venue - excemed · 09.10 l1: qms systems in art: iso standard certification and accreditation p....

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LanguageSimultaneuos translation from English into Chinese and from Chinese into English will be provided.

General information

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Course on quality management system (QMS) in ART

Serono Symposia International Foundation workshop on:

Course on quality management system (QMS) in ARTBeijing, P.R. China - February 23, 2012

Aim of the workshopReproductive Medicine has made tremendous advances in the field of quality management and these need to be spread also to

the Asia Pacific audience: in particular, for the ART laboratory, several professional associations and laboratory organizations

have already framed and published standards and guidelines. Different QM have been put in place however the systems that

followed the manuals of the International Standardization Organization (ISO 9000 manual series) became the most popular

standard. Today tihe ISO 9000:2008 for IVF centers is the option for those that choose to be accredited, together with ISO 15189:2007

for their laboratories techniques.

Learning objectivesAt the end of the workshop, the attendees will be able to:

•be updated on some of the most relevant outcomes of basic research in infertility

• improve laboratory outcomes

•apply the highest standards of laboratory procedures

•discuss the best option to improve assisted reproduction outcomes

Target audienceThe program is targeted to clinicians and biologists with particular interest in quality management of ART clinic and advanced

techniques.

AccreditationSerono Symposia International Foundation (www.seronosymposia.org) CME activity "Course on quality management system (QMS)

in ART" Beijing, P. R. China 23 February, 2012 was granted 6 European CME credits (ECMEC) by the European Accreditation

Council for Continuing Medical Education (EACCME).

All Serono Symposia International Foundation programs are organized solely to promote the exchange and dissemination of scientific and medical information. Noforms of promotional activities are permitted. All Serono Symposia International Foundation programs are made possible thanks to educational grants receivedfrom: Centre d’Esclerosi Multiple de Catalunya, ComtecMed, Congrex Sweden, Congrex Switzerland, Cryo-Save, Datanalysis, Esaote, European Society of Endocri-nology, Fondazione Humanitas, Fundación IVI, ISFP International Society for Fertility Preservation, ISMH International Society of Men’s Health, K.I.T.E., MerckSerono, Sanofi-Aventis, University of Catania, Vall d'Hebron University Hospital.

Scientific organizersJie Qiao

Peking University Third Hospital

Beijing, P. R. China

Canquan Zhou

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, P. R. China

Scientific secretariatSerono Symposia International Foundation

Salita di San Nicola da Tolentino, 1/b - 00187 Rome, Italy

Senior Project Manager: Vanessa Spaziano

Phone: +39-06-420413 569 - Fax: +39-06-420413 677

E-mail: [email protected]

Serono Symposia International Foundation is a Swiss

Foundation

with headquarters in 14, rue du Rhône, 1204 Geneva,

Switzerland

Organizing secretariatMeridiano Congress International

Via Mentana, 2/B - 00185 Rome - Italy

Project Coordinator: Debora Urbinelli

Phone: +39-06-88595 232 - Fax: +39-06-88595 234

E-mail: [email protected]

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List of faculty membersSue Brown

Repromed

Dulwich

Adelaide, Australia

Zi-Jiang Chen

Center for Reproductive Medicine

Shandong Provincial Hospital, Shandong University

Jinan, P. R. China

Robert Fischer

Fertility Centre Hamburg

Hamburg, Germany

Hefeng Huang

Women's Hospital

School of Medicine

Zhejiang University

Hangzhou, Zhangjiang

P.R. China

Peter Kastrop

University Medical Center Utrecht

Department of Reproductive Medicine

Utrecht, The Netherlands

Jie Qiao

Peking University Third Hospital

Beijing, P. R. China

Douglas Saunders

University of Sydney

Sydney, Australia

William Blaine Schoolcraft

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, USA

Cecilia Sjoblom

Westmead Fertility Centre

University of Sydney

Sydney, Australia

List of faculty members

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P.C. Wong

Department of Obstetrics & Gynaecology

Yong Loo Lin School of Medicine

National University of Singapore

Department of Obstetrics & Gynaecology

National University Hospital

Canquan Zhou

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, P. R. China

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Scientific programThursday, February 23 - 2012

08.30 Scientific Organizers’ welcomeJie Qiao, China - Canquan Zhou, China

08.45 SSIF welcomeRobert Fischer, Germany

Session I

Chairmen: R. Fischer, Germany - C. Zhou, China

09.00 V1: initial voting system to test actual status of practice

09.10 L1: QMS systems in ART: ISO standard certification and accreditationP. Kastrop, The Netherlands

09.40 L2: How to implement QMS in ART: center managementS. Brown, Australia

10.10 L3: How to implement QMS in ART: laboratory- how to set up laboratory space- SOP- air quality as a key elementC. Sjöblom, Australia

10.40 Coffee Break

Session II

Chairmen: R. Fischer, Germany – Jie Qiao, China

11.10 L4: How to manage staff: tools to improve QM- tasks assignment, continuous education- benchmarking- surveysP. Kastrop, The Netherlands

11.40 L5: Tools to improve QM in the laboratory: quality assurance of personnel, troubleshootingC. Sjöblom, Australia

12.10 L6: What are the benefits of QMS in ART- how the system profits- How the staff profitsD. Saunders, Australia

12.40 Lunch

Session III

Chairmen: R. Fischer, Germany – H. Huang, China

13.40 L7: Experiences on QM implementation:the gold-standard in ChinaZ. Chen, China

14.10 L8: Experiences on QM implementation:the gold-standard in USAW. B. Schoolcraft, USA

14.40 Coffee break

15.00 L9: Experiences on QM implementation:the gold-standard in AustraliaD. Saunders, Australia

15.30 L10: Experiences on QM implementation:the gold-standard in Asia Pacific RegionP.C. Wong, Singapore

16.00 Voting system to test again practice and comparison with 1st voting

16.10 Discussion

17.00 Summary of the course take-home messages

17.20 Concluding remarks by the Scientific Organizers

17.30 End of the course

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Serono Symposia International Foundation adheres to guidelines of the European Accreditation Council for Continuing Medical Education

(EACCME) and all other professional organizations, as applicable, which state that programs awarding continuing education credits must

be balanced, independent, objective, and scientifically rigorous. Investigative and other uses for pharmaceutical agents, medical devices,

and other products (other than those uses indicated in approved product labeling/package insert for the product) may be presented in the

program (which may reflect clinical experience, the professional literature or other clinical sources known to the presenter). We ask all

presenters to provide participants with information about relationships with pharmaceutical or medical equipment companies that may

have relevance to their lectures. This policy is not intended to exclude faculty who have relationships with such companies; it is only intended

to inform participants of any potential conflicts so participants may form their own judgments, based on full disclosure of the facts. Further,

all opinions and recommendations presented during the program and all program-related materials neither imply an endorsement, nor a

recommendation, on the part of Serono Symposia International Foundation. All presentations solely represent the independent views of the

presenters/authors.

The following faculty provided information regarding significant commercial relationships and/or discussions of investigational or non-

EMEA/FDA approved (off-label) uses of drugs:

Sue Brown Declared no potential conflict of interest

Zi-Jiang Chen Declared no potential conflict of interest

Robert Fischer Declared to receive honoraria by Serono Symposia International Foundation as Scientific Committee Member

Peter Kastrop Declared no potential conflict of interest

Douglas Saunders Declared to be member of institutional ethics committee, IVF Australia, honorary capacity

William Blaine Schoolcraft Declared receipts of honoraria and consultation fees from Merck Serono

Cecilia Sjoblom Declared no potential conflict of interest

P.C. Wong Declared having received honoraria and consultation fees from Merck. Prof PC Wong declared

to be stakeholder in NIL.

The following faculty has provided no information regarding significant relationship with commercial supporters and/or discussion

of investigational or non-EMEA/FDA approved (off-label) uses of drugs as of January 30, 2012:

Hefeng Huang

Jie Qiao

Canquan Zhou

Disclosure of faculty relationships

AbstractsKey slides

Formal definitions of quality are quite difficult to understand. But when putting it very simple, quality can be considered as a reflection

of expectations, trust and satisfaction. In an ART center, quality can be seen as striving to provide the highest level of patient’s care with

the highest chance to get pregnant. To achieve and maintain that goal, a quality management system should be implemented. Several

guidelines, international standards and quality management models can be applied.

Some professional associations and laboratory organizations have framed and issued standards and guidelines mainly focussed on

the ART laboratory. These guidelines are very valuable, not only because they offer embryologists practical and ART specific guidelines,

but they also incorporate basic safety guidelines. They form a good basis to establish a quality management system in an ART laboratory.

However, they are not approved as official standards and consequently not suitable when seeking formal recognition by an authoritative

body. Whenever formal recognition is pursued, official international standards, as those developed and released by the International

Organization for Standardization (ISO) should be implemented. ISO standards that can be applied in an ART program are ISO 9001 and

ISO 15189.

ISO 9001: Quality management systems – Requirements, is a common quality management model providing a framework for quality

management. The standard has been widely adopted in numerous organizations in most various areas. Primarily, ISO 9001 applies a

process approach and is directed to the outcome of the process. Compliance with this standard can lead to certification.

Based on their nature, ART laboratories should meet additional requirements, including standards concerning qualification and

competence. Such requirements are incorporated in the ISO standard ISO 15189: Medical laboratories – Particular requirements for

quality and competence. Compliance with this standard can lead to accreditation, which represent a higher level of quality management.

Although both ISO standards are not identical, establishing and maintaining a quality management systems in an ART unit based on

either of them will assure improved reproducibility, traceability, effectiveness and reliability, as well as patients’ satisfaction.

L1 - QMS systems in ART: ISO standard certification and accreditation

Peter KastropUniversity Medical Center Utrecht, Department of Reproductive MedicineUtrecht, The Netherlands

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Key slides


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Key slides

Background Motivation

In 1998 I was given the role of managing two ART units within Adelaide, South Australia; plus two units in other States. All units were

working in isolation with no management systems in place. It was classic disaster management on the run. It was evident that to

achieve business and personal goals a structured business management system was required.

Solution

I commenced the process of introducing QMS to all areas of the business in 1998 in Australia and 2009 in New Zealand. The ISO 9001-

2008 Quality Management System was introduced to all company sites, and continued certification has been achieved with continual

improvement as our aim.

This presentation will give you the benefit of what I have learnt over the last 12 years to assist in introducing and maintaining a successful

QMS.

I will share my experience and tips regarding processes required to get staff committed to the introduction and maintenance of the

QMS. I will outline the eight (8) principles of a good QMS.

The essential key elements that are required to successfully introduce a QMS:

• Key staff requirements

• How to get started

• Introducing the QMS Process into an ART unit

"practically everyone in an organization is already willing, and potentially able, to work in a new way. They only need to be

shown HOW - to be enabled, entrusted, empowered."

Bill Conway

This presentation will give you an overview of how to achieve this goal.

L2 - How to implement QMS in ART: center management

Sue BrownRepromed, DulwichAdelaide, Australia

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Key slides

Sue BrownRepromed, DulwichAdelaide, Australia

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Key slides

Quality assurance, quality control and accreditation are concepts that seem to touch on a wide range of functions in our society. Quality

management (QM) and standardisation is of utmost importance in the field of Assisted Reproductive Techniques (ART) to assure

conformity of all methods and high competency of staff. The necessity of a quality control system becomes even clearer when considering

the possible risks of ART. Over the years that ART have been practiced, much knowledge has been gained on how to run an ART

laboratory, and what methods to use in order to achieve ultimate success. Facing the future, we encounter other variables such as the

safety and efficiency of the laboratory and quality management and standardisation becomes key features.

Three very important parts of the implementation of QM are the provision of suitable laboratory facilities, the standardisation of methods

and the creation of Standard Operating Procedures (SOP’s) and to control the air quality.

The Embryology Laboratory

The laboratory need to ensure that the environmental conditions of the laboratory are suitable for safe handling of gametes and embryos

and don’t invalidate the results or adversely affect the quality of any procedure. In simple words this means that the IVF laboratory has

to be designed in such a way that the outcome of any procedure is optimal and not effected by environmental parameters. Defining the

environment and setting limits for acceptable working conditions will help in reducing variables and result in the patient being the only

factor that varies. Exactly what this encompasses will always be down to interpretation and international, national or regional regulations;

however the standard have some clear demands and some environmental factors can not be ignored including; General laboratory

layout, Access rules, Health and safety, Temperature and Light

Methods and Standard Operating Procedures SOP

The methods and procedures we use in the embryology laboratory and their efficacy has a direct impact on the pregnancy results of

the clinic. It is therefore hugely important that we standardize these methods and make sure that they are reproducible.

Air quality

An area of great debate is the demands of clean air in the IVF laboratory. The standard requires that attention is paid to sterility and

presence of dust and it is highly recommended that laboratories periodically monitor the particle count and presence of volatile organic

compounds in the air together with microbial monitoring using settlement Blood Agar plates to detect bacteria and Sabouraud Dextrose

Agar (SAB) plates for detection of fungus. The plates should be exposed in key positions in the laboratory, theatre and treatment rooms

for 4 hours. Acceptable limits are; zero colonies inside the flow hoods or handling chambers and < 10 colonies outside the hoods in

the laboratory.

L3 - How to implement QMS in ART: laboratory

Cecilia SjoblomWestmead Fertility Centre, University of SydneySydney, Australia

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Key slides


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Key slides

Both international standards, ISO 9001 and ISO 15189, contain requirements to improve quality management. So if one of these standards

is used to establish a quality management system, several tools to improve quality management are provided. However, to make these

tools work, all staff members have to get involved.

This is even more important in an ART unit, where several very different disciplines have to work together in order to accomplish the

desired results. To operate as one team, commitment, cooperation and communication between all disciplines is a necessity. Each

individual staff member should know his duties and be aware of the responsibilities. Technical skills have to be developed by appropriate

education and training. Additionally a program of continuous education is needed to ensure technical competency of all employees.

The requirements related to problem management, risk management and workload management can also be used as tools to improve

quality management. Of all these elements of a QMS, it is the PDCA or Deming cycle that underlies improvements. This quality cycle

reflects the process whereby a problem, risk or issue is recognised, a solution, corrective or preventive measure is identified and

subsequently put into effect. The last step in the cycle is to check the outcome or result to ensure that the problem or issue has been

resolved or prevented. The cycle has to be applied whenever a so-called non-conformity is detected, be it by chance or during an internal

or external audit.

In order to assess whether all efforts to improve quality management paid off, benchmarking can be used. In order to answer the

question: “How are we doing?”, pre-defined performance indicators have to be analysed and compared with those of other ART centers.

In general only pregnancy rates and implantation rates can be used for comparison. But many other performance indicators, focussed

on different levels, can be used as a continuous internal surveillance program of your performances.

Finally, quality management in ART is about patients’ satisfaction. To determine the patients’ needs and expectations, communication

is a prerequisite. Patient surveys are an important part of communication. But also complaints, comments and suggestions from

patients should not be ignored.

L4 - How to manage staff: tools to improve QM


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Key slides


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Key slides

Having achieved laboratory accreditation and certification and implemented a quality management system (QM) doesn’t mean that the

quality work ends. A quality system needs to be improved and updated continuously and it is only after the formal recognition, when the

certificate has been awarded, that we can start seeing the real benefits of QM. Continuos monitoring of results, key performance

indicators (KPI’s) and benchmarking assures that we are aware of ‘problems’ at the earliest possible time, and this introduces the need

for trouble shooting, tools for improvement of the quality management in the laboratory.

While the embryology laboratory could be seen as any other clinical medical laboratory there are some major differences to do with the

delicacy of the samples we handle. While mistakes and problems in the day to day pathology laboratory can be rectified by re-sampling,

a mistake or problems in the embryology laboratory can lead to major irreparable trauma for the patients. Therefore it is of great

importance that we acknowledge these differences and implement processes, which help safeguard us from incidents and that we

have set procedures for trouble shooting when problems occur.

There are different approaches to trouble shooting and tools for monitoring allowing for the laboratory to have an ‘early detection

system’. While the monitoring of KPI’s warns us reasonably early about problems monitoring of equipment, devices and core physical

embryo culture parameters allows the laboratory to take action in order to avoid declines in fertilisation rates, blastulation rates and

pregnancy rates.

With the increase in IVF cycle number world wide it has become evident that just like in other areas of medicine and health care, errors

are inherent. But it is important to remember that these errors are most often resulting from a complex interplay of multiple factors;

only rarely are they due to the carelessness or misconduct of single individuals. A culture of blame and finding a scapegoat has commonly

been the response to adverse events and this is an approach, which can never improve the system and prevent the incident form

reoccurring.

In order to prevent errors and identify risks IVF laboratories must introduce robust risk management including an analysis of systems

and structures in advance of those risks actually materializing, so embedding risk management into the daily routine for embryologists.

This will vastly decrease the risk of adverse events and near misses, and also provide tools for how to learn form incidences when they

happen and prevent them from happening again. In the There are three core tools for helping us address risk; Failure Mode and Effects

Analysis (FMEA), Root Cause Analysis and Audit.

Finally, it is important to acknowledge that quality management together with a never ending commitment to improve our service,

beyond standards, is the only way forward towards a future where we can guarantee safe efficient IVF treatment for all patients and the

birth of children, who goes on to live a healthy life.

L5 - Tools to improve QM in the laboratory: quality assurance of personnel, troubleshooting


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Key slides


William Blaine SchoolcraftColorado Center for Reproductive MedicineLone Tree, Colorado, USA

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Key slides

Quality Management Systems (QMS) began to be applied to already established ART Clinics, several years after these clinical services

commenced in both the public and private sectors in Australia. This was in the hope that clinical errors with potential clinical and legal

consequences could be avoided. Other areas throughout the world were adapting ISO guidelines in various areas, and similar Guidelines

were found to be adaptable to complex ART procedures, where there was already intense public scrutiny. Australia covers a large area,

and Clinics were being set up to bring ART to regional areas.

The Fertility Society of Australia (FSA) had developed a “Code of Practice” and the Medical Directors willingly accepted the need to be

FSA approved. A committee of the FSA, the Reproductive Technology Accreditation Committee (RTAC) was set up to accredit these

Clinics. Overseas-reported “mistakes” could then be avoided. QMS made preparation for RTAC accreditation by inspection easier and

less subjective. Once the individual Clinics accepted QMS as part of Clinic life, the benefits to patients, regulators, financial supporters

including Governments, became apparent. The staff then felt that they were members of a well-run Clinic, where their future was

secure and of which they could be proud. Government funding of ART services followed, which are now part of the clinical profiles of all

parts of Australia.

L6 - What are the benefits of QMS in ART

Douglas SaundersUniversity of SydneySydney, Australia

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Key slides


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Key slides

Medical Quality (MQ) is very crucial for clinic development, which covers aspects of medical technology and medical service. In medical

service, there is a large number of links which can directly affect MQ. The link quality control (QC) becomes more important for the

particularity of Assisted Reproductive Technology (ART). According to the characteristics of ART, we established the comprehensive

medical quality management system. The detailed program includes outpatient service, laboratory examination, patient selection and

pretreatment, filing document planning individualized treatment proposal and implementation of ART. The corresponding measures

of QC are formulated on the basis of clinical procedures (i.e. indication of assisted reproduction, controlled ovarian hyperstimulation, in

vitro fertilization and embryo transfer), laboratory processing (i.e. intracytoplasmic sperm injection, embryo transfer, freezing and thaw)

and follow-up. In summary, QC is very important for ART. QC contributes to ensure medical safety, avoid medical risks and improve the

MQ. Furthermore, QC can help to strengthen the quality view of medical staff, to increase satisfaction with patients and to improve

clinical successful rate, as well as to decrease medical risk to the minimum.

陈子江

山东大学附属生殖医院，山东省立医院生殖医学中心

摘要

医疗质量涵盖了医疗技术和医疗服务的各个层面,是整个医院发展的决定性因素。在医疗工作中,存在着众多环节,环节质量直接影

响整体医疗质量,环节质量控制是医疗质量控制的关键。由于辅助生殖技术的特殊性，环节质量控制显得更为重要。根据ART的特

点，我院建立了“网格式”全面医疗质量管理系统。

根据ART的特点是环节多、开放时间长、涉及伦理、法规、夫妇双方及其后代的安全。我院辅助生殖技术流程包括：门诊初诊、

完成相应的化验检查、入选进入实施辅助生殖技术、完成进入周期前的准备、建立相应的辅助生殖技术档案、制定治疗方案、进

入治疗周期。

在辅助生殖技术流程中的重点环节主要有辅助生殖临床（助孕指征、促排卵方案、胚胎移植）、实验室（拆卵、受精尤其是ICSI

操作、胚胎移植、冷冻与复苏等）及随访。针对这3个重点环节制定相应的质控措施。

总之，在辅助生殖技术中，保证医疗质量尤为重要。质量控制可以强化医务人员的质量意识,自觉遵守各项工作制度、操作规程,

严格规范自己的医疗和实验室操作行为,把医疗缺陷控制到最低限度。对于保障医疗安全、规避医疗风险、提高整体医疗质量起

到十分重要的作用。由于辅助生殖技术流程中环节众多，因此做好临床、实验室及随访三个重点环节的质控可以起到事半功倍的

效果。

L7 - Experiences on QM implementation:the gold-standard in China

Zi-Jiang ChenCenter for Reproductive Medicine, Shandong Provincial Hospital, Shandong UniversityJinan, P. R. China

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Key slides


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Key slides

Key slides


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(total medical quality

management TMQM) ;TMQM ,

,

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IUI A BB C FF EN

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Hospital information system, HIS

HIS ART

- -

2

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Key slides

Controlling all the variables of the system�to achieve the best potential outcome. Quality control of both the clinical and laboratory

elements of the IVF treatment cycle is required for optimal outcome. Lifestyle can have a significant effect on reproductive treatment

outcome. Careful assessment of male, ovulatory and uterine factors is essential in order to design an optimal treatment cycle. Tools

are becoming available to assess the quality of oocytes and sperm utilized for ART.

During the pre-implantation period, the embryo undergoes significant changes in its physiology, metabolism and genetic control. These

changes are so dramatic that the starting point of development, the zygote, and the final stage, the blastocyst, can be likened to two

very different somatic cell types. This change in embryo function serves as the basis for the construction of modern sequential

chemically defined media

Genomics and transcriptomics are invasive, but effective tools to assess the competence of embryos. Metabolism / the metabolome

of individual embryos can be readily quantified. Both specific nutrient analysis, metabolic pathway flux, amino acid turnover and general

analysis of metabolic footprint are significantly correlated with human embryo viability. Such non-invasive tests of viability should be

used to augment the alpha-numeric grading systems to quantify embryo viability prior to transfer. Simplification of metabolic analysis

through microfluidic devices may serve as an economic methodology in clinical practice in the future.

L8 - Experiences on QM implementation:the gold-standard in USA


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Key slides

The Fertility Society of Australia (FSA) began as a multidisciplinary Society to promote education and research in the rapidly changing

ART area. Later, when the respective States and Federal Governments appeared to be not keen to become involved, the FSA commenced

setting standards, enshrined in a “Code of Practice”, and later inspecting Units requesting accreditation. The independent sub-

committee for this purpose was the Reproductive Technology Accreditation Committee (RTAC). Compulsory reporting of all ART

procedures (including “success” rates) to the National Perinatal Statistics Unit (NPSU) was required. The NPSU was perceived to be

independent as it was University based with established credentials. The yearly submissions are available to RTAC inspectors, with

results expressed in quartiles, and multiple pregnancy rates (less than 10%, with maximum 2 embryo transfer). Public anxiety was

relieved by the open transparency of the process. The consumers were also reassured, and became a very effective group to press the

Government for universal health insurance funding, which subsequently followed. One child in 29 in Australia is now an ART child.

Additional inspections of a group of Clinics in Japan (JISART) were invited, using similar protocols.

More recently, with the expanding number of Clinics, and the pressure on the time of the RTAC volunteers, the Code of Practice was

revised to incorporate the employment of JAS-ANZ to subcontract professional inspections, and the Reports were then sent in confidence

to RTAC. The system is working smoothly. JAS-ANZ is available to offer advice to Asian Clinics.

L9 - Experiences on QM implementation:the gold-standard in Australia


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The ART programme in the National University Hospital (NUH) started since the hospital opened in 1985. NUH is an acute care tertiary

general hospital, and also a training hospital with a residency programme in Obstetrics and Gynaecology.

Initially the programme was smaller and the manpower viz the nurses, laboratory personnel, embryologists and physicians were fewer

in numbers. When the numbers grew, it became evident that a quality management (QM) system was needed to standardise our

functions and operations. If the growth of the ART programme were to progress effectively, procedures need to be standardized. Any

deficiency needs to be identified and dealt with early and efficiently.

As the programme grew, the pressures were increasing from many quarters to produce a quality manual. All our staff members needed

to be doing the same procedure over and over again with no variation by individuals or day of the work week.

From all quarters of staff ie. physicians, nurses, technicians, embryologists and resident, there was an increasing need to be uniform

in everything we did. We initially chose ISO-9001 system. The difficulties and challenges in implementing the system will be discussed.

Subsequently the hospital decided to be certified by the Joint Committee International (JCI), an international version of the Joint

Committee Accreditation of Health Care Organisation (JCAHCO). The necessary changes were made to be certified by JCI. The benefits

of this certification will be described. In conclusion, in developing a quality management system (QMS) in our ART programme we have

been able to standardise all of our procedures so that we can systematically make changes to our protocols and to be able to measure

the impact of these changes.

L10 - Experiences on QM implementation:the gold-standard in Asia Pacific Region

P.C. WongDepartment of Obstetrics & Gynaecology, Yong Loo Lin School of Medicine, National University of SingaporeDepartment of Obstetrics & Gynaecology, National University Hospital

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Key slides

P.C. WongDepartment of Obstetrics & Gynaecology, Yong Loo Lin School of Medicine, National University of SingaporeDepartment of Obstetrics & Gynaecology, National University Hospital

28

1 3

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Key slides

Notes

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