifying information must be collected about each donor
Units must have written donor-recipient linking procedures.

Donors from outside Australia - must met the same requirements as if they donated in Australia. Use of imported donor sperm should be supported by written independent legal opinion.

Where state/country legislation doesn’t apply - a maximum of 10 donor families per sperm donor.
Reasonable expenses - reasonable medical, travel or accomodation costs assoc with oddering to be a donor and assoc with donation.
Receiving any legal advice associated with donation.

Question 30

ECART/ACART requirements in NZ

Answer 30

Provisions that apply to sperm, egg, embryo donation and surrogacy:
- No undue influence
- Consent for all parties involved
- Procedure is the best or only opportunity for IPs to have a child
- IPs are not using procedure for social or financial convenience or gain
- Potential genetic, social, cultural and intergenerational aspects of the proposed arrangements safeguard the wellbeing of all parties and especially resulting children
- Any relationship between the parties safeguards the wellbeing of all parties especially any resulting children.
- Conselling requirements; all donors, recipients and surrogates require counselling (as well as partners if present).

Question 31

ECART applications needed for:

Answer 31

All embryo donation and surrogacy
Sperm and oocyte donation required for some in family donations but not for:
Donor egg -
1. Clinic/unknown egg donor
2. Donor is a sister or cousin of the recipient woman (age ≥20yrs)
3. Reciprocal donation within a same sex couple (may need ECART for donor sperm)
Donor sperm -
1. Clinic/unknown sperm donor
2. Donor is a brother or cousin of the recipient woman’s partner (age≥20yrs)

Research on embryos
HLA matching PGT-M for a sick sibling
If deceased persons sperm is to be used and request for use differs from what is on the consent form.

Question 32

Embryo donation in NZ

Answer 32

• Consent can be withdrawn up to the point of placing embryo into gestating woman’s uterus.
• Joint counselling
• All parties have decided on matters relating to use and storage of embryos and disposal of any unused embryos
• If the original IP are donating embryos for the first time
• Have been created for the fertility treatment of the donor(s)
• Are surplus to the needs of the donor
• Police vetting has been done
• Can be used to produce full genetic siblings in up to 2 families

Question 33

Gestational carrier/surrogacy in NZ

Answer 33

• Procedure facilitated by a NZ fertility clinic where a woman gestates an embryo for one or more IPs.
• Surrogate is a woman who becomes pregnant and carriers and delivers a child on behalf of one or more IPs.
• Commercial surrogacy prohibited HART Act
• Both surrogate and IPs need to obtain independent legal advice.
• All affected parties have received joint and individual counselling
• Counselling available before and after pregnancy too
• Main discussion points:
• Each other’s needs and plans for continuing contact
• Issues that might affect wellbeing of affected parties
• Discussed and declared intentions between themselves about day-to-day care, guardianship and adoption of any resulting child and any ongoing contact.
• Application to ECART must cover risks assoc with surrogacy for the adult parties and any resulting child.
• Includes risks to surrogate of pregnancy, childbirth, relinquishment of child to IPs
• That IPs may change their mind about parenting resulting child
• Risk to reproductive capability in the future
• The risk to IPs including that the surrogate may change mind about relinquishing child
• Risks that arise to resulting child if they become subject to a dispute if the relationship between surrogate and IPs breaks down
• Residency status safeguard the health and wellbeing

Question 34

RTAC recommendation to reduce MPR

Answer 34

Regular audit (at least annually of MPR and corrective action taken that continuously attempts to reduce incidence (including in DI and OI and IUI) Aim should be <10%.
Recommend only one embryo is transferred in first cycle if <35yo female at time of egg collection
Must ensure that no more than 2 embryos are transferred in any one treatment cycle in a woman under age 40 years at the time of oocyte collection
Patients must receive info on the economic, medical, social and psychological hazards assoc with multiple pregnancy.

Question 35

Role of the medical director

Answer 35

Oversee the clinical governance of the IVF unit.
Ensure that pateint care complies with all legislative and regulatory standards.
Manage the performance of other clinical staff to ensure progessional standards are met.
Ensure data monitoring and reporting requirements are met.
Advocate for the fertility care of patients to government.

Question 36

Relevant legislative and regulatory guidelines you need to consider for importing donated sperm.
Standards that are adhered to.

Answer 36

Legislative:
HART act 2004
Legislation in the country sperm comes from

Regulatory:
RTAC code of practice, Nga Parewa, ACART guidelines

• altruisitic - no commercial sperm bank, resonable expenses only
• rigorous health screening for donors,
  - genetic - ECS,
  - HIV/Hep B/Hep C
  - full medical and family history
• Details stored in BDM and available to donor conceived children at 18
• Comply with family limit guidelines
• ANZICA counselling
• informed consent, signed consents, process for withdrawal of consent

Question 37

a 32 yo with Mullerian agenesis and her 34yo partner see you for advice as they would like to find a surrogate. Outline the principals behind the surrogacy process in your region.

Answer 37

• Illegal to advertise for a surrogate
• Altruitics - reasonable expenses only
• Independent legal advice for both IPs and surrogate
• Couselling with ANZICA counselling for IPs, surrogate + partner (if present), and joint session
• Application ECART (review by independent body) - ethics committee for ART.
• medical assessment critical - evaluate obstetric and medical risk
• document a formal surrogacy agreement
• Involvement of Oranga Tamariki for adoption processes

Question 38

A couple decide to explore the possibility of surrogacy overseas. What advice would you give?

Answer 38

• NZ arrangements are highly regulated and should be considered first
• Do not recommend commercial surrogacy
• Seek independent expert legal advice re citizenship, immigration, parentage orders
• consider travel and medical insurance.
• Research safety of clinic re accreditation, care of surrogates, identification and traceability policies, availablility of neonatal care, infection control/quarenaten, genetic screening, record keeping
• document a surrogacy agreement
• Encourage single emrbyo transfers

Question 39

You need to consent a 13 yo for OTC. What factors do you need to consider

Answer 39

• involve the child in the decision making process at their developmental level
  Have the been provided with all the relevant information
  Do the parents understand the procedure, risks/benefits/alternatives
• how much does the child understand
• have they been offered counselling
• do they undersatnd the risks
• obtain valid consent from guardian for procedures and for storage of tissue

Question 40

Patient requests the use of her dead husbands sperm. What do you need to conisder before you proceed with treatment?

Answer 40

• evidence of reproductive intent, previous children?
• If no evidence then ECART - through independent body
• if no written consent, is there verbal consent?
• absence of evidence of a wish not to conceive?
• adequate time for grieving?
• adequate counselling with an ANZICA counsellor?

Question 41

You want to introduce a new tech to your IVF unit. What do you need to consider?

Answer 41

Is there evidence of successful clinical outcomes?
Are there short/long term consequences
Has there been safety and efficacy evaluations
Should a research project be undertaken first
Does the tech complet with legislation
HAve all the ethical issues been considered?
Ensure valid consent
HAve staff been adequately trained?
Is there a quality assurance/auditing process in place including data recording and adverse event reporting.

Question 42

What are the ethical principals that guide ART research

Answer 42

Respect all participants and keep the unborn children at forefront of ddecision making
Respect human embryos
Don’t use any unacceptable or prohibited practices
Minimse risks
Offer separate decision making processes (no coersion)
Provide information
Obtain consent
Keep detailed records
Collect and report data on outcomes
Diclose financial interests
Respect conscientious objections

Question 43

Before embryos are created the NHMRC guidelines state people should understand their options with regard to storage and disposal of embryos
What are these optoins?

Answer 43

use in their partners treatment
posthumous use
Donation to another individual or couple
use in research (not in NZ)
Use in training and quality activities
Transfer to another clinic
Storage - length of time and ethics regulation
Disposal

Question 44

A couple request tx with donor sperm from your donor bank. They tell you that thye have no intention of telling the future child they were conceived with the help of a donor. What are their obligations?

Answer 44

Clinic must:
Encourage gamete recipients to disclose to their children their genetic origin
Provide ongoing support to parents, to help them to understand the potneital significance of the biological conneciton and the benefits of early disclosure
assist parents to find effective ways of diclosing to their children their genetic origins

Question 45

A couple are both carriers of a genetic condition that would severely limit the qol of the child to be born. What information should they be provided to devide whether to undertake PGT

Answer 45

Impact of condition = symptoms, age of onset, severity
Available treatments
Experiences of families living with this condition
Extent of social supports available
Impact on other siblings
Possibility that all embryos can be affect
Results may indicate variants of unknown significance
May find genetic conditions that were not subject of testing
Likelihood of FP and FN
Other abnormalities that can occur, despite PGT