MODERN REQUIREMENTS OF AN ASSISTED REPRODUCTIVE CENTER OF EXCELLENCE
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Dr. Sandro C. Esteves discusses the essential qualities and requirements for establishing an 'Art Center of Excellence' in in vitro fertilization (IVF) clinics. He emphasizes the importance of quality management systems and clinical information systems in improving patient outcomes, including effectiveness, efficiency, and safety. The lecture highlights the need for comprehensive patient care that includes personalized treatment plans, continuous improvements, and adherence to quality indicators.
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MODERN REQUIREMENTS OF AN ASSISTED REPRODUCTIVE CENTER OF EXCELLENCE
- 1. Sandro C. Esteves, MD., PhD. ANDROFERT & University of Campinas (UNICAMP) Campinas, BRAZIL MODERN REQUIREMENTS OF AN ART CENTER OF EXCELLENCE
- 2. Esteves, 2 Sandro Esteves, MD., PhD. • Medical and Scientific Director, ANDROFERT, Campinas, BRAZIL • Professor, Department of Surgery (Division of Urology), University of Campinas (UNICAMP), BRAZIL • Research Associate, American Center for Reproductive Medicine, Cleveland Clinic, USA • Professor of Reproductive Endocrinology (Honorary), Faculty of Health, Aarhus University, DENMARK Declare receipt of honoraria for lectures from Merck, Besins, Lilly, and Gedeon- Richter. Affiliation & Disclosure
- 3. 1.Contextualize IVF success in a quality framework 2.Critical attributes of ART Centers of excellence 3.Role of quality management and clinical information systems to achieve excellence Lecture Outline Esteves, 3
- 4. What is the success track record of your IVF clinic?
- 5. n Established 2013 n 100 babies born n Few credentials experience n IVF first-line treatment n Avoid to treat low prognosis pts. n Record of errors/pt. complaints n High rate of multiples n Advertise a lot n Established 1997 n >2,000 babies born n Lots of credentials/experience n All treatment options available n Individualized approach n Rare errors/patient complaints n Low rate of multiples n Educational marketing Doctor ‘Look Good’ PR/cycle = 60% Doctor ‘Look Bad’ PR/cycle = 30% Practice patterns can lead to high pregnancy rates at expense of good patient care
- 6. üDelphi method (structured communication technique) üDevelopment of 298 quality indicators üTwenty-four indicators selected based on consensus of importance; Six quality dimensions ESTEVES, 6
- 7. 6Most Important Quality Dimensions in Infertility Care 1. Effectiveness 2. Efficiency 3. Safety 4. Patient centeredness 5. Timeliness 6. Equity Success in ART goes far beyond pregnancy rate… Dancet et al. Hum Reprod 2011; Mainz. Int J Qual Health Care 2003; Bento & Esteves 2016 Esteves, 7
- 8. Quality in IVF is how well the outputs of our processes comply with a set of pre-defined requirements Esteves, 8 Compliance with guidelines, regulations, and expected results Meeting client’s needs and expectations Continuous improvement Dancet et al. Hum Reprod 2011; Mainz. Int J Qual Health Care 2003; Bento & Esteves 2016
- 9. Quality can be measured… •Live birth rate per patient group; cumulative live birth rate; time to live birthEffectiveness •No. staff & equipment per No. treatments; No. Oocyte/embryo as per OS protocol/patient group; Website with information, contracts, informed consents; Clinical information system allowing input of relevant info and extraction of reports, etc.; No. patients (relative to total) taking throughout diagnostic phase to optimize effectiveness and safety Efficiency •No. ART cycles with (1) complications (OHSS, bleeding, infection, complaints of serious pain; multiple pregnancy, ectopic pregnancy), (2) No. non-conformities (clinical mistakes, lab incidents) Safety •No. clients (relative to total) who opinionated about their experiences (surveys, questionnaires); No. psychological support offered; No. nurse support offered; Dropout rate Patient centeredness •Average duration waiting time pre- and during various IVF sub-processesTimeliness •Clear inclusion/exclusion criteria (eg. donation, surrogacy); transparent reporting of outcomes; counselling about chances of success; provision of treatment/protocols as per legislation/guidelines; provision of ethical vision of the clinic (experimental treatment, etc.) Equity
- 10. Effectiveness Indicator: CLBR The International Glossary on Infertility and Fertility Care Zegers-Hochschild et al. FS 2017 Term Definition Cumulative delivery rate per aspiration or initiated cycle with at least one live birth The number of deliveries with at least one live birth resulting from one initiated or aspirated ART cycle, including all cycles in which fresh and/or frozen embryos are transferred, until one delivery with a live birth occurs or until all embryos are used, whichever occurs first
- 11. The International Glossary on Infertility and Fertility Care, 2017 Zegers-Hochschild et al. FS 2017 Term Consensus Time to pregnancy (TTP) The time taken to establish a pregnancy, measured in months or in numbers of (menstrual) cycles Effectiveness Indicator: TTLB
- 12. Poor quality of service, physical burden, and lack of psychological support account for ~60% dropout Patient centeredness indicator: Dropout Rates Gameiro et al. Hum Reprod Update 2012 22 studies 21,453 patients 8 countries
- 13. Interplay between CLBR and dropout rates critical to shorten TTLB
- 15. Patient engagement in care • Treatment options and plan • Self-care and assistance with self-care • Patient education Care coordination • System to prevent errors, follow-up and support, patient adherence monitoring, communication among care providers and patients (hotline, chats, etc.) Clinical information system • Ease of access to reports and results, satisfaction surveys, feedback Publicly available information on practices • Web based info (credentials, office location, hours, quality of care, etc.) Davis et al. J Gen Intern Med 2005 Attributes of excellence in healthcare
- 16. Coordinated activities to direct and control an organization with regard to quality Service provided in a standardized way Results analyzed Improvements constantly made To secure a service of excellence with consistent and stable results
- 18. SOPs • Mission • Quality policies, objectives & indicators • Document control system • Reviews, auditing, retention • How to register and control non-conformities, corrective & preventive actions • Auditing system • Improvement system • Laboratories description • Personnel, job descriptions, responsibilities • Training program • Safety instructions • General rules Quality Management System Expresses the organizational structure, policies, procedures, processes and resources used to implement quality actions Technical manual Clinical and laboratory SOP manual Quality manual
- 19. Worldwide Tendency to Make QMS Mandatory Australia Code of practice for assisted reproductive technology units, Reproductive Technology Accreditation Committee (RTAC) Brazil RDC 23/2011, National Agency of Sanitary Surveillance (ANVISA) European Union EU directive 2004/23/EG, 2006/17/EG, 2006/86/EG South Africa National Health Act 61/2003; Human Tissue Act USA CLIA for Andrology laboratories; FDA for cryobiology
- 20. Brazilian Directive Cells and Germinative Tissues • Art.60 – quality management system RDC 23, 27/May/2011 (revised RDC 72, 30/3/16) QC Art. 41 Preventive maintenance & equipment calibration QC Art. 51 Daily record critical equipment operation (incubators, freezers, refrigerators) QA Art. 9 e 58 Control of records QA Art. 60 Periodic training QA/QI Art. 60 Internal audits QA Art. 12 e 60 Control of non-conformities and corrective actions QI Art. 50 Preventive actions QC: quality control; QA: assurance; QI: quality improvement
- 21. Quality Management System 1996 – Androfert founded 2006 – QMS implementation started 2010 – ISO 9001:2008 certification 2013 – Recertification 2015 – Recertification 2017 – Recertification 2018 – ISO 9001:2015 certification British Standards Institution
- 22. Other international standards • ISO 15189: Medical laboratories particular requirements for quality and competence • ISO 17025: General requirements for the competence of testing and calibration laboratories • Clinical and Laboratory Standards Institute (CLSI) • QMS model for health care (HSI-A2) • QMS model for laboratory services (GP26-A3)
- 23. ISO* 9001 model easily adapted to ART Units Customer service Document control system Personnel management Audits Procedures for detection, registration, correction and prevention of errors and non-conformities Risk management System to evaluate and control materials and equipment *ISO: International Standardization Organization
- 24. Bento & Esteves. MEDICALEXPRESS 2016;3(3):M160302 http://www.dx.doi.org/10.5935/MedicalExpress.2016.03.02
- 25. QMS - ISO 9001 Determine needs and expectations of customers and others (legislation, professional societies, etc.) Mission Establish a quality policy, quality objectives, and quality indicators for the organization QM focus Determine processes/procedures to achieve the quality objectives; Identify and provide necessary resources Process Determine means to prevent nonconformities (NC) (variation) and eliminate their causes; Register quality actions; Verify compliance (auditing) Registering & Auditing Establish and apply methods to measure effectiveness/efficiency of each process Monitoring Establish and implement a process that involves all personnel for continual improvement Continual improvement Say what you do and what your requirements are Show how you do Show how you ensure you follow what you say you do Show what you do to improve what you do
- 26. • Very well-organized workflow • Reduction of incidents/deviations • Focus on customers needs/satisfaction • Enhanced quality of services provided • Increased operational efficiency and profitability • Continuous improvement QMS Strategic decision to build up long term value for patients/customers
- 27. A powerful “wedge” Holds the gains achieved through the quality journey and prevent good practices from slipping
- 28. 1. Treatment personalization 2. Reproductive andrology 3. Modern IVF laboratory • Paper-free lab • Clean room technology • Time-lapse embryo culture • Vitrification 4. Quality management system Quality-centered strategies at Androfert
- 29. Treatment personalization from OS to LPS The bottom line • Evaluate properly • Give a fair estimate of outcome • Develop an effective, safe, patient-centered, and time-limited treatment plan Dancet et al. Hum Reprod 2011; Mainz. Int J Qual Health Care 2003; Esteves MedicalExpress 2015 Esteves, 29
- 30. Poseidon G1 Poseidon G2 Poseidon G3 Poseidon G4 Non Poseidon patients Low Prognosis Patients Gonadotropin starting dose and regimen can be determined in all patient categories by Poseidon-based stratification INDIVIDUALIZATION Esteves, 30 Andersen et al. (eds.) Research Topic Frontiers in Endocrinology. https://www.frontiersin.org/research-topics/6849/poseidons-stratification-of-low-prognosis-patients-in-art-the-why-the-what-and-the-how
- 31. What the critics say… Esteves, 31
- 34. What the supporters of individualization say… Esteves, 34 Reduces variability in the number of retrieved oocytes Increases the number of retrieved oocytes in poor responders Optimize such numbers in hyper responders Reduces the proportion of women with poor or hyper response Reduces the risk of cycle cancellation Increases the % of patients reaching an ET Reduces the risk of OHSS It achieves all that while maintaining cumulative live birth rates
- 35. • Reduces wastage • Increases efficiency • Allows real time reporting and analysis • Information easily retrievable from remote sites • Fully integrated with QMS concept The modern IVF Clinic ART software management system http://www.clinisys.com.br/
- 37. • Online platform hosted in the Cloud • High performance database • Mobile connectiveness from any device with internet • End-to-end encryption for information protection • Dedicated, audited, and protected traffic • Protection against DDoS attacks • Daily backups stored separately in 3 different locations in addition to the primary cloud server • System logs of all user actions • Compliance with NGS1 safety standards
- 45. Real time monitoring – QC, QA, Reports
- 51. …ease communication with patients and staff
- 53. ART Centers of excellence integrate objective quality indications for all dimensions of health care • Success is measured by how well quality indicators of infertility care are achieved • Focus on CLBR and dropout remains essential to enhance the beneficial effect of treatment Critical attributes of Excellence in healthcare include: • Patient engagement in care (personalized treatments) • Care coordination (QMS, clinical information system) • Publicly available information on practices CONCLUSIONS (1)
- 54. Novel state-of-the art tools & devices helping to improve patient adherence and clinical outcomes • iCOS, laboratory technology, and online connectedness CONCLUSIONS (2) Quality Management and clinical information systems help to achieve excellence • Allow systematic approach to implement, monitor, and improve quality actions focused on the organizational structure, policies, procedures, processes, resources, and risk management • Customer-focused tools
- 55. Dr. Sandro C. Esteves Dr. Marcelo Scandiucci Dr. José Eduardo Orosz Dr. Renan Andreollo Fabiola Bento Cristiane Medina Sidney Verza Jr. Camila Pompeu Luciana Oliveira Vanessa Moreno Ellen Silva Roseane Oliveira Thais Paiva Sarah Queiroz Katia Pereira Sandra Souza Leila Simplicio Shirley Machado Jonathan Santos Dr. Silval Zabaglia Dra. Fabiana Nakano Dr. Julio Voget Dr. Ricardo Miyaoka Dr. Ricardo Barini Dr. Wail Margeotto Dra. Cristiane Moreira Dr. Arnaldo Gomes Marisa Russo Ivanete Santos Sandra Santana Ana Paula Barbosa Ana Pastorelli OBRIGADO GRACIAS THANK YOU