Business Case for Services
The cost of validation is planned and controllable. The cost of inadequate validation is often unexpected, disruptive, and substantially higher."
What is it costing your laboratory every week that the service isn't live
Cost of delay
- Staff time
- Referral testing
- Reagent/analyser under-utilisation
- Project management time
- Repeat validation work
- Delayed clinical pathway
- Delayed patient results
- Lost service capacity
ISOCHECKS investment
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Faster, controlled implementation
↓
Earlier clinical service delivery
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Earlier return on laboratory investment
The Cost of Poor or Delayed Validation to Organisations
Cost incurred to correct mistakes to the health services
Cost incurred to correct mistakes to the health services
Cost incurred to correct mistakes to the health services
Failure to validate a diagnostic service properly can expose laboratories to significant financial, operational, regulatory, and clinical risks.
A robust validation programme typically costs a fraction of the expenses associated with remediation, regulatory findings, or delayed implementation.
Minor Compliance Gap
Cost incurred to correct mistakes to the health services
Cost incurred to correct mistakes to the health services
- Additional staff time to generate missing evidence
- Repeat validation studies
- Documentation updates
- Corrective action plans
- UKAS non-conformity response
Typical Cost: £2,000 to £10,000
Delayed Service Implementation
Cost incurred to correct mistakes to the health services
Delayed Service Implementation
- Project delays
- Lost referral income
- Extended reagent evaluations
- Additional training requirements
- Delayed patient access to testing
Typical Cost: £10,000 to £50,000+
Major Validation Deficiency
Failed New Technology Implementation
Delayed Service Implementation
- Full revalidation of the service
- Consultant and specialist support
- Repeat method comparisons and statistical analysis
- Additional UKAS assessment activity
- Service suspension or restricted accreditation scope
Typical Cost: £25,000 to £100,000+
Patient Safety Incident
Failed New Technology Implementation
Failed New Technology Implementation
- Investigation costs
- Repeat patient testing
- Clinical review and governance processes
- Legal and indemnity costs
- Reputational damage
- Service redevelopment
Typical Cost: £50,000 to £500,000+
Failed New Technology Implementation
Failed New Technology Implementation
Failed New Technology Implementation
- Instrument underutilization
- Wasted procurement investment
- Delayed commissioning
- Additional validation and verification work
- Loss of business case benefits
Typical Cost : £100,000 to £1M+
Validation Cost-Impact Matrix
This matrix can be used to help laboratories quantify the business risk associated with inadequate or delayed validation activities.
ISO 15189 Compliance
Medium Risk: Non-conformity requiring corrective action (£5k-15k).
Severe Risk: Loss of accreditation or suspended service (£50k+).
Staff Resource Impact
Medium Risk: Repeat validation studies (£5k-20k)
Severe Risk: Dedicated recovery project (£50k+)
Service Implementation Delay
Medium Risk: 1-3 months (£10k-30k)
Severe Risk: Project failure or cancellation (£100k+)
Revenue & Referrals
Medium Risk: Loss of referrals (£25k-100k)
Severe Risk: Contract loss or service decommissioning (£100k+)
Patient Safety Risk
Medium Risk: delay in diagnosis
Severe Risk: Potential diagnostic error. Significant incident requiring investigation.
If external specialist support gets your service live weeks earlier, the investment in validation can be small compared with the cost of delay.