Speaker Contact info

40
The Use Of Systems Engineering Tools To Improve Processes in Healthcare: Six Sigma and Lean Improvement Methodologies as they Apply to Healthcare

description

The Use Of Systems Engineering Tools To Improve Processes in Healthcare: Six Sigma and Lean Improvement Methodologies as they Apply to Healthcare. Speaker Contact info. Muhanad Hirzallah Quality Improvement Black Belt Quality Management Services Mayo Clinic 200 First St. SW - PowerPoint PPT Presentation

Transcript of Speaker Contact info

  • The Use Of Systems Engineering Tools To Improve Processes in Healthcare:

    Six Sigma and Lean Improvement Methodologies as they Apply to Healthcare

    DMAIC

    Speaker Contact infoMuhanad Hirzallah Quality Improvement Black Belt Quality Management ServicesMayo Clinic200 First St. SWRochester, MN, USA(507) 266-3216 (phone)(507) 255-9689 (fax)[email protected]

    DMAIC

    Engineering the Healthcare System

    DMAIC

    Mayo Clinics Quality ExperienceProcess Improvement Section within the Quality Management Services Department

    The Quality Academy: now part of Mayo Clinic College of Medicine.

    Mayo Clinics System Wide Initiatives: IRB review cycle time

    DMAIC

    The IRB experienceUnder federal regulations, an Institutional Review Board (IRB) is a constituted group formally designated to review and monitor research involving human subjects.

    Its work must comply with the Federal Wide assurance agreement with the government in order to receive federal funding for research.

    Delays in making a decision may result in loss of funding and delays in patients being offered access to potential new treatments.

    DMAIC

    Problem & GoalThe IRB turnaround time for protocol review has been identified as a source of dissatisfaction by the researchers and the IRB Staff.

    On average, the review of protocols took 38 days. The customers expect a more predictable and timely turnaround.

    The goal is to reduce the protocol turnaround time to no more than 21 days, while maintaining the IRB responsibility to uphold the regulations.

    DMAIC

    Team members:

    Project Sponsor : Chair, Research AdministrationProcess Owner : IRB Medical Director Core Team: IRB AdministratorMeasurement Coordinator/ IRB Operations ManagerProject ManagerProcess Improvement Expert

    DMAIC

    ResultsMetrics: BeforeAfterAverage Cycle time 38d16d- 21 days compliance27%83% For new submissionFull board

    Average CT (w/out PI)31d11d- 21 days compliance38%100% For new submissionFull board

    DMAIC

    DMAIC Methodology

    DMAIC

    Project CharterAn explanation for the projectGoals and desired results in measurable termsProject plan and milestonesRoles and responsibilities

    DMAIC

    Survey ofInvestigators

    DMAIC

    Potential Impact for the CustomerPatients / ParticipantsGreater access to clinical trialsInvestigatorImproved satisfactionIndustryImproved satisfactionIRBEnhanced complianceImproved MoraleFederal AgenciesEnhanced compliance

    DMAIC

    High Level Process Mapping

    CS-IRB

    IRB Process Improvement Project

    Customer Satisfaction Survey

    This survey is designed to measure your satisfaction with few aspects of the services provided by the IRB department

    For questions 1-9, please choose from the following:

    1: Very Unsatisfied (VU)4: Satisfied (S)

    2: Unsatisfied (U)5: Very Satisfied (VS)

    3: Neutral / Neither satisfied or unsatisfied (N)

    Please feel free to add any comments on the back.

    CharacteristicsRating

    12345

    VUUNSVS

    1IRB training12345

    2Clarity of the IRB function and approval process12345

    3Expertise of the IRB staff (IRB specialists)12345

    4Responsiveness, Open Communications and Interactions of the IRB staff12345

    5Quality of the IRB approval process12345

    6Speed of the IRB approval process12345

    7Consistency of the IRB approval process12345

    8Overall satisfaction with the IRB approval process12345

    9How many submissions did you have to do of the last protocol (same protocol)12 to 56 to 10> 10

    10How long did it take to approve your last protocol (including the several submissions of the same protocol)less than 14 days15-21 days22-28 days29-35 days> 35 days

    11Was your last protocol a minimum risk OR greater than minimum riskminimum riskgreater than minimum risk

    12How many protocols have you submitted in the last year12 to 56 to 10> 10

    13How long did it take to approve your protocols (on average) for eachless than 14 days15-21 days22-28 days> 28 days

    14If you could think of one change that you would most like the improvement team to ensure is included in their process improvement plan, what would that be and why?

    15If you could think of one aspect of the IRB process as it exists presently that you would NOT want to have changed as this project is undertaken, what would that one aspect be and why?

    Thank you for your support of the IRB process improvement project. Your input will be given strong consideration as the team embarks on identification of issues and opportunities.

    Please return to: Muhanad Hirzallah, Quality Management Office, Mayo Clinic Rochester, MN 55905 OR fax to 507-266-6806 on / or before August 24, 2006.

    CS-IRB (2)

    CharacteristicsCustomers

    Federal GovermentPrincipal Investigators / Research TeamPatients / ParticipantsSponsors

    1IRB trainingX

    2Clarity of the IRB function and approval processXX

    3Expertise of the IRB staff (IRB specialists)XX

    4Responsiveness, Open Communications and Interactions of the IRB staffX

    5Quality of the IRB approval processXXXX

    6Speed of the IRB approval processXXX

    7Consistency of the IRB approval processXX

    8Human Subjects ProtectionXXXX

    Research Team submits protocol

    IRB Intake person assigns a board

    IRB Specialist reviews protocol & assign reviewer

    IRB meets/ discusses/ decides

    IRB Board member reviews protocol

    IRB specialist communicates decision

    DMAIC

    Measure

    DMAIC

    Value Stream Mapping ToolExamine the flow of information and workLocate the largest sources of wasteEnvision a less wasteful stateDevelop plans for future activities

    DMAIC

    Current State Value Stream MapHigh Error Rate in processing detected after 5 daysRework on submissions take about 6 days2-week Board Cycle means waiting time of at least 10-14 daysMinute Excerpts take about 5 days to go out to PIsBoard capacity not well defined, leads to inequitable distributionDouble layer intake results in redundancy

    DMAIC

    Results of the Current State Value Stream Map:

    DMAIC

    Chart5

    0.55

    7

    31

    Sheet1

    VA0.55

    NVA - E7

    NVA31

    Sheet1

    0

    0

    0

    Sheet2

    Sheet3

    DMAIC

    IRB Wastes

    DMAIC

    Data Collection# of IRB submissions# of submission outside the 21d target.Time to process a new submissionErrors

    DMAIC

    Analyze

    DMAIC

    Analysis for New SubmissionsWorking d/yr = 365 - weekends- PTO= 230 d/ yrAnnual Demand of new full protocols for yr 2005 = 345Daily Demand = 345/230= 1.5 protocols/dayWork time a day = (8 hrs X 60 min) (2 X 15 min Breaks) = 450 minutes

    DMAIC

    Takt* = ( 450 min/ day) / (1.5 protocols/ day) = 300 min/ protocolVariation adjusted Takt = (.85)X(300)= 255 min

    *The pace (German)

    Analysis for New Submissions

    DMAIC

    Operator Chart

    Chart5

    110

    61.3

    60

    Time

    CURRENT

    2 days5.3 days6 days2.7 days2.7 days5.3 days

    25-40 min35-63 min5-10 min1-2 min11.3 min15 - 30 min

    W: 7 daysWait 7 days

    P/T 77.1 - 89.1

    Total Wait Time: 38

    Total Process Time: 169.4 - 245.4 min

    0.38 - 0.55 days

    Total Lead Time (Turnaround): 38.38 - 38.55 days

    Value Added Ratio: 1% - 1.43%

    FUTURE

    Future state Map

    IRB - Process

    Principal Investigators

    FIFOFIFO

    7 days

    60 min11.3 min85.5 min22.5 min

    Total Wait:7 days

    Total Processing:178.3 min/ 0.4 days

    Total Turnaround Time:7.4 days

    Value added ratio:5.40%

    P/T=37-83 (60 ave)C/T=37-83 (60 ave)Uptime (U/T)=98%First Pass Yield=95%# of shifts=1Available Time=450 min/day# of Staff =5

    Review Protocol Prior to meeting-------------------IRB specialist

    P/T=11.3C/T=11.3Uptime (U/T)=98%First Pass Yield=99%# of shifts=1Available Time=450# of Staff =1

    Prepare agenda-------------------Administrative Assistant

    P/T=C/T=76-95 (85.5 ave)Uptime (U/T)=First Pass Yield=# of shifts=Available Time=# of Staff =

    Scientific Reviews + IRB Board Meeting and Decision Making

    P/T=15-30 (22.5 ave)C/T=15-30 (22.5 ave)Uptime (U/T)=98%First Pass Yield=# of shifts=Available Time=# of Staff =5 Specialists + 1 AA

    Inform PI and Communicate DecisionsSpecialist + AA

    0

    Standardize + waste elimination

    Standardize + waste elimination

    Error reduction/ knowledge management / Training

    Meeting Times Re-structure

    PDC Format & Improvement

    Communication Plan

    Operator Charts

    40

    63

    10

    2

    11.3

    5

    20

    30

    60

    Un-Utilized Capacity

    Max Time

    Process Steps

    Max Time needed

    Collective

    110

    61.3

    60

    Operator Chart

    ProcessresponsibilityMax Time

    Step 1I40

    Step 2S63

    Step 3S10

    Step 4S2

    Step 5A11.3

    Step 6S5

    Step 7A20

    Step 8A & S30

    Step 9R60

    FunctionTime

    Specialist110

    Assistant61.3

    Reviewer60

    Operator Chart

    0

    0

    0

    Time

    Untilized Capacity

    MBD00006A30.vsd

    XYZ Corp.

    C/T =45 sec.

    C/O =30 min.

    3 shifts

    2 % scrap

    C/T = C/O = Uptime = % sec. availEPE = # operators

    process name

    detail

    Production Control

    MRP

    I

    quantitydescription

    Weekly Schedule

    double clickto type indetail info

    outside sources

    Company Name

    Double-click here and type notes.

    OXOX

    Title

    Double-click to type notes.Subselect "Title" to edit the title.

    Company Name

    Double-click to type notes. Subselect "CompanyName" to edit the title.

    Company Name

    new!

    Tasks

    Text

    Title

    Text

    1

    Drag the side handles to change the width of the text block.

    Title

    Info

    Principal InvestigatorsResearch ParticipantsSponsors (funding Agencies)Regulatory

    8

    P/T = 25 40 minC/T = 25 40 min# of Staff: 1First Pass Yield: 20%Errors from upstream 90%Batch Size = 1Uptime = 98%Unit of Work = 1 Protocol

    Intake Person

    Review Protocol for completeness and assign board

    3

    P/T = 35-63 minC/T = 35-63 min# of Staff: 5First Pass Yield: 95%Errors from upstream 80%Batch Size = 1Uptime = 98%Unit of Work = 1 Protocol

    IRB Specialist

    Review Protocol and address questions (if any)

    9

    P/T = 5-10 minC/T = 5-10 min# of Staff: 5First Pass Yield: 95%Errors from upstream 50%Batch Size = 1Uptime = 98%Unit of Work = 1 ProtocolWAIT: 7 days

    IRB Specialist

    Receive answers and re-Review Protocol

    4

    P/T = 1-2 minC/T = 1-2 min# of Staff: 5First Pass Yield: 99%Errors from upstream 0%Batch Size = 1Uptime = 98%Unit of Work = 1 Protocol

    IRB Specialist

    Assign protocol to reviewer and put on agenda

    4

    P/T = 3 hoursC/T = 11.3 min# of Staff: 5First Pass Yield: 99%Errors from upstream 1%Batch Size = 34Uptime = 98%Unit of Work = 1 Protocol

    Admin Assistant

    Prepare agenda

    12

    P/T =160 minC/T = 4.1 min# of Staff: 9First Pass Yield: ?Errors from upstream ?Batch Size = 39Uptime = 100%Unit of Work = 1 Protocol

    IRB Board

    Meet and Discuss

    8

    P/T = 1 hours?C/T = 60 min# of Staff: 3First Pass Yield: 99%Errors from upstream 1%Batch Size = 1Uptime = 100%Unit of Work = 1 Protocol

    Scientific Reviewer

    Review Protocol

    12

    C/T = 3-5 minC/T = 3-5 min# of Staff: 5First Pass Yield: 98%Errors from upstream 2%Batch Size =1Uptime = 98%Unit of Work = 1 Protocol

    IRB Specialist

    Create a draft minute

    12

    C/T = 10-20 minC/T = 10-20 min# of Staff: 5First Pass Yield: 95%Errors from upstream 2%Batch Size =1Uptime = 98%Unit of Work = 1 Protocol

    Admin Assistant

    Prepare Minute

    P/T =15-30 minC/T = 15-30 min# of Staff: 10 (5/5)First Pass Yield: 95%Errors from upstream 1%Batch Size = 1Uptime = 98%Unit of Work = 1 Protocol

    IRB Specialist & Admin Assistant

    Finalize Minute, consent form and inform PI

    Performing Labs DLMP LabsLab ConsultantsExternal Labs (Clinical Trials)

    LAB3

    P/T = C/T = Batch Size = C/O = Uptime = %Intro errors = %Inh errors = .%Unit of Work =

    Total Wait time =

    Total Process Time =

    Total Lead Time (Turnaround) =

    Last Update:

    Sponsor:

    Administrator:

    V.S. Manager:

    PatientsClients

    Project Title

    Date:

    Sponsor:

    Administrator:

    V.S. Manager:

    1

    DMAIC

    Analyze PhaseIntake person has a very low yield (i.e. quality) IRB has more capacity than the demandRCA for errors required.

    Conclusion: Opportunities for improvement

    DMAIC

    Improve

    DMAIC

    Brainstorm ImprovementsEliminate the Intake function IRB Specialist reviews 1st Standardize work elements.Mistake proofing to reduce errors.Communicate with the Research audienceContinuously improveSeek feedback from customersAnalyze data

    DMAIC

    Standardize + waste eliminationEnhanced board functioningFuture State mapError reduction/ knowledge management/ trainingCommunication planPDC format improvement

    DMAIC

    Future State map results

    DMAIC

    Chart6

    0.4

    7

    0

    Sheet1

    VA0.4

    NVA - E7

    NVA0

    Sheet1

    0

    0

    0

    Sheet2

    Sheet3

    DMAIC

    Validate Improvement Compliance

    Compliance Chart

    0.27Baseline

    0.29/25 - 9/29

    0.12510/2 - 10/6

    0.545454545510/9 - 10/13

    0.2510/16 - 10/20

    0.555555555610/23 - 10/27

    0.610/30 - 11/3

    0.333333333311/6 - 11/10

    0.555555555611/13 - 11/17

    Improvement

    Improvement

    Improvement

    Baseline

    Baseline

    New Protocol (full-Board)

    Time period

    Compliance

    IRB Targets Compliance Chart

    Chart2

    0.270.690.690.270.95

    0.20.87234042550.690.270.95

    0.1250.85714285710.690.270.95

    0.54545454550.85294117650.690.270.95

    0.250.89285714290.690.270.95

    0.55555555560.91666666670.690.270.95

    0.60.83333333330.690.270.95

    0.33333333330.8478260870.690.270.95

    0.55555555560.86486486490.690.270.95

    11/20 - 11/240.88636363640.690.270.95

    New Protocol (full-Board)

    Expedited (A&B)

    Baseline Exp

    Baseline New Full

    Target

    Time Periods

    compliance

    Compliance Chart

    ChartIIE

    0.27

    0.2

    0.125

    0.5454545455

    0.25

    0.5555555556

    0.6

    0.3333333333

    0.5555555556

    0.71

    0.75

    0.83

    Improvement

    Compliance

    Time

    Percentage

    Improvement over time

    Sheet1

    New ProtocolsModificationsExpedited A&B

    Tine periodNew Protocol (full-Board)Total ## CompliedTotal ## CompliedTotal ## Complied

    Baseline27.00%

    9/25 - 9/2920.00%514741

    10/2 - 10/612.50%813530

    10/9 - 10/1354.55%1163429

    10/16 - 10/2025.00%825650

    10/23 - 10/2755.56%953633

    10/30 - 11/360.00%533630

    11/6 - 11/1033.33%1244639

    11/13 - 11/1755.56%953732

    4439

    3/19-3/2371.00%

    3/26-3/3075.00%

    4/2 - 4/683.00%

    Sheet2

    Sheet3

    DMAIC

    Validate Improvements Error Frequency

    Errors Frequency

    3020155

    9204

    2000

    7030

    6254

    1317318

    0203

    0553

    0360

    67516527

    9/27 - 10/6

    10/6 - 10/27

    10/30 - 11/13

    11/13 - 12/6

    Type

    Frequency

    Errors Frequency

    Error Percentage

    0.4477611940.39215686270.23076923080.1851851852

    0.13432835820.039215686300.1481481481

    0.0298507463000

    0.104477611900.04615384620

    0.08955223880.03921568630.07692307690.1481481481

    0.19402985070.33333333330.47692307690.2962962963

    00.039215686300.1111111111

    00.09803921570.07692307690.1111111111

    00.05882352940.09230769230

    9/27 - 10/6

    10/6 - 10/27

    10/30 - 11/13

    11/13 - 12/6

    Type

    Percentage

    Errors percentage over time

    Erros Bars

    3020155

    9204

    2000

    7030

    6254

    1317318

    0203

    0553

    0360

    9/27 - 10/6

    10/6 - 10/27

    10/30 - 11/13

    11/13 - 12/6

    Type of Error

    Frequency

    Error Frequency over time

    Submission Problem Collection

    DatesApplication/ Information ClarityAdim /Clerical ProblemsSponsor ProblemsMulti Site ProblemsIRBe ProblemsConsent Form ProblemsFDA ProblemsBudget ProblemsSub Committee ProblemsTotaldaysDatesApplication/ Information ClarityAdim /Clerical ProblemsSponsor ProblemsMulti Site ProblemsIRBe ProblemsConsent Form ProblemsFDA ProblemsBudget ProblemsSub Committee ProblemsTotal

    9/27 - 10/6309276130006799/27 - 10/63.331.000.220.780.671.440.000.000.007.44

    10/6 - 10/2720200217253512110/6 - 10/270.950.100.000.000.100.810.100.240.142.43

    10/30 - 11/1315003531056651410/30 - 11/131.070.000.000.210.362.210.000.360.434.64

    11/13 - 12/6540048330272411/13 - 12/60.210.170.000.000.170.330.130.130.001.13

    DatesApplication /Information ClarityAdim /Clerical ProblemsSponsor ProblemsMulti Site ProblemsIRBe ProblemsConsent Form ProblemsFDA ProblemsBudget ProblemsSub Committee ProblemsDatesApplication /Information ClarityAdim /Clerical ProblemsSponsor ProblemsMulti Site ProblemsIRBe ProblemsConsent Form ProblemsFDA ProblemsBudget ProblemsSub Committee Problems

    9/27 - 10/644.78%13.43%2.99%10.45%8.96%19.40%0.00%0.00%0.00%9/27 - 10/644.78%13.43%2.99%10.45%8.96%19.40%0.00%0.00%0.00%

    10/6 - 10/2739.22%3.92%0.00%0.00%3.92%33.33%3.92%9.80%5.88%10/6 - 10/2739.22%3.92%0.00%0.00%3.92%33.33%3.92%9.80%5.88%

    10/30 - 11/1323.08%0.00%0.00%4.62%7.69%47.69%0.00%7.69%9.23%10/30 - 11/1323.08%0.00%0.00%4.62%7.69%47.69%0.00%7.69%9.23%

    11/13 - 12/618.52%14.81%0.00%0.00%14.81%29.63%11.11%11.11%0.00%11/13 - 12/618.52%14.81%0.00%0.00%14.81%29.63%11.11%11.11%0.00%

    141.79%0.00%0.00%0.00%0.00%60.96%0.00%0.00%0.00%

    &C&"Arial,Bold Italic"&12New Protocol Submission Problem Collection Main Category

    Application Sub Category

    Missing ProtocolStudy Design QuestionsClarify Enrollment NumbersContact Materials (wrong version, missing, clarification)Study Title different title on various formsClarify inclusion/exclusion criteriaClarification how pts. Will be identified/recruitedClarification renumeration/reimbursementClarify where data speciments are coming from (write in)Protocol/CF/Budget do not match Expedited Missing CFNeed DSMP/DSMB Charter

    9/27 - 10/641510113131

    10/6 - 10/272222

    10/30 - 11/13353111115

    11/13 - 12/0611114

    &C&"Arial,Bold Italic"&12Application/Information Clarity: Sub-Category

    Application Sub Category

    0

    0

    0

    0

    0

    0

    0

    0

    0

    0

    Sheet11

    Sheet10

    Sheet9

    Sheet8

    Sheet7

    Budget Problems

    Need revised budget to reflect studyNIH Grant Information

    9/27 - 10/06

    10/06 - 10/2741

    10/30 - 11/1341

    11/13 - 12/063

    FDA Problems

    Response to FDA concerns neededIND/FDA letter questions (missing, incorrect letter)

    9/27 - 10/61

    10/6 - 10/2711

    11/13 - 12/063

    &C&"Arial,Bold Italic"&12FDA Problem: Sub-Category

    FDA Problems

    0

    0

    Sub-Committee Problems

    Need detp. Approval minute excerptEnrollment of pregranet women Ob-Gyn approval clarificationQuestions related to Biospecimens Sub-Committee minutesNeed PI's response to Dept. concerns

    9/27 - 10/61

    10/6 - 10/273

    &C&"Arial,Bold Italic"&12Sub-Committee Problems: Sub Category

    Sub-Committee Problems

    0

    0

    0

    0

    IRBe Problems

    IRBe attachments illegible - need to re-sendIRB questions response errorsWaiver questionsContact Information

    9/27 - 10/6

    10/6 - 10/2655313

    10/30 - 11/135

    11/13 - 12/06224

    Outside Gov. Agency Problems

    9/27 - 10/6

    10/6 - 10/26

    Consent Form Problems

    9/27 - 10/6Expedited Missing CFOthers

    10/6 - 10/27116

    10/30 - 11/13130

    Multi Site Problems

    Need to add/remove MCA site documents (Res Comm approval, bud)

    9/27 - 10/6

    10/6 - 10/27

    10/30 - 11/133

    Sponsor Problems

    Sponsor Correspondance / memos missingOuestions on protocol forms with patient identifiers

    9/27 - 10/6

    10/6 - 10/27

    AdministrativeClerical Problems

    Expired Progress ReportsStudy Personel listed w/o COI board reviewFDA personnel problems (blank-illegible, names do not match)

    9/25 - 10/69

    10/6 - 10/272

    10/30 - 11/13

    &C&"Arial,Bold Italic"&12Administrative/Clerical Problems: Sub-Category

    AdministrativeClerical Problems

    0

    0

    0

    DMAIC

    Pareto Chart for Errors

    DMAIC

    Average Days Turnaround of New Full Board Protocols

    Chart1

    31

    23

    16

    11

    Period

    Days

    Average Turnaround Time (without PI delay)

    Sheet1

    Baseline31

    Sept /Oct 0623

    Nov. 0616

    Apr. 0711

    Sheet2

    Sheet3

    DMAIC

    Control

    DMAIC

    Control Charts

    March_2007_NEWMinRisk

    Protocol IDStatusParent CommitteePI Delay (DAYS)IRB Delay (DAYS)UCLLCLCLUSLCompliance

    07-001935ActiveExpedited Review A0.001.931606140

    07-001573ActiveExpedited Review A0.000.971606140

    07-001955ActiveExpedited Review A0.006.821606140

    07-002326ActiveExpedited Review A1.1712.731606140

    07-002470ActiveExpedited Review A0.016.751606140

    07-002508ActiveExpedited Review A0.006.671606140

    07-002358ActiveExpedited Review A0.006.621606140

    07-000195ActiveExpedited Review B0.0026.941606141

    07-001875ActiveExpedited Review B0.005.091606140

    07-000349ActiveExpedited Review B34.8712.131606140

    07-001554ActiveExpedited Review B0.004.921606140

    07-001937ActiveExpedited Review B0.004.041606140

    06-004969ActiveExpedited Review B0.003.931606140

    07-001271ActiveExpedited Review B0.003.891606140

    07-001569ActiveExpedited Review B0.003.041606140

    07-001821ActiveExpedited Review B0.002.151606140

    07-001945ActiveExpedited Review B0.158.551606140

    07-000900ActiveExpedited Review B0.011.261606140

    07-001916ActiveExpedited Review B0.008.291606140

    07-001946ActiveExpedited Review B2.1413.771606140

    07-001759ActiveExpedited Review B0.007.981606140

    07-001871ActiveExpedited Review B0.007.951606140

    07-001972ActiveExpedited Review B0.007.851606140

    07-001982ActiveExpedited Review B0.007.711606140

    07-001602ActiveExpedited Review B0.007.721606140

    07-001809ActiveExpedited Review B0.0816.151606141

    07-001166ActiveExpedited Review B3.134.001606140

    07-001998ActiveExpedited Review B0.006.981606140

    07-001996ActiveExpedited Review B0.006.951606140

    07-001852ActiveExpedited Review B0.006.951606140

    07-002003ActiveExpedited Review B0.006.851606140

    07-002012ActiveExpedited Review B0.006.141606140

    06-005275ActiveExpedited Review B3.083.061606140

    07-001983ActiveExpedited Review B0.006.181606140

    07-001851ActiveExpedited Review B0.176.031606140

    07-002006ActiveExpedited Review B0.006.061606140

    07-002031ActiveExpedited Review B0.006.051606140

    07-002032ActiveExpedited Review B0.006.001606140

    07-002043ActiveExpedited Review B0.006.001606140

    06-008803ActiveExpedited Review B0.025.991606140

    07-002044ActiveExpedited Review B6.666.231606140

    07-001330ActiveExpedited Review B0.005.951606140

    07-001971ActiveExpedited Review B4.198.661606140

    07-001931ActiveExpedited Review B0.005.131606140

    07-002011ActiveExpedited Review B5.040.061606140

    07-002082ActiveExpedited Review B1.373.661606140

    07-000739ActiveExpedited Review B0.005.041606140

    07-002088ActiveExpedited Review B0.004.941606140

    07-002114ActiveExpedited Review B0.004.041606140

    07-002127ActiveExpedited Review B0.003.931606140

    07-002125ActiveExpedited Review B1.402.541606140

    07-001999ActiveExpedited Review B0.000.981606140

    07-002074ActiveExpedited Review B20.248.641606140

    07-002137ActiveExpedited Review B0.007.751606140

    07-002159ActiveExpedited Review B0.007.641606140

    07-002158ActiveExpedited Review B0.007.271606140

    07-002165ActiveExpedited Review B0.007.171606140

    07-002185ActiveExpedited Review B0.016.891606140

    07-002073ActiveExpedited Review B0.026.901606140

    07-002144ActiveExpedited Review B0.006.871606140

    07-002208ActiveExpedited Review B0.006.001606140

    07-002209ActiveExpedited Review B0.005.991606140

    07-002076ActiveExpedited Review B0.005.951606140

    07-002215ActiveExpedited Review B0.005.911606140

    07-001966ActiveExpedited Review B0.015.911606140

    07-002222ActiveExpedited Review B0.005.131606140

    06-005796ActiveExpedited Review B7.684.481606140

    07-001700ActiveExpedited Review B0.7411.431606140

    07-002228ActiveExpedited Review B0.005.101606140

    07-002149ActiveExpedited Review B0.005.021606140

    07-002236ActiveExpedited Review B0.005.001606140

    07-002241ActiveExpedited Review B22.573.381606140

    06-006695ActiveExpedited Review B0.004.851606140

    07-002257ActiveExpedited Review B0.004.121606140

    07-002262ActiveExpedited Review B0.4410.551606140

    07-000085ActiveExpedited Review B0.003.961606140

    07-001911ActiveExpedited Review B0.0210.811606140

    07-002249ActiveExpedited Review B0.129.961606140

    07-002278ActiveExpedited Review B5.8410.331606140

    07-002283ActiveExpedited Review B0.001.791606140

    07-002284ActiveExpedited Review B0.001.771606140

    07-002247ActiveExpedited Review B4.9010.781606140

    07-002266ActiveExpedited Review B0.001.141606140

    06-006983ActiveExpedited Review B13.198.741606140

    07-002304ActiveExpedited Review B0.008.061606140

    07-002308ActiveExpedited Review B0.007.861606140

    07-002313ActiveExpedited Review B0.007.871606140

    07-002255ActiveExpedited Review B0.007.181606140

    07-002270ActiveExpedited Review B0.006.101606140

    07-002368ActiveExpedited Review B0.035.951606140

    07-002382ActiveExpedited Review B0.060.891606140

    07-002379ActiveExpedited Review B1.044.721606140

    07-002385ActiveExpedited Review B0.005.671606140

    07-002392ActiveExpedited Review B0.005.191606140

    07-002396ActiveExpedited Review B0.005.171606140

    07-002397ActiveExpedited Review B0.005.191606140

    07-002398ActiveExpedited Review B0.005.171606140

    07-002389ActiveExpedited Review B0.005.131606140

    07-002400ActiveExpedited Review B0.005.121606140

    07-002401ActiveExpedited Review B0.005.111606140

    07-001586ActiveExpedited Review B0.005.011606140

    07-002345ActiveExpedited Review B0.000.771606140

    07-002423ActiveExpedited Review B0.004.191606140

    07-002408ActiveExpedited Review B0.004.211606140

    07-002038ActiveExpedited Review B0.004.961606140

    07-002436ActiveExpedited Review B0.0810.841606140

    07-002441ActiveExpedited Review B0.0010.041606140

    07-002234ActiveExpedited Review B0.019.231606140

    07-002439ActiveExpedited Review B0.008.811606140

    07-002435ActiveExpedited Review B0.009.011606140

    07-002135ActiveExpedited Review B0.008.081606140

    07-002455ActiveExpedited Review B0.7616.061606141

    07-002459ActiveExpedited Review B0.007.981606140

    07-002467ActiveExpedited Review B0.007.951606140

    07-002347ActiveExpedited Review B0.007.841606140

    07-002201ActiveExpedited Review B0.007.171606140

    07-002494ActiveExpedited Review B0.006.951606140

    07-001398ActiveExpedited Review B6.179.801606140

    07-002504ActiveExpedited Review B4.279.681606140

    07-002206ActiveExpedited Review B0.006.941606140

    07-002500ActiveExpedited Review B5.117.951606140

    07-002369ActiveExpedited Review B0.025.901606140

    07-001987ActiveExpedited Review B0.005.871606140

    07-002496ActiveExpedited Review B0.005.861606140

    07-002267ActiveExpedited Review B0.005.681606140

    07-002478ActiveExpedited Review B6.096.531606140

    07-002203ActiveExpedited Review B0.015.051606140

    07-002534ActiveExpedited Review B0.005.141606140

    07-002327ActiveExpedited Review B0.005.001606140

    07-002332ActiveExpedited Review B0.004.831606140

    06-007020ActiveExpedited Review B0.004.081606140

    07-002454ActiveExpedited Review B0.004.061606140

    07-001717ActiveExpedited Review B0.004.071606140

    07-002330ActiveExpedited Review B0.144.621606140

    07-002360ActiveExpedited Review B0.003.941606140

    07-002048ActiveExpedited Review E0.004.701606140

    07-002056ExemptExpedited Review A49.274.711606140

    07-002463ExemptExpedited Review A0.007.781606140

    07-002533ExemptExpedited Review A0.005.011606140

    07-001891ExemptExpedited Review B0.005.141606140

    07-001905ExemptExpedited Review B26.196.711606140

    07-001129ExemptExpedited Review B0.004.201606140

    07-002019ExemptExpedited Review B0.006.151606140

    07-002104ExemptExpedited Review B0.2311.571606140

    07-002118ExemptExpedited Review B0.003.991606140

    07-001877ExemptExpedited Review B0.0010.961606140

    07-000506ExemptExpedited Review B0.0110.871606140

    07-001924ExemptExpedited Review B0.006.871606140

    07-001097ExemptExpedited Review B0.0011.861606140

    06-006685ExemptExpedited Review B0.224.631606140

    07-002287ExemptExpedited Review B6.918.121606140

    07-002445ExemptExpedited Review B1.021.441606140

    07-001974ExemptExpedited Review E0.142.531606140

    07-001907ExemptExpedited Review E0.110.851606140

    07-002314Not ResearchExpedited Review E0.002.611606140

    07-002479Not ResearchExpedited Review E0.002.561606140

    07-002498Not ResearchExpedited Review E0.001.801606140

    average1.576.2998.09%

    standard dev5.893.30

    upper control limit16.20

    lower control limit0

    March_2007_NEWFULL

    Protocol IDParent CommitteePI Delay (DAYS)IRB Delay (DAYS)Avg TATUCLLCLCLUSLNon-ComplianceCompliance%

    07-000352Full-Blue Friday0.06413.91636013.7215297907210

    06-007133Full-Blue Friday3.88211.37712.6536013.7215297907210100%

    06-007194Full-Blue Thursday2.83311.07936013.7215297907210

    06-008814Full-Blue Thursday13.16026.99836013.7215297907211

    07-000960Full-Blue Thursday0.81714.47236013.7215297907210

    06-007035Full-Blue Thursday7.74013.24836013.7215297907210

    06-009671Full-Blue Thursday0.84919.00536013.7215297907210

    07-001074Full-Blue Thursday1.76615.42036013.7215297907210

    06-009690Full-Blue Thursday27.90613.99416.3236013.721529790721086%

    07-001023Full-Orange Friday11.81220.10236013.7215297907210

    07-001018Full-Orange Friday0.00015.09436013.7215297907210

    06-009091Full-Orange Friday0.00023.89836013.7215297907211

    07-001546Full-Orange Friday0.02026.35836013.7215297907211

    06-005723Full-Orange Friday1.82115.95236013.7215297907210

    07-001240Full-Orange Friday19.52818.40136013.7215297907210

    07-001022Full-Orange Friday1.08317.85436013.7215297907210

    07-000214Full-Orange Friday0.10221.80636013.7215297907211

    07-001438Full-Orange Friday0.00317.82119.7036013.721529790721067%

    06-003032Full-Orange Thursday5.02311.07236013.7215297907210

    07-001301Full-Orange Thursday5.93814.17336013.7215297907210

    06-004871Full-Orange Thursday3.06635.85636013.7215297907211

    07-001301Full-Orange Thursday5.93811.01336013.7215297907210

    07-001630Full-Orange Thursday1.10714.00636013.7215297907210

    07-002526Full-Orange Thursday0.03622.78518.1536013.721529790721167%

    07-000922IRB Wednesday Board17.93619.21836013.7215297907210

    06-006358IRB Wednesday Board2.59010.10836013.7215297907210

    07-000419IRB Wednesday Board0.00015.28436013.7215297907210

    06-005559IRB Wednesday Board0.00013.98536013.7215297907210

    07-001944IRB Wednesday Board0.12417.61636013.7215297907210

    07-000543IRB Wednesday Board5.40310.50436013.7215297907210

    06-009152IRB Wednesday Board20.17115.68436013.7215297907210

    06-009173IRB Wednesday Board0.0606.04336013.7215297907210

    06-006504IRB Wednesday Board0.0206.07536013.7215297907210

    06-002969IRB Wednesday Board5.99015.94036013.7215297907210

    07-000095IRB Wednesday Board13.4209.70436013.7215297907210

    07-000495IRB Wednesday Board11.79120.41936013.7215297907210

    07-000537IRB Wednesday Board0.08113.17136013.7215297907210

    07-001001IRB Wednesday Board0.00012.00013.2736013.7215297907210100%

    07-001825NO Assignment?65.0004.74836013.7215297907210

    07-000097NO Assignment?65.0000.97936013.7215297907210

    06-006539NO Assignment?64.0000.04636013.7215297907210

    07-002133NO Assignment?59.0002.07836013.7215297907210

    06-007193NO Assignment?15.8539.13336013.7215297907210

    07-001173NO Assignment?51.0000.07436013.7215297907210

    06-009380NO Assignment?49.0000.03436013.7215297907210

    07-002574NO Assignment?0.0002.6462.4736013.722210

    average12.19413.722

    standard dev19.35418260427.4945020549

    upper control limit36.2050359555

    lower control limit0

    April_2007_NEWMinRisk

    Protocol IDParent CommitteePI Delay (DAYS)IRB Delay (DAYS)UCLLCLCLUSLCompliance

    07-002582Expedited Review A0.007.9215.5206.0140

    07-002181Expedited Review A0.005.7715.5206.0140

    07-002612Expedited Review A0.004.9415.5206.0140

    07-002617Expedited Review A0.024.8915.5206.0140

    07-000225Expedited Review A0.004.8715.5206.0140

    07-002580Expedited Review A0.004.4815.5206.0140

    07-001631Expedited Review A0.003.9415.5206.0140

    07-002627Expedited Review A0.005.9215.5206.0140

    07-002626Expedited Review B0.158.1115.5206.0140

    07-002565Expedited Review B0.007.8815.5206.0140

    06-009458Expedited Review B0.107.7915.5206.0140

    07-002552Expedited Review B0.007.2815.5206.0140

    07-002642Expedited Review B0.047.2215.5206.0140

    07-001270Expedited Review B0.117.0715.5206.0140

    07-002641Expedited Review B0.007.1615.5206.0140

    07-001224Expedited Review B0.007.9715.5206.0140

    06-005772Expedited Review B0.007.0915.5206.0140

    06-006926Expedited Review B37.000.0415.5206.0140

    07-002615Expedited Review B0.046.8915.5206.0140

    07-001194Expedited Review B0.006.8315.5206.0140

    07-002376Expedited Review B0.875.7515.5206.0140

    06-005503Expedited Review B4.1610.7715.5206.0140

    07-002673Expedited Review B0.005.9815.5206.0140

    07-002678Expedited Review B0.005.8815.5206.0140

    07-002371Expedited Review B0.005.8415.5206.0140

    07-002681Expedited Review B0.005.7315.5206.0140

    07-002628Expedited Review B0.005.7415.5206.0140

    07-002665Expedited Review B1.2311.2715.5206.0140

    07-002607Expedited Review B0.005.1915.5206.0140

    07-001217Expedited Review B14.1811.9915.5206.0140

    06-008910Expedited Review B0.004.9815.5206.0140

    07-002041Expedited Review B0.264.6215.5206.0140

    07-002720Expedited Review B0.004.8915.5206.0140

    07-002363Expedited Review B0.004.1315.5206.0140

    07-002654Expedited Review B0.283.8115.5206.0140

    07-002724Expedited Review B10.7214.4315.5206.0141

    07-002731Expedited Review B0.034.0515.5206.0140

    07-002089Expedited Review B0.004.1015.5206.0140

    07-000710Expedited Review B0.003.9915.5206.0140

    07-002707Expedited Review B0.0111.7715.5206.0140

    07-002346Expedited Review B0.118.1515.5206.0140

    06-005654Expedited Review B0.001.0115.5206.0140

    06-009404Expedited Review B0.000.8615.5206.0140

    07-002747Expedited Review B1.066.9215.5206.0140

    07-002570Expedited Review B0.047.8415.5206.0140

    07-002522Expedited Review B0.007.5715.5206.0140

    07-002315Expedited Review B30.000.1115.5206.0140

    07-000992Expedited Review B0.006.9115.5206.0140

    07-002772Expedited Review B0.006.9215.5206.0140

    07-001500Expedited Review B0.006.9415.5206.0140

    07-002784Expedited Review B0.716.1615.5206.0140

    06-006656Expedited Review B0.006.1215.5206.0140

    07-001092Expedited Review B0.006.0315.5206.0140

    07-002403Expedited Review B0.005.8815.5206.0140

    07-002804Expedited Review B0.006.9315.5206.0140

    07-002705Expedited Review B10.519.3915.5206.0140

    07-001550Expedited Review B27.061.0215.5206.0140

    07-002743Expedited Review B0.005.1315.5206.0140

    07-002428Expedited Review B6.356.5115.5206.0140

    07-001546Expedited Review B0.005.0415.5206.0140

    07-002827Expedited Review B0.005.0215.5206.0140

    07-000977Expedited Review B0.355.5215.5206.0140

    07-002838Expedited Review B5.2513.6115.5206.0140

    07-000221Expedited Review B0.004.7915.5206.0140

    07-002845Expedited Review B0.004.9415.5206.0140

    07-002725Expedited Review B1.0710.0315.5206.0140

    07-000161Expedited Review B0.003.9815.5206.0140

    07-001701Expedited Review B0.003.9115.5206.0140

    07-002719Expedited Review B0.003.7515.5206.0140

    07-002691Expedited Review B0.001.3415.5206.0140

    07-002859Expedited Review B0.001.2515.5206.0140

    07-002614Expedited Review B0.011.1315.5206.0140

    07-000560Expedited Review B0.008.9515.5206.0140

    06-004775Expedited Review B0.038.8215.5206.0140

    07-000788Expedited Review B14.988.9615.5206.0140

    07-001487Expedited Review B0.001.0615.5206.0140

    06-002878Expedited Review B0.017.0815.5206.0140

    07-000135Expedited Review B0.000.9715.5206.0140

    06-009537Expedited Review B0.000.8715.5206.0140

    07-002850Expedited Review B0.060.7915.5206.0140

    07-002786Expedited Review B9.255.6315.5206.0140

    07-002474Expedited Review B0.007.1815.5206.0140

    07-002862Expedited Review B1.945.9415.5206.0140

    07-002860Expedited Review B0.006.9815.5206.0140

    07-002873Expedited Review B0.007.0015.5206.0140

    07-002338Expedited Review B0.056.9115.5206.0140

    07-002602Expedited Review B0.016.9615.5206.0140

    07-002883Expedited Review B0.016.9515.5206.0140

    07-002875Expedited Review B0.006.6415.5206.0140

    07-000763Expedited Review B0.006.2015.5206.0140

    07-002890Expedited Review B0.026.2215.5206.0140

    07-002892Expedited Review B0.006.1315.5206.0140

    07-002901Expedited Review B6.996.1015.5206.0140

    07-000529Expedited Review B14.016.8515.5206.0140

    07-002816Expedited Review B0.006.1115.5206.0140

    07-002903Expedited Review B22.000.0915.5206.0140

    07-002906Expedited Review B2.014.0115.5206.0140

    07-002163Expedited Review B0.005.9215.5206.0140

    07-002877Expedited Review B0.005.8815.5206.0140

    07-002912Expedited Review B3.772.0815.5206.0140

    07-002907Expedited Review B0.335.5315.5206.0140

    07-002263Expedited Review B20.880.1615.5206.0140

    07-002916Expedited Review B0.604.4315.5206.0140

    07-002929Expedited Review B14.016.7315.5206.0140

    07-002931Expedited Review B0.004.9515.5206.0140

    06-009617Expedited Review B0.004.8715.5206.0140

    06-006825Expedited Review B0.004.1315.5206.0140

    07-002942Expedited Review B0.004.1315.5206.0140

    07-002696Expedited Review B10.219.9815.5206.0140

    07-001466Expedited Review B0.003.8215.5206.0140

    07-002933Expedited Review B0.001.8815.5206.0140

    07-002951Expedited Review B17.000.5115.5206.0140

    07-002263Expedited Review B0.001.1715.5206.0140

    07-002966Expedited Review B0.001.1015.5206.0140

    07-002406Expedited Review B0.477.5815.5206.0140

    07-002930Expedited Review B17.000.1315.5206.0140

    07-002802Expedited Review B17.000.1615.5206.0140

    07-002715Expedited Review B0.608.4215.5206.0140

    07-002919Expedited Review B0.000.9215.5206.0140

    07-002886Expedited Review B0.007.9615.5206.0140

    07-002737Expedited Review B0.437.3715.5206.0140

    07-002658Expedited Review B0.007.3415.5206.0140

    07-002974Expedited Review B0.007.2415.5206.0140

    06-008944Expedited Review B0.007.0815.5206.0140

    07-002986Expedited Review B0.006.9715.5206.0140

    07-002711Expedited Review B0.006.9415.5206.0140

    07-002778Expedited Review B0.006.9115.5206.0140

    07-001702Expedited Review B10.055.8315.5206.0140

    06-005269Expedited Review B0.006.8015.5206.0140

    06-006308Expedited Review B0.006.7415.5206.0140

    07-001912Expedited Review B0.016.6615.5206.0140

    07-002606Expedited Review B0.132.2615.5206.0140

    07-002886Expedited Review B0.006.0815.5206.0140

    06-008907Expedited Review B0.045.9415.5206.0140

    07-001806Expedited Review B1.0113.8415.5206.0140

    07-003005Expedited Review B2.753.1815.5206.0140

    06-003926Expedited Review B7.007.1615.5206.0140

    07-003010Expedited Review B6.797.1815.5206.0140

    07-001147Expedited Review B1.7012.2915.5206.0140

    07-003013Expedited Review B0.025.0315.5206.0140

    07-003018Expedited Review B0.015.0215.5206.0140

    07-003034Expedited Review B11.902.0415.5206.0140

    07-002331Expedited Review B4.948.9915.5206.0140

    07-003040Expedited Review B0.004.9115.5206.0140

    07-003045Expedited Review B0.034.7715.5206.0140

    07-003042Expedited Review B0.0013.8915.5206.0140

    07-003055Expedited Review B0.0313.5815.5206.0140

    07-001682Expedited Review B0.0013.4815.5206.0140

    07-003060Expedited Review B0.004.1315.5206.0140

    06-007008Expedited Review B0.004.1615.5206.0140

    07-003024Expedited Review B0.0012.9415.5206.0140

    07-002067Expedited Review B0.004.0615.5206.0140

    07-003066Expedited Review B1.9111.0615.5206.0140

    07-002950Expedited Review B0.0012.7815.5206.0140

    07-001314Expedited Review B0.013.9415.5206.0140

    07-001304Expedited Review B0.003.8815.5206.0140

    07-002455Expedited Review B1.009.0115.5206.0140

    07-003071Expedited Review B0.009.7915.5206.0140

    07-002985Expedited Review B0.089.6615.5206.0140

    07-003031Expedited Review B0.009.8115.5206.0140

    06-005773Expedited Review B0.009.6115.5206.0140

    06-009410Expedited Review B0.008.8215.5206.0140

    07-001611Expedited Review E0.000.1215.5206.0140

    07-003072Expedited Review E0.036.5615.5206.0140

    07-002713Expedited Review E0.000.2615.5206.0140

    average2.275.9999.39%

    standard dev5.883.18

    upper control limit15.52

    lower control limit0

    CC EXP 4-07

    7.922627314815.522198058405.985894009514

    5.773657407415.522198058405.985894009514

    4.937395833315.522198058405.985894009514

    4.885995370415.522198058405.985894009514

    4.867372685215.522198058405.985894009514

    4.481273148115.522198058405.985894009514

    3.939340277815.522198058405.985894009514

    5.921469907415.522198058405.985894009514

    8.107777777815.522198058405.985894009514

    7.884155092615.522198058405.985894009514

    7.789594907415.522198058405.985894009514

    7.279155092615.522198058405.985894009514

    7.220289351915.522198058405.985894009514

    7.070509259315.522198058405.985894009514

    7.161307870415.522198058405.985894009514

    7.97203703715.522198058405.985894009514

    7.091273148115.522198058405.985894009514

    0.037291666715.522198058405.985894009514

    6.889675925915.522198058405.985894009514

    6.829363425915.522198058405.985894009514

    5.751608796315.522198058405.985894009514

    10.765590277815.522198058405.985894009514

    5.983969907415.522198058405.985894009514

    5.883692129615.522198058405.985894009514

    5.836157407415.522198058405.985894009514

    5.730555555615.522198058405.985894009514

    5.735925925915.522198058405.985894009514

    11.267060185215.522198058405.985894009514

    5.18641203715.522198058405.985894009514

    11.990914351915.522198058405.985894009514

    4.980833333315.522198058405.985894009514

    4.624884259315.522198058405.985894009514

    4.888842592615.522198058405.985894009514

    4.128495370415.522198058405.985894009514

    3.812395833315.522198058405.985894009514

    14.432060185215.522198058405.985894009514

    4.053888888915.522198058405.985894009514

    4.102916666715.522198058405.985894009514

    3.994004629615.522198058405.985894009514

    11.773356481515.522198058405.985894009514

    8.148321759315.522198058405.985894009514

    1.014641203715.522198058405.985894009514

    0.85921296315.522198058405.985894009514

    6.922187515.522198058405.985894009514

    7.836527777815.522198058405.985894009514

    7.571574074115.522198058405.985894009514

    0.106782407415.522198058405.985894009514

    6.909594907415.522198058405.985894009514

    6.924942129615.522198058405.985894009514

    6.935821759315.522198058405.985894009514

    6.162515.522198058405.985894009514

    6.115891203715.522198058405.985894009514

    6.032743055615.522198058405.985894009514

    5.87702546315.522198058405.985894009514

    6.933298611115.522198058405.985894009514

    9.394293981515.522198058405.985894009514

    1.023888888915.522198058405.985894009514

    5.125034722215.522198058405.985894009514

    6.510729166715.522198058405.985894009514

    5.037638888915.522198058405.985894009514

    5.020428240715.522198058405.985894009514

    5.522245370415.522198058405.985894009514

    13.609618055615.522198058405.985894009514

    4.786307870415.522198058405.985894009514

    4.941851851915.522198058405.985894009514

    10.032013888915.522198058405.985894009514

    3.976886574115.522198058405.985894009514

    3.909432870415.522198058405.985894009514

    3.74921296315.522198058405.985894009514

    1.340717592615.522198058405.985894009514

    1.247557870415.522198058405.985894009514

    1.126574074115.522198058405.985894009514

    8.946516203715.522198058405.985894009514

    8.820023148115.522198058405.985894009514

    8.957893518515.522198058405.985894009514

    1.057824074115.522198058405.985894009514

    7.084456018515.522198058405.985894009514

    0.967766203715.522198058405.985894009514

    0.870092592615.522198058405.985894009514

    0.788402777815.522198058405.985894009514

    5.625451388915.522198058405.985894009514

    7.176747685215.522198058405.985894009514

    5.941770833315.522198058405.985894009514

    6.981354166715.522198058405.985894009514

    6.997928240715.522198058405.985894009514

    6.91171296315.522198058405.985894009514

    6.963425925915.522198058405.985894009514

    6.949780092615.522198058405.985894009514

    6.641851851915.522198058405.985894009514

    6.19702546315.522198058405.985894009514

    6.21687515.522198058405.985894009514

    6.129293981515.522198058405.985894009514

    6.095370370415.522198058405.985894009514

    6.850266203715.522198058405.985894009514

    6.107233796315.522198058405.985894009514

    0.094745370415.522198058405.985894009514

    4.005254629615.522198058405.985894009514

    5.920266203715.522198058405.985894009514

    5.875254629615.522198058405.985894009514

    2.082407407415.522198058405.985894009514

    5.529675925915.522198058405.985894009514

    0.164814814815.522198058405.985894009514

    4.433668981515.522198058405.985894009514

    6.733645833315.522198058405.985894009514

    4.953356481515.522198058405.985894009514

    4.866435185215.522198058405.985894009514

    4.128333333315.522198058405.985894009514

    4.126678240715.522198058405.985894009514

    9.982395833315.522198058405.985894009514

    3.81827546315.522198058405.985894009514

    1.88171296315.522198058405.985894009514

    0.508182870415.522198058405.985894009514

    1.166851851915.522198058405.985894009514

    1.09812515.522198058405.985894009514

    7.581006944415.522198058405.985894009514

    0.131678240715.522198058405.985894009514

    0.164317129615.522198058405.985894009514

    8.416342592615.522198058405.985894009514

    0.92422453715.522198058405.985894009514

    7.958541666715.522198058405.985894009514

    7.372245370415.522198058405.985894009514

    7.341296296315.522198058405.985894009514

    7.236562515.522198058405.985894009514

    7.084629629615.522198058405.985894009514

    6.971863425915.522198058405.985894009514

    6.942515.522198058405.985894009514

    6.907638888915.522198058405.985894009514

    5.828148148115.522198058405.985894009514

    6.798240740715.522198058405.985894009514

    6.743217592615.522198058405.985894009514

    6.655717592615.522198058405.985894009514

    2.259189814815.522198058405.985894009514

    6.081666666715.522198058405.985894009514

    5.943773148115.522198058405.985894009514

    13.835578703715.522198058405.985894009514

    3.175023148115.522198058405.985894009514

    7.163541666715.522198058405.985894009514

    7.181620370415.522198058405.985894009514

    12.293043981515.522198058405.985894009514

    5.03484953715.522198058405.985894009514

    5.023576388915.522198058405.985894009514

    2.043333333315.522198058405.985894009514

    8.989340277815.522198058405.985894009514

    4.914236111115.522198058405.985894009514

    4.769062515.522198058405.985894009514

    13.887515.522198058405.985894009514

    13.581701388915.522198058405.985894009514

    13.48422453715.522198058405.985894009514

    4.131782407415.522198058405.985894009514

    4.162754629615.522198058405.985894009514

    12.942453703715.522198058405.985894009514

    4.056817129615.522198058405.985894009514

    11.06359953715.522198058405.985894009514

    12.775520833315.522198058405.985894009514

    3.944421296315.522198058405.985894009514

    3.883726851915.522198058405.985894009514

    9.010729166715.522198058405.985894009514

    9.789513888915.522198058405.985894009514

    9.663773148115.522198058405.985894009514

    9.812916666715.522198058405.985894009514

    9.60937515.522198058405.985894009514

    8.824548611115.522198058405.985894009514

    0.117048611115.522198058405.985894009514

    6.564803240715.522198058405.985894009514

    0.25952546315.522198058405.985894009514

    IRB Delay (DAYS)

    UCL

    LCL

    CL

    USL

    Control Charts for Expedited

    April_2007_NewFULL

    Protocol IDParent CommitteePI Delay (DAYS)IRB Delay (DAYS)Avg (IRB) TATUCLLCLCLUSLNon-ComplianceCompliance%

    07-001194Full-Blue Friday4.4711.6225.90.011.4210

    06-005503Full-Blue Friday0.6120.1325.90.011.4210

    06-009404Full-Blue Friday0.0111.2525.90.011.4210

    07-000529Full-Blue Friday24.000.5125.90.011.4210

    06-006308Full-Blue Friday8.3113.6925.90.011.4210

    06-007008Full-Blue Friday14.043.0925.90.011.4210

    07-002497Full-Blue Friday0.7312.1710.3525.90.011.4210100%

    07-001092Full-Blue Thursday5.2010.8825.90.011.4210

    07-002428Full-Blue Thursday4.7810.2825.90.011.4210

    07-001487Full-Blue Thursday27.790.1725.90.011.4210

    07-002474Full-Blue Thursday15.7012.0725.90.011.4210

    07-002338Full-Blue Thursday2.6310.5125.90.011.4210

    07-001147Full-Blue Thursday4.9215.3325.90.011.4210

    06-009410Full-Blue Thursday1.8814.2625.90.011.4210

    07-001611Full-Blue Thursday1.7114.3525.90.011.4210

    07-002685Full-Blue Thursday0.0614.9825.90.011.4210

    07-000099Full-Blue Thursday3.0111.9011.4725.90.011.4210100%

    07-001546Full-Orange Friday0.0219.0825.90.011.4210

    07-000788Full-Orange Friday0.0018.0725.90.011.4210

    06-009537Full-Orange Friday0.223.7325.90.011.4210

    07-001682Full-Orange Friday1.9315.0525.90.011.4210

    06-005773Full-Orange Friday2.6213.6725.90.011.4210

    07-002524Full-Orange Friday1.7513.3325.90.011.4210

    06-006437Full-Orange Friday1.0612.8413.6825.90.011.4210100%

    06-005654Full-Orange Thursday0.0011.1325.90.011.4210

    07-000763Full-Orange Thursday27.000.2025.90.011.4210

    07-002410Full-Orange Thursday3.094.7125.90.011.4210

    07-001136Full-Orange Thursday2.7410.1825.90.011.4210

    06-005570Full-Orange Thursday6.036.866.6225.90.011.4210100%

    06-009458IRB Wednesday Board0.0714.9525.90.011.4210

    07-000710IRB Wednesday Board0.0811.8825.90.011.4210

    06-006656IRB Wednesday Board12.2916.8125.90.011.4210

    07-000161IRB Wednesday Board0.0014.5425.90.011.4210

    06-005269IRB Wednesday Board1.1012.7725.90.011.4210

    07-002067IRB Wednesday Board0.168.8125.90.011.4210

    07-001314IRB Wednesday Board0.1515.7225.90.011.4210

    07-001304IRB Wednesday Board0.7415.1325.90.011.4210

    06-008852IRB Wednesday Board11.304.7825.90.011.4210

    07-000419IRB Wednesday Board0.0014.2525.90.011.4210

    07-002549IRB Wednesday Board4.659.4625.90.011.4210

    07-001228IRB Wednesday Board1.0814.2225.90.011.4210

    07-003161IRB Wednesday Board0.009.0312.4925.90.011.4210100%

    average4.7111.39

    standard dev7.154.84

    upper control limit25.92

    lower control limit0

    min0.17

    New Full - April 07

    11.61983796325.9213153107011.390138337721

    20.125173611125.9213153107011.390138337721

    11.253472222225.9213153107011.390138337721

    0.512083333325.9213153107011.390138337721

    13.688229166625.9213153107011.390138337721

    3.09187525.9213153107011.390138337721

    12.170208333325.9213153107011.390138337721

    10.876273148125.9213153107011.390138337721

    10.283622685225.9213153107011.390138337721

    0.171238425925.9213153107011.390138337721

    12.073113425925.9213153107011.390138337721

    10.506967592625.9213153107011.390138337721

    15.327847222325.9213153107011.390138337721

    14.263414351925.9213153107011.390138337721

    14.35141203725.9213153107011.390138337721

    14.980104166725.9213153107011.390138337721

    11.897777777825.9213153107011.390138337721

    19.082824074125.9213153107011.390138337721

    18.069548611125.9213153107011.390138337721

    3.729687525.9213153107011.390138337721

    15.050196759325.9213153107011.390138337721

    13.670532407425.9213153107011.390138337721

    13.328020833325.9213153107011.390138337721

    12.840821759325.9213153107011.390138337721

    11.127881944425.9213153107011.390138337721

    0.195254629625.9213153107011.390138337721

    4.712592592625.9213153107011.390138337721

    10.181145833325.9213153107011.390138337721

    6.86015046325.9213153107011.390138337721

    14.945405092625.9213153107011.390138337721

    11.876678240725.9213153107011.390138337721

    16.813888888925.9213153107011.390138337721

    14.543229166725.9213153107011.390138337721

    12.768402777825.9213153107011.390138337721

    8.807303240725.9213153107011.390138337721

    15.720023148125.9213153107011.390138337721

    15.131307870425.9213153107011.390138337721

    4.777743055625.9213153107011.390138337721

    14.251990740725.9213153107011.390138337721

    9.461759259325.9213153107011.390138337721

    14.2187525.9213153107011.390138337721

    9.028020833325.9213153107011.390138337721

    IRB Delay (DAYS)

    UCL

    LCL

    CL

    USL

    IRB Full Board Control Chart

    DMAIC

    Control PhaseConsistent and improved process Within control: Control Charts

    Control planMeasurement System Assurance: Including monitor (Alerts) to ensure the process success.Reaction plan.

    DMAIC

    Lessons to shareDMAIC proved to be effective in Healthcare processes including administrative/ business processes.

    Research Administration, as a result launched 3 system-wide process improvement teams and established their own Research Quality Office recently.

    Other institutions benchmark with Mayo IRB

    DMAIC

    Lessons to shareStaff resistance to change!

    Information Technology (IT) support

    Process owners commitment is critical to the success of the initiative.

    The right skills on the team.

    Customer and External effect.

    DMAIC

    Thank You.Questions?

    Track1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QCTrack1B.Hirzallah--8.20@2pm QC