Blood and Tissue (Transmissible Diseases) Regulations 1985

The regulations operate using a small set of defined and operating concepts. Understanding those terms is essential because the rules hinge on their scope.

blood: Defined in reg 2(1) to include “any substance derived from blood”. The definition therefore sweeps beyond whole blood to plasma, platelets and any derived fractions where those are “substances derived from blood”. Because the definition is statutory, any compliance or enforcement question must treat derived substances as within scope unless a tighter reading is authorised elsewhere.

therapeutic use: Also defined in reg 2(1). It covers three classes of uses: (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; (b) influencing, inhibiting or modifying a physiological process in persons; and (c) testing susceptibility to a disease or ailment in persons. That is a broad tripartite definition. It includes diagnostic tests, prophylaxis, curative treatments, physiological modulation (which could cover hormone therapies and related interventions) and susceptibility testing. The breadth matters because the declaration requirement and the offence in reg 3(1) apply only to blood intended for therapeutic use. Uses outside those classes are expressly excluded by reg 3(3)(b).

donating/donating of blood: Reg 2(2) clarifies that references to donating blood should be read as including donating any substance obtained from blood or any ovum or semen. The cross‑reference to ova and semen extends the procedural requirement to other human tissues beyond circulating blood, to the extent those donations are used for therapeutic purposes.

declaration in approved form: The regulations require a declaration in the approved form (reg 6). The “approved form” is not reproduced in the text of the regulations; reg 6 as inserted by SL 2020/47 requires compliance with whatever form is approved under the relevant administrative arrangements. That creates a compliance dependency on an externally prescribed form and its content.

authorised person/witness: Reg 5 lists categories of persons authorised to permit declarations to be made before them and to sign and endorse the declaration. The categories are: a person who is an authorised witness for a statutory declaration under the Oaths, Affidavits and Statutory Declarations Act 2005 s 12(6); a designated officer or delegate for the purposes of the Human Tissue and Transplant Act 1982; and a staff member of Australian Red Cross Lifeblood. Each authorised person must state their full name, sign the declaration, date it and endorse the time it was made and the category of authorisation (reg 5).

medically justifiable exception and discretion: Reg 3(2) creates an exception where the donor is incapable of making the declaration due to injury or illness, but only if a designated officer or their delegate for the purposes of the Human Tissue and Transplant Act 1982 forms the opinion that taking or accepting that donation for therapeutic use is medically justifiable. That operative gateway turns on the subjective or professional opinion of the designated officer or delegate and is both a medical and administrative discretion embedded in the scheme.

offence and penalty: Reg 7 makes contravention of reg 3(1) or reg 4 an offence with a fine fixed at $1,000. The regulations do not, within the text provided, specify other enforcement mechanisms or alternative penalties; the statutory penalty is the explicit criminal sanction.

Other structural features: The "Other notes" section states the regulations were originally made under the Health (Miscellaneous Provisions) Act 1911 and continue in force as if made under the Public Health Act 2016 s 304 following s 321 coming into operation. The compilation table tracks numerous amendment instruments and reprints through to SL 2020/47. Several regulations and a schedule have been deleted or inserted at various times (for example, reg 2A deleted 2017, reg 6 inserted 2020, schedule 1 deleted 2020).

Understanding these concepts is necessary to determine whether a particular donation falls inside the regime and, if so, what documentary and witnessing steps must be taken before a person or organisation takes or accepts blood for therapeutic use.

The regulations create discrete legal obligations and permissions that fall on a small set of actors. The primary actors affected are donors, persons or organisations who take or accept blood for therapeutic use, authorised witnesses (and their employers), and designated officers or delegates under the Human Tissue and Transplant Act 1982. Secondary operational actors include Australian Red Cross Lifeblood, and persons authorised under the Oaths, Affidavits and Statutory Declarations Act 2005 to act as statutory declaration witnesses.

Donors: A person who intends to donate blood for therapeutic use is required to provide a written declaration in the approved form made within the previous 12 hours and to do so before an authorised witness (reg 4). A donor who fails to furnish such a declaration before donation may commit an offence under reg 7 because reg 4 is made an offence by that provision. Donors who are injured or ill and therefore incapable of making the declaration fall under a narrow exception (reg 3(2)), but that exception turns on the opinion of a designated officer or delegate.

Persons taking or accepting blood for therapeutic use: Reg 3(1) makes it an offence for a person to take any blood intended for therapeutic use or knowingly to accept for therapeutic use any blood donated unless the required declaration has been made in the preceding 12 hours. The phrase “a person” is broad; it will catch clinicians, transfusion services, hospitals and any organisation or individual who takes or knowingly accepts blood for therapeutic use. The duty is reactive as well as proactive: the taker/acceptor must ensure the declaration exists and is compliant with reg 4 and reg 6.

Authorised witnesses: Those listed in reg 5 , authorised witnesses under the Oaths, Affidavits and Statutory Declarations Act 2005 s 12(6); designated officers (and delegates) under the Human Tissue and Transplant Act 1982; and staff members of Australian Red Cross Lifeblood , are empowered to permit declarations to be made before them and must sign and endorse the declaration with their full name, the time of the declaration and the category of their authorisation (reg 5). That makes particular staff of Lifeblood an operational focal point for compliance. It also means the staffing and training policies of Lifeblood and any relying organisations are directly implicated.

Designated officers and delegates: The regulations give these officers two roles. They may be authorised witnesses (reg 5), and they have the capacity to form an opinion that donation without a declaration is medically justifiable in circumstances where the donor is incapable of making the declaration (reg 3(2)). This dual role concentrates both procedural and discretionary responsibilities within the Human Tissue and Transplant Act 1982 designated officer function.

Regulators, prosecutors and courts: The text does not identify an enforcing agency or the procedural vehicle for prosecution. The offence and fine under reg 7 are statutory, so enforcement would proceed through the criminal or regulatory machinery available under Western Australian law, but no enforcement agency is named in the regulations themselves.

Entities performing non‑therapeutic uses: Where donation is for the donor’s own use or for non‑therapeutic uses, reg 3(3) expressly excludes those categories from the documentary requirement. That affects research facilities, forensic services, and others who take blood for non‑therapeutic purposes, provided the use falls outside the statutory definition of “therapeutic use” in reg 2(1).

Persons relying on or preparing the approved form: Because reg 6 ties validity to an “approved form”, whoever controls or issues the approved form (not named in the regulations) will effectively influence compliance. Australian Red Cross Lifeblood’s inclusion in reg 5 suggests operational co‑ordination between the regulator and the major blood collection body.

In short, the regulations allocate substantive documentary duties to donors and to recipients/takers of blood for therapeutic use, prescribe who may witness those declarations, and confer discretion to designated officers to allow exceptions in medically justifiable emergency circumstances. Employers and institutional actors that manage blood collection and transfusion processes will be materially affected by the procedural and recordkeeping implications.

The regulations create a set of specific duties, limited rights (principally exceptions), and procedural obligations. Here are the operative duties and the main statutory rights or exemptions, each grounded in the regulation citations.

Duty to require and obtain a declaration: Regs 3(1) and 4 together allocate duties to both the donor and the person taking the blood. Reg 4 imposes on a donor intending to donate blood for therapeutic use the requirement to furnish in writing to the person taking the blood a declaration in the approved form, made within the preceding 12 hours, and made before a properly authorised witness. Reg 3(1) prohibits the taking or the knowing acceptance for therapeutic use of such blood unless the donor made the requisite declaration within the 12 hours preceding donation. Practically, this means the person who takes (or accepts) blood must verify the donor’s declaration exists and is correctly witnessed, and the donor must supply that declaration to the taker at the time of donation.

Form and witnessing requirements: Reg 6 requires the declaration to be in the approved form. Reg 5 sets out who may act as the authorised witness: persons authorised under the Oaths, Affidavits and Statutory Declarations Act 2005 s 12(6); designated officers or delegates for the purposes of the Human Tissue and Transplant Act 1982; and staff members of Australian Red Cross Lifeblood. The authorised witness must state their full name on and sign the declaration, date it, and endorse on it the time it was made and the category of authorisation to which they belong (reg 5). These procedural steps are mandatory to validate a declaration.

Duty not to take/accept without declaration: Reg 3(1) makes it an offence to take or knowingly accept for therapeutic use blood donated where the declaration requirement has not been satisfied. That places an evidentiary and procedural obligation on transfusion services, hospitals and clinicians to check the declaration and the witness endorsement at or before taking the blood.

Exception where donor incapable: Reg 3(2) creates a statutory right to take/accept blood without a declaration in a specific emergency or incapacity situation. Where a donor is by reason of injury or illness incapable of making the declaration, a person who takes or accepts the donation for therapeutic use will not be taken to have contravened reg 3(1) if 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. This is a professional opinion‑based gateway and thus a statutory, discretionary exemption.

Exclusion for donor’s own use and non‑therapeutic uses: Reg 3(3) expressly excludes from the prohibition any taking or accepting of blood intended for the use of the donor (reg 3(3)(a)) or for a use other than a therapeutic use (reg 3(3)(b)). These are statutory exemptions that remove both the declaration requirement and the criminal exposure for those categories.

Obligation on the authorised witness: Reg 5 includes a positive duty on the authorised witness to add identifying and attestation information: full name, signature, date, time of declaration, and to endorse their category of authorisation. This distributes a compliance duty to third parties who witness declarations.

Penalty for breach: Reg 7 turns contravention of reg 3(1) and reg 4 into a criminal offence with a specified monetary penalty of a fine of $1,000. The regulations therefore impose criminal exposure on those who fail to obtain or produce the declaration as required. The text is direct: “A person who contravenes regulation 3(1) or 4 commits an offence and is liable to a penalty of a fine of $1 000” (reg 7).

Rights of organisations such as Lifeblood: While the regulations do not create affirmative property or operational rights, reg 5’s specific inclusion of Australian Red Cross Lifeblood staff as authorised witnesses allocates to those staff an operational role in validating declarations. That statutory authorisation is a procedural right to act as an authorised witness and thereby to enable lawful taking of blood for therapeutic use under the scheme.

Cross‑legislative interplay that creates duties: The regulations reference the Human Tissue and Transplant Act 1982 and the Oaths, Affidavits and Statutory Declarations Act 2005 to define who may act as designated officers and authorised witnesses respectively. That cross‑reference creates duties that sit at the intersection of the regulatory frameworks: for example, delegates under Human Tissue and Transplant Act 1982 may both make the medically justifiable opinion and act as authorised witnesses (regs 3(2), 5).

In sum, duties are both procedural (produce/obtain declaration in approved form, verify witness endorsements) and substantive (do not take/accept without the declaration), while statutory rights are limited to the explicit exceptions and the specific authorisations conferred on particular categories of witnesses and officials.

The regulations specify a narrow enforcement mechanism: a single offence provision and a fixed monetary penalty. No separate regulatory enforcement body or administrative penalty regime is set out in the text of the instrument; the enforcement mechanism therefore relies on standard criminal or regulatory processes applicable to offences created by subsidiary legislation in Western Australia.

Offence and fine: Regulation 7 provides the decisive detail: “A person who contravenes regulation 3(1) or 4 commits an offence and is liable to a penalty of a fine of $1 000.” The two contraventions captured are (a) taking or knowingly accepting for therapeutic use donated blood without the required declaration (reg 3(1)), and (b) the donor’s failure to furnish the written declaration in the approved form before donating (reg 4). The language “a person who contravenes” is broad and can be read to capture donors, persons taking blood, persons accepting donated blood for therapeutic use, and any person who otherwise breaches reg 4 or reg 3(1).

Criminal vs administrative enforcement: The regulations create an offence and prescribe a fine; they do not, in the text provided, define whether the fine is a summary fine, an infringement notice scheme amount, or the maximum fine on conviction in a particular court. That means enforcement requires resort to the general statutory and procedural framework that applies to offences created by regulations in Western Australia. The regulations themselves do not name a prosecuting agency or outline an administrative enforcement pathway.

Proof and evidentiary posture: The offence in reg 3(1) hinges on factual elements such as whether a declaration was made in the required form and within the 12‑hour window, and whether the person taking or accepting the blood “knowingly” accepted it for therapeutic use without the declaration. Establishing that a person acted “knowingly” may require proof of what documents were presented, who checked them and what the taker was told. Reg 5’s requirement for witness name, signature, date, time and category of authorisation provides a documentable chain that addresses evidentiary risk. Conversely, failure to follow the endorsement steps will make it difficult to demonstrate compliance.

Scope for defence via exceptions: Reg 3(2) creates an exception where the donor is incapable of making the declaration and a designated officer or delegate considers the decision medically justifiable. A person taking or accepting blood in such circumstances can rely on that professional opinion to avoid contravention of reg 3(1). The nature of that opinion,whether it must be recorded, contemporaneous, written or orally given,is not prescribed in the regulations. The absence of procedural formalities for recording the designated officer’s opinion may create a practical enforcement and evidentiary gap.

No specified enforcement agency or procedure in the text: Because the regulations do not themselves appoint an enforcement agency or specify the court or penalty recovery mechanism, practical enforcement will be conducted under the broader framework for offences in Western Australia. That means familiar enforcement pathways,police, health department inspectors, or prosecutorial agencies,could bring charges, but the regulations do not state which body has responsibility. Practitioners should therefore identify the likely prosecuting agency in context (for example, WA Health, local police or the Director of Public Prosecutions) when advising clients, but that identification is not provided by the regulations themselves.

Monetary level and potential deterrence: The single fine of $1,000 is the only specified sanction. The regulations do not provide for higher fines, imprisonment, disqualification or licence consequences. The limited range of penalties narrows the statutory risk to monetary exposure at that fixed level, although an actual prosecution could carry reputational costs beyond the financial penalty.

In practice, enforcement and sanctioning will turn on how public health authorities and prosecutors choose to treat contraventions, how strictly regulated bodies like Lifeblood structure their internal compliance procedures, and what documentary evidence is available to prove either a contravention or the applicability of an exception under reg 3(2). The regulations set the offence, but procedural enforcement elements, prosecutorial practice and evidentiary arrangements are left to the broader legal and administrative system.

The regulations are explicitly interwoven with other statutory instruments and pre‑existing bodies. The text itself cross‑references two Acts and contains a note about continuity under the Public Health Act 2016. Those cross‑references create substantive and procedural interdependencies.

Human Tissue and Transplant Act 1982: Two provisions in the regulations reference designated officers and delegates under that Act. Reg 3(2) permits taking or accepting blood without the declaration when the donor is incapable, provided a designated officer or their delegate for the purposes of the Human Tissue and Transplant Act 1982 forms the opinion that the taking/accepting is medically justifiable. Reg 5 also lists a designated officer or delegate under the Human Tissue and Transplant Act 1982 as an authorised person to witness declarations. That Act therefore supplies key personnel and the professional judgment that activates the medical exception in reg 3(2). Any administrative definitions, appointment procedures, qualifications and delegation rules in the Human Tissue and Transplant Act 1982 will affect how reg 3(2) is applied and who may act as an authorised witness under reg 5.

Oaths, Affidavits and Statutory Declarations Act 2005: Reg 5(a) authorises “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)” to permit a declaration to be made before them. That cross‑reference means that the categories of persons empowered to witness statutory declarations under the Oaths Act (for example, certain legal practitioners, justices of the peace and others) may also act as authorised witnesses for these blood‑related declarations. The procedural integrity of a declaration will therefore be influenced by the Oaths Act’s witness rules.

Public Health Act 2016: The “Other notes” section records that these regulations were made under the Health (Miscellaneous Provisions) Act 1911 and “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.” This continuity clause mechanically preserves the validity of the regulations under the new public health statute and brings their operation under the administrative umbrella of the Public Health Act 2016, including its enforcement and interpretive frameworks. It means the regulations should be read in the context of the Public Health Act 2016’s provisions for public health administration, powers of authorised officers, and potentially recordkeeping and disclosure rules applicable to public health measures.

Health (Miscellaneous Provisions) Act 1911: Historically the instrument was made under that Act. Although the notes indicate continuity under the Public Health Act 2016, the original statutory provenance remains part of the compilation history.

Approved form regime and administrative instruments: Reg 6 requires the declaration to be “in the approved form.” The regulations do not specify who approves the form or where it is published. That gap creates a dependency on subordinate administrative instruments, ministerial approvals, or operational directives (for example, paperwork issued by the health department or Lifeblood) for the content and availability of the form. Interactions with administrative law,delegations, approvals, and publication of forms,are therefore relevant to compliance.

Criminal and procedural law frameworks: The offence in reg 7 sits inside the general criminal and procedural machinery of Western Australia. Enforcement and prosecution will therefore interact with the Criminal Procedure Act, evidentiary rules, and general principles that govern proving statutory offences. The regulations themselves do not alter prosecution competency, limitation periods, or evidentiary burdens, but prosecutions will need to be managed through existing courts and prosecutorial practices.

Other statutory regimes governing tissue, privacy and health: While not referenced explicitly in the text, the regulations will commonly interact with privacy and health records regimes when authorities and transfusion services record and retain declarations and witness endorsements. That interaction is a practical consideration for implementers, though the regulations themselves do not create privacy obligations.

In sum, the regulations function inside a small network of statutory cross‑references: they depend on the Human Tissue and Transplant Act 1982 to supply designated officers and their judgment; they rely on Oaths Act categories for witness eligibility; and they have been continued under the Public Health Act 2016. The approved form requirement creates an administrative dependency on whatever authority issues the approved form.

The regulations have an extensive amendment and reprint history set out in the compilation table and in bracketed amendment notes within the body of the instrument. The table shows the original enactment and subsequent instruments that changed content, added or deleted provisions, or updated cross‑references.

Original enactment: Blood and Tissue (Transmissible Diseases) Regulations 1985, published 8 February 1985, commenced on the same day. The 1985 regulations are the foundational instrument.

Subsequent amendments and insertions: The compilation table lists amendment regulations in 1986, 1988, 1991, 1999, 2010, 2011, 2012, 2014, 2016 (two instruments), 2017 (as part of Public Health consequential amendments), 2018 and 2020. Specific in‑text bracketed notes show certain insertions and deletions.

Key textual changes indicated in the text:

• Reg 2 was inserted on 17 May 1991 (Gazette reference) and later amended (reg 2 insertion note and amendment reference to Gazette 19 Sep 2017 p. 4883‑4). The present reg 2 contains the definitions of “blood” and “therapeutic use” and the extended reading of “donating of blood” to include substances obtained from blood and ova and semen (reg 2(1)-(2)). The 1991 insertion formalised these definitions.

• Reg 3 has been amended on multiple occasions. The in‑text note shows an amendment on 13 May 1988 and a later amendment under SL 2020/47 r. 4. The current reg 3 includes subregulations (1)-(3), the medically justifiable exception under subreg (2) and the exclusions under subreg (3).

• Reg 4 was amended on 13 May 1988 and by SL 2020/47 r. 5, as reflected in the bracketed notes. Reg 4 sets the donor’s furnishing obligation.

• Reg 5 was amended several times: Gazette 13 May 1988 p. 1596; 1 Apr 2011 p. 1177; and SL 2020/47 r. 6. One explicit change visible in the current text is the inclusion of Australian Red Cross Lifeblood staff as authorised witnesses (reg 5(d) insertion dates align with the 2011 amendment mention).

• A previous reg 2A was deleted (Gazette 19 Sep 2017 p. 4883). The deletion is recorded in the text as “[2A. Deleted: Gazette 19 Sep 2017 p. 4883.]”

• Reg 6 (Form of declaration) was inserted by SL 2020/47 r. 7, which emphasised the need for an “approved form.” That was a recent formalisation of formality.

• Reg 7 (Offences) was inserted originally in 1988 (Gazette 13 May 1988 p. 1596) and amended in 2017 (Gazette 19 Sep 2017 p. 4884). The current offence provision fixes the penalty at $1,000.

• Schedule 1 was deleted by SL 2020/47 r. 8. The schedule no longer appears.

Reprints and reprints dates: The compilation table records reprints, including a reprint as at 11 October 2002 and Reprint 2 as at 14 November 2014. These reprints incorporated prior amendments listed in the table.

Carriage under new public health statute: The “Other notes” disclose that the regulations were originally made under the Health (Miscellaneous Provisions) Act 1911 and continue under the Public Health Act 2016 (s 321), to be treated as if made under s 304 of the Public Health Act 2016. This structural continuity was implemented via the Health Regulations Amendment (Public Health Consequential Amendments) Regulations 2017 Pt. 2 (Gazette 19 Sep 2017), with the commencement noted as 20 Sep 2017.

Summary timeline of substantive operational changes visible in the text:

• 1988: Early amendments including the insertion of offence provision reg 7 (1988 Gazette citations).

• 1991: Formal insertion of definition provisions for “blood” and “therapeutic use” (reg 2).

• 2011: Inclusion of Australian Red Cross Lifeblood staff in the authorised witness categories (reg 5 amendment dated 1 Apr 2011).

• 2017: Deletion of reg 2A and amendment of reg 7; transitional movement under the Public Health Act 2016.

• 2020: SL 2020/47 introduced several modernising edits: amendments to reg 3, reg 4, reg 5; insertion of reg 6 requiring an approved form; deletion of Schedule 1. SL 2020/47 was published 24 Apr 2020 and became effective for regulations other than r. 1 and 2 on 25 Apr 2020 (compilation table).

The amendment history shows an incremental modernisation trajectory: expansions of definitional scope, explicit authorisation of Lifeblood staff, formal adoption of an approved form, and continuity under the Public Health Act 2016. Each change altered either the scope or the administrative mechanics applicable to donors and takers.

The instrument as compiled does not record any litigation history, judicial decisions, or citations to cases. There are no cases named in the text of these regulations and the compilation table does not reference any judicial proceedings.

Consequently, within the source provided there is no recorded line of authority interpreting these specific regulations, no appellate or statutory interpretation decisions to cite, and no reported prosecutions or penalties recorded. The regulations themselves are silent about case law, and they do not reserve or confer any particular right of review or appeal beyond the ordinary common law and statutory remedies that would apply to enforcement actions against a person who “commits an offence” under reg 7.

Practically, this means:

• There is no text‑based guidance in these regulations about how courts have interpreted the 12‑hour window, the content of the “approved form”, what constitutes a “medically justifiable” opinion under reg 3(2), or what suffices for the “knowing” element in reg 3(1).

• Any interpretive questions or disputes about the application of these regulations would have to be determined by referencing general principles of statutory interpretation and by litigating facts in a court or tribunal, because no precedents are supplied in the instrument.

• Administrative or criminal proceedings initiated under these regulations would therefore establish first‑instance factual findings that could later generate case law, but the regulations themselves contain no litigation record.

For practitioners, the absence of recorded litigation means that compliance advice must be based on the plain text and cross‑statutory references rather than on an existing body of judicial interpretation. If contentious facts arise (for example, the temporal sufficiency of a declaration made 13 hours before donation, or the adequacy of a designated officer’s “medically justifiable” judgment), courts will need to resolve those issues de novo in the absence of prior authoritative rulings referenced by the regulations.

The regulations are short, but several operational, evidentiary and interpretive pitfalls arise from their structure and wording. These are the concrete practical “gotchas” that compliance officers, clinicians, transfusion services and legal advisers should watch for, with citations to the relevant provisions.

12‑hour timing requirement (regs 3(1), 4): The donor’s declaration must have been made “within the 12 hours preceding the donation” (reg 3(1); reg 4 repeats the 12‑hour window). Declarations outside that window are not compliant. There is no explicit provision for rounding, time zone issues or for a declaration made shortly before 12 hours that is later relied upon; the text is strict. Organisations must record precise times (witnesses must endorse the time, reg 5), and failure to do so could convert what was intended as lawful practice into an offence.

Approved form requirement (reg 6): The declaration must be “in the approved form.” The regulations do not include the approved form nor state who approves it. Using a non‑approved or customised form will render the declaration non‑compliant even if the content is substantively identical. Entities must locate the current approved form and any administrative directions about how it is approved and published.

Who is an authorised witness and how they must endorse (reg 5): Only persons falling within the three categories in reg 5 may permit the declaration to be made before them. That includes Oaths Act authorised witnesses, designated officers/delegates under the Human Tissue and Transplant Act 1982, and Australian Red Cross Lifeblood staff. The authorised witness must state full name, sign, date and endorse the time and their category of authorisation. Failure to make these endorsements will likely render the declaration invalid. For example, if a Lifeblood staff member witnesses a declaration but neglects to note the time or their authorisation category, the declaration may not satisfy regs 4 and 5.

Dual duties and dual exposure (regs 3(1), 4, 7): Both the taker/acceptor and the donor have duties. Reg 3(1) prohibits the taking/accepting without a valid declaration and reg 4 requires the donor to furnish the declaration. Reg 7 makes contravention of either an offence. Practically, organisations and donors can both be exposed to the same $1,000 fine for a single transaction. That creates potential finger‑pointing risk between clinical staff and donors when paperwork is incomplete.

Broad definition of “therapeutic use” (reg 2(1)): Because “therapeutic use” includes diagnostic testing and “testing susceptibility to a disease or ailment”, organisations undertaking diagnostic or susceptibility testing may inadvertently trigger the declaration requirement if the blood or derived substance is “intended” for those uses. Misclassification of purpose (therapeutic vs non‑therapeutic) is therefore a compliance risk.

Scope beyond blood to derived substances, ova and semen (reg 2(1)-(2)): The statutory definition of “blood” includes “any substance derived from blood,” and reg 2(2) extends “donating of blood” to substances obtained from blood and to ova and semen. That may surprise units that treat the regulations as applying only to whole blood; derived products and other tissues are captured.

Medically justifiable exception requires an opinion (reg 3(2)): The exception for incapacitated donors depends on the opinion of a designated officer or their delegate that taking or accepting the donation is “medically justifiable.” The regulations do not require that opinion to be recorded in writing or given before the taking; they do not set criteria for “medically justifiable.” Organisations relying on this exception should be aware that magistrates or prosecutors may scrutinise whether a bona fide professional opinion existed and whether it was formed contemporaneously.

No enforcement agency or procedural enforcement details in the text: The regulations do not identify who enforces or prosecutes the offence. If prosecutions arise, the question of which agency brings them and what evidence is required will be determined under general statutory and prosecutorial frameworks. That uncertainty complicates planning for enforcement risk.

Timing of amendments and transitional provisions (Compilation table; Other notes): The regulations have been amended repeatedly and were continued under the Public Health Act 2016. Practitioners must ensure they consult the current version, including the approved form and any subsidiary administrative instruments that flow from the Public Health Act 2016. Using an out‑of‑date procedure manual or form could create non‑compliance.

Recordkeeping expectations (implicit): The regulations implicitly require recordkeeping , the witness must endorse time and category of authorisation (reg 5), and the donor must furnish the declaration to the taker (reg 4). However, no retention period is specified. Organisations must decide reasonable retention practices to demonstrate compliance if challenged.

Potential confusion about “knowingly accept” (reg 3(1)(b)): The criminal element for a person accepting blood “knowingly” raises evidentiary issues. An organisation could argue it accepted in good faith on the basis of an apparently valid declaration, but proving scienter may be complex. Conversely, recklessness about paperwork may be treated as knowledge by a prosecutor.

Deletion of previous schedule(s) and forms (SL 2020/47): The deletion of Schedule 1 and the insertion of an “approved form” requirement in 2020 may have removed formerly standard content. Entities relying on old schedule wording should verify current requirements.

These gotchas require close operational attention to time stamping, using the approved form, checking witness endorsements, and documenting any use of the reg 3(2) exception via a designated officer’s opinion. Failure in any of these areas is the primary way compliance can fail under the express text of the regulations.

The regulations prescribe a limited set of documentary and procedural steps. The following compliance checklist and operational measures are grounded in the text and the risk points identified above. They are practical steps to align behaviour with regs 2-7 and to manage exposure under reg 7.

1. Obtain and use the approved form (reg 6)

   • Locate the current “approved form” for the declaration and ensure the version in use is the one officially approved. The regulation requires the declaration be in the approved form; any other form risks invalidity.
   • Ensure the approved form is accessible at donation points and integrated into electronic systems if declarations are being captured digitally.

2. Time the declaration and enforce the 12‑hour rule (regs 3(1), 4, 5)

   • Require every donor whose blood is intended for therapeutic use to make the declaration within the 12 hours immediately preceding donation.
   • Ensure the authorised witness records the precise time the declaration is made, as reg 5 requires endorsing the time on the declaration.
   • Operationalise time‑stamping procedures (synchronise clocks, capture times electronically where possible) to avoid disputes over whether the 12‑hour window was met.

3. Ensure proper witnessing and endorsements (reg 5)

   • Only allow the categories listed in reg 5 to witness declarations: Oaths Act authorised witnesses (s 12(6) category), designated officers or their delegates under the Human Tissue and Transplant Act 1982, and staff of Australian Red Cross Lifeblood.
   • Train authorised witnesses to add their full name, sign, date, endorse the time of the declaration, and record their category of authorisation on the declaration in the manner reg 5 prescribes.
   • Maintain a roster or verification process to confirm that the person witnessing a declaration actually falls within one of the authorised categories.

4. Verify declarations at point of taking and retention (regs 3(1), 4)

   • Make verification of the declaration a precondition before taking or accepting any blood for therapeutic use. Reg 3(1) creates an offence for taking/accepting without the declaration.
   • Retain copies of the approved form declarations and associated endorsements. The regulations require the donor to furnish the declaration to the person taking the blood (reg 4), and retention will provide evidence of compliance in the event of inquiry or prosecution.
   • Although the regulations do not specify retention periods, maintain records for a reasonable period consistent with clinical governance and potential litigation timelines; this mitigates evidentiary risk.

5. Procedures for incapacitated donors (reg 3(2))

   • Establish an operational protocol for dealing with donors who are incapable of making the declaration due to injury or illness.
   • Ensure that a designated officer or an authorised delegate for the Human Tissue and Transplant Act 1982 is available, or that their opinion can be promptly sought and, where practicable, recorded contemporaneously to document that taking/accepting is “medically justifiable.”
   • If the designated officer provides an oral opinion, contemporaneously document the opinion (time, name, reasons to the extent practicable) to create an audit trail.

6. Distinguish therapeutic from non‑therapeutic uses (reg 2(1), 3(3)(b))

   • Implement intake and triage procedures to determine whether a given intended use is a “therapeutic use” under reg 2(1). If use is non‑therapeutic or for the donor’s own use (reg 3(3)(a)), the declaration requirement does not apply.
   • Document the intended use at the point of donation so it is clear which regulatory path applies.

7. Integrate cross‑statutory requirements (regs 3(2), 5; Other notes)

   • Coordinate with nominated designated officers under the Human Tissue and Transplant Act 1982; understand delegation rules and how to contact those officers in emergencies.
   • Where statutory witnesses are relied upon under the Oaths Act, verify their authorisation under s 12(6) and keep a register or standard operating procedure for witness verification.

8. Training and internal controls

   • Train donors (where appropriate), clinical staff and administrative staff on the statutory requirements: the 12‑hour window, approved form, witness categories, endorsements, and record retention.
   • Implement checklists at donation stations requiring staff to confirm the presence of the approved form, the witness signature, and the time endorsement before accepting or taking blood for therapeutic use.

9. Audit and quality assurance

   • Periodically audit a sample of declarations to confirm that the form, witnessing and time‑stamping are correctly completed, and that records are retained in line with internal policies.
   • Use audit results to remediate training gaps or procedural weaknesses.

10. Legal and operational liaison

• Maintain contact with the entity that issues the approved form (for example, a health department or Australian Red Cross Lifeblood) to receive updates on approved forms, administrative guidance, or procedural changes.
• If an incident occurs where a declaration is missing or the time is close to the 12‑hour threshold, consult legal counsel and consider documenting the facts contemporaneously to preserve evidence of the decision‑making rationale.

11. Risk management for enforcement exposure (reg 7)

• Recognise that failure to comply with regs 3(1) and 4 exposes the person and the donor to a statutory fine of $1,000; recordkeeping and contemporaneous documentation aim to provide a defence or mitigation in the event of an enforcement action.
• Where there is uncertainty about whether a donation is for therapeutic use, consider a conservative approach , require the approved form and witness endorsement or contemporaneous written confirmation of intended use.

These compliance steps flow directly from the statutory text. They address the key operational elements: approved form, timing, witness eligibility and endorsement, exceptions where the donor is incapable, and recordkeeping to meet evidentiary needs. Implementing these measures will reduce the risk of contravening regs 3(1) or 4 and therefore the exposure to the penalty in reg 7.