Healthcare Services (Human Tissue Banking Service) Regulations 2023

each personnel is adequately trained for the work performed by the personnel and attends regular training in accordance with a continuing training programme;

each personnel is assessed periodically on the personnel’s competencies and work performance;

each of the following personnel is supervised by an experienced person when performing any task or providing any service in relation to a specified service that the licensee is approved to provide:

any personnel with less than 2 years of work experience in performing that task or providing that service;

any personnel who has not been assessed by an experienced person to be able to perform the task or provide the service competently without supervision.

a Clinical Governance Officer; or

another of the licensee’s personnel with at least 5 years of relevant work experience in providing the specified service and who is designated by a Clinical Governance Officer to provide supervision.

the safety of donors and recipients;

the safety and quality, and, where applicable, the viability and potency, of human tissue collected, tested, processed, stored and distributed by the licensee;

the proper collection, testing, processing, storage and distribution of human tissue.

investigation of any occurrence or complaint that discloses or may disclose any weakness or inadequacy affecting the quality of the human tissue banking service;

identification and implementation of appropriate and effective actions to address any weakness or inadequacy mentioned in sub-paragraph (a) and prevent a recurrence;

measures to ensure that the provision of the human tissue banking service complies with any written law governing the service and licence conditions imposed under section 13(1) of the Act;

implementation of quality control measures for all human tissue collected, tested, processed, stored and distributed by the licensee, including measures pertaining to the safety and quality, and, where applicable, the viability and potency of the human tissue in relation to —

where the licensee recruits donors — the recruitment of donors;

the collection and transport of the human tissue;

the processing (including testing and quarantine) of the human tissue; and

the preservation, storage and distribution of the human tissue;

implementation of appropriate and effective measures to ensure the safety or health of donors in relation to the collection of human tissue, including the detection and management of any finding or observation that has or may have an adverse effect on the safety or health of the donors;

maintenance of adequate and appropriate documentation on the clinical outcomes of the transplant or other clinical use of all human tissue distributed by the licensee, including documentation relating to any event, finding or observation that —

adversely affects or may adversely affect the safety or health of any recipient; and

relates to or is the result of the collection, testing, processing, storage or distribution of human tissue by the licensee;

quality control measures for tests performed and equipment used in the provision of the human tissue banking service, including acceptance testing, quality control tests and regular monitoring of equipment performance;

a system to ensure the appropriate and adequate documentation of the licensee’s policies and processes, including —

creating, reviewing and updating documentation for the licensee’s quality assurance measures and all personnel’s compliance with those measures; and

ensuring proper document control of all such documentation;

implementation of a system for appropriate accountability, roles and responsibilities of and continuing educational programmes for all personnel;

identification of key performance indicators for assessing performance outcomes of the human tissue banking service, including mechanisms for periodic monitoring and evaluation of these indicators;

the conduct of regular risk assessments of every activity conducted as part of the provision of the human tissue banking service and, where necessary, the implementation of appropriate measures to mitigate or manage the risks identified in those assessments.

review the effectiveness of the quality management system for the human tissue banking service on an annual basis; and

ensure that the quality management system is updated periodically.

participate in and perform satisfactorily for the relevant external quality assessment programme for every type of test that the licensee conducts on human tissue as part of the human tissue banking service; and

ensure that a Clinical Governance Officer or any other suitably qualified personnel designated by a Clinical Governance Officer reviews the results of the quality assessment programmes mentioned in sub‑paragraph (a) and implements appropriate and effective actions to address any weakness or inadequacy in the provision of the human tissue banking service.

safe and secure; and

set up in a manner that is appropriate and adequate for the provision of the human tissue banking service.

the equipment and materials used or intended to be used in the provision of the human tissue banking service are safe for such use; and

the equipment and materials are used in a manner that ensures the safe provision of the human tissue banking service.

each instrument and each equipment is installed, commissioned and used or operated properly, in accordance with the instructions of the manufacturer of the instrument or equipment;

every refrigerator or storage tank undergoes periodic maintenance to ensure the quality and usability of human tissue and reagents kept in the refrigerator or storage tank;

all refrigerators and storage tanks are used in a manner that —

prevents the mix-up, or contamination or cross‑contamination, of units of human tissue; and

ensures the safety and quality, and, where applicable, the viability and potency, of human tissue;

all instruments and other equipment, supplies and reagents used in the provision of the human tissue banking service are effective to ensure the safety and quality, and, where applicable, the viability and potency, of human tissue;

procedures are implemented for monitoring, inspecting and sterilising or cleaning each equipment used in the provision of the human tissue banking service;

appropriate tests and procedures are carried out periodically to ensure that any equipment or reagent used in the provision of the human tissue banking service complies with at least the tolerance limits determined by the manufacturer of the equipment or reagent;

the suppliers of any materials, the use of which is likely to have a material impact on the safety or quality, and, where applicable, the viability or potency, of human tissue, are selected and regularly evaluated to ensure that the materials obtained from the suppliers are safe and effective;

the following information about any supplies or reagent used in the collection, testing, processing and storage of human tissue by the licensee is identified and recorded:

the name of the supplies or reagent;

the name of the manufacturer;

the lot number;

the expiry date;

all sterilised instruments, supplies and reagents are clearly labelled to indicate the date on which the sterilisation took place;

procedures are implemented to monitor and maintain the conditions in which human tissue is stored, including the immediate notification of and response to temperature deviations outside acceptable ranges;

adequate, stable and appropriate electricity supply is provided for all laboratory equipment, including an adequate number of grounded electrical outlets and an emergency power supply for each piece of equipment that is essential for maintaining the safety and quality, and, where applicable, the viability and potency, of human tissue; and

procedures are implemented to ensure the safety of personnel using all facilities and equipment for the human tissue banking service.

electrical safety and safety of water supply and outlets;

the handling and disposal of sharp apparatus and objects that can readily puncture or cut human skin when encountered;

the safety of all personnel and donors during the conduct of any test;

waste management;

spills management;

ensuring that there is adequate space, ventilation and lighting for every personnel to perform work safely;

ensuring that all safety or emergency equipment are kept in good working order and there is an adequate stock of materials required for the handling of any medical emergency or adverse incident; and

ensuring the cleanliness of every approved permanent premises.

where the human tissue is to be collected from the body of a living donor — the living donor; or

subject to paragraph (2), where the human tissue is to be collected from the body of a deceased individual — the authorised person.

section 4(1) of the Human Organ Transplant Act 1987;

a gift made by a deceased individual under section 3 of the Medical (Therapy, Education and Research) Act 1972; or

a donation under section 4 of the Medical (Therapy, Education and Research) Act 1972.

provide the following information to the living donor or the authorised person, as the case may be:

the purposes for which the human tissue collected is to be used;

every test that will be conducted on the human tissue for assessing the suitability of the human tissue for use;

where the human tissue is found to be of low potency or contaminated — the manner in which the licensee will deal with the human tissue;

the disposal of unused donated human tissue at the end of their viability period;

where the human tissue is distributed for the purpose of transplant — that the licensee will disclose to the transplanting licensee to which the human tissue is distributed the following information:

the medical history of the individual from whom the human tissue is collected;

information relating to the licensee’s testing and processing of the human tissue;

whether there is evidence of therapeutic use of the human tissue;

the options for how excess human tissue collected and other surgical residues are to be dealt with; and

where the donor is a living donor, ascertain whether the donor, in the event of any abnormal finding or incidental finding relating to the donor, consents to either or both of the following:

the licensee informing the donor of the abnormal finding or incidental finding;

the licensee informing the medical practitioner overseeing or performing the collection of the human tissue, or any medical practitioner nominated by the donor, of the abnormal finding or incidental finding.

the information mentioned in paragraph (3)(a) is explained to the donor or authorised person by a transplanting clinician or a transplant coordinator;

the donor or authorised person is given sufficient time, after the information mentioned in paragraph (3)(a) is explained to the donor or authorised person, to decide whether or not to give consent under paragraph (1);

the consent under paragraph (1) is not obtained by means of harassment, coercion, intimidation, deception, misrepresentation, reward or remuneration by any officer, employee or agent of the licensee; and

records are kept in relation to the explanation of the information mentioned in paragraph (3)(a) that has been explained to the donor or authorised person.

obtain from the person who collected the human tissue a copy of the consent given by the living donor for the collection; and

keep records of that consent.

has at least a diploma in nursing, science, social work or psychology;

has at least 6 months on-the-job training under the supervision of a Clinical Governance Officer, transplanting clinician or another of the licensee’s personnel with at least 2 years of experience providing donor counselling in relation to the provision of a human tissue banking service; and

has been assessed by a Clinical Governance Officer or any suitably qualified personnel designated by a Clinical Governance Officer to have the appropriate competency in providing donor counselling in relation to the provision of the human tissue banking service.

the collection of information —

relating to the medical history of the donor known or available to the licensee;

relating to the medical history of the donor known or available to the donor or authorised person, as the case may be; and

where the medical history of the donor’s immediate family is relevant in determining the suitability of the human tissue collected — relating to the medical history of every member of the donor’s immediate family;

subject to paragraph (4), the signing of a declaration by the donor or authorised person (as the case may be), that all relevant information mentioned in sub‑paragraph (a)(ii) and (iii) has been disclosed to the licensee, to the best of the knowledge of the donor or authorised person (as the case may be), at the time of making the declaration;

a review by a medical practitioner of the information mentioned in sub‑paragraph (a);

where the donor is a living donor — a clinical evaluation of the donor conducted by a medical practitioner;

a requirement for the donor of a type of human tissue, in relation to every infectious disease applicable to that type of human tissue as specified in the first column of the Second Schedule, to undergo all of the tests specified opposite that infectious disease in the second column of that Schedule;

the conduct of all other necessary tests on the donor to assess whether the donor is eligible to donate the type of human tissue intended for donation.

section 4(1) of the Human Organ Transplant Act 1987;

a gift made by a deceased individual under section 3 of the Medical (Therapy, Education and Research) Act 1972; or

a donation under section 4 of the Medical (Therapy, Education and Research) Act 1972.

develop and implement appropriate protocols for the safe and proper collection of human tissue to ensure the retention of the biological functions compatible with the intended use of the human tissue;

ensure that each individual who collects human tissue for or on behalf of the licensee is trained and competent in the protocols mentioned in sub‑paragraph (a);

provide all equipment and materials necessary for the safe and proper collection of the human tissue to ensure the retention of biological functions compatible with the intended use of the human tissue; and

ensure that the donor is not subject to any procedure or test that is unnecessary for the purpose of collecting the human tissue.

the time of cooling or refrigeration of the body of the deceased donor; and

the time of cardiac death.

implement appropriate and adequate processes for the processing, testing and quarantine of all human tissue in the possession or custody of the licensee; and

determine and implement all tests for the human tissue that may be necessary.

develop and implement written policies and procedures for the processing, testing and quarantine of human tissue;

develop and implement written criteria and procedures for the evaluation and assessment of the quality of the human tissue for the purposes of storage or distribution, in particular the safety and quality, and, where applicable, the viability and potency, of the human tissue;

where the human tissue is collected from the body of a deceased donor, ensure that the body is reconstituted with dignity and sensitivity;

ensure that the environment within which the human tissue is collected, processed, tested and quarantined is appropriate to ensure the safety and quality, and, where applicable, the viability and potency, of the human tissue, and the safety of all personnel handling the human tissue;

establish and validate the time period within which the processing and testing of human tissue has to be completed such that the human tissue remains suitable for its intended use at the end of that time period;

ensure that the human tissue is collected, processed and stored within the appropriate time period for the particular type of human tissue to ensure the retention of the biological functions compatible with the intended use of the human tissue;

ensure that the human tissue collected from a donor is not pooled with the human tissue collected from any other donor;

take all reasonable steps to minimise the risk of contamination of the human tissue throughout the processes of retrieval, processing and storage of the human tissue;

use methods validated by the licensee and appropriate protocols for the processing and testing of human tissue, to maintain the safety and quality, and where applicable the viability and potency, of the human tissue and ensure the retention of the biological functions compatible with the intended use of the human tissue;

where the size or dimensions of the human tissue processed by the licensee may be measured — keep and maintain records of the size or dimensions of the human tissue;

maintain the traceability of all materials and equipment by keeping records of each material or equipment used to process any human tissue such that the specific material or equipment used to process the human tissue is known;

before any human tissue (other than ocular tissue) is cryopreserved, ensure that representative microbiological cultures of the human tissue are obtained and tested for bacteria and fungi;

discard the human tissue if any pathogenic and highly virulent microorganism is found to be present, unless treated with an appropriate sterilising procedure that has been validated to eliminate the infectivity of the microorganism;

where the safety or quality, and, where applicable, the viability or potency, of the human tissue may be affected by its release into the licensee’s inventory — quarantine the human tissue while it is being processed or tested; and

ensure that any quarantined human tissue is released into the licensee’s inventory or distributed to any other person only in accordance with the licensee’s written criteria and procedures and with the approval of a Clinical Governance Officer or any other suitably qualified personnel designated by a Clinical Governance Officer.

the biological and functional properties of all human tissue in the licensee’s custody are preserved; and

the risk of contamination of the human tissue is minimised.

store the human tissue in a validated container;

package all human tissue appropriately;

maintain the licensee’s inventory system for the human tissue in the licensee’s custody, including all human tissue under quarantine;

internally audit the inventory system at appropriate intervals to ensure that the inventory system is accurate;

implement an appropriate labelling system to ensure that each human tissue is correctly identified and traceable from the time of its collection to the time it is distributed;

store all human tissue that has been tested and processed at an appropriate temperature;

ensure that the storage requirements (including storage conditions and expiry date) for the human tissue is appropriate, having regard to —

the type of human tissue concerned;

the requirements in regulation 19 for that type of human tissue; and

the intended use of that human tissue;

ensure that the maximum storage period for every human tissue is appropriate, having regard to the following factors:

the type of human tissue concerned;

the appropriate storage temperature for that type of human tissue;

the requirements in regulation 19 for that type of human tissue;

the intended use for that human tissue;

ensure that any human tissue that is under quarantine is clearly labelled and segregated from any human tissue intended for distribution;

where any human tissue is determined to be unsuitable for transplant or other clinical use, label the human tissue with all of the following:

that the human tissue is unsuitable for transplant or other clinical use;

any other purpose for which the human tissue may be distributed; and

distribute the human tissue only in accordance with the written consent by the donor or authorised person (as the case may be) and the requirements of any other written law.

for transplant or other clinical use generally; and

for transplant to or other clinical use by the proposed recipient of the human tissue.

before distributing any human tissue (other than ocular tissue) for transplant or other clinical use, test the human tissue for bacteria or fungi; and

record the results of the tests conducted under sub‑paragraph (a) in relation to the donor of the human tissue.

the person is another licensee that is approved to provide a human tissue banking service for that type of human tissue;

the person is licensed under the Act to provide a licensable healthcare service for the purpose of treating a condition treatable by the transplant of that type of human tissue; or

where the person is established or incorporated outside Singapore — the person is licensed, registered, approved or otherwise regulated to carry on the activities of a human tissue bank or healthcare institution under the laws of the jurisdiction in which the person is established or incorporated.

the biological and functional properties of the human tissue are preserved; and

the risk of contamination of the human tissue is minimised.

ensure that the human tissue is packaged and transported in a validated container;

distribute the human tissue in the appropriate environmental conditions;

take appropriate measures to ensure the human tissue is distributed to the intended recipient;

establish and implement written policies and procedures for —

the recall of the human tissue; and

the notification of any person who receives or has received the human tissue,where the suitability of any human tissue for its intended use is or is believed to have been adversely affected for any reason; and

ensure that an instruction sheet which includes all of the following information accompanies each human tissue distributed by the licensee:

the specific storage conditions for the human tissue prior to its transplant or other clinical use;

any special requirement or measure that the medical practitioner using the human tissue must take to ensure the safe and effective use of the human tissue;

the measures that must be taken if there is any evidence of damage to or mislabelling of the human tissue or its packaging.

the Clinical Governance Officer or designated personnel has reviewed —

the results of any representative microbiological culture performed on the human tissue, including any variance from the applicable standard for microbiological cultures determined by a Clinical Governance Officer; and

the results of the tests conducted on the donor, including any variance from the applicable standard for determining the suitability of the human tissue for recipients determined by a Clinical Governance Officer; and

the Clinical Governance Officer or designated personnel is satisfied that —

the human tissue is safe and has met the licensee’s written criteria and procedures for distribution; and

where the human tissue is non-conforming human tissue —

there is clinical indication for the human tissue to be used for the transplant or other clinical use; and

having regard to the particular circumstances, there is medical urgency to use the human tissue.

collected from a donor of any type of human tissue who was, at the time of the collection, suffering from any infectious disease applicable to that type of human tissue as specified in the first column of the Second Schedule or any other infectious disease specified by a Clinical Governance Officer; or

determined by a Clinical Governance Officer to not have met all criteria of safety and quality, and, where applicable, the viability and potency, for transplant or other clinical use.

the medical history of the donor;

information relating to the licensee’s testing and processing of the human tissue.

information concerning any adverse reaction arising from the transplant of the human tissue;

information about the recipient of the human tissue.

in a manner that preserves the biological and functional properties of the human tissue;

in a manner that minimises the risk of contamination of the human tissue; and

only where the criteria for the return of unused human tissue established by a Clinical Governance Officer are met.

establish and implement policies and procedures for the return of unused human tissue;

document the policies and procedures mentioned in sub‑paragraph (a) and the criteria mentioned in paragraph (1)(c);

take appropriate measures to examine the integrity of the validated container and the human tissue for contamination and mishandling; and

take appropriate measures to ensure that any human tissue which may have been contaminated or mishandled is not placed back in the licensee’s inventory.

the living donor has, under regulation 16(3)(b), consented to be informed or for the licensee to inform a relevant medical practitioner of any abnormal or incidental finding pertaining to the living donor; and

the licensee becomes aware of an abnormal or incidental finding relating to the living donor,the licensee must inform the living donor or relevant medical practitioner (as the case may be) of the finding.

any human tissue from a living donor is handled, processed, tested, stored or distributed by a licensee but not collected by the licensee; and

the licensee becomes aware of an abnormal or incidental finding pertaining to the living donor,the licensee must inform the person from whom the licensee received the human tissue of the finding.

the identity of the donor of each human tissue the licensee collects or receives;

the identity of the recipient of each human tissue that the licensee has distributed human tissue to; and

every human tissue bank that the human tissue was stored in from the time the human tissue was collected to the time the human tissue was transplanted or used for any other clinical use.

the confidentiality, integrity and security of every applicable record are maintained at all times; and

every personnel handling any applicable record is aware of his or her role and responsibility in maintaining the confidentiality, integrity and security of the applicable records.

implement adequate safeguards and appropriate protocols and processes to protect the applicable records against accidental or unlawful loss, modification or destruction, or unauthorised access, disclosure, copying, use or modification; and

periodically monitor and evaluate the safeguards, protocols and processes mentioned in sub-paragraph (a) to ensure that they are effective and being complied with by the personnel involved in handling the applicable records.

maintain proper, complete and accurate records of every programme, policy, system, measure, protocol or process that the licensee is required to implement under these Regulations, and every activity undertaken under or change made to that programme, policy, system, measure, protocol or process;

maintain proper, complete and accurate records of each human tissue that is received by the licensee for processing, including the time at which the human tissue is received for processing;

maintain records of every approval given by a Clinical Governance Officer or any other suitably qualified personnel designated by a Clinical Governance Officer under these Regulations;

maintain records of every policy and procedure established by a Clinical Governance Officer under these Regulations; and

take reasonable steps to ensure the confidentiality, integrity and security of every record mentioned in sub‑paragraphs (b) and (c).

establish and implement a process to ensure there is proper document control of all documents relating to the human tissue banking service;

ensure that a Clinical Governance Officer approves, signs and dates each record mentioned in paragraph (1)(a); and

ensure that at least one personnel is responsible for the document control of all documents relating to the human tissue banking service.

contracts or other arrangements for or in relation to the prompt restoration of the licensee’s operations or the transfer of human tissue in the licensee’s custody to another licensee;

processes to inform, without undue delay, a relevant donor of the proposed transfer or disposal of any human tissue as a result of the disruption to the licensee’s operations;

processes to obtain the express written consent of the relevant donor for the proposed transfer or disposal in the event of any disruption to the licensee’s operations;

where there is any human tissue in the licensee’s custody that was not collected by the licensee — processes to inform, without delay, the person from whom the licensee received the human tissue, of the proposed transfer or disposal of any human tissue as a result of the disruption to the licensee’s operations.

another licensee that is approved to provide a human tissue banking service for the same type of human tissue;

a person who is authorised by a licence to provide a clinical laboratory service;

a person who operates a human tissue bank for the same type of human tissue or a clinical laboratory outside Singapore that is accredited by an accreditation body acceptable to the Director‑General.

to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both; and

in the case of a continuing offence, to a further fine not exceeding $1,000 for every day or part of a day during which the offence continues after conviction.