1 - QUALITY ASSURANCE IN DIAGNOSTIC LABORATORY Flashcards
- Accuracy, reliability, and timeliness of the reported test results
- Maintained through a laboratory management system
Laboratory Quality
- The overall process used to ensure that laboratory results meet the requirements for health care services to patients
- Coordinated set of activities to direct and control an organization with regard to quality
Quality Management
- Management method
- All planned and systematic actions needed to provide adequate confidence that a product, service or result will satisfy given requirements for quality and be fit for use
- The sum total of the activities aimed at achieving a required standard
Quality Assurance (QA)
- Mainly concerned with the inspection of the process in the clinical laboratory
- The systematic monitoring of analytical processes to detect analytic errors that occur during analysis and to ultimately prevent the reporting or incorrect patient test results
- Part of the performance monitoring that occurs after a test has been established
- Monitoring of analytical methods is performed by assaying stable control materials and comparing their determined values with their expected values
- The expected values are represented by intervals of acceptable values with upper and lower limits (Control limits)
- Includes pre-analytical, analytical, and post-analytical processes
Aims to identify and correct errors
Quality Control (QC)
threshold at which the value is statistically unlikely
Control limits
Preventing defects
Proactive process
Process-based
Manages quality
Quality Assurance
Identifying defects (inspection)
Reactive process (after possible errors have been corrected)
Product-based approach
Verifies the quality
Quality Control
This guideline provides a structure for a comprehensive, systematic approach to building quality into the laboratory’s processes, assessing the laboratory’s performance, implementing quality improvements, and assisting in preparing for or maintaining accreditation
CLSI Guideline QMS01
A Quality Management System Model for Laboratory Services
Specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements
International Organization for Standardization
ISO 9001:2000 Quality Management Systems
- An independent, not-for-profit organization that accredits and certifies health care organizations and programs across the globe
- JCI accreditation and certification is recognized as a global leader for health care quality of care and patient safety
- To continuously improve the safety and quality of care in the international community through education, advisory services, and international accreditation and certification
- Identify, measure, and share best practices in quality patient safety with the world
- Concerned of patient’s safety within the entire hospital, including the laboratory
Joint Commission International (JCI)
- The leading organization of board-certified Pathologists serves patients, pathologists, and the public by fostering and advocating excellence in the practice of Pathology and Laboratory Medicine worldwide
- Gold standard for Interlaboratory QA
Includes in the accreditation of blood banking
Member-based physician organization founded in 1946
Comprising approximately 18,000 board-certified pathologists
It serves patients, pathologists, and the public by fostering and advocating best practices in pathology and laboratory medicine
College of American Pathologists
- Is set a by list of standards in order to produce the desired results
- The goal is always to achieve the highest quality percentage because every percent cost something, especially in the clinical laboratory
- Laboratory results should be accurate, reliable, & timely
- Pre-, post-, and analytical phase
- Laboratory errors cost in time, personal effort, patient outcomes
- Patients outcomes are the most crucial result of efforts
- Every element of Quality management system is geared towards excellence
Quality
focuses on preventing defects
Quality Assurance (QA)
focuses on identifying defects
Quality Control (QC)
- Coordinated activities to direct and control an organization with regard to quality (ISO, CLSI)
- Produce quality results
- Test results are affordable, relevant, interpreted correctly
- Quality assurance is continuous
- Continuously improving because there will always be space for improvement and corrections
Quality Management System
