Start a clinical laboratory service

UKAS accreditation - the quality foundation

UKAS (United Kingdom Accreditation Service) accreditation to ISO 15189 is the quality standard for medical laboratories. It's mandatory for NHS laboratories and strongly recommended for private laboratories. Without it, you cannot tender for NHS contracts.

ISO 15189 covers both quality management (like ISO 9001) and technical competence. It's specific to medical laboratories and more demanding than general laboratory standards.

Choosing your laboratory scope

You must define which clinical disciplines you'll cover. Each discipline may require additional assessment days and costs. Starting with a narrow scope and expanding later is often more practical than seeking full multi-discipline accreditation from the outset.

Preparing for UKAS assessment

Before you apply, you need:

• A complete Quality Management System (QMS) with documented procedures
• Validated testing methods with performance data
• Internal quality control (IQC) running for at least 3 months
• External quality assessment (EQAS) participation
• Staff competency assessments completed
• Equipment validation and calibration records
• At least 6 months of operational data demonstrating you meet the standard

Many laboratories fail their first assessment due to insufficient preparation. Consider hiring a consultant with ISO 15189 experience for gap analysis.

Which quality standard do you need?

Different laboratory types require different ISO standards:

CQC registration for diagnostic services (England)

If you're providing diagnostic and screening procedures in England, you must register with the Care Quality Commission (CQC). This applies to pathology laboratories, imaging centres, and screening services that directly provide services to patients.

Do you need to register? You need CQC registration if:

• Patients attend your facility for sample collection or testing
• You provide diagnostic reports directly to patients
• You operate imaging equipment (X-ray, MRI, CT, ultrasound)

You may not need registration if you're purely a reference laboratory processing samples from other healthcare providers without direct patient contact.

CQC fundamental standards for laboratories

Registered laboratories must meet CQC's fundamental standards, including:

• Safe care and treatment - Risk assessments for hazardous materials, infection control
• Safeguarding - Policies for vulnerable adults and children
• Staffing - Sufficient numbers of qualified staff
• Fit and proper persons - DBS checks, professional registration verification
• Good governance - Quality monitoring, incident reporting, duty of candour

CQC inspections assess laboratories against these standards and publish ratings (Outstanding, Good, Requires Improvement, or Inadequate).

Human Tissue Authority licensing

If your laboratory works with human tissue for research, post-mortem examination, or transplantation, you need a licence from the Human Tissue Authority (HTA). HTA licensing under the Human Tissue Act 2004 applies in England, Wales and Northern Ireland; in Scotland these activities are governed by the Human Tissue (Scotland) Act 2006. The HTA licenses UK-wide only for tissues and cells for human application under the 2007 Quality and Safety Regulations.

When you need HTA licensing:

• Storing human tissue for research purposes
• Performing post-mortem examinations
• Processing tissue for transplantation or assisted conception
• Storing organs or tissue for anatomical examination

Routine diagnostic testing on samples (blood tests, biopsies sent for diagnosis) does not require HTA licensing. The licensing requirement applies to storage and use beyond diagnosis.

Appointing a Designated Individual

Every HTA licensed establishment must have a Designated Individual (DI) - the person legally accountable for the licensed activities. The DI must:

• Be suitably qualified (usually medical or scientific degree)
• Have sufficient authority within the organisation
• Not have been disqualified by HTA
• Complete HTA training on the Human Tissue Act

The DI cannot delegate this accountability, though day-to-day management can be performed by others.

Blood transfusion and MHRA authorisation

If you're operating a hospital blood bank or blood establishment, you need MHRA authorisation in addition to UKAS accreditation.

Blood traceability requirements

Blood establishments must maintain complete traceability from donor to recipient and vice versa for 30 years. This means:

• Electronic systems capable of tracking every unit
• Archive systems for 30-year data retention
• Procedures for "look-back" when donor issues are identified
• Statutory reporting of serious adverse reactions and events to the MHRA via the SABRE system
• Voluntary haemovigilance reporting to SHOT (Serious Hazards of Transfusion)

This is one of the most demanding record-keeping requirements in healthcare.

Genetic testing services

Genetic testing has additional regulatory requirements due to the sensitive nature of genetic data and the implications for patients and their families.

When genetic counselling is required

For medical-grade genetic tests offered directly to consumers, you must provide access to genetic counselling. This includes:

• Pre-test counselling about what the test can and cannot tell them
• Post-test counselling to explain results
• Referral pathways to clinical genetics services for abnormal results

Recreational ancestry tests don't require counselling, but any test marketed for health purposes does.

Point of care testing (POCT) governance

If you're providing oversight for near-patient testing (tests performed outside the laboratory, such as ward-based glucose testing or GP surgery INR monitoring), you need robust governance frameworks. POCT is assessed under ISO 15189:2022, which absorbed the former ISO 22870 standard (now withdrawn).

Managing POCT across multiple sites

As the governing laboratory, you're responsible for:

• Approving which devices can be used
• Training and authorising all operators
• Providing and monitoring quality control
• Auditing compliance at POCT sites
• Ensuring results are correctly recorded in patient records

POCT is often underestimated in complexity. A single laboratory might govern hundreds of devices across dozens of sites.

Workforce and professional registration

Clinical laboratories must employ appropriately qualified and registered professionals. Registration is a legal requirement for certain roles.

Building your laboratory team

Minimum staffing for a small laboratory:

• Laboratory Director - Consultant pathologist (GMC registered) or senior clinical scientist (HCPC registered)
• Quality Manager - Experienced biomedical scientist with QMS knowledge
• Biomedical Scientists - HCPC registered, minimum 2 FTE for 24/5 operation
• Medical Laboratory Assistants - Non-registered support staff for sample processing

Consultant pathologist oversight is essential for histopathology and some microbiology services. For clinical biochemistry and haematology, a clinical scientist can provide clinical leadership.

Laboratory equipment and IVD devices

All laboratory equipment and In Vitro Diagnostic (IVD) devices must be:

• CE or UKCA marked - Depending on when placed on market and where used
• Validated - Performance verified against manufacturer's claims
• Calibrated - Regular calibration with traceability to reference standards
• Maintained - Preventative maintenance schedules followed

Keep validation records, calibration certificates, and maintenance logs - UKAS will inspect these during assessment.

Information governance and data protection

Clinical laboratories handle sensitive patient data and must comply with:

• UK GDPR - Data protection for patient information
• NHS Data Security and Protection Toolkit - For NHS contractors
• Caldicott Principles - NHS information governance standards
• ISO 27001 (optional) - Information security management

Genetic data is "special category data" under UK GDPR and requires additional safeguards, including explicit consent for processing.

Your pathway to launching a clinical laboratory

Phase 1: Planning (Months 1-3)

1. Define your laboratory scope and services
2. Secure suitable premises with appropriate facilities
3. Develop business case and secure funding
4. Identify regulatory requirements (UKAS, CQC, HTA, MHRA)

Phase 2: Quality System Development (Months 4-9)

1. Develop Quality Management System documentation
2. Write standard operating procedures (SOPs)
3. Implement LIMS (Laboratory Information Management System)
4. Validate testing methods
5. Recruit qualified staff
6. Join EQAS schemes

Phase 3: Accreditation and Registration (Months 10-18)

1. Run internal quality control for 3-6 months
2. Apply for UKAS accreditation
3. Register with CQC (if applicable)
4. Apply for HTA licence (if applicable)
5. Complete UKAS assessment and corrective actions
6. Achieve accreditation

Phase 4: Operational Launch (Month 18+)

1. Begin accepting samples
2. Implement post-market surveillance
3. Maintain annual UKAS surveillance
4. Prepare for CQC inspection

Common pitfalls to avoid

Underestimating timescales: Many laboratories assume they can achieve accreditation in 6 months. The reality is 12-18 months minimum. Plan accordingly.

Insufficient QMS documentation: UKAS requires comprehensive documentation. Every process needs an SOP. Budget time for this.

Inadequate validation data: You need months of performance data before UKAS assessment. Don't apply too early.

Wrong staffing mix: You need HCPC-registered biomedical scientists for certain roles. MLAs alone are insufficient.

Ignoring scope creep: Expanding your scope post-accreditation requires additional UKAS assessment and fees. Plan your full scope from the start.

Overlooking HTA: Working with tissue for research? You need HTA licensing. Don't assume diagnostic work exempts you.