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