This Regulation uses a small set of interlocking concepts to govern parentage testing. They are procedural and evidentiary, not programme‑funding or benefit‑allocating. Key concepts are:

• Parentage testing procedure: The instrument treats “parentage testing procedure” as an activity that includes DNA typing (clause 4). The definition in clause 3(1) imports operational terms used throughout the Regulation (for example, “testing” as implementation of a parentage testing procedure).
• Accredited laboratory and NATA: “Accredited laboratory” is a laboratory accredited by NATA to carry out parentage testing procedures, and NATA is the National Association of Testing Authorities, Australia (clause 3(1)). Clause 5(1)(b) and (c) require testing to occur at an accredited laboratory and in accordance with the standards that entitle a laboratory to NATA accreditation. The Regulation therefore conditions lawful testing on external accreditation standards.
• Donor, sampler and nominated reporter: The Regulation distinguishes the person providing the bodily sample (donor), the person who takes it (sampler) and the person nominated by an accredited laboratory to prepare the report (nominated reporter) (clause 3(1)). The nominated reporter is responsible for Part 1 of Form 3 (clause 6(2)), while Part 2 is for the tester or supervisor (clause 6(3)).
• Representative: For donors under 18 or donors with disability, the Regulation uses the term “representative” to mean a parent, guardian, trustee, manager or legally responsible carer as applicable. The definition is in clause 3(1) with further specification about incapacity under the Disability Inclusion Act 2014 (clause 3(2)). Clause 3(3) empowers the Supreme Court to appoint a representative where none is available or suitable.
• Forms and evidentiary formality: The Regulation prescribes forms in Schedule 1 and defines the division of responsibility between parts and signatories. Form 1 is the sworn affidavit by or in relation to the donor (clause 7(1)(a); Schedule 1). Form 2 is the sampler’s statement completed after sampling and must carry the donor photograph (clause 10). Form 3 is the statutory parentage testing procedure report (clause 6(1); Schedule 1). Form 4 is the paternity acknowledgement instrument used under s 19 of the Act (clause 13(1); Schedule 1).
• Chain of custody and sample integrity: The Regulation demands immediate placement of samples into unused containers, sealing that reveals subsequent opening, permanently inscribed labels signed by sampler and donor, and packing/storage that preserves integrity and makes testing results equivalent to immediate testing (clauses 9 and 11). It also requires the affidavit and sampler’s statement to be sent with the sample to the laboratory (clause 11(2)).
• Quality control at testing: Requirements on sterility of swabs/implements and on disposable needles and skin antisepsis for blood draws (clause 8); testing completion within a reasonable time (clause 12); and Part 2 of Form 3 requires the tester to certify controls, reagents and testing conditions (Form 3 Part 2).
• Evidentiary "no effect" rule for non‑conforming reports: Clause 6(4) takes reports completed otherwise than in accordance with clause 6 as being of no effect. That is a legal consequence internal to the Regulation attaching to non‑conformity with prescribed form and allocation of responsibility.

These concepts create a compliance chain from the non‑technical act of swearing an affidavit and taking a photograph to technical testing in a NATA‑accredited laboratory and the certification of controls and methods in the laboratory report. The Regulation structures roles and documentary artefacts to support the identification and integrity of samples and to allocate accountability for the reporting that follows.

The Regulation sets duties and procedural obligations that affect a limited and identifiable set of actors involved in parentage testing:

• Donors (persons giving samples): donors must complete (or have their representative complete) an affidavit in Form 1 immediately before sampling, and must provide or arrange for a recent passport-type photograph to be attached and to be affixed to the sampler’s statement (clause 7(1)(a)-(b); clause 10(b)). Donors also must sign the label on the sample container (clause 9(1)(f)). Donors who are under 18 or have a disability are specifically treated: the affidavit must be completed only by the donor’s representative (clause 7(3)), and, where the donor is under 18 or has a disability, the container labelling signature requirement is satisfied only if the representative signs (clause 9(2)(b)).
• Donors’ representatives: the Regulation defines representatives and assigns them multiple concrete responsibilities where applicable: completing the Form 1 affidavit on behalf of minors/incapacitated donors (clause 7(3); Form 1 Part 2); being present when containers are sealed and labelled (clause 9(2)(a)); and signing labels if the donor cannot (clause 9(2)(b)). The Regulation also provides for the Supreme Court to appoint a representative where no suitable representative is available (clause 3(3)).
• Samplers: the person who takes the bodily sample must comply with procedural rules at collection: secure the affidavit and photograph (clause 7(1)), use sterile, unused swabs and implements or disposable needles as prescribed for DNA typing / blood (clause 8), place the sample in an unused container immediately in the donor’s presence, seal and label it in a tamper‑evident way and sign the label jointly with the donor (clause 9(1)(a)-(f)), complete Form 2 after taking the sample and affix the donor photograph (clause 10), and ensure the required documents accompany the sample to the laboratory (clause 11(2)). Samplers are central to chain-of-custody.
• Accredited laboratories and their personnel: testing must be done at an accredited laboratory (clause 5(1)(b)); the laboratory must apply NATA-equivalent standards (clause 5(1)(c)) and ensure testing is completed in a reasonable time (clause 12). Accredited laboratories must nominate a “nominated reporter” to prepare Part 1 of the report (clause 6(2); Form 3 Part 1), and someone who carried out or supervised testing must complete Part 2 (clause 6(3); Form 3 Part 2). Laboratories must also handle samples in a way that preserves integrity and equivalence to immediate testing (clause 11(1)).
• Nominated reporters and testing supervisors: the Regulation separates the reporting role between the nominated reporter (Form 3 Part 1) and the person who carried out or supervised testing (Form 3 Part 2) (clause 6(2)-(3)). The nominated reporter must identify the samples and state the outcomes; the tester/supervisor must record identification numbers, test controls, reagents, methods and corroborate that results are true and correctly transcribed (Form 3 Part 2).
• Witnesses and authorised signatories: Form 1 requires the affidavit be sworn or affirmed in the presence of an authorised witness (Schedule 1 Form 1) and includes a certificate under the Oaths Act 1900 (Schedule 1). Form 4 (paternity acknowledgement) must be witnessed by an Australian legal practitioner or a nominated officer of the Registry of Births, Deaths and Marriages (Schedule 1 Form 4; clause 13(1) and clause 13(2)).
• Hospitals, pathology practices, parentage testing practices, medical practitioners and their employees: clause 15 prescribes persons employed by those entities for the purpose of taking bodily samples as “qualified persons” for the purpose of s 33(2)(c) of the Act. The Regulation therefore affects the staffing and delegation practices of those institutions.
• NSW Trustee and Guardian, licensed trustee companies, executors/trustees/administrators: clause 14 prescribes certain persons and classes of persons who may make applications for declarations by the Supreme Court of parentage for the purposes of section 21(1)(e) of the Act.

Who pays: the Regulation imposes operational and documentary burdens on samplers, laboratories and donors. Accredited laboratories carry the cost of maintaining NATA accreditation and implementing quality controls and timely testing; samplers or their employing bodies must supply sterile consumables, certified unused containers and handle documentation; donors or their representatives must attend swearing of affidavits and provide photographs. The Regulation does not prescribe fees or funding in itself.

Who decides: the Regulation allocates decision points to multiple actors , the sampler decides whether prescribed pre-sampling steps are complete, the laboratory decides nomination of the reporter and the testing pathway (subject to NATA standards), the Supreme Court may decide on appointment of representatives where required (clause 3(3)), and the Registrar may nominate Registry officers authorised to witness paternity acknowledgements (clause 13(2)). The Regulation therefore decentralises operational decisions to professional actors while reserving supervisory appointment power to the Court in specific incapacity cases.

The Regulation creates explicit duties and prescribes forms; it also creates a few limited rights (for example, access to a representative) and leaves other enforcement and remedial rights to the Act. Main duties and a small set of rights follow from the text.

Primary duties

• Duty to comply with Part 2 and to use accredited lab: A parentage testing procedure must be carried out in compliance with Part 2 of the Regulation, at an accredited laboratory, and according to NATA-equivalent standards (clause 5(1)(a)-(c)). This is a foundational duty that constrains where and how testing may lawfully proceed under the Act.
• Duty to complete forms correctly: Parentage testing procedure reports must be prepared in Form 3 and the parts allocated between nominated reporter and testing person must be completed as specified (clause 6(1)-(3)). Clause 6(4) makes a report completed otherwise than in accordance with clause 6 “taken to be of no effect”. Form 1 and Form 2 must also be completed at prescribed times and with photographs attached (clause 7; clause 10).
• Sampler duties at collection: Before taking a sample, the sampler must ensure the donor has completed Form 1 and provided the required photograph or arrangement for the photograph (clause 7(1)). After taking the sample, the sampler must put the sample immediately into an unused container in the donor’s presence, seal it so tampering is evident, label it with specific particulars (donor name, date of birth, sex, date/time) permanently inscribed and signed by both sampler and donor, and, where donor is a minor or with disability, ensure presence and signature of the representative (clause 9(1)-(2)). The sampler must then complete Form 2 (clause 10).
• Sterility and procedural duties: For DNA typing, the sampler must use sterile, unused swabs or implements for non-blood samples, and sterile disposable needles/syringes and antiseptic skin cleaning for blood draws (clause 8).
• Packaging and documentation duties: The sampler must pack, store and transport samples so as to preserve integrity and ensure equivalent results to immediate testing, and must send the Form 1 affidavit and Form 2 sampler statement to the laboratory with the sample (clause 11(1)-(2)).
• Laboratory duties: The laboratory receiving a sample for DNA typing must complete testing within a reasonable time (clause 12) and must ensure testing is carried out in accordance with the standards entitling it to NATA accreditation (clause 5(1)(c)). The laboratory must produce a parentage testing procedure report in Form 3; Part 1 by its nominated reporter and Part 2 by the tester or supervisor (clause 6(1)-(3)).

Specified rights and controls

• Right to representation for minors and persons with disability: For donors under 18 or lacking capacity by virtue of disability, the Regulation channels decision-making through a “representative” (clause 3(1); clause 7(3)). The Supreme Court may appoint a representative where none is available or suitable (clause 3(3)). This creates a route to protect decision-making for persons who cannot lawfully give consent or comply with the formality.
• Right to have an affidavit witnessed: Form 1 must be sworn or affirmed and witnessed; Form 1 includes the text of a certificate under s 34(1)(c) of the Oaths Act 1900 (Schedule 1 Form 1). The Regulation therefore embeds the right of parties to formal oath/affirmation processes.
• Allocation of reporting responsibility: The Regulation gives nominated reporters and testing personnel clear rights to sign and state the testing outcome in their respective parts of Form 3 (clause 6(2)-(3) and Schedule 1 Form 3). The nominated reporter is the laboratory’s nominated person to prepare the report (Form 3 Part 1), and the tester/supervisor has the right to certify technical controls (Form 3 Part 2).

Negative legal consequence embedded

• Report “taken to be of no effect” where not in accordance with clause 6 (clause 6(4)). The Regulation makes the form and allocation of reporting duties dispositive of the legal effect of the report under this Regulation.

Unspecified or reserved matters

• The Regulation does not itself specify penalties, enforcement mechanisms, or admissibility rules outside its own “no effect” clause for reports. The Act and other statutes referenced (for example the Oaths Act 1900) are invoked where necessary (clause 3 and Schedule 1), but this Regulation primarily focuses on process and form rather than sanctions.

The Regulation largely prescribes process and form rather than enforcement mechanisms. It embeds one explicit legal effect for non‑compliance and otherwise leaves regulatory enforcement and penalties to the Act or other laws that it references.

Express enforcement‑type provision in the Regulation

• Clause 6(4): “A parentage testing procedure report completed otherwise than in accordance with this clause is taken to be of no effect.” This is the Regulation’s single explicit substantive sanction: failure to prepare the report in the prescribed Form 3, and to allocate and complete Parts 1 and 2 as required, nullifies the report for the purposes of this Regulation.

What the Regulation does not do (and the implications)

• No express penalty schedule: The Regulation contains no penalty provisions, fine amounts or criminal offences. It does not set out administrative enforcement powers such as inspection, licensing, suspension, or civil relief mechanisms.
• No procedural enforcement steps: The Regulation does not prescribe audits, reporting to government bodies, or remedial processes should procedures be breached (for example, no mandatory re‑sampling regime is set out in the text). The Regulation’s enforcement lever is primarily evidentiary: adherence to form determines whether a report has legal effect under the Regulation.
• Interaction with the Act and other laws left unspecified within the Regulation: The Regulation repeatedly references the Act (clause 3(1)), the Oaths Act 1900 (Schedule 1 Form 1), and NATA accreditation standards. Enforcement mechanisms, if any, that flow beyond the Regulation , for example, penalties in the Act or admissibility rules in court practice , are not enacted here. Users must therefore check the Act for complementary enforcement mechanisms.

Practical enforcement risks and compliance attention

• The “no effect” rule is a practical enforcement tool. It makes precise collection, labelling, and reporting steps gating conditions for the report to be effective. This puts the compliance burden on samplers and laboratories: procedural lapses (wrong form, missing signatures, misallocated report parts) can produce a report that the Regulation treats as void for its purposes (clause 6(4)). The text does not specify how a court or other decision maker must treat a “no effect” report, but within the Regulation the formal effect is clear.
• Where the Regulation is silent on enforcement, operational compliance may be shaped by professional standards, NATA accreditation processes, contractual arrangements between parties, or agency practices (for example, the Registry of Births, Deaths and Marriages), rather than by the Regulation’s own penalty framework.

In short, the Regulation enforces process chiefly by making process determinative of a report’s legal effect under the instrument. It does not itself create a broader penalty or enforcement apparatus.

The Regulation embeds and relies on a small number of external legal instruments and standards. Those interactions are concrete: the Regulation imports definitions, evidentiary forms and standards by reference rather than attempting to reproduce them.

Primary interactions recorded in the text

• Status of Children Act 1996 (the Act): The Regulation is subordinate to and operates for the purposes of the Act. It repeatedly references specific sections of the Act as the legal hooks for its prescriptions, for example the definition of parentage testing procedure in section 3(1) (clause 4), the requirement for parentage testing procedure reports to meet Form 3 for purposes of the Act (clause 6(1)), the use of Form 4 for acknowledgements under section 19(1)(a) of the Act (clause 13(1)), and the prescribing of persons for section 21(1)(e) applications (clause 14). The Regulation therefore functions as the Act’s procedural scaffolding for parentage testing.
• National Association of Testing Authorities (NATA) standards: The Regulation requires testing at laboratories accredited by NATA and “in accordance with the standards of practice that entitle a laboratory to be accredited by NATA” (clause 5(1)(b)-(c)). This imports technical quality standards and the accreditation regime into the legal requirement without reproducing their content.
• Subordinate Legislation Act 1989: Clause 2 notes that the Regulation repeals and replaces the Status of Children Regulation 2013 and that without this instrument the 2013 Regulation would have been repealed on a date specified in the Subordinate Legislation Act 1989. This is an administrative contextualisation of commencement and repeal.
• Disability Inclusion Act 2014: Clause 3(2) ties the concept of donor with a disability to the Disability Inclusion Act 2014 by reference to its legal effect , specifically, where a disability “results in the donor lacking the legal capacity to comply with or consent to a requirement of this Regulation” or otherwise prevents compliance.
• Oaths Act 1900: Schedule 1 Form 1 includes a “Certificate under section 34(1)(c) of Oaths Act 1900” and the affidavit is to be sworn or affirmed in accordance with the Oaths Act (Schedule 1 Form 1). The Regulation therefore relies on the Oaths Act for formalities around sworn affidavits.
• Corporations Act 2001 (Commonwealth): Clause 14 prescribes as eligible applicants for Supreme Court declarations persons such as “a licensed trustee company within the meaning of Chapter 5D of the Corporations Act 2001” , a direct cross-reference to a Commonwealth statute to identify a class of corporate actors.
• Registry and administrative rules: Clause 13(2) prescribes “officers of the Registry of Births, Deaths and Marriages nominated for the time being by the Registrar” as authorised witnesses for paternity acknowledgements. That imports internal Registry nomination practice into the legal regime.

What is not imported or altered

• The Regulation does not amend or restate the Act’s substantive rules on legal parentage, rights, obligations, or enforcement; it confines itself to process for testing and documentation. Any substantive changes to parentage law would continue to lie in the Act.
• The Regulation does not create or override NATA’s accreditation processes; it conditions the legality of testing on NATA accreditation without attempting to define accreditation standards itself.
• The Regulation is not an exhaustive code for evidentiary admissibility in court. It provides forms and a statutory “no effect” rule for non‑conforming reports but does not purport to govern how courts should treat non‑statutory evidence or other types of expert reports.

Practical effects of cross‑references

• Delegation of technical standard‑setting: By referencing NATA standards and NATA accreditation, the Regulation creates a legal duty whose technical content is defined externally. Accredited labs and parties must therefore maintain compliance both with the Regulation’s documentary demands and with NATA’s technical standards.
• Capacity and consent coordination: The Regulation’s reference to the Disability Inclusion Act 2014 and the Supreme Court’s appointment power (clause 3(2)-(3)) coordinates incapacity determinations across instruments, giving a route for surrogate decision‑makers consistent with other NSW law.
• Administrative delegation for witnessing: By prescribing Registry officers nominated by the Registrar as authorised witnesses for paternity acknowledgements (clause 13(2)), the Regulation creates a delegated administrative interface between forms under the Regulation and the birth registry.

In practice, compliance requires attention to both the Regulation’s procedural prescriptions and to the external legal and technical instruments it imports.

The Regulation replaces and repeals the Status of Children Regulation 2013. The instrument contains three short, concrete items of amendment history or transitional continuity.

• Repeal of the 2013 Regulation: Clause 16(1) expressly repeals the Status of Children Regulation 2013.
• Savings provision: Clause 16(2) preserves continuity by stating that any act, matter or thing that, immediately before repeal of the 2013 Regulation, had effect under that Regulation continues to have effect under this Regulation. This is a standard savings mechanism to prevent legal gaps on repeal.
• Commencement: Clause 2 sets the commencement date as “the day on which it is published on the NSW legislation website.” It also contains an explanatory note that, absent this instrument, the 2013 Regulation would have been repealed on 1 September 2019 under section 10(2) of the Subordinate Legislation Act 1989. That note provides context for the timing but is not itself operative law beyond clause 2.

No other amendment history is recorded in the text provided. The Regulation’s transitional clause means that activities properly done under the 2013 Regulation remain valid under the 2019 Regulation. The instrument therefore aims to be a direct successor regime without creating retroactive invalidation of prior acts taken under the repealed Regulation.

The Regulation itself records no litigation, and its Schedule and clauses do not cite any judicial decisions or proceedings. The instrument contains no decisions, case law references or reported litigation arising under its terms.

What the text does record relevant to judicial activity

• Clause 3(3) authorises the Supreme Court to appoint a representative for a donor for the purposes of the Regulation if the Court is satisfied there is no other representative available or suitable. That provision creates a specific, court‑directed route for substitute decision‑making in particular cases, but the Regulation does not provide examples, procedures or reported decisions exercising that power.

Implications for practitioners

• The Regulation’s silence on litigation history means there is no adjudicated interpretation within the instrument itself to guide disputes over form, signatures, admissibility, or the meaning of “taken to be of no effect.” Practitioners should therefore expect that any dispute about the Regulation’s operation would require applying the text against the facts in litigation or administrative decision contexts and that courts would be asked to interpret the Regulation in the absence of prior appellate rulings recorded in the instrument.
• Clause 6(4)’s “no effect” rule could be a focal point for litigation where parties challenge the validity or admissibility of a report that departs from the prescribed forms or signatory allocation. The Regulation itself supplies the textual basis for that argument; how courts treat a “no effect” report in a given proceeding is not settled within the Regulation.

Because there is no litigation record in the instrument, practitioners must treat the Regulation as the starting point for any judicial interpretation rather than as one point in an already-developed judicial line.

The Regulation creates multiple precise procedural traps where failure to follow the text will have concrete, source‑grounded consequences. Below are the main practical “gotchas” that arise directly from the Regulation’s wording.

1. Form‑and‑allocation fatality for reports (clause 6(1)-(4))

   • A parentage testing procedure report must be prepared in Form 3. Clause 6(4) states that a report completed otherwise than in accordance with clause 6 is “taken to be of no effect.” The “gotcha” is that minor deviations in how the report is completed, or misallocation of signatures between Part 1 and Part 2, may render the report void for the purposes of the Regulation. Practitioners must ensure strict compliance with Form 3 and the division of responsibilities between nominated reporter (Part 1) and testing person/supervisor (Part 2).

2. Dual photograph and affidavit timing (clause 7; clause 10)

   • Clause 7(1)(a) requires the donor to have, immediately before sampling, completed an affidavit in Form 1 with a photograph attached. Clause 7(1)(b) separately requires the donor to provide a recent photograph or make a written arrangement for one to be taken. Clause 10(b) requires the sampler to affix the photograph referred to in clause 7(1)(b) to Form 2 and create a joined inscription across photograph and statement. The “gotcha” is that the Regulation requires both an attached photograph on the affidavit and a separately provided photograph affixed to Form 2; failure to secure and correctly affix both photographs at the appropriate times risks non‑compliance.

3. Signature and representative requirements for minors and persons with disability (clause 7(3); clause 9(2))

   • If the donor is under 18 or has a disability, the affidavit must be completed only by the donor’s representative (clause 7(3)), and the label-signature requirement is taken to be complied with only if the representative signs (clause 9(2)(b)). Practically, samplers accustomed to obtaining a minor’s signature risk creating a defective chain‑of‑custody unless they obtain the representative’s signature and presence. The Supreme Court may appoint a representative if none is available (clause 3(3)), but that is a potentially time-consuming court process.

4. Sterility and disposable equipment for DNA sampling and blood (clause 8)

   • The Regulation mandates unused sterile swabs/implements and disposable needles/syringes and antiseptic skin cleaning for blood samples. Using re‑used or non‑sterile equipment is an explicit breach. The “gotcha” is that low-cost or ad hoc samplers must stock and document appropriate consumables; otherwise testing quality and procedural compliance will be in question.

5. Container and label permanence and tamper evidence (clause 9)

   • Labels must be inscribed permanently and designed so removal, impairment or erasure is evident on inspection; the container must be sealed so that opening is evident. Practically, this requires use of tamper‑evident containers and durable labelling systems. Informal packaging or non‑tamper-evident labelling risks non‑compliance and challenges to integrity.

6. Required documents accompanying the sample (clause 11(2))

   • The sampler must ensure the affidavit (Form 1) and the sampler’s statement (Form 2) accompany the sample to the laboratory. Failure to do so can interrupt the link between sample and sworn identification evidence, and may affect the report’s status under the Regulation.

7. Timing expectation for testing (clause 12)

   • A laboratory must ensure testing is completed within a “reasonable time” after the sample is taken. “Reasonable time” is not defined in the Regulation. The lack of an objective deadline is a “gotcha” for parties relying on quick results; it will invite disputes where delay undermines statutory or administrative timelines.

8. Health disclosure particulars on Form 1 (Schedule 1 Form 1)

   • Form 1 requires disclosure of past leukaemia, bone marrow transplant and recent blood transfusions. These items materially affect test interpretation, and failing to secure these particulars at the time of affidavit can impair a lab’s ability to interpret results or to rely on Form 1 as truthful. The Regulation makes these disclosures a formal part of the affidavit.

9. Witnessing and certification formalities (Schedule 1)

   • Affidavits must be sworn or affirmed and carry the witness’s certification under the Oaths Act. Practitioners must ensure the witness either sees the face of the person or follows the Oaths Act certificate options in Form 1. Mistakes here may render the affidavit procedurally defective.

10. Paternity acknowledgment witnessing (Schedule 1 Form 4; clause 13)

• Form 4 must be witnessed by an Australian legal practitioner or an officer of the Registry of Births, Deaths and Marriages nominated by the Registrar. Using an inappropriate witness or failing to record the witness’s qualification and contact details (as required in the form) risks invalidating the acknowledgment process.

11. Qualified persons and delegation (clause 15)

• Clause 15 prescribes employees of hospitals, pathology practices, parentage testing practices or medical practitioners as “qualified persons” for s 33(2)(c) of the Act. Parties relying on an alternative sampler or an outsourced provider must ensure their staff fall within the prescribed classes; otherwise, the sample-taking may not meet the Act’s qualification test.

In short, the Regulation is form‑sensitive and procedural. Small administrative oversights , wrong photograph, missing signature, unsealed container, incorrect person completing an affidavit , can produce materially different legal outcomes because the instrument makes legal effect turn on form and allocation of responsibilities.

Compliance requires attention to sequence, documentation, equipment, and role allocation. The steps below set out a practical compliance checklist grounded in the Regulation’s clauses and forms.

1. Ensure sampling will be conducted at a NATA‑accredited laboratory or under its arrangements (clause 5(1)(b)-(c))

   • Only accredited laboratories are prescribed for parentage testing procedures. Before any sampling, confirm that the testing laboratory is NATA‑accredited for parentage testing or has accreditation for the relevant DNA typing procedures.

2. Pre‑sampling affidavit and photograph (clause 7(1)(a)-(b); Schedule 1 Form 1)

   • Immediately before sampling, the donor must complete and swear or affirm Form 1. Attach a recent 45 mm by 35 mm full-face photograph to Form 1 as Attachment A, and ensure the affidavit includes the health disclosure items (leukaemia, bone marrow transplant, transfusion history).
   • If the donor is under 18 or has a disability, the donor’s representative must complete and swear/affirm Form 1 (clause 7(3); Form 1 Part 2).

3. Obtain and secure the separate photograph required by clause 7(1)(b)

   • In addition to the photograph on Form 1, obtain or arrange for a separate recent photograph approximately 45 mm by 35 mm to be affixed to Form 2. If the donor cannot provide it immediately, make a written arrangement with the sampler for the photograph to be taken.

4. Use prescribed sampling equipment and sterile procedure (clause 8)

   • For DNA typing, use sterile, unused swabs for non‑blood samples; use sterile, disposable needles/syringes for blood draws and clean the skin with antiseptic before blood withdrawal. Maintain records of equipment batch or identifier where possible.

5. Immediate container placement, sealing, and labelling in donor’s presence (clause 9(1)(a)-(f))

   • Place the sample in an unused container immediately after collection in the presence of the donor. Seal the container so that opening is visually evident, label it with permanently inscribed particulars (full name, date of birth, sex, date/time of sample), and ensure the label is signed by both the sampler and the donor. For donors under 18 or with disability, the representative must be present for sealing and must sign the label (clause 9(2)).

6. Complete Form 2 and perform joined inscription across photograph and statement (clause 10)

   • After taking the sample, complete the sampler’s statement in accordance with Form 2, affix the photograph required under clause 7(1)(b), and write the donor’s name partly on the photograph and partly on the statement so that later removal is evident (clause 10(c)).

7. Package and transport to laboratory preserving sample integrity; include documents (clause 11(1)-(2))

   • Pack, store and transport the sample in a manner that preserves integrity and ensures testing would produce the same result as immediate testing. Send Form 1 (affidavit) and Form 2 (sampler’s statement) with the sample to the laboratory (clause 11(2)).

8. Laboratory testing and timely completion (clause 12)

   • The receiving laboratory must ensure testing is completed within a reasonable time. Laboratories should document testing timelines and any delays, and have protocols to keep samples stable pending testing.

9. Allocate and complete Form 3 correctly (clause 6(1)-(3); Schedule 1 Form 3)

   • The accredited laboratory must nominate a nominated reporter who completes Part 1 of Form 3 (nominating the person and certifying which samples were tested and the result). The person who carried out the testing or the supervisor must complete Part 2, record identification numbers, set out results, state controls and reagents used, and certify the accuracy and transcription of results.
   • Ensure that the Part 1 and Part 2 signatories are properly authorised and that Part 2 contains the laboratory’s technical confirmations (controls, parallel testing with known controls, reagent specificity/potency or probe/primer usage and fragment/hybridisation standards as applicable).

10. Preserve copies and chain-of-custody documentation

    • Retain copies of Form 1, Form 2 and Form 3, the sealed container identifiers, batch or kit numbers for consumables and reagents, and any dispatch records. These are essential to demonstrate compliance with the Regulation’s chain-of-custody and reporting requirements.

11. For donors with incapacity or minors, organise representation or court appointment where necessary (clause 3(2)-(3); clause 7(3))

    • If the donor is under 18 or has a disability that prevents legal capacity, secure a representative to complete Form 1 and sign the label, or apply to the Supreme Court to have a representative appointed where none is available or suitable (clause 3(3)).

12. Use authorised witnesses for Form 1 and for paternity acknowledgements (clause 13; Schedule 1)

    • Ensure the affidavit is sworn or affirmed before an authorised witness as required by the Oaths Act 1900. For paternity acknowledgements in Form 4, ensure witnessing by an Australian legal practitioner or a nominated Registry officer (clause 13(1)-(2) and Schedule 1 Form 4).

13. Staff training and consumables management

    • Employers of samplers should ensure staff are trained in the Regulation’s procedural steps, sterile technique requirements, container sealing and labelling protocols, and handling of the affidavit/photo requirements. Maintain inventory of sterile consumables and tamper‑evident containers.

14. Check organisational eligibility for “qualified persons” (clause 15)

    • If relying on a person to be a “qualified person” under s 33(2)(c) of the Act, confirm they are employed by a hospital, pathology practice, parentage testing practice or a medical practitioner as prescribed in clause 15.

15. Audit compliance against the Regulation regularly

    • Because clause 6(4) renders non‑compliant reports of no effect, implement spot‑checks on the completeness of Forms 1-3, signatures, photographs, container seals and dispatch of documents to laboratories.

Following these steps aligns operations with the Regulation’s prescriptive sequencing and reduces the risk that a report prepared under it will be “taken to be of no effect.” Where legal questions remain about how these procedures interact with the Act or other statutes, seek statutory interpretation advice focused on the Act and court practice.