Quest Diagnostics’ Experience: Non-Regulatory
Quality Standards
Presented by George Pounds MT(ASCP), CLS, MBA
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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?
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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
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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
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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!
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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
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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
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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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rs)
ProcessIm provem ents InPlace
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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Rel
ease
to F
inal
TA
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
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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.
CLI
A/C
AP
New
ISO
15 1
8 9
ISO
90 0
1
SIX SIGMA
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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
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MER
REQ
UIR
EMEN
TS
CU
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MER
SA
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AC
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N
Quality Management System(Clause 4)
PurchasingDesign
ISO 15189 does not develop these aspects
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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
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?