{"id":"blood-and-tissue-transmissible-diseases-regulations-1985","name":"Blood and Tissue (Transmissible Diseases) Regulations 1985","slug":"blood-and-tissue-transmissible-diseases-regulations-1985","collection":"regulation","jurisdiction":"wa","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":174140,"registerId":"wa-blood-and-tissue-transmissible-diseases-regulations-1985-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Blood and Tissue (Transmissible Diseases) Regulations 1985","content":"![Crest]()Western Australia\n\nPublic Health Act 2016 1\n\nBlood and Tissue (Transmissible Diseases) Regulations 1985\n\nWestern Australia\n\nBlood and Tissue (Transmissible Diseases) Regulations 1985\n\nContents\n\n1. Citation 1\n\n2. Terms used 1\n\n3. Taking of blood without declaration 1\n\n4. Declaration to be required from donor 2\n\n5. Person authorised to permit declarations to be made 3\n\n6. Form of declaration 3\n\n7. Offences 3\n\nNotes\n\nCompilation table 4\n\nOther notes 5\n\nDefined terms\n\n  \n\nPublic Health Act 2016 1\n\nBlood and Tissue (Transmissible Diseases) Regulations 1985\n\n##### 1. Citation\n\nThese regulations may be cited as the *Blood and Tissue (Transmissible Diseases) Regulations 1985*.\n\n[**2A.** Deleted: Gazette 19 Sep 2017 p. 4883.]\n\n##### 2. Terms used\n\n(1) In these regulations —\n\n  blood includes any substance derived from blood;\n\ntherapeutic use means a use for the purpose of —\n\n(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons;\n\n(b) influencing, inhibiting or modifying a physiological process in persons;\n\n(c) testing susceptibility to a disease or ailment in persons.\n\n(2) A reference in these regulations to the donating of blood shall be read as including a reference to the donating of any substance obtained from the blood, or of any ovum or semen.\n\n[Regulation 2 inserted: Gazette 17 May 1991 p. 2480; amended: Gazette 19 Sep 2017 p. 4883‑4.]\n\n##### 3. Taking of blood without declaration\n\n(1) Subject to this regulation, a person shall not —\n\n(a) take any blood intended for therapeutic use; or\n\n(b) knowingly accept for therapeutic use any blood donated,\n\nunless the person donating the blood made a declaration in the form required under regulation 6 within the 12 hours preceding the donation of the blood.\n\n(2) Where the donor of any blood is by reason of injury or illness incapable of making a declaration in the form required under regulation 6, a person who takes, or accepts a donation of, blood from that donor for therapeutic use where the circumstances are such as to be, in the opinion of a person who is a designated officer, or the delegate of a designated officer, for the purposes of the *Human Tissue and Transplant Act 1982*, medically justifiable shall not be taken to have contravened subregulation (1).\n\n(3) The taking or accepting of blood that is intended —\n\n(a) for the use of the donor; or\n\n(b) for a use other than a therapeutic use,\n\nshall be taken not to contravene subregulation (1) notwithstanding that no declaration is made in respect of that blood.\n\n[Regulation 3 amended: Gazette 13 May 1988 p. 1596; SL 2020/47 r. 4.]\n\n##### 4. Declaration to be required from donor\n\nA person who intends to donate blood for therapeutic use is required to furnish in writing to the person taking the blood at the time of donating that blood a declaration made in the form required under regulation 6 before a witness who is authorised by these regulations to permit such a declaration to be made in their presence, that declaration having been made within the preceding 12 hours, and shall not donate blood unless such a declaration is furnished.\n\n[Regulation 4 amended: Gazette 13 May 1988 p. 1596; SL 2020/47 r. 5.]\n\n##### 5. Person authorised to permit declarations to be made\n\nFor the purpose of taking declarations required by these regulations, a person who is within one of the following categories of authorised persons may permit such a declaration to be made before them —\n\n(a) a person who is an authorised witness for a statutory declaration in accordance with the *Oaths, Affidavits and Statutory Declarations Act 2005* section 12(6);\n\n(b) a person who is a designated officer, or the delegate of a designated officer, for the purposes of the *Human Tissue and Transplant Act 1982*;\n\n[(c) deleted]\n\n(d) a staff member of Australian Red Cross Lifeblood,\n\nand shall state his or her full name on and sign the declaration, date it and endorse on it the time at which it was made and the category of authorisation to which he or she belongs.\n\n[Regulation 5 amended: Gazette 13 May 1988 p. 1596; 1 Apr 2011 p. 1177; SL 2020/47 r. 6.]\n\n##### 6. Form of declaration\n\nA declaration made for the purposes of these regulations must be in the approved form.\n\n[Regulation 6 inserted: SL 2020/47 r. 7.]\n\n##### 7. Offences\n\nA person who contravenes regulation 3(1) or 4 commits an offence and is liable to a penalty of a fine of $1 000.\n\n[Regulation 7 inserted: Gazette 13 May 1988 p. 1596; amended: Gazette 19 Sep 2017 p. 4884.]\n\n[Schedule 1 deleted: SL 2020/47 r. 8.]\n\n![dline]()\n\nNotes\n\nThis is a compilation of the *Blood and Tissue (Transmissible Diseases) Regulations 1985* and includes amendments made by other written laws. For provisions that have come into operation, and for information about any reprints, see the compilation table.\n\nCompilation table\n\n| **Citation** | **Published** | **Commencement** |\n| --- | --- | --- |\n| *Blood and Tissue (Transmissible Diseases) Regulations 1985* | 8 Feb 1985 p. 517‑19 | 8 Feb 1985 |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 1986* | 12 Sep 1986 p. 3350 | 12 Sep 1986 |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 1988* | 13 May 1988 p. 1596‑7 | 13 May 1988 |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 1991* | 17 May 1991 p. 2480‑1 | 17 May 1991 |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 1999* | 12 Feb 1999 p. 474‑7 | 12 Feb 1999 |\n| **Reprint of the *Blood and Tissue (Transmissible Diseases) Regulations 1985* as at 11 Oct 2002**  (includes amendments listed above) | | |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 2010* | 22 Jun 2010 p. 2769-71 | r. 1 and 2: 22 Jun 2010 (see r. 2(a));   Regulations other than r. 1 and 2: 4 Jul 2010 (see r. 2(b)) |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 2011* | 1 Apr 2011 p. 1177 | r. 1 and 2: 1 Apr 2011 (see r. 2(a));   Regulations other than r. 1 and 2: 2 Apr 2011 (see r. 2(b)) |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 2012* | 22 May 2012 p. 2163-6 | r. 1 and 2: 22 May 2012 (see r. 2(a));   Regulations other than r. 1 and 2: 1 Jul 2012 (see r. 2(b)) |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 2014* | 6 Jun 2014 p. 1788‑9 | r. 1 and 2: 6 Jun 2014 (see r. 2(a));   Regulations other than r. 1 and 2: 6 Jul 2014 (see r. 2(b)) |\n| **Reprint 2: The *Blood and Tissue (Transmissible Diseases) Regulations 1985* as at 14 Nov 2014**  (includes amendments listed above) | | |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 2016* | 11 Mar 2016 p. 681‑2 | r. 1 and 2: 11 Mar 2016 (see r. 2(a));   Regulations other than r. 1 and 2: 13 Mar 2016 (see r. 2(b)) |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations (No. 2) 2016* | 9 Sep 2016 p. 3885 | r. 1 and 2: 9 Sep 2016 (see r. 2(a));   Regulations other than r. 1 and 2: 11 Sep 2016 (see r. 2(b)) |\n| *Health Regulations Amendment (Public Health Consequential Amendments) Regulations 2017* Pt. 2 | 19 Sep 2017 p. 4883‑5 | 20 Sep 2017 (see r. 2(b) and *Gazette* 19 Sep 2017 p. 4880) |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 2018* | 14 Sep 2018 p. 3309‑10 | r. 1 and 2: 14 Sep 2018 (see r. 2(a));   Regulations other than r. 1 and 2: 15 Sep 2018 (see r. 2(b)) |\n| *Blood and Tissue (Transmissible Diseases) Amendment Regulations 2020* | SL 2020/47 24 Apr 2020 | r. 1 and 2: 24 Apr 2020 (see r. 2(a));   Regulations other than r. 1 and 2: 25 Apr 2020 (see r. 2(b)) |\n\n\nOther notes\n\n1 Made under the *Health (Miscellaneous Provisions) Act 1911*; these regulations continue in force, after the *Public Health Act 2016* s. 321 came into operation, as if these regulations were made under the *Public Health Act 2016* s. 304.\n\nDefined terms\n\n*[This is a list of terms defined and the provisions where they are defined. The list is not part of the law.]*\n\n**Defined term Provision(s)**\n\nblood 2(1)\n\ntherapeutic use 2(1)\n","sortOrder":0}],"analysis":{"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"},"summary":{"complexity_score":1,"scope_assessment":{"changed":false,"description":"Scope cannot be assessed. The provided content contains no legislative text, only a webpage unavailability notice. It is impossible to determine whether the legislation's scope changed from its original intent without access to the actual regulations."},"complexity_factors":["No legislative text was provided — only an error/unavailability notice from the WA legislation website","Complexity cannot be meaningfully assessed without access to the actual instrument","Score of 1 reflects absence of content, not simplicity of the law itself"],"plain_english_summary":"The actual text of the Blood and Tissue (Transmissible Diseases) Regulations 1985 is unavailable here, so specific rules, affected parties, and penalties cannot be confirmed. From the title alone, it likely governs handling, donation, testing or use of blood and human tissue in Western Australia to prevent transmissible diseases, affecting hospitals, blood banks, donors and patients. To check the law, consult the WA legislation website or the Parliamentary Counsel’s Office."},"issue_detection":{"absurdities":[],"contradictions":[]},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"The regulations have been updated over time (see compilation table) to modernise and clarify administration rather than to change the core regulatory scope. Notable mechanical changes include: (a) expanding the definition of \"blood\" to expressly include substances derived from blood and to cover ovum and semen (reg 2); (b) formalising an \"approved form\" for declarations (reg 6); and (c) updating the list of authorised witnesses to include Australian Red Cross Lifeblood staff and to rely on contemporary statutory witness categories (reg 5). These are refinements to implementation, record‑keeping and authorised persons rather than a significant broadening of the regulations' original purpose of requiring donor declarations for blood intended for therapeutic use."},"complexity_factors":["Short instrument: 7 operative regulations plus citation and notes","Small number of defined terms (2 defined terms in reg 2: 'blood' and 'therapeutic use')","Time‑sensitive requirement (12 hour window) creates operational conditionality (regs 3(1), 4)","Several exceptions and conditional rules (incapacity + medical‑justifiability in reg 3(2); donor's own use/non‑therapeutic uses in reg 3(3))","Cross‑references to other Acts for authorised persons and delegations (Oaths/Statutory Declarations Act 2005 s.12(6); Human Tissue and Transplant Act 1982) increase interpretive dependencies (reg 5)","Authorised witness categories and documentary formalities (name, signature, time, category) add procedural detail (reg 5)","Delegated administrative discretion (designated officer or delegate) affects scope of exception (reg 3(2))","Unspecified \"approved form\" referenced but not reproduced, requiring separate instrument or guidance (reg 6)","Fixed monetary penalty specified (low complexity) but enforcement consequences concentrated on providers (reg 7)"],"plain_english_summary":"**What these regulations do (mechanically)\n\n- Require a written, witnessed declaration from a person donating blood (or substances derived from blood, or ova/semen) when the blood is intended for \"therapeutic use\" (that is, use to prevent, diagnose, cure or manage a disease or to influence a physiological process). The declaration must have been made within the 12 hours before donation (regs 2, 3(1), 4).\n\n- Allow narrow exceptions: a health‑care worker may take or accept blood without that declaration if the donor is incapable of making one and a designated officer (or the delegate for the Human Tissue and Transplant Act 1982) considers the taking or acceptance medically justifiable (reg 3(2)). Blood taken for the donor's own use or for non‑therapeutic uses is exempt from the declaration requirement (reg 3(3)).\n\n- Specify who can act as the authorised witness who permits and witnesses the declaration. That list includes people authorised to witness statutory declarations, designated officers (or their delegates) under the Human Tissue and Transplant Act, and staff members of Australian Red Cross Lifeblood. The authorised witness must sign, name, date and record the time and their category of authorisation on the declaration (reg 5).\n\n- Require the declaration to be in an approved form (reg 6).\n\n- Make it an offence for a person to take or accept blood for therapeutic use without the required declaration, or for a donor to fail to provide the declaration when donating; the penalty is a fine of $1,000 (reg 7).\n\nWho is affected\n\n- Service providers who take or accept blood for therapeutic use: hospitals, clinics, blood banks, transfusion services and other organisations that supply blood products (reg 3(1), reg 4).\n\n- Donors: individuals who give blood or substances derived from it for therapeutic purposes must make a written, witnessed declaration in the approved form within 12 hours before donation (reg 2, reg 4).\n\n- Authorised witnesses: persons listed in regulation 5 will be asked to witness and record declarations (reg 5).\n\nWhy it matters (official purpose claim, then mechanistic testing)\n\n- The regulations are framed to reduce the risk that transmissible diseases are passed via therapeutic blood products by creating a contemporaneous, witnessed declaration from the donor about relevant facts (see regs 2–4). That is the stated operational purpose.\n\n- Mechanically, the measure substitutes a short administrative and evidentiary step (a signed, witnessed declaration in an approved form) for other controls. The cost is primarily administrative: time taken by donors and staff, maintaining and using the approved form, and training or authorising witnesses (regs 4–6). The risk of non‑compliance is borne by the person taking or accepting the blood (possible $1,000 fine under reg 7), which creates an incentive for providers to enforce the declaration requirement.\n\nCosts, incentives and trade‑offs\n\n- Who pays: donors pay time and effort to complete the declaration; providers pay the administrative cost of witnessing, storing records and training authorised witnesses; providers also bear legal risk and potential fines for non‑compliance (reg 7).\n\n- Behavioural incentives: providers are incentivised to refuse blood without the required declaration (to avoid penalties) or to rely on the medical‑justifiability exception where the donor cannot sign (reg 3(2)). That exception vests discretion in designated officers or their delegates (reg 3(2), reg 5), which concentrates decision power in authorised officials.\n\n- Substitution effects: the 12‑hour window requirement could change logistics for mobile donation drives or scheduled donations — donors may need to sign a new declaration immediately prior to donation rather than rely on an older consent form. Non‑therapeutic donations or donations for the donor's own use are exempt, so providers can continue those practices without the declaration (reg 3(3)).\n\nImplementation and compliance risks\n\n- Administrative friction: the 12‑hour timing, requirement for a specific approved form and the need for an authorised witness to log the time may increase the administrative burden at donation points (regs 4–6).\n\n- Delegated discretion: the medical‑justifiability exemption requires the judgement of a designated officer or delegate under the Human Tissue and Transplant Act 1982; how that judgement is exercised will affect access in emergencies (reg 3(2)).\n\n- Dependence on cross‑referenced instruments: the regulations rely on other statutes for roles and authorisations (Public Health Act 2016 transitional note; Human Tissue and Transplant Act 1982 for designated officers; Oaths, Affidavits and Statutory Declarations Act 2005 for authorised witnesses). That creates a small risk of mismatch if those instruments change (reg 5 and compilation notes).\n\nNet operational effect\n\n- The regulations impose a short, enforceable administrative step intended to document donor statements immediately prior to therapeutic blood donations. The effect on private enterprise and clinical services is primarily procedural compliance: small ongoing costs and some potential logistical changes for donor management, with legal risk focused on the entity taking or accepting the blood (reg 3–7)."},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The legislation maintains its original narrow focus on requiring health declarations from blood and tissue donors. While amended 11 times since 1985, these changes have been technical updates (updating witness categories, simplifying form requirements, adjusting commencement provisions) rather than expansion of scope. The 2020 amendments actually reduced complexity by removing the detailed form specification from Schedule 1 and replacing it with a generic 'approved form' reference."},"complexity_factors":["Short length (7 substantive regulations)","Minimal defined terms (only 2: 'blood' and 'therapeutic use')","Simple conditional structure with clear exceptions in regulation 3(2) and 3(3)","No nested cross-references beyond single-layer references to the Oaths Act and Human Tissue Act","Straightforward offence provision with flat penalty structure","Recent amendments (2020) simplified the legislation by removing Schedule 1 and replacing detailed form requirements with 'approved form' delegation"],"plain_english_summary":"**What this legislation does:**\n\nThese regulations set the rules for donating blood, semen, or eggs in Western Australia when those donations will be used for medical treatment (what the law calls \"therapeutic use\"). The core requirement is that donors must complete a formal declaration about their health status before giving blood or tissue.\n\n**Key requirements:**\n\n* **The 12-hour rule:** Donors must make a written declaration within 12 hours before donating. This declaration must be witnessed by an authorised person.\n* **Who can witness:** Authorised witnesses include statutory declaration witnesses, designated medical officers under the Human Tissue and Transplant Act, and Australian Red Cross Lifeblood staff.\n* **Emergency exception:** If a donor is injured or too ill to make a declaration, blood can still be taken if a designated medical officer decides it's medically justified.\n* **Personal use exception:** No declaration is needed if the blood is for the donor's own use or for non-medical purposes.\n* **Penalties:** Breaking the main rules carries a $1,000 fine.\n\n**Who it affects:**\n\n* Blood and tissue donors in Western Australia\n* Medical professionals collecting donations\n* Australian Red Cross Lifeblood staff\n* Hospitals and tissue banks handling therapeutic donations\n\n**Why it matters:**\n\nThese rules protect patients who receive blood transfusions or tissue transplants by ensuring donors are screened for transmissible diseases. The declaration system creates a legal record of the donor's health disclosure, helping prevent the spread of infections through medical procedures. The regulations balance public safety with practical exceptions for emergencies and personal treatment."}},"importantCases":[],"_links":{"self":"/api/acts/blood-and-tissue-transmissible-diseases-regulations-1985","history":"/api/acts/blood-and-tissue-transmissible-diseases-regulations-1985/history","analysis":"/api/acts/blood-and-tissue-transmissible-diseases-regulations-1985/analysis","conflicts":"/api/acts/blood-and-tissue-transmissible-diseases-regulations-1985/conflicts","importantCases":"/api/acts/blood-and-tissue-transmissible-diseases-regulations-1985/important-cases","documents":"/api/acts/blood-and-tissue-transmissible-diseases-regulations-1985/documents"}}