Quality management PRELIM lab Flashcards
facility outside of the hospital
blood center
same with the blood centers but it is within the
hospital
hospital blood bank
4 governing agencies
- united states food and drug administration
- the joint commission
- college of pathologist
- Association for the Advancements of Blood and biotherapies
who mandates and inspect the different anticoagulants that we use for blood
preservation
United States Food and Drug Administration (FDA)
Compliance inspections is conducted every
2 years
Evaluate how effectively the facility meets regulatory and accreditation a requirement by detecting errors, deficiencies, and deviations.
Compliance program
measure the state of the facility’s program with respect to the applicable requirements
Compliance inspections
Compliance inspections also called as
surveys or assessment
actively and continuously practiced by blood bank leaders, managers, and staff throughout all blood bank operations
Quality management
(3) foundation of a quality
management system
Quality Control (QC), Quality Assurance (QA), and the Quality Management System (QMS)
who is responsible to mandates
the different guidelines, the standardization, the policies that we have in every procedures
Association for the Advancement of Blood and Biotherapies
allows each laboratory to customize its QC program, but it must be still within the AABB guidelines
Individualized Quality Control Plan (IQCP)
The three parts of IQCP
- laboratory risk assessment
- pre-analytical, analytical, post-analytical process
- customize its QC program
parts ofRisk Assessment (RA)
Specimen
Reagents
Test system
Environment
Testing personnel
Part of specimen
PSS
- patient preparation
- specimen collection
- specimen labelling
Part of reagent
PSS
- Preparation
- shipping and receiving
- storage conditions