1. IVF Maribor Lacerta D54° 18’59.66’’ UNIVERSITY MEDICAL CENTRE MARIBOR Department for reproductive medicine www.ivf.mb.net ivf.mb@ukc-mb.si Is accredited by UEMS/ EBCOG / ESHRE as Evropean Centre for Reproductive Medicine

2. Quality control in clinical and laboratory procedures in MAR: ISO or TQM? Veljko Vlaisavljevic Department of Reproductive Medicine and Gynecologic Endocrinology University Medical Centre Maribor Slovenia

3. Steptoe, Edwards and Purdy: Louise Brown 25 July 1978 Pregnancy rate/started cycle : 0,5%

5. Maribir IVF 1984

6. Reproductive medicine today Quality control becomes a key feature ! Quality=competent, intensive individualized care with personal involvement before treatment, during the treatment process and after the treatment. guidelines international QM standards laws ( national level, EU level )

7. In daily routine usually quality considers only medico-technological aspects of services (therapeutical results) „pregnancy rates“

8. Quality means much more! Medico-technological aspects (PR) Psychological and ethical aspects Organisatory and economical aspects Fulfillment of quality expectations from the patient´s perspective

9. WHY QUALITY MANAGEMENT ? QM is needed to ensure consistency and reproducibility of all methods and competence in all duties performed by the personell Today every ART laboratory in EU is obliged to implement a QM system to establish and maintain a strict QC and QA

10. Running of IVF Center 10% clinical skills 30% scientific skills 60% sheer organization TQM= the scientific way of doing bussines From: Mortimer D& Mortimer S.T. : Quality and risk management in the IVF laboratory. Cambrdge University Press, 2005

11. Human Reproducttion vol.15 no.10 pp2241-2246, 2000 ESHRE guidelines for good practice in IVF laboratories Luca Gianarolli, Michael Plachot, Roelof van Kooij, Safaa Al-Hasani, Karin Dawson, Anick DeVos, M.Cristina Magli, Jaqueline Mandelbaum, Jaqueline Selva and Wouter van Inzen (Comitee of the Special Interest Group on Embriology)

12. STANDARDIZACIJA LABORATORIJSKE PRAKSE DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells EUTCD is NOT concerned with increasing „performance“ (succes rates)

13. Whenever a formal recognition is desired – official standards such as developed and released by International Organization for Standardization should be implemented

14. QM system ISO – an international standard since its first publication in 1987 EN ISO 9001 certification EN ISO 170 25 accreditation EN ISO 151 89 accreditation Certification The whole clinic –Third party inspection and verification that a product, process or service conforms to specific requirements (valid for a defined, limited period) BUT –Does not ensure that the laboratory achieves the highest level of care for patients Accreditation Accreditation (method): a procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks

15. ISO requirements Responsibility of management Management of resources Management of processes Analysis and quality improvement

16. The basis for a documentation of any functioning QM system is a manual describing the QM processes in IVF clinic

17. Paperless office

18. Study / research data National IVF Register Individual data analysis Serial Letters Contracts Labels Bills Lab. Software Clin. Software RecDate Devices Data entry and Import Data Management Evaluation and Export Validation Work Lists Checklists appointment calendar Reports

19. Shows that the system is operating Infertility consultations Urology OP Urology Anesthesia Gynaecology OP IVF lab Defines Who? What? and When? External QM manual QM-review EN/ISO 9001 : 2000 Level 1: QM Manuals Levels 3: SOP ´s (job instructions) Level 4: Results and other documentation Level 2: Procedures Defines approach and responsibility, outlines the structure of documentation Answers how Mardesic, 2012

21. From: Frances Hill, Queen‘s University in Belfast,1999

22. What is TQM ? Total → everyone is involved in Quality →continouousely improving service to patients Management → with data and profound knowledge Ron Fotzgerald

23. Quality of organization = quality of care (patients satisfaction + better outcome)

24. Patients pathway & satisfaction TQM implementation Cost of quality European Tissue Directives Andrology laboratory Embriology laboratory Reproductive surgery Complications

25. Impact of TQM in the Andrology Lab (take home message) TQM ( embarcing quality management, risk management and process management) creates the environment for effective and efficiant lab operations, including “quality results ( i.e. accurate, precise, low uncertainty). Results lacking in quality are meaningless, and hance clinically useless- perheps even misleading or even dangerious. How much of the “poor clinical relevance” of andrology lab results might be due to their poor quality ? D.Mortimer

26. TQM in the IVF-laboratory Implementation of TQM takes time and efforts –It does not come easily and you are never finished It is a tool –not a goal in itself Quality culture makes our Lab more dynamic, flexible and adaptable –Not the opposite… In times of crisis –it is very useful to have “full traceability and documentation” No guarantee that you clinical results will improve –You have to define your success criteria and quality parameters yourself –TQM is a tool to get there… Arne Sunde

27. TQM and reproductive surgery Endoscopy should be the gold standard in Gynaecological Surgery it enlarges the surgical possibilities and increases patient compliances when performed by a trained and skilled surgeon in an appropriated conditions. This asks for universal accepted and validated structured training programme leading to an endoscopic surgery EBCOG, ESGE and ESHRE have recognised the problem and are in the final phase of establishing a curriculum of competence based on the best available scientific evidence. ESHRE has established the ECRES program which defines the criteria for the Diploma of Reproductive surgeon. Go for your certificate if you want to be a reproductive surgeon !!! R.Campo

28. TQM & complications related to ART Apply selection criteria before starting treatment Detect and treat/manage pre-treatment risks (myomas, thrombotic risks, systemic diseases) Think ectopic Minimize twins – avoid high order multiples Know and recognize rare complications Register complications Maintain quality control in the clinic as in the lab J. Gerris

29. Patient pathway and patient satisfaction Patient expectations: treatment according to the state of the art and real chance for success (delivery of – one - healthy child)

30. How to implement TQM TQM is a way of thinking, it encompasses all aspects of an organization Quality management can only be described as „Total“ when all employees and managers become engaged in the effort and think of quality not as one-off program but as an ongoing, integral part of daily practice Quality in today´s health care can and must be managed Processes, not people, are the problem Every employee is responsible for quality Quality must be measurable Quality improvements must be continuous Quality is a long term investment ESHRE PCC London 2013 T. Mardesic

31. The cost of quality Non-Quality costs are the most significant costs related to quality Quality should be evaluated as an investment to eliminate the cost of non-quality The objective of the Continuous Improving based Management is to improve Quality and meet or exceed the Customer Expectations “Improvement is infinite” C.Blanes

32. The role of the European Tissue Directive on TQM The implementation of the EUTC Directive offers an opportunity to strive for the delivery of a high quality ART treatment through regular assessment and continuous improvement of our services for patients. E.Mocanu

33. Future ?