QUALITY ASSURANCE IN THE BLOOD BANK 3.57.51 PM

QUALITY ASSURANCE IN THE BLOOD BANK 3.57.51 PM - QUALITY...

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Unformatted text preview: QUALITY ASSURANCE IN THE BLOOD BANK DR. WAN ASWANI WAN YUSOF M. PATH YEAR 1 INTRODUCTION Quality management is an integrated systems of quality assurance covering all matters which individually or collectively influence the components in order to guarantee their quality. Good Manufacturing Practice (GMP), quality control and audit programmed, all are closely linked together with the management of errors and accidents. Internal quality control and proficiency testing are aspects of quality system concerns with examination of material component and the proficiency of the staff The quality requirements involve:- Quality control and proficiency testing Internal and external audits Personnel and organization Premises, equipment and materials Documentation Blood processing Complaints and component recall Investigation of errors and accidents Quality control- activities including steps of verification and testing which are used to assure the materials and processes meet their intended specifications. Proficiency testing an aspect of Quality Assurance which monitors the ability to perform laboratory procedures within established limits of accuracy through the analysis of unknown specimens distributed by an external source The line between QC and PT in some cases is ill defined. The performance of QC procedures on component and reagent will be in itself a measure of the proficiency of the staff preparing these components. Internal audits-to ensure that all procedure and associated quality control are performed according to the principles of GMP, and should be carried out according to an established programme by responsible person. External audits should also be performed by a designated approved authority. Personnel and organization-adequate number of qualified and trained personnel.Presence of organization chart showing the hierarchical structure of the blood transfusion service. Premises-must be located , designed, constructed and adapted to suit the operation to be carried out.It should include separate areas for :-a) Donor selection b) Blood collection c) Blood processing d) Storage e) Laboratory facilities f) Auxiliary facilities . Cont. Cont Equipment- manufactured equipment should be designed and maintained to suit its intended purpose and should not present any hazard to donors, components or operators. Periodic maintenance and calibration should be carried and documented according to established procedures . Documentation-adequate documentation prevent errors which may result from communication.It include:-all manufactures steps, data affecting the quality of the component to be checked, from the donor to the recipient of the blood component and vice-versa Blood processing :-a) Donor selection b) Blood collection c) Component preparation d) Storage , issue and transportation e) Contract testing Cont Complaints and component recall- investigate as soon as possible the complaint and information that...
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This note was uploaded on 12/24/2011 for the course STEP 1 taught by Professor Dr.aslam during the Fall '11 term at Montgomery College.

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QUALITY ASSURANCE IN THE BLOOD BANK 3.57.51 PM - QUALITY...

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