1

Blanchard Valley Hospital LaboratoryBlanchard Valley Hospital Laboratory

Bonnie Van SchoikBonnie Van SchoikDirector of Laboratory ServicesDirector of Laboratory Services

Our Journey to CAP 15189Our Journey to CAP 15189SMSM

AccreditationAccreditation

September 30, 2009September 30, 2009

2

BVHS LAB

3

Building Our ShipBuilding Our Ship

HistoryHistory

Why ISO?Why ISO?

ISO Implementation/QMSISO Implementation/QMS

The ISO Difference/BenefitsThe ISO Difference/Benefits

RecommendationsRecommendations

Standardization/AccreditationStandardization/Accreditation

AABB (1975)AABB (1975)

CLIA CLIA ’’8888

Joint Commission (1992)Joint Commission (1992)

CAP (1994)CAP (1994)

CAP 15189CAP 15189SMSM April 23April 23rdrd, 2009, 2009

4

Why ISO?Why ISO?What Is ISO:15189?What Is ISO:15189?

Medical Laboratories Medical Laboratories –– Particular Particular Requirements for Quality and Requirements for Quality and CompetencyCompetency

40 Page Document Of Written 40 Page Document Of Written StandardsStandards

Thou Thou ““ShallShall”” Develop a Total QMSDevelop a Total QMS

ISOISO ImplementationImplementation

CAP/ISO Pilot ProgramCAP/ISO Pilot Program

CAP Visit in Dec. 2007CAP Visit in Dec. 2007

One of Three LabsOne of Three Labs

First Clinical Lab of our size in theFirst Clinical Lab of our size in theNationNation

5

ISO:15189 QMSISO:15189 QMS

Implementation Began Implementation Began JUNE 2008JUNE 2008

Required Written Quality Manual Required Written Quality Manual

Encompasses Entire Lab OperationEncompasses Entire Lab Operation

Document Control SystemDocument Control System

ISO:15189 QMS cont.ISO:15189 QMS cont.

Not Expected to be Perfect/Continuous PINot Expected to be Perfect/Continuous PI

Tracking and TrendingTracking and Trending

Root Cause AnalysisRoot Cause Analysis

Problems are Simply Opportunities for Problems are Simply Opportunities for ImprovementImprovement

6

ISO:15189 QMS cont.ISO:15189 QMS cont.

SoftTech Software WebSoftTech Software Web--Based Quality ManagementBased Quality ManagementSystemSystem

Management ReviewManagement Review

7

8

ISO 15189: What have we done….

9

Management ReviewManagement Review

ISO Scorecard DocumentationISO Scorecard Documentation

Targets Set and Evaluated Targets Set and Evaluated

Scheduled ReviewsScheduled Reviews

Action Plans Developed Action Plans Developed

Management Review cont.Management Review cont.

Internal AuditsInternal Audits

Reference Lab EvaluationReference Lab Evaluation

Problem LogsProblem Logs

Suppliers ReviewedSuppliers Reviewed

Contracts/Client PricingContracts/Client Pricing

10

Crew Crew –– All Hands On Deck!All Hands On Deck!

ISOtize suggestionsISOtize suggestions

Procedure WritingProcedure Writing

Treasure ChestTreasure Chest

ISO ScoutingISO Scouting

RCAsRCAs

Treasure ChestTreasure Chest

II--SS--O game piecesO game piecesEarned by: Earned by:

Submitting an ISOtize formSubmitting an ISOtize formCost saving ideas Cost saving ideas Procedure writingProcedure writingCompleting a scavenger hunt in SoftTechCompleting a scavenger hunt in SoftTechFinding a CAP deficiency and fixing the problemFinding a CAP deficiency and fixing the problemAttending laboratory and hospital meetingsAttending laboratory and hospital meetingsCompleting projects above and beyond daily Completing projects above and beyond daily dutiesduties

11

ISO Scouting/TeachingISO Scouting/Teaching

ISO Scouts SelectedISO Scouts Selected

Scouts ISOtized the CrewScouts ISOtized the CrewEducational opportunitiesEducational opportunities

ISO Specific informationISO Specific informationSoftTech search/ ease of useSoftTech search/ ease of useLab Quality Manual ReviewLab Quality Manual Review

Root Cause Analysis (RCA)Root Cause Analysis (RCA)

Process ImprovementProcess ImprovementCrew Invited to ParticipateCrew Invited to Participate

Not a Punitive ActionNot a Punitive ActionAll Job ClassificationsAll Job ClassificationsProvide Direct Impact on PIProvide Direct Impact on PI

12

The ISO Difference/BenefitsThe ISO Difference/Benefits

Culture ChangeCulture ChangeCrew EngagementCrew Engagement

Enhanced QMSEnhanced QMSFinancial GainsFinancial Gains

Operational EfficienciesOperational Efficiencies-- SoftTechSoftTechSupply Cost ReductionsSupply Cost ReductionsMarketing ToolMarketing Tool

13

14

RecommendationsRecommendations

ISO StandardISO StandardAppoint ChampionAppoint ChampionSelect Core ISO TeamSelect Core ISO TeamAssessmentsAssessments

DeskDeskGapGapPrePreFinalFinal

BVHS LAB

15

The BVHS Lab CrewThe BVHS Lab Crew