Quest Diagnostics’ Experience: Non-Regulatory

Quality Standards

Presented by George Pounds MT(ASCP), CLS, MBA

2

Presentation Objectives

The presentation will answer the questions …

Why ISO 9001 & Six Sigma?How did Quest Diagnostics do it?What did we learn?What were the benefits?What’s the difference between all these standards and how do they relate to Quality?

3

Why Non-Regulatory Standards?While Regulatory standards are essential and provide a necessary foundation, compliance to Regulatory Standards were not helping the business;

meet customer needs…the best laboratory services possibledrive productivity and quality improvement…industry competitionimprove employee hiring and retention…employee market competitionprovide assay design standards…industry leadership

4

Quest Diagnostics Non-Regulatory History

1997 Pilot ISO 9001 at Nichols Institute as a Quality framework 1998 Expanded certification to other clinical and non-clinical

facilities. 2000 Initiated Six Sigma as a Quality improvement program within

ISO 9001 framework. Maintained ISO certification for currently certified labsReplicate ISO learnings to the remaining labs through Six Sigma and Corporate Medical Quality.

2001 10 facilities Certified (5 clinical labs and 5 non-clinical)2003 Fully implemented Six Sigma program

throughout Quest Diagnostics

5

How was ISO implemented?Identified a corporate ISO leader.Identified an on-site ISO project leader.Identified an on-site project team (20 – 40 staff)Implemented a standard project plan (approximately 52 steps)Performed staff training (just-in-time method).First lab took 15 months, subsequent labs took 10 months.Cost of Certification: $10,000 - $15,000Ongoing annual costs: $8,000 - $12,000

6

What did we learn from ISO?ISO represents a cultural change to the organization.Resistance to change is normal … must establish & communicate clear need and benefits.Key integrated components for success …• Clear and visible management participation is required.• Solid tools for process management at all levels of the

organization. • Solid document management at all levels of the

organization.• Solid measurement system to know how you are doing.• Solid training and competency for all staff.• Solid supplier management process.• Solid design control processMinimal recognition of ISO by Hospital and Physician clients

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What are the Benefits from ISO?Management Participation!Setting clear organizational goals and alignment around those goals.

Quality Planning!Places customer defined outcomes as the goal of the organization!

Process Management!This is where most errors and problems occur! Removes department barriers!

8

What are the Benefits from ISO?Document Management System!Controls document and records at all levels... not just SOPs.

Measurement and Improvement System!Process and customer measures areembedded in the lab operation.

Plan, Do, Check, Act!

Supplier Management System! Supplier performance is monitored and they are accountable to meet quality measures.

Design Control System!

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Example: Quality Planning Business Quality Council, Meeting Process Flow / Input - Output

Process Inputs Process OutputsProcess Flow

Review Nichols Operating Plan

Review Nichols Metrics (By Core Process / VOC Review / Customer Trends & Data / Internal VOC)

Review Nichols Selected Projects and Initiatives

Identify Gaps Against Op Plan & Assign or Modify Resources

Review Status of All Projects Against the Plan(Green/Yellow/Red)

Operating Plan & Champion Responsible

Focus on Meeting Operating Plan Objectives

Metrics Based on Balanced BU Scorecard

Current & YTD Metric Status for BU Targets & Performance; New Issues

Project Status SummaryFocus on Project Progressing Toward Meeting Op Plan & BU Resource Allocation

Selected Project Reviews

Drives Project Progress, Focus on Achieving Project Desired Results

Parking Lot and Issues Identified During Review

Meet Business Unit Targets; Quality Improvement Plans

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Core Process Alignment Nichols-

Example: Process Management

Pr. Owner: Dave PauluzziPr. Owner: Dr. Raj Pandian

Develop New Products/Services

AcquireThe Customer

SpecimenSubmission

TransportSpecimen

ProcessSpecimen

TestSpecimen

Report Results

Bill &Collect

ManageCustomer Relationship

Enabling Processes

Pr. Owner: Dr. Richard Reitz

Pr. Owner Carl Burgess

Pr. Owner: Carl Burgess

Pr. Owner: Katie Bishar

Pr. Owner: John Besser

Pr. Owner: Carl Burgess

Pr. Owner: Carl Burgess

Pr. Owner: Marianne Weinell/ Lee Lavi/ Karen Dow / John Besser/ Marc Gray

Quality/Six Sigma, HR, Finance, Materials, IT

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Process ManagementProcess Management

MANAGE ACCOUNTS

ACQUIRECUSTOMERS

1.0

ACQUIRE SPECIMENSAND ENTER ORDERS

TEST & REPORTRESULTS BILL &

COLLECT6.0

Acquire PatientSamples

2.0

Transport PatientSamples

3.0

Process PatientSamples

4.0

Test & ReportPatient Results

5.0

Serve Customers7.0

CU

STO

MER

NEE

DS

CU

STO

MER

SA

TISF

AC

TIO

N

FINANCE11.0

MEDICAL12.0

RESEARCH &DEVELOPMENT

13.0QUALITY PLANNING

Vision, Mission, Values, Roadmap 2000, Six Sigma, ISO, Ops Excellence, Document Control, Quality Metrics, Training, Internal Audits

HUMAN RESOURCES8.0

MATERIALSMANAGEMENT

9.0INFORMATIONTECHNOLOGY

14.0

LEGAL/COMPLIANCE10.0

ENABLERS

MACRO MAP

Example: Process Management

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PerformPre-route

DutiesSOP

PSC /ClientVisitSOP

Are thereany Sample or

InformationProblems?

Client VisitProblem

ResolutionSOP

DeliverSamples toProcessing

SOP

PrepareSamples for

ShipmentSOP

All Other Non-Sample

DeliveriesSOP

TRANSPORT PATIENT SAMPLECourier Service

Map 3.0

Return to TestingLab or Courier

Hub

Post RouteDutiesSOP

AreThere any

OutstandingIssues?

ProcessPatient

SamplesMap 4.0

ACQUIREPATIENTSAMPLESMap 2.0 &

2.1

Post RouteProblem

ResolutionSOP

DocumentStorage

ACQUIRECUSTOMERS

Map 1.0

Check withDispatch forMessages

No

Yes

Yes

No

September 2, 1999

Record SampleInformation

SupportiveDocuments

Process ManagementProcess ManagementExample: Process ManagementA deeper dive!

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Document Management

Document Structure

Policies

Processes

Procedures

Records

A

B

C

D

What to do

How it Happens

How to do it

Evidence of Compliance

Example: Document Management

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Document Management (Quality Manual)

Document Structure

ActualCOMPLIANCE

MANUALEMPLOYEEHANDBOOK

QUALITYMANUAL

GENERALPROCEDURES

ANDINFORMATION

RESEARCH &DEVELOPMENT

MANUAL

GENERALLAB

MANUAL

QAMANUAL

MATERIALSMANAGEMENT

MANUAL

SHIPPING &RECEIVING

MANUAL

18 LAB DEPT.MANUALS

LEVEL A

LEVEL B

LEVEL COTHERDEPT.

MANUALS

RECORDSLEVEL D

QUALITY BINDER

Example: Document Management

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Management ResponsibilitiesExample: Management Responsibility and Measurement

Management Review

Quality Measures include results of:Quality Measures include results of:all audits, internal or externalall audits, internal or externalcustomer feedback including surveys and complaints customer feedback including surveys and complaints employee surveysemployee surveyskey process measureskey process measures

Then provide for corrective and preventive actions &follow-up actions from previous management reviews

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Client Retention Team in place. Service Solutions Specialists assess Clients At Risk. Top 25 Tests TAT, SF and TNP activity for prior month. Contact Sales Rep and summarize findings.Team members assign action items for improved retention. In addition, will evaluate early intervention data.

Client Retention Team

Draw to Release

Total Tests

Unit Code Test Description

Expected Release to Final

Under Expected

Over Expected

Percent Failed

034:34 255 450 Hepatitis B Surface Antigen 021:23 008:07 8%038:26 167 3701 Hepatitis C Antibody, EIA 033:39 014:16 2%039:09 145 558 Hepatitis B Core Antibody (IgM) 025:53 006:21 0%038:22 143 478 Hepatitis A (IgM), Acute Status 025:54 006:22 0%068:26 108 6960 HIV-1/HIV-2 Antibody Screen 017:06 000:54 35%028:11 94 4362 T4, Free, Non-Dialysis 049:59 035:40 1%028:32 47 409 CA 125, MEIA 049:45 021:48 0%027:23 47 983 CA 27.29 052:27 039:19 0%023:05 40 4360 LEAD, BLOOD (PT-DEMO) 050:41 026:45 10%022:18 38 672 WBC/Lymphs 016:08 003:50 5%032:13 36 514 Alpha-Fetoprotein, Serum 037:48 026:55 0%028:47 31 6037 Homocysteine (Cardiovascular), Serum, FPIA 056:27 038:25 10%031:24 31 9199 MATERNAL SERUM SCREEN 4 071:45 030:18 6%035:20 29 475 CA 19-9, Serum 021:50 009:47 0%036:03 25 910 Hepatitis B Surface Antibody Quantitation 030:57 006:15 8%026:08 21 562 PTH, Intact and Calcium 052:57 027:59 0%031:56 21 6732 Methylmalonic Acid 115:10:00 053:45 5%034:04 18 295 Thyroid Peroxidase Antibody (Anti-TPO) 051:39 037:21 0%041:20 18 4210 Vitamin B1, Plasma 071:44 026:05 61%030:33 17 412 Prolactin 020:26 005:20 0%036:52 16 218 ANCA Vasculitides 056:38 021:09 19%252:27:00 16 6309 Estradiol, Ultra Sensitive 018:24 039:06 13%045:24 15 701 Ceruloplasmin 026:52 006:19 0%038:29 14 404 Thyroglobulin Antibody 045:23 030:15 0%026:36 13 406 Thyroglobulin 058:45 042:30 8%

Average TAT 8%

Example: Measurement

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Client Retention TeamService Event Summary ReportClient 52572From 01 MAY 2004 to 31 MAY 2004Origin Desc Cause Description Count Total %CLIENT NO SAMPLE RECEIVED 11 24%STEROIDS DELAY 9 20%CLIENT SPILT ORDER PRIMARY SAMPLE RECEIVED 7 16%CLIENT TEST NOT ACCESSIONED 3 7%CLIENT BATCH NOT CROSSED 3 7%CLIENT ADDITIONAL INFORMATION REQUESTED TO REPORT TEST 2 4%CLIENT TEST ADD HOLD 1 2%CLIENT INCORRECT SAMPLE TYPE SUBMITTED 1 2%CLIENT STABILITY SAMPLE 1 2%CLIENT TEST CANCELED BY CLIENT 1 2%CLIENT PATIENT VERIFY 1 2%SEROLOGY DELAY 1 2%SEROLOGY MISSING SPECIMEN 1 2%TEST SEND OUTS COMMUNICATION COMPLAINT 1 2%ENDOCRINE PEPTIDES MISSING SPECIMEN 1 2%IMMUNOCHEMISTRY DELAY 1 2%

Total 45

TNP Comment DescriptionTNP-INTERFERING SUBSTANCE PRESENT. UNABLE TO QUANTITATE. Count 1TNP-Specimen exceeds Quest Diagnostics, Nichols Institute's recommended; stability range. Please resubmit. Charges have been cancelled. Count 1TNP-The EDTA blood specimen that we received was too old to yield an accurate; white blood cell count. We are unable, therefore, to calculate or report; absolute values for the lymphocyte subsets. Count 1

TNP-Unable to perform ordered test with sample type submitted. Please contact; Quest Diagnostics Client Services for the sample requirements for this test,; or if an alternative test is desired. Charges have been cancelled. Count 1

TNP-Unable to perform ordered test because the specimen was submitted in an; incorrect transport medium. Please contact Quest Diagnostics, Nichols; Institute Client Services at (800) 553-5445 for the transport medium; requirements for this test, or if a 1TNP-Duplicate test order. Test has been cancelled. Count 5TNP-INTERFERING SUBSTANCE PRESENT. UNABLE TO QUANTITATE.; TNP-Unable to calculate due to interfering substance. Count 1TNP-TEST REQUEST CANCELLED - NO CHARGE. Count 5TNP-Cancelled per client request. Count 9TNP-Cancelled per client request.; TNP-NO SAMPLE RECEIVED. Count 1Grand Count 35

Service Event Analysis

Test Not Performed (TNP) Analysis

Example: Measurement

18

Training Management

Job Descriptions - describe the qualifications and tasks for all job titles.

Learning & Development - formal instruction to enhance overall knowledge or insight related to current or future job positions for all employees.

Training - formal instruction on SOPs or any other document necessary to perform the tasks in the Job Description for all employees.

Competency - periodic assessment of task performance for all employees.

Example: Training Management

19

Training Management

TRAINING PROCESS

IDENTIFY TRAININGNEEDS BASED ON

DUTIES ANDPROCEDURES TO BE

PERFORMED

PERFORM &DOCUMENTTRAINING

FILE TRAININGRECORD IN

DEPARTMENT

CREATE TRAININGCHECKLIST

DOCUMENT JOBREQUIREMENTS

AND DUTIES IN JOBDESCRIPTION

Are additionaltasks to be

performed ?

Are new tasksdocumented in thejob description ?

NOACTION

YES

YES

NO

NO

Example: Training Management

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Example: Supplier Management

SUPPLIER NON-CONFORMANCE DATA COLLECTION

&DOCUMENTATION PROCESS FLOW

Lab Identifies Supplier Performance Deficiency forMaterial or Service Provided

Lab Contacts Supplier forTechnical Assistance & Deficiency Resolution

Lab Reports Supplier PerformanceDeficiency at Daily Lab Ops Meeting

Using Applicable DatabaseNon-Conformance Code

Lab Ops Database is UpdatedWith Supplier Performance

Deficiency Data

Lab Ops Database GeneratesSupplier Root Cause

Analysis/Corrective ActionForm & Cover Letter

Materials Department Edits/IssuesCover Letter & Root Cause

Analysis/Corrective Action FormTo Supplier

Supplier Completes/ReturnsRoot Cause Analysis/Corrective

Action Form to MaterialsManager & Distribution

Supplier Root Cause Analysis/Corrective Action Form Response

Entered into Lab Ops Database

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How does Six Sigma fit into a Non-Regulatory

approach to Quality?

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How was Six Sigma implemented?

Identified a corporate Six Sigma leader.Identified Master Black Belts (BB) as on-site project leaders.Identified and trained on-site Black Belts.Implemented a standard project plan.Identified and initiated Six Sigma projects.Identified and trained Green Belts (GB).2000 – 2003: 330 BB & 1245 GB projects complete.

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What are we learning from Six Sigma?A cultural change to the organization ... expect resistance!Better Six Sigma results from ISO certified facilities!Management participation required.Project selection and alignment required for success.Sharing of key learnings essential to overall success.Effective and practical statistical and team management tools.Hospital and Physician recognition of Six Sigma is growing.

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What are the Benefits from Six Sigma?Highly evolved tool (statistical and team management) for improvement!…Best results if there is a well defined infrastructure to support it.Extremely customer focused…get the voice of the customer with specific critical to quality measures! Focus on specific problems!…Don’t boil the ocean!Focus on data … not opinion!…Get the right data in the right format!

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What are the Benefits from Six Sigma?

Focus on root cause analysis!…Practical use of statistical tools to understand the root cause of the problem.Focus on sustaining the gain!…The process owner participates in solution design, monitoring and correcting future problems.Focus on risk assessment! …FMEA tool for anticipating problems and identifying solutions prior to incident.Proven Results!…Customer Satisfaction: improved 20%Savings: Exponential

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H IV G enotype A ssay Cycle Tim e

Target Cycle Tim e 168 H ours

Example: HIV Genotype TAT

Key Tools: VOC, Process Mapping, Time Study, Process Capacity analysis

Improvements: Streamlined repeat process & instrument schedules.Implemented IT automation for reviews and reporting

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Key Tools: VOC, created a reliable measure and display system5/16/0053

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ease

to F

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T (H

rs)

ProcessImprovements InPlace

HIV Genotype Assay Cycle Time

Target Cycle Time 168 Hours

Key Learnings: streamline repeat process, instrument schedules, Implementing IT automation for reviews and reporting

Key Tools: VOC, Process Mapping, Time Study, Process Capacity analysis

Human Contact in the Laboratory

UCL=0.57569

LCL=0.43948

CEN=0.50759

UCL=0.36237

LCL=0.22757

CEN=0.29497

UCL=0.18202

LCL=0.05409

CEN=0.11806

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3First Round of Workouts

Second Round of Workouts

Improvements: wireless head-sets, accurate contact information in the LIS, dedicated staff for answering the phone.

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ISO

Impl

emen

ted

BENEFITS

1997 1998 1999 2000 2001 2002 2003

ISO

Six

Sigm

a

What are the Overall Benefits?

Savings

Customer Satisfaction

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QUALITY EVOLUTION

STRATEGIC QUALITY MANAGEMENT (1980s) (2000s*)

OPERATIONAL QUALITY MANAGEMENT (1950s) (1980s*)

WORK FORCE QUALITY CONTROL (1920s) (1950s*)

*wide use by clinical lab industry!

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STAGES OF QUALITYNCCLS Guideline GP26 (based on ISO 9000)

STAGE ACTIVITIES PERFORMED Total Quality Management Total management approach centered around

“Customer Satisfaction”

Quality Improvement Formal process to achieve significant improvements and cost savings

Quality System “Comprehensive and Coordinated” system to meet quality objectives

Quality Assurance

Organized activities to provide “Confidence” that the organization meets requirements for quality

Quality Control Operational techniques applied to “Specific Tasks” for quality and regulatory compliance.

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JURAN AND NCCLSJURAN NCCLS GP26

Total Quality Management Strategic Quality Management Quality Improvement

Quality System Operational Quality Management

Quality Assurance

Work Force Quality Control Quality Control

32

STAGES OF QUALITYNCCLS Guideline GP26 (based on ISO 9000)

STAGE ACTIVITIES PERFORMED Total Quality Management Total management approach centered

around “Customer Satisfaction” Quality Improvement Formal process to achieve significant

improvements and cost savings Quality System “Comprehensive and Coordinated”

system to meet quality objectives Quality Assurance Organized activities to provide

“Confidence” that the organization meets requirements for quality

Quality Control Operational techniques applied to “Specific Tasks” for quality and regulatory compliance.

CLI

A/C

AP

New

ISO

15 1

8 9

ISO

90 0

1

SIX SIGMA

33

ISO 9001 - 2000 Revision

Management Responsibility(Clause 5)

Resource Management(Clause 6)

Measurement, Analysis & Improvement(Clause 8)

Plan -Do - Check -

Act

Service Realization(Clause 7)

Input Process Output

CU

STO

MER

REQ

UIR

EMEN

TS

CU

STO

MER

SA

TISF

AC

TIO

N

Quality Management System(Clause 4)

PurchasingDesign

ISO 15189 does not develop these aspects

34

Document Management

Document Structure

Policies

Processes

Procedures

Records

A

B

C

D

What to do

How it Happens

How to do it

Evidence of Compliance

CLIA/CAP & ISO 15189 DO NOT DEVELOP THIS LEVEL

CLIA/CAP ISO 9001ISO 15189

35

Presentation Objectives

The presentation will answer the questions …

Why ISO 9001 & Six Sigma?How did Quest Diagnostics do it?What did we learn?What were the benefits?What’s the difference between all these standards and how do they relate to Quality?

36

Thank You for Your Time and Attention

Questions?