STATUS OF CHILDREN REGULATIONS 1996

The Regulations organise around three interlocking concepts: qualifying procedures, chain of custody and documentary form, and institutional accreditation and reporting.

1. Qualifying procedures (reg 3)

• The Regulations list specific laboratory methods that constitute parentage testing procedures: red cell antigen blood grouping; red cell enzyme grouping; HLA tissue typing; testing for serum markers; and DNA typing. This list prescribes the technical scope of "parentage testing procedure" as used in the parent Act.

2. Chain of custody and specimen integrity (regs 6-11)

• Pre‑collection identity and health disclosures: Before sampling the donor must complete an affidavit in Form 1 (reg 6(1)(a), Sch Form 1) and either provide a recent photograph approximately 45 mm by 35 mm or arrange for one to be taken (reg 6(1)(b)).
• Immediate pre‑sampling declaration: The donor must complete Form 2 immediately before sampling, confirming whether blood or blood products have been received since signing Form 1 (reg 6(2), Sch Form 2).
• Who may take samples: Only specified persons may take bodily samples (medical practitioners or certain employees), limiting the class of samplers (reg 5).
• Sterility and single‑use requirements: Needles, syringes and swabs must be unused and sterilised and, for blood, disposable (regs 7-8).
• Sealing and labelling: Samples must be placed immediately in a previously unused container, sealed in a tamper‑evident way, labelled in ink with full name, date of birth and sex of the donor and the date and time of collection; the sampler and donor must sign the label in ink (reg 9(1)(a)-(f)).
• Sampler statement and photograph: The sampler must complete Form 3, affix the donor’s photograph to it and sign partly on the photo and partly on the statement (reg 10, Sch Form 3). The signature across the photograph and statement creates a physical check against removal or substitution.

3. Institutional accreditation and reporting formality (regs 4, 11-13)

• NATA accreditation is required for laboratories performing parentage testing procedures and testing must be carried out in accordance with standards that entitle the laboratory to accreditation (reg 4(a)(ii)-(iii)).
• Laboratories must complete tests within prescribed timeframes (red cell antigen/enzyme/serum markers within six days; HLA within three days; DNA within a reasonable time) and must receive the affidavit, declaration and sampler statement with the sample (regs 11-12).
• Reporting is tightly prescribed: reports must follow Form 4 with Part 1 filled by the nominated reporter and Part 2 by the testing person or supervisor; otherwise the report is of no effect (reg 13(1)-(5), Sch Form 4).
• The Attorney‑General publishes the list of accredited laboratories and nominated reporters in the Gazette (reg 14).

Terminology and procedural detail in the Schedule (Forms 1-4) operationalise the above concepts: Form 1 addresses donor identity, racial background and recent haematological history; Form 2 captures interim transfusion history; Form 3 documents the collection event and the sampler’s attestation; Form 4 structures the report and requires explicit findings, indices and laboratory controls.

Taken together, the Regulations define what counts as a legally effective parentage test, create a chain‑of‑custody protocol to protect sample integrity, limit who may collect samples, set laboratory accreditation requirements, and lock reporting into a specific format and allocation of responsibility between nominated reporter and testing personnel.

The Regulations create obligations and produce legal consequences for distinct groups. The text identifies who must act and who bears the consequences of non‑compliance.

• Donors and persons whose bodily samples are taken: Every person from whom a bodily sample is taken for parentage testing is affected. They must provide sworn information and declarations (Form 1 and Form 2) and supply or permit a photograph (reg 6(1), Sch Forms 1-2). Donors under 18 or persons with a mental disability are subject to modified signing and presence requirements; a person responsible for long‑term care may sign on behalf of a minor and a trustee or carer must sign for a person who lacks capacity (reg 6(3), reg 9(2)-(3)).

• Samplers: Individuals who take bodily samples are subject to detailed procedural duties. Only specified persons may act as samplers (reg 5). Samplers must obtain and verify affidavit and photograph requirements before taking a sample (reg 6(1)), observe sterility and single‑use rules for equipment (regs 7-8), place samples in unused containers in the donor’s presence and seal and label them with specified particulars and signatures (reg 9), complete Form 3 with the donor’s photograph attached and sign across it (reg 10), and ensure documentary transmission to the laboratory (reg 11(2)).

• Laboratories and laboratory personnel: Laboratories must be NATA‑accredited for parentage testing procedures and must implement standards that entitle that accreditation (reg 4(a)(ii)-(iii)). Laboratories must complete testing within set timeframes (reg 12), ensure testing is done with appropriate controls and documentation (Sch Form 4 Part 2), and receive the affidavit, declaration and sampler statement with the sample (reg 11(2)). Testing personnel or their supervisors must complete Part 2 of the report (reg 13(4), Sch Form 4 Part 2).

• Nominated reporters: Each NATA‑accredited laboratory nominates a person to prepare the legal report. The nominated reporter must complete Part 1 of the Form 4 report (reg 13(3), Sch Form 4 Part 1). The Attorney‑General is required to publish the nominated reporter’s name alongside accredited laboratories in the Gazette (reg 14).

• The Attorney‑General and Registrar: The Attorney‑General must publish accredited laboratories and nominated reporters (reg 14). The Regulations prescribe a $50 fee for instruments filed with the Registrar under s 10(1) of the Act (reg 15), creating an administrative interaction with the Registrar’s filing function.

• Courts and decision‑makers receiving parentage evidence: Although the Regulations do not directly command courts, they determine the form and content that testing and reports must take to be "taken to be carried out in accordance with these Regulations" and to be legally effective for the purposes of the Act (reg 4, reg 13(5)). A report not prepared in the prescribed form is "of no effect" (reg 13(5)), which affects litigating parties who seek to rely on laboratory evidence.

• Healthcare and pathology employers: Hospitals, pathology practices and parentage testing practices that employ samplers will need operational procedures that ensure their employees meet the technical and documentary requirements (reg 5).

Who is not directly regulated by the text: The Regulations do not specify who pays for testing, shipping, or the $50 filing fee beyond stating the filing fee (reg 15). They also do not impose express criminal penalties or administrative sanctions in the instrument itself; instead they make legal effectiveness contingent on compliance (reg 4, reg 13(5)).

Concentrated effects and incentives

• Accreditation requirement concentrates testing functions at NATA‑accredited laboratories (reg 4), which benefits those laboratories and their nominated reporters and creates a compliance barrier for non‑accredited providers.
• The procedural burden on samplers (forms, signatures, tamper‑evident labelling, sterile single‑use equipment) increases time and material costs per sample and imposes recordkeeping duties on employers.

Geographic and operational impacts

• Time limits for testing (three or six days for several procedures) interact with transport and logistics; laboratories and samplers operating in remote locations must plan for packing and transport that preserve sample integrity and meet timelines (regs 11-12).

The Regulations create specific obligations on samplers, laboratories, nominated reporters and the Attorney‑General, and confer a conditional legal status on properly prepared tests and reports.

Key duties

• Samplers (reg 5; regs 6-11; Sch Forms 1-3)

  • Authorization: Only a medical practitioner or specified employee may take samples (reg 5).
  • Pre‑collection documentation: Obtain a completed Form 1 and a photograph or arrangement for one before sampling; ensure a Form 2 declaration is completed immediately before sampling (reg 6(1)-(2), Sch Forms 1-2).
  • Sterility and single‑use: Use new, sterilised and, where required, disposable needles/syringes; use unused, sterilised swabs and implements for DNA and skin/hair sampling (regs 7-8).
  • Container handling: Place the sample into an unused container immediately and in the donor’s presence, seal it tamper‑evidently, label in ink with specified particulars and have the donor and sampler sign the label in ink (reg 9(1)(a)-(f)).
  • Minor and capacity adjustments: For donors under 18 or with mental disability, follow presence and signature rules; responsible persons or trustees may sign (reg 6(3), reg 9(2)-(3)).
  • Sampler’s statement: Complete Form 3, affix the photograph and sign partly on the photograph and statement so removal is evident (reg 10, Sch Form 3).
  • Transmission: Ensure Form 1, Form 2 and Form 3 are sent with the sample to the laboratory (reg 11(2)).

• Laboratories (reg 4; regs 11-13; Sch Form 4)

  • Accreditation and standards: Ensure NATA accreditation for parentage testing procedures and carry out testing in accordance with standards that entitle them to such accreditation (reg 4(a)(ii)-(iii)).
  • Timing: Complete testing within specified periods for each technique (reg 12).
  • Sample integrity: Pack and store samples to preserve integrity so testing would yield the same results as immediate testing (reg 11(1)).
  • Reporting: Ensure reports are prepared in Form 4 with Part 1 by the nominated reporter and Part 2 by the testing person or supervisor; reports not in compliance are of no effect (reg 13(1)-(5), Sch Form 4).

• Nominated reporter (reg 13, reg 14)

  • Prepare Part 1 of the Form 4 report and be listed by the Attorney‑General in the Gazette as the nominated reporter for the accredited laboratory (reg 13(3), reg 14).

• Attorney‑General (reg 14)

  • Publish in the Gazette the names of NATA‑accredited laboratories able to carry out parentage testing and the nominated reporter for each accredited laboratory.

• Registrar (reg 15)

  • The Regulations prescribe a $50 fee for instruments filed with the Registrar under s 10(1) of the Act; parties filing instruments must pay that fee (reg 15).

Key legal effects and rights

• Validation conditional on compliance: A parentage testing procedure is "taken to be carried out in accordance with these Regulations" only if it complies with Part 2, is done at a NATA‑accredited laboratory in accordance with accreditation standards, and is supplemented by a Part 3 report (reg 4). This makes the legal effectiveness of testing contingent on compliance.
• Report admissibility: A report not prepared in accordance with the Regulations is expressly "of no effect" for the purposes of s 15 of the Act (reg 13(5)), which limits the evidential utility of non‑compliant reports.
• Rights of minors and persons lacking capacity: The Regulations specify who may sign on behalf of minors or persons with mental disability, thereby preserving the ability to obtain samples in those circumstances while imposing safeguards via presence and trustee signatures (reg 6(3), reg 9(2)-(3)).

What the Regulations do not do in positive terms

• They do not set fees for laboratory testing (other than the $50 filing fee in reg 15) nor do they prescribe penalties or criminal sanctions within the Regulations themselves.
• They do not define the procedural consequences in the Act for reliance on a report that is "of no effect"; they limit themselves to making reports non‑compliant if Form 4 is not used or the Parts are not completed by the specified persons.

Practical implication of duties

• The allocation of responsibilities to particular actors (sampler vs testing person vs nominated reporter) creates discrete points of accountability in the chain of custody and reporting, with documentary artefacts (Form 1, Form 2, Form 3, labelled sealed container, Form 4) functioning as triggers for legal effectiveness under reg 4 and reg 13.

The Regulations themselves do not prescribe express criminal penalties or administrative fines for non‑compliance within their text. Their enforcement mechanism is largely procedural and evidentiary: the Regulations condition the legal effect of parentage testing on procedural compliance and the use of specified forms.

Enforcement mechanisms appearing in the text

• Legal effectiveness as regulatory sanction (reg 4; reg 13(5))

  • Reg 4 establishes the conditions under which a parentage testing procedure is "taken to be carried out in accordance with these Regulations": compliance with Part 2, testing at a NATA‑accredited laboratory in accordance with standards entitling accreditation, and supplementation by a Part 3 report. This creates a de facto regulatory sanction: failure to satisfy these conditions means the test will not be "taken to be" compliant with the Regulations for the purposes of the Act.
  • Reg 13(5) states that a report completed otherwise than in accordance with the regulation is "of no effect." That is a direct evidentiary consequence: reports not prepared as required cannot be relied upon for the statutory purposes of s 15 of the Act.

• Publication requirement (reg 14)

  • The Attorney‑General must publish the names of NATA‑accredited laboratories and their nominated reporters in the Gazette. Publication creates transparency and makes it straightforward for parties and courts to check whether a laboratory was accredited and which reporter was nominated, indirectly aiding enforcement by third parties and decision makers.

What the Regulations do not include

• No penalty clauses: The Regulations do not set specific civil penalties, administrative fines or criminal offences for breaches of the sampling, sealing, labelling, signature or reporting requirements. The instrument relies on evidentiary invalidation (reports of no effect) rather than express statutory sanctions.
• No direct inspection or compliance regime: The Regulations require NATA accreditation and standards but do not in themselves set an inspection power, reporting obligations to regulatory agencies beyond the Gazette publication, or enforcement procedures for non‑compliance by samplers or laboratories.

Practical enforcement risks and mechanisms

• Evidential exclusion is likely the immediate practical sanction: a party relying on a parentage testing report that is not prepared in accordance with these Regulations risks the report being rejected as "of no effect" under reg 13(5) and could therefore lose the evidential basis for legal claims or defences that depend on such testing.
• The requirement that testing be done at a NATA‑accredited laboratory in accordance with accreditation standards (reg 4) creates an external oversight mechanism because accreditation is an institutional process managed by NATA; failure to be accredited will directly affect a laboratory’s ability to produce a valid report for the purposes of the Act.
• The Regulations rely on professional and institutional incentives and accreditation regimes rather than on direct statutory sanctions. Employers and laboratories have a reputational and professional interest in compliance with NATA standards; those incentives substitute for on‑the‑face penalties in the Regulation.

Implication for regulated parties

• Parties procuring tests (litigants, clinics, parents) must ensure that samplers and laboratories meet the procedural and accreditation requirements or face the risk that evidence will be disregarded. The absence of express penalties suggests that civil or professional consequences (including rejection of evidence, inability to rely on a report, and professional discipline arising from failure to meet accreditation standards) are the likely enforcement pathways.

The Regulations are drafted as subordinate legislation made under the Status of Children Act 1978 and cross‑refer to specific provisions of that Act. They also reference external accreditation and capacity regimes and, indirectly, other State and Territory laws concerning trustees, managers and guardians.

Direct interactions recorded in the instrument

• Status of Children Act 1978

  • The Regulations are "Regulations under the Status of Children Act 1978" (heading) and repeatedly invoke sections of the Act. For example, reg 3 prescribes medical procedures for the purposes of the definition of parentage testing procedure in section 3 of the Act. Reg 13 refers expressly to "section 15 of the Act" when prescribing reports, and reg 15 prescribes a fee "for the purposes of section 10(1) of the Act." Therefore the Regulations only operate within the scope given by the parent Act and implement procedural requirements for evidence used under that Act.

• NATA and accreditation standards (reg 4)

  • The Regulations require parentage testing to be carried out at laboratories "accredited by NATA for the purpose of carrying out parentage testing procedures" and "in accordance with standards of practice that entitle the laboratory to be so accredited" (reg 4). That creates an interface with the accreditation regime managed by the National Association of Testing Authorities (a Commonwealth body). Compliance with NATA standards is thus an external legal and professional requirement for producing a valid report under the Act.

• State and Territory trustee/manager laws (reg 6(3), reg 9(3))

  • The Regulations refer to "a trustee or manager in relation to the person under a law of the State or Territory of the Commonwealth whose laws apply to the person" (reg 6(3)(b)(i), reg 9(3)(b)(i)). That language integrates guardianship and trusteeship regimes under State and Territory law into the process, by requiring signature or presence of such persons for certain donors lacking capacity.

• Oaths, Affidavits and Declarations Act 2010 (Endnotes)

  • The endnotes record that the Oaths, Affidavits and Declarations (Consequential Amendments) Act 2010 (Act No. 40, 2010) amended the Regulations and commenced on 1 March 2011. That suggests the form and attestation requirements (Forms 1 and 2) interact with the jurisdiction’s rules for affidavits and declarations, as updated by that Act.

What is not specified or left to other laws and regimes

• Testing costs and billing: The Regulations do not set fees for laboratory testing; those will be governed by contractual arrangements between laboratories and clients, and by market pricing or other regulatory regimes outside this instrument. The only monetary prescription is the $50 filing fee for instruments filed with the Registrar under s 10(1) (reg 15).
• Criminal or administrative enforcement: The Regulations do not set out an enforcement code; they rely on evidentiary consequences and accreditation standards rather than creating separate statutory penalties. Any criminal or regulatory consequences for misconduct would need to be found in the parent Act or other external laws and professional disciplinary regimes.
• Admissibility in other legal contexts: The Regulations are framed for the purposes of the Status of Children Act 1978 and s 15 in particular. They do not by themselves control admissibility of parentage test results in other statutory regimes or private proceedings, though courts may draw on them when assessing chain of custody and reliability.

Operational interactions

• The sampling and reporting chain involves multiple legal instruments: trustee/guardian appointment laws for persons lacking capacity, NATA accreditation standards for laboratories, oaths and affidavits legislation for attestations, and the Registrar’s filing processes under the parent Act for instruments that attract the $50 fee. Practitioners must coordinate compliance across these frameworks to produce a legally effective parentage report.

The instrument includes a concise amendment history in its Endnotes that records formal amendments and the repeal of prior Regulations.

Key dates and instruments

• Original enactment: Status of Children Regulations (SL No. 29, 1996) were notified and commenced on 1 July 1996 (Endnotes, List of Legislation).
• Repeal of prior regulations: Regulation 16 repeals the Status of Children Regulations (No. 17 of 1979) (reg 16).
• Oaths, Affidavits and Declarations (Consequential Amendments) Act 2010 (Act No. 40, 2010): This Act, assented to on 18 November 2010, effected consequential amendments to the Regulations and commenced on 1 March 2011 (Endnotes, List of Legislation). The Endnotes also note that s 2 of that Act and Gazette notice G7, 16 February 2011, p 4, are relevant to commencement.
• Formal amendments by Interpretation Legislation Amendment Act 2018 (Act No. 22, 2018): The Endnotes state that general amendments of a formal nature were made to r 1 and the Schedule by this Act (Endnotes, General Amendments).
• Specific amendment notation: The Schedule was amended by Act No. 40, 2010, s 163 (Endnotes, List of Amendments).

What the amendment history shows about intent and stability

• The Regulations have a stable core since 1996 with limited targeted amendments: the 2010 amendments were consequential on a Commonwealth Act dealing with oaths, affidavits and declarations, which suggests adjustments to attestation requirements and minor schedule/form changes to align with broader procedural law reforms.
• The 2018 amendments recorded are described as "general amendments of a formal nature", implying editorial or drafting modernisation rather than substantive policy change to procedural requirements in the Regulations themselves.

Practical note for users

• The instrument as presented is the reprint "as in force at 1 March 2011", but the Endnotes record subsequent formal amendments in 2018. Practitioners must check the current consolidated or reprinted text available from official legislative sources for any further technical amendments after the dates in the Endnotes. The Regulations themselves mandate publication of accredited laboratories and nominated reporters in the Gazette (reg 14), so users should check Gazette notices for the current list.

The Regulations as provided contain no reported litigation history. The text names no cases and the Endnotes do not list judicial determinations or references to litigation concerning these Regulations.

What the instrument indicates about likely litigation topics

• Because the Regulations make reports "of no effect" unless prepared in Form 4 with specified parts completed by the nominated reporter and the testing person/supervisor (reg 13(1)-(5)), one potential litigation locus is disputes over admissibility and the legal effect of non‑compliant reports in proceedings under the Status of Children Act 1978. The text itself, however, contains no case law or judicial guidance on how courts have applied the "of no effect" rule, or on what evidentiary weight, if any, courts may give to non‑complying evidence.
• Timeliness of testing (reg 12) and chain‑of‑custody breaches (regs 6-11) are other areas where disputes commonly arise in parentage testing contexts. The Regulations provide precise requirements, and litigation may reasonably follow from contested compliance, but no cases are cited in this instrument.

Practical implication for practitioners

• Because the statutory instrument supplies procedural criteria that determine the formal effect of tests and reports, practitioners should treat the Regulations as a critical checklist for producing admissible evidence. In the absence of reported litigation in the instrument, parties should anticipate that courts will scrutinise compliance with these Regulations when parentage testing is in issue. Where compliance is in doubt, the report may be challenged as "of no effect" under reg 13(5).

The Regulations contain several detailed procedural points that create risk for parties who do not observe them precisely. The following are practical pitfalls that arise directly from the text and forms.

1. Documentation sequence and timing

• Affidavit before sampling: Form 1 must be completed before the sampler takes the bodily sample (reg 6(1)(a)). If the affidavit is completed after sampling the chain of custody will not meet the requirement in reg 6(1) and reg 4, which may render the test not "taken to be carried out in accordance" with the Regulations.
• Declaration immediately before sampling: Form 2 must be completed "immediately before" the sampler takes the sample (reg 6(2)). A failure to obtain this immediate declaration risks a procedural infirmity.

2. Photo and signature mechanics

• Size and attachment of photograph: The photograph must be approximately 45 mm by 35 mm and show a full face/head and shoulders against a plain background (reg 6(1)(b)(i)). The sampler must affix that photograph to Form 3 and sign partly on the photograph and partly on the statement so removal is evident (reg 10). Failure to do so can be a precise technical defect that may be contested.
• Label signatures in ink: Labels must be inscribed in ink with particulars and signed by both sampler and donor in ink (reg 9(1)(e)-(f)). Use of pencil, fading pen ink, or failure to sign in ink could be raised as a chain‑of‑custody problem.

3. Container and equipment conditions

• Unused containers and implements: The Regulations require that containers and swabs/implements "have not previously been used" and be sterilised (reg 7(1)(a)-(c); reg 8(2)-(3); reg 9(1)(b)). Reuse or non‑sterile implements breach the Regulations’ explicit requirements.
• Tamper‑evident sealing and labelling: The container must be sealed so that any later opening would be evident on inspection, and labels must be resistant to removal or erasure (reg 9(1)(c)-(d)). Simple tape or non‑tamper‑evident seals may not meet the standard.

4. Transmission of documents to the laboratory

• The sampler must ensure that Form 1, Form 2 and Form 3 are sent to the laboratory with the sample (reg 11(2)). Failure to include these documents risks rendering the laboratory unable to prepare a Form 4 report that complies with reg 13, with the result that any report may be "of no effect" (reg 13(5)).

5. Time limits for testing and remote collection

• Prescribed timelines: For red cell antigen/enzyme and serum marker testing the lab must complete testing within six days of sampling; for HLA within three days; DNA testing must be carried out within a "reasonable time" (reg 12). Remote collection locations or shipping delays can make it difficult to meet the three or six day deadlines or preserve sample integrity as required by reg 11(1).
• Dry sample alternative for enzyme/serum markers: For red cell enzyme grouping or testing for serum markers the lab complies if a dried sample is prepared within six days after sampling (reg 12(2)). Failing to prepare a dried sample within six days may jeopardise compliance.

6. Division of reporting responsibility

• Part 1 must be completed by the nominated reporter and Part 2 by the person who carried out or supervised the testing (reg 13(3)-(4)). Misallocation of these tasks, or omission of signatures by the specified persons, makes the report non‑compliant and therefore "of no effect" (reg 13(5)).

7. Accreditation requirement

• NATA accreditation: The requirement in reg 4 that testing be performed at a laboratory accredited by NATA for parentage testing procedures, and "in accordance with standards of practice that entitle the laboratory to be so accredited", is a strict condition on legal effect. Using a non‑accredited laboratory will likely render the report unusable under the Act.

8. Special rules for minors and persons lacking capacity

• Presence and signature rules for minors and mentally disabled persons are precise (reg 6(3), reg 9(2)-(3)). Sampling without the required presence or signature of a responsible person or trustee risks non‑compliance.

9. Reports of no effect

• A report not in Form 4 or with Parts completed by the incorrect person is "of no effect" under reg 13(5). That is an absolute phrase in the instrument and may be decisive in litigation.

10. Filing fee context

• The $50 prescribed fee (reg 15) applies to "instruments filed with Registrar" for s 10(1) of the Act; parties should not assume testing fees or other administrative costs are covered by this fee. The Regulations do not set testing fees.

These "gotchas" are not merely drafting quibbles. The Regulations make legal effect of testing contingent on procedural compliance. Small procedural lapses in signature placement, document transmission, seal integrity, or choice of laboratory may have determinative consequences for the admissibility and legal utility of test results.

This section provides a practical compliance checklist mapped to the Regulations. It is organised by actor: samplers/employers, laboratories, nominated reporters, and litigants/clients. Each step references the regulating provision.

For samplers and sample collectors (reg 5; regs 6-11; Sch Forms 1-3)

1. Verify authorised status

   • Ensure the person taking the sample is a medical practitioner or employed by a hospital, pathology practice, parentage testing practice or a medical practitioner for that purpose (reg 5).

2. Obtain and retain Form 1 before collection

   • Have the donor (or authorised person for minors or persons with mental disability) complete the affidavit in Form 1 before any sample is taken (reg 6(1)(a), Sch Form 1). Retain the original and ensure it accompanies the sample to the laboratory (reg 11(2)).

3. Photograph

   • Obtain a recent full face photograph approximately 45 mm by 35 mm showing head and shoulders against a plain background, or arrange for such a photograph to be taken (reg 6(1)(b)(i)-(ii)). Affix it to Form 3 later and ensure signing across photograph and statement (reg 10).

4. Pre‑sampling declaration

   • Immediately before taking the sample, have the donor complete Form 2 declaring any blood transfusions since the affidavit (reg 6(2), Sch Form 2).

5. Sterile single‑use equipment

   • For blood use a new, sterilised, disposable needle or syringe (reg 7(1)). For DNA swabs ensure they are unused and sterilised; for skin scraping or hair root sampling ensure sterilised implements (reg 8(2)-(3)).

6. Container, sealing and labelling

   • Place the sample into an unused container in the donor’s presence immediately after collection (reg 9(1)(a)-(b)).
   • Seal the container in a tamper‑evident manner so subsequent opening is evident (reg 9(1)(c)).
   • Label with ink the donor’s full name, date of birth and sex, date and time of collection (reg 9(1)(e)(i)-(iii)). Ensure label is affixed so removal or erasure is evident (reg 9(1)(d)).
   • Have both the sampler and donor sign the label in ink (reg 9(1)(f)).

7. Special cases: minors and persons with mental disability

   • For donors under 18, allow a person responsible for long‑term care to complete affidavits/declarations and be present for container procedures as allowed by regs 6(3) and 9(2).
   • For donors with mental disability obtain signatures from a trustee or manager under applicable State/Territory law or the person responsible for care, as specified, and ensure presence for sample placement (reg 6(3)(b), reg 9(3)).

8. Complete Form 3 and attach photograph

   • After sampling complete the sampler’s statement in Form 3, affix the photograph, and sign partly on the photograph and partly on the statement (reg 10, Sch Form 3). Date and retain a copy.

9. Package and send with documents

   • Pack and store the sample so integrity is preserved and testing would produce the same results as immediate testing (reg 11(1)). Send to a NATA‑accredited laboratory and ensure Form 1, Form 2 and Form 3 accompany the sample (reg 11(2)).

For laboratories (reg 4; regs 11-13; Sch Form 4)

1. Accreditation and standards

   • Verify NATA accreditation for parentage testing procedures and ensure laboratory practices are in accordance with standards that entitle accreditation (reg 4).

2. Receive and inspect incoming samples and documents

   • Confirm receipt of Form 1 (affidavit), Form 2 (declaration) and Form 3 (sampler statement) with the sample (reg 11(2)).
   • Check container seals, labelling, signatures and photograph attachment for compliance; document any discrepancies.

3. Adhere to testing timeframes and controls

   • Complete red cell antigen/blood grouping, red cell enzyme grouping and serum marker tests within six days of collection; HLA within three days; DNA within a reasonable time (reg 12).
   • For enzyme or serum marker testing a prepared dried sample within six days satisfies reg 12(2).
   • Use appropriate controls and document reagents, probes/primers, fragment and hybridisation patterns as required in Sch Form 4 Part 2.

4. Allocate identification numbers and maintain workbooks

   • Allocate and record identification numbers for samples in containers and log receipt dates (Sch Form 4 Part 2 items 1-2).
   • Record laboratory controls, reagents and index data and be prepared to attest in Part 2 that controls demonstrate reagent specificity and potency (Sch Form 4 Part 2).

5. Prepare Form 4 report

   • Ensure the laboratory’s nominated reporter completes Part 1 of Form 4 and that the person who carried out or supervised testing completes Part 2 (reg 13(3)-(4), Sch Form 4).
   • Include the required statements about inclusion or exclusion, Paternity/Maternity Index and probability, or specific genetic marker contradictions as appropriate (Sch Form 4 items 6-8).

6. Maintain records and support publication checks

   • Ensure that the laboratory’s accredited status and nominated reporter are current and that the Attorney‑General’s Gazette list reflects the laboratory’s nomination (reg 14).

For nominated reporters (reg 13; reg 14)

1. Be formally nominated by the accredited laboratory and ensure your name is the one published in the Gazette (reg 13(1)-(3), reg 14).
2. Complete Part 1 of Form 4 accurately, identifying procedures carried out, donors, sample containers and the accredited laboratory (Sch Form 4 Part 1).

For litigants, solicitors and clinics

1. Choose accredited providers

   • Contract with a NATA‑accredited laboratory and use samplers who meet reg 5 to avoid the "of no effect" risk (reg 4, reg 13(5)).

2. Verify chain of custody documentation

   • Before relying on a report, obtain and check copies of Form 1, Form 2, Form 3, the sealed container identification number, and the completed Form 4 with appropriate signatures and dating (regs 6, 10, 11, 13; Sch Forms 1-4).

3. Plan logistics and timelines

   • Where red cell antigen/enzyme or serum marker testing is contemplated, coordinate sampling and transport to ensure testing occurs within six days or dried sample is prepared within six days (reg 12(1)(a), reg 12(2)). For HLA ensure three day window (reg 12(1)(b)). For DNA assume expedited handling because the term "reasonable time" is open to dispute (reg 12(1)(c)).

4. File instruments with the Registrar where necessary

   • Pay the prescribed $50 filing fee for instruments filed with the Registrar under s 10(1) of the Act (reg 15).

Recordkeeping and quality assurance

• Employers and laboratories should build checklists and SOPs that mirror the Regulations: pre‑collection affidavit and photo, Form 2 immediate declaration, single‑use sterile equipment check, tamper‑evident sealing and labelling with inked particulars and signatures, Form 3 completion and photo affixation, transmission of Forms 1-3 to the laboratory, timely testing, and completion of Form 4 with required parts by nominated reporter and testing personnel.

Contingency planning

• Remote or rural collection: Plan for same‑day courier or on‑site dried sample preparation for tests with strict timelines (reg 12(2)).
• Capacity and guardianship: Identify trustees or carers and confirm their authority under applicable State/Territory laws before attempting sampling for donors lacking capacity (reg 6(3), reg 9(3)).

Following the Regulations’ precise procedural steps, maintaining documentary evidence of each step, and using accredited laboratories and nominated reporters are the practical means by which regulated parties can ensure parentage testing produces reports that meet the legal requirements set out in reg 4 and reg 13.