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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 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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WELCOMETEAM LAMBDA
Clinic Process Flow
PROCESS MAPPING
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 specific
service or product for customers/clients • Something which can be viewed from
beginning to end
What is Process Mapping?• Process Mapping is a tool to understand, analyze &
document processes & activities in an organization and help identify opportunities for improvement
• Process Map depicts the sequential steps involved in converting a specific input to required output.
Why Map a Process?
• Pictures are worth 1000 words • Visualizing processes makes the problem
clearer from the start• Improves understanding the work process
(Resource and Staff allocation) & tracks work flow
• Process improvement can be instituted• Identify efficiency issues & where and how
systems can support these
"The first step in any organisation is to draw a flow diagram to show how each component depends on others. Then everyone may understand what their job is. If people do not see the process, they cannot improve it."
William Edwards Deming
(1900-1993)
Symbols
Action/Process
Start or End
Decision
Flow Direction
On Page Connector
Off Page Connector
DocumentNO
YES
The Process Framework
Continuous Improvement
AS-IS
Design ►
AS-IS
Design ►Identify Best
Practices ►
Identify Best
Practices ► TO-BE
Design ►
TO-BE
Design ►Analyze &
Evaluate ►
Analyze &
Evaluate ►Implement
►
Implement
►
BPI BT
BPR
Steps
• Start with a high-level flow (Context Diagram) and then drop
to the next level of detail if necessary (i.e. sub processes) • Define the beginning and end of each sub process (stay
focused)• Define key inputs and outputs• Walk through each key sub process step by step• Don't waste time: If you get bogged down, take a break or
move on to another area • Identify process and technology opportunities for
improvement as you go or at the end of each sub process • Verify the accuracy of the flow
Process Selection
Mapping Process
Plan & Schedule Resources
Select Technique
IndividualInterviews
Group Mapping
As-is ProcessOpportunities for
Improvement
To-be Process
Continuous Monitoring
Implement
Redesign
Study Check-in Process
Informed Consent(Period 1 only)
Physical Examination(As applicable)
Compliance, BagSearch & Vital Signs
Subject ID Verification
Photo ID check(1a)
Preprinted wristband checked and
applied to thehand of the
Subject.(1d)
Subject screeningFile checked with
the Wrist Band(2a)
Physiciancompletes physicalexamination forms
(2b)
PI renders subjecteligible for the
study(2c)
Restricted itemsconfiscated,
Laptop camerataped(3c)
Breathalyzer(Alcohol)
(3e)
Urine Samplecollection
Nicotine + Drugsof abuse
(3f)
Beta- HCG for allfemale subjects
(3g1)
PI Signs the ICFdocument
(4d)
Ensure that theyhave understood
while they consentfor study
(4b)
Subjects Sign theICF document
(4c)
Subjects are readthe ICF by the RN
/ Designate(4a)
Click to goto page 2
Copy of ICF & Clinicrules distributed to
subjects(4e)
ComplianceQuestionnaire
(3a)
Click togo to
page 1
Other applicabletests(3g2)
Subject Signs theCheck in Record
(1b)
SignatureVerification with
Records(1c)
Detailed body &Bag Search
(3d)
Vital Signs Check(3b)
CRITICALPROCESS
(Amend SOP &Form)
CRITICALPROCESS
(Needs morededicated Staff)
CRITICALPROCESS
SOP needs to befollowed and Strictmonitoring in place
CRITICALPROCESS
Restrictions to beobserved more
stringent
Post Check-in Clinic Process
Dosing day activities
*Check - Out
*Post-dosing activities
*
Pre-dosing dayactivities
*
Overnight Pre-doseactivities
*
Check-inMeal(5a)
Sleep(5b)
Fluid Preparation(5c)
Pre-doseblood
collection andcatheterinsertion
(6d)
Hands MouthCheck(Not for
Injectibles)(7b)
Subjectsfollow posture
restrictions(7c)
ScheduledBlood Draws
as 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 blood
draws as per studyrequirement
Blood Draw &catheter removal
(9b)
Click to goto Page 3
Beta-HCGresult report
collection(5d)
RestrictionsStart(6b)
High Fat Breakfast(if applicable)
(6e)
ReturnConfiscated Items
to subjects(9c)
Wallet card,Snack &
Compensation
(9d)
DrugAdministration
(7a)
*Continuous AE Monitoring & Record
Release of SB’safter PI
assessment(If Applicable)
Results out ofRange PI should
be consultedbefore exit.
Additional Process for Return Blood Draws
Return Blood Draws
Subjectsattend theClinic for
Return BloodDraw(10a)
Return BloodDraw Cardgiven to the
subject(10b1)
Staff verifiesID and Signs
subject in(10b)
Return BloodDraw
Compliance(10d)
Staff Checksthe ID andthe ReturnBlood Draw
card(10e)
SampleProcessing
(10f1)
Subject Leaves the Clinic withfurther instructions
(10h)
Click to goto page 2
SubjectCompensation(If Required)
(10g)
Click to goto page 1
Signaturesverified with
records(10c)
Protocol requiredactivities e.g.
Vitals and BloodDraw(10f)
DYNAMIC CLINIC TEAM
DO map the process as it actually happens
DO think about the process across the entire organisation
DO talk to the other people who are involved in the process
DO define the beginning and end of the process before you start
DO the process map at a high level
DO ask questions
DON’T map the process as you think it happens or as you think it
ought to happen
DON’T restrict your process map to the activities in your own department
DON’T work in a vacuum
DON’T attempt to process map before you identify a beginning and an end
DON’T get bogged down with too much detail
DON’T struggle on your own
Do’s Don’ts
Results
Re-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 to
easily understand the flow without any explanation
• The level of detail should be adequate to describe
inefficiencies
THANK YOU
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