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Faculty of Allied Medical Science. Blood Banking (MLBB 201). Quality Management in Blood Banking . Prof. Dr. Nadia Aly Sadek Prof. in Haematology and Director of Blood Bank Centre, Medical Research Inst, University of Alexandria. ILOs.

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Faculty of Allied Medical Science

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    1. Faculty of Allied Medical Science Blood Banking (MLBB 201)

    2. Quality Management in Blood Banking Prof. Dr. Nadia AlySadek Prof. in Haematology and Director of Blood Bank Centre, Medical Research Inst, University of Alexandria

    3. ILOs • By the end of this lecture, the students will be able to recognize; • What is Quality Management? Audit? Accreditation?

    4. What is Quality? Quality means that a product or service does its intended job which should: - meet the customer’s requirements - be fit for purpose - conform to the requirements.

    5. What is Quality Management? • It is the aspect of management function that determines and implements the “Quality policy” and the overall direction regarding quality as authorized by top management.

    6. The basic elements of quality management are: - An appropriate infrastructure or “Quality system” including procedures, processes and resources. - The systematic actions necessary to ensure adequate confidence that a product or service will satisfy the required quality.

    7. Quality Assurance (QA) Quality assurance is a management tool that covers everything that can affect the quality of the products supplied or services. It aims at safety and effectiveness of all procedures.

    8. Personnel in Blood Banks • Personnel in blood banks should be:- - Adequate in number for different shifts - Well qualified - With adequate practical experience. They must work according to defined procedures: standard operating procedure (SOP)

    9. They must be aware of good manufacturing practice (GMP). They must receive training in GMP either: - at initial training - or at continuing training including hygiene standards

    10. Training should be kept in records. They should be motivated to support their workplace and maintain high quality standards. • They must report any errors or mistakes.

    11. Quality Control • Quality control is concerned with sampling, specification and testing as well as final product testing and release. • Sample of the products needs to ensure that:- - The system is working well

    12. - The products meet the specification - The products will be effective for their intended use - The products are safe.

    13. Quality Indicators • They are a measure of performance. They include incidents, contacts/ complaints, deviations from the standards.

    14. Corrective and preventive actions • “ Corrective action” is the immediate action that is taken to correct a problem. • “ Preventive action “ is a long-term action that prevents future recurrence of the problem.

    15. Audit • It is a way of inspecting systems to make sure that they are carried out against “standards”. • An audit may be : - internal audit - external audit

    16. Internal audit • This is a self inspection used by staff to their own systems. • Auditors should be independent of the departments they are auditing.

    17. External audit • It is the customers to ensure that the organization meets the specified requirement.

    18. Impact of GMP in blood banks - Donors should be carefully selected - Ensure proper skin disinfection of puncture site before blood collection - Reduction of errors and technical problems in collection, preparation, testing and distribution.

    19. - Proper storage of blood and its components, maintaining a cold chain. - Maintain adequate documentation and full traceability for each procedure from donor to recipient.

    20. - upgrading the competence of the personnel - continuous improvement in collection, preparation and testing of materials. - Staff should be trained to use SOPs in order to assure quality.

    21. Accreditation • Accreditation is a non-governmental, voluntary process that evaluates institutions, agencies and educational programs. • It is defined as the process by which an agency grants public recognition to Blood Banks for having met the established standards.

    22. For a Blood Bank to be accredited, it should establish and maintain quality systems involving all the activities performed taking into account the principles of Good Manufacturing Practice

    23. Systems of accreditation help any institution to know its strengths and weakness through an informed review process. • Any assessment and subsequent accreditation is made with reference with other similar institutions.

    24. Benefits of Blood Bank Accreditation - It stimulates continuous improvement - It enables the blood bank service to demonstrate commitment to quality - It raises community confidence in the services provided by the blood bank - It provides the staff with continuous learning, good working environment and leadership.

    25. Study questions 1- Define GMP 2- What is meant by quality? 3- Mention the benefits of acrreditation in a blood bank.

    26. Assignments • Stem cell and Transplantation رحمة عبد المنعم