Organization and management of IVF units

Organization and Management of IVF Units A Practical Guide for the Clinician Steven D Fleming Alex C Varghese Editors 123 Organization and Management of IVF Units Steven D Fleming • Alex C Varghese Editors Organization and Management of IVF Units A Practical Guide for the Clinician Editors Steven D Fleming, BSc, MSc, PhD School of Medicine University of Sydney Sydney, NSW, Australia Alex C Varghese, PhD ASTRA Fertility Group Mississauga, ON, Canada ISBN 978-3-319-29371-4 ISBN 978-3-319-29373-8 DOI 10.1007/978-3-319-29373-8 (eBook) Library of Congress Control Number: 2016943043 © Springer Science+Business Media New York 2016 This work is subject to copyright All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed The use of general descriptive names, registered names, trademarks, service marks, etc in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer Science+Business Media LLC New York Preface A number of books have been published on the scientific aspects of assisted reproduction However, they have been mainly aimed at the experienced practitioner alone, with limited benefit to those working in ancillary areas relevant to the IVF unit in its entirety In contrast, the primary objective of this book is to provide an easy to read, comprehensive guide to establishing and managing an IVF unit from its very inception, with an emphasis on quality control Therefore, an attempt has been made to direct the material at a broad readership, including those in the clinic, the laboratory, marketing, and IT While every effort has been made to ensure that the information contained in this book is as up to date as possible, it should be noted that manufacturers and distributors reserve the right to change product specifications and discontinue product lines without prior notice New products will invariably be introduced in the future, and it is hoped that future editions of this book will address such innovations The editors welcome feedback and further discussion regarding any of this book’s content Sydney, NSW, Australia Mississauga, ON, Canada Steven D Fleming Alex C Varghese v Contents Part I IVF Unit Establishment and Organization IVF Unit Location, Design, and Construction Jason Spittle Batch IVF Programme in ART: Practical Considerations Baiju P Ahemmed and Alex C Varghese 27 Risk and Regulation: The Role of Regulation in Managing an IVF Unit John Peek Part II 51 Total Quality Management Risk and Disaster Management for the IVF Laboratory Charles L Bormann and Erin I Lewis 71 Staff Management: Leading by Example Steven D Fleming 85 Patient Management: A Nursing Perspective 103 Denise Donati Low-Risk Laboratory Management 115 Simon Cooke Cryobank Management 153 John P Ryan Management of a Preimplantation Genetic Diagnosis and Screening Service 179 Steven D Fleming, Jane Fleming, and Joyce Harper 10 Data Management in the ART Unit 193 John P.P Tyler vii viii Contents 11 Implementation of a Total Quality Management System 217 James Catt 12 Optimization of Treatment Outcomes for Assisted Reproductive Technologies 231 Shahryar K Kavoussi and Thomas B Pool 13 Statistical Process Control Analysis to Assess Laboratory Variation as a Means of Quality Control in ART Labs 253 Alex Steinleitner Part III IVF Units and Society 14 Ethics of IVF Treatment: Remember the Patient! 269 Anne Melton Clark 15 Implementing and Managing Natural and Modified Natural IVF Cycles 287 Mara Kotrotsou, Geeta Nargund, and Stuart Campbell 16 Public and Low-Cost IVF 301 Ian D Cooke 17 Private and Corporate IVF Units 315 Amparo Ruiz and Luis Saurat Part IV Advertising and Marketing IVF Units 18 Marketing of IVF Units and Agencies 329 Veronica Montgomery 19 Websites for IVF Clinics 343 James D Stanger 20 IVF Units and Social Media 353 Jonathan Pollinger Index 371 Contributors Baiju P Ahemmed, MBBS, DGO, DNB Reproductive Medicine, NCARE IVF CENTRE, Balram Memorial Building, Kannur, Kerala, India Charles L Bormann, PhD, HCLD Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA Stuart Campbell, DSc, FRCPEd, FRCOG Create Fertility, London, UK James Catt, PhD Optimal IVF, Melbourne, VC, Australia Anne Melton Clark, MPS, MBCHB, FRCOG, FRANZCOG, CREI Fertility First, Hurstville, NSW, Australia Ian D Cooke, FRCOG, F Med Sci, FRANZCOG (Hon) Academic Unit of Reproductive and Developmental Medicine, The University of Sheffield, Sheffield, UK Simon Cooke, BSc Agr, PhD (Med) IVF Australia, Greenwich, NSW, Australia Denise Donati, RN, CM, BAppSc(Nsg), MN Fertility Solutions, Sunshine Coast Clinic, Buderim, QLD, Australia Jane Fleming, BSc, MSc, PhD Master of Genetic Counselling Program, Royal North Shore Hospital, Sydney, NSW, Australia Steven D Fleming, BSc (Hons), MSc, PhD Discipline of Anatomy and Histology, School of Medical Sciences, University of Sydney, Sydney, NSW, Australia Joyce Harper, BSc, PhD Embryology, IVF and Reproductive Genetics Group, Institute for Women’s Health, University College London, London, UK Shahryar K Kavoussi, MD, MPH Austin Fertility and Reproductive Medicine/ Westlake IVF, Austin, TX, USA Mara Kotrotsou, MUDr Create Fertility, West Wimbledon, UK ix 20 IVF Units and Social Media 365 It is really straightforward to add someone to a Twitter list: Select the cog symbol that represents the profile of the person you wish to add Then select “Add or remove from lists” You can then create a new list or select a tick box to add the person to one of your existing Twitter Lists You can view existing Lists and create new ones from your Lists page, which you can access via Lists on your Profile page See Fig 20.3—“How to create Twitter lists” Twitter lists can be used in a number of ways: • Segment people into useful groups—create Lists for suppliers, prospects, clients or people that tweet about a particular subject, e.g fertility This helps you focus on a particular type of person and their tweets • Group people you are not following—you not have to be following someone in order to add them to a List For example, if might be useful to have a list of your competitors or local people • Research—you not always need to create your own lists as you can subscribe and follow public lists How to Use Twitter Favourites Twitter Favourites have limited functionality; you cannot create folders by category or subject like you can for Internet browser bookmarks, as they are all stored together Nevertheless, here is a couple of ways they can be useful: Use the favouriting feature as a “read later” function—simply save your tweets that you want to read another time Handy if you are busy and not have the time to click the link and read a useful article that has been posted Fig 20.3 How to create Twitter lists 366 J Pollinger • Use to record testimonial tweets—you can build up an authentic record of testimonials tweets that recommend your clinic If patients are tweeting positively about your clinic and its services, why not use their tweets to help promote your business? How to Embed Tweets Twitter makes it easy to embed tweets on your website or blog By embedding a tweet you retain the full functionality that users have on Twitter For example, readers can retweet, reply or favourite the embedded tweet direct from your website To embed a tweet you need to copy and paste the HTML code of the tweet you wish to display into your website or blog On Twitter.com, hover over the tweet you wish to embed and select …, then Embed Tweet See Fig 20.4—“How to embed a tweet” The code for you to copy and paste into your website or blog will then be displayed You can choose how the tweet is aligned on the page, e.g Left, Right or Centre Here are some ideas on using embedded tweets: • Use embedded tweets containing quotes as an alternative to a text quote • Instead of quoting opinions, you can display original tweets—far more authentic than putting text in quotation marks • Embedded tweets can help promote awareness of events and gain feedback about events • Use embedded tweets when you receive positive feedback or testimonials Fig 20.4 How to embed a Tweet 20 IVF Units and Social Media 367 For more advice on using Twitter for your clinic, I recommend you visit Twitter’s own business guide at www.business.twitter.com Social Advertising You can set up your own adverts or ”promotions” on Facebook and Twitter On Facebook, you can use Ads in a number of ways including; to increase Page Likes, to increase clicks to your website and to boost engagement on Posts on your Page Facebook Adverts Advertising to increase Page Likes can be an effective way to boost the audience for your Page All Facebook Ads should be set up to target and reach your appropriate audience Criteria includes age, gender, location and interests You can display your website or blog on an Ad to encourage visitors to your website This can be effective if there is content such as a new blog post or a video that you wish to promote With only around % of Page Posts now appearing in Facebook News Feeds [6] Social@Ogilvy (2014), advertising is required if you want your posts to reach a meaningful sized audience You can promote or boost Posts so that they reach not only all your Fans but other people on Facebook too Targeting can be very precise, reach large numbers of people and when compared with other types of advertising are good value You can boost a page directly from your Page or using the Ads Manager, which is recommended as this gives you more options Each Facebook Ad includes a title, thumbnail image and body copy which is limited to 90 characters Ads can be displayed on the right hand side and in the News Feed both on desktop and on mobile Twitter: Promoted Accounts and Tweets On Twitter you can promote tweets as well as your account With Promoted Tweets you can extend the reach of your tweets You can select which tweets you wish to promote or create a specific tweet for your campaign With a Promoted Account, in return for payment of anything from US cent upwards, Twitter will add your Account to the top of the “Who to follow” section and mark it as “Promoted” With both Promoted Accounts and Tweets you can target your audience by interest as well as followers of any Twitter accounts This means that you can target Twitter followers of other IVF clinics 368 J Pollinger Recommended Social Media App/Tool Buffer There are plenty of Social Media Apps and Tools available but if I had to recommend just one, it would be Buffer (www.bufferapp.com) It is a web based tool and mobile App that provides a smart way to share your posts to your social networks It enables you to schedule your favourite articles, photos, videos and links so that they are posted out across your social networks at a schedule of your choosing You can also set a specific time for publication of a post or tweet So for example, you could share four or five articles early in the morning that would be published onto Twitter at different times throughout the day This approach has the advantage of helping you both organise your time and maximise the visibility of your posts You can also post to Facebook (both your Profile and Page), LinkedIn (Profiles, Pages and Groups and Google + (Pages only) If you use Chrome, you can add the Buffer extension, which makes it easy to post and tweet content you find around the web Measurement To make sure that your social media efforts are worthwhile you need to measure the results of your activity To measure the effectiveness of your use of social networks, as stated in the Strategy and Planning section, it is vital that you are clear on your business objectives To be able to measure you will need to have clearly defined goals and a timeframe for each For example, “increase website visitors from Twitter from 200 to 500 in months” You can apply this approach to each of your objectives, although some are harder to accurately measure than others, e.g increase in patients resulting from social media use To help with measurement I would recommend the following three tools: Google Analytics—use for measuring origin of website visitors Facebook Insights—use for general measurement of Facebook activity Tweet Analytics—use to measure reach on Twitter You need to have a Google Account to access and use Google Analytics As a Facebook Admin you can access and use Insights once you have more than 30 Likes and Twitter Analytics is part of Twitter’s Advertising platform If you are not going to use Twitter Ads, then Tweet Binder (www.tweetbinder.com) is a good alternative Measurement should be carried out regularly and your efforts should be tailored accordingly You should aim to repeat and build on Facebook posts that are providing results and reduce posts that are less successful 20 IVF Units and Social Media 369 Following the advice in this chapter and taking this approach to measurement will help to ensure that your use of social media in achieving your clinic’s business objectives is effective Good luck! References Kagan M.: What the f*** is social media www.slideshare.net/mzkagan/what-the-fk-socialmedia 2008 Hubspot Study www.blog.hubspot.com/blog/tabid/6307/bid/33800/Photos-on-FacebookGenerate-53-More-Likes-Than-the-Average-Post-NEW-DATA.aspx Accessed Oct 2012 Twitter for Business #TwitterAcademy webinar www.webcaster4.com/Webcast/ListenPage? companyId = 214&webcastId = 3892 Accessed 16 Apr 2014 Falls J www.socialmediaexaminer.com 2011 Buddy Media Report (now salesforce.com) 2011 Social@Ogilvy Survey (2014) Index A Achievement level, 149 Adequate pituitary suppression, 40 Adverse events, 107 Advertising apps, 340 banner, 332, 334 billboard and screen, 335 conferences, 337–338 educational seminars, 339 exhibitions, 337 Facebook, 338–339 in flight infomercials and print adverts, 336 Google, 339 print advertisement, 332, 333 publicity, 336–337 radio, 335 social networking, 338 TV and video, 335–336 website profiles, 332–334 American Society for Assisted Reproductive Technology (SART), 253, 258 American Society of Reproductive Medicine (ASRM), 73 Aneuploidy, 179 Antagonist, 294 Anti-Mullerian hormone (AMH) testing, 39, 231, 276 Antral follicle count (AFC), 38, 288 Aspiration pump, 47 Assisted hatching (AH) artificial thinning/breaching, 241 IVF cycles, 241 monozygotic twins, 241 Assisted reproductive technology (ART), 52, 233–238 AH, 241 cytoplasmic transfer, 243–244 embryo glue, 241 extended culture, 242 ICSI, 238 IMSI, 239 multiple embryo transfer, 243 ovarian factor, 231–232 PGS, 242–243 PICSI, 239–240 program, 253 treatments, 296 tubal factor, 232–233 Assisted reproductive technology (ART) clinic, 3–24 considerations during planning building revenue stream, 4, patient pathway review, purpose of clinic, design, planning process, process mapping, space required, spheres of influence, essential services air-conditioning and air quality, 12, 13 emergency access, 14 gas, 11 lifts, 14 liquid nitrogen, 12 power, 10, 11 © Springer Science+Business Media New York 2016 S.D Fleming, A.C Varghese (eds.), Organization and Management of IVF Units, DOI 10.1007/978-3-319-29373-8 371 372 Assisted reproductive technology (ART) clinic (cont.) floor plan and room design ambiance and stress reduction, 14, 15 counseling rooms, 17 information technology, 17 patient traffic and ergonomics, 17 privacy and confidentiality, 15, 16 semen collection rooms, 16 treatment rooms, 16 laboratory, 18 airflow, 19, 20 andrology and diagnostic labs, 20 benches and cupboards, 24 ceilings, 23 construction, 21 controlled access, 18 culture lab lighting, 23 ergonomics and efficiency, 18, 19 floor coverings, 22 furnishings, 24 quality management, 20, 21 safety, 21 storage, 21 walls, 22 windows and sunlight, 20 location EMF, external pollution, 6, patient access, patient population demographics, zoning, Assisted reproductive technology (ART) unit, data management access and security, 204–205 audit and research, 209 commercial vs in-house development, 198 couple medical history, 200–201 data backup, 209 databases, 195, 204 data collection, 195, 200 data entry validation, 207 data export, 209 data import, 207 embryo cryopreservation, 203 female ovarian stimulation and oocyte collection, 201–202 fertilisation and embryo culture, 202–203 ICSI procedures, 208 in-house developed systems, 199 integrated systems, 198 internal quality assurance, 212 layout and navigation, 206 Index male semen data and sperm preparation, 202 patient management, 195 patient medical record, 193, 194 quality system, 210 regulatory bodies, 210 spreadsheet vs.database, 195–196 staff competency, 211–212 survey responses, 200 treatment plan, 201 B “Baby Gammy” case (Thailand), 272 Barbados Fertility Centre (BFC) 2013 success rates, 329, 330 (see also Advertising) commercial marketing methods, 330 fertility treatment, 329 international patients, 329 live birth rate, 329 low cost treatment, 330 marketing budget, 331 prospective patients, 340 strategic marketing, 341 treatment experience, 340–341 websites, 331 Bar codes and radio-frequency identification devices (RFID), 165 Barker Hypothesis, 277 Batch IVF programme, 27, 29–30, 32–36, 38–42, 47, 48 advantages, 43–44 background of, 27–28 cycle programming, 37–38 disadvantages, 44 donor–recipient and cryo cycle synchronisation, 42–43 inventory management, 45 laboratory cleaning procedure, 32–34 incubator cleaning, 34 of laboratory equipment, areas, 33 laboratory maintenance schedule, 34 materials used, 33 solutions used, 32 ovarian stimulation individualising FSH dose, 38–39 LH activity, 39 monitoring, 40–42 optimum number of oocytes, 39 preparation, 29–32 cleaning and air quality, 32 instrument calibration, 32 lab, 30 373 Index ordering for gonadotropins, 30 of patients, 29–30 settings types, 28–29 strategies to optimise outcome, 45–46 troubleshooting, 46–48 consistent biochemical pregnancies, 48 hormonal manipulation, 47 infection of culture dish, 48 infection of semen sample, 47 IVF culture media, 48 poor follicular growth, 47 poor oocyte yield, 47 problems with aspiration pump, 47 work co-ordination fundamentals of stimulation, 36 optimum number of incubators, 35 optimum number of patients, 34–36 Biopsy blastomeres, 186–187 equipment and working areas, 185 media and consumables, 184–185 polar body, 185–186 preparation, co-ordination and dispatch, 188–189 sterile clothing and aseptic technique, 185 trophectoderm, 187–188 Blastocyst culture, 271 Blastocyst transfer, 271 Box style incubators, 19 Budget, 331 C CAB See Certification accreditation bodies (CAB) Carcinomas, 295 Centers for Disease Control (CDC), 72 Certification accreditation bodies (CAB), 221 Certification standards, 220–221 CLBR See Cumulative live birth rates (CLBR) Clinical Laboratory Improvement Amendments (CLIA), 72 Clinical pregnancy rate (CPR) hysteroscopic uterine septum resection, 235 and LBR, 236 Clinical priority access criteria (CPAC), 304 Clomiphene, 294 Clomiphene citrate, 291 College of American Pathologists (CAP), 72 Comparative genomic hybridisation (CGH), 190 Competency, 219–220 Competitive advantage, 319 Control chart, 261, 263 Controlled ovarian stimulation, 42 CPAC See Clinical priority access criteria (CPAC) CPR See Clinical pregnancy rate (CPR) Cross border reproductive care (CBRC), 272–274 Cryobank management common discrepancies, 172 contamination, 164–165 cryopreservation process, 175 design and location requirements, 156 embryos, 155 gametes and embryos, 153 inventory system, 166–167 laboratory and sample security, 158 legislative requirements, 154 oocytes, 155 ovarian tissue, 153, 155 personal safety equipment, 162 record keeping processes, 175 reproductive science, 153 risk assessment and cryostorage, 171 safety considerations, 156–157 sperm and testicular tissue, 154–155 sperm storage, 163 staff education, 162–163 storage container labelling, 165–166 storage tank audits process, 171–172 thawed tissue, 153 vitrification, 155 Cryopreservation, 29 Cryopreserved embryos, 77 Cryovials, 163 Culture dish, infection, 48 Cumulative live birth rates (CLBR), 307 Cumulative pregnancy rate, 271 Cycle:staff ratio, 121 Cystic fibrosis, 270 D Database cryostorage, 169 search and report functions, 169–170 Denied treatment See Treatment, denied DNA fragmentation and damage, 276 Donor–recipient cycles, 42 Dry shipper, 173, 174 Dual suppression strategy, 37 E Electromagnetic fields (EMFs), Electronic medical records systems, 254 Embryo culture, 141–144, 264 Embryo implantation, 292 374 Embryo transfer (ET), 27, 62, 306 EmbryoGlue™, 241 Embryos, 155 Embryosafe cleaning solutions, 32 Emergency plan elements, IVF program, 73–77 ART procedures, 75–76 cryopreserved specimens, 76, 77 off-site tissue storage, 77 patient care continuity, 75 safety and protection of program personnel and patients, 73–74 staff communication, 75 Employment contracts, 90 Endocrinological, 40 Endometrial injury (EI) endometrial biopsy/scratch, 235 oocyte retrieval, 236 subclinical hypothyroidism, 237 Endometriosis, 276 Endometrium, 292 EQA See External quality assurance (EQA) ESHRE study, 273 Essure device, 232, 233 Estradiol valerate, 38 European Society for Human Reproduction and Embryology (ESHRE) PGD Consortium, 180 External analysis, 320 External quality assurance (EQA), 221–222 F Facebook after pm/weekend, 358 apps, 358, 359 “Calls to action” and action words, 358 cover photos, 359 enable messages button, 360, 361 encourage interaction, 357 engagement, 357 groups, 361–362 highlight photos, 360 mobile, 360 posts concise, 357 tagging, 360 timelines, 359 web address, 361 Federal Emergency Management Agency (FEMA) regulatory standards, 78 Fertility clinics, 270 Fertility nurse, 103–104 Fertility Society of Australia (FSA), 52, 87 Fluorescent In Situ Hybridisation (FISH), 190 Index Follicular development, initial and cyclic recruitment, 288 Follicular Stimulating Hormone (FSH), 287 window, 289 Freelancing embryologist, 28 Frozen embryos, 271 Full Time Equivalent (FTE), 120, 122 G Gamete donors, 270 Gametes and embryos, 143 dry shippers, 173 logistics of transportation, 174–175 transport coordination, 173 General practitioner (GP), 98, 274, 276, 346 Generic biopsy worksheet, 183 Global strategy clinic organization, 323 cost control, 325 day-to-day basis, 323 decision-making, 321 “de novo”, 322 doctors and collaborators, 325 gestation, 322 management, 322 obviousness, 322 organization of the activity, 323 organization of the employees, 323, 325 organization of time, 325 patient and staff, 326 patient satisfaction, 321 patients’ opinions, 322 relationships, 326 services for patients, 323, 324 statistical reports, 322 surveys, 322 time organization, 325 unit activities, 323, 324 Gonadotrophin Releasing Hormone (GnRH) agonist, 287 Gonadotrophins, 291 Gross misconduct, 101 H Health on the Net Foundation code of conduct (HONcode), 345 Health services, 315–316 Heparin anticoagulant and immunomodulatory properties, 236 LMWH, 236 375 Index HFEA Code of Practice See Human Fertilisation and Embryology Authority (HFEA) code of practice Holidays and annual leave, 98–99 Hormonal manipulation, 47 Hospital Preparedness Program (HPP), 73 Human chorionic gonadotrophin (hCG), 290 Human factors risk, 128, 129 Human Fertilisation and Embryology Act, 52 Human Fertilisation and Embryology Authority (HFEA) code of practice, 52, 54, 57, 58, 65, 275 Human menopausal gonadotrophin (hMG), 290 Human Rights Act in New Zealand, 53 Hydrosalpinges Adiana, 233 CPR, 233 embryotoxicity, 232 Essure device, 232 hysteroscopic polypectomy, 234 intrauterine lesion, 234 salpingectomy, 232 Hysterocontrastsonography (HyCoSy), Hysterosalpingography (HSG), Hysteroscopy, uterine cavity evaluation, 233 I ICSI See Intracytoplasmic sperm injection (ICSI) Idealized patients, 263 Impaired ovarian reserve, 261 IMSI See Intracytoplasmic morphologically selected sperm injection (IMSI) Incubator, 35 openings, 141–142 Indomethacin, 294 Institutional Ethics Committees (IEC), 284 Integrate technology, 353 Internal analysis, 319 Internal quality assurance (IQA), 221–222 International Organisation for Standardisation (ISO), 220 International society for implementing mild and natural approaches to stimulation (ISMAAR), 288, 289 Internet service provider (ISP), 344 Intracytoplasmic morphologically selected sperm injection (IMSI) MSOME, 239 spermatozoa, 239 Intracytoplasmic sperm injection (ICSI), 8, 284, 303 advantage and disadvantage, 239 male factor infertility, 238 rescue, 238 Intrauterine insemination (IUI), 75, 270 Inventory system, 166–167 In vitro fertilization (IVF), 291–297 baby, 287 centre staff chart, 86 culture media, 48 emergency plan program, 71–77 elements of, 73–77 regulatory agencies, 71–73 laboratory infrastructure design, 77–79 equipment, 79 equipment records, 80 laboratory equipment, 79 post emergency considerations, 81–82 testing equipment, 80 modified natural cycle, 290 natural cycle, 289 indications, 295–297 in poor responders, 296 potential advantages of, 291–294 pregnancy rates, 258, 261 technologies, 275 unit different approaches to regulations, 54–56 goals and KPI, 59 incident reporting, 61 internal audit, 65 KPI dashboard for staff, 60 limitations to regulations, 56–58 quality management, 59 range of regulations, 53 risk assessment matrix, 63–64 risk mitigation, 64 risk register, 62, 66 In vitro maturation (IVM), 288 cycles, 296 IQA See Internal quality assurance (IQA) IVF See In vitro fertilization (IVF) IVM See In vitro maturation (IVM) J Joint Commission International (JCI), 329 K Key performance indicators (KPI), 60, 61, 148 Alpha/ESHRE consensus, 223, 224 business, 223 clinical, 211 376 Key performance indicators (KPI) (cont.) dashboards, 225, 226 embryologist, 202 OHSS, 202 peer review, 225 process controlling, 223–224 staff performance, 224–225 statistics, 344 Key strategic concepts, 317 KPI See Key performance indicators (KPI) L Laboratory performance measure, 130 activities, 149 AS/NZS 2982:2010, 129 comparing equipment, 124 consecutive days, 122 data reviewed, 150 design alteration, 124 detection device, 127 embryo transfer, 130 Employment Agreements and Work Health Safety criteria, 123 endocrine pathology, 118 Enterprise Agreements, 122 fresh and frozen cycles, 121 fresh cycles, 121 heating of media, 143–144 Humidicrib systems, 124 identity witnessing systems, 127 interlinked stages, 147 internal culture access system, 133 iquid nitrogen tanks, 131 ISO 14644 Cleanrooms and associated controlled environments, 129 ISO14644 compliant clean room, 131 ISO9001, 144 IVF laboratory, 145 lab concentration, 123 laboratory design standards, 130 LPM, 148 management pathway, 139 manufacturer’s products, 126 methodology, 145 pathology laboratory, 123 pregnancy rate reduction, 151 products and suppliers, 126 programmes and software, 127 recording and documenting, 147 Scientific Director, 118 scoring system, 124 service and calibration, 145 speed charger, 127 Index sperm preparation workstations, 134 staff movement areas, 131 staff numbers, 118, 120–122 staff ratios, 123 stage comparison, 124 supervisor, 119 technical processes, 151 TESTO Saveris Liquid Nitrogen, 136 UPS + battery pack, 127 League tables, 283 Leukaemia, 277 Liquid nitrogen frozen sample storage risk electronic monitoring, 138, 141 multipath alarm system, 140 replacement value, 138 sensors, 140 temperature, 140 inspection and maintenance schedule, 161 non-pressurised tanks, 158 pressurised tanks, 158, 159 storage tanks, 131, 158–160 tanks requirement, 161 tipping device, 157 vapour phase storage vessels, 79, 160 Live birth rate (LBR) endometrial scratch, 236 hysteroscopy, 233 intramural fibroids, 235 varicocelectomy group, 237 Low molecular weight heparin (LMWH), 236 Low-cost IVF ART units, 310 embryo culture environment, 309 ET, 309 external financial support, 310 fresh and frozen/thawed transfers, 308 FSH, 309 GnRH antagonist, 309 ICMART minimum data set, 310 indomethacin, 309 inexpensive approach, 309 minimal stimulation, 309 ovarian stimulation protocols, 308 pelvic ultrasound, 310 pregnancy rate per embryo transfer, 308 state support, 310 technical and therapeutic options, 308 testicular sperm aspiration and intracytoplasmic sperm injection, 309 Low-risk management concepts, 115 Index financial cost, 118 human IVF, 115 ISO15189, 116 IVF system, 116 laboratory process, 144 laboratory system, 115 medical pathology, 116 national accreditation codes, 117 QC checks, 146 QC programmes, 116 risk method, 118 risk minimisation, 117 whilst culture media, 117 Luteinizing Hormone (LH) surge, 287 M Male factor infertility, 297 DNA fragmentation, 237 varicocele and varicocelectomy, 237, 238 Mean embryo score (MES), 259 Medical ethics, moral principles, 269–277, 281–284 beneficence involve other health professionals, 275 professional training, 274 selected treatments, 274 justice, denied treatment, 281–284 non-maleficence, 275 epigenetics, 276, 277, 281 literature as guide, 276 new treatments, 275 respect for autonomy, 269 CBRC, 272, 273 informed consent and counselling, 270–272 treatment, banned or restricted, 274 Medication management, 110–111 Medicines and Healthcare Regulatory Agency (MHRA), 72 Medico-legal issues adverse events, 107 gametes and embryos, 108 informed consent, 107, 108 medical treatment, 106 open disclosure, 107 patients privacy, 107 practitioners, 107 welfare of the child, 108 Medium density fiberboard (MDF), 24 Millennium development goals (MDG), 305 Mosaicism, 179 377 N National Association of Testing Authorities (NATA), 144 Natural cycle IVF See In vitro fertilization (IVF), natural cycle Natural killer (NK) cells, 275 Next generation sequencing (NGS), 4, 179 Non-steroidal anti-inflammatory drug (NSAID), 294 Normal distribution, 256 Nutrients essential in pregnancy, 279–280 Nutritional deficiencies and fertility, 277, 278 O OE See Ovarian endometriomas (OE) Oocytes, 155, 288 aspiration, 263 and embryos slow freeze devices, 164 vitrification, 164 maturation, 41, 290 retrieval, 28, 35, 76 retrieval under local anaesthetic, 293 Oosafe solution, 33 Oral contraceptive pill (OCP), 35 Ovarian endometriomas (OE), 232 Ovarian factor, AMH, 231 Ovarian hyperstimulation syndrome (OHSS), 38, 56, 64, 109, 292, 295 Ovarian stimulation strategy, 39 Ovarian tissue, 155 P Parental karyotypes, 238 Patient expectations, 104–105 Patient information litigation, 347 privacy, 348 public and private, 347–348 recording activity, 347 traceability, 347 Patient interaction EmbryoScope time-lapse system, 351 IVF databases, 350 new technologies, 351 online health services, 351 semi-digital process, 351 Patient management communication, 105–106 counselling, 111 fertility nurse, 103–104 managing patient expectations, 104–105 378 Patient management (cont.) medication administration frequency, 111 medication routes of administration, 111 minimising risk, 109–110 multiple pregnancies, 109 psychological sequelae, 111–112 Peak systolic velocity (PSV), 295 Peer review, 225 Performance appraisal, 95 Personal safety equipment, 162 PGD See Preimplantation genetic diagnosis (PGD) PGS See Preimplantation genetic screening (PGS) Physiological intracytoplasmic sperm injection (PICSI) HA, 239, 240 ICSI, 240 SAB rates, 240 Plan, Do, Assess, Check (PDAC) cycles, 258 Plastic straw system, 163 Polycystic ovarian syndrome (PCOS), 344 Polytetrafluoroethylene (PTFE) tubing, 11 Poor follicular growth, 47 Poor oocyte yield, 47 Post-employment relationships, 102 Pregnancy marker, 150 Preimplantation genetic diagnosis (PGD), 4, 270, 272, 303 array CGH, 190 (see also Biopsy) embryos, 179 equipment and consumables, 182 FISH, 190 genetic counselling and patient consent, 180–182 human chromosomes, 190 labelling, records and database entry, 183 legislation and licencing, 180 pregnancies, 179 risk assessment and auditing, 190 scheduling and planning, patient treatment, 184 Preimplantation genetic screening (PGS), 96–97, 272 blastocyst biopsy, 243 embryonic cells, 242 and male partner, 276 nutritional deficiencies, 277 trophectoderm biopsy, 242 Primary oocytes, 288 Primary ovarian failure (POF), 42 Primordial follicle, 288 Professional counsellors and counselling services, 270 Index Prohibition of Human Cloning for Reproduction and Regulation of Human Embryo Research Amendment Act 2006, 52 Psychological counseling, Psychological sequelae, 111–112 Public provision abortion and maternal sepsis, 305 ART, 303–305 blastocyst stage, 303 catastrophic expenditure, 303 CLBR, 307 cost, 302, 303 CPAC, 304 cryopreservation, 307 deliver services, 305 demographic methods, 304 ET, 306 EU tissue directive, 303 evidence based medicine principles, 307 financial constraints, 304 hearing and visual problems, 305 human right, 305 ICMART and WHO, 305 ICSI, 303 investigation and management, 307 laboratory procedures and stimulation protocols, 303 MDG, 305 minimal stimulation regime and SET, 306 out-of-pocket payments, 307 ovarian hyper-stimulation, 306 PGD, 303 prevalence of infertility, 304 psychological trauma, 303 quality systems, 303 restrictive criteria, 303 SET, 304 society and civil government, 306 state funding, 304 Pulsatility index (PI), 295 Q Quality assurance programs, 253 Quality management system (QMS), 51 Quality response, 61 R Randomised controlled trials (RCT’s), 293 Record keeping database, 169–170 patient communication, 170 sample identification, 167–168 Index Recruitment process advertising staff positions, 87 employment contracts, 90 interviewing and vetting applicants, 88–90 workforce planning, 86–87 Recurrent implantation failure (RIF) abnormal karyotypes, 238 hysteroscopy, 233 LMWH vs control/placebo, 237 Recurrent pregnancy loss (RPL), 237, 238, 242 Regulations, 52 Reproductive Endocrinology and Infertility (REI), 274 Reproductive medicine, 270, 275 Reproductive Technology Accreditation Committee (RTAC), 154, 200 code of practice, 52, 54, 55, 57, 58, 65 Risk mitigation, 64 Risk register, 62 regulations and guidelines, 65 S Sample witnessing risk, 136–138 Semen sample, infection, 47 Senior management, 99 Sex selection, 274 Sickness leave, 98 Single embryo transfer (SET), 294, 304 Single sex relationships, 281 Slow-freeze methods to preserve tissues, 76 Social advertising Facebook, 367 Twitter, 367 Social interaction, 353 Social media buffer, 368 definitions, 353 effective and powerful, 354 Facebook and Twitter, 356 good customer service, 355 human, 355 listening, 355 low cost, 354 measurement, 368–369 publish photos and videos, 356 real time, 354 strategy and planning, 356–357 value, 355 Social networks, 353, 354 Sonohysterography (SHG), Sonological, 40 379 SOP See Standard operating procedure (SOP) Staff education, 162–163 Staff management, 93, 94 career progression, 85 character and personality, 85 clinical embryologist, 87, 88 conflict and grievance resolution, 99–100 42-day rolling roster, 97 generic competency checklist administration staff, 93 medical staff, 94 nursing staff, 93 scientific staff, 94 generic employment termination checklist, 102 generic induction checklist, new staff, 92 generic performance appraisal form, 96 gross misconduct, 101 holidays and annual leave, 98–99 induction and orientation, 91–92 interview, 89 misconduct and disciplinary procedures, 100 performance appraisal, 95 post-employment relationships, 102 principles, 85 professional relationship, 85 rosters, 96–97 sickness leave, 98 termination of employment, 101 training and competency, 92–95 workload, 97–98 Staff rosters, 96 Staff workload, 97–98 Stakeholders adequate process, 316 competitive strategy, 316 stages, 317 strategic planning, 316 Standard deviation (SD), 149 Standard operating procedure (SOP), 10, 51, 219 Statistical Process Control (SPC), 254, 255, 264 analysis, 255, 256 in ART practice, 258–264 Strategic formulation, 321 Strategic marketing, 341 Strategic planning, 316 Strategic thinking mission, 318 values, 317, 318 vision, 318, 319 Surrogates, 270 380 T Termination of employment, 101–102 Top down approach, 218 Total quality management system (TQMS) certification standards, 220–221 competency, 219–220 development and implementation, 218 IQA and EQA schemes, 221–222 manufacturing process and the quality systems, 217 process mapping, 218 quality assurance and quality control, 218 SOP, 219 sperm and oocytes, 217 top down approach, 218 TQMS See Total quality management system (TQMS) Treatment, denied, 281 age, 282 league tables, 283 medical futility, 283 medically unfit patients, 282 single sex relationships, 281 Tubal factor infertility, 287 Twitter audience, 363–364 conversation, 362 embedded tweets, 366–367 favourites, 365–366 hashtags, 362–363 Index listening, 362 lists, 364–365 scheduling tweets, 364 U Uterine fibroids, 234–235 Uterine septum, 235 V Virtual private networks (VPNs), 16 Vitrification, 155 Volatile organic compound (VOC) level, 6, 8, 11, 12, 14, 32 W Warning level, 149 Website, IVF client interaction, 350–351 design, 349–350 honesty, 345–346 KPI statistics, 344–345 referrals, 346–347 search engines, 344, 345 static and interactive, 343–344 Whole genome amplification (WGA), 179 Workforce planning, 86–87 World Health Organisation (WHO), 277 .. .Organization and Management of IVF Units Steven D Fleming • Alex C Varghese Editors Organization and Management of IVF Units A Practical Guide for the Clinician... and Luis Saurat Part IV Advertising and Marketing IVF Units 18 Marketing of IVF Units and Agencies 329 Veronica Montgomery 19 Websites for IVF Clinics 343 James D Stanger 20 IVF. .. Natural and Modified Natural IVF Cycles 287 Mara Kotrotsou, Geeta Nargund, and Stuart Campbell 16 Public and Low-Cost IVF 301 Ian D Cooke 17 Private and Corporate IVF Units