^ µ À Ç P ] v P ] ] } v } ( u ] o o } } ] Á ] Z ] v tD ] î ... · dqg wkh vdph txdolw\...
Transcript of ^ µ À Ç P ] v P ] ] } v } ( u ] o o } } ] Á ] Z ] v tD ] î ... · dqg wkh vdph txdolw\...
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Survey regarding accreditation of medical laboratories within EA – Mid
2019Survey sent to 34 ABs
Received form 32 ABs (94 %)
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
ISO 15189 only 59% (19)
Both standards but with preference of ISO 15189 25% (8)
Both standards (ISO 15189 and ISO/IEC 17025) without any preference
16% (5)
No answer
Standard usedfor accreditationfor medical laboratories
32 AB accredit medical laboratories
NB: DAkkS - ISOIEC 17020 for clinical pathology
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Figures in accreditation (1/8)
28
35
33
41
47
60
67
75
85
106
98
230
256
446
638
813
5
0
6
3
1
0
5
3
8
20
17
0
24
56
9
0 100 200 300 400 500 600 700 800 900
TURKEY (TURKAK)
NORWAY (NA)
CYPRUS (CYS-CYSAB)
DENMARK (DANAK)
LATVIA (LATAK)
IRELAND (INAB)
SPAIN (ENAC)
SWEDEN (SWEDAC)
BELGIUM (BELAC)
SWITZERLAND (SAS)
GREECE (ESYD)
NETHERLANDS (RvA)
CZECH REPUBLIC (CAI)
GERMANY (DAkkS)
UK (UKAS)
FRANCE (COFRAC)
Number of medical laboratories(entities) already accredited
Number of new medical laboratories(entities) in the process ofaccreditation
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Figures in accreditation (2/8)
0
1
2
3
5
8
9
13
12
12
14
13
14
22
26
30
0
1
0
0
0
1
0
2
2
1
2
4
1
1
2
0 10 20 30
MALTA (NAB MALTA)
BELARUS (BSCA)
MOLDOVA (MOLDAC)
LITHUANIA (LA)
GEORGIA (GAC)
HUNGARY (NAH)
LUXEMBOURG (OLAS)
ESTONIA (EAK)
ITALY (ACCREDIA)
NORTH MACEDONIA (IARNM)
CROATIA (HAA)
AUSTRIA (AA)
POLAND (PCA)
PORTUGAL (IPAC)
FINLAND (FINAS)
SERBIA (ATS)
Number of medical laboratories (entities)already accredited
Number of new medical laboratories (entities)in the process of accreditation
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67%65%
56%
51%
43%
25%23% 21%
15% 14%
10% 10% 9%7%
4% 3%0% 0% 0% 0% 0% 0% 0%
0%
10%
20%
30%
40%
50%
60%
70%
Survey regarding accreditation of medical laboratories within EA
Mid 2019
Figures in accreditation (3/8) 23 answers
% of medical laboratories in a process of scope extension
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Remarks:
BELGIUM (BELAC): 39.4% of the pathology labs, 55.9% of the clinical biology labs and 100% of the genetic centers
DENMARK (DANAK): almost 100% for Biochemistry
FRANCE (COFRAC): 100% of the medical laboratories having a medical biology activity
Percentage of accreditedmedical laboratories considering the total number of medical laboratories
of the country
< 10% (12)
10% - 49% (2)
50% - 79% (3)
80%-99% (6)
100% (0)
I do not know (9)
No answer
Figures in accreditation (4/8)
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Figures in accreditation (5/8) 31 AB accredit in a multi-site approach
% of medical laboratories with multi-site accreditation
0%
10%
20%
30%
40%
50%
60%
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Pre-analytical, analytical and/or
post-analyticalactivities
(15)
Only analyticalactivities
(8)
Only pre-analyticalactivities
(1)
Poland, North Macedonia, Belgium,
France, Czech Republic, Greece, Cyprus, Latvia, Norway, Serbia, Turkey,
Italy, Germany, Switzerland, Denmark
Croatia, Portugal, UK, Netherlands,
Luxemburg, Spain, Estonia, Sweden
Georgia
Figures in accreditation (6/8)
A site is a location belonging to the organization of a medical laboratory, under the same management and the same quality management system, where all or part of examinations are carried out : different building and/or different address.
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Figures in accreditation (7/8)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
% with only one site % with 2 to 5 sites % with 6 to 10 sites
% with 11 to 20 sites % with more than 20 sites
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Percentage of hospitalmedical labs in accredited
medical labs
<= 30% (11)
31% - 60% (10)
> 60% (10)
No data (1)
No answer
Figures in accreditation (8/8)
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Technical fields in the medical area coveredby accreditation
Others: Clinical neurophysiology, nuclear medicine, medical autopsy, detect the Lead in Blood and hear, Metabolic disorders, Prenatal and neonatal screening, Gasometry,Biometric activities and research
97%
75%
53%
22%
72%
66%
84%
97%
44%47%
88%
72%69%
66%69% 69%
84%
63%
72% 72%
59% 59%
53%
16%
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0%
20%
40%
60%
80%
100%
120%
Survey regarding accreditation of medical laboratories within EA
Mid 2019
Average % of offered examinations in the scope of accreditation
Nb of technical fields covered in average in medical laboratory accreditations
ND : No Data
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Yes 44% (14)
No 56% (18)
No answer
Do AB accredit for Point of care testing (POCT) (according to ISO 22870)? (1/2)
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Do AB accredit for Point of care testing (POCT) (according to ISO 22870)? (2/2)
79
38
10
7
4
4
2
2
1
1
1
0
0
0
2
8
5
0 10 20 30 40 50 60 70 80
NETHERLANDS (RvA)
FRANCE (COFRAC)
IRELAND (INAB)
GERMANY (DAkkS)
UK (UKAS)
DENMARK (DANAK)
BELGIUM (BELAC)
SPAIN (ENAC)
FINLAND (FINAS)
NORWAY (NA)
SWEDEN (SWEDAC)
ITALY (ACCREDIA)
GREECE (ESYD)
HUNGARY (NAH)
Number of medical laboratories (entities) already accredited for POCT by your AB
Number of medical laboratories (entities) in the process of accreditation forPOCT (new medical laboratories or accredited medical laboratories (entities) in aprocess of scope extension)
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Yes, different types of flexibility 62% (20)
Yes, only one type of flexibility 22% (7)
No 16% (5)
No answer
100 %100 %
100 %100 %
Percentage of accredited medical laboratories with flexible scope are displayed
75 %
100 %
75 %
onlyfew
25 %
25 %
25 %
onlyfew
onlyfew
onlyfew
onlyfew
25 %50%
onlyfew
75 %
25 %
Do AB offeraccreditation with flexible scope?
onlyfew
onlyfew
onlyfew
75 %
50%
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
For 34% of AB (11), there are specific requirements for the accreditation of medical laboratories:
FINLAND (FINAS)The microbiological laboratories need to have a permission from the National Institute for Health and Welfare for the testing of infectious diseases
(national law for infectious diseases).
SWITZERLAND (SAS)
- There are several legal requirements (e.g. health, safety, PT participation, qualification of technical staff)- To perform medical testing in some special fields (e.g. hematology, serology, microbiology, genetics) the medical laboratories are obliged to get a
governmental (federal) authorization (requirements are established in ordinances and periodically checked)- In genetics also accreditation can be used besides inspection by authorities in health care as a base to state necessary competency for federal
authorization.
GEORGIA (GAC) subcontracting for sampling
IRELAND (INAB) Clinical advice must be provided by medically trained staff according to standard set down by the Department of Health / HSE
BELGIUM (BELAC) extra legal obligations NGS guidelines
FRANCE (COFRAC)Management of the medical laboratory - Personnel qualifications - Subcontracting - Responsibility for the pre-analytical phase, even if the sample
collection is not carried out in the laboratory by personnel from the laboratory - EQA
GREECE (ESYD)ESYD's Guideline G-CLINLAB refers to procedures required for Accreditation of Medical Laboratories that apply, either approved standardized methods (CEIVD), which require verification by the Lab, or laboratory-developed tests (LDTs or else in-house methods) and modified approved
methods, which require analytical validation and clinical verification.
CYPRUS (CYS-CYSAB) External quality control - Verification of methods
NETHERLANDS (RvA) Several professional societies have drafted additional requirements with regard to specific aspects of the technical field.
GERMANY (DAkkS) Quality management system, internal and external quality controls in RiLi-BÄK (Guidelines of Germans doctors chamber).
SWEDEN (SWEDAC) There are Swedish regulations for subcontracting and how to refere to accreditation when using subcontractors
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Yes 9% (3)
Yes, partially 28% (9)
No 63% (20)
No answer
Is accreditation of medicallaboratories mandatory by law? (1/2)
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Accreditation of medical laboratories mandatory
by law (2/2)
the types of laboratories/technical fields for which accreditation is mandatory
the deadlines to which accreditation is mandatory
the number of laboratories holding accreditation in this
context
the number of laboratories seeking accreditation in this context
ITALY (ACCREDIA) Only laboratory of the Province of Trento, except transfusion and Anatomy Pathology End 2018 4 1
NORTH MACEDONIA (IARNM)
Before several years ago there was Governmental decision for obligatory accreditation of eight (8) medical laboratories within public hospitals in
Macedonia
not clearly defined 1 1
SWITZERLAND (SAS) Pre-implantation genetic diagnosis (PGD/PID) 5 years after application 3 to 5 3 to 5IRELAND (INAB) Blood Transfusion only -- 60 0
BELGIUM (BELAC)mandatory accreditation for a number of molecular
tests (NIPT, microbiology, pathology, oncology, ...) and 80% of all genetic testing
-- 75 7
FRANCE (COFRAC) All medical laboratories for all medical biology fields (all their medical biology activity) 1st November 2020 790 2
CZECH REPUBLIC (CAI) genetics - only hereditary (not somatic changes in genes) 2011 62 0
GREECE (ESYD) Private diagnostic laboratories providing services to other laboratories and/or healthcare organizations. November 2013 -- --
HUNGARY (NAH) Medical diagnostical laboratories, molecular geneticallaboratories 01/01/2019 8 0 (other to come)
LATVIA (LATAK) All medical laboratories, but fields are not clarified 31.12.2018. 47 1
SERBIA (ATS)medical examination connected with the
consequences of radioactivity (changes on chromosomes)
RADIATION PROTECTION AND NUCLEAR SAFETY LAW ("Fig.
Gazette", Nos. 36/2009 and 93/20123 --
GERMANY (DAkkS) newborn screening before 2010 12 0
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Accreditation of medical laboratories mandatory,
other than by law, in your country (reimbursement …)
the types of laboratories/technical fields for which accreditation is mandatory
the context for which accreditation is
mandatory (reimbursement …)
the number of laboratories holding accreditation in this
context
the number of laboratories seeking accreditation in this
context
NETHERLANDS (RvA)For most clinical laboratories accreditation is
strongly recommended by the assurance companies with regard to reimbursements.
- - -
LUXEMBOURG (OLAS)
(1) medical laboratories in the non-hospital sector and (2) medical laboratories in the hospital sector, but only for analyses of
ambulatory patients
reimbursement by the National Health Fund
(CNS)5 1
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Yes 56% (18)
No 44% (14)
No answer
Is there a specific quality monitoring scheme by your national healthcare system? (1/2)
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
(2/2) Specific quality monitoring scheme by the national healthcare system
AUSTRIA (AA) mandatory participation in PT-ProgrammesBELGIUM (BELAC) mandatory EQA participation / inspections by national healthcare system for recognition of medical laboratories
CROATIA (HAA) professional audit of medical biochemistry labs by croatian chamber of biochemistry is mandatory
CZECH REPUBLIC (CAI) The Czech Medical Society has own system for monitoring quality in medical laboratories. This system is based on ISO 15189.
GEORGIA (GAC) regulation for monitoring ML
GERMANY (DAkkS) Requirements of RiLi-BÄK (internal and external quality control) is checked in different parts of Germany (Länder) by different authorities on very different levels and frequencies.
IRELAND (INAB) HIQA organisation that monitors hospitals. ITALY (ACCREDIA) Law 502/1992 (National Health System)
LITHUANIA (LA)
Minimum requirements for health care services quality control are established by the order of the Minister of Health of the Republic of Lithuania (No V-998, 5 December, 2007) "Description of the assessment of health care laboratories". For medical laboratories internal quality
controls systems and participation in EQA schemes (including plans and results) are periodically overseen by the State Health Care Accreditation Agency under the Ministry of Health (Accreditation Agency) during supervision visits according to the annual inspections plan.
LUXEMBOURG (OLAS) There is a quality monitoring scheme by the Ministry of Health, based on the participation in a list of mandatory PTs. This applies to all laboratories, regardless whether they are accredited or not.
MALTA (NAB MALTA) Licensing of medical/clinical laboratories is under the control of the Ministry of Health.
NETHERLANDS (RvA) This only accounts for fertility laboratories and donortest Laboratories as well as transplantation laboratories
POLAND (PCA) ILC for microbiology examinations / ILC for clinical chemistry, hematology, coagulologySERBIA (ATS) Agency for accreditation medical institutions
SWITZERLAND (SAS) PT participation /Qualification of technical staff
UK (UKAS) Joint Working Group on Quality Assurance - monitors EQA performanceSWEDEN (SWEDAC) The laboratory can choose any supplier of PT-programs.
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Yes 22% (7)
No but it is planned 28% (9)
No 50% (16)
No answer
Does your AB accredit for medical imaging?(1/3)
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Yes: (2/3)
Standard(s) used for accreditation for medical imaging
Technical fields covered by accreditation for medical imaging
Number of organizations
already accredited by your AB:
Number of new organizations in the process of accreditation:
Is accreditation mandatory for
medical imaging?
FINLAND (FINAS) Both ISO 15189 and ISO/IEC 17025 Nuclear imaging / clinical neurophysiology 1 0 no
POLAND (PCA) ISO/IEC 17025 Radiography (incl. Angiography, Mammography) / CT 41 1yes (Polish law: The
Act of November 29, 2000 / Atomic law)
UK (UKAS)Standard developed by Professional Bodies in
UK
Radiography (incl. Angiography, Mammography) / Scan / Bone / densitometry / MR imaging / Ultrasound / Nuclear
imaging44 21 no
GREECE (ESYD) Both ISO 15189 and ISO/IEC 17025
Radiography (incl. Angiography, Mammography) / Scan / Bone / densitometry / MR imaging / Ultrasound / Nuclear
imaging1 2 no
NETHERLANDS (RvA) ISO 15189
Bone densitometry / MR Imaging / Ultrasound / Blood pressure measurement, ECGs, Fundusfotography,
audiotmetry and wrist-arm index are occasionally covered by accreditation
6 0 no
SWEDEN (SWEDAC) ISO/IEC 17025
Radiography (incl. Angiography, Mammography) / Scan / Bone densitometry / MR imaging / Ultrasound /
Nuclear imaging15 1 no
DENMARK (DANAK) ISO 15189 Nuclear imaging 0 0 no
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
No but it is planned:(3/3)
Standard(s) planned to be used for accreditation for medical imaging
NORTH MACEDONIA (IARNM) Both ISO 15189 and ISO/IEC 17025
PORTUGAL (IPAC) ISO 15189
FRANCE (COFRAC) ISO 15189
HUNGARY (NAH) -
NORWAY (NA) ISO 15189
SERBIA (ATS) -
SPAIN (ENAC) ISO 15189
ESTONIA (EAK) -
TURKEY (TURKAK) ISO 15189
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Survey regarding accreditation of medical laboratories within EA
Mid 2019
Reminder