Clinical Governance & Policies
Pre-launch regulatory framework covering Scope of Practice, UK GDPR Special Category controls, CQC pending disclaimers, and Clinical Escalation pathways.
CQC Registration Assessment Status
CQC registration assessment pending / to be confirmed based on final regulated activities. In England, the Care Quality Commission (CQC) regulates diagnostic and screening services. Aven Health is currently structuring its pre-launch operational model to ensure full regulatory registration where regulated medical activities are introduced. Currently, all processed pathology assays are completed under the direct registration of accredited partner laboratories.
Scope of Practice Matrix
We enforce strict operational limits on all clinical staff. The matrix below defines what activities are permitted and prohibited on our platform:
Registered General Nurse (RGN)
Permitted: Venous blood collection, baseline vitals checks, recording medical observations, patient onboarding check, clinical escalation triggers.
Prohibited: Issuing prescriptions, establishing definitive medical screens, altering existing prescription dosages, conducting surgical interventions.
UKAS-Accredited Laboratory Partner
Permitted: Chemical assay analysis, validation of reference ranges, secure electronic result uploads, sample viability preservation under UKAS guidelines.
Prohibited: Direct patient consultation, medical diagnosis delivery, prescribing medical protocols.
Aven Clinical Oversight (HCPC)
Permitted: Oversight of clinical protocols, Health Intelligence Hub template reviews, signing off critical anomaly reference ranges, advising clinical signposting templates.
Prohibited: Direct primary GP care (unless structured via independent referral channels), emergency acute medical rescue.
Consent & UK GDPR Special Category Data
Under UK GDPR Article 9, biological blood values constitute **Special Category Health Data**. Processing requires explicit, unambiguous consent from the data subject.
Our digital booking portal collects explicit consent logs, which are stored securely alongside IP addresses and timestamps. Patients have the right to request access to their diagnostic logs (Subject Access Requests) or demand record deletion (Right to be Forgotten), subject to mandatory clinical record retention guidelines under NHS England protocols (which require holding medical observation histories for a standard legal liability duration).
Result Review, Red Flags & Clinical Escalation
Aven Health operates a standardized result verification pipeline:
Analytical labs verify test validity and upload raw biochemical logs under strict barcode separation.
Reports are reviewed and communicated in accordance with the service selected and the appropriate clinical governance pathway. If a result falls outside reference limits, a clinical review note is prepared.
If biomarker readings hit critical physiological thresholds (e.g. extreme blood sugar levels or indicators of acute organ dysfunction), our clinical escalation protocol is triggered:
1. Immediate clinical advisor telephone contact.
2. Signposting the patient to standard NHS GP pathways or NHS 111.
3. If life-threatening conditions are suspected, the patient is advised to call 999 or proceed to A&E immediately.
Safeguarding & Incident Reporting
All clinicians undergo mandatory safeguarding training. Platform operational incidents (such as sample collection failures or transport temperature deviations) are logged immediately under our incident audit policy to assess lab quality controls.
Complaints & Auditing Policy
Complaints are managed under our clinical complaints handling policy, with clinical coordinators responding within 48 hours. Internal clinical audits are performed quarterly to assess reference range accuracy, phlebotomy complications, and RGN NM PIN validations.