Eighth Edition - R.3 - Human Fertilisation & Embryology Authority

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Mandatory requirements (cont) T29 T30 T31 When reusable instruments are used, a validated cleaning and sterilisation procedure for removal of infectious agents has to be in place. Wherever possible only CE marked medical devices must be used. The procedures for licensable activities must detail the specifications for all critical materials and reagents. In particular, specifications for additives (eg, solutions) and packaging materials must be defined. Critical reagents and materials must meet documented requirements and specifications and, when applicable, the requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and Directive 98/79/EC of the European Parliament under the Council of 27 October 1998 on In vitro Diagnostic Medical Devices. HFEA guidance Scope 26.1 For the purpose of this Code of Practice, ‘equipment and materials’ includes all equipment, disposables, reagents, and calibration and control materials used in the conduct of assisted conception processes. Protection and hygiene of staff 26.2 The centre should provide proper clothing and equipment for the personal protection and hygiene of staff carrying out licensed activities, together with written instructions for their use. Managing equipment and material 26.3 The centre should establish documented procedures for managing equipment and materials, including: (a) selecting and procuring equipment and materials (b) (c) ensuring the traceability of any products or materials that come into contact with gametes or embryos and that affect their quality and safety, and maintaining inventory information and records for stock control. See also guidance note: 19 – Traceability 31 – Record keeping and document control Safety of equipment used to store cryopreserved gametes and embryos 26.4 All centres storing gametes and embryos should have effective alarms and monitoring systems to ensure the safety of cryopreserved gametes and embryos. These systems should have: (a) local alarms (ie, on individual dewars for either temperature or liquid nitrogen level) (b) (c) (d) an auto-dial facility or similar (eg, link to fire-alarm board) to contact staff outside normal working hours adequate staffing and funding to implement formal emergency procedures, including having on-call arrangements, and adequate spare storage space or vessels to enable transfer of samples if a vessel fails. Human Fertilisation and Embryology Authority Guidance note | 26. Equipment and materials Version 1.0
HFEA guidance (cont) See also guidance note: 17 – Storage and gametes of embryos Other legislation, professional guidelines and information Directive 98/79/EC and Directive 93/42/EC can be found at www.eur-lex.europa.eu/en/index.htm Human Fertilisation and Embryology Authority Guidance note | 26. Equipment and materials Version 1.0
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Code of Practice 8TH EDITION This C
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Contents User guide to the Code Reg
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Contents Facilities and administrat
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User guide to the Code Guidance not
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1. Person responsible This guidance
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XX. Title of Guidance Note Mandator
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2. Staff This guidance note contain
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v HFEA guidance (cont) 2.3 All staf
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v HFEA guidance (cont) 2.19 The ind
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3. Counselling This guidance note c
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= HFEA guidance (cont) Interpretati
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4. Information to be provided prior
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HFEA guidance (cont) Interpretation
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5. Consent to treatment, storage, d
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Mandatory requirements (cont) Proce
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HFEA guidance Consent to use and st
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HFEA guidance (cont) (c) (d) they w
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HFEA guidance (cont) Additional con
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HFEA guidance (cont) Mandatory requ
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6. Legal parenthood This guidance n
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Mandatory requirements (cont) (1) W
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Mandatory requirements (cont) 42 Wo
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Mandatory requirements (cont) (3) S
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Mandatory requirements (cont) (2) T
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v HFEA guidance (cont) See also: H
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HFEA guidance (cont) Parenthood aft
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HFEA guidance (cont) People not to
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HFEA guidance (cont) Information pr
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7. Multiple births This guidance no
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HFEA guidance (cont) 7.5 If a woman
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HFEA guidance (cont) The welfare of
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HFEA guidance (cont) Refusing treat
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Mandatory requirements (cont) T89 (
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10. Embryo testing and sex selectio
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HFEA guidance (cont) Preimplantatio
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11. Donor recruitment, assessment a
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Mandatory requirements (cont) (9) I
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HFEA guidance (cont) 11.3 Unless th
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HFEA Mandatory guidance requirement
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12. Egg sharing arrangements This g
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HFEA guidance (cont) Consent 12.7 T
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HFEA guidance (cont) 12.19 The agre
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HFEA guidance (cont) 12.31 If eggs
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HFEA guidance (cont) 13.1 HFEA Dire
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Mandatory requirements (cont) (b) a
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HFEA guidance (cont) See also guida
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Mandatory requirements (cont) Direc
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HFEA guidance (cont) 15.4 Sperm sho
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HFEA guidance (cont) Processing and
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HFEA guidance (cont) 15.16 (cont) (
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Mandatory requirements (cont) (4) D
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HFEA guidance (cont) General Direct
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17. Storage of gametes and embryos
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Mandatory requirements (cont) (2) N
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Mandatory requirements (cont) (3) (
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Mandatory requirements (cont) (b) e
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v HFEA guidance (cont) 17.10 In add
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v HFEA guidance (cont) Mandatory re
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18. Witnessing and assuring patient
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HFEA guidance (cont) 18.4 (cont) (j
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HFEA guidance (cont) 18.24 Centres
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HFEA guidance (cont) Risk assessmen
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20. Donor-assisted conception This
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Mandatory requirements (cont) (2) (
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Page 167 and 168: HFEA guidance (cont) Consent Interp
Page 169 and 170: HFEA guidance (cont) Mandatory requ
Page 177 and 178: HFEA guidance (cont) Interpretation
Page 183: HFEA guidance (cont) Human admixed
Page 186 and 187: XX. Title of Guidance Note Mandator
Page 188 and 189: HFEA guidance (cont) 23.10 Centre m
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Page 193 and 194: 24. Third party agreements This gui
Page 195 and 196: Mandatory requirements (cont) T117
Page 197 and 198: 25. Premises and facilities This gu
Page 199 and 200: HFEA guidance Definition of premise
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Page 206 and 207: Mandatory requirements (cont) Licen
Page 208 and 209: HFEA guidance (cont) 27.4 A ‘near
Page 211 and 212: 28. Complaints This guidance note c
Page 213 and 214: 29. Treating people fairly This gui
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Page 217 and 218: 30. Confidentiality and privacy Thi
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Page 223 and 224: HFEA guidance (cont) 30.7 A person
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Page 234 and 235: Mandatory requirements (cont) (2) (
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Page 238 and 239: HFEA guidance Legal obligations tow
Page 240 and 241: Glossary D Data subject: Defined by
Page 242 and 243: Glossary N Near miss: Any occurrenc
Page 244 and 245: Glossary S Serious adverse reaction
Page 246 and 247: Index C carrier embryos, transfer o
Page 248 and 249: Index donation for research/trainin
Page 250 and 251: Index of justification for use of g
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Index charges and benefits 12.20 co
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Index embryonic stem cells/lines se
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Index preimplantation tissue typing
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Index L labelling dishes and tubes
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Index likely, information provision
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Index identification of processes n
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Index licence R25(22), 22A, 22.1 An
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Index additional requirements 5D, 5
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Index communication barrier handlin
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Eighth Edition - R.3 - Human Fertilisation & Embryology Authority

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