Quest Diagnostics'Experience Non-Regulatory Quality Standards by kby12992

VIEWS: 6 PAGES: 36

									Quest Diagnostics’ Experience:
       Non-Regulatory
      Quality Standards


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




                                               2
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 possible
 drive productivity and quality improvement
 …industry competition
 improve employee hiring and retention
 …employee market competition
 provide assay design standards
 …industry leadership


                                                                3
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 labs
            Replicate 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




                                                                        4
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 - $15,000
  Ongoing annual costs: $8,000 - $12,000




                                                       5
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 process
  Minimal recognition of ISO by Hospital and
  Physician clients



                                                              6
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!




                                                     7
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 are
  embedded 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!


                                                  8
Example: Quality Planning        Business Quality Council, Meeting
                                      Process Flow / Input - Output

        Process Flow           Process Inputs              Process Outputs

        Review Nichols        Operating Plan &           Focus on Meeting
        Operating Plan        Champion Responsible       Operating Plan Objectives

   Review Nichols Metrics
   (By Core Process / VOC     Metrics Based on           Current & YTD Metric
   Review / Customer Trends   Balanced BU Scorecard      Status for BU Targets &
   & Data / Internal VOC)                                Performance; New Issues

                                                         Focus on Project
   Review Status of All       Project Status Summary     Progressing Toward
   Projects Against the                                  Meeting Op Plan & BU
   Plan(Green/Yellow/Red)                                Resource Allocation

   Review Nichols
                                                         Drives Project Progress,
   Selected Projects and      Selected Project           Focus on Achieving
   Initiatives                Reviews                    Project Desired Results

  Identify Gaps Against Op                                Meet Business Unit
                               Parking Lot and Issues
  Plan & Assign or Modify                                Targets; Quality
                              Identified During Review
  Resources                                              Improvement Plans



                                                                                     9
Example: Process Management                                                   Core Process Alignment
                                                                                             Nichols-
     Pr. Owner: Dr. Raj Pandian                    Pr. Owner: Dave Pauluzzi


Develop New Products/                                Acquire
      Services                                    The Customer




 Pr. Owner: Carl       Pr. Owner: Carl     Pr. Owner: Carl          Pr. Owner: Katie         Pr. Owner: Dr.         Pr. Owner: John
 Burgess               Burgess             Burgess                  Bishar                   Richard Reitz          Besser


Specimen                Transport            Process                    Test                    Report                  Bill &
Submission              Specimen            Specimen                  Specimen                  Results                Collect




                                                Manage                                   Pr. Owner Carl Burgess
                                          Customer Relationship


                                                                                         Pr. Owner: Marianne Weinell/ Lee Lavi/
                                           Enabling Processes                            Karen Dow / John Besser/ Marc Gray
                                         Quality/Six Sigma, HR, Finance, Materials, IT
                                                                                                                                      10
Example: Process Management                                                                              Process Management
                                                                                                         Process Management


                                                                     MANAGE ACCOUNTS

                                             ACQUIRE SPECIMENS                                   TEST & REPORT
                    ACQUIRE                                                                                                                BILL &
                                             AND ENTER ORDERS                                       RESULTS
                   CUSTOMERS                Acquire Patient    Transport Patient            Process Patient     Test & Report             COLLECT
                       1.0                    Samples              Samples                     Samples          Patient Results              6.0
                                                  2.0                3.0                         4.0                  5.0




                                                                                                                                                           CUSTOMER SATISFACTION
                                                                             Serve Customers
                                                                                   7.0
  CUSTOMER NEEDS




                                                                             ENABLERS

                                                                       MATERIALS
                                  HUMAN RESOURCES                                        LEGAL/COMPLIANCE
                                                                      MANAGEMENT
                                         8.0                                                    10.0
                                                                           9.0
                                                                                 RESEARCH &          INFORMATION
                         FINANCE                              MEDICAL
                                                                                DEVELOPMENT          TECHNOLOGY
                           11.0                                 12.0
                                                                                     13.0                14.0
                                                                    QUALITY PLANNING
                     Vision, Mission, Values, Roadmap 2000, Six Sigma, ISO, Ops Excellence, Document Control, Quality Metrics, Training, Internal Audits



                                           MACRO MAP
                                                                                                                                                                                   11
Example: Process Management                                                      Process Management
                                                                                 Process Management
         A deeper dive!
                               ACQUIRE
       ACQUIRE                 PATIENT
      CUSTOMERS                SAMPLES               Client Visit
        Map 1.0                Map 2.0 &              Problem
                                 2.1
                                                     Resolution
                                                        SOP

                                                          Yes


 Perform              PSC /                             Are there             Process
 Pre-route            Client      Record Sample      any Sample or             Patient
  Duties               Visit       Information        Information             Samples
   SOP                SOP                              Problems?              Map 4.0

                                                          No


                                                                               Deliver
                                                    Check with
                                                                             Samples to
                                                    Dispatch for
                                                                             Processing
                                                     Messages
                                                                                SOP




                                                                              Prepare
                                                  Return to Testing                          Post Route
                                                                             Samples for
                                                   Lab or Courier                              Duties
                                                                              Shipment
                                                        Hub                                    SOP
                                                                                SOP




                                                                            All Other Non-
                                                                                                 Are
                  Supportive                                                    Sample        There any
                  Documents                                                   Deliveries                   No
                                                                                             Outstanding
                                                                                 SOP           Issues?

                                                                                                            Document
                                                                                                 Yes         Storage

     TRANSPORT PATIENT SAMPLE                                                                Post Route
                                                                                              Problem
           Courier Service                                                                   Resolution
                                                                      September 2, 1999        SOP
              Map 3.0

                                                                                                                12
Example: Document Management        Document Management


   Document Structure


             Policies       What to do
                        A

      Processes                How it Happens
                        B

Procedures              C          How to do it

 Records                D     Evidence of Compliance


                                                          13
Example: Document Management                            Document Management
                                                           (Quality Manual)
 Document Structure
                            LEVEL A
 Actual
          COMPLIANCE                          QUALITY                   EMPLOYEE
            MANUAL                            MANUAL                    HANDBOOK


                                         QUALITY   BINDER


                                            GENERAL
              GENERAL       LEVEL B       PROCEDURES                   MATERIALS
                LAB                                                   MANAGEMENT
              MANUAL                          AND                       MANUAL
                                          INFORMATION




                            LEVEL C
                                 RESEARCH &                  OTHER    SHIPPING &
             18 LAB DEPT.                            QA
                                DEVELOPMENT                  DEPT.    RECEIVING
               MANUALS                             MANUAL
                                   MANUAL                   MANUALS    MANUAL




                            LEVEL D
                                              RECORDS




                                                                                   14
 Example:                          Management Responsibilities
 Management Responsibility
 and Measurement

                  Management Review
Quality Measures include results of:
    all audits, internal or external
    customer feedback including surveys and complaints
    employee surveys
    key process measures

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


                                                                 15
Example: Measurement                                                                    Client Retention Team
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.
                                                                               Expected
       Draw to     Total   Unit                                                Release to   Under      Over       Percent
       Release     Tests   Code   Test Description                             Final        Expected   Expected   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%




                                                                                                                            16
               Example: Measurement                                                                 Client Retention Team
Service Event Summary Report
Client 52572                      Service Event Analysis
From 01 MAY 2004 to 31 MAY 2004
Origin 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%
                                                                                                                     Test Not Performed
CLIENT
CLIENT
                          BATCH NOT CROSSED
                          ADDITIONAL INFORMATION REQUESTED TO REPORT TEST
                                                                            3
                                                                            2
                                                                                          7%
                                                                                          4%
                                                                                                                     (TNP) Analysis
CLIENT                    TEST ADD HOLD                                     1             2%
CLIENT                    INCORRECT SAMPLE TYPE SUBMITTED                   1             2%
CLIENT                    STABILITY SAMPLE                                  1             2%
                                                                                    TNP Comment Description
CLIENT                    TEST CANCELED BY CLIENT                           1            2%
                                                                                    TNP-INTERFERING SUBSTANCE PRESENT. UNABLE TO
CLIENT                    PATIENT VERIFY                                    1            2%
                                                                                    QUANTITATE. Count                                                         1
SEROLOGY                  DELAY                                             1            2%
                                                                                    TNP-Specimen exceeds Quest Diagnostics, Nichols Institute's
SEROLOGY                  MISSING SPECIMEN                                  1       recommended; stability range. Please resubmit. Charges have been
                                                                                         2%
                                                                                    cancelled. Count                                                          1
TEST SEND OUTS            COMMUNICATION COMPLAINT                           1             2%
                                                                                    TNP-The EDTA blood specimen that we received was too old to yield
ENDOCRINE PEPTIDES        MISSING SPECIMEN                                  1             2%
                                                                                    an accurate; white blood cell count. We are unable, therefore, to
IMMUNOCHEMISTRY           DELAY                                             1             2%
                                                                                    calculate or report; absolute values for the lymphocyte subsets.
                                                                      Total 45      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                 1
                                                                                    TNP-Duplicate test order. Test has been cancelled. Count                  5
                                                                                    TNP-INTERFERING SUBSTANCE PRESENT. UNABLE TO
                                                                                    QUANTITATE.; TNP-Unable to calculate due to interfering substance.
                                                                                    Count                                                                     1
                                                                                    TNP-TEST REQUEST CANCELLED - NO CHARGE. Count                             5
                                                                                    TNP-Cancelled per client request. Count                                   9
                                                                                    TNP-Cancelled per client request.; TNP-NO SAMPLE RECEIVED.
                                                                                    Count                                                                     1
                                                                                    Grand Count                                                               35


                                                                                                                                                                   17
Example: Training Management           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.



                                                             18
Example: Training Management                                              Training Management

                                                                                FILE TRAINING
                                                                                  RECORD IN
                                                                                DEPARTMENT




                                                                   PERFORM &
                                                                   DOCUMENT
                                                                    TRAINING


                                                                                 Are additional
                                                                                                           NO
                                                                                   tasks to be      NO
                                                                                                         ACTION
                                                                                  performed ?
                                           CREATE TRAINING
                                             CHECKLIST

                                                                                      YES



                       IDENTIFY TRAINING
                        NEEDS BASED ON                                           Are new tasks
                          DUTIES AND                         YES               documented in the
                      PROCEDURES TO BE                                          job description ?
                          PERFORMED


                                                                                      NO
   DOCUMENT JOB
   REQUIREMENTS
  AND DUTIES IN JOB
    DESCRIPTION
                                  TRAINING PROCESS




                                                                                                                  19
Example:                                                  SUPPLIER NON-CONFORMANCE
                                                                    DATA COLLECTION
Supplier Management                                                               &
                                                        DOCUMENTATION PROCESS FLOW


                                                                     Lab Reports Supplier Performance
  Lab Identifies Supplier          Lab Contacts Supplier for
                                                                    Deficiency at Daily Lab Ops Meeting
Performance Deficiency for         Technical Assistance &
                                                                         Using Applicable Database
Material or Service Provided        Deficiency Resolution
                                                                         Non-Conformance Code




                                  Lab Ops Database Generates         Materials Department Edits/Issues
Lab Ops Database is Updated
                                    Supplier Root Cause                Cover Letter & Root Cause
 With Supplier Performance
                                  Analysis/Corrective Action         Analysis/Corrective Action Form
      Deficiency Data
                                    Form & Cover Letter                         To Supplier




              Supplier Completes/Returns
                                                      Supplier Root Cause Analysis/
            Root Cause Analysis/Corrective
                                                     Corrective Action Form Response
               Action Form to Materials
                                                       Entered into Lab Ops Database
                Manager & Distribution


                                                                                                          20
   How does Six Sigma
fit into a Non-Regulatory
   approach to Quality?




                            21
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.




                                                 22
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.


                                                  23
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!




                                                 24
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




                                                       25
                                                                                                                                                                            Release to Final TAT (Hrs)




                                                                                                                                                                        0
                                                                                                                                                                            100
                                                                                                                                                                                  200
                                                                                                                                                                                        300
                                                                                                                                                                                              400
                                                                                                                                                                                                    500
                                                                                                                                                                                                          600
                                                                                                                                                                                                                 700



                                                                                                                                                               5/1/02
                                                                                                                                                               5/2/02
                                                                                                                                                               5/3/02
                                                                                                                                                               5/4/02
                                                                                                                                                               5/5/02
                                                                                                                                                               5/6/02
                                                                                                                                                               5/7/02
                                                                                                                                                               5/8/02
                                                                                                                                                               5/9/02
                                                                                                                                                              5/10/02
                                                                                                                                                              5/11/02
                                                                                                                                                              5/13/02
                                                                                                                                                              5/14/02
                                                                                                                                                              5/15/02
                                                                                                                                                              5/16/02
                                                                                                                                                              5/17/02
                                                                                                                                                              5/18/02
                                                                                                                                                              5/20/02
                                                                                                                                                              5/21/02
                                                                                                                                                              5/22/02
                                                                                                                                                              5/23/02
                                                                                                                                                              5/24/02
                                                                                                                                                              5/25/02
                                                                                                                                                              5/27/02
                                                                                                                                                              5/29/02
                                                                                                                                                              5/30/02
                                                                                                                                                              5/31/02
                                                                                                                                                               6/1/02
                                                                                                                                                               6/3/02
                                                                                                                                                               6/4/02
                                                                                                                                                               6/5/02
                                                                                                                                                               6/6/02
                                                                                                                                                               6/7/02
                                                                                                                                                               6/8/02
                                                                                                                                                              6/10/02
                                                                                                                                                              6/11/02
                                                                                                                                                              6/12/02
                                                                                                                                                              6/13/02
                                                                                                                                                              6/14/02
                                                                                                                                                              6/15/02
                                                                                                                                                              6/17/02
                                                                                                                                                              6/18/02
                                                                                                                                                              6/19/02
                                                                                                                                                              6/20/02
                                                                                                                                                              6/21/02
                                                                                                                                                              6/22/02
                                                                                                                                                              6/24/02
                                                                                                                                                              6/25/02
                                                                                                                                                              6/26/02
                                                                                                                                                              6/27/02
                                                                                                                                                              6/28/02
                                                                                                                                                              6/29/02
                                                                                                                                                               7/1/02
                                                                                                                                                               7/2/02
                                                                                                                                                                                                                                                                                                    Example: HIV Genotype TAT




                                                                                                                                                               7/3/02
                                                                                                                                                               7/4/02
                                                                                                                                                               7/5/02
                                                                                                                                                               7/6/02
                                                                                                                                                               7/8/02
                                                                                                                                                               7/9/02
                                                                                                                                                              7/10/02
                                                                                                                                                 Setup Date

                                                                                                                                                              7/11/02
                                                                                                                                                              7/12/02
                                                                                                                                                              7/13/02
                                                                                                                                                              7/15/02
                                                                                                                                                              7/16/02
                                                                                                                                                              7/17/02
                                                                                                                                                              7/18/02
                                                                                                                                                              7/19/02
                                                                                                                                                              7/20/02
                                                                                                                                                              7/21/02
                                                                                                                                                              7/22/02
                                                                                                                                                              7/23/02
                                                                                                                                                              7/24/02
                                                                                                                                                              7/25/02
                                                                                                                                                                                                                           T arget C ycle T im e 168 H ours




                                                                                                                                                              7/26/02
                                                                                                                                                              7/27/02
                                                                                                                                                              7/29/02
                                                                                                                                                              7/30/02
                                                                                                                                                              7/31/02
                                                                                                                                                               8/1/02
                                                                                                                                                               8/2/02
                                                                                                                                                               8/3/02
                                                                                                                                                               8/4/02
                                                                                                                                                               8/5/02
                                                                                                                                                                                                                                                              H IV G enotype A ssay C ycle T im e




                                                                                                                                                               8/6/02
                                                                                                                                                               8/7/02
                                                                                                                                                               8/8/02
                                                                                                                                                               8/9/02
                                                                                                                                                              8/10/02
                                                                                                                                                              8/11/02
                                                                                                                                                              8/12/02
                                                                                                                                                              8/13/02
                                                                                                                                                              8/14/02
                                                                                                                                                              8/15/02
                                                                                                                                                              8/16/02
                                                                                                                                                              8/17/02
                                                                                                                                                              8/18/02
                                                                                                                                                              8/19/02
                                                                                                                                                              8/20/02
                                                                                                                                                              8/21/02
                                                                                                                                                                    *
                                                                                                                                                                                                                P lace
                                                                                                                                                                                                                P rocess




           Implemented IT automation for reviews and reporting
                                                                                                                                                                                                                Im provem ents In




     Improvements: Streamlined repeat process & instrument schedules.
                                                                        Key Tools: VOC, Process Mapping, Time Study, Process Capacity analysis




26
                                                                                                                                                                                           12




                                                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                                                                                  0.1
                                                                                                                                                                                                                                                                                                                                                               0.2
                                                                                                                                                                                                                                                                                                                                                                                       0.3
                                                                                                                                                                                                                                                                                                                                                                                                                      0.4
                                                                                                                                                                                                                                                                                                                                                                                                                                                         0.5
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               0.6
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      0.7
                                                                                                                                                                                               /7
                                                                                                                                                                                                 /2                                                                                                                                                                                                                                                                                                                                                           0.8
                                                                                                                                                                                                    00
                                                                                                                                                                                          12           2
                                                                                                                                                                                             /1
                                                                                                                                                                                                4/
                                                                                                                                                                                                   20
                                                                                                                                                                                          12          02
                                                                                                                                                                                             /2
                                                                                                                                                                                                1/
                                                                                                                                                                                                   20
                                                                                                                                                                                                      02




                                                                                                                                                                                                                                                                                                                                                                                                                            LCL=0.43948
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             UCL=0.57569

                                                                                                                                                                                                                                                                                                                                                                                                                                                                        CEN=0.50759
                                                                                                                                                                                          12
                                                                                                                                                                                             /2
                                                                                                                                                                                                8/
                                                                                                                                                                                                   20
                                                                                                                                                                                                      02
                                                                                                                                                                                             1/
                                                                                                                                                                                                4/




                                                                                                                                             53
                                                                                                                                                                                                   20
                                                                                                                                                                                                      03
                                                                                                                                                                                           1/
                                                                                                                                                                                              13
                                                                                                                                                                                                  /2




                                                                                                                                             5/16/00
                                                                                                                                                                                                    00
                                                                                                                                                                                                       3
                                                                                                                                                                                           1/
                                                                                                                                                                                              20                                                                                                                                                         Release to Final TAT (Hrs)
                                                                                                                                                                                                  /2



                                                                                                                                                                                                                                                                                                                                           0
                                                                                                                                                                                                                                                                                                                                                         100
                                                                                                                                                                                                                                                                                                                                                                      200
                                                                                                                                                                                                                                                                                                                                                                                 300
                                                                                                                                                                                                                                                                                                                                                                                       400
                                                                                                                                                                                                                                                                                                                                                                                                       500
                                                                                                                                                                                                                                                                                                                                                                                                                600
                                                                                                                                                                                                                                                                                                                                                                                                                             700




                                                                                                                                                                                                    00
                                                                                                                                                                                                       3
                                                                                                                                                                                           1/
                                                                                                                                                                                                                                                                                                                                  5/1/02
                                                                                                                                                                                              27
                                                                                                                                                                                                                                                                                                                                  5/2/02
                                                                                                                                                                                                                                                                                                                                  5/3/02
                                                                                                                                                                                                                                                                                                                                  5/4/02
                                                                                                                                                                                                                                                                                                                                  5/5/02
                                                                                                                                                                                                 /2
                                                                                                                                                                                                                                                                                                                                  5/6/02
                                                                                                                                                                                                                                                                                                                                  5/7/02
                                                                                                                                                                                                                                                                                                                                  5/8/02
                                                                                                                                                                                                                                                                                                                                  5/9/02
                                                                                                                                                                                                    00
                                                                                                                                                                                                       3                                                                                                                         5/10/02
                                                                                                                                                                                                                                                                                                                                 5/11/02
                                                                                                                                                                                                                                                                                                                                 5/13/02
                                                                                                                                                                                                                                                                                                                                 5/14/02
                                                                                                                                                                                                                                                                                                                                 5/15/02
                                                                                                                                                                                                                                                                                                                                 5/16/02
                                                                                                                                                                                                                                                                                                                                 5/17/02
                                                                                                                                                                                                                                                                                                                                 5/18/02
                                                                                                                                                                                             2/
                                                                                                                                                                                                                                                                                                                                 5/20/02
                                                                                                                                                                                                                                                                                                                                 5/21/02
                                                                                                                                                                                                                                                                                                                                 5/22/02
                                                                                                                                                                                                3/
                                                                                                                                                                                                                                                                                                                                 5/23/02
                                                                                                                                                                                                                                                                                                                                 5/24/02
                                                                                                                                                                                                                                                                                                                                 5/25/02
                                                                                                                                                                                                   20
                                                                                                                                                                                                                                                                                                                                 5/27/02
                                                                                                                                                                                                                                                                                                                                 5/29/02
                                                                                                                                                                                                                                                                                                                                 5/30/02
                                                                                                                                                                                                                                                                                                                                 5/31/02
                                                                                                                                                                                                      03
                                                                                                                                                                                                                                                                                                                                  6/1/02
                                                                                                                                                                                                                                                                                                                                  6/3/02
                                                                                                                                                                                                                                                                                                                                  6/4/02
                                                                                                                                                                                                                                                                                                                                  6/5/02
                                                                                                                                                                                                                                                                                                                                  6/6/02
                                                                                                                                                                                           2/
                                                                                                                                                                                                                                                                                                                                  6/7/02
                                                                                                                                                                                                                                                                                                                                  6/8/02
                                                                                                                                                                                                                                                                                                                                 6/10/02
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            First Round of Workouts




                                                                                                                                                                                              10
                                                                                                                                                                                                                                                                                                                                 6/11/02
                                                                                                                                                                                                                                                                                                                                 6/12/02
                                                                                                                                                                                                                                                                                                                                 6/13/02
                                                                                                                                                                                                 /2
                                                                                                                                                                                                                                                                                                                                 6/14/02
                                                                                                                                                                                                                                                                                                                                 6/15/02
                                                                                                                                                                                                                                                                                                                                 6/17/02
                                                                                                                                                                                                    00
                                                                                                                                                                                                                                                                                                                                 6/18/02
                                                                                                                                                                                                                                                                                                                                 6/19/02
                                                                                                                                                                                                                                                                                                                                 6/20/02
                                                                                                                                                                                                       3
                                                                                                                                                                                                                                                                                                                                                                   LCL=0.22757




                                                                                                                                                                                                                                                                                                                                 6/21/02
                                                                                                                                                                                                                                                                                                                                                                                                             UCL=0.36237

                                                                                                                                                                                                                                                                                                                                                                                         CEN=0.29497




                                                                                                                                                                                                                                                                                                                                 6/22/02
                                                                                                                                                                                                                                                                                                                                 6/24/02
                                                                                                                                                                                                                                                                                                                                 6/25/02
                                                                                                                                                                                           2/
                                                                                                                                                                                                                                                                                                                                 6/26/02
                                                                                                                                                                                                                                                                                                                                 6/27/02
                                                                                                                                                                                                                                                                                                                                 6/28/02
                                                                                                                                                                                              17
                                                                                                                                                                                                                                                                                                                                 6/29/02
                                                                                                                                                                                                                                                                                                                                  7/1/02
                                                                                                                                                                                                                                                                                                                                  7/2/02
                                                                                                                                                                                                 /2                                                                                                                               7/3/02
                                                                                                                                                                                                                                                                                                                                  7/4/02
                                                                                                                                                                                                                                                                                                                                  7/5/02
                                                                                                                                                                                                                                                                                                                                  7/6/02
                                                                                                                                                                                                    00
                                                                                                                                                                                                                                                                                                                                  7/8/02
                                                                                                                                                                                                       3                                                                                                                          7/9/02
                                                                                                                                                                                                                                                                                                                                 7/10/02
                                                                                                                                                                                                                                                                                                                    Setup Date




                                                                                                                                                                                                                                                                                                                                 7/11/02
                                                                                                                                                                                                                                                                                                                                 7/12/02
                                                                                                                                                                                                                                                                                                                                 7/13/02
                                                                                                                                                                                                                                                                                                                                 7/15/02
                                                                                                                                                                                           2/
                                                                                                                                                                                                                                                                                                                                 7/16/02
                                                                                                                                                                                                                                                                                                                                 7/17/02
                                                                                                                                                                                                                                                                                                                                 7/18/02
                                                                                                                                                                                              24
                                                                                                                                                                                                                                                                                                                                 7/19/02
                                                                                                                                                                                                                                                                                                                                 7/20/02
                                                                                                                                                                                                 /2                                                                                                                              7/21/02
                                                                                                                                                                                                                                                                                                                                 7/22/02
                                                                                                                                                                                                                                                                                                                                 7/23/02
                                                                                                                                                                                                                                                                                                                                 7/24/02
                                                                                                                                                                                                    00
                                                                                                                                                                                                                                                                                                                                 7/25/02
                                                                                                                                                                                                                                                                                                                                                                                                                                          Target Cycle Time 168 Hours




                                                                                                                                                                                                                                                                                                                                 7/26/02
                                                                                                                                                                                                                                                                                                                                 7/27/02
                                                                                                                                                                                                       3                                                                                                                         7/29/02
                                                                                                                                                                                                                                                                                                                                 7/30/02
                                                                                                                                                                                                                                                                                                                                 7/31/02
                                                                                                                                                                                                                                                                                                                                  8/1/02
                                                                                                                                                                                                                                                                                                                                  8/2/02
                                                                                                                                                                                                                                                                                                                                  8/3/02
                                                                                                                                                                                             3/
                                                                                                                                                                                                                                                                                                                                  8/4/02
                                                                                                                                                                                                                                                                                                                                  8/5/02
                                                                                                                                                                                                                                                                                                                                                                                                                                                                             HIV Genotype Assay Cycle Time




                                                                                                                                                                                                                                                                                                                                  8/6/02
                                                                                                                                                                                                2/
                                                                                                                                                                                                                                                                                                                                  8/7/02
                                                                                                                                                                                                                                                                                                                                  8/8/02
                                                                                                                                                                                                                                                                                                                                  8/9/02
                                                                                                                                                                                                   20
                                                                                                                                                                                                                                                                                                                                 8/10/02
                                                                                                                                                                                                                                                                                                                                 8/11/02
                                                                                                                                                                                                                                                                                                                                 8/12/02
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Human Contact in the Laboratory




                                                                                                                                                                                                                                                                                                                                 8/13/02
                                                                                                                                                                                                      03
                                                                                                                                                                                                                                                                                                                                 8/14/02
                                                                                                                                                                                                                                                                                                                                 8/15/02
                                                                                                                                                                                                                                                                                                                                 8/16/02
                                                                                                                                                                                                                                                                                                                                 8/17/02
                                                                                                                                                                                                                                                                                                                                 8/18/02
                                                                                                                                                                                                                                                                                                                                 8/19/02
                                                                                                                                                                                             3/
                                                                                                                                                                                                                                                                                                                                 8/20/02
                                                                                                                                                                                                                                                                                                                                 8/21/02
                                                                                                                                                                                                                                                                                                                                       *
                                                                                                                                                                                                9/
                                                                                                                                                                                                   20
                                                                                                                                                                                                                                                                                                                                                                                                                           Place




                                                                                                                                                                                                      03
                                                                                                                                                                                                                                                                                                                                                                                                                           Process




                                                                                                                                                                                           3/
                                                                                                                                                                                              16
                                                                                                                                                            Implementing IT automation for reviews and reporting




                                                                                                                                                                                                 /2
                                                                                                                                                                                                    00
                                                                                                                                                                                           3/          3
                                                                                                                                                                                              23
                                                                                                                                                       Key Learnings: streamline repeat process, instrument schedules,




                                                                                                                                                                                                  /2
                                                                                                                                                                                                                                                                                                                                                                                                                           Improvements In




                                                                                                                                                                                                    00
                                                                                                                                                                                                       3
                                                                                                                                                                                                                         Key Tools: VOC, Process Mapping, Time Study, Process Capacity analysis




                                                                                                                                                                                           3/
                                                                                                                                                                                              30
                                                                                                                                                                                                  /2
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Second Round of Workouts




                                                                                                                                                                                                    00
                                                                                                                                                                                                       3
                                                                                                                                                                                                                                                                                                      LCL=0.05409
                                                                                                                                                                                                                                                                                                                                                               UCL=0.18202

                                                                                                                                                                                                                                                                                                                                           CEN=0.11806




               LIS, dedicated staff for answering the phone.


                                                                                                                                                                                             4/
                                                                                                                                                                                                6/
                                                                                                                                                                                                   20
                                                                                                                                                                                                      03
                                                                                                                                                                                           4/
                                                                                                                                                                                              13
                                                                                                                                                                                                 /2
                                                                                                                                                                                                    00
                                                                                                                                                                                           4/          3
                                                                                                                                                                                              20
                                                                                                                                                                                                 /2
                                                                                                                                                                                                    00
                                                                                                                                                                                                       3
                                                                             Key Tools: VOC, created a reliable measure and display system




                                                                                                                                                                                           4/
                                                                                                                                                                                              27
                                                                                                                                                                                                 /2
                                                                                                                                                                                                    00
                                                                                                                                                                                                       3
     Improvements: wireless head-sets, accurate contact information in the



27
       What are the Overall Benefits?
                                      BENEFITS




             ISO Implemented




                                              Six Sigma
       ISO




             Customer Satisfaction

                                                          Savings



1997         1998              1999    2000               2001      2002   2003


                                                                                  28
  QUALITY EVOLUTION

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


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



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


  *wide use by clinical lab industry!

                                        29
             STAGES OF QUALITY
NCCLS 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.




                                                                         30
               JURAN AND NCCLS
            JURAN                       NCCLS GP26
Strategic Quality Management   Total Quality Management
                               Quality Improvement

Operational Quality            Quality System
Management                     Quality Assurance

Work Force Quality Control     Quality Control




                                                          31
                    STAGES OF QUALITY
    NCCLS 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
   SIX SIGMA                                             improvements and cost savings
Quality System         New                               “Comprehensive and Coordinated”
                                                         system to meet quality objectives


                                              ISO 9001
Quality Assurance                 ISO 15189              Organized activities to provide
                                                         “Confidence” that the organization
                                                         meets requirements for quality
                       CLIA/CAP




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




                                                                                                 32
                          ISO 9001 - 2000 Revision
                             Quality Management System
                                      (Clause 4)
CUSTOMER REQUIREMENTS




                                                                                       CUSTOMER SATISFACTION
                                 Management Responsibility
                                        (Clause 5)

                                                                           Plan -
                                   Resource Management                  Do - Check -
                                        (Clause 6)                           Act


                        Design      Service Realization    Purchasing
                                        (Clause 7)
                          Input          Process          Output



                        Measurement, Analysis & Improvement
                                     (Clause 8)


                            ISO 15189 does not develop these aspects
                                                                                                       33
                  Document Management


 Document Structure


            Policies        What to do
                       A
  CLIA/CAP & ISO 15189 DO NOT DEVELOP THIS LEVEL
     Processes                   How it Happens
                       B


Procedures              C              How to do it

Records                 D        Evidence of Compliance
          CLIA/CAP   ISO 15189    ISO 9001
                                                      34
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?




                                               35
Thank You for Your
Time and Attention

   Questions?




                     36

								
To top