lab admin 1
Quality Management in the Laboratory
Ensuring all lab work meets required quality standards
Focuses on producing accurate, reliable, and consistent test results
Involves proper handling of samples, equipment, and reagents
Includes staff training, safety practices, and documentation
Supports correct patient diagnosis and treatment
Involves everyone working in the lab
Laboratory Accreditation
Definition
A process by which an authoritative body gives formal recognition that a laboratory is competent to carry out specific tests/tasks in a reliable, credible, and accurate manner
Recognition of the laboratory’s quality and competence
Accreditation
Achieved when the laboratory has a quality management system (QMS) in place that complies with the requirements of the ISO 15189 standard
ISO 15189 and Its Importance
ISO Explained
ISO stands for the International Organization for Standardization
ISO 15189
An international standard specifically for medical laboratories
Latest version: ISO 15189:2022
Specifications
Specifies requirements for both quality management and technical competence
Ensures lab test results are accurate, reliable, and timely
Coverage
Includes all lab activities, such as:
Staff competence
Equipment
Procedures
Quality control
Used for laboratory accreditation worldwide
Quality Management System Implementation
Accreditation Canada Diagnostics
Embraces the quality principles of the International Organization for Standardization (ISO)
Provides facility management with a systematic set of tools to:
Document processes and procedures
Control documents
Measure progress with quality indicators
Manage occurrences
Conduct internal audits and management reviews
Benefits
Utilization of tools promotes continual improvement
Assurance of Technical Competence
AC Diagnostics/IQMH Accreditation Program
Contains management requirements and specific technical requirements ensuring overall competence in performing services
Assessment teams are composed of peers selected to mirror the entire scope of services
Provide the right technical expertise
Risk Reduction
An effective quality management system:
Reduces risk
Improves patient safety through tools to measure and mitigate risk
Staff Confidence and Development
A QMS fosters healthcare reform, providing an environment where:
Staff can perform their best
Contribution, involvement, and professionalism are encouraged
Morale improvement
Opportunities for Staff
Implementation presents new learning opportunities and career paths, such as quality manager positions
Validation of service quality
Peer assessor participation develops valuable tools for individual growth and professional development
Improved Communication
Clear documentation of processes and procedures leads to improved communication and reduced variability
International Recognition
AC Diagnostics accreditation is a worldwide recognized mark of excellence, promoting competitiveness and assisting facilities in business expansion
Peer Assessment
Accreditation assessments conducted by a team of trained, certified peers
Commitment to Quality and Accountability
Investment in accreditation demonstrates a commitment from management to deliver quality service and accountability to patients, accreditors, and regulators
A clear indication that the service can be trusted
Sustainment of Gains
AC Diagnostics program cycle encourages continuous review and maintenance of documentation and processes
Momentum is sustained over time
Cultivation of Fresh Ideas
Accreditation process allows for scrutiny from different perspectives, cultivating new ideas to enhance the overall system
Opportunities for unique observations and alternative approaches by volunteering as an assessor
Laboratory Licensing and Accreditation in Ontario
All medical laboratories must be licensed for the tests they perform
In Ontario, all licensed laboratories must also be accredited
Before Mandatory Accreditation
Laboratories were periodically inspected by Laboratory Licensing authorities
Required participation in the Laboratory Program (LPTP)
Institute for Quality Management in Healthcare (IQMH)
Offers accreditation to ISO 15189:2022
Largest provider of medical laboratory accreditation and proficiency testing in Canada
Issuing accreditation certificates since 2003
In Ontario, accreditation certificates are valid for 4 years
Structure Based on ISO 15189:2022
Sections of IQMH
Organizational Structure
Quality Management System
Physical Facilities
Equipment, Reagents, and Supplies
Pre-Analytical Process
Analytical Process
Quality Assurance
Post-Analytical Process (Reporting)
Laboratory Information System
Safety
Point-of-Care Testing
Benefits of Laboratory Accreditation
Quality Management System Confirmation
Accreditation shows that a lab has a QMS in place ensuring reliable results
Risk Reduction and Patient Safety
Standardized processes minimize errors
Support for Healthcare Reform
Promotes consistent, high-quality practices across the healthcare system
Enhanced Staff Performance
Trained staff work more efficiently and accurately
How a Laboratory Becomes Accredited
Requirements
Implement a Quality Management System (QMS) that meets ISO 15189:2022 standards
Participate in and demonstrate competence through External Quality Assessment (EQA) programs such as:
IQMH (Institute for Quality Management in Healthcare)
CAP (College of American Pathologists)
One World Accuracy
Outcome of Accreditation
Ensures adherence to international standards and proves testing accuracy and reliability
Total Quality Management (TQM)
A comprehensive approach covering laboratory services
Focuses on:
Key Aspects
Accurate and precise results
Appropriate test selection
Timely reporting
Correct interpretation of results
Clinical usefulness
Appropriate follow-up testing
Involves coordinated efforts from test order to result delivery
Quality Manual
Provides overall guidance for the laboratory
Describes the laboratory’s Quality Management System (QMS)
Includes essential Quality Assurance (QA) elements
Represents the highest level in the QMS document hierarchy
Contains policies and processes but does not include Standard Operating Procedures (SOPs)
Policies and Processes in the Quality Manual
Policies
General administrative statements across all divisions (e.g., Pathology, Hematology)
Define goals and intent
Explain actions and justifications
Processes
Describe interrelated activity steps
Show workflow and assigned responsibilities
Often illustrated as flowcharts
Essential Elements of the Quality Manual
Organization & Personnel
Organizational structure, staffing, and personnel management policies
Quality Management System (QMS)
Framework for planning, implementing, and monitoring quality
Physical Facilities
Laboratory space, layout, and environmental conditions
Equipment, Reagents & Supplies
Acquisition, maintenance, calibration, and inventory control
Pre-Examination Process
Test ordering, specimen collection, handling, and transport
Examination Process
Testing procedures and analytical performance
Quality Assurance of Examinations
Quality control, audits, and performance monitoring
Post-Examination Process
Result review, reporting, and communication
Laboratory Information System (LIS)
Data management, result entry, and information security
Safety
Personnel safety, biosafety, and regulatory compliance
Point-of-Care Testing (POCT)
Oversight and quality management of testing outside the central lab
Achieving Excellent Performance in the Laboratory
12 Quality System Essentials (QSEs) in the CLSI HS1-A Model:
Organization
Personnel
Equipment
Purchasing and Inventory
Process Control
Information Management
Documents and Records
Occurrence Management (Nonconformance/Corrective Actions)
Assessment (Internal Audits and External Assessments)
Process Improvement
Customer Service
Facilities and Safety
Relating QSEs to IQMH
Examples of QSEs
Organization, Personnel, Lab Management: Org chart, training, competency assessment
Quality Management System: Internal audits, corrective actions
Physical Facilities: Lab layout, fire safety, controlled environment
Equipment, Reagents & Supplies: Calibrated analyzers, maintenance, inventory
Documents and Records Requirements
Procedure Reviews
Procedures must be regularly reviewed to ensure completeness and compliance per ISO 15189:2022 clause 4.3h
Assessors look for:
Recent review records
Signatures and dates for confirmed reviews
Organizational Structure and Quality Management
Purpose
Ensure clear leadership and control in the laboratory
Organizational Chart
Shows responsibilities, reporting lines, and management of tasks
Personnel Management and Competency
Purpose
Ensure laboratory staff are competent and continuously improving
Human Resources
Recruitment, job qualifications, training, and competency assessments
Equipment Management
Key Components
Acquisition, installation, validation, maintenance, calibration, troubleshooting, and record-keeping
Purchasing and Inventory Management
Purchasing Process
Steps for acquiring supplies, vendor selection, and inventory control
Process Control Across Testing Phases
Ensuring Quality
Monitoring at Pre-analytical, Analytical, and Post-analytical stages
Information Management in the Laboratory
Key Focus
Manage laboratory data accurately and securely, including confidentiality of patient information
Management of Documents and Records
Purpose
Support compliance and quality, including creation and control of documents, as well as data collections for evidence of activities
Occurrence Management
Purpose
Identify and resolve problems to maintain quality, including documentation of non-conformities
Laboratory Assessment
Internal and External Assessments
Monitoring laboratory performance to ensure quality and compliance through internal audits, external proficiency testing, and inspections
Process Improvement and Customer Service
Focus on Enhancement
Continuous improvement aimed at optimizing laboratory quality, addressing stakeholder feedback, and ensuring customer satisfaction
Facilities and Safety Management
Key Aspects
Policies for a safe work environment, secure transport of specimens, containment of hazardous materials, and overall laboratory safety measures
Key Canadian Health Regulations
Canada Health Act
Sets conditions for healthcare funding across provinces, including five principles: Public Administration, Comprehensiveness, Universality, Portability, and Accessibility
Health Care Consent Act, 1996
Regulates consent across healthcare settings and protects autonomy of those lacking capacity
Laboratory and Occupational Safety Regulations
Laboratory and Specimen Collection Centre Licensing Act
Regulates medical laboratories and specimen collection centers in Ontario
Occupational Health and Safety Act (OHSA)
Protects workers, public, and employers by ensuring safe environments
Personal Health Information Protection Act (PHIPA)
Protects personal health information in Ontario ensuring privacy and proper usage
Personal Information Protection and Electronic Documents Act (PIPEDA)
Governs the collection and use of personal data in private sector
Glossary of Terms
CAP: College of American Physicians
CLSI: Clinical and Laboratory Standards Institute
CMLTO: College of Medical Laboratory Technologists of Ontario
SOP: Standard Operating Procedure
Quality Control: Process monitoring accuracy and reproducibility
Document Control
Regulates handling and management of documents within the Quality Management System
Conclusion
A comprehensive quality management approach ensures efficient laboratory services, protection of patients, and adherence to international standards.