atmc 10 - kuwait 29th nov - 1st dec 2012. aabb accreditation salwa hindawi president of saudi...

ATMC 10 - Kuwait 29th Nov - 1st

Dec 2012

AABB Accreditation

Salwa HindawiPresident of Saudi Society of Transfusion Medicine

Medical Director of Blood Transfusion ServicesKAUH, JeddahSaudi Arabia


Dec 2012

Introduction

Process of AABB Accreditation

Quality System Essentials

Conclusions


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


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.


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.


Dec 2012

• 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


Dec 2012

AABB Accreditation Process

• It is a process of peer review by experts to ensure the compliance of practice with the recognized standards.


Dec 2012

Accreditation Process

•Application

•Pre-assessment

•Assessment

•Corrective actions

•Decision on Accreditation

•Re-assessment


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


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.


Dec 2012

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


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)..


Dec 2012

Quality System Essentials

They are:

those elements which must be applied to all operations in the service’s path of workflow


Dec 2012

QSEs Then and Now

1997-2010 2011-2012

1. Organization2. Resources3. Equipment4. Supplier and Customer Issues5. Process Control6. Documents and Records7. 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 Resources4. Suppliers and Supply

Management5. Equipment Management6. Process Management7. Documents, Records, and

Information Management8. Nonconforming Events9. Monitoring and Assessments10.Continual Improvement


Dec 2012

•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


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.


Dec 2012

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.


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


Dec 2012

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?


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


Dec 2012

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?


Dec 2012

Competency Program

Competency Program include:

-Written evaluations.-Direct observation of test procedures-Review of work records or reports-samples Testing of unknown.


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


Dec 2012

Supplies and Supply Management

A new agreement/contract? Modification to existing agreement/contract? A Maintenance/Service contract? Supplier qualification review? Critical Materials log?


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.


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.


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


Dec 2012

Quality System Documentation Hierarchy


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.


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.


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.


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.


Dec 2012

ConclusionsAn 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.


Dec 2012

ConclusionsAccreditation 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


Dec 2012


Dec 2012

atmc 10 - kuwait 29th nov - 1st dec 2012. aabb accreditation salwa hindawi president of saudi...

Documents

practice atmc

aabb accreditation process

quality essentials

aabb requirements

high quality

quality journey

consumerfriendly atmc

jeddah saudi arabia