What is Pathology Automation?
The Pathology Automation software is a Class I Software as a Medical Device (SaMD) designed to automate the administrative review and filing of pathology results determined to be 'normal'. It operates as an autonomous Robotic Process Automation (RPA) bot that securely logs into your Electronic Health Record system, analyses patient pathology data using strict rule-based logic incorporating numerical thresholds, trend analysis, and keyword verification — then performs one of two actions:
With 80+ biomarker tests configured across 17 test categories, the system filters high volumes of normal results, allowing qualified healthcare professionals to focus their attention on results that are abnormal, ambiguous, or otherwise require clinical judgement. The result is faster turnaround, safer workflows, and dramatically reduced admin burden for your clinical team.
Get in TouchKey Benefits
6 key features that make our Pathology Automation service essential for your practice.
- 80+ Biomarkers Covered Comprehensive coverage across 17 test categories including FBC, LFTs, Renal Function, Thyroid, Lipid Profile, Bone Profile, and many more.
- Gender & Age-Specific Ranges Evaluates results against reference ranges tailored to patient gender (e.g. Haemoglobin, Creatinine, Gamma GT) and age (e.g. PSA thresholds for ages 40-49, 50-59, 60-69, 70-79).
- Intelligent Routing Three clear actions: File Without Comments for normal results, Skip for results needing doctor review, and Sample Unavailable when no valid sample is detected.
- Sample Quality Detection Automatically identifies 6 sample quality issues: No sample, Contaminated, Unable to provide, Regret error, Haemolyzed, and Duplicate specimens.
- Trend Detection Detects clinically significant trends by comparing against previous values -- such as significant drops in Haemoglobin or spikes in Creatinine -- and flags them for review.
- 100% Accuracy Clinically reviewed workflows maintained by a Clinical Safety Officer, ensuring every result is evaluated correctly and routed appropriately.
17 Test Categories. 80+ Biomarkers.
Every major pathology test category is covered, with gender-specific and age-specific reference ranges applied where clinically appropriate.
How It Works
A six-step processing pipeline that evaluates every lab report with clinical precision and routes it to the right action.
- 1. Submit Lab Report EMIS-format pathology report is received by the processing service via API.
- 2. Check Sample Quality The system checks for 6 sample quality issues -- no sample, contaminated, unable to provide, regret error, haemolyzed, or duplicate -- and flags them immediately.
- 3. Extract Biomarker Values Numerical values are extracted from unstructured lab report text for each biomarker present in the report.
- 4. Evaluate Against Reference Ranges Each value is compared against gender-specific and age-specific reference ranges to determine normal, low, or high status.
- 5. Apply Custom Logic Advanced rules are applied: age-based PSA thresholds, previous value trend detection for Haemoglobin and Creatinine, and keyword filtering for clinical terms.
- 6. Return Structured Results The service returns a structured response with a recommended action: File Without Comments (normal), Skip (needs doctor review), or Sample Unavailable.
The Merlin Dashboard
The device has no direct operational user interface — its functions are fully autonomous. The primary human interaction point is the Clinical Oversight Dashboard, designed for monitoring and auditing purposes.
General Processing Rules
The core algorithm is a rule-based decision engine that categorises results based on pre-defined clinical criteria. Every rule is clinically approved during a formal hazard workshop with each organisation's Clinical Director.
Example: PSA Clinical Logic
PSA is produced by prostate cells and is specific to males. Levels increase with age due to benign enlargement. PSA is used for cancer screening and monitoring, with age-dependent reference ranges essential for accurate interpretation.
Intended Users
The Pathology Automation software is an autonomous system that operates at scheduled times without direct user interaction. The "users" are defined by their roles and responsibilities in relation to the system:
System Configuration & Approval
The rules and logic for automated filing are established and clinically approved by senior healthcare professionals (Medical Director, designated clinicians) during a formal clinical hazard workshop for each organisation.
System Oversight
The autonomous operation is monitored by qualified healthcare professionals and trained administrative staff via the Merlin Dashboard, which provides full visibility of the bot's actions.
Clinical Responsibility
Qualified healthcare professionals (GPs, Specialist Doctors, Clinical Pharmacists, Practice Nurses) are solely responsible for the manual review, interpretation, and clinical management of all results skipped by the automation.
Safety & Compliance
Safety First, Innovation Second
Our pathology automation is built on a foundation of clinical safety and regulatory compliance.
UKCA Class I Medical Device
Rule 11(a) + MDCG 2019-11 guidance. Non-invasive SaMD that does not by itself drive diagnosis or therapy.
DCB0129 Compliant
Strict clinical risk management with documented hazard logs and safety cases.
Clinical Safety Officer
Safety cases approved and maintained by a registered CSO with ongoing clinical oversight.
ALARP Verified
All residual risks reduced to As Low As Reasonably Practicable. Clinical hazard workshops conducted with each organisation's Clinical Director.
Conservative by Design
Our system prioritises safety over sophistication. Every guardrail is adjustable per practice needs, ensuring clinical governance is maintained at every step.
1 Trend Analysis (Safety) Detects clinically significant changes between results
- Skips results if Creatinine increases ≥1.5x from previous result (AKI risk)
- Skips results if Haemoglobin drops >10 units from previous value
- Ensures emerging clinical trends are caught before they escalate
2 Context & Exclusions Age-based rules, PSA logic, and diabetes checks
- Patients under age 12 are automatically excluded from auto-filing
- PSA results use age-specific thresholds (40-49, 50-59, 60-69, 70-79)
- Diabetes-related biomarkers flagged with appropriate clinical context
3 Safety Keywords Clinical keyword detection and flagging
- Detects AKI (Acute Kidney Injury) keywords and flags for immediate review
- Identifies CKD (Chronic Kidney Disease) indicators
- 'Not Detected' rules ensure negative results are handled appropriately
4 Lab Errors & Quality Sample quality detection and error handling
- Detects haemolysed samples and prevents filing
- Catches null values and incomplete results
- Identifies lab processing errors and duplicate specimens
Clinical Governance Based On
Clinical Safety & Risk Management
The Pathology Automation system has undergone a comprehensive clinical risk management process in accordance with DCB0129. Hazard identification workshops, risk assessment, and mitigation controls ensure that all identified risks are managed to an acceptable level.
The system does not handle abnormal results or make clinical decisions — its function is limited to filtering and filing normal results. Abnormal or ambiguous results are always left for clinician review.
Identified Hazards & Controls
Unauthorised access to the system could lead to breaches of patient confidentiality and compromised data integrity.
- Robust authentication protocols with encrypted credential vaults
- Multi-factor authentication and regular security training
- Appointed Data Protection Officer (DPO) with regular policy reviews
Insufficient access controls might allow unauthorised data alterations, risking data integrity across the system.
- Refined access controls — only authorised personnel access sensitive information
- Encryption of all stored credentials and clinical rules
- Regular security audits and access reviews
Inaccuracies in digital patient records could lead to medical errors arising from incorrect automated filing decisions.
- Practices encouraged to adopt robust quality checking processes for digital records
- Regular audits and feedback mechanisms to improve data accuracy
- System handles naming variations (serum/plasma) and detects lab errors automatically
Filing an eGFR result as normal when it is not could delay CKD diagnosis or miss acute kidney injury indicators.
- Files only if eGFR >86; skips if creatinine increases ≥1.5x from previous result
- Keyword detection for "AKI" and "CKD" — presence triggers automatic skip
- Logic aligned with NICE and KDIGO guidelines for CKD staging
The simplified File/Skip logic could potentially lead to misclassification of results or overlooked clinical conditions.
- Comprehensive keyword and trend checks for creatinine, haemoglobin, HbA1c, thyroid, PSA, Helicobacter, and HLA-B27
- Clinical dashboard provides transparent display of all decision logic
- Regular clinical audits and feedback loops to ensure continued accuracy
A data breach of the automation process due to unauthorised access could expose sensitive patient information.
- Regular data security and protection training for all staff
- System operates within the secure environment of the healthcare organisation's network
- Bot securely logs out and resets session after each run
Following rigorous evaluation, the updated system (Version 1.2) demonstrates significantly improved clinical safety through simplified yet highly robust automated pathology management logic. With stringent keyword and trend checks, clear clinical oversight via dashboards, and regular clinical audits, patient safety and clinical efficacy are comprehensively safeguarded. This version aligns with best clinical practices and meets DCB0129 compliance effectively.
Need the Full Safety Documentation?
Request the complete Clinical Safety Case Report, Hazard Log, and Process Definition Document for your ICB or procurement process.
Questions about clinical safety? Email our Clinical Safety Officer
Why Choose ApolloIQ's Pathology Automation?
- Clinically Validated: Workflows reviewed and maintained by a Clinical Safety Officer.
- Reduces Admin Burden: Automatically files normal results, freeing clinician time for patients needing advanced care.
- Gender & Age Aware: Reference ranges adapt to patient demographics -- not a one-size-fits-all approach.
- Trend Detection: Catches clinically significant changes between current and previous results before they reach a doctor.
- Sample Quality Screening: Identifies six distinct sample quality issues so they never get filed as valid results.
- Keyword Filtering: Checks for specific clinical terms to ensure results are routed appropriately.
Unlike rigid systems or slow manual processing, our automation is flexible, safe, and constantly refined by real NHS clinicians. You get faster turnaround, safer workflows, and reduced pressure on your clinical team -- all from day one.
Simple, Transparent Pricing
No hidden fees. No complex contracts. Just straightforward pricing that saves you thousands.
- 6-month initial contract
- Then flexible month-by-month
- No setup fees
- Includes full support