MIDTERMS: QA & LABORATORY'S PATH OF WORKFLOW Flashcards
A degree to which a set of inherent characteristics fulfills the requirement (ISO 9000 [3.1.1])
Quality
Other term for QA and Laboratory’s Path of Workflow
Phase of the Laboratory
CLSI
Clinical and Laboratory Standards Institute
ISO
International Organization for Standardization
What are the stages of Quality? (highest to lowest)
Total Quality Management
Quality Cost Management
Quality Management System
Quality Assurance
Quality Control
It is a ladder synthesized from the concepts of acknowledged quality experts. A laboratory can best obtain the next higher stage by mastering the preceding one, ultimately reaching the top rung.
Stages of Quality
It is an operational process control technique to fulfill quality requirements for regulatory compliance and accreditation.
Quality Control
It is planned and systematic activities to provide confidence that an organization fulfills requirements for quality.
Quality Assurance
It is a systematic process-oriented approach to meeting quality objectives.
Quality Management System
It is a measurement system for the economic aspects of the “cost of quality”
Quality Cost Management
It is a management approach centered on sustained high quality, by focusing on long-term success through customer satisfaction.
Total Quality Management`
It is part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000 [3.2.11])
Quality Assurance
A comprehensive set of policies, procedures, and practices are followed to ensure that laboratory results are reliable (accuracy and precision)
Quality Assurance
It also includes record keeping, maintenance, and calibration of equipment, proficiency testing, quality control, and training of personnel.
Quality Assurance
A sequential process in laboratory activities transforms a request for examination into the laboratory information that is captured in the report of results.
Path of workflow, laboratory
What are the three phases under the Path of Workflow?
Pre-analytical
Analytical
Post-analytical
The process starts, in chronological order, from the request for examination and including the transportation to or within the laboratory, and ends when the analytical examination procedure begins (modified from ISO 15198)
Pre-analytical/Pre-analytics/Pre-examination procedure
What are the different individuals that are involved in the pre-analytical phase?
Receptionist/Clerk of the Laboratory
Medical Technologist
Clinician
Patient
A set of operations, described specifically, used in the performance of examinations according to a given method (ISO 15198)
Analytical/Analytics/Examination procedures
Processes following the examination include systematic review, formatting and interpretation, authorization for release, reporting, and transmission of the results, and storage of samples of the laboratory examinations. (ISO 15189[3.9])
Post-analytical/analytics/examination procedures
Phlebotomy –> Send to the lab. –> Reception –> Centrifuge –> Aliquot –> Distribute –> Load
Pre-analytical
Pre-order/order entry –> Collection –> Register and ID –> Automated routing –> Device connectivity
Pre-analytical
Ordering –> Blood collection –> Transport/scan –> Pre-analytics –> Analytics –> Validation –> Sample archiving –> Reporting
Quality
Automation of complex processes –> Production monitoring –> Quality assurance –> Open connectivity
Quality
