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KATSUO KUBONO, Ph.DDeputy Director-General
Japan Accreditation Board
The 3rd GCC Laboratory Proficiency ConferenceMarch 24-25, 2015, Dubai
Medical Laboratory Accreditation and its utilization in Japan
JAB and the Gulf Cooperation Center (GCC) Accreditation Center (GAC) signed a Memorandum of Communication (MOC) to provide a framework for cooperation for accreditation.
MOU with the GCC Accreditation Center
3
Medical Laboratory Accreditation Scheme in Japan
Accreditation Activities for Medical Laboratories
Effectiveness and Application
CONTENTS
7
JAB and the Japanese Committee for Clinical Laboratory Standards (JCCLS) jointly developed the accreditation scheme for Japanese medical laboratories based on the accreditation criteria of ISO 15189, and JAB started its accreditation service in August 2005. Supported by both The Ministry of Health, Labor and Welfare and Ministry of Economy, Trade and Industry
Medical Laboratory Accreditation
8
Accredited Medical Laboratories in Japan.
23
26
20
31
University Hospital General Hospital
Registered Clinical Laboratory Health Check Laboratory
Clinical Trial Laboratory
9
Scope of AccreditatonGeneral Testing: 2005Biochemistry, Hematology, Immunology, Chromosome,
Gene, Biology, Urinalysis
Health Checkup: (Specified health checkup
testing ) 2007
Biochemistry, Hematology, UrinalysisPathology: 2009Processing of fixed specimens for histopathology, Cytodiagnosis, Histopahology
Physiology: 2015Echography, Electrocardiography, Electroencephalography,Spirometry
Participation every year in proficiency testing programs provided by at least three associations.
NOTE: In the field of pathology, to participate in a proficiency testing program provided by Japan Association of Medical Technologists.
At the time of on-site assessment, to participate in an on-site practical examination providedby JAB.
Participation Proficiency Testing
11
Improvement of proficiency test results
95
95.5
96
96.5
97
97.5
98
98.5
99
99.5
100
Initial Reassessment(1) Reassessment(2)
98.21±1.14
99.09±1.05 99.15±0.97
1212
July 1, 2013Pharmaceutical and Food Safety Bureau,Ministry of Health, Labour and Welfare
Use the laboratory accreditation (ISO 15189 accreditation) to the quality control for medical laboratory in clinical trial
Use the laboratory accreditation (ISO 15189) to the quality control of medical testing in clinical trial
In the medical institutions that actively conducted clinical research or clinical trial beginning with the physician-led clinical trials and global clinical trials, in order to ensure the testing accuracy of the medical institution, medical institution have to be accredited by an external evaluation of ISO 15189, etc.. "
4.1 組織とマネジメント
4.2 品質マネジメントシステム
4.3 文書管理
4.4 契約の内容の確認
4.5 委託検査室による検査
4.6
│
外部からのサ
ビス及び供給品
4.7
│
アドバイスサ
ビス
4.8 苦情処理
4.9 不適合の識別と管理
4.10 是正
処置
4.11 予防
処置
4.12 継続
的改善
4.13 品質
及び技術的記録
4.14 内部
監査
4.15
│
マネジメントレビュ5.1 要員
5.2 施設及び環境条件
5.3 検査室の機材
5.4 検査前手順
5.5 検査手順
5.6 検査手順の品質保証
5.7 検査後手順
5.8 結果の報告
0.0
0.5
1.0
1.5
2.0
2.5
3.0
Continual Improvement
(Transition of findings)
Initial Assessment
First Surveillance
Second Surveillance
Re-assessment
Requirements
15
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0Purpose %
a Needs
of cust
omer
b Le
gal re
quest an
d resp
onse
c Improv
ement
of visib
ility
d Impro
vemen
t of p
erform
ance
e Deve
lopment
of hu
man resou
rce
f Impro
vement
of te
chnica
l capa
bilitie
s
g Social
respon
sibilit
y
h Vers
us co
nsumer
i Othe
rs NA
Purpose of accreditation Laboratory Survey
16
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
1
Merit 3
Merit 2
Merit 1
Merit 0
N.A.
Survey result for Improvement of Technical Capability
Very Well Well
17
Effect of QMSEffect of technical
competenceReduction of the incorrect frequency by the standardization of work and the promotion of organization / documentation / the transparence.
Evaluation of value from a customer (patients, doctors) improved by getting third party evaluation.
Convergence of the human unevenness by clarification of responsibility and authority, documentation of operation procedure.
Examination result report used in the world wide by the ILAC/APLAC MRA.
Taking chance for international clinical trial.
Certainty of setting up the work, rule making, certifying, instructions, taking over and investigation.
Improvement of the personnel competence
Possibility of maintenance by resignation, making change in the staff
Improvement of the evaluation result in PT/EQA
Effectiveness after accreditation
71
125
49
102
30
66
18
46
0
20
40
60
80
100
120
140
2005 2006 2007 2008 年
苦情不適合苦情/
不適合の件数
Effectiveness in a accredited Medical laboratory
Decreasing of Nonconformities/Complaints
ComplaintsNonconformities