{"id":"nsw:sl-2020-0454","name":"Human Tissue Regulation 2020","slug":"human-tissue-regulation-2020","collection":"regulation","jurisdiction":"nsw","status":"in_force","isInForce":true,"actNumber":"454 of 2020","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":176426,"registerId":"nsw-nsw:sl-2020-0454-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name of Regulation","content":"#### 1 Name of Regulation\n\n1 Name of Regulation\n\n> This Regulation is the [Human Tissue Regulation 2020](/view/html/inforce/current/sl-2020-0454).","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n2 Commencement\n\n> This Regulation commences on the day on which it is published on the NSW legislation website.\n> \n> Note.\n> \n> This Regulation repeals and replaces the [Human Tissue Regulation 2015](/view/html/repealed/current/sl-2015-0185), which would otherwise be repealed on 1 September 2020 by section 10(2) of the [Subordinate Legislation Act 1989](/view/html/inforce/current/act-1989-146).","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Definition","content":"#### 3 Definition\n\n3 Definition\n\n> > (1) In this Regulation—\n> > \n> > the Act means the [Human Tissue Act 1983](/view/html/inforce/current/act-1983-164).\n> > \n> > Note.\n> > \n> > The Act and the [Interpretation Act 1987](/view/html/inforce/current/act-1987-015) contain definitions and other provisions that affect the interpretation and application of this Regulation.\n> \n> > (2) Notes included in this Regulation do not form part of this Regulation.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Prescribed contaminants","content":"#### 4 Prescribed contaminants\n\n4 Prescribed contaminants\n\n> For the purposes of the definitions of prescribed contaminant in sections 4(1) and 20F(6) of the Act, the following organisms or substances are prescribed or declared—\n> \n> > (a) hepatitis B virus,\n> \n> > (b) hepatitis B surface antigen,\n> \n> > (c) hepatitis C virus,\n> \n> > (d) hepatitis C antibody,\n> \n> > (e) Human Immunodeficiency Virus (HIV),\n> \n> > (f) Human Immunodeficiency Virus (HIV) antibody,\n> \n> > (g) Human T-Lymphotropic Virus Type-I (HTLV-I),\n> \n> > (h) Human T-Lymphotropic Virus Type-I (HTLV-I) antibody,\n> \n> > (i) treponema pallidum,\n> \n> > (j) treponema pallidum-related antibody.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Classes of designated specialists","content":"#### 5 Classes of designated specialists\n\n5 Classes of designated specialists\n\n> > (1) For the purposes of section 5(2)(b) of the Act, a person who holds a specialist registration in one of the following specialties is prescribed—\n> > \n> > > (a) anaesthesia,\n> > \n> > > (b) emergency medicine,\n> > \n> > > (c) intensive care medicine,\n> > \n> > > (d) obstetrics and gynaecology,\n> > \n> > > (e) physician,\n> > \n> > > (f) surgery.\n> \n> > (2) In this clause—\n> > \n> > health profession has the same meaning as in the [Health Practitioner Regulation National Law (NSW)](/view/html/inforce/current/act-2009-86a).\n> > \n> > specialist registration means a person who holds a specialist registration in a recognised specialty in a health profession in accordance with Division 2 of Part 7 of the [Health Practitioner Regulation National Law (NSW)](/view/html/inforce/current/act-2009-86a).","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Certificates","content":"#### 6 Certificates\n\n6 Certificates\n\n> > (1) For the purposes of the definition of certificate in section 20D(1) of the Act, the prescribed form of the certificate is set out in Schedule 1.\n> \n> > (2) For the purposes of section 20D(2) of the Act, the following persons, if employed where the blood is to be removed, are prescribed witnesses—\n> > \n> > > (a) medical practitioners,\n> > \n> > > (b) nurses,\n> > \n> > > (c) persons employed to work as donor services nursing assistants at the Australian Red Cross Society,\n> > \n> > > (d) persons who have been nominated by their employer, and approved by the Secretary in writing, as appropriate persons to witness signatures.\n> \n> > (3) A certificate signed for the purposes of section 20D of the Act must be retained, for a period of not less than 10 years from the date on which it was signed, by—\n> > \n> > > (a) the person who removed the blood, or\n> > \n> > > (b) if the person who removed the blood did so in the person’s capacity as an employee or agent of some other person or body—that other person or body.\n> > \n> > Maximum penalty—2 penalty units.","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Presumption that person is carrying on blood supply business","content":"#### 7 Presumption that person is carrying on blood supply business\n\n7 Presumption that person is carrying on blood supply business\n\n> For the purposes of section 21A(b) of the Act—\n> \n> > (a) the prescribed quantity of blood is 1 litre, and\n> \n> > (b) the prescribed quantity of blood products is, in relation to any particular kind of blood product, the quantity of blood products of that kind that can be derived or extracted from 1 litre of blood.","sortOrder":6},{"sectionNumber":"8","sectionType":"section","heading":"Removal of tissue after death","content":"#### 8 Removal of tissue after death\n\n8 Removal of tissue after death\n\n> > (1) For the purposes of sections 23(3)(b) and 24(3) of the Act, the consent of a senior available next of kin of a deceased person may be given verbally if—\n> > \n> > > (a) an audio or audio visual recording is made of the consent, and\n> > \n> > > (b) the senior available next of kin has consented to the making of that audio or audio visual recording.\n> > \n> > Note.\n> > \n> > See section 23 of the Act for other manners in which consent may be given.\n> \n> > (2) For the purposes of section 34(1)(b2) of the Act, tissue may be retained for a period not exceeding 72 hours if the tissue was removed from the body of a person during medical, dental or surgical treatment performed as a matter of urgency in order to save the life of the person or to prevent serious damage to the health of the person.","sortOrder":7},{"sectionNumber":"9","sectionType":"section","heading":"Repeal and savings","content":"#### 9 Repeal and savings\n\n9 Repeal and savings\n\n> > (1) The [Human Tissue Regulation 2015](/view/html/repealed/current/sl-2015-0185) is repealed.\n> \n> > (2) Any act, matter or thing that, immediately before the repeal of the [Human Tissue Regulation 2015](/view/html/repealed/current/sl-2015-0185), had effect under that Regulation continues to have effect under this Regulation.","sortOrder":8},{"sectionNumber":"Schedule 1","sectionType":"schedule","heading":"Blood donor certificate","content":"# Schedule 1 Blood donor certificate\n\nSchedule 1 Blood donor certificate\n\n(Clause 6(1))\n\n([Human Tissue Act 1983](/view/html/inforce/current/act-1983-164), section 20D)\n\nQuestions\n\n(Please circle your answers)\n\n| 1 | To the best of your knowledge, have you ever thought you could be infected with HIV or have AIDS? | Yes/No |\n| 2 | To the best of your knowledge, have you ever had a test which showed you had hepatitis B, hepatitis C, HIV or HTLV? | Yes/No |\n| 3 | To the best of your knowledge, in the last 5 years, have you “used drugs” by injection or been injected with drugs not prescribed by a doctor or dentist? | Yes/No |\n| 4 | In the last 12 months, have you had an illness with both a rash and swollen glands, with or without a fever? | Yes/No |\n| 5 | In the last 3 months, have you engaged in sexual activity with someone who—(a) you think could be infected with HIV or have AIDS?(b) had a test which showed they had hepatitis B, hepatitis C, HIV or HTLV?(c) ever “used drugs” by injection or has been injected with drugs not prescribed by a doctor or dentist?(d) had an illness with both a rash and swollen glands, with or without a fever? | Yes/No |\n| 6 | In the last 12 months, have you had sexual activity with a new partner who currently lives or has previously lived overseas? | Yes/No |\n| 7 | In the last 3 months, have you had sex (with or without a condom) with a man who you think may have had oral or anal sex with another man? | Yes/No |\n| 8 | In the last 3 months, have you had male-to-male sex (that is, oral or anal sex) with or without a condom? | Yes/No/I am female |\n| 9 | In the last 3 months, have you been a sex worker (eg received payment for sex in money, gifts or drugs)? | Yes/No |\n| 10 | In the last 3 months, have you engaged in sexual activity with a sex worker? | Yes/No |\n| 11 | In the last 12 months, have you been imprisoned in a prison or held in a lock-up or detention centre? | Yes/No |\n| 12 | In the last 4 months, have you had a blood transfusion? | Yes/No |\n| 13 | In the last 12 months, have you had (yellow) jaundice or hepatitis or been in contact with someone who has? | Yes/No |\n| 14 | In the last 4 months, have you been injured with a used needle (needlestick)? | Yes/No |\n| 15 | In the last 4 months, have you had blood or other bodily fluid come into contact with your eyes, mouth, nose or to broken skin? | Yes/No |\n| 16 | In the last 4 months, have you had a tattoo, body and/or ear piercing or acupuncture? | Yes/No |\n\nI declare that I have understood the information on this form and have answered the questions in the declaration honestly and to the best of my knowledge. I understand that there are penalties, including fines and imprisonment, for providing false or misleading information.\n\n**Donor (please print)**\n\nSurname/family name\n\nGiven name\n\nDate of birth\n\n**Please ONLY sign in the presence of the interviewer**\n\nSignature\n\nDate\n\n**sch 1:** Am 2020 (702), cl 3; 2022 (709), sec 3.","sortOrder":9}],"analysis":{"issue_detection":{"absurdities":[],"contradictions":[]},"summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"The original regulation from 2020 has been incrementally expanded. The upcoming Human Tissue Amendment (Blood Donor Certificate) Regulation 2026 suggests the scope has broadened beyond the original organ/tissue donation framework to specifically address blood donation certification — indicating the regulation has evolved to cover additional administrative mechanisms not clearly part of its original focus."},"complexity_factors":["Operates as subordinate legislation (a regulation) under a parent Act, requiring understanding of both documents together","Deals with sensitive and technical medical/ethical subject matter (human tissue, organ donation)","Has been amended multiple times since 2020, creating multiple versions to navigate","Pending amendment (Blood Donor Certificate) not yet in force adds a layer of transitional complexity","Staged automatic repeal mechanism under the Subordinate Legislation Act 1989 adds a sunset dimension","Limited substantive content is visible in the provided text — the full operative provisions are not shown, limiting full assessment"],"plain_english_summary":"This NSW regulation sets the practical rules for donating, transplanting and using human tissue (including organs and blood), affecting hospitals, clinicians, registered donors and recipients.  \n\nIt matters because it prescribes consent, safety and record-keeping procedures that protect donors and recipients. An amendment on blood donor certificates takes effect 19 April 2026, and the regulation is scheduled for automatic repeal on 1 September 2026 unless remade."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"The instrument repeals and replaces the Human Tissue Regulation 2015 but expressly preserves any act, matter or thing that had effect under the previous regulation (clause 9(1)–(2)). The text supplied makes primarily technical and procedural prescriptions (contaminant list, specialist classes, certificate form, consent and retention rules, 1‑litre presumption) without indicating a material expansion or contraction of regulatory scope beyond the prior regime; commencement is on publication (clause 2)."},"complexity_factors":["Cross‑references to multiple statutes increase interpretive load (definition of \"the Act\" and notes: clause 3; specialist registration reference to Health Practitioner Regulation National Law: clause 5(2)).","Technical lists and medical terms require subject‑matter alignment (prescribed contaminants enumerated in clause 4).","Qualification rules for designated specialists depend on external registration regimes, creating dependency on another body's classifications (clause 5(1)–(2)).","Prescribed certificate form and witness rules create concrete compliance obligations: use of Schedule 1, prescribed witness classes and retention of certificates for 10 years with a penalty (clause 6(1)–(3)); this is an ongoing recordkeeping cost for clinicians or employers.","Operational presumption sets quantitative threshold for blood‑supply business (1 litre) that affects when business rules apply (clause 7).","Consent and evidence rules permit verbal consent only if audio/visual recorded with prior consent to recording; this changes how next‑of‑kin consent can be documented and creates procedural and privacy implications (clause 8(1)).","Emergency tissue retention limited to 72 hours where removed during urgent life‑saving treatment, imposing a time bound on retention decisions (clause 8(2)).","Schedule 1 donor questionnaire prescribes sensitive questions (sexual history, injection drug use, imprisonment, tattoos, recent transfusions) that affect donor eligibility and create evidentiary/penalty exposure for false answers (Schedule 1; clause 6 cross‑ref).","Repeal and savings clause preserves existing effects of the prior regulation while replacing its text, requiring attention to transitional continuity rather than substantive extension (clause 9(1)–(2); commencement clause 2)."],"plain_english_summary":"This Regulation supplies technical rules under the Human Tissue Act: it lists the infectious agents to be treated as prescribed contaminants, defines which medical specialists count for specific functions, prescribes the blood-donor certificate and witness classes, sets a 1‑litre presumption for blood-supply activity, permits recorded verbal consent in certain next‑of‑kin cases, and limits emergency retention of tissue. It primarily affects hospitals, blood services, donors and next‑of‑kin by creating recordkeeping, witnessing and testing duties and attaching penalties for non‑compliance."},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The Regulation maintains its original scope as subordinate legislation supporting the Human Tissue Act 1983. It updates the 2015 version without expanding beyond the established framework of blood safety, donor screening, and tissue removal procedures."},"complexity_factors":["Short length (9 clauses plus 1 schedule)","Minimal defined terms (only 3 explicit definitions in clause 3 and 5(2))","Straightforward prescriptive provisions without nested conditions","Single cross-reference to parent Act (Human Tissue Act 1983) and Health Practitioner Regulation National Law","No exceptions to exceptions or complex conditional logic","Schedule 1 consists of a simple form with yes/no questions"],"plain_english_summary":"This Regulation sets out the practical rules for handling human tissue and blood in New South Wales, working alongside the main Human Tissue Act 1983.\n\n**What it does:**\n\n*   **Blood safety:** It lists specific infections (like HIV, hepatitis B and C, and syphilis) that make blood unsafe for transfusion. It also specifies which medical specialists can authorise blood collection and who can witness donor consent forms.\n*   **Donor screening:** It includes a mandatory questionnaire (Schedule 1) that blood donors must complete, asking about risk factors like recent travel, sexual history, drug use, and medical procedures to protect the blood supply from contamination.\n*   **Record keeping:** Requires blood collection certificates to be kept for at least 10 years.\n*   **Tissue removal after death:** Allows a deceased person's next of kin to give verbal consent for tissue removal (like organ donation) if the conversation is recorded, rather than requiring written consent.\n*   **Urgent medical situations:** Permits hospitals to keep tissue removed during emergency life-saving surgery for up to 72 hours.\n\n**Who it affects:**\n\n*   Blood donors and people receiving blood transfusions\n*   Hospitals, blood banks, and the Australian Red Cross\n*   Medical practitioners, nurses, and other health workers involved in tissue removal or transfusion\n*   Families of deceased persons considering organ or tissue donation\n\n**Why it matters:**\n\nThis Regulation protects public health by ensuring blood transfusions are safe from serious infections, while also making it easier for families to consent to organ donation in difficult circumstances. It balances strict safety standards with practical flexibility for medical emergencies."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/human-tissue-regulation-2020","history":"/api/acts/human-tissue-regulation-2020/history","analysis":"/api/acts/human-tissue-regulation-2020/analysis","conflicts":"/api/acts/human-tissue-regulation-2020/conflicts","importantCases":"/api/acts/human-tissue-regulation-2020/important-cases","documents":"/api/acts/human-tissue-regulation-2020/documents"}}