1 - LABORATORY QUALITY MANAGEMENT SYSTEM Flashcards
The Quality Management System
Organization
Personnel
Equipment
Purchasing & Inventory
Process Control
Information Management
Documents & Records
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities & Safety
- degree of excellence
- It is essential to all aspects of healthcare are laboratory results that are accurate, reliable, & timely
What is Quality?
Laboratory errors cost in:
Time
Personnel Effort
Patient Outcomes
Coordinated activities to direct and control an organization with regard to quality (ISO, CLSI)
Quality Management System
All aspects of the laboratory operation need to be addressed to assure quality; this constitutes a ?
Quality Management System
Patient/Client Preparation / Sample Collection
Personal Competency / Test Evaluations
Sample Receipt and Accessioning
Sample Transport
Pre-Examination
Quality Control Testing
Examination
Record Keeping
Reporting
Post Examination
Path of Workflow
THE PATIENT → Test Selection → Sample Collection → Sample Transport → Laboratory Analysis Examination Phase → Report Creation → Report Transport → Post Examination Phase → Result Interpretation
The entire process of managing a sample must be considered:
The beginning: Sample Collection
The end: Reporting and Saving of Results
All processes in between
Why is the Path of Workflow Essential to Consider in Health Laboratories?
Laboratory Tests are Influenced by:
Laboratory Environment
Knowledgeable staff
Competent staff
Reagents and equipment
Quality control
Communications
Process management
Occurrence management
Record keeping
Set of coordinated activities that function as building blocks for quality management
Twelve Quality System Essentials
Responsibilities, Authorities
Provision of Resources
Communication
all entails Quality Policy
Organization
Human resources
Job qualifications
Job descriptions
Orientation
Training
Competency Assessment
Professional Development
Continuing Education
Personnel
Acquisition
Installation
Validation
Maintenance
Calibration
Troubleshooting
Service and Repair
Records
Equipment
Vendor qualifications
Supplies and reagents
Critical services
Contract Review
Inventory Management
Purchasing and Inventory
Quality Control
Sample Management
Method Validation
Method Verification
Process Control
Confidentiality
Requisitions
Logs and records
Reports
Computerized Laboratory Information Systems (LIS)
Information Management
Documents
Creation
Revisions and review
Control and Distribution
Records
Collection
Review
Storage
Retention
Documents & Records
Complaints
Mistakes and problems
Documentation
Root cause analysis
Immediate actions
Corrective actions
Preventive actions
Occurrence Management
Internal
Quality Indicators
Audit Program
Audit review
External
Proficiency Testing (EQA)
Inspections
Accreditations
Laboratory Assessment
Opportunities for improvement (OFIs)
Stakeholder feedback
Problem resolution
Risk assessment
Preventive actions
Corrective actions
Process Improvement
Customer group identification
Customer needs
Customer feedback
Customer Service
Safe working environment
Transport management
Security
Containment
Waste Management
Laboratory Safety
Ergonomics
Facilities and Safety
Coordinated activities to direct and control an organization with regard to quality
ISO 9000:2000
Laboratory Quality Management System
Statistical Process Control
Walter A. Shewhart
Continual Improvement
W. Edwards Deming
Quality Toolbox
Joseph M. Juran
Quality by Requirement
Philip B. Crosby
Micro Scale Error Reduction
Robert W. Galvin
Guidance for quality in manufacturing and service industries
Broad applicability; used by many kinds of organization
Use consensus process in developing standards
ISO - International Organization for Standardization
Standards, guidelines, and best practices for quality in medical laboratory testing
Detailed; applies specifically to medical laboratories
Uses consensus process in developing standards
CLSI - Clinical and Laboratory Standards Institute (formerly known as NCCLS)
NCCLS stands for
National Committee for Clinical Laboratory Standards Institute
Model for QA in design, development production, installation, and servicing
ISO 9001:2000 Quality Management System Requirements
General requirements for the competence of testing and calibration laboratories
ISO / IEC 17025:2005
Quality Management in the clinical laboratory
ISO 15189:2007
- the foundation of international medical laboratory quality management
- medical laboratories - particular requirements for quality and competence
ISO 15189:2007
- describes quality system model, 12 essentials
- aligns to ISO 15189 and parallels ISO 9000
- applies to all health care systems
HS1-A2 A Quality Management System Model for Health Care
- describes laboratory application of quality system model
- relates the path of workflow to the quality system essentials
- assists laboratory in improving processes
- relates to HS1-A2 and ISO 15189
GP26-A3 Application of Quality Management System Model for Laboratory Services
