ATMC 10 - Kuwait
29th Nov - 1st Dec 2012
AABB Accreditation
Salwa Hindawi
ATMC 10 - Kuwait
29th Nov - 1st Dec
2012
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
Introduction
Process of AABB Accreditation
Quality System Essentials
Conclusions
ATMC 10 - Kuwait
29th Nov - 1st Dec 2012
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
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
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
AABB Accredited Facilities
Around the World 2011
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United Sates
Canada
United Kingdom
Italy
Greece
Poland
Germany
Spain
Republic of Korea
Japan
Taiwan
Singapore
Hong Kong
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India
Saudi Arabia
Kuwait
Mexico
Dominican
Republic
Honduras
Columbia
Brazil
Portugal
Argentina
Hungary
China
Thailand
ATMC 10 - Kuwait
29th Nov - 1st Dec 2012
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
Accreditation Process
• Application
• Pre-assessment
• Assessment
• Corrective actions
• Decision on Accreditation
• Re-assessment
ATMC 10 - Kuwait
29th Nov - 1st Dec 2012
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
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
How Is a Survey Conducted?
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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
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
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
QSEs Then and Now
1997-2010
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
2011-2012
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
Quality Standards Implementation
• 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.
ATMC 10 - Kuwait
29th Nov - 1st Dec 2012
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
Organization, Leadership and Customer
Focus
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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
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
Facilities, Work Environment, and
Safety
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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
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
Human Resources
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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
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
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
Supplies and Supply Management
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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
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
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
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
Quality System Documentation Hierarchy
ATMC 10 - Kuwait
29th Nov - 1st Dec 2012
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
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
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
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
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
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.
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Encourage team work.
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Continuous improvement to the quality of our services
ATMC 10 - Kuwait
29th Nov - 1st Dec 2012