PMLS2_LEC13 Flashcards
It can be defined as accuracy, reliability, and timeliness of reported test results
LABORATORY QUALITY
● Involves procedures to ensure that acceptable standards are being met while the procedures are being performed
● Employs the use of standards, calibrators, and controls
→ ____ are used to adjust customer system to
an established reference system or method
→ ____ are verifiers on the recovery of levels of
the standardized ranges of reagents and calibrators
→ Both ____ are used to ensure
reliability and consistency of the assay results
→ ____ are materials containing precisely known
concentration of the substance being analyzed
QUALITY CONTROL; Calibrators; Controls; calibrators and controls; Standards
● Set of activities to ensure confidence that quality
requirements will be fulfilled
● Addresses procedures in all phases of the laboratory process, which includes QC (Quality Control)
QUALITY ASSURANCE
A systematic and independent examination to determine the degree of conformity to predetermined standards and criteria are exemplified
QUALITY ASSESSMENT
● Focuses specifically on the testing process, or analytical phase of the lab process
● Limited to a test or procedure
QUALITY CONTROL
● Encompasses everything (all phases of the lab process)
● ”Big picture”
QUALITY ASSURANCE
● Voluntary, non-governmental agency
● Establish standards for the operation of hospitals and other-health related facilities and services
● Goals:
◆ To continuously improve healthcare by evaluating
institutions or organizations
◆ Inspire said institutions to excel in providing safe and effective care of the highest value and quality
JOINT COMMISSION INTERNATIONAL (JCI)
● Global, non-profit standards developing organization with representatives from the profession, industry, and government
● Goals:
◆ Develop best practices in clinical and laboratory
testing and promote their use throughout the world
◆ Use a process that balances the viewpoints of the
industry, government, and the healthcare professions
CLINICAL AND LABORATORY STANDARDS INSTITUTE (CLSI)
● International standard-setting body composed of
representatives from various national standards
organizations
● Goal: Develop worldwide standardization by promoting adoption of international quality standards
● ____ – provides guidance for quality in service industries
● – requirements for quality and
competence in Medical Laboratories
INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION (ISO); ISO 9001; ISO 15189:2007
● State policies and procedures that apply to each test or practice performed
PROCEDURE MANUALS
◆ Notify changes
◆ Make annual reviews
Responsibilities of supervisor
◆ Read and familiarize the procedures that are in
the manuals
Responsibilities of staff
The procedure manual indicates:
◆ Principle and Purpose of the test
◆ Sample Type and Method of Collection
◆ Equipment & Supplies Needed
◆ Standards & Controls
Forms used to record equipment checks used in the laboratory
◆ Verification of new lot numbers (tube additives,
vacuum strength, and expiration dates)
◆ Refrigerator and freezer temperatures (should be
recorded)
◆ Centrifuge maintenance checklist
EQUIPMENT CHECK FORMS
Instances where ____ is given
◆ Injury that occurs during the performance of the
procedure (needlestick injury, slipping on wet floor, back injury)
◆ Errors in labeling and processing of samples
◆ Insubordination and other misdemeanors
Confidential incident reports (IR)
(IR must state facts, not feelings)