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Elements of Quality Management Systems

A clinical or forensic laboratory's core quality principle should be continuous improvement of all processes and services supporting the business and operational areas. To support this principle, PBSI endorses the Quality System Framework. The Quality System Framework will allow your lab to deliver consistent, cost-effective and superior service to your clients. The system is comprised of 12 Quality System Essentials (QSEs) and organized as structure, process and outcome. The policies, processes and procedures associated with these QSEs are applied to all operations in the path of workflow (e.g., pre-analytic, analytic and post-analytic). Quality management focuses on continuous quality improvement as measured by customer satisfaction.

Quality System Essentials

Key Performance Quality Indicators 

Every laboratory should identify and track key performance indicators for business and operational areas.  The indicators should be reviewed on a regular basis to ensure the laboratory continues to  maintain high standards. A sampling of these metrics includes:

Pre-analytic performance indicators- Incoming defects, lost samples, sample identification

Analytic performance indicators - Performance testing reliability, analytic turnaround

Post-analytic performance indicators - Revised reports, number of CODIS hits

Operational performance indicators- Caseload backlog, case completion rate, customer satisfaction surveys

Scope of Services

PBSI has researched dozens of quality management systems - from those suitable for one to 5 users and enterprise wide solutions.  PBSI can assist you in the selection and or implementation of your next quality management system through: 

• Current state/gap analysis of your current policies and procedures
• Development of a project plan (or management of the project itself) to correct the deficiencies identified in the current state/gap analysis
• Draft the business case for the selection and implementation of a Quality Management System
• Provide training and technical assistance to process map AS IS /TO BE quality processes in anticipation of process improvement initiatives or selection of a Quality Management System
• Selection and implementation key performance indicators and automated quality management systems
• Provide training in internal auditing guidelines for laboratories
• Lead laboratory process improvement and process mapping initiatives