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Process mapping


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The Check-in process for the Clinical Study at the CRO had issues, we call it opportunity for improvement, the Clinical Quality department decided to apply quality improvement tools to improve the …

The Check-in process for the Clinical Study at the CRO had issues, we call it opportunity for improvement, the Clinical Quality department decided to apply quality improvement tools to improve the process. The Process was mapped in entirety with the input from the representatives of the clinical team. Some critical areas were identified and SOP amendments, increase in the staffing etc were incorporated in the process to streamline it. Results were, improved check-in time for each study volunteer by about 15 minutes and this improved the morale of the staff, an increase in volunteer satisfaction was observed and the errors in the process was reduced by about 35% all this resulted in 20% reduction in cost for the study and more savings for the organization.

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  • 1. WELCOMETEAM LAMBDAClinic ProcessFlow
  • 3. What is a Process?• Is a series of related activities that “flow”through an organization• Is not limited to a single function/area• Activities or tasks that produce a specificservice or product for customers/clients• Something which can be viewed frombeginning to end
  • 4. What is Process Mapping?• Process Mapping is a tool to understand, analyze &document processes & activities in an organizationand help identify opportunities for improvement• Process Map depicts the sequential steps involved inconverting a specific input to required output.
  • 5. Why Map a Process?• Pictures are worth 1000 words• Visualizing processes makes the problemclearer from the start• Improves understanding the work process(Resource and Staff allocation) & tracks workflow• Process improvement can be instituted• Identify efficiency issues & where and howsystems can support these
  • 6. "The first step in any organisation is todraw a flow diagram to show how eachcomponent depends on others. Theneveryone may understand what their jobis. If people do not see the process, theycannot improve it."William Edwards Deming(1900-1993)
  • 7. SymbolsAction/ProcessStart or EndDecisionFlowDirectionOn PageConnectorOff PageConnectorDocumentNOYES
  • 8. The Process FrameworkContinuous ImprovementAS-ISDesign ►Identify BestPracticesTO-BEDesign ►Analyze &Evaluate ►Implement►BPI BTBPR
  • 9. Steps• Start with a high-level flow (Context Diagram) and then dropto the next level of detail if necessary (i.e. sub processes)• Define the beginning and end of each sub process (stayfocused)• Define key inputs and outputs• Walk through each key sub process step by step• Dont waste time: If you get bogged down, take a break ormove on to another area• Identify process and technology opportunities forimprovement as you go or at the end of each sub process• Verify the accuracy of the flow
  • 10. Process SelectionMapping ProcessPlan & ScheduleResourcesSelect TechniqueIndividualInterviewsGroupMappingAs-is ProcessOpportunities forImprovementTo-beProcessContinuousMonitoringImplementRedesign
  • 11. Study Check-in ProcessInformed Consent(Period 1 only)Physical Examination(As applicable)Compliance, BagSearch & Vital SignsSubject ID VerificationPhoto ID check(1a)Preprinted wristband checked andapplied to thehand of theSubject.(1d)Subject screeningFile checked withthe Wrist Band(2a)Physiciancompletes physicalexamination forms(2b)PI renders subjecteligible for thestudy(2c)Restricted itemsconfiscated,Laptop camerataped(3c)Breathalyzer(Alcohol)(3e)Urine SamplecollectionNicotine + Drugsof abuse(3f)Beta- HCG for allfemale subjects(3g1)PI Signs the ICFdocument(4d)Ensure that theyhave understoodwhile they consentfor study(4b)Subjects Sign theICF document(4c)Subjects are readthe ICF by the RN/ Designate(4a)Click to goto page 2Copy of ICF & Clinicrules distributed tosubjects(4e)ComplianceQuestionnaire(3a)Click togo topage 1Other applicabletests(3g2)Subject Signs theCheck in Record(1b)SignatureVerification withRecords(1c)Detailed body &Bag Search(3d)Vital Signs Check(3b)CRITICALPROCESS(Amend SOP &Form)CRITICALPROCESS(Needs morededicated Staff)CRITICALPROCESSSOP needs to befollowed and Strictmonitoring in placeCRITICALPROCESSRestrictions to beobserved morestringent
  • 12. Post Check-in Clinic ProcessDosing day activities*Check - Out*Post-dosing activities*Pre-dosing dayactivities*Overnight Pre-doseactivities*Check-inMeal(5a)Sleep(5b)Fluid Preparation(5c)Pre-dosebloodcollection andcatheterinsertion(6d)Hands MouthCheck(Not forInjectibles)(7b)Subjectsfollow posturerestrictions(7c)ScheduledBlood Drawsas perprotocol(8a)ScheduledVital checks,ECG,Glucose &HSM.(8b)Meals as perprotocol(8c)Pre-doseVitals Check& HSM(6a)Suitablity forDosing(6c)End of Restrictions(7d)SampleProcessing(8a1)HSM, Vitals,ECG,Biochemistry,Hematology,Urine(9a)Subject ChecksOut(9e)Subjects mightreturn for blooddraws as per studyrequirementBlood Draw &catheter removal(9b)Click to goto Page 3Beta-HCGresult reportcollection(5d)RestrictionsStart(6b)High Fat Breakfast(if applicable)(6e)ReturnConfiscated Itemsto subjects(9c)Wallet card,Snack &Compensation(9d)DrugAdministration(7a)*Continuous AE Monitoring & RecordRelease of SB’safter PIassessment(If Applicable)Results out ofRange PI shouldbe consultedbefore exit.
  • 13. Additional Process for Return Blood DrawsReturn Blood DrawsSubjectsattend theClinic forReturn BloodDraw(10a)Return BloodDraw Cardgiven to thesubject(10b1)Staff verifiesID and Signssubject in(10b)Return BloodDrawCompliance(10d)Staff Checksthe ID andthe ReturnBlood Drawcard(10e)SampleProcessing(10f1)Subject Leaves the Clinic withfurther instructions(10h)Click to goto page 2SubjectCompensation(If Required)(10g)Click to goto page 1Signaturesverified withrecords(10c)Protocol requiredactivities e.g.Vitals and BloodDraw(10f)
  • 15. DO map the process as itactually happensDO think about the processacross the entireorganisationDO talk to the other peoplewho are involved in theprocessDO define the beginning andend of the process beforeyou startDO the process map at ahigh levelDO ask questionsDON’T map the process as youthink it happens or as you think itought to happenDON’T restrict your process map tothe activities in your owndepartmentDON’T work in a vacuumDON’T attempt to process mapbefore you identify a beginning andan endDON’T get bogged down with toomuch detailDON’T struggle on your ownDo’s Don’ts
  • 16. ResultsRe-check the process by looking at the following:• Start, end points and customers should be clear• Inputs and outputs should be identified• Indicate title of person / area responsible for each task• A person not familiar with the process should be able toeasily understand the flow without any explanation• The level of detail should be adequate to describeinefficiencies
  • 17. THANK YOU