Quality Management Systems (QMS) in ART - How, Why & Who? INTRODUCTION: LEARNING OBJECTIVES Identifying the benefits Objective Outlining Quality Control & Quality(QC) Assurance(QA) procedures in ART Objective Objective Understanding the concept of Quality in ART HOW? Quality Management Standards are based on eight quality management principles EXAMPLE of QMS PROCESS – Factual Approach to Decision Making Initial Information Investigation Treatment Follow-up QUALITY CONTROL & QUALITY ASSURANCE The terms “quality assurance” and “quality control” are often used interchangeably to refer to ways of ensuring the quality of a service or product The terms, however, have different meanings QUALITY CONTROL CONTROL: An EVALUATION to INDICATE NEEDED CORRECTIVE RESPONSES; the act of guiding a process in which variability is attributable to a constant system of chance causes QUALITY CONTROL: The OBSERVATION TECHNIQUES and ACTIVITIES used to fulfil requirements for quality QUALITY ASSURANCE ASSURANCE: The ACT of GIVING CONFIDENCE, the state of being certain or the act of making certain QUALITY ASSURANCE: The PLANNED and SYSTEMATIC ACTIVITIES implemented in a quality system so that quality requirements for a product or service will be fulfilled QUALITY ASSURANCE & QUALITY CONTROL QUALITY in A.R.T Determine which factors may affect the ART services, both the processes involved in delivering the services and the outcomes Clear idea of the variables 10 WHY? 27 QUALITY BENEFITS of QMS – ADVANTAGE TO THE BUSINESS QUALITY ADVANTAGES:  Setting Objectives – planning for the future (e.g introducing a new service or technology)  Training – clear procedures ensuring all staff are trained consistently (e.g new clinicians;  Consistency in procedures – ability to assess outcomes by controlling variables identify the needs of customers – internal & external; address expectations; retain staff) (e.g document control) (e.g auditing)  Identify risks & implement mitigation strategies (e.g minimising errors) embryologists)  Improve customer service (e.g  Defining protocols – agreeing to best practice  Competency – ensuring staff are competent following training & in the future (e.g minimum no of procedures)  Continual Improvement (review data to continually implement improvements)  Identification & review of critical parameters (Q.C & Q.A.) (e.g Fert.; Preg.; Miscarriage; Live Birth rates) 28 COMMERCIAL BENEFITS of QMS – ADVANTAGE TO THE BUSINESS BUSINESS ADVANTAGES:  Assess the market – SWOT; competitors (e.g competitor offering new services or technology)  Minimise waste through efficiency (e.g wasted culture medium)  Set Objectives / Goals – Clinical & Financial – budget for Cap Exp  Manage expenses and suppliers  Identify risks & implement mitigation strategies (avoiding  Manage resources – stock & people (e.g holding too much additional expense)  Plan & prepare for growth in advance (e.g employ & train  Negotiate contracts with suppliers (both costs & services) additional staff to deploy with increase)  Manage cash flow stock; stock rotation; rostering staff)  Identify and monitor financial KPIs (e.g revenue / IVF cycle; consumable costs / cycle; staffing costs / cycle; EBITDA margin)  Manage debt  Provide effective services – minimising complaints & free cycles; expense to patient SWOT – Strengths; Weaknesses; Opportunities; Threats PESTLE – Political; Economic; Sociological; Technology; Legal; Environment 29 WHO? 30 REGULATORY BODIES: Regulatory control of ART has evolved slowly over the years since the first IVF birth in 1978 It has often been in response to: Public concern; Incidents relating to safety; Implementation of best practice 31 REGULATORY BODIES: COUNTRY: ART REGULATORY ACTION: European Union EU Parliament Directives – 2004/23/EC; 2006/17/EC United Kingdom HFEA – Legislation & Monitoring USA Clinical Laboratory Improvements Act (CLIA) – College of American Pathologists (CAP) – ASRM – Society for Assisted Reproductive Technology (SART) Guidelines & Data monitoring Australia FSA – RTAC (1987); State Leg.; ANZARD – data monitoring; NHMRC – Ethical guidelines on the use of ART in clinical practice and research 2007 (Under review) Singapore Legislation – MOH Licensing terms & conditions – 1.1.13 (response to identification incident) India Surrogacy Brazil Brazilian National Agency for Sanitary Surveillance 2006 – Directive on laboratory requirements (air quality) similar to EU Thailand Europe New Zealand 20th Feb 2015 Commercial surrogacy banned ESHRE – Guidelines on best practice in ART NZS 8181:2007 32 REGULATORY BODIES: DONATED GAMETES & EMBRYOS Rights of children to know genetic parents Vs anonymity Sibling / half sibling – consanguinity issues Donor coercion - vulnerability Rights of donors  Registers  Non-identifying information  Trading in biological material – altruistic Vs commercial donation  Safety of reproductive material  Infection risks  Chain of custody risks  Limit of number of genetic parents (2 only in most countries – UK mitochondrial     transfer)  Legal issues of birth registration and property  Cultural issues & acceptance 33 REGULATORY BODIES: SURROGACY  Religious & cultural issues – banned in many countries  Rights of child, surrogate (partner) & intended / commissioning parents  Commercial Vs altruistic surrogacy  Gestational surrogacy most common  Surrogate coercion – vulnerability; surrogate farming  Safety   Infectious disease screening  Genetic testing of child re: genetic parents  Obstetrical risks Legal issues of birth registration – birth mother & adoption requirements 34 REGULATORY BODIES: SEX SELECTION – FAMILY BALANCING  Cultural desire for specific sex of child  Societal & religious opinions towards sex selection  Sex selection for genetic disease 35 ROLE of REGULATORY BODIES: SAFETY – Minimising risks of:             Infection Adverse obstetrical outcomes Multiple pregnancy – health of babies OHSS Medication issues Identification & witnessing errors Legal disputes over parentage Accidents or errors Inappropriate equipment or consumables Untrained / inexperienced staff Offspring unable to track genetic origins Social unrest 36 ROLE of REGULATORY BODIES: EFFICACY – Ensure:  Treatments offered provide required outcomes  Benchmarking  Data collection & review 37 ROLE of REGULATORY BODIES: EFFICIENCY – Review:     Costs associated with care – value for money Resources appropriate Outcomes timely Key personnel requirements - competency 38 ROLE of REGULATORY BODIES: CUSTOMER FOCUS – Ensure:  Treatments meet patient expectations  Patients are fully informed of outcomes & potential issues  Information relating to outcomes is reported to regulatory bodies  Society has a role in determining options for care  Financial constraints are addressed – value of government funding (health economics) 39 SUMMARY Quality Management Systems – Relevance in ART clinical outcomes • Outline objectives / goals for clinical care • Determine the variables that impact on success • Control the majority of variables • Improve efficacy & efficiency • Ensure safety • Conformity in service delivery 40 Questions? 41