The Experiences in Quality Management System Implementation in Slovenia

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The Experiences in Quality Management System
Implementation in Slovenia

• Pika Mesko Brguljan
• Sasa Bratoz

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STATE-OF-THE-ART IN SLOVENIA
Slovenia joined the European Union in 2004. The
national regulations are in accordance with EU
legislation. THE ACTUAL SITUATION
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LABORATORY MEDICINE IN SLOVENIA

• Four specialities (scientific fields) of
  laboratory medicine
• Clinical chemistry
• Microbiology
• Blood banking
• Cytopathology
• Speciality is a nationally or internationally
  recognised area of medical specialisation for
  which a structured postgraduate training
  programme exists.

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CLINICAL CHEMISTRY IN SLOVENIA

• Clinical biochemistry
• Immunochemistry
• Haematology
• Endocrinology
• Coagulation
• Toxicology
• (Molecular Biology)

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LAWGIVERS AND COMPETENT AGENCIES
           REPUBLIC OF SLOVENIAMINISTRY OF
HEALTH SLOVENIAN COLLEGIATE BOARD FOR LABORATORY
DIAGNOSTICS
SCB for laboratory medicine - clinical
chemistry SCB for microbiology and immunology SCB
for transfusion medicine SCB for pathology and
forensic medicine
SCBs represent the advisory commission at
Ministry of Health which harmonize the proposals
from clinics, professional associations,
chambers, healthcare institutions, colleges and
other education centres or individual
professionals
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LAWGIVERS AND COMPETENT AGENCIES
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LAWGIVERS AND COMPETENT AGENCIES

• The Slovenian Accreditation (SA) is a public
  institute which, in the manner and under the
  terms applicable to the public service, performs
  the tasks of the national accreditation service
  in the Republic of Slovenia in accordance with
  the Accreditation Act and the Decision on
  establishment of the public institute Slovenian
  Accreditation. SA operates as an independent
  service, performing the accreditation procedures
  in such a way to ensure that accreditations and
  accredited activities as well as the service
  itself are recognised as competent and reliable
  at the national and international level.

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LAWGIVERS AND COMPETENT AGENCIES
Slovenian Association for Clinical Chemistry
Slovenian Chamber of Laboratory Medicine
The purpose of SZKK is to maintain and look after
the qualitative professional work and to
encourage education and scientific work in fields
of clinical chemistry and laboratory medicine in
Slovenia.
ZLMS represents and shields interests of
laboratoy medicine, the reputation of science
and their members. The main emphasis is the
reestablishment of direct connection of
proffessionals from different fields and
exchanging of their experiences. ZLMS has been
granted public authority for keeping register of
professionals of the 4 fields, granting and
disposition of licences and supervision of
specialisation course.
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THE BYLAW ON LABORATORY MEDICINE
Rules on the requirements to be met by
laboratories designated to carry out analyses in
the field of laboratory medicine
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It is all about quality and competence!
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QUALITY SYSTEM
ISO 9001
ISO 15189
Medical Laboratory Bylaw
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QUALITY SYSTEM IN MEDICAL LABORATORY
Medical laboratories - Particular requirements
for quality and competence ISO 15189
Management requirements
Technical requirements


Requirements for POCT ISO 22870
Requirements for safety ISO 15190
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BYLAW STRUCTURE

• Minimal standards for medical laboratories in
  conformity with ISO 15189
• Particular requirements for quality and
  competence
• Management requirements Technical
  requirements

Requirements for POCT (briefly, detailed in
preparation)
Requirements for safety (briefly, detailed in
preparation)
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ISO 15189 IN SLOVENIA
Accreditation body
Assessment according to 17011
ACCREDITATION
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ISO 15189

• Depends on demands from laboratories
• Introduction of a new standard in accreditation
  of testing laboratories
• training lead assessors to working with new
  requirements
• finding competent technical assessors and if
  possible start training domestic ones
• form sector commitee (if necessary)

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THE SLOVENIAN BYLAW
Commitee (appointed by the Minister of Health
upon proposal of four SCBs)
Assessment according to the procedure of Ministry
of Health. Procedures prepared by laboratory
professionals.
LABORATORY WORKING LICENCE
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ISO 15189
Laboratory director competent person(s) with
resposability for, and authority over, a
laboratory NOTE 2 National, regional and local
regulations may apply with regard to
qualifications and training
Competence result of academic and continuing
education training and experiance
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THE SLOVENIAN BYLAW

• Laboratory director
• specialist with corresponding specialisation
• Medical biochemistry (clinical chemistry)
• Clinical / medical microbiology
• Transfusiology
• Anatomic pahology and cytopathology

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REQUIRED EDUCATION, VOCATIONAL TRAINING AND
EXPERIENCE

• Syllabus for postgraduate training
• (EC4 European Syllabus for Post-Graduate Training
  in Clinical Chemistry and Laboratory Medicine
  version 3 2005)
• Is the basis for
• The European Register of Specialists in Clinical
  Chemistry and Laboratory Medicine
• Minimum 9 years
• EC4 Register

• Slovenian Bylaw for medical laboratories (2004)
• Bylaw for training in medical biochemistry (2006)
  completelly in agreement with Syllabus
• National Register
• Equivalence of standard
• EC4 Register

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SYLLABUS

• Describes a common minimal programme of
  postgradute training Main points of this
  programme are
• pre-analytical conditions,
• evaluation of results,
• interpretations (post-analytical phase),
• laboratory management,
• knowledge in Biochemistry, Haematology,
  Immunology, etc... ,
• quality management.

Source Syllabus for Post-Graduate Training in
Clinical Chemistry and Laboratory Medicine
version 3 2005)
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MEDICINE-PHARMACY-SCIENCES (5-6 Years)
Training in Clinical Chemistry or Medicine
Training in BASIC Polyvalent Clinical Biology
(12 years)
Training in Polyvalent clinical Biology (4-5
Years)

• MONOSPECIALISATION (3-4 years)
• Biochemistry
• Hematology
• Microbiology
• Molecular Genetics

EUROPEAN SPECIALISTS INCLINICAL CHEMISTRY and
LABORATORY MEDICINE
Source EC4 Register Comission
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Equivalence of Standards (EOS) SLOVENIA
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PERSONNEL UNIVERSITY DEGREE
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PERSONNEL medical biochemistry specialists
4 years of postgraduate training 26 MSc 19 PhD
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PERSONNEL medical biochemistry specialists
4 years of postgraduate training
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APPLICATIONS FOR LABORATORY WORKING LICENCE

• Ministry of Health made a call to medical
  laboratories to apply for working licence.
• The written applications with laboratory
  specifications and enclosed list of analyses
  performed were assembled in 2005.

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APPLICATIONS FOR LABORATORY WORKING LICENCE
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APPLICATIONS CLINICAL CHEMISTRY
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EXTERNAL ASSESSMENTS OF MEDICAL LABORATORIES

• Working licences to be granted upon succesful
  external assessments.
• Laboratories to perform previous internal
  assessments.
• WHO IS THE ASSESSOR?

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TRAINING OF ASSESSORS
SZKK in cooperation with SIQ
SA
External auditors
Internal auditors
4 days training ( 36 hours) in a group of 15-20
persons with 2 tutors. Programme with lectures,
group discussions and exercises. Final exam.
Common introduction Background of the scheme
Knowledge of ISO 15189, Quality system and
Quality Manual.
2 days training ( 18 hours) in a group of 15-20
persons with 3 tutors. Programme with lectures,
group discussions and exercises. Final
exam. Common introduction Background of the
scheme Knowledge of ISO 15189, Quality system
and Quality Manual, Bylaw
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• Role of inspectors in external review mechanisms
• Criteria for selection, training and appraisal
  
• M. Plebani et alCCA 309 (2001) 147-159
• Accreditation of medical laboratories in the
  European Union
• W. Huisman et al Clin Chem Lab Med 2007
  45(2)268-75.

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• ISO 10011 (1993) Guidelines for auditing quality
  systems
• Part 1 Auditing
• Part 2 Qualification criteria for quality
  auditors
• Part 3 Management of audit programmes
• ISO 58 - item 5
• ILAC G11 (1998)
• Guidelines on assessor qualifications and
  competence
• EAL G 8 (1994)
• Guidelines for selection of participants to
  courses for the training of assessors involved in
  assessment of laboratories applying for
  accreditation

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• Professional qualifications
• at least 2 years experience as consultant in a
  medical laboratory
• expert in a specific field (f.i. immunology)
• Personal qualifications
• open mindedness willingness to consider
  alternative ideas.
• diplomacy - tact and skill in dealing with people
• being observant - constantly aware of physical
  surroundings
• perceptiveness - ability to use instinct
• tenacity - persistence

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AUDIT
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AUDIT
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WORKSHOPS

• Slovenian Association for Clinical Chemistry
• and Slovenian Chamber for Laboratory
• Medicine
• The support/ assistance of laboratories in
  implementation of the
• quality system according to Bylaw

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QUESTIONNAIRE SELF-EVALUATION
EXAMPLE
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It is all about quality and competence!
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CONCLUSION THE ACTUAL STATE

• Legal platform

Bylaw
Laboratory working licence
Register
Professional licence
Programme of specialisation
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CONCLUSION THE ACTUAL STATE

• Proffesional Associations

SZKK
Slovenian Accreditation
ZLMS
Health Care Organizations
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CONCLUSION THE ACTUAL STATE
Ministry of Health
Working licence 2008