Health Insurance (Quality Assurance Activity – CareFlight Clinical Review Meetings) Declaration 2025

The instrument deploys a few discrete legal and operational concepts, each rooted in the Schedule and the linking provisions to the Health Insurance Act 1973.

Quality assurance activity: The central legal concept is a "quality assurance activity" as applied under Part VC of the Health Insurance Act 1973. The instrument does not define Part VC or restate its substantive content; it simply declares that the specific activity described in the Schedule is to be treated as a quality assurance activity to which Part VC applies (s 5). The Schedule then operationalises that abstract label by describing the concrete meeting format and governance inputs.

Scope limitation: The declaration is expressly territorial and activity‑specific. Section 5 limits the statutory declaration “to the extent that the quality assurance activity relates to health services provided in Australia.” The Schedule defines the activity as CareFlight’s clinical review meetings, thereby tethering the legal recognition to those meetings and to Australian health services (Schedule, items 1-2).

De‑identification and confidentiality practice: The Schedule requires that case presentations use de‑identified patient information when used in the Activity. That treatment of patient identifiers is a core procedural element. The Schedule does not spell out a legal definition of "de-identified" or procedures for de‑identification; it records that case presentations use de‑identified patient information to highlight significant missions and other matters for discussion (Schedule, item 2).

Governance roles and delegation: The Schedule assigns concrete roles and delegation points within CareFlight. Case presentations are prepared by a senior clinician as delegated by the service’s Medical Director. The Head of Clinical Governance monitors an Action Register. Action items are assigned to the appropriate committee. Recommendations are shared with the Clinical Practice Team and disseminated to executive and other applicable services (Schedule, item 2). These roles disclose the internal decision points that structure the Activity.

Lifecycle and reporting: The Schedule describes an operational lifecycle: case identification from electronic medical records or clinician request; preparation of a presentation by a senior clinician; multidisciplinary discussion of clinical, logistical and human factor components; production of a post‑CRM clinical governance report; recording and tracking of recommendations and action items on an Action Register; and assignment of tasks to committees. This is a process‑driven conception of quality assurance rather than a single event.

Statutory linkage and temporality: The instrument is made under subsection 124X(1) of the Health Insurance Act 1973 (s 3). It commences the day after registration (s 2) and is expressly subject to repeal under subsection 124X(4) (s 4). The instrument therefore operates as a time‑limited statutory declaration that attaches the regulatory consequence of Part VC to the described activity for the period the declaration is in force.

Record‑keeping implication: Although the instrument does not set explicit record‑keeping rules, the Schedule describes post‑meeting reports and an Action Register monitored by a named governance post. Those elements create an internal record trail that will be central to demonstrating the activity occurred as declared and to supporting any reliance on the protection or consequences conferred by Part VC.

Primary actor , CareFlight: The Schedule names CareFlight Limited (ABN 18 210 132 023) as the body conducting the Activity (Schedule, item 2). All operational obligations and procedures in the Schedule , meeting frequency, case identification, preparation and delegation of presentations, post‑meeting reports, Action Register oversight and assignment of actions , are framed as activities conducted by CareFlight staff and committees.

Clinical staff: Clinical personnel who participate in the clinical review meetings are directly involved. The Schedule refers to "clinical staff", "senior clinician" presenters, and the delegation role of the service’s Medical Director. It also specifies multidisciplinary participation covering clinical, logistical and human factor components , indicating that nurses, doctors, paramedics and potentially allied clinical staff are implicated in both providing and receiving feedback in the Activity (Schedule, item 2).

Governance roles within CareFlight: The Medical Director, senior clinicians, Head of Clinical Governance, Clinical Practice Team, and the executive are named decision‑points and recipients of outputs. Those roles have specified responsibilities: delegation of presenters (Medical Director), preparation and presentation (senior clinician), monitoring the Action Register (Head of Clinical Governance), and dissemination of recommendations (Clinical Practice Team to executive and other services) (Schedule, item 2).

Patients (indirectly): Patients whose cases are discussed are affected indirectly through quality improvement outcomes. The Schedule states case presentations use de‑identified patient information to highlight significant missions, deaths and deteriorations, sentinel events and medication errors when required, and clinical complaints are discussed (Schedule, item 2). The instrument does not create new patient rights or direct obligations to patients, but the Activity’s outputs (recommendations and action items) are intended as service quality improvements that may change clinical practice.

Regulatory interaction participants: The declaration connects the Activity to Part VC of the Health Insurance Act 1973 (s 5). Any entity or person whose legal position depends on whether the Activity is a Part VC quality assurance activity , for example internal auditors, any external reviewers tasked with assessing compliance with Part VC, or legal advisers assessing privilege or disclosure issues that turn on Part VC status , will be affected by this instrument’s classification.

Third parties and external contractors: The Schedule does not name external parties beyond CareFlight staff. However, the Schedule notes case selection can derive from the electronic medical record or clinician request and that multidisciplinary meetings consider logistical components. If external contractors (for example, vehicle operators, maintenance providers, or data hosts) are part of those logistical considerations, their operations may be discussed; the text in the Schedule allows for such elements to be part of the meetings but does not name or impose obligations on third parties.

Territorial limitation: The declaration applies "to the extent that the quality assurance activity relates to health services provided in Australia" (s 5). That wording narrows the instrument’s legal scope to activities connected to Australian health services, affecting cross‑border or offshore operations differently; only activities connected to Australia are within the declared Part VC coverage.

Legal advisers and compliance officers: Because the instrument creates a statutory characterisation (a Part VC quality assurance activity) of a specific internal process, legal, compliance and governance staff within CareFlight and any other body analysing the Activity will need to understand and apply that characterisation. The instrument therefore affects advisors tasked with ensuring the Activity remains within the Schedule’s description so that the Part VC consequences continue to attach.

The instrument itself primarily declares an activity and supplies an operational description; it does not create freestanding statutory duties or rights beyond importing Part VC by reference (s 5). The Schedule, however, sets out internal duties and processes that will operate as de facto organisational duties for CareFlight.

Declared duty‑like processes within CareFlight

• Hold periodic clinical review meetings, occurring monthly to quarterly, for review of quality of care provided to patients (Schedule, item 2). This establishes an organisational expectation of regular review cycles.
• Use de‑identified patient information for case presentations to highlight significant missions, opportunities for improvement, or instances of exceptional care (Schedule, item 2). The text thereby constrains how patient data is to be presented in the Activity.
• Discuss deaths, deteriorations, sentinel events and medication errors "when required" and consider quality improvement activities and clinical complaints (Schedule, item 2). The "when required" formulation gives clinical leadership judgement about inclusion, but also signals that these matters are within the remit of the CRM.
• Identify cases either via the electronic medical record or clinician request, and prepare presentations by a senior clinician delegated by the service’s Medical Director (Schedule, item 2). This establishes a chain of delegation and responsibility for preparation.
• In multi‑disciplinary CRMs discuss clinical, logistical and human factor components with service and quality improvement focus (Schedule, item 2). The multidisciplinary requirement places an organisational duty to include appropriate perspectives.
• Prepare a post‑CRM clinical governance report summarising information presented, discussions and outcomes, and share recommendations with the Clinical Practice Team for dissemination to the executive and other applicable services (Schedule, item 2). This creates a documentation and reporting duty.
• Track CRM action items on an Action Register monitored by the Head of Clinical Governance, and assign action items to the appropriate committee (Schedule, item 2). This establishes monitoring and follow‑up responsibilities.

Rights and protections

• The instrument does not explicitly create patient rights or statutory immunities within its text. Its effect is to import Part VC of the Health Insurance Act 1973 to the declared activity (s 5). Any rights or protections , for example privilege, confidentiality protections, evidentiary regimes, or disclosure exemptions , that may be available under Part VC will depend on the content of Part VC itself. The instrument does not restate those consequences, it merely declares the activity to be within Part VC’s scope.

Delegation and discretion

• The Schedule vests key discretionary decisions inside the organisation: the Medical Director delegates who prepares presentations, the Head of Clinical Governance monitors the Action Register and assigns items to committees. The instrument therefore creates internal decision points where choices will determine whether the activity remains consistent with the Schedule description.

Territorial constraint on duties and rights

• The declaration’s legal effect is limited to the extent the Activity relates to health services provided in Australia (s 5). Duties and any Part VC‑linked rights therefore apply only to those portions of the Activity with an Australian connection.

No additional statutory obligations or enforcement clauses in this instrument

• There are no independent penalty, sanction, or enforcement provisions within this instrument itself (cf. ss 1-5 and Schedule). Enforcement and any statutory consequences derive from applying Part VC to the declared activity.

This instrument does not include its own penalty or enforcement regime. It is a declaratory instrument that brings the specified Activity within the scope of Part VC of the Health Insurance Act 1973 (s 5). Therefore, any penalties, enforcement mechanisms, or statutory protections that attach to a quality assurance activity will be those set out in Part VC of the Health Insurance Act 1973, not in this instrument.

Statutory linkage to enforcement provisions

• The instrument is made under subsection 124X(1) of the Health Insurance Act 1973 (s 3). Section 5 then applies Part VC to the described activity. The precise enforcement consequences , whether they be regulatory oversight, sanctions, evidentiary effects, or other statutory outcomes , will depend entirely on Part VC’s text and are not reproduced in this declaration. Users must refer to Part VC of the Health Insurance Act 1973 to identify specific penalties, offences, exceptions, immunities or disclosure rules that may apply once the Activity is declared.

Practical enforcement implications within CareFlight

• Internally, the Schedule establishes monitoring and follow‑up responsibilities , a Head of Clinical Governance monitors an Action Register, and action items are assigned to committees (Schedule, item 2). While the instrument does not create enforcement sanctions, these governance practices create internal accountability mechanisms that can drive compliance with the scheduled process. Non‑compliance with the Schedule’s processes would therefore be a matter for internal governance and management, and potentially for regulatory review if Part VC imposes statutory obligations that the organisation must meet.

Temporal enforcement considerations

• The instrument commences the day after registration (s 2) and is repealed when it ceases to be in force according to subsection 124X(4) of the Health Insurance Act 1973 (s 4). Any enforcement action tied to Part VC would only apply while the declaration is in force and to the extent the Activity relates to Australian health services (s 5).

Limitations on enforcement information in the instrument

• Because the instrument does not contain Part VC itself, it does not provide detail on enforcement thresholds, notice requirements, appeal mechanisms, or culpability standards. Those substantive enforcement matters must be sourced directly from the Health Insurance Act 1973, Part VC.

Implication for external parties

• External parties (inspectors, regulators, courts) assessing whether the Activity is a Part VC quality assurance activity will rely on the wording here: the Schedule’s description and the territorial limitation in s 5. Any regulatory enforcement action that requires proof that the Activity falls within Part VC can point to this instrument as the statutory declaration, subject to factual questions about whether the Activity conducted matches the Schedule’s description.

Direct statutory link: The instrument operates by reference to the Health Insurance Act 1973. Section 3 records the enabling authority , subsection 124X(1) of the Health Insurance Act 1973 , and section 5 declares the Activity to be a quality assurance activity "to which Part VC of the Health Insurance Act 1973 applies." Therefore the primary statutory interaction is that the Schedule’s described processes are folded into the legal category governed by Part VC. The instrument itself does not reproduce or interpret Part VC; it merely applies Part VC to a particular activity.

Territorial nexus: Section 5 qualifies the application of Part VC to "to the extent that the quality assurance activity relates to health services provided in Australia." That phrase creates an interactional boundary between Australian statutory law and any activity or data that may be offshore. Where elements of CareFlight’s operations are outside Australia, those elements may fall outside the declared scope and thus outside the Part VC consequences created by the declaration.

Data and privacy law interfaces (practical but not stated): The Schedule requires case presentations to use "de‑identified patient information" (Schedule, item 2). The instrument does not reference the Privacy Act 1988 or state medical confidentiality statutes, nor does it define "de‑identified." In practice, de‑identification will need to be compatible with any applicable privacy or health records legislation. The instrument does not displace those laws; it operates alongside them. Organisations should therefore check whether de‑identification practices used in the Activity align with obligations under privacy law, though those privacy obligations are not set out in this instrument.

Internal corporate law and governance: The Schedule assigns tasks to internal posts and committees (Medical Director delegated presenter; Head of Clinical Governance monitoring the Action Register; assignment to appropriate committee; dissemination to Clinical Practice Team and executive). Those internal governance directives will interact with corporate governance rules, employment contracts, professional supervision obligations, and clinical governance standards. The instrument does not alter statutory company law, employment law, or professional registration requirements, but it sets an organisational practice that will interface with them.

Evidence and disclosure regimes: Because the instrument brings the Activity within Part VC, any evidentiary or disclosure consequences that Part VC prescribes will now apply to the meetings as declared. The instrument does not state what those evidentiary rules are; it only establishes that they will apply. Parties seeking to compel materials from the CRM or relying on privilege or protection must therefore consult Part VC for exact parameters.

Commencement and repeal rules interaction: The commencement clause sets the instrument to commence the day after registration (s 2). The repeal clause ties the instrument’s expiry to subsection 124X(4) of the Health Insurance Act 1973 (s 4). Those procedural points interact with administrative law principles about validity and timing of statutory instruments and may affect transitional arrangements or the survival of records created while the declaration was in force.

No reference to other Commonwealth, state or territory statutes: The instrument does not expressly amend, displace or interact with any named Commonwealth, state or territory statute beyond the Health Insurance Act 1973. Any indirect interactions (for example with state health records legislation or practitioner regulation) are possible but not specified.

This instrument’s text contains a commencement table and two notes about the table’s status and content which set the framework for amendments and publication, even though the instrument itself, as provided, is an original instrument rather than an amended one.

Commencement and original effect

• Section 2 establishes commencement. The commencement table lists "The whole of this instrument" as the provision commencing "The day after this instrument is registered." The table is explicitly described as relating only to the provisions "as originally made" and not amended to deal with later amendments (s 2 and the commencement table). That indicates the instrument’s published commencement record is fixed to the original instrument and separate amendment entries would not be inserted in that table.

Notes about published versions

• Section 2(2) states that information in column 3 of the commencement table is not part of the instrument and that information may be inserted or edited in any published version. That means ancillary publication metadata (for example, editorial notes or dates in column 3) do not alter the legal content of the instrument. The text creates a formal separation between the instrument’s legal text and editorial material in published tables.

Authority for amendment and repeal

• Section 3 states the instrument is made under subsection 124X(1) of the Health Insurance Act 1973, which is the statutory power that permits such declarations. Section 4 then provides that the instrument "is repealed when it ceases to be in force in accordance with subsection 124X(4) of the Health Insurance Act 1973." The instrument therefore anticipates that amendments or repeal will be governed by the parent Act’s mechanisms. The instrument itself does not set out a discrete amendment mechanism nor does it provide saving or transitional clauses for amendments.

No recorded amendments within the instrument text

• As provided, the instrument contains no schedule of amendments, amending instruments, or historical notes indicating prior versions. The one‑page schedule and the five sections constitute a single instrument. The commencement table’s note that it relates only to the provisions "as originally made" signals that subsequent amendments, if any, will not be recorded by altering the original table in this document.

Practical amendment implications

• Because the declaration is activity‑specific, any material change to the actual conduct of CareFlight’s Clinical Review Meetings that would take them outside the Schedule’s description could affect whether the instrument’s declaration remains accurate. The instrument does not set out a procedure for re‑declaring a materially altered activity; such re‑declarations would require action under the parent statute (subsection 124X(1) and related provisions). The instrument’s repeal link to subsection 124X(4) means periodic administrative checks on in‑force declarations will be necessary to determine whether the instrument still applies.

Record of repeal and replacement

• The instrument does not specify transitional protections for documents or actions taken while it was in force. Because the declaration imports Part VC to the Activity only while it is in force, any question about the status of records or actions taken during the declared period will rely on the parent Act and administrative practice. The instrument itself leaves such questions to the Health Insurance Act 1973 mechanisms.

The instrument contains no litigation record, judicial interpretation, or references to cases. It is a stand‑alone declaration consisting of five numbered provisions and a Schedule describing the declared activity; nothing in the instrument cites judicial decisions or describes prior litigation concerning the instrument.

Consequences of the absence of litigation history

• The absence of a litigation history in the instrument means there is no internal precedent about how courts or tribunals have interpreted this particular declaration’s scope, the adequacy of its Schedule description, or the interaction between this declaration and Part VC of the Health Insurance Act 1973. Any adjudicative questions that might arise , for example, whether a particular CRM discussion fell within the Schedule, whether the de‑identification was adequate, or whether a particular action item was properly designated and tracked , will need to be resolved against the statutory text (this instrument and the Health Insurance Act 1973) and factual records by the relevant tribunal or court.

Potential for future litigation

• Because the declaration imports Part VC, if Part VC contains privileges, confidentiality protections, or limits on disclosure, disputes may arise about whether those protections apply to specific materials generated by the CareFlight CRMs. Litigation could address whether the CareFlight Activity as conducted conforms to the Schedule’s description and thus qualifies for Part VC treatment. The instrument itself, however, provides no litigation history or interpretive guidance on likely points of dispute.

Practical effect for risk assessment

• In the absence of judicial guidance, CareFlight and its advisers must rely on the instrument’s text and on Part VC (as enacted in the Health Insurance Act) to predict outcomes. That produces a degree of legal uncertainty: the instrument establishes the declaration but does not answer borderline questions (for example, whether a meeting that uses identified information in a rare instance remains protected). The Schedule’s specific operational content (de‑identification, delegation, monitoring) will be important factual anchors if any legal dispute arises.

Recordkeeping for future disputes

• Because the instrument provides no litigation history and because any future legal questions will depend on factual demonstration of the Activity as described, maintaining contemporaneous records , post‑CRM reports, action registers, delegation records and the de‑identification process , will be essential to defending the Activity’s status as declared. The Schedule’s own reporting and Action Register processes support that evidentiary trail (Schedule, item 2).

Scope and territorial limitation

• The declaration applies "to the extent that the quality assurance activity relates to health services provided in Australia" (s 5). If CareFlight conducts similar CRMs that discuss missions or personnel outside Australia, those elements may fall outside the statutory declaration. CareFlight must therefore be precise about which meetings and which cases are within the declared scope, and must be able to show the Australian nexus for matters that it treats as covered by the declaration.

Reliance on description fidelity

• The protection or regulatory consequences from Part VC apply only insofar as the Activity matches the Schedule's description. The Schedule sets out specific process features: monthly‑to‑quarterly occurrence, use of de‑identified patient information, presentation preparation by a senior clinician delegated by the Medical Director, post‑CRM clinical governance reports, Action Register oversight by Head of Clinical Governance, and assignment to committees (Schedule, item 2). Material deviations from these process features may lead to arguments that the meetings no longer fall within the declared activity and thus are not within Part VC.

"De‑identified" is not defined here

• The Schedule requires presentations use "de‑identified patient information" but does not define what de‑identification entails. Different legal and regulatory regimes may take different views of sufficiency of de‑identification. Failure to properly de‑identify could raise privacy law risks and could jeopardise any protections Part VC might otherwise confer. Organisations should therefore avoid assuming the Schedule’s use of the term alone satisfies privacy obligations.

Discretionary language creates uncertainty

• Several provisions use discretionary phrasing, for example "Deaths and deteriorations, sentinel events and medication errors are discussed when required" (Schedule, item 2). Who determines "when required"? The Schedule assigns operational roles (Medical Director, Head of Clinical Governance), but the discretion may produce disputes about omissions or inclusions if incidents are not escalated. That discretion also creates a risk that an external reviewer could find that, in practice, the Activity is not addressing matters that the Schedule contemplates.

Internal governance reliance

• The schedule places monitoring responsibility on the Head of Clinical Governance and assigns action items to "appropriate committee." If those internal governance structures are weak, under‑resourced or poorly documented, the Action Register and follow‑up may be ineffective. From a legal perspective, poor internal governance can undermine claims that the Activity constitutes a bona fide quality assurance process in line with Part VC.

No standalone protection or penalty detail in the instrument

• This instrument does not itself create evidentiary privileges or penalties; it only triggers Part VC by declaration (s 5). Parties should not assume protections exist without checking Part VC’s text. Assuming protections without checking could lead to inadvertent disclosure or regulatory non‑compliance.

Commencement timing and records

• The instrument commences the day after registration (s 2). If CareFlight began similar meetings before that date, those earlier meetings are not covered by this declaration unless they otherwise fall within Part VC by some other means. CareFlight should be cautious about retroactive treatment.

Column 3 content is not legally operative

• The instrument notes that information in column 3 of the commencement table is not part of the instrument (s 2(2)). If published materials or databases include explanatory notes in that column, they are not part of the legal instrument and cannot be relied on as carrying legal effect. Practitioners must base legal positions on the instrument’s operative text not on ancillary publication metadata.

Risk of scope creep

• The Schedule’s phrases such as "clinical complaints" and "any quality improvement activities being undertaken" are broad. There is a risk that over time the CRM remit could expand beyond the Schedule’s original focus. If the Activity evolves materially, CareFlight should consider whether a fresh declaration or amendment under subsection 124X(1) is required to preserve Part VC status for the altered activity.

Action Register as evidentiary target

• The Schedule identifies the Action Register as the place where action items are tracked and monitored by the Head of Clinical Governance. That Register will likely be a primary piece of evidence in any dispute about whether recommended improvements were implemented. If the Register is incomplete, contested or poorly maintained, it could undermine claims about the Activity’s effectiveness or compliance.

To maintain alignment with this declaration and to secure the intended application of Part VC to CareFlight Clinical Review Meetings, the organisation should ensure that the Activity is conducted and documented in close conformity with the Schedule’s description (Schedule, item 2) and that the territorial nexus to Australian health services is demonstrable (s 5). The Schedule describes specific steps; compliance should replicate those steps and build documentary evidence.

Operational steps to mirror the Schedule

• Meeting cadence: Hold CRMs on a monthly to quarterly basis as described (Schedule, item 2). Document dates and attendance for each meeting.
• Case selection: Capture case selection processes. Identify whether cases were flagged from the electronic medical record or requested by clinicians. Keep contemporaneous records showing how each case was selected and by whom.
• De‑identification: Ensure presentations use de‑identified patient information. Adopt and record a written de‑identification protocol that explains the steps taken to remove identifiers, the rationale for chosen methods and the person responsible for de‑identifying. Retain copies of de‑identification checks or logs.
• Delegation and presentation preparation: Record the Medical Director’s delegations when a senior clinician is tasked with preparing a presentation. Keep copies of presentation materials and a record that the presenter was delegated by the Medical Director.
• Multidisciplinary content: Document the multidisciplinary composition of each CRM and the clinical, logistical and human factor elements discussed. Save minutes or a post‑CRM report that summarises these discussions and links them to quality improvement recommendations.
• Post‑CRM reporting: Produce a post‑CRM clinical governance report after each meeting that summarises information presented, the discussions held and the outcomes or recommendations. Archive these reports systematically.
• Action Register and monitoring: Maintain the Action Register described in the Schedule, with fields for action item description, responsible person/committee, due date, status updates and closure evidence. Ensure the Head of Clinical Governance monitors and signs off the Register periodically. Retain audits of Register changes.
• Assignment to committees: Where action items are assigned to committees, produce and retain evidence of committee minutes or correspondence showing receipt of the assignment and subsequent action.
• Dissemination: Keep records showing recommendations were shared with the Clinical Practice Team and disseminated to the executive and applicable services, as required under the Schedule.
• Territorial connection: For each discussed case and each CRM, record the Australian nexus , for example, mission location, patient location, or service provided in Australia , to demonstrate the Activity relates to Australian health services as required by s 5.

Governance and training

• Clarify and publish role responsibilities: Define the roles of Medical Director, senior clinician presenters, Head of Clinical Governance, Clinical Practice Team and any relevant committees in written policies that mirror the Schedule.
• Train staff on de‑identification and documentation practices so that practitioners know how to prepare de‑identified case presentations and what records to keep.
• Institute quality control checks: Periodically review the Action Register and post‑CRM reports to ensure follow‑up is occurring and that documentation meets internal and any external standards required by Part VC.

Legal and privacy alignment

• Although the instrument does not reference privacy laws, ensure de‑identification and data handling practices comply with applicable privacy legislation and health records obligations. Document the legal basis for de‑identification practices and perform periodic audits of practice against the organisation’s privacy policy.

Change management and re‑declaration

• If the CRMs change materially (frequency, scope of issues discussed, use of identified information, governance structure), evaluate whether the Activity still fits the Schedule’s description. If not, consult the parent statute’s mechanisms for amendment or re‑declaration; do not assume Part VC coverage will continue for materially different activities.

Record retention

• Retain post‑CRM reports, Action Register entries, delegations, and de‑identification logs for a readily justifiable period, acknowledging that any future legal review will rely on these records to demonstrate that the Activity followed the Schedule.

Audit preparedness

• Prepare a compliance file that aggregates: the instrument itself, the Schedule, copies of post‑CRM reports, the Action Register, delegation records and evidence of dissemination. That file will be the starting point for any regulator or legal review asserting the Activity’s Part VC status.

Internal review and assurance

• Conduct internal assurance reviews to confirm that actual practice matches the Schedule. Where gaps are found, document remedial actions and ensure corrective steps are recorded in the Action Register and followed through by the assigned committees.