Organization and Management of IVF Units : A Practical Guide for the Clinician.
Fleming, Steven D.
Organization and Management of IVF Units : A Practical Guide for the Clinician. - 1st ed. - 1 online resource (378 pages)
Intro -- Preface -- Contributors -- Contents -- Part I: IVF Unit Establishment and Organization -- Chapter 1: IVF Unit Location, Design, and Construction -- Primary Considerations During Planning -- Purpose of Clinic -- Patient Pathway Review: What Will Be Done in the Clinic? -- Outsourcing Versus Insourcing -- Location -- Patient Population Demographics -- Zoning -- Patient Access -- External Pollution -- Electromagnetic Fields -- Design -- The Planning Process -- How Much Space Is Required? -- Spheres of Influence -- Process Mapping -- Essential Services -- Power -- Gas -- Liquid Nitrogen (LN2) -- Air-Conditioning and Air Quality -- Lifts -- Emergency Access -- The Floor Plan and Room Design -- Clinic: The Doctor, Nurse, and Patient Interface -- Ambiance and Stress Reduction -- Privacy and Confidentiality -- Semen Collection Rooms -- Treatment Rooms -- Counseling Rooms -- Patient Traffic and Ergonomics -- Information Technology -- Laboratory -- Security: Stored Embryos, Patient Data, and Staff -- Controlled Access -- Ergonomics and Efficiency -- Airflow -- Windows and Sunlight -- Andrology and Diagnostic Labs -- Computerization and Wiring for Quality Management -- Safety -- Storage -- Construction -- Floor Coverings -- Walls -- Ceilings -- Lighting for the Culture Lab -- Lab Benches and Cupboards -- Lab Furnishings -- Conclusion -- References -- Chapter 2: Batch IVF Programme in ART: Practical Considerations -- Batch IVF Programme -- Background of Batch IVF Programme -- Types of Settings of Batch IVF -- Batch IVF Preparation -- Preparation of Patients -- Ordering for Gonadotropins -- Getting the Lab Ready for Batch IVF -- Calibration of Instruments -- Cleaning and Air Quality -- Laboratory Cleaning Procedure [3-5] -- Cleaning Solutions Used -- Materials Used for Cleaning -- Method of Cleaning. Cleaning of Laboratory Equipment, Laboratory Areas and Surroundings -- Incubator Cleaning -- Laboratory Maintenance Schedule -- Work Co-ordination in Batch IVF -- Optimum Number of Patients -- Optimum Number of Incubators -- IVF Batching: A Practical Approach to Make It Possible (See Table 2.3) -- Fundamentals of Stimulation in Batch IVF -- Cycle Programming -- Cycle Pretreatment with Combined OCP (COCP) -- Other Strategies for Cycle Programming -- Cycle Pretreatment with Estradiol Valerate in Antagonist Cycles [17] -- Ovarian Stimulation in Batch IVF -- Individualising the FSH Dose -- Addition of LH Activity [21, 22] -- Optimum Number of Oocytes for Best Outcome -- Monitoring of Ovarian Stimulation (NCARE IVF, India) -- Criteria for Adequate Pituitary Suppression -- Controlled Ovarian Hyperstimulation -- Follicular Phase Progesterone Elevation [23] -- Criteria for Triggering Final Oocyte Maturation [24] -- Triggering for Final Oocyte Maturation -- Coasting of a Cycle -- Donor-Recipient and Cryo Cycle Synchronisation in Batch IVF -- Basic Fundamentals of Endometrial Preparation in Donor-Recipient Cycles -- Advantages of Batch IVF Programme -- Disadvantages of Batch IVF Programme -- Inventory Management -- Strategies to Optimise Outcome in Batch IVF -- Summary -- Troubleshooting in Batch IVF -- Hormonal Manipulation -- Poor Follicular Growth -- Poor Oocyte Yield -- Infection of Semen Sample -- Problems with Aspiration Pump -- IVF Culture Media -- Infection of Culture Dish -- Consistent Biochemical Pregnancies in Batch IVF -- References -- Chapter 3: Risk and Regulation: The Role of Regulation in Managing an IVF Unit -- Introduction -- What Are Regulations? -- The Range of Regulations Relevant to an IVF Unit -- Different Approaches to IVF Regulation -- Limitations to Regulations for Containing Risk -- What Regulations Do Not Address. A Simple Risk-Focussed Approach to Quality Management in an IVF Unit -- Setting Mission Statement, Goals, and Key Performance Indicators (KPI) -- Incident Reporting -- Creating a Risk Register -- Risk Mitigation -- Internal Audit -- Regulations as a Resource for Your Risk Register -- Summary -- References -- Part II: Total Quality Management -- Chapter 4: Risk and Disaster Management for the IVF Laboratory -- Introduction -- Creating an Emergency Plan -- Regulatory Agencies -- Elements of an Emergency Plan -- Safety and Protection of Program Personnel and Patients -- Staff Communication -- Continuity of Patient Care -- ART Procedures -- Cryopreserved Specimens -- Off-Site Tissue Storage -- Laboratory Infrastructure -- Laboratory Design -- Laboratory Equipment -- Testing Laboratory Equipment -- Equipment Records -- Post Emergency Considerations -- Summary -- References -- Chapter 5: Staff Management: Leading by Example -- Introduction -- Staff Recruitment -- Workforce Planning -- Advertising Staff Positions -- Interviewing and Vetting of Applicants -- Employment Contracts -- Staff Induction, Training and Performance Appraisal -- Staff Induction and Orientation -- Staff Training and Competency -- Performance Appraisal -- Staff Working Hours and Absences -- Staff Rosters -- Staff Workload -- Sickness Leave -- Holidays and Annual Leave -- Conflict, Grievances and Misconduct -- Conflict and Grievance Resolution -- Misconduct and Disciplinary Procedures -- Gross Misconduct -- Employment Termination and Post-employment Relationships -- Termination of Employment -- Post-employment Relationships Between Staff and Management -- Summary -- Chapter 6: Patient Management: A Nursing Perspective -- Evolution of the Fertility Nurse's Role in IVF Clinics -- Managing Patient Expectations -- Communication -- Medico-legal Aspects -- Minimising Risk. Medication Management -- Psychological Sequelae of ART Treatments -- Conclusions -- References -- Chapter 7: Low-Risk Laboratory Management -- Introduction -- Starting to Reduce Risk Using Quality Systems -- Staffing an IVF Laboratory -- Laboratory Supervisor -- Laboratory Staff Numbers Required -- How Often Should Staff be Working and for How Long? -- Laboratory Equipment to Reduce Risk -- Dealing with Laboratory Risk -- Human Factors Risk -- Laboratory Design and Reducing Risk -- Sample Witnessing Risk -- Liquid Nitrogen Frozen Sample Storage Risk -- Embryo Culture and the Benefits of Low Risk Strategies -- Reducing Incubator Openings -- Be Clear on Reasons for Touching Gametes or Embryos -- Leave Embryos Alone and Reduce Heating of Media -- Service, Maintenance and Fit-for-Purpose Testing -- Frequency of Laboratory Quality Control -- Methodology of Laboratory Quality Control -- Recording and Documenting Laboratory Quality Control -- Reducing Laboratory Risk Using Laboratory Performance Measures -- What is a "Laboratory Performance Measure"? -- What are the "Achievement Level" the "Warning Level" and the "Action Level"? -- How Often do You Collect Pregnancy Marker Data? -- How is the Data Reviewed? -- What to Cover During a Laboratory Review? -- References -- Chapter 8: Cryobank Management -- Introduction -- Establishing a Cryostorage Facility -- Legislative Requirements -- Material to Be Cryopreserved -- Sperm and Testicular Tissue -- Oocytes, Embryos, Ovarian Tissue -- Cryostorage Facility -- Design and Location Requirements -- Safety Considerations -- Laboratory and Sample Security -- Cryopreservation Equipment -- Liquid Nitrogen Tanks -- Bulk Liquid Nitrogen Tanks -- Liquid Nitrogen Storage Tanks -- Nitrogen Vapour Phase Storage Tanks -- Number of Tanks Required -- Inspection and Maintenance Schedule of Storage Tanks. Personal Safety Equipment -- Staff Education -- Choice of Storage Container -- Sperm Storage -- Oocytes and Embryos -- Slow Freeze Devices -- Vitrification Devices -- Contamination Considerations -- Storage Container Labelling Considerations -- Inventory System -- Choice of Inventory System -- Comparison of Two Inventory Systems -- Record Keeping -- Sample Identification -- Database Considerations -- Database Cryostorage Details -- Search and Report Functions -- Patient Communication -- Risk Assessment and Cryostorage -- Potential Areas of Concern -- Auditing Storage Facilities -- Process of Storage Tank Audits -- Common Discrepancies -- Transportation of Gametes and Embryos -- Transport Coordination -- Use of Dry Shippers -- Logistics of Transportation -- Conclusions -- References -- Chapter 9: Management of a Preimplantation Genetic Diagnosis and Screening Service -- Introduction -- Implementation of a Clinical Service for PGD/PGS -- Legislation and Licencing -- Genetic Counselling and Patient Consent -- Equipment and Consumables -- Labelling, Records and Database Entry -- Provision of a Clinical Service for PGD/PGS -- Scheduling and Planning of Patient Treatment -- Preparation of Biopsy Media and Consumables -- Decontamination of Biopsy Equipment and Working Areas -- Sterile Clothing and Aseptic Technique -- Polar Body Biopsy -- Blastomere Biopsy -- Trophectoderm Biopsy -- Preparation, Co-ordination and Dispatch of Biopsied Material -- Methods of Analysis and Interpretation of Results -- Fluorescence In Situ Hybridisation -- Comparative Genomic Hybridisation -- Risk Assessment and Auditing of PGD/PGS -- Summary -- References -- Chapter 10: Data Management in the ART Unit -- Introduction -- Current Use of Databases in ART Units -- Database vs. Spreadsheet -- Commercial Versus In-House Development of a Database -- Commercially Available Systems. In-House Developed Systems.
9783319293738
Gynecology.
Electronic books.
R1
362.1981780599
Organization and Management of IVF Units : A Practical Guide for the Clinician. - 1st ed. - 1 online resource (378 pages)
Intro -- Preface -- Contributors -- Contents -- Part I: IVF Unit Establishment and Organization -- Chapter 1: IVF Unit Location, Design, and Construction -- Primary Considerations During Planning -- Purpose of Clinic -- Patient Pathway Review: What Will Be Done in the Clinic? -- Outsourcing Versus Insourcing -- Location -- Patient Population Demographics -- Zoning -- Patient Access -- External Pollution -- Electromagnetic Fields -- Design -- The Planning Process -- How Much Space Is Required? -- Spheres of Influence -- Process Mapping -- Essential Services -- Power -- Gas -- Liquid Nitrogen (LN2) -- Air-Conditioning and Air Quality -- Lifts -- Emergency Access -- The Floor Plan and Room Design -- Clinic: The Doctor, Nurse, and Patient Interface -- Ambiance and Stress Reduction -- Privacy and Confidentiality -- Semen Collection Rooms -- Treatment Rooms -- Counseling Rooms -- Patient Traffic and Ergonomics -- Information Technology -- Laboratory -- Security: Stored Embryos, Patient Data, and Staff -- Controlled Access -- Ergonomics and Efficiency -- Airflow -- Windows and Sunlight -- Andrology and Diagnostic Labs -- Computerization and Wiring for Quality Management -- Safety -- Storage -- Construction -- Floor Coverings -- Walls -- Ceilings -- Lighting for the Culture Lab -- Lab Benches and Cupboards -- Lab Furnishings -- Conclusion -- References -- Chapter 2: Batch IVF Programme in ART: Practical Considerations -- Batch IVF Programme -- Background of Batch IVF Programme -- Types of Settings of Batch IVF -- Batch IVF Preparation -- Preparation of Patients -- Ordering for Gonadotropins -- Getting the Lab Ready for Batch IVF -- Calibration of Instruments -- Cleaning and Air Quality -- Laboratory Cleaning Procedure [3-5] -- Cleaning Solutions Used -- Materials Used for Cleaning -- Method of Cleaning. Cleaning of Laboratory Equipment, Laboratory Areas and Surroundings -- Incubator Cleaning -- Laboratory Maintenance Schedule -- Work Co-ordination in Batch IVF -- Optimum Number of Patients -- Optimum Number of Incubators -- IVF Batching: A Practical Approach to Make It Possible (See Table 2.3) -- Fundamentals of Stimulation in Batch IVF -- Cycle Programming -- Cycle Pretreatment with Combined OCP (COCP) -- Other Strategies for Cycle Programming -- Cycle Pretreatment with Estradiol Valerate in Antagonist Cycles [17] -- Ovarian Stimulation in Batch IVF -- Individualising the FSH Dose -- Addition of LH Activity [21, 22] -- Optimum Number of Oocytes for Best Outcome -- Monitoring of Ovarian Stimulation (NCARE IVF, India) -- Criteria for Adequate Pituitary Suppression -- Controlled Ovarian Hyperstimulation -- Follicular Phase Progesterone Elevation [23] -- Criteria for Triggering Final Oocyte Maturation [24] -- Triggering for Final Oocyte Maturation -- Coasting of a Cycle -- Donor-Recipient and Cryo Cycle Synchronisation in Batch IVF -- Basic Fundamentals of Endometrial Preparation in Donor-Recipient Cycles -- Advantages of Batch IVF Programme -- Disadvantages of Batch IVF Programme -- Inventory Management -- Strategies to Optimise Outcome in Batch IVF -- Summary -- Troubleshooting in Batch IVF -- Hormonal Manipulation -- Poor Follicular Growth -- Poor Oocyte Yield -- Infection of Semen Sample -- Problems with Aspiration Pump -- IVF Culture Media -- Infection of Culture Dish -- Consistent Biochemical Pregnancies in Batch IVF -- References -- Chapter 3: Risk and Regulation: The Role of Regulation in Managing an IVF Unit -- Introduction -- What Are Regulations? -- The Range of Regulations Relevant to an IVF Unit -- Different Approaches to IVF Regulation -- Limitations to Regulations for Containing Risk -- What Regulations Do Not Address. A Simple Risk-Focussed Approach to Quality Management in an IVF Unit -- Setting Mission Statement, Goals, and Key Performance Indicators (KPI) -- Incident Reporting -- Creating a Risk Register -- Risk Mitigation -- Internal Audit -- Regulations as a Resource for Your Risk Register -- Summary -- References -- Part II: Total Quality Management -- Chapter 4: Risk and Disaster Management for the IVF Laboratory -- Introduction -- Creating an Emergency Plan -- Regulatory Agencies -- Elements of an Emergency Plan -- Safety and Protection of Program Personnel and Patients -- Staff Communication -- Continuity of Patient Care -- ART Procedures -- Cryopreserved Specimens -- Off-Site Tissue Storage -- Laboratory Infrastructure -- Laboratory Design -- Laboratory Equipment -- Testing Laboratory Equipment -- Equipment Records -- Post Emergency Considerations -- Summary -- References -- Chapter 5: Staff Management: Leading by Example -- Introduction -- Staff Recruitment -- Workforce Planning -- Advertising Staff Positions -- Interviewing and Vetting of Applicants -- Employment Contracts -- Staff Induction, Training and Performance Appraisal -- Staff Induction and Orientation -- Staff Training and Competency -- Performance Appraisal -- Staff Working Hours and Absences -- Staff Rosters -- Staff Workload -- Sickness Leave -- Holidays and Annual Leave -- Conflict, Grievances and Misconduct -- Conflict and Grievance Resolution -- Misconduct and Disciplinary Procedures -- Gross Misconduct -- Employment Termination and Post-employment Relationships -- Termination of Employment -- Post-employment Relationships Between Staff and Management -- Summary -- Chapter 6: Patient Management: A Nursing Perspective -- Evolution of the Fertility Nurse's Role in IVF Clinics -- Managing Patient Expectations -- Communication -- Medico-legal Aspects -- Minimising Risk. Medication Management -- Psychological Sequelae of ART Treatments -- Conclusions -- References -- Chapter 7: Low-Risk Laboratory Management -- Introduction -- Starting to Reduce Risk Using Quality Systems -- Staffing an IVF Laboratory -- Laboratory Supervisor -- Laboratory Staff Numbers Required -- How Often Should Staff be Working and for How Long? -- Laboratory Equipment to Reduce Risk -- Dealing with Laboratory Risk -- Human Factors Risk -- Laboratory Design and Reducing Risk -- Sample Witnessing Risk -- Liquid Nitrogen Frozen Sample Storage Risk -- Embryo Culture and the Benefits of Low Risk Strategies -- Reducing Incubator Openings -- Be Clear on Reasons for Touching Gametes or Embryos -- Leave Embryos Alone and Reduce Heating of Media -- Service, Maintenance and Fit-for-Purpose Testing -- Frequency of Laboratory Quality Control -- Methodology of Laboratory Quality Control -- Recording and Documenting Laboratory Quality Control -- Reducing Laboratory Risk Using Laboratory Performance Measures -- What is a "Laboratory Performance Measure"? -- What are the "Achievement Level" the "Warning Level" and the "Action Level"? -- How Often do You Collect Pregnancy Marker Data? -- How is the Data Reviewed? -- What to Cover During a Laboratory Review? -- References -- Chapter 8: Cryobank Management -- Introduction -- Establishing a Cryostorage Facility -- Legislative Requirements -- Material to Be Cryopreserved -- Sperm and Testicular Tissue -- Oocytes, Embryos, Ovarian Tissue -- Cryostorage Facility -- Design and Location Requirements -- Safety Considerations -- Laboratory and Sample Security -- Cryopreservation Equipment -- Liquid Nitrogen Tanks -- Bulk Liquid Nitrogen Tanks -- Liquid Nitrogen Storage Tanks -- Nitrogen Vapour Phase Storage Tanks -- Number of Tanks Required -- Inspection and Maintenance Schedule of Storage Tanks. Personal Safety Equipment -- Staff Education -- Choice of Storage Container -- Sperm Storage -- Oocytes and Embryos -- Slow Freeze Devices -- Vitrification Devices -- Contamination Considerations -- Storage Container Labelling Considerations -- Inventory System -- Choice of Inventory System -- Comparison of Two Inventory Systems -- Record Keeping -- Sample Identification -- Database Considerations -- Database Cryostorage Details -- Search and Report Functions -- Patient Communication -- Risk Assessment and Cryostorage -- Potential Areas of Concern -- Auditing Storage Facilities -- Process of Storage Tank Audits -- Common Discrepancies -- Transportation of Gametes and Embryos -- Transport Coordination -- Use of Dry Shippers -- Logistics of Transportation -- Conclusions -- References -- Chapter 9: Management of a Preimplantation Genetic Diagnosis and Screening Service -- Introduction -- Implementation of a Clinical Service for PGD/PGS -- Legislation and Licencing -- Genetic Counselling and Patient Consent -- Equipment and Consumables -- Labelling, Records and Database Entry -- Provision of a Clinical Service for PGD/PGS -- Scheduling and Planning of Patient Treatment -- Preparation of Biopsy Media and Consumables -- Decontamination of Biopsy Equipment and Working Areas -- Sterile Clothing and Aseptic Technique -- Polar Body Biopsy -- Blastomere Biopsy -- Trophectoderm Biopsy -- Preparation, Co-ordination and Dispatch of Biopsied Material -- Methods of Analysis and Interpretation of Results -- Fluorescence In Situ Hybridisation -- Comparative Genomic Hybridisation -- Risk Assessment and Auditing of PGD/PGS -- Summary -- References -- Chapter 10: Data Management in the ART Unit -- Introduction -- Current Use of Databases in ART Units -- Database vs. Spreadsheet -- Commercial Versus In-House Development of a Database -- Commercially Available Systems. In-House Developed Systems.
9783319293738
Gynecology.
Electronic books.
R1
362.1981780599