Introduction to Laboratory Quality Management System Flashcards
This is a coordination of activities to direct and control an organization with regards to quality.
Quality Management System
This constitutes to all aspects of laboratory operation needed to be addressed to ensure quality.
Quality Management System
These are essential aspects of health care a laboratory result should have.
Accurate, Reliable, and Timely
These are the costs of errors found in laboratories.
- Time
- Personal Effort
- Patient Outcomes
This is how we can achieve excellent performance in the laboratory.
Twelve Quality System Essentials
These are the phases regarding the complexity of a laboratory system.
- Pre-examination
- Examination
- Post-examination
These are the steps in the path of workflow.
- The Patient
- Test Selection
- Sample Collection
- Sample Transport
- Laboratory Analysis
- Report Creation
- Report Transport
- Result Interpretation
Patient or Client Prep Sample Collection
Pre-examination
Personnel Competency Test Evaluations
Pre-examination
Sample Receipt and Accessioning
Pre-examination
Sample Transport
Pre-examination
Quality Control Testing
Examination
Record Keeping
Post-examination
Reporting
Post-examination
The Patient
Pre-examination
Test Selection
Pre-examination
Sample Collection
Pre-examination
Laboratory Analysis
Examination
Result Interpretation
Post-examination
This is the reason why the path of workflow is essential in health laboratories.
The entire process of managing a sample must be considered.
These are the considerations in the entire process of managing a sample.
- The beginning: sample collection.
- The end: reporting and saving files.
- All processes in between.
These are the aspects that influence laboratory tests.
- Laboratory Environment
- Knowledgeable Staff
- Competent Staff
- Reagents and Equipment
- Quality Control
- Communication
- Process Management
- Occurrence Management
- Record Keeping
These are sets of coordinated activities that function as building blocks for quality management.
Twelve Quality System Essentials
These are each of the twelve sets of quality management building blocks.
- Organization
- Personnel
- Equipment
- Purchasing and Inventory
- Process Control
- Information Management
- Documents and Records
- Occurrence Management
- Assessment
- Process Improvement
- Customer Service
- Facilities and Safety
These are an essential part of the path workflow.
Twelve Quality System Essentials.
They are described by its quality policy with regards to their given responsibilities and authorities, provision of resources, and communications.
Organization
The person in charge of creating a quality policy form.
CEO
This is defined as the most valuable asset (if competent).
Personnel
These include human resources, job qualifications, orientations, training, competency assessments, professional development, and continuing education.
Personnel
These are subjected to acquisition, installation, validation, maintenance, calibration, troubleshooting, service, repair, and records.
Equipment
These include vendor qualifications, supplies, reagents, critical services, contract reviews, and inventory management.
Purchasing and Inventory
These are quality control, sample management, method validation and verification.
Process Control
These include the confidentiality, requisitions, logs and records, reports, and computerized LIS’s.
Information Management
This is the unabbreviated term of LIS.
Laboratory Information Systems
These are focused on creation, revisions, reviews, control, and distribution of information. They are used to inform how to do things.
Documents
These are focused on the collection, review, storage, and retention of information. They must be meticulously maintained.
Records
These include the complaints, mistakes, problems, documentations, root cause analysis, immediate, corrective, and preventive actions.
Occurrence Management
These include two factors: internal and external aspects of a laboratory.
Laboratory Assessment
These are the quality indicators, audit programs and review of a laboratory.
Internal (Laboratory Assessment)
These are the proficiency testing (EQA), inspections, and accreditations of a laboratory.
External (Laboratory Assessment)
The unabbreviated term for EQA’s.
External Quality Assessment
This includes the opportunities for improvement (OFIs), stakeholder feedback, problem resolution, risk assessment, preventive and corrective actions.
Process Improvement
This includes the customer group identification, customer needs, and customer feedback.
Customer Service
This includes a safe working environment, transport management, security, containment, waste management, laboratory safety, and ergonomics.
Facilities and Safety
This is the study wherein people’s efficiency and comfort are taken into account with their working environment.
Ergonomics
This is includes policies and procedures to prevent workers and visitors from harm.
Safety
This seeks to minimize risks and prevent hazards from leaving the labortory space and causing harm.
Containment
This is the process of preventing unwanted risks and hazards from entering the laboratory.
Security
This is what implementing laboratory quality management doesn’t guarantee.
It does not guarantee an error-free laboratory.
This is the bright side of implementing quality management.
Detection of errors and preventing them from occurring or reoccurring.
This is what happens to laboratories not implementing quality management systems.
It guarantees undetected errors.
