Japan Accreditation Board
KATSUO KUBONO, Ph.DJapan Accreditation Board
( Convener, Medical Sub-committee, APLAC TC )
JCCLS Symposium 201314:00-17:00, April 4, 2013. ESSAM KANDA Hall
「分析前後段階の品質保証の指針」
Guidance for Quality Assurance on Pre-examination Phase)
Japan Accreditation Board
Uncertainties in Medical Laboratory Examination
Standardization of Medical Laboratory Examination in Japan
APLAC and its Activities
Developing Guidance Document for APLAC MRA
CONTENTS
Japan Accreditation Board
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110
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160
空腹
時
1時
間未
満
1-2時
間
2-3時
間
3-4時
間
4-5時
間
5-6時
間
6-7時
間
7-8時
間
8-9時
間
9時間
以上
Elapsed Time
mg/dl
中性脂肪
血糖
Koyanagi, et,al.;NIIGATA Association of Occupational Health, INC.
Health guidance value for Triglyceride
Health guidance value for Glucose
Influence of after feeding
Japan Accreditation Board
Lipoprotein composition of Lipid samples
(External Quality Assessment Scheme, Japan Association of Medical Technologists 2011)
Japan Accreditation Board
Transfer BOX
XX Medical CenterRefrigerant
Sample Container
Is temperature maintained ? Samples
Japan Accreditation Board
15〜20℃ (in summer) ,
With Using Refrigerants
Transfer BOX
XX Medical Center
Container
Refrigerant
Is it enough ?
Japan Accreditation Board
Urinary test items Variation Causes/Factors
Color brownish discoloration Urobilinogen→oxidation→urobilin
Opacity/Turbidity Increase Bacterial growth, salt precipitationUrinary Protein Increase AlkalizationUrinary Glucose Decrease Glucose consumption by bacteriaUrobilinogen Decrease Urobilinogen→oxidation→urobilinBilirubin Decrease Bilirubin→oxidation→biliverdineKetones Decrease Volatilization of acetone, acetoacetateOccult blood Decrease Decreasing of POD-like activityLeukocytic response Decrease Decreasing of esterase activityNitrite Decrease Reduction of nitrite by bacteriaGravity Increase ConsentrationpH alkalization Urea desolving by bacteria→ammonium formed
Variation of urinary constituents accompanying neglect
Japan Accreditation Board
項目 CVA かたよりBA 項目 CVA かたよりBA
AST 7.6 7.1 TP 1.5 1.2
ALT 11.1 12.4 ALB 1.6 1.3
LD 3.4 3.9 UN 7.1 6.0
CK 11.1 11.3 CRE 2.7 4.8
ALP 3.9 6.5 UA 4.4 6.5
γ-GT 8.2 12.8 TB 11.7 21
AMY 4.2 6.8 Na 0.4 0.3
Ch-E 2.6 4.7 K 2.6 1.9
LAP 2.4 5.6 Cl 0.7 0.5
TC 3.4 4.5 Ca 1.3 1.0
TG 14.8 15.4 IP 4.6 3.5
HDL-C 4.2 6.0 Fe 16.9 11.3
LDL-C 4.6 6.9 GLU 2.9 2.3
Acceptable Error based on Individual Physiological Variation J. JSCC, 35:144-153, 2006
Japan Accreditation Board
General Information
ost of medical care: 37.4 trillion yen vs. GDP : 7.8%vs. National income : 10.7%
Number of Medical Institutes: 108,494Hospitals: 8,670
National 274Public 1,278Others 7,118
Clinics 99,824
October, 2010
Japan Accreditation Board
Important Components for Standardization of Medical Laboratory’s Examination Result
Reference Material
Reference Measurement Procedure
Competence of Laboratory
Traceability & Measurement Uncertainty
Accreditation
Japan Accreditation Board
RM/RMP Standardization of Results
Development of Data Base
Establishing; National high level reference materials, reference measurement procedures・・・
Performing; Internal and external quality assurance, collection of regional difference of date
Promotion for; development of data base, diffusing procedure, maintain of system healthy
JCCLS Exploratory Committee on Fundamentals of Standardization
Standardization of Medical Laboratory Examination in Japan
JCTLM
Co-operation
EU Directives
CLSI
Asian countries
Collaborate with
Other Academies, JACRI・・・
Japan Accreditation Board
To Hospital Laboratory⇒Medical Service Act
No Special requirementsTo Independent Laboratory
⇒Act on Medical Laboratory Technologists, etc.
Regulation regarding Medical Laboratory in Japan
Japan Accreditation Board
For Hospital Japan Council for Quality Health Care :2409Joint Commission International (JCI) :7
For LaboratoryISO 15189 Accreditation :66Association for Promotion of Health Care Service:145
ISO 9001 Certification : 300<
Accreditation or Certification for Japanese Hospitals and Laboratories
KUBONO
April 2013
Japan Accreditation Board
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
Japan Accreditation Board15
開発委員会準備委員会を発足April 2003, Establish the Preparatory Committee
September 2004, Started assessment for Pilot Accreditation
August 2005, Started Accreditation Service
Development Process of Medical Laboratory Accreditation Scheme
JCCLS (Japanese Committee for Clinical Laboratory Standards)
・Industry-Government-Academia consortium
・Resources of medical personnel
JAB (Japan Accreditation Board )
・Organization and Financial base・Performance in industry・ILAC MRA Member
Accreditation Criteria
Assessor Training
Japan Accreditation Board
Function of Accreditation Body (JAB)Accreditation Body;
authoritative body that performs accreditation
CustomerCertain ?become reliable
ABs(JAB)
ILAC(APLAC)
Mutual Recognition Agreement(MRA)
LaboratoryTest Report
Certain ?become reliable
Certain ?become reliable
Japan Accreditation Board17
16
Clinical TrialLab., 2
Hospital Lab.,12
UniversityLab., 16
Health Check-up Lab., 3
RegisteredLab., 33
Accredited Medical Laboratories in Japan Mar. 21, 2013
University Lab. 16
Hospital Lab. 12
Clinical Trial Lab. 2
Registered Lab. 33
Health Check-up Lab. 3
Japan Accreditation Board
ILAC
EA APLAC IAAC
SADCA
Laboratory Accreditation Corporations
HKAS(Hong Kong)、 JAB(Japan)、 ema(Mexico)、STANDARDS MALAYSIA(Malaysia)、IANZ(New Zealand) 、TAF(Chinese Taipei)、 SAC(Singapore)、DMSc(Thailand)、CNAS(China) 、NABL (India)、QMPLS (Cnada)、SLAB (Sri Lanka)、A2LA (USA)、BoA (Vietnam) 、KAN (Indonesia) ・・・15Economies
APLAC MRA Mutual Recognition Agreement
Japan Accreditation Board
0
100
200
300
400
500
600
700
800
Aus
trar
ia
Eng
land
Ger
man
y
Sou
th A
frica
India
Fran
ce
Can
ada
Cze
ch
Taiwan
Tha
iland
China
Swed
en
Japa
n
New
Zea
land
Irelan
d
Beigium
Gre
ese
Swiss
Hon
g Kon
g
Mex
ico
Norway
UAE
Malay
sia
Viet Num
Finlan
d
Indo
nesia
Chile
Singa
pore
Cyp
rus
Ned
erland
Israel
Tur
ky
Polan
d
Cro
atia
Gat
emara
Philip
pine
s
USA
Ehy
pt
Brazil
Colom
bia
Accredited Medical Laboratories in the world
January 28, 2013
Japan Accreditation Board
0 200 400 600 800
Austraria
India
Canada
Taiwan
Thailand
China
Japan
New Zealand
Hong Kong
Mexico
Malaysia
Biet Num
Indonesia
Singapore
Phillipines
USA
Accredited Medical Laboratories in Asia
January 2013
Japan Accreditation Board
0
50
100
150
200
250
300
350
400
2008 2009 2010 2011 2012 2013
Hong Kong
China
Taiwan
Thailand
Malaysia
India
Japan
21
Trend of Accredited Medical Laboratories in Asia
Japan Accreditation Board
Considering the elements of uncertainty in the Medical Laboratory Examination
K.KUBONO, Rinsho Byori 55(11) 2007, modified
Sample Site
Sampling technique
Patient preparation
Stress, age, sex, drug profile, dietary, physiological variation
Sampling, sample transfer, sample storage
Medical Laboratory
Sample treatmentExamination
(Analysis)
Examination result reporting
Biological reference interval
Explanation of examination result
Measurement Uncertainty
Japan Accreditation Board
Fish-bone diagram for Uncertainty components
Uncertainty components should be taken into account.
Japan Accreditation Board
Back Ground
According to statistics, more than 50% of the errors in medical examiation field are in the pre-examination phrase, so this process is very important for securing of the examination results.
Japan Accreditation Board
Scope of APLAC Guidance Document, Pre-examination phase
Primary sample
collection
Interim storage
Transportation
Receipt of
samples, Sample portions
Examination
Blood, Serum,Urine, etc.
Conveyance system in hospital
Transportation by air, truckSampling site
Refrigeration,Freezing, etc.
Scope of ISO 15189
Case in Hospital
Case in Independent laboratory
Pre-Examination Phase
Japan Accreditation Board
Guidance for Quality Assurance on Pre- and Post-examination Phase <For Medical Laboratories>
Published by JAB in 2009
This guidance is for quality assurance that should be considered for containing at minimum the factors affecting examination results by the activities of a medical laboratory undertaken at the pre- and post-examination phase, based on ISO 15189:2007.When a medical laboratory seeks to be granted accreditation to ISO 15189, the conditions given in this guidance shall be satisfied.
JAB RM 320
Japan Accreditation Board
1. Scope2. Reference documents
2.1 Normative documents2.2 Reference documents
3. Objectives and background4. Necessary items at the stages of receiving
request for examination until receiving a specimen4.1 Request for examination4.2 Matters related to collection of primary samples4.3 Transportation of specimens to the laboratory4.4 Procedure for receiving transported specimens at
the laboratory
Contents of RM 320
Japan Accreditation Board
5. Procedures at the phases from receiving a specimen at the laboratory up to its analysis
5.1 Procedures for separation of serum, etc.5.2 Transporting inside the laboratory up to analysis
6. Procedures after the end of examination upto reporting the result
7. Storage and disposal of specimensInformative Documents
ANNEX A “Role of Quality Management in Health Checkups”
Contents of RM 320
Japan Accreditation Board
To assist accreditation bodies that are performing a medical laboratory accreditation program in understanding issues on pre-examinantion phase
APLAC TC XXX
Japan Accreditation Board
1) At the stages of receiving request forexamination until receiving a specimen
・Request for examination・Matters related to collection of primary samples
・Transportation of specimens to the laboratory
・Procedure for receiving transported specimens at the laboratory
Considering items are;
Japan Accreditation Board
2) At the phases from receiving a specimen at the laboratory up to itsanalysis
・Procedures for separation of serum, etc.・Transporting inside the laboratory up
to analysis
Considering items are;
Japan Accreditation Board
ILAC G26:07/2012Guidance for the Implementation of a Medical Laboratory Accreditation SystemThis is a practical guide for accreditation bodies implementing a medical laboratory accreditation system using ISO 15189. It identifies key aspects of the standard, points out its unique element, and provides advice for the development and maintenance of an accreditation program that is based on ISO 15189.
ILAC (International Laboratory Accreditation Cooperation) AIC WG6
Relating Activities
Japan Accreditation Board
SPIDIA: Standardization and Improvement of generic pre-analytical tools and procedures for in vitro diagnostics.CEN/TC 140 ‘In vitro diagnostic medical devices’
Approved Guidance for the Quality Management of Specimens for Molecular Methods;Procurement, transport, and preparation of specimens JCCLS MM5-A1, 2011 JAPAN
Relating Activities
Japan Accreditation Board
JAB RM320: Guidance for Quality Assurance on Pre- and Post-examination Phase <For Medical Laboratories>Japan Accreditation Board, 2009
ISO/TC212 WG1; Developing the document for Specimen ProcurementSheila Woodcock, Canada
Relating Activities
Japan Accreditation Board
Rough ScheduleSeptember 2011
Proposal and agreement for preparing the guidance document
December 2011Preparing speculated draft document
Discussing with Medical-SC members
April 2013Submitting Draft Document (Ver.1)
Japan Accreditation Board
Medical SC MemberMegan Nelson, NATABella Shiu Wun Ho, HKASChin Poh Yin, SACChih-Heng Liao, TAFRajesh Maheshwari, NABLSiripan Wongwanich, DMScRay Minnick, A2LATran Thu Thi Ha, BoAJoo-Shil Lee, NIH
Hyun-Ja Lee, KOLASFariza Wan Abdullah, SMHu Dongmei, CNASJennie León, emaMartha Mejia. emaShelli Turner, IANZGum Ho-Cho, KOLASKatsuji Shimoda, JABKatsuo Kubono, JAB(Convener)