PART 7 REQUIREMENTS RELATING TO
PROVISION OF SERVICE |
| Division 1 — Provision of service to patients |
| When assisted reproduction service may be provided |
31.—(1) A licensee must not perform any assisted reproduction procedure on a patient unless —| (a) | a qualified assisted reproduction practitioner who is the licensee’s personnel is of the view that the assisted reproduction procedure may be carried out safely on the patient; and | | (b) | any condition in paragraph (2) applies. |
(2) The conditions mentioned in paragraph (1)(b) are the following:| (a) | where the assisted reproduction procedure is elective oocyte storage — the patient —| (i) | has any medical condition that significantly, permanently and adversely affects the patient’s fertility; | | (ii) | is undergoing any medical treatment that will significantly, permanently and adversely affect the patient’s fertility; | | (iii) | is a patient in respect of whom there is otherwise a medical indication for the storage of the oocyte, and is undergoing an assisted reproduction procedure (other than elective oocyte storage) for that medical indication; or | | (iv) | is at least 21 years of age but below 38 years of age; |
| | (b) | where the assisted reproduction procedure is not elective oocyte storage — the patient —| (i) | is above 35 years of age; or | | (ii) | is 35 years of age or younger and there are medical indications for the performance of the assisted reproduction procedure on the patient. |
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(3) A licensee must not provide a restricted procedure to a patient unless —| (a) | the patient is legally married to a man; and | | (b) | the patient’s husband consents to the restricted procedure. |
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(4) A licensee must not provide any ovarian stimulation treatment where the licensee is not also providing any assisted reproduction procedure to a patient unless —| (a) | a qualified assisted reproduction practitioner who is the licensee’s personnel is of the view that the provision of the ovarian stimulation treatment may be provided safely to the patient; and | | (b) | the purpose of the patient receiving the ovarian stimulation treatment is to enable the patient to undergo either or both of the following procedures on the following conditions:| (i) | a procedure to collect one or more oocytes for storage that is to be performed by another person, whether in or outside Singapore, if any condition in paragraph (5) applies; | | (ii) | an assisted reproduction procedure (other than elective oocyte storage) that is to be performed by another person, whether in or outside Singapore, if all the conditions in paragraph (6) are satisfied. [S 851/2023 wef 18/12/2023] |
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(5) The conditions mentioned in paragraph (4)(b)(i) are any of the following:| (a) | the patient has any medical condition that significantly, permanently and adversely affects the patient’s fertility; | | (b) | the patient is undergoing any medical treatment that will significantly, permanently and adversely affect the patient’s fertility; | | (c) | the patient is a patient in respect of whom there is otherwise a medical indication for the storage of the oocyte; | | (d) | the patient is at least 21 years of age but below 38 years of age. [S 851/2023 wef 18/12/2023] |
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(6) The conditions mentioned in paragraph (4)(b)(ii) are —| (a) | either —| (i) | the patient is above 35 years of age; or | | (ii) | the patient is 35 years of age or younger and there are medical indications for the performance of the assisted reproduction procedure on the patient; |
| | (b) | the patient is legally married to a man; and | | (c) | the patient’s husband informs the licensee in writing that he consents to the patient receiving the assisted reproduction procedure to be performed by another person, whether in or outside Singapore. [S 851/2023 wef 18/12/2023] |
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| (7) A licensee must record a patient’s purpose of receiving any ovarian stimulation treatment as part of the patient’s patient health record. [S 851/2023 wef 18/12/2023] |
| (8) In this regulation, “ovarian stimulation treatment” is a treatment that is provided by a licensee to a patient to increase the number of mature oocytes of the patient available for fertilisation, without collecting any oocyte from the patient. [S 851/2023 wef 18/12/2023] |
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| Assessment of patients above 45 years of age |
32. A licensee must establish and implement processes to ensure that —| (a) | a qualified assisted reproduction practitioner who is the licensee’s personnel assesses the fitness of each patient to carry a pregnancy, deliver and care for the child if the patient is or likely to be above 45 years of age at the start of the pregnancy; and | | (b) | appropriate clinical management and medical advice is given to a patient mentioned in paragraph (a) in the provision of the assisted reproduction service. |
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| Preventing ovarian hyperstimulation syndrome |
33.—(1) A licensee must establish and implement policies and procedures to minimise the incidence of the development of ovarian hyperstimulation syndrome in any woman in the provision of the assisted reproduction service.(2) Without limiting paragraph (1), the policies and procedures mentioned in that paragraph must —| (a) | identify and manage patients at risk of or experiencing ovarian hyperstimulation syndrome; | | (b) | monitor the incidence of ovarian hyperstimulation syndrome; and | | (c) | document the efforts taken to minimise the incidence of ovarian hyperstimulation syndrome. |
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| Transfer of multiple embryos |
34.—(1) Subject to paragraph (2), a licensee must not transfer more than 2 embryos into a patient’s body in a single assisted reproduction cycle.(2) Despite paragraph (1), a licensee may transfer no more than 3 embryos, each of which is not past the cleavage stage, into a patient’s body in a single assisted reproduction cycle if the patient —| (a) | is 37 years of age or older; and | | (b) | has undergone one or more stimulated cycles in which no oocytes were collected, or from which no oocyte collected resulted in a blastocyst. |
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| (3) A licensee must, before transferring 2 or more embryos into a patient’s body, inform the patient and the patient’s husband that delivery for a multiple pregnancy is recommended to be carried out by an acute hospital licensee with the appropriate neonatal intensive care facilities for extremely premature infants. |
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| No combination of certain assisted reproduction procedures |
| 35. A licensee must not transfer any embryo into the body of a patient in the same assisted reproduction cycle that a gamete intrafallopian transfer was carried out for the same patient. |
36. A licensee must not —| (a) | transfer an embryo into the body of a woman who intends to give the child up for adoption; | | (b) | engage in any practice or carry out any procedure, including sperm sorting techniques, for the purpose of selecting or creating an embryo for transfer on the basis of the sex of the embryo, except where a qualified assisted reproduction practitioner assesses that there is a clinical need to do so; or | | (c) | perform mitochondrial replacement therapy. |
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| When donor reproductive cells or embryos may be used |
37.—(1) A licensee must not transfer into the body of a patient any embryo that —| (a) | was not created from an oocyte collected from the patient, unless —| (i) | the patient is unable to produce any viable oocytes for collection; | | (ii) | the patient has had one or more unsuccessful attempts at the collection of viable oocytes; or | | (iii) | a qualified assisted reproduction practitioner who is the licensee’s personnel is of the view that the likelihood of a foetus with no significant health condition or disability developing from any of the patient’s oocytes is low; [S 851/2023 wef 18/12/2023] |
| | (b) | was not created from sperm collected from the patient’s husband, unless —| (i) | the patient’s husband is unable to produce viable sperm for fertilisation of an oocyte; or | | (ii) | a qualified assisted reproduction practitioner who is the licensee’s personnel is of the view that the likelihood of a foetus with no significant health condition or disability developing from any of the patient’s husband’s sperm is low; or [S 851/2023 wef 18/12/2023] |
| | (c) | is a consanguineous embryo. |
(2) Where a donor reproductive cell or donor embryo is used in the provision of an assisted reproduction service by a licensee to a patient, the licensee must ensure the following:| (a) | there is a clear set of criteria for the selection and acceptance of donors, which is documented; | | (b) | donor sperm is accepted only from a man who is at least 21 years of age but below 41 years of age; | | (c) | a donor oocyte is accepted only from a woman who is at least 21 years of age but below 38 years of age; | | (d) | a donor embryo is accepted only where the embryo is created from an oocyte from a woman mentioned in sub‑paragraph (c). |
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(3) In this regulation —“consanguineous embryo” means an embryo created from —| (a) | an oocyte from a woman and sperm collected from a man who is the woman’s biological grandfather, father, uncle, brother, half‑brother, son, nephew or grandson; or | | (b) | sperm collected from a man and an oocyte collected from a woman who is the man’s biological grandmother, mother, aunt, sister, half‑sister, daughter, niece or granddaughter; |
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| [Deleted by S 851/2023 wef 18/12/2023] |
| “viable oocyte” means an oocyte that can result in the formation of an embryo; [S 851/2023 wef 18/12/2023] |
| “viable sperm” means a sperm that can result in the formation of an embryo. [S 851/2023 wef 18/12/2023] |
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| Restriction on the use of certain embryos |
38.—(1) A licensee must, before carrying out any procedure that will result in the fertilisation of an intergenerational embryo —| (a) | obtain approval for the procedure from a clinical ethics committee appointed by a section 25 licensee; and | | (b) | obtain signed written consent for the procedure and the intended use of the intergenerational embryo from each person from whom the reproductive cells for the fertilisation of the intergenerational embryo were collected. |
| (2) Except with the Clinical Governance Officer’s written approval, a licensee must not transfer into the body of a patient any embryo that is created from a reproductive cell collected from a donor whose donated reproductive cells had previously resulted in at least 5 live birth events. |
(3) The Clinical Governance Officer must not approve the transfer of an embryo mentioned in paragraph (2) to a patient unless —| (a) | another embryo created from reproductive cells collected from the donor had previously been transferred to the patient, and resulted in a live birth event; and | | (b) | the patient has requested the transfer. |
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(4) In this regulation, “intergenerational embryo” means an embryo created from —| (a) | an oocyte from a woman and sperm collected from the biological father of the woman’s husband; or | | (b) | sperm collected from a man and an oocyte collected from the biological mother of the man’s wife. |
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39.—(1) A licensee must establish and implement a system to evaluate the medical fitness and suitability of every donor of a reproductive cell or an embryo before the reproductive cell or embryo is accepted for use in the provision of the assisted reproduction service.(2) Without limiting paragraph (1), the system mentioned in that paragraph must include the following:| (a) | the conduct of a clinical evaluation and the review of the medical history of the donor, carried out by a qualified assisted reproduction practitioner; | | (b) | the signing of a written declaration by each donor, to the best of the donor’s knowledge, of the following matters:| (i) | information relating to the donor’s medical history; | | (ii) | whether the donor has engaged in behaviour that exposes the donor to a high risk of contracting or developing communicable diseases, including drug use and unprotected sex with multiple partners. |
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| Confidentiality of donor’s identity |
40. A licensee must not disclose to any person the identity of a donor of a reproductive cell or an embryo, except —| (a) | as required by or under any written law; | | (b) | as authorised or required by an order of court; or | | (c) | with the consent of the donor or the donor’s legal representative. |
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41. Where a donor donates any reproductive cell or embryo to a specified person, the licensee must not —| (a) | use the reproductive cell or embryo for a purpose other than for the provision of an assisted reproduction service to the specified person unless the donor has given written consent for the use of the reproductive cell or embryo for that other purpose; and | | (b) | use the reproductive cell or embryo for the provision of an assisted reproduction service to the specified person unless the donor has consented to disclose the donor’s identity to the specified person. |
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| Division 3 — Storage and disposal requirements |
| Storage and disposal in accordance with terms of consent |
42.—(1) A licensee must ensure that the storage, distribution for transfer, donation or disposal of any reproductive cell or embryo is carried out in accordance with the terms of the written consent given by all relevant donors.(2) Where, in relation to a reproductive cell or an embryo in the custody of a licensee, the licensee is for any reason unable to obtain instructions from all relevant donors on the storage, distribution for transfer, donation or disposal of the reproductive cell or embryo, the licensee must —| (a) | obtain guidance from a clinical ethics committee appointed by a section 25 licensee on how the reproductive cell or embryo should be handled; and | | (b) | inform the Director‑General of every action or measure taken by the licensee in relation to the reproductive cell or embryo. |
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| (3) Where all relevant donors have consented to the storage of the reproductive cell or embryo for a specified period, the licensee must request each relevant donor to confirm the continued storage of the reproductive cell or embryo before the expiry of the specified period. |
(4) In this regulation, “relevant donor” means —| (a) | in relation to a reproductive cell — the person from whom the reproductive cell is collected; and | | (b) | in relation to an embryo — each person from whose reproductive cells the embryo is created. |
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| Reproductive cells and embryos that may be stored |
43. A licensee must not store any reproductive cell or embryo except the following:| (a) | any reproductive cell (except an oocyte) or embryo for the purpose of providing an assisted reproductive service to a patient; | | (b) | any sperm or human tissue containing any human gamete or germ cells at any stage of maturity for the purpose of preventing infertility, where the individual from whom the sperm or human tissue is collected —| (i) | has any medical condition that significantly, permanently and adversely affects the individual’s fertility; or | | (ii) | is undergoing any medical treatment that will significantly, permanently and adversely affect the individual’s fertility; |
| | (c) | an oocyte collected from a patient —| (i) | to whom the licensee intends to provide a restricted procedure; and | | (ii) | who has, together with the patient’s husband, given signed written consent for the restricted procedure, |
| if the licensee is unable to, for any reason, provide the restricted procedure in the same assisted reproduction cycle that the oocyte is collected; |
| | (d) | any oocyte collected from a patient mentioned in regulation 31(2)(a). |
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| Storage of reproductive cells and embryos |
44.—(1) A licensee must store each reproductive cell and embryo in the licensee’s custody in a manner that ensures that —| (a) | the biological and functional properties of each reproductive cell and embryo are preserved; and | | (b) | the risk of contamination of each reproductive cell and embryo is minimised. |
(2) Without limiting paragraph (1), the licensee must —| (a) | ensure that each reproductive cell and embryo is stored in a validated device that is appropriate for the reproductive cell or embryo and the intended use of the reproductive cell or embryo; | | (b) | ensure that each reproductive cell and embryo is appropriately packaged and stored; | | (c) | maintain an inventory system for each reproductive cell and embryo in the licensee’s custody (including those under quarantine); | | (d) | ensure that an inventory check is performed at least once every 2 years, where the purpose and duration of storage for every reproductive cell and embryo is reviewed to ensure compliance with these Regulations; | | (e) | implement an appropriate labelling system to ensure that each reproductive cell and embryo is correctly identified and traceable from the time of its collection until the time it is distributed; | | (f) | ensure that each reproductive cell and embryo that has been tested and processed is stored at an appropriate temperature; | | (g) | ensure that the storage requirements (including storage conditions) for each reproductive cell and embryo are appropriate, having regard to —| (i) | the type of reproductive cell and stage of embryo concerned; | | (ii) | the packaging and processing requirements for the reproductive cell and embryo; and | | (iii) | the intended use of the reproductive cell or embryo; |
| | (h) | for any reproductive cell or embryo which is determined to be unsuitable for clinical use — ensure that the container or tank in which the reproductive cell or embryo is stored is clearly labelled with all of the following:| (i) | that the reproductive cell or embryo is unsuitable for clinical use; | | (ii) | the purpose for which the reproductive cell or embryo may be distributed; |
| | (i) | ensure any reproductive cell or embryo that is under quarantine must be clearly labelled and segregated from any reproductive cell or embryo intended for distribution; and | | (j) | ensure that a reproductive cell or an embryo that is to be used for a purpose is not stored together with another reproductive cell or embryo that is not to be used for the same purpose. |
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| Division 4 — General requirements |
| Verification of identity when semen or seminal fluid submitted |
45. A licensee must establish and implement processes in relation to the submission of any semen or seminal fluid to the licensee for any purpose related to the provision of the assisted reproduction service that include the following:| (a) | requiring a person (whether a patient’s husband or a donor) to submit his semen or seminal fluid in person at any of the licensee’s approved permanent premises; | | (b) | verification and counterchecking of the person’s identity by the licensee’s personnel, with reference to any photo identification document; | | (c) | the signing of a written declaration by the person that the semen or seminal fluid submitted belongs to the person; | | (d) | the keeping of a record of the date and time that the person submitted his semen or seminal fluid at the licensee’s approved permanent premises. |
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| Counterchecking procedures |
46.—(1) A licensee must establish and implement processes to prevent the use of the wrong specimens in any laboratory or clinical procedure.(2) Without limiting paragraph (1), a licensee must ensure the following:| (a) | the implementation of a protocol where 2 personnel check that the specimen relating to the correct patient has been collected for use in the laboratory or clinical procedure; | | (b) | the assignment of personnel who has the appropriate training or competencies for the protocol mentioned in sub‑paragraph (a); | | (c) | documentation of the personnel who performed each check mentioned in sub‑paragraph (a). |
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| Tests for specified pathogens |
47.—(1) Subject to paragraph (2), a licensee must ensure that, before collecting or receiving any reproductive cell from a patient, patient’s husband or donor (called in this regulation the relevant person) or storing any reproductive cell collected from a relevant person, the relevant person has been tested for each specified pathogen within 6 months before the collection of the reproductive cell.(2) A licensee must ensure that a donor of a reproductive cell is tested for the Human Immunodeficiency Virus —| (a) | immediately before the licensee collects the reproductive cell from the donor; and | | (b) | after a period of at least 3 months after the collection of the reproductive cell. |
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(3) Where a relevant person tests positive for a specified pathogen, the licensee must do the following:| (a) | inform the following persons of the positive test:| (i) | the proposed recipient of a reproductive cell collected from the relevant person and the proposed recipient’s husband; | | (ii) | the proposed recipient of an embryo that is created from a reproductive cell collected from the relevant person and the proposed recipient’s husband; |
| | (b) | explain to the persons mentioned in sub‑paragraph (a)(i) or (ii) (as the case may be) the risk of either of the persons or the child contracting an infectious disease caused by the specified pathogen or developing any related condition; | | (c) | obtain from each of the persons mentioned in sub‑paragraph (a)(i) or (ii), as the case may be —| (i) | a signed written declaration that the licensee has explained, and the person is aware of, the risk mentioned in sub‑paragraph (b); and | | (ii) | a signed written consent for the transfer of the reproductive cell or embryo. |
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| (4) Where a relevant person tests positive for a specified pathogen, a licensee must ensure that any reproductive cell collected from the relevant person or embryo created from a reproductive cell collected from the relevant person is stored in a manner that minimises the risk of cross‑contamination with reproductive cells or embryos from persons who have tested negative for the specified pathogen. |
| (5) Where a patient intends to use a reproductive cell collected from a donor at any time before the donor is tested for the Human Immunodeficiency Virus under paragraph (2)(b), then the donor is deemed to have tested positive for the Human Immunodeficiency Virus for the purposes of paragraphs (3) and (4). |
(6) In this regulation, “specified pathogen” means any of the following viruses or bacteria:| (a) | Human Immunodeficiency Virus; | | (b) | hepatitis B virus; [S 851/2023 wef 18/12/2023] | | (c) | hepatitis C virus; [S 851/2023 wef 18/12/2023] | | (d) | Treponema pallidum bacterium. [S 851/2023 wef 18/12/2023] |
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| Conduct of ultrasound imaging |
48.—(1) A licensee must not conduct any ultrasound imaging on a patient unless a qualified assisted reproduction practitioner orders the ultrasound imaging for the patient.(2) A licensee must ensure that any ultrasound imaging conducted on a patient is conducted —| (a) | only as a service incidental to the provision of an assisted reproduction service; and | | (b) | by or under the supervision of the licensee’s personnel who is —| (i) | a medical practitioner; | | (ii) | a radiographer who is a duly qualified allied health professional; or | | (iii) | a sonographer. |
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49.—(1) A licensee may test any specimen for a patient if —| (a) | a medical practitioner who is the licensee’s personnel orders the test for the patient; | | (b) | the testing of the specimen only involves the conduct of a simple in vitro diagnostic test; and | | (c) | the testing of the specimen is provided only as a service incidental to the provision of an assisted reproduction service. |
| (2) A licensee who is approved to provide an assisted reproduction service by remote provision must not, in the course of providing the service by that service delivery mode, direct a person to conduct a self‑administered test on himself or herself if the testing material for the self‑administered test is a “professional use only” medical device within the meaning given by regulation 2 of the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010). |
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| Conduct of simple in vitro diagnostic test |
50.—(1) A licensee must ensure that any simple in vitro diagnostic test on a specimen or patient must be conducted —| (a) | using testing material, where —| (i) | the expiry date of the testing material has not passed; and | | (ii) | the personnel who is administering the test does not suspect or have any reason to suspect that the testing material is no longer fit for use; and |
| | (b) | in accordance with the instructions specified by the manufacturer of the testing material. |
| (2) A licensee must ensure that any testing material that may be used to conduct any simple in vitro diagnostic testing is stored under the conditions, and handled in the manner, specified by the manufacturer of the testing material so as to lower the risk of unnecessary exposure of the testing material to the environment and early deterioration of the testing material. |
| (3) In paragraph (1), “expiry date” has the meaning given by regulation 2 of the General Regulations. |
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| Instructions for self‑collection of specimens |
51. Where any specimen is to be collected from a person by the person himself or herself, for the purpose of conducting any test on it (whether or not the test is to be self‑administered by the person), a licensee must provide the person with —| (a) | instructions on how and when the specimen is to be collected; and | | (b) | the precautions that are to be taken to avoid contamination and degradation of the specimen. |
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| Provision of life‑saving measures |
52.—(1) Without affecting Part 5, a licensee must —| (a) | ensure that adequate and appropriate facilities, equipment and drugs for the provision of any essential life‑saving measure to a patient are readily available at each approved permanent premises; and | | (b) | at all times, be capable of providing any essential life‑saving measure to any patient who is at risk of death. |
(2) Without limiting paragraph (1), a licensee must ensure the following:| (a) | resuscitation equipment and drugs are effective, functional and readily available for use at any time in the approved permanent premises; | | (b) | every personnel who provides any essential life‑saving measure to a patient is adequately trained —| (i) | to provide the essential life‑saving measure in a proper, effective and safe manner; and | | (ii) | in the use of the equipment that is needed to deliver the essential life‑saving measure; |
| | (c) | there is a comprehensive and detailed response plan to resuscitate, treat and transfer unstable patients; | | (d) | the licensee’s personnel promptly assesses a patient who shows any sign of being unwell at any time after an assisted reproduction procedure and delivers the necessary treatment to stabilise the patient; | | (e) | any patient who remains unwell despite the delivery of treatment to stabilise the patient is transferred to the care of an acute hospital service licensee who is equipped to deliver the appropriate treatment to the patient; | | (f) | any patient who requires conveyance by an emergency ambulance is conveyed by an emergency ambulance operated by an emergency ambulance service licensee. |
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| Transfer of reproductive cells and embryos to and from other licensees, etc. |
53.—(1) A licensee must not transfer any reproductive cell or embryo to or receive any reproductive cell or embryo from another person unless the person is —| (a) | another licensee; or | | (b) | a person in a foreign jurisdiction that is licensed, registered, approved or otherwise allowed to provide an assisted reproduction service or to carry on the activities of a reproductive cell or embryo bank under the laws of the foreign jurisdiction. |
| (2) A licensee must not transfer a reproductive cell or an embryo to a person mentioned in paragraph (1)(a) or (b) unless the licensee has obtained written consent for the transfer from the person from whom the reproductive cell was collected, or the person from whose reproductive cell the embryo is created, as the case may be. |
| (3) A licensee must not receive a reproductive cell or an embryo from a person mentioned in paragraph (1)(b) unless the licensee is satisfied that the person is able to comply with regulation 54. |
(4) In this regulation, “transfer”, in relation to a reproductive cell or an embryo, does not include the transfer of the reproductive cell or embryo —| (a) | into the body of an individual; or | | (b) | to a person conducting research on the reproductive cell or embryo. |
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| Requirements relating to transfer of reproductive cells and embryos |
54.—(1) A licensee must ensure that the transfer of any reproductive cell or embryo to or from the licensee is carried out in a manner that —| (a) | preserves the biological and functional properties of the reproductive cell or embryo; and | | (b) | minimises the risk of contamination of the reproductive cell or embryo. |
(2) Without limiting paragraph (1), a licensee must —| (a) | ensure that the reproductive cell or embryo is at all times during the transfer packaged and transported in a validated device that is appropriate for the reproductive cell or embryo and the intended use of the reproductive cell or embryo; | | (b) | implement and maintain a system to prevent or control the spread of any communicable disease due to the contamination or infection of any reproductive cell or embryo in the licensee’s custody, including the traceability of all equipment and materials used in the processing of the reproductive cell or embryo; | | (c) | ensure that the reproductive cell or embryo is transported and transferred in appropriate environmental conditions; | | (d) | ensure that an instruction sheet accompanies each transfer from the licensee of any reproductive cell or embryo stating all of the following information:| (i) | the results of all tests performed on the person from whom the reproductive cell is collected or from whose reproductive cell the embryo is created; | | (ii) | the appropriate storage condition for the reproductive cell or embryo prior to its clinical use; | | (iii) | any special requirement or measure that the medical practitioner using the reproductive cell or embryo must take to ensure the safe and effective use of the reproductive cell or embryo; | | (iv) | the measures that must be taken if there is any evidence of damage to or mislabelling of the reproductive cell or embryo or its packaging; and |
| | (e) | in relation to each transfer from the licensee of any reproductive cell or embryo, ensure that the movement of the reproductive cell or embryo is tracked in a document, and that every person who receives the reproductive cell or embryo signs the document upon receipt. |
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| Requirements for remote provision |
55.—(1) This regulation applies to a licensee who is approved to provide an assisted reproduction service by remote provision.(2) The licensee must not provide an assisted reproduction service by remote provision unless it is for either of the following:| (a) | the provision of clinical care incidental to the services mentioned in paragraph (a), (b), (c) or (d) of the definition of “assisted reproduction service” in paragraph 2 of the First Schedule to the Act; | | (b) | the administration of donor questionnaires in relation to donor screening. |
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(3) For the purposes of paragraph (2)(a), before the licensee provides an assisted reproduction service to a patient by remote provision, the licensee must ensure that —| (a) | the licensee’s personnel who is a healthcare professional first conducts a clinical assessment of the patient in person at any of the licensee’s approved permanent premises to determine the suitability of the patient to be provided the assisted reproduction service by remote provision; and | | (b) | the assisted reproduction service can be provided by remote provision safely. |
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| (4) For the purposes of paragraph (2)(b), before the licensee provides an assisted reproduction service to a patient by remote provision, the licensee must ensure that the assisted reproduction service can be so provided in a manner that ensures the confidentiality and security of any information relating to donor screening. |
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