1. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

2. AABB Accreditation Salwa Hindawi President of Saudi Society of Transfusion Medicine Medical Director of Blood Transfusion Services KAUH, Jeddah Saudi Arabia ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

3. Introduction Process of AABB Accreditation Quality System Essentials Conclusions ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

4. Introduction: Facilities and services are of high quality if they are: 1. SAFE 2. Effective 3. Appropriate 4. Easily accessed 5. Efficient 6. Patient-centered and consumer-friendly ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

5. The AABB Accreditation In 1958 the association implemented the Inspection and Accreditation Program The Program objective is to improve the quality and safety of collecting, processing, testing, distributing and administering blood and blood products and to advance quality in tissues and blood transfusion services. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

6. A Quality Journey: 1997 to 2012 In 1997, ▫ AABB was at the forefront of adopting quality management principles. ▫ The QSEs were adopted over time in all program units – but with slight variation and some inconsistency. In 2012, ▫ Quality management is familiar and well established in AABB accredited facilities. ▫ The field of quality management has advanced. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

7. United Sates Canada United Kingdom Italy Greece Poland Germany Spain Republic of Korea Japan Taiwan Singapore Hong Kong AABB Accredited Facilities Around the World 2011 India Saudi Arabia Kuwait Mexico Dominican Republic Honduras Columbia Brazil Portugal Argentina Hungary China Thailand ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

8. AABB Accreditation Process It is a process of peer review by experts to ensure the compliance of practice with the recognized standards. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

9. Accreditation Process Application Pre-assessment Assessment Corrective actions Decision on Accreditation Re-assessment ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

10. What is a standard? Standards are evidence based requirements that provide the basis for an accreditation program Standards are required goals, not methods Standards are minimal requirements that may be exceeded in practice ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

11. AABB requirements To Comply with the standards through applying Quality essentials to all function in the BTS. Variance to the standard may be submitted to AABB with evidence based practice. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

12. How Is a Survey Conducted? A team (assessors) surveys the institution through: ▫ Review of required documents ▫ Review of documents implementation:  Charts  Control sheets  Employees’ file  Interviews with staff and patients  Environmental rounds ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

13. How Is a Survey Conducted? Conclusions and reports are provided at the end of survey Nonconformance is to be included in the report. Action plan to be initiated by the facility for improvement (30 days).. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

14. Quality System Essentials They are: those elements which must be applied to all operations in the service’s path of workflow ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

15. QSEs Then and Now 1997-2010 2011-2012 1. Organization 2. Resources 3. Equipment 4. Supplier and Customer Issues 5. Process Control 6. Documents and Records 7. Deviations, Nonconformances, and Adverse Events 8. Assessments: Internal and External 9. Process Improvement Through Corrective and Preventive Action 10. Facilities and Safety 1. Organization, Leadership and Customer Focus 2. Facilities, Work Environment, and Safety 3. Human Resources 4. Suppliers and Supply Management 5. Equipment Management 6. Process Management 7. Documents, Records, and Information Management 8. Nonconforming Events 9. Monitoring and Assessments 10. Continual Improvement ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

16. Facilities will not need to reorganize their Quality System documents or approach in order to meet the updated AABB standards – just look for and address the gaps. New template is easily understood and verified by assessors. Quality Standards Implementation ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

17. Organization - Each Laboratory can define its structure in any format that suits its operations. -The Laboratory mission or vision statement should show support of its quality functions. -There should be an active participation by the management in the review and approval of quality and technical policies, processes, and procedures. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

18. Organization, Leadership and Customer Focus The role or responsibilities of Executive Management? The role or responsibilities of the Medical Director. The Quality Management program. the Emergency Preparedness program. Communication with our internal/external customers. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

19. Laboratories Safety Safety Procedures must be in place and should cover: Staff should be trained on all aspects related to safety Biologic Safety Radiation Safety Chemical Safety ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

20. Facilities, Work Environment, and Safety Additional power sources, regular or emergency? Additional telephone or computer lines? Update of Hazardous Chemical list? Changes to the biohazard waste disposal? Use of any gas cylinders or tanks? Any physical changes to address ergonomics? ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

21. Human Resources The Clinical Laboratory should have highly qualified personnel who have appropriate education, training, and experience to ensure competent performance of assigned duties. It include: -Job Description -Orientation Program -Competency Program ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

22. Human Resources The number of personnel required to perform the task/s? The skill set or qualifications of the personnel required? Training requirements? Competency assessment requirements? Task description of the required personnel? The personnel files? ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

23. Competency Program Competency Program include: -Written evaluations. -Direct observation of test procedures -Review of work records or reports -samples Testing of unknown. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

24. Supplier &Supply Management The Laboratory should use the following criteria to rate supplier performance : -Quality of products of materials provided -Delivery performance -Service provided -Maintenance ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

25. Supplies and Supply Management A new agreement/contract? Modification to existing agreement/contract? A Maintenance/Service contract? Supplier qualification review? Critical Materials log? ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

26. Equipments Management Approved supplier by: -FDA, CE and ISO 9000 should be the source of equipment and reagents. -Validation, calibration, and preventive maintenance should be established for all equipments. -All records of maintenance, repairs, or calibrations should be kept and reviewed periodically. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

27. process Management Elements of a process control system: Development and use of standard operating procedures (SOPs). Processes to validate or control change to policies, processes, or procedures. Monitoring of quality control policies, processes and procedures. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

28. Documents and Records Management The laboratory should have a process to ensure that documents (policies, process, and procedures) are identified, approved by medical director, implemented, and retained. Master List Forms should be controlled, and the records (completed forms) stored and archived in a defined manner ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

29. Quality System Documentation Hierarchy ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

30. Nonconformance Events -The laboratory should have a process in place to capture and assess incidents, errors, and accidents occurrences. -Staff should be encouraged to report any concerns about breakdowns or potential problems. -The reports should be submitted directly to QA coordinator. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

31. Monitoring and Assessments Internal Assessments May include routine, scheduled system checks (also called quality indicators), audits, and other findings initiated by the facility. External Assessments Include inspections, surveys, some audits, etc, performed by facilities not affiliated with organization, such as FDA, CAP and AABB. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

32. continual Improvement -Follow-up of findings from external assessments, reviews, and inspections, as well as occurrence reporting provide mechanisms for continued improvement. -A summary of error and accident records provides an overview of operations and may identify processes and procedures that need clarification and personnel who need retraining. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

33. Conclusions  AABB Accreditation Program continues to provide the model for transfusion and cellular therapies worldwide  Quality Essentials are the key to the success of a quality management program (QMP).  QMP will includes management commitment, effective training, regular audits of critical functions to identify potential problems, implementation of effective corrective action, and establishment of priorities for improvement. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

34. Conclusions  An active quality management program also is an effective way of assuring both management and external inspectors that systems are in control.  Accreditation provides assurance that Blood Bank is operating to a prescribed level of technical competency that meets Regulatory requirements.  It provides for continuous learning and professional development of all the staff. ATMC 10 - Kuwait 29th Nov - 1st Dec 2012

35. Conclusions  Accreditation requirements are not just a burden, but are a framework that labs can use to ensure best practices.  Accreditation results in improving the quality and safety of collection, processing, testing, transfusion and distribution of blood and blood products.  Encourage team work.  Continuous improvement to the quality of our services ATMC 10 - Kuwait 29th Nov - 1st Dec 2012