Risk Management in NHS Laboratories – Quality Management System (Part 2)

Learning Outcomes

• Importance of quality in NHS laboratories
• Components & monitoring of the Quality Management System (QMS)
• Laboratory response to incidents and continual improvement

Quality Management System (QMS)

• Coordinated activities that direct & control quality
• Quality = accuracy, reliability, timeliness of results
• Poor quality → misdiagnosis, treatment delay, incorrect therapy, repeat testing

Quality Framework: QMS vs QA vs QC

• QMS – overall structure (policies, objectives, procedures)
• QA – activities that give confidence requirements are met (e.g. audits)
• QC – operational checks fulfilling requirements (e.g. IQC runs)

Roles & Responsibilities

• Laboratory Director / Clinical Services Manager – overall accountability
• Quality Manager – coordinates QMS, chairs Quality meetings
• Departmental Quality Officer – implements quality locally
• Section Leads – ensure QC is executed correctly
• Everyone – responsible for maintaining quality

QMS Phases

• Pre-analytical: sample collection → transport → receipt
• Examination: analytical testing
• Post-examination: result reporting & interpretation

Standards & Accreditation

• ISO 15189:2022 – benchmark for medical labs; assessed by UKAS (voluntary)
• BSQR 2005 – legal for Blood Banks; inspected by MHRA

Key QMS Elements

• Personnel: adequate numbers, defined roles, training, competency, authorisation
• Document management: controlled, current, accessible (e.g. Q-Pulse system)
• Equipment: acceptance testing, maintenance, status, records
• Facilities & environment: safe, appropriate space, services, containment
• Pre-, Examination & Post-process controls
• Non-conformances: capture, investigation, corrective action, follow-up

Internal Quality Control (IQC)

• Real-time statistical check on every analyte
• Uses third-party material with known levels (low/normal/high)
• Run at start-up & during day; plotted on Levey-Jennings charts
• Acceptable if within \pm 2SD of target mean; assess bias & imprecision
• Westgard rules applied for decision making

External Quality Assurance (EQA)

• Retrospective performance check via external provider (e.g. NEQAS)
• Lab tests blinded samples; provider compares to reference & peer labs
• Reports give accuracy, bias, consistency (traffic-light scoring)

Audit Types

• Internal (self-check): Vertical, Horizontal, Examination, Clinical, etc.
• External: UKAS (ISO 15189), MHRA (Blood Bank), HSE, HTA
• Purpose: verify practice vs criteria, find errors, drive improvement

Non-Conformances & CAPA

• Any incident or policy deviation (e.g. near-miss, wrong result, equipment failure)
• Logged in Q-Pulse CAPA module
  • Remedial action (immediate)
  • Root-cause investigation
  • Corrective action & follow-up (audit) – usually within 28 days
• Enables trend analysis & assignment of tasks

Incident Example (Water Inlet Error)

• Wrong tube removed during maintenance → >500 L water loss
• Contributing layers (Swiss-Cheese): unlabelled pipes, hidden shut-off, limited OOH support
• Corrective measures: label pipes, relocate valve, staff communication – issue not repeated

Contingency Planning

• Backup plans for loss of critical resources (e.g. send samples to other lab if water supply fails)

KPIs & Quality Objectives

• Measurable targets: turnaround times, error rates, CAPA closure, audit completion
• Objectives = projects to improve quality; progress monitored regularly

Key Takeaways

• High-quality lab results underpin \approx 70\% of diagnoses
• QMS integrates people, processes, documents & equipment across all phases
• Continuous monitoring (IQC), periodic assessment (EQA/audit) and effective incident management sustain quality and patient safety