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

                                                                                                         

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