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

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

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Index<br />

embryonic stem cells/lines see stem cell lines<br />

emergency procedures<br />

alarms/monitoring equipment<br />

for cryopreserved gametes/embryos 17.6, 26.4c<br />

clinical facilities for 25.11b<br />

exception to need for consent during 5.23a<br />

disclosure of information<br />

30A<br />

storage vessel damage 17.3<br />

Equality Act 2010 29A, 29.1<br />

equipment and materials 26.1–26.4<br />

adverse incidents due to, reporting 27.8<br />

CE marked medical devices to be used<br />

wherever possible<br />

T30(26)<br />

critical<br />

maintenance, servicing and disinfection T26(26)<br />

procedures for operation of<br />

T27(26)<br />

procedures to details specifications<br />

T31(26)<br />

designated for purpose of activities<br />

T23(26)<br />

documented procedures 26.3<br />

identified, validated, inspected and maintained T24(26)<br />

identifying information to be documented<br />

T22(26)<br />

inventory and stock control 26.3c<br />

management of 26.3<br />

new/repaired or recommissioned,<br />

testing before use<br />

T25(26)<br />

for protection and hygiene of staff 26.2<br />

scope/definition 26.1<br />

selection/procurement 26.3a<br />

serial numbers/batch numbers 19.3b<br />

sterile, for procurement of gametes/embryos T28(26)<br />

for storage of gametes/embryos 17.5–17.7<br />

safety/alarms 17.5, 17.6, 26.4<br />

suppliers, third party agreements 24.1b<br />

traceability T101(19), 16.3, 19.3, 26.3b<br />

records 19.1c<br />

validated sterilisation procedure<br />

for removal of infectious agents<br />

T29(26)<br />

errors<br />

interruptions/distractions causing 18.16<br />

mismatching of gametes/embryos see<br />

mismatches of gametes/embryos<br />

witnessing, patient/donor identification 18.27<br />

European Economic Area (EEA),<br />

importing/exporting of gametes/embryos<br />

decision tree for 16.2<br />

documentation and traceability 16.3<br />

General Directions<br />

16B<br />

Special Directions 16.4–16.5<br />

European Tissues and<br />

Cells Directive (EUTCD) 16B, 16.3, 16.4, 16.5<br />

expenses of donors<br />

recording/log 13.10<br />

reimbursement for 13.2, 13.6, 13.8<br />

direct expenses only 13.3<br />

illness of egg donors 13.9<br />

see also compensation for loss of earnings, donors<br />

exports, of gametes/embryos see imports<br />

and exports (of gametes/embryos)<br />

external reviews, participation,<br />

in review of quality management system 23.12e<br />

F<br />

facilities see premises and facilities<br />

fair treatment of people see treatment of people<br />

family<br />

consideration in welfare of child risk assessment 8.11<br />

number, limit per donor see donors<br />

(embryos/gametes), 10 family limit<br />

family history, of donors 11.8–11.10<br />

refusal to give consent for information on 11.10<br />

fees<br />

egg sharing 12.20, 12.28<br />

information provision on 4.3<br />

payments for donors see payments for donors<br />

female partners, as legal parent<br />

6D<br />

counselling provision<br />

3A<br />

information provision before consent<br />

T62(6), 4A<br />

see also partner of patient<br />

fertility treatments,<br />

information provision about types 4.2d<br />

follow-up arrangements,<br />

preimplantation tissue typing 10.27<br />

Freedom of Information Act 2000 32.1<br />

G<br />

gamete(s)<br />

anonymised, for research/training 22.7c, 22.8c, 22.8d,<br />

22.8e, 22.10c<br />

barcoding light effect 18.39c, 18.40, 18.42, 18.43<br />

collection without consent as assault<br />

5A<br />

critical processing procedures, validation<br />

T72(15)<br />

cryopreserved<br />

documents indicating post-thaw quality 15.19<br />

safety of equipment for, and alarms 17.5, 26.4<br />

see also storage of gametes/embryos<br />

data registered at centre about<br />

T110(15)<br />

disposal 17.14c<br />

witnessing 18.4j<br />

donors and donation see donors (embryos/gametes)<br />

handling/processing, consent,<br />

documented procedures 5.3<br />

identification from procurement to<br />

disposal, documentation T70(15), 19.1a<br />

identifying codes 18.5, 18.20, 18.21, 19.2b<br />

import/export see imports and exports<br />

(of gametes/embryos)<br />

labelling 15.2, 15.10c, 15.10d, 15.15c, 18.20<br />

mixture, recording procedures/information 15.16e<br />

packaging conditions<br />

T105(15)<br />

packaging/distribution and recall 15C, 15.14–15.15<br />

<strong>Human</strong> <strong>Fertilisation</strong> and <strong>Embryology</strong> <strong>Authority</strong><br />

Index<br />

Version 3.0

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