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The Experiences in Quality Management System
Implementation in Slovenia
Pika Mesko Brguljan
Sasa Bratoz
Slovenia joined the European Union in 2004. The national regulations are in accordance with EU
legislation.
THE ACTUAL SITUATION
STATE-OF-THE-ART IN SLOVENIA
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.
CLINICAL CHEMISTRY IN SLOVENIA
• Clinical biochemistry• Immunochemistry• Haematology• Endocrinology• Coagulation• Toxicology• (Molecular Biology)
LAWGIVERS AND COMPETENT AGENCIES
REPUBLIC OF SLOVENIAMINISTRY OF HEALTH
SLOVENIAN COLLEGIATE BOARD FOR LABORATORY DIAGNOSTICS
SCB for laboratory medicine - clinical chemistrySCB for microbiology and immunologySCB for transfusion medicineSCB 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
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.
LAWGIVERS AND COMPETENT AGENCIES
Slovenian Association for Clinical Chemistry
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.
Slovenian Chamber of Laboratory Medicine
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
It is all about quality and competence!
QUALITY SYSTEM
ISO 9001
ISO 15189
Medical Laboratory Bylaw
QUALITY SYSTEM IN MEDICAL LABORATORY
Medical laboratories - Particular requirements for quality and competence
ISO 15189
Requirements for POCT
ISO 22870
Requirements for safety
ISO 15190
Management requirements Technical requirements
+ +
BYLAW STRUCTUREMinimal 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)
+ +
ISO 15189 IN SLOVENIA
Accreditation body
Assessment according to 17011
ACCREDITATION
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)
THE SLOVENIAN BYLAW
Commitee (appointed by the Minister of Health upon proposal of four SCBs)
Assessment according to theprocedure of Ministry of Health.Procedures prepared by laboratory professionals.
LABORATORY WORKING LICENCE
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
THE SLOVENIAN BYLAW
Laboratory director: specialist with corresponding specialisation:
•Medical biochemistry (clinical chemistry)•Clinical / medical microbiology•Transfusiology•Anatomic pahology and cytopathology
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 forThe 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
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.
SYLLABUS
Source: Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine: version 3 – 2005)
MEDICINE-PHARMACY-SCIENCES (5-6 Years)
Training in Clinical Chemistry or Medicine
Training in Polyvalent
clinical Biology(4-5 Years)
Training in BASIC Polyvalent Clinical Biology (1+2 years)
MONOSPECIALISATION (3-4 years)BiochemistryHematologyMicrobiologyMolecular Genetics
EUROPEAN SPECIALISTS INCLINICAL CHEMISTRY and LABORATORY MEDICINE
Source: EC4 Register Comission
Equivalence of Standards (EOS) SLOVENIA
EC4 Register Standard EQUIVALENT National Standard
University degree University degree:
Medicine: 6 years
Pharmacy: 5 years
Chemistry: 4 years
Biochemistry: 4 years
Biology: 4 years
•Minimum of 9 years undergraduate and postgraduate study
•Minimum of 9 years undergraduate and postgraduate study
•Minimum of 4 years specialist training in an approved laboratory•Training multidisciplinary or in a single discipline.
• 1 year common training in clinical chemistry and haematology laboratory with state examination
• 4 years specialist training in an approved clinical chemistry, haematology and microbiology laboratories according to the European Syllabus. After the training students have to pass a state examination.
PERSONNEL: UNIVERSITY DEGREE
0
10
20
30
40
50
Nr. 47 39 25 2 7
% 39,2 32,5 20,8 1,7 5,8
PharmacyChem./
Biochem.Biology Medicine Others
PERSONNEL – medical biochemistry specialists
4 years of postgraduate training26 MSc; 19 PhD
0
10
20
30
40
50
Nr. of Spec. 30 20 7 2 1
% 50 33,3 11,6 3,3 1,8
Pharmacy
Chem./ Biochem.
Biology Medicine Others
PERSONNEL – medical biochemistry specialists
4 years of postgraduate training
0
20
40
60
80
Nr. 40 12 2 6
% 67 20 3 10
HospitalsPrimary
CarePrivate
Lab.Others
(educ., ..)
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.
APPLICATIONS FOR LABORATORY WORKING LICENCE
Number and % of applications
140; 73%
23; 12%
8; 4%21; 11%
Clinical Chemistry
Microbiology
Transfusiology
Cyto/histopathology
APPLICATIONS – CLINICAL CHEMISTRY
26%
52%
15%
7%HospitalsLaboratories
Primary CareLaboratories
PrivateLaboratories
Other
EXTERNAL ASSESSMENTS OF MEDICAL LABORATORIES
Working licences to be granted upon succesful external assessments.
Laboratories to perform previous internal assessments.
WHO IS THE ASSESSOR?
TRAINING OF ASSESSORS
SZKK in cooperation with SIQ SA
Internal auditors External auditors4 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
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.
ISO 10011 (1993) Guidelines for auditing quality systemsPart 1 AuditingPart 2 Qualification criteria for quality auditorsPart 3 Management of audit programmesISO 58 - item 5ILAC G11 (1998) Guidelines on assessor qualifications and competenceEAL G 8 (1994) Guidelines for selection of participants to courses for the training of
assessors involved in assessment of laboratories applying for accreditation
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
AUDIT
ASK
LISTEN and OBSERVE
CHECK and COMPARE
WRITE DOWN
AUDIT
Why?
Solutions?
Problems?
Data evaluation?
TAT?
How?
Equipment?
Who?
Report
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
QUESTIONNAIRE – SELF-EVALUATION
ISO/IEC 17025:2005
ISO 1518:2003
Pravilnik o minimalnih pogojih, ki jih mora izpolnjevati laboratorij za izvajanje preiskav na področju laboratorijske medicine, Ur.l. RS 64/2004, čl. / Bylaw
DA/Yes
NE/No
Dokazila (dokumentacija), ugotovitve, opombe/ documents, findings, remarks
II. ORGANIZIRANOST
4.1.1 4.1.1 5. 1.Ali je zagotovljena strokovna samostojnost laboratorija ne glede na statusno obliko
4.1.5 e 4.1.5 e 5.2 Ali ima medicinski laboratorij dokumentacijo, ki vsebuje:a)organizacijsko strukturo
4.1.5 e 4.1.5 e a)povezanost laboratorija z drugimi org. enotami organizacije katere del je in drugimi pravnimi ali fizičnimi osebami
5.2.14.1.5 a
5.1.3 a)ime in priimek vodje laboratorija ter njegovo specializacijo;
4.1.5 j 4.1.5 j a)poimensko imenovane namestnike in njihova pooblastila;
5.2.5 5.1.7 a)pooblastila laboratorijskemu osebju za izvajanje postopkov in preiskav;
a)obratovalni čas laboratorija, kako in v kakšnem obsegu so storitve dostopne med prazniki in v nujnih primerih;
5.4.3 a)seznam preiskav, ki jih laboratorij izvaja in način njihovega naročanja;
a)način in pooblastila za izvajanje preiskav ob preiskovancu;
4.2.1 4.2.1 a)opis sistema zagotavljanja kakovosti;
4.8 4.8 a)postopek reševanja pritožb?
6.1 Ali je laboratorij vključen v izvajanje posameznih laboratorijskih preiskav ob preiskovancu?
It is all about quality and competence!
CONCLUSION – THE ACTUAL STATE
Legal platform
Bylaw
Register Professional licence
Programme
of specialisation
Laboratory working licence
CONCLUSION – THE ACTUAL STATE
SZKKZLMS
Health Care Organizations
Slovenian Accreditation
Proffesional Associations
CONCLUSION – THE ACTUAL STATE
Ministry of Health
Working licence 2008