Guidance for Quality Assurance on Pre-examination … Accreditation Board JAB and the Japanese Committee for Clinical Laboratory Standards (JCCLS) jointly developed the accreditation

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)


Uncertainties in Medical Laboratory Examination

Standardization of Medical Laboratory Examination in Japan

APLAC and its Activities

Developing Guidance Document for APLAC MRA

CONTENTS


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空腹

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間未

満

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2-3時

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4-5時

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5-6時

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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


Lipoprotein composition of Lipid samples

（External Quality Assessment Scheme, Japan Association of Medical Technologists 2011）


Transfer BOX

XX Medical CenterRefrigerant

Sample Container

Is temperature maintained ? Samples


15〜20℃ (in summer) ,

With Using Refrigerants

Transfer BOX

XX Medical Center

Container

Refrigerant

Is it enough ?


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


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


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


Important Components for Standardization of Medical Laboratory’s Examination Result

Reference Material

Reference Measurement Procedure

Competence of Laboratory

Traceability & Measurement Uncertainty

Accreditation


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・・・


To Hospital Laboratory⇒Medical Service Act

No Special requirementsTo Independent Laboratory

⇒Act on Medical Laboratory Technologists, etc.

Regulation regarding Medical Laboratory in Japan


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


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


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


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


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Accredited Medical Laboratories in the world

January 28, 2013


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Austraria

India

Canada

Taiwan

Thailand

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Japan

New Zealand

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Mexico

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Accredited Medical Laboratories in Asia

January 2013


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2008 2009 2010 2011 2012 2013

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Trend of Accredited Medical Laboratories in Asia


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


Fish-bone diagram for Uncertainty components

Uncertainty components should be taken into account.


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.


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


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


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


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


To assist accreditation bodies that are performing a medical laboratory accreditation program in understanding issues on pre-examinantion phase

APLAC TC XXX


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;


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;


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


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


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


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)


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)