Survey on: Accreditation of medical laboratories
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1 Příloha č. 7 Survey on: Accreditation of medical laboratories within EA Survey sent to 29 ABs Received from 19 Abs (65.5 %) Date: March, 2011 ENAC 1 Standard used for accreditation Accreditation body/country Standard CYPRUS (CYS CYSAB) ISO CZECH REPUBLIC (CAI) ISO & ISO/IEC DENMARK (DANAK) ISO & ISO/IEC ESTONIA (EAK) ISO & ISO/IEC FINLAND (FINAS) ISO & ISO/IEC FRANCE (COFRAC) ISO & ISO/IEC (until nov 2013) ISO ISO in Anatomical Pathology GREECE (ESYD) ISO & ISO/IEC IRELAND (INAB) ISO & ISO/IEC LATVIA (LATAK) ISO MALTA (NAB MALTA) ISO ISO RWAY (NA) ISO & ISO/IEC PORTUGAL (IPAC) ISO & ISO/IEC REPUBLIC OF CROATIA (HAA) ISO SERBIA (ATC) ISO & ISO/IEC SPAIN (ENAC) ISO ISO & ISO/IEC ISO Only 15189: 42 % Mainly 15189: 37 % Both standards: 21 % 2
2 Accreditation mandatory Accreditation body/country Mandatory CYPRUS (CYS CYSAB) CZECH REPUBLIC (CAI) DENMARK (DANAK) ESTONIA (EAK) FINLAND (FINAS) FRANCE (COFRAC) YES. All medical labs, for all sites, for all activities. Deadline: 1 st November 2016 GREECE (ESYD) IRELAND (INAB) LATVIA (LATAK) MALTA (NAB MALTA) RWAY (NA) PORTUGAL (IPAC) REPUBLIC OF CROATIA (HAA) SERBIA (ATC) SPAIN (ENAC) Only for newborn screening YES, for hospital laboratories. In force from ; Law on Protection against ionizing Radiation and Nuclear Safety; Department of antirabic Protection.Comment: There are less inspections in human genetics laboratories from other governmental bodies, when accredited. ROMANIA BELGIUM: Molecular genetics. 3
3 Legal requirements for medical laboratories Accreditation body/country Legal requirements CYPRUS (CYS CYSAB) (Law hazardous wastes; quality and safety of human tissue cells ). CZECH REPUBLIC (CAI) DENMARK (DANAK) ESTONIA (EAK) FINLAND (FINAS) FRANCE (COFRAC) YES. laboratories have to fulfill the guidelines of German Medical Association. This guideline contains requirements for quality management system and for internal and external quality control. GREECE (ESYD) YES. IRELAND (INAB) LATVIA (LATAK) YES. If not accredited, requirements in accordance to MALTA (NAB MALTA) YES. There is a system of licensing which is administered by the Ministry responsible for Health Services. The Ministry has established basic application and license conditions. : Legionella in water, semenbanking, donorlab s, paternity testing RWAY (NA) Yes in some technical fields (e.g. blood banks) PORTUGAL (IPAC) YES REPUBLIC OF CROATIA (HAA) SERBIA (ATC) SPAIN (ENAC) YES. clinical labs have to fulfill specific requirements for their authorization granted by regional healthcare authorities Yes, there are several legal requirements 4 Legal requirements for sampling sites Accreditation body/country Legal requirements CYPRUS (CYS CYSAB) CZECH REPUBLIC (CAI) DENMARK (DANAK) ESTONIA (EAK) FINLAND (FINAS) FRANCE (COFRAC) There are not sampling sites in Germany GREECE (ESYD) IRELAND (INAB) n/a LATVIA (LATAK) MALTA (NAB MALTA). The NAB MALTA is not aware of any such requirements. RWAY (NA) PORTUGAL (IPAC) YES REPUBLIC OF CROATIA (HAA) SERBIA (ATC) SPAIN (ENAC) YES. Units for collection of biological samples must be authorized by regional healthcare authorities. For this authorization the unit must be linked to amedical laboratory which takes the responsibility for the whole process. 1
4 6 7% 19% 34% 21% 44% 22% 31% 44% 33% 7
5 Accreditation since Accreditation since 2005 (2) 9
6 Public/Private Country Public : Private 50 : 50 FRANCE (COFRAC) 10 : 90 No answer CZECH REPUBLIC (CAI) 27 : 73 IRELAND (INAB) 70 : 30 RWAY (NA) 75 : 25 SPAIN (ENAC) 84 : 16 GREECE (ESYD) 30 : 70 FINLAND (FINAS) 85 : 15 DENMARK (DANAK) 91 : 9 PORTUGAL (IPAC) 40 : 60 SERBIA (ATC) 44 : 56 CYPRUS (CYS CYSAB) 7 : 93 ESTONIA (EAK) 88 : : 10 REPUBLIC OF CROATIA (HAA) 80 : 20 No answer MALTA (NAB MALTA) LATVIA (LATAK) 20:70 10 Scope of accreditation % of AB 50 90% of AB <50% of AB Other medical areas Clinical Chemistry Clinical Microbiology Haematology Immunology Histocompatibility Point of care Immunohematology Parasitology Clinical Toxicology Pharmacology Anatomical Pathology (Cytology and Histopathology) Molecular genetics Cytogenetics Imaging Radiotoxicology Biological dosimetry IVF Pathology : Molecular pathology In situ techniques Anticoagulation centers Sampling Forensic Testing Clinical physiology Nuclear medicine Clinical neurophysiology POCT FRANCE (COFRAC) IRELAND (INAB) DENMARK (DANAK) 11
7 100% 42% 2% 90% 50% 9% 4% 22% 30% 10% 20% 100% 12
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