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1. Please give an overview of your entry and experience in IVF
Adrianne Pope has a background in science with a PhD in genetics and
over 27 years experience in Assisted Reproductive Technology (ART)
and pathology services. She commenced her career as an embryologist
in 1986 in Queensland, Australia. ART Launched Adrianne into a varied
career around the world having directed a number of ART facilities in
Australia and overseas with positions in the USA and Ireland.
Adrianne has a vast wealth of experience in dealing with issues related
to ART and was very active in the Australian Reproductive Technology
Accreditation Committee (RTAC), the peak auditing body, for many
years. Her involvement included the co-ordination and writing of the
2005 RTAC Code of Practice and the 2008 review.
Dr. Pope was elected President of the Fertility Society of Australia (FSA)
in 2003. In 2005 she was re-elected, thus making her the first FSA
president to serve two terms. She has represented the FSA on many
government reviews on accreditation and undertaken many submissions relating to
legislation and regulation. Having commenced a professional career as an embryologist in a
pioneering area of healthcare, her work lead her out of the laboratory and into many varied
roles in healthcare management, establishing ART facilities, implementing Quality
Management Systems, strategic planning and business development.
PROFESSIONAL HIGHLIGHTS
ü President of the Fertility Society of Australia 2003 2007
ü Member of NHMRC Licensing Committee Working Party on Definition of an Embryo 2005
ü Scientific Representative on Reproductive Technologies Accreditation Committee (RTAC)
2001 2007
ü Chairperson Scientists In Reproductive Technology (SIRT) 2001 2003
ü Director Fertility Society of Australia 2002 2007
ü Co-opted supporting committee member of MSAC on Intra Cytoplasmic Sperm Injection
2002 2003
ü Monash IVF Standards Sub-Committee secretary 2000 2004
ü Monash IVF Research Sub Committee 1999 2004
ü NATA Assessor ISO 15189
ü Review Committee RTAC Code of Practice 2004, 2005, 2006 & 2007
ü Scientific Advisor to Victorian Infertility Treatment Authority (VARTA) 2004 2010
ü Consultant to Dept. Health & Ageing Regulation of Solid Organs, Tissue & Reproductive
Tissues 2007
Profile Adrianne K. Pope, BSc(Hons), PhD, GAICD
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ü RTAC Code of Practice Technical Expert Committee for the revision of Code 2007 2008
ü RTAC Auditor Technical Expert
ü National Pathology Accreditation Advisory Council Supervision Drafting Committee 2008
2014
Adriannes professional responsibilities have included:
CEO (Qld.) Monash IVF
Director of Business Development, Repromed
Operations Manager, Wesley Monash IVF & Monash IVF Regional Qld.
Director of Laboratory Services, Monash IVF
Director of Embryology, Monash IVF
Reproductive Biology Supervisor, Qld. Fertility Group
Consultant to Embryology Human Assisted Reproduction in Ireland
Director of Andrology & In Vitro Fertilisation Hillcrest Fertility Centre, Tulsa USA
Director of Reproductive Biology Southern California Fertility Institute Los Angeles USA
IVF Scientist Qld. Fertility Group
2. Could you highlight the organizational structure of IVF lab in Australia and regulations for
embryologists / scientists
ART clinics in Australia must be certified annually to the Reproductive Technology
Accreditation Committee (RTAC) Code of Practice. The Code of Practice stipulates the key
personnel accepting authority and responsibility for the delivery of ART services. These
include a medical specialist to act as Medical Director; a scientist to act as Scientific Director;
a nurse to act as Nurse Manager and a psychologist or social worker to act as Senior
Counsellor. The scientist must have experience in the management of a clinical embryology
or clinical andrology laboratory as appropriate to services offered and must possess
demonstrable knowledge of and continuing education in all laboratory aspects of the
Organisation. The scientific director must:
· have a higher degree (PhD; Masters or Postgraduate diploma) demonstrating
a broadly based scientific experience in reproductive biology, with expertise
and/or specialised training in the physiology of reproduction, cell biology and
biochemistry, and experience in experimental design, statistics and problem
solving. Must also have a minimum of four years of ART clinical laboratory
experience and two years of experience in a managerial and/or supervisory
role: OR
· have a minimum of five years previous experience in a scientific directors role
The Fertility Society of Australia (FSA) has a subcommittee for embryologists Scientists In
Reproductive Technology (SIRT) which undertakes training activities and CME management.
Any ART clinic undertaking pathology testing such as semen analyses, hormone assays or
serology screening must also comply with the Australian Department of Health and Ageing.
All pathology laboratories must be certified by the National Association of Testing Authorities
(NATA - Australia) annually for compliance with ISO 15189:2012. The National Pathology
Accreditation Advisory Council (NPAAC) also outline requirements for laboratories which
include supervision. These requirements reflect the RTAC Code of Practice key personnel
requirements.
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3. Is there any strict regulation for clean room facility for IVF lab in Australia? And what is your
experience with air quality control in IVF lab?
No. The RTAC Code of Practice does not stipulate how ART laboratories must be designed.
The Code of Practice is based on risk management and the Scientific Director must decide on
all laboratory design and procedures. ART clinics are aware of the potential impact of airborne
particles / VOCs. Many clinics use HEPA filters and stationery photocatalytic air purification
systems. Activated carbon and potassium permanganate filters with HEPA filtration
components or activated carbon filters alone are often installed in gas lines to the incubators.
The IVF chambers (e.g. www.tekevent.com) are commonly used in Australia to manage
environmental conditions and these are slowly being introduced for ICSI rigs as well.
4. Many centres do an extended culture with either sequential media or single step media. What
are the precautions to be taken for extended culture?
Extended culture requires adherence to the culture media manufactures specifications. Culture
medium is designed specifically for use with each of the components. As the pH and osmolality
may vary between brands, culture media should not be interchanged with other brands.
Preparation of culture medium should take into consideration any evaporation which could
result in a change in osmolality and ample time to equilibrate (pH) prior to use. Consider the
elevation of the laboratory in regards to CO
2
partial pressure and pH higher CO
2
concentrations may be necessary at higher altitude to maintain a fixed pH. pH is highly
temperature dependent (calibrate at 37
0
C) and methods for measuring pH should consider the
relevant variables. Also consider the thickness of the oil overlay in the time necessary to
equilibrate medium. Australian laboratories all culture in special gas mix 5%O
2
, 6CO
2
; 89%
N
2
.
Temperature is one of the most crucial components of culturing and temperatures should be
controlled at every phase of development. Temperature control during the initial recovery of
oocytes is most important as cooling may cause the spindle to depolymerize. Repolymerizing
may result in subsequent aneuploidy. Use of environmental control chambers is extremely
useful in managing pH and temperature variations during each phase of gametes and embryo
handling.
The other issues to consider include monitoring gas supply and incubator functioning. It is
recommended that gas manifolds have automatic changeover systems in case a gas bottle
empties during the night. Incubators should have some form of alarm monitoring to notify staff
if an incubator malfunctions whilst unattended.
Gas cylinders should be medical grade as the cleaning is superior to food grade gas cylinders.
5. There is a trend towards all ICSI in many countries! What is the scenario in Australia?
ART laboratories in Australia were undertaking 67.8% of inseminations with ICSI based on the
last ANZARD report of 2011. Standard IVF is performed either as short insemination or
overnight insemination. ICSI will not guarantee fertilisation and as there is still evidence
required to confirm the safety of ICSI, its use should be clearly stipulated based on clinical
criteria.
6. There are many lab and incubator cleaning products and different embryologists use different
ones. What should be an ideal embryo safe cleaning agent?
There are a number of products now on the market specifically designed for ART laboratories.
70% Ethanol and hydrogen peroxide have been used in the past but have long been a concern
to laboratories considering the effects of VOCs on embryo development. Evidence suggesting
efficacy and safety of specific products is scarce, however quaternary ammonium compounds
in MEA tested laboratory disinfectants maybe an option. Some Australian laboratories are
utilising steam cleaning as an alternative.
7. What is KPI? And which ones are important for lab and clinical efficacy?
KPIs are Key Performance Indicators. This is a term used in Quality Management to aid in
determining which factors play a significant role in the success of an ART laboratory.
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Laboratories use Quality Control to measure the performance of equipment etc.and Quality
Assurance to confirm the outcomes are being achieved.
QUALITY CONTROL: The OBSERVATION TECHNIQUES and ACTIVITIES used to fulfil
requirements for quality.
TE NEEDED C
ORRECTIVE RESPONSES;
QUALITY ASSURANCE: The PLANNED and SYSTEMATIC ACTIVITIES implemented in a
quality system so that quality requirements for a product or service will be fulfilled.
ART laboratory KPIs may include:
EMBRYOTOXICITY
Safety of all
products that
come in
contact with
gametes or
embryos
TEMPERATURE
Control at
every phase
of culturing
Osmolarity
pH
Gas
environment
SAFETY
Culturing
conditions
maintained
Culture
medium
storage
KEY PERFORMANCE
INDICTATORS
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Competency of embryologist
Competency of clinician
Oocyte numbers
Timing of egg retrieval
Oocyte Maturation rates
Culturing conditions
Sperm preparation ICSI option
Fertilisation rates
Competency of ICSI skills
ICSI Lysis rate
Culturing conditions - pH; osmolarity; temperature
Culture Mediun
Embryo Development Rates
Freezing techniques
Freeze / Warm Survival
Embryo transfer technique
Culturing conditions
Pregnancy rates
Efficacy of treatment techniques
Cumulative Pregnancy Rates
Culturing conditions
Temperature & pH control at time of egg collection
Implantation rates
Temperature & pH control
VOC / contaminant levels
Miscarriage rates
Culturing conditions
Treatment selection
Live birth rates
Incubators, microscopes, refrigerators
Fluids containing gametes / embryos
Temperature
Culturing fluids
pH
Incubator readings
Gas mix & quality of cylinder
Gas supplies
LN
2
loss from tanks integrity of tanks
Oxygen displacement alarms
LN
2
levels
Emergency power generators / UPS
Battery power to alarms
Emergency backup
Test response systems regularly
Trigger alarms
Alarm systems
Culture medium - EQA
Disposables Lot. Nos. (dishes, tubes, gloves)
Embryotoxicity
Culture plates for infection
Culture medium
Contamination
VOC levels
Air filter function
Air Purity - VOC
QUALITY ASSURANCE
QUALITY CONTROL