1. “Quality assurance programme in EFI accredited laboratory in Novi Sad, Serbia” Svetlana Vojvodić MD.PhD. Institute for Blood Transfusion of Vojvodina

2. REGION OF VOJVODINA
The province of Vojvodina, as a northern part of Serbia extends on area of km2
According to the census in 2011, there are inhabitants

3. INSTITUTE FOR BLOOD TRANSFUSION OF VOJVODINA
ISO 9001:2008 (1998/2008)
ISO 14000(2002)
EFI accredited HLA laboratory (2010)
The most important institution in transfusion medicine for the region of Vojvodina
Established by the Government of Autonomous Province of Vojvodina

4. LABORATORY TECQNIQUES & ACTIVITIES
HLA typing by low resolution SSP (2006)
KIR SSP genotyping (2010)
ABO.CDE,MNS,KKD,D zygosity blood group genotyping (2010)
HLA typing by SSO (2012)
KIR genotyping by SSO (2012)
Anti HLA Ab detection/ identification
CDC (NIH/immunofluorescence test (1980/1998)
CDC-AHG (2012)
ELISA (2011)
Luminex (2012)
Anti-MICA Ab detection (2012)
Complement binding Ab (2012)
Anti-platelet Ab:
immunifluoresce test (2004)
ELISA (2010)
Anti neutrophile Ab: immunifluoresce test (2004)
Crossmatching:
CDC (NIH/immunofluorescence test (1980/1998)
CDC-AHG (2012)
ELISA (2011)
Luminex (2012)

5. SERVICES Bone Marrow Transplantation (related) Liver Transplantation
Renal Transplantation
Heart Transplantation
National Bone Marrow donor registry (2012)
Disease association
HLA and transfusion

6. Quality Assurance
1)Procedure manual
2)Evaluation of proficiency testing performance
3)Personnel technical competency assessment
4)Systems for Continuous Test Evaluation and Monitoring
5)Client service evaluation and communication
6)Quality Assurance Evaluation
7) Internal audit
Specifically designed for the Tissue Typing Compartment defined by the:
1)European Federation for Immunogenetics
2) ISO 9001:2008
3) ISO 14000

7. QUALITY ASSURANCE CYCLE

8. SYSTEM of DOCUMENTATION
Quality Manual-QM- ZTKV-01, version 6
SOPs:
Good Laboratory Practice-DLP:23
Serological Testing- SERO:33
DNA Testing-DNA:32
Quality Control-KM:12
Apparature-AP:32
List of records

9. PROFICIENCY TESTING EVALUATION
Satisfacorily started in EPT participation since 2005, gradually increased the participation in EPT (8 EFI EPT centers)
Complex system of benefits from EPT:
Accreditation PT provider Proffesional
Body body
Laboratory Ref.Material Standards
Provider
Direct customer

10. BENEFITS FROM EPT for Laboratory
Confirming competent performance

Identifying testing or measurement problems

Comparing methods and procedures

Improving performance

Educating staff

Instilling confidence in staff, management and external users of laboratory services

Comparing operator capabilities

Generating reference materials

Determining method
precision and accuracy

Satisfying regulators and accreditation bodies

Monitoring and improvement of measurements
Benchmarking against other laboratories
Improved process control
Demonstrate competency to customers and accreditation bodies
Staff development and training
Evaluate methods and instrumentation calibration
Establishes the effectiveness and comparability of test methods
Validates tolerances and uncertainty claims
Providing laboratories with additional risk management

11. PERSONNEL TECHNICAL COMPETENCE EVALUATION
Within the internal control (audit) once per year including:
-theoretical knowledge (written testing)
- evaluating the performance and attitude of staff
- technical competence evaluation
Scoring system:
60 points = incompetent
60-80 points = average competent
80-90 points =very competent
points = competent

12. Systems for Continuous Test Evaluation and Monitoring
Identifying, recording, analysing and solving the inconsistencies that can occure in testings, when results:
-do not meet laboratory’s established criteria
-errors are detected in the reported patient results
-all other inconsistencies: procedures, reagents,equipment maintenance, QA elements,internal control

13. CLIENT SERVICE EVALUATION
Regulary checked twice a year:
-clients from the Clinics
-service users to be sampled at the Institute for Blood Transfusion
-evaluation of customer complaints through the protector of patients' rights

14. Quality Assurance Evaluation
-Evaluation is based on an analysis of records of discrepancies arising in any segment of quality assurance
-Establishment of corrective and preventive actions
-Their implementation in procedures and policies of the laboratory
-Assessment on the effectiveness of the laboratory pointing to the main problems to be solved
-Proposal of development and progress of the laboratory
- Drawing up a qualiy assurance plan for the coming year

15. INTERNAL CONTROL (AUDIT)
1) Organization and Quality Management
2) evaluation of the quality control system
3) staff training
4) maintenance of equipment
5) SOP and methods of testing
6) sample handling
7) documentation and records
8) documents of the quality system
9) Good Laboratory Practice
10) to expand the category of accreditation

16. BENEFITS OF QUALITY ASSURANCE
-enables the confidence, reliability and safety of work where you are doing the right things, the right way
-makes the opportunity to enhance the existing quality of services by optimizing the existing working processes and introducing new processes and techniques
-enables greater levels of customer satisfaction
-a motivated team that not only understand the policy objectives of the quality assurance plan, but who also actively participate in executing the plan

17. CONCLUSION
QA Programme is very imortant and essential for the work of our Tisse Typing Copmartment since it:
-enables the confidence, reliability and safety of work where you are doing the right things at the right way
-makes the opportunity to enhance the existing quality of services by optimizing the existing working processes and introducing new processes and techniques
-enables greater levels of customer satisfaction
-creates a motivated team who not only understand the policy objectives of the quality assurance plan, but who also actively participate in executing the plan