Tài liệu Qms in art how why and who ms pope

Quality Management Systems (QMS) in ART - How, Why & Who? 1 INTRODUCTION: LEARNING OBJECTIVES Identifying the benefits Objective 3. Outlining Quality Control & Quality(QC) Assurance(QA) procedures in ART Objective 2. Objective 1. Understanding the concept of Quality in ART 2 HOW? 3 Quality Management Standards are based on eight quality management principles 4 EXAMPLE of QMS PROCESS – Factual Approach to Decision Making Initial Information Investigation Treatment Follow-up 5 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. 6 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. 7 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. 8 QUALITY ASSURANCE & QUALITY CONTROL 9 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 KEY PERFORMANCE INDICTATORS Set the Key Performance Indicators      BATCH NUMBERS TOLERANCE LEVELS Recording Acceptable Consumables Culture medium EPU needles & ET catheters Drugs used in Ovarian Stim. Any item used in IVF      Temperature Range pH CO2 levels LN2 levels Non embryotoxic 11 KEY PERFORMANCE INDICTATORS EMBRYOTOXICITY • Safety of all products that come in contact with gametes or embryos TEMPERATURE • Control at every phase of culturing pH • Gas environment SAFETY • Culturing conditions maintained • Culture medium storage 12 QUALITY CONTROL MEASURES: Temperature pH Gas supplies LN2 levels Emergency backup Alarm systems • Incubators, microscopes, refrigerators • Fluids containing gametes / embryos • Culturing fluids • Incubator readings • Gas mix & quality of cylinder • LN2 loss from tanks – integrity of tanks • Oxygen displacement alarms • Emergency power – generators / UPS • Battery power to alarms • Test response systems regularly • Trigger alarms Embryotoxicity • Culture medium - EQA • Disposables – Lot. Nos. (dishes, tubes, gloves) Contamination • Culture plates for infection • Culture medium 13 Air Purity - VOC • VOC levels • Air filter function QUALITY CONTROL - EXAMPLE Oocyte Temperature Process Map Oocyte in follicle Oocyte aspirated to test tube Test tube in heating block prior to ID Oocyte inseminated on m/scope stage Oocyte cultured in incubator to D1 Cleavage check on m/scope stage D3 – embryo moved to blastocyst medium Oocyte in dish on warm stage Fertilization check on m/ scope stage Embryo moved to ET dish Oocyte transfer to culture dish Oocyte dish transferred to incubator Embryo moved to CM in new dish Oocyte culture in incubator D2 Embryo loaded into catheter Embryo transferred into uterus Legend: AUDIT Blastocyst vitrified 14 Embryo in LN2 Tank RISK PROCESS QUALITY ASSURANCE MEASURES: Oocyte numbers Oocyte Maturation rates Fertilisation rates ICSI Lysis rate Pregnancy rates Implantation rates Miscarriage rates Embryo Development Rates • Competency of embryologist • Competency of clinician • Timing of egg retrieval • Culturing conditions • Sperm preparation – ICSI option • Competency of ICSI skills • Embryo transfer technique • Culturing conditions • Culturing conditions • Temperature & pH control at time of egg collection • Temperature & pH control • VOC / contaminant levels • Culturing conditions • Culture medium 15 Live birth rates • Culturing conditions • Treatment selection BENEFITS of QMS – BENEFITS of QMS – Identification & Review of Critical IDENTIFICATION & REVIEW OF CRITICAL PARAMETERS (Q.C. & Q.A.) Parameters (Q.C. & Q. A.)       Develop process to identify nonconformities Determine the causes of these problems or variations Evaluate actions to prevent a recurrence Determine and implement the action necessary to address the issue Record action taken and results Review these actions to ensure the matter is satisfactorily addressed Decreases in          Fertilisation rates Pregnancy rates (+βhCG; clinical) Live birth rates No. of eggs retrieved Increased miscarriage rates Blastocyst development Utilisation rates Frozen embryo survival Revenue per cycle Increase in      Customer complaints OHSS rates Infections Multiple pregnancy 16rates Business costs QUALITY ASSURANCE - RESOURCES Determine the resources necessary to achieve the ART clinic objectives / KPIs. 17 QUALITY ASSURANCE - RESOURCES 1. Staff required to deliver service 18 RESOURCES – STAFFING REQUIREMENTS Team Player Based on ART Clinic values Embryologists required per IVF cycle – 1 embryologist per 150 - 200 cycles Attention to detail Technical capabilities Empathy towards patients & staff; customer focussed Good communication skills IT skills Responsible, dedicated & hard working 19 Organised QUALITY ASSURANCE - RESOURCES 2. Physical resources required to deliver service Buildings; equipment; environs (e.g. ample space & equipment to undertake cases; air-conditioning; emergency back-up) Validate equipment to ensure suitability Introduce calibration and maintenance processes to ensure ongoing reliability & safety of equipment 20