^ µ À Ç p ] v p ] ] } v } ( u ] o o } } ] Á ] z ] v td ] î ... · dqg wkh vdph txdolw\...

$: ^ µ À Ç P ] v P ] ] } v } ( u ] o o } } ] Á ] Z ] v tD ] î ... · dqg wkh vdph txdolw\ pdqdjhphqw v\vwhp zkhuh doo ru sduw ri h[dplqdwlrqv duh fduulhg rxw gliihuhqw exloglqj$
Survey regarding accreditation of medical laboratories within EA – Mid

2019Survey sent to 34 ABs

Received form 32 ABs (94 %)

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


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


Mid 2019


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

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%


Mid 2019

Figures in accreditation (3/8) 23 answers

% of medical laboratories in a process of scope extension


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



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%


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


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.


Mid 2019


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


Mid 2019

Percentage of hospitalmedical labs in accredited

medical labs

<= 30% (11)

31% - 60% (10)

> 60% (10)

No data (1)

No answer



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%

0%

20%

40%

60%

80%

100%

120%


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


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)


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)


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%


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


Mid 2019

Yes 9% (3)

Yes, partially 28% (9)

No 63% (20)

No answer

Is accreditation of medicallaboratories mandatory by law? (1/2)


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


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


Mid 2019

Yes 56% (18)

No 44% (14)

No answer

Is there a specific quality monitoring scheme by your national healthcare system? (1/2)


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.


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)


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


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


Mid 2019

Reminder

^ µ À Ç p ] v p ] ] } v } ( u ] o o } } ] Á ] z ] v td ] î ... · dqg wkh vdph txdolw\...

Documents