Laboratory AccreditationLaboratory Accreditation Program in Koreag

Hwan Sub, LIM MD, PhD, ,Dept of Laboratory Medicine,

Kwandong University College of Medicine,Korea

ContentsContentsContentsContents

H l h S i K• Healthcare System in Korea

• History of KLAP (Korean Laboratory Accreditation Program)History of KLAP (Korean Laboratory Accreditation Program)

• KLAP : Present status

• Inspection

• Education• Education

• Research & Developments

• Future of KLAP

Healthcare System in KoreaHealthcare System in KoreaHealthcare System in KoreaHealthcare System in Korea

H lth f ALL• Healthcare for ALL• Fee for service (traditional reimbursement)• National Healthcare Insurance System (incl. lab)National Healthcare Insurance System (incl. lab)

• Healthcare Policy• Ministry of Health & Welfare (MOHW)y ( )

• Oversees the national health insurance system• National Health Insurance Corporation (NHIC)• Health Insurance Review & Assessment Service• Health Insurance Review & Assessment Service

• Conduct reviews• Assessment of medical fees

History of KLAPHistory of KLAPHistory of KLAPHistory of KLAP

KLAP• KLAP ; Korean Laboratory Accreditation Program

• 1998, Ministry of Health & Welfare• Inspection & quality certification program for

improving & managing the quality of clinicalimproving & managing the quality of clinical laboratory tests

• 1999, pilot project launched• Mandatory qualification program for Ref. Lab• Organized by KSLM (Korean Society for

Laboratory Medicine, formerly known as KSCP)Laboratory Medicine, formerly known as KSCP)

• 1999 Laboratory Accreditation Committee• 1999, Laboratory Accreditation Committee, KSLM

• Standing committeeg• Laboratory inspection and its related works

• Qualification• Duties of responsible lab personnelDuties of responsible lab personnel• Lab facilities & safeties• Quality controls• Quality improvements• Quality improvements

• Checklists for 11 areasL b l Di i H l Cli i l Ch i• Lab general, Diagnostic Hematology, Clinical Chemistry (General Chemistry, Urinalysis, Special Chemistry), Clinical Microbiology, Transfusion Medicine, Immunoserology, HLA, Molecular Biology, Flowcytometry, Cytogenetics, LimitedMolecular Biology, Flowcytometry, Cytogenetics, Limited Lab Service

• 2000, ,• Added - comprehensive laboratory test verification• Abolished – limited lab service

• 2004 13 areas covered• 2004, 13 areas covered• POCT, reference lab – pilot program

• 2010, Laboratory Medicine Foundation (LMF, www.lmf.or.kr)

• Close collaboration with KSLMClose collaboration with KSLM• Joint Certificate for Accreditation• Structure of LMF

• Board Memberso d e be s• 18 Board Members

• Director• Business Manager – inspection, education, R&D, treasurer

KLAP :KLAP :KLAP : KLAP : Present StatusPresent StatusPresent StatusPresent Status

Structure of KLAPStructure of KLAP

Chair, Board MemberChair, Board Member

Board MemberDirectorDirector

Inspection Education R & D Treasurer

Goal for KLAPGoal for KLAPGoal for KLAPGoal for KLAP

A f t t t lt• Assurance for accurate test results• Continuous service improvements

• Efforts to show visible improvements in lab safety & effective test performanceeffective test performance

• Continuous improvements in steps affecting patients’ test results

SKSLM(1949/1980)

Korean Society for Laboratory Medicine

LMF(2010)KAQACL (1976)

( )

Laboratory Medicine Foundation

Korean Association of Quality Assurance for Clinical

Laboratory

CAP vs ISOCAP vs ISO 1518915189 vs KLAPvs KLAPCAP vs ISO CAP vs ISO 15189 15189 vs KLAPvs KLAPCAP ISO 15189 KLAPCAP ISO 15189 KLAP

Participation Mandatory (in US)Voluntary (outside US)

Voluntary Voluntary

Accreditation Peer review 3rd party Peer reviewAccreditation Peer-review 3rd party Peer-review

Assessment CompetenceTechnical procedure

ConformityRisk assessment

CompetenceComformity

Assessment Pass/Fail Pass/Fail Unique ScoringAssessment Method

Pass/FailPhase 1Phase 2

Pass/Fail Unique Scoring system

Accreditation 2 years 3~4 years 1-year : 80~89%Accepted/Deficiency/RecommendationsCorrection needed before accreditation

Deficiency Report 2-year : ≥90%

Fail : <80%

Unique Scoring SystemUnique Scoring SystemUnique Scoring SystemUnique Scoring System

S d di it i t• Scores : depending on its importance• Essential for good lab practice• Quality Improvements• Focus on . . . . . . .

M d t d t & d• Mandatory documents & procedures• Initial stage : giving high scores• If all lab satisfy the conditions, tapering the score to y , p g

minimum of 1.

• Scores summed up & converted to %• Scores summed up & converted to %

Business Area of KLAPBusiness Area of KLAPBusiness Area of KLAPBusiness Area of KLAP

Chair, Board MemberChair, Board Member

Board Member

Director

R & D N ??Inspection Education R & D New ??

For InspectionFor InspectionFor InspectionFor Inspection

L b t A dit ti & I ti• Laboratory Accreditation & Inspection• Comprehensive Verification management• Accreditation & Inspection for Reference

Laboratory ServicesI i C tifi t f A dit ti• Issuing Certificates for Accreditation

• Hospital Laboratory• Reference Laboratoryy

Checklist of KLAPChecklist of KLAPChecklist of KLAPChecklist of KLAP• Lab organizational system• Proficiency testing• Quality Assurance Strategy• Internal Quality Control• Analytic Process

• Pre /Post analytical• Pre-/Post-analytical• Analytical

• Analyzers & instrumentsy• Inventory• Lab personnel/environments

Documents needed for inspectionDocuments needed for inspectionDocuments needed for inspectionDocuments needed for inspection

C tifi t f fi i t ti ti i ti• Certificate for proficiency testing participation• Problem report for participated proficiency tests• CQI – structure, proceedings(minutes)• Guide books for Quality Control• Technical Manual for tests & procedures• Lists for lab analyzers and maintenance records

No of Lab participation & resultsNo. of Lab participation & results300

200

250

150

200

100

0

50

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

No. of Participants 2-Year 1-Year Self Withdrwal Disqualified Re-inspection

Results of AccreditationResults of AccreditationResults of AccreditationResults of AccreditationYear No. of

Participation2-year

accreditation1-year

accreditationSelf

inspection Disqualified Re-inspectionp inspection inspection

1999 96 0 96 0 0 0

2000 178 55 116 0 7 0

2001 187 52 62 55 18 1

2003 188 53 59 65 10 5

2005 204 49 71 81 3 112005 204 49 71 81 3 11

2007 232 67 68 80 14 7

2009 238 71 65 95 3 7

2010 251 104 39 72 2 6

2011 256 89 59 103 3 3

2012 260 119 49 89 5 82012 260 119 49 89 5 8

2013 276 108 50 118 6 0

No of Inspectors participatedNo of Inspectors participatedNo. of Inspectors participatedNo. of Inspectors participatedYear No. of Lab

i t dInspectors

Year No. of Lab No. of Lab InspectorsA N f A N finspected Total No. Average No. Man-days

1999 96 140 3.8 5322000 178 183 3.5 641

Year participated inspected Total No. Average No. of participation

Average No. of Inspectors

1999 96 96 140 3.8 5.52000 178 178 183 3 5 3 6

2002 187 226 2.4 5432004 192 202 3.1 6262006 226 243 3 5 851

2000 178 178 183 3.5 3.62002 187 135 226 2.4 4.02004 192 139 202 3.1 4.5

2006 226 243 3.5 851

2008 241 282 2.9 6882010 251 308

2006 226 179 243 3.5 4.8

2008 241 174 282 2.9 4.72010 251 179 308 2.9 5.1

2011 256 2842012 260 3222013 276 340

2011 256 153 284 2.8 5.32012 260 171 322 3.0 5.62013 276 158 340 2 6 5 5

2014 274 ?2013 276 158 340 2.6 5.52014 274 167 ? 3.0 ?

For EducationFor EducationFor EducationFor Education

1999 1st d ti f i t• 1999, 1st education for inspectors• Peer-reviewer (Inspector) & examinee

• Twice a yearTwice a year• Changes in checklists• Quality improvements

Ed ti f R id t• Education for Residents• Once a year• At least 2 times throughout whole 4-year residentshipg y p

• R&D for quality assurance system for laboratory & new standardized education programs

For Research & DevelopmentsFor Research & DevelopmentsFor Research & DevelopmentsFor Research & Developments

Ch kli t d t & i i• Checklists updates & revisions

• Funding researches for Laboratory Quality Improvements

• Information System• On line registration for inspectors• On-line registration for inspectors• On-line application for inspections• On-line assessments of checklists & summation

Contents of ChecklistsContents of ChecklistsContents of ChecklistsContents of Checklists• Lab organizational systemg y• Proficiency testing• Lab quality assurance strategy• Internal quality control• Pre-analytic process• Analytic process• Analytic process• Post-analytic process• Laboratory equipment and instrumentbo o y equ p e d s u e• Inventory• Lab personnel• Lab environment

Detailed QuestionnairesDetailed QuestionnairesDetailed QuestionnairesDetailed Questionnaires

C• Common• Qualification of directors• Facilities and safetiesFacilities and safeties

• Space, analyzers, utensils etc• Communications (LIS)• Medical waste disposal managements• Medical waste disposal managements

• Program for Quality improvements & Quality Control

P i i i f P fi i T i P• Participation of Proficiency Testing Program• Frequency of Internal Quality Control Program & its

managementsT i f QI & it t• Topics of QI & its reports

• Basic conditions for accredited laboratoryy• Managerial statistics for

• Key indicators• TATs (Turnaround Time) for emergency & routine

• Temperature /Humidity Monitoring• Refrigerators• Freezers/Deep freezers• Room temperature

• Laboratory Procedures• Parallel tests for lot changesg

• Reagents, calibrators• Decision criteria

• Reagent Lot controlg• Analytical Measurement Interval verification

• Special or field specific• Specific questionnaires for each field

• Typical analyzers needed to run the tests• Temperature monitoring records for PCR etc• Separated room for acid-fast bacillus• Ocular micrometer• Review the effects of complements• Parallel tests due to lot changes ore reagent changes• Parallel tests due to lot changes, ore reagent changes• False negative rate for amplification tests

• POCTPOCT• Every POCT analyzer should be controlled• QC & maintenance• Education program for users

• Ref. Lab• Specimen transportation – temp., quality indicators..• Reception, handling, reporting• Data transactions…….

Committee for Committee for ChecklistChecklist RevisionRevision

D l t f N Q ti i & ki• Development of New Questionnaire & making guidelines for it

• Delete old fashioned out dated questionnaires• Delete old fashioned, out-dated questionnaires• Update all the guidelines

P ti i t I t• Participate as an Inspector• Monitor New Questionnaires & scores for

adjustments if neededadjustments, if needed.

Checklists RevisionChecklists RevisionChecklists RevisionChecklists Revision

2000 1 t i i ith d ti f l t l b• 2000, 1st revision with adoption of complementary lab verification report

• 2001, 2nd revision & applied in year 2002, pp y• 2003, 3rd revision

• Pilot project for POCT, Ref. Lab

• 2005, 4th revision • Pilot project for POCT• Ref. Lab – Routine Checklists

• 2007, 5th revision• 2010, 6th revision• 2013, 7th revision

• POCT – Routine checklists

Checklists (Checklists (19991999))Checklists (Checklists (19991999))A N f Q ti i A N f Q ti iAreas No of Questionnaires Areas No of Questionnaires

Lab General 203 Flowcytometry 102

Diagnostic H t l

146 Histocompatability 117Hematology

Chemistry 409 General – 114Special – 210

UA – 85

Cytogenetics 137

Clinical Microbiology

282 Molecular Biology 232

Transfusion 246 Limited Lab Service 542Medicine

Immunoserology 70 Total 2,486

Checklists Checklists –– BasicBasicFields 1999 2000 2002 2004 2006 2008 2009 2011 2014

Total 2,486 1,969 1,788 1,798 1,762 1,658 1,659 1,604 1,590

Lab General 203 203 199 198 168 172 172 153 156

Hematology 146 146 135 135 156 147 147 147 145

Chemistry 409 409 382 382 274 258 258 251 239

General 114 114 127 131 100 90 89 92 92

Special 210 210 185 188 73 76 77 74 66

Urinalysis 85 85 70 73 101 92 92 85 80

Microbiology 282 282 254 256 155 160 160 159 166

Transfusion Medicine 246 246 184 185 313 295 295 298 270Medicine

DiagnosticImmunology 70 70 87 89 86 86 86 84 82

Comp.LabVerification - 25 25 25 23 23 23 25 19Verification

Limited Lab Service 542 - - - - - - - -

Checklists Checklists –– SpecialSpecialFields 1999 2000 2002 2004 2006 2008 2009 2011 2014

Flowcytometry 102 102 98 95 107 86 87 88 87

pp

HLA 117 117 100 106 105 90 90 92 100

Cytogenetics 137 138 124 134 134 103 103 106 106

Molecular Biology 232 232 200 204 143 139 139 138 139

POCT - - - 71 61 64 64 27 32

Ref. Lab - - - 37 37 35 35 36 49

Checklists (Checklists (20142014))Checklists (Checklists (20142014))A N f Q ti i A N f Q ti iAreas No of Questionnaires Areas No of Questionnaires

Lab General 156 Flowcytometry 87

Diagnostic H t l

145 Histocompatability 100Hematology

Chemistry 239 General – 93Special – 66

UA – 80

Cytogenetics 106

Molecular Biology 139

Clinical Microbiology

166 ComprehensiveLab Verification

19

Transfusion 270 POCT 32Medicine Ref. Lab 49

Immunoserology 82 Total 1,590

Future of KLAPFuture of KLAPFuture of KLAPFuture of KLAP

S f l i l t ti f KLAP• Successful implementation of KLAP• Voluntary, peer-reviewer

• International Recognition for AccreditationInternational Recognition for Accreditation program in Korea (KLAP)

• Establishing guidelines for Standardization• Suggest Standard Lab procedures• Development of Statistical ProgramsDevelopment of Statistical Programs

• Education for inspectors & participants• Development of standardized education programs

Thank you forThank you forThank you for Thank you for Your Attention!Your Attention!