ENDOSCOPY UNIT FMEA

• is a systematic, proactive method

for evaluating a process to identify
where and how it might fail and to
assess the relative impact of
different failures, in order to
identify the parts of the process About FMEA
that are most in need of change. Failure Mode and Effect Analysis

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Step One
Select a process to evaluate
with FMEA

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Step 1 : Select a process to evaluate with FMEA
 The endoscopy study process, That starts from patient registration and ends with
patient discharge and reporting results
• The sleep study is a newly added service in ABAH
• It is a test used to monitor errors, complication during and after the procedure.
• The process start during the admission either day case (selective case) or emergency
case(primary case).

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Step Two
Recruit a multidisciplinary
team

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Step 2 : Recruit a multidisciplinary team
N. Name Department Team
1 Dr. Abdulla Aljabri GI Consultant Team Leader
2 Mrs. Esraa Niazy Quality manager Team Facilitator
3 Mr. Ahmad Abuali CNO Coordinator
4 Engr. Gassan FMS Officer Timekeeper
5 Mr. Hassan Hoban Support Services Manager Team member
6 Mr. Ahmed Ombabi Purchasing Manager Team member
7 Mrs. Sharehan Elmasri PCI manager Team member
8 Engr. Romeo Biomed Engineer Team member
9 Mr. Amroo RCM Officer Team member
10 Mr. Maned Admitting Officer Team member

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StepThree
List all steps in the process

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Step 3 : List all steps in the process

 Have the team meet together to list all of the steps in the process

 Number every step of the process, and be as specific as possible.

Flowcharting can be a helpful tool for outlining the steps.

Team should agree that the steps enumerated in the FMEA accurately describe the

process

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Step 3 : List all steps in the process : Detailed Flowchart
The CCL study process

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Step Four

Have the team list failure

modes, effects and causes

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List of failure modes, effects and causes ( ENDOSCOPY UNIT study
process)Process Step Potential Failure Mode Potential Effect Causes
N
Pt Registration 1-1 Delayed patient approval for Procedures case is ----
1
  Insurance Company delayed
  2-1 Rejected Approval
2 Doctor Examines 2-1 Doctor overload in the clinic / Missing some No specific
the Pt in the ER (Examination of patients - patients technician or
clinic/ER/IPD/ICU setting appointments - changing coordinator for
  appointments in record logbook) appointments
 
3 Doctor request the 3-1 The service is not appear in Wrong entry of the System is not
service  the system code of the service updated from HIS
team
3-2 Doctor use hard copy form for It affects achieving of System is not
service request strategic goal of updated or system is
:Adoption of a in downtime
paperless system

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List of failure modes, effects and causes (Cath Lab study process)
N Process Step Potential Failure Mode Potential Effect Causes
4 The Nurse sends -------- -------- --------
the papers to
approval
5 The approval sends 5-1 Difficult approval from The service will not Wrong or incomplete
request to insurance company approved from the data sent to insurance
insurance insurance company company
5-2 Approval clerk enters the  The service will not Wrong data sent to
code wrongly into the insurance approved from the insurance company
system insurance company
6 Doctor sends -------- -------- --------
justification if
needed

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List of failure modes, effects and causes (Cath Lab study process)
N Process Step Potential Failure Mode Potential Effect Causes

7 Doctor call the Pt 7-1 No one call the patient for Approved procedure No Appointment
for Appointment  appointment not done system for sleep lab
studies
7-2 The appointment is given to Approved procedure  -------
the patient after one month not done
(approval is not valid)
7-3 The insurance card of the Approved procedure No one follow up the
patient needs update not done insurance card due
date

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List of failure modes, effects and causes (Cath Lab study process)
N Process Step Potential Failure Mode Potential Effect Causes

8 Confirming/changing 8-1 Not reaching the patient for The service will be The patient is not
the appointment confirming the appointment postponed/canceled answering
 
 
9 Pt goes directly to 10-1 Lack of the environmental Patient Lack of
the cath lab cleaning dissatisfaction supervision/Training
10 Nurses connects the 11-1 Non compliance with Transmitting an Lack of training of
patient with infection control precautions infection to the the staff
machine patient

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List of failure modes, effects and causes (Cath Lab study process)
N Process Step Potential Failure Mode Potential Effect Causes

12 Pt is in the 12-1 No patient data is endorsed Wrong information Lack of forms and
procedures room enter in the system system
  12-2 Procedure table is not clean Patient Lack of supervision
dissatisfaction
  12-3 Personal items is found Patient will return Patient belonging
inside the room back to get his policy is not
belonging implemented
  12-4 Waste is not removed Patient Lack of supervision
dissatisfaction
12-5 Patient Falls from the bed Patient harm Procedure straps and
arm support not in
used.
12-6 Patient is feel the urge to Delayed the Lacking of
urinate procedure instructions and care

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List of failure modes, effects and causes (Cath Lab study process)
N Process Step Potential Failure Mode Potential Effect Causes

13 Monitoring 13-1 Crash Cart is not ready Lead the patient to Lack of training,
Complication cardiac arrest maintenance and
equipment
  13-2 Lacking of equipment like Lead the patient to Lack of training,
[Temp PaceMaker] cardiac arrest maintenance and
13-3 Lacking of important equipment
Medical Consumable [Snare and
all size of Balloon and Stents]
  13-4 Malfunction of machine Prolonging  Software/hardware
Procedure and Leads malfunction
to patient
dissatisfaction.
13-5 Exposed to Radiation Failure of service - Lack of equipment
  staff harm
   

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List of failure modes, effects and causes (Cath Lab study process)
N Process Step Potential Failure Mode Potential Effect Causes

14 Door to PCI within 14-1 Difficult engagement of the Triggers some Lacking of sizes of the
60mins catheter complication catheter.
15 Pre-Cath Checklist 15-1 Wrong Site, Wrong Patient  ---------- Protocol is not
TIME-OUT, SIGN- and Wrong Procedure. implemented
OUT
implementation
16 Pt is transferred to 16-1 Failure to monitor Leads to Re-procedure Lacks of knowledge,
recovery room complication and Death training and
communication
17 Pt is discharged ----- ------ -----
18 Pt comes after one 17-1 reports is not entered into Continuity of care System is not
week for the results the HIS will be affected updated
19 Require immediate 19-1 Severe complication occurs Leads to Death -----
surgery (CABG)

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Step Five
For each failure mode, the team
assign the Risk Priority Number

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The risk priority number

For each failure mode, the team assign a numeric value ( known as the risk Priority

Number, or RPN) for:

1. Rank the severity of harm resulting from the error (S)

2. Rank the estimated likelihood of occurrence (O)

3. Rank the likelihood that the error will be detected (D)

Calculate the risk Priority Number, or RPN = Severity x Occurrence x Detection

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Detectability Rating Scale(D) Occurrence Rating Scale(O) Severity Rating Scale(S)

1 = Almost certain to be detected 1 = It is unlikely/ it’s never 1= No effect

happened before

2 = High likelihood of detection 2 = Low/relatively few failures 2=Minimal effect

3 = Moderate likelihood of detection 3 = Moderate/occasional failures 3 = Moderate, short-term effect

4 = Low likelihood of detection 4 = High/repeated failures 4 = Significant, long-term effect

5 = Very high/failure almost 5 = Catastrophic

inevitable

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The risk Priority Number
N Process Step Potential Failure Mode Potential Effect S O D RPN
1 Pt 1-1 Delayed patient approval for Procedures case is delayed
4 3 1 12
Registration admission
2 Doctor 2-1 Doctor overload in the clinic / Missing some patients
Examines ER (Examination of patients -
the Pt in setting appointments - changing
2 4 1 8
the clinic/ER appointments in record logbook)
 
 
3 Doctor 3-1 The service is not appear in the Wrong entry of the code of
request the system the service 2 3 1 6
service 
3-2 Doctor use hard copy form for It affects achieving of
service request strategic goal of :Adoption 2 3 1 6
of a paperless system

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The risk Priority Number
N Process Step Potential Failure Mode Potential Effect S O D RPN
4 The Nurse sends the -------- --------
1 1 1 3
papers to approval
5 The approval sends 5-1 Difficult approval from The service will not
request to insurance insurance company approved from the 3 4 2 24
insurance company
5-2 Approval clerk enters  The service will not
the code wrongly into the approved from the 2 2 4 16
insurance system insurance company
6 Doctor sends justification -------- --------
1 1 1 1
if needed

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The risk Priority Number
N Process Step Potential Failure Mode Potential Effect S O D RPN
7 Doctor call the 7-1 No one call the patient for Approved procedure not
Pt for appointment done 2 2 1 4
Appointment 
7-2 The appointment is given Approved procedure not
to the patient after one month done 2 2 1 4
(approval is not valid)
7-3 The insurance card of the Approved procedure not
3 2 1 6
patient needs update done
8 Confirming/cha 8-1 Not reaching the patient The service will be
nging the for confirming the postponed/canceled 2 3 2 12
appointment appointment
9 Pt goes directly 10-1 Lack of the environmental Patient dissatisfaction
1 1 1 1
to the cath lab cleaning

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The risk Priority Number
N Process Step Potential Failure Mode Potential Effect S O D RPN
1 Nurses connects the 11-1 Non compliance with Transmitting an
0 patient with machine infection control precautions infection to the 3 2 2 12
patient
1 Pt is in the 12-1 No patient data is endorsed Wrong information
3 2 1 6
2 procedures room enter in the system
  12-2 Procedure table is not clean Patient
3 2 1 6
dissatisfaction
  12-3 Personal items is found Patient will return
inside the room back to get his 1 1 1 1
belonging
12-4 Waste is not removed Patient
1 1 1 1
dissatisfaction
12-5 Patient Falls from the bed Patient harm 3 3 1 6
12-6 Patient is feel the urge to Delayed the
urinate 2 2 1 4
procedure

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The risk Priority Number
N Process Step Potential Failure Mode Potential Effect S O D RPN
1 Monitoring 13-1 Crash Cart is not ready Lead the patient to
5 3 1 15
3 Complication cardiac arrest
  13-2 Lacking of equipment like [Temp Lead the patient to
PaceMaker] cardiac arrest
13-3 Lacking of important Medical 4 3 1 12
Consumable [Snare and all size of
Balloon and Stents]
  13-4 Malfunction of machine Prolonging Procedure
and Leads to patient 3 2 1 6
dissatisfaction.
13-5 Exposed to Radiation Failure of service -
4 2 3 24
staff harm
1 Door to PCI within 14-1 Difficult engagement of the Triggers some
catheter complication 3 2 2 12
4 60mins
15 Pre-Cath Checklist 15-1 Wrong Site, Wrong Patient  ----------
TIME-OUT, SIGN-OUT and Wrong Procedure. 3 1 1 3
implementation

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The risk Priority Number
N Process Step Potential Failure Mode Potential Effect S O D RPN
16 Pt is transferred 16-1 Failure to monitor Leads to Re-procedure and
to recovery complication Death 5 1 1 5
room
17 Pt is discharged ----- ------ 1 1 1 1
18 Pt comes after 17-1 reports is not entered Continuity of care will be
one week for into the HIS affected 1 2 1 2
the results
19 Require 19-1 Severe complication Leads to Death
immediate occurs (CABG) 5 1 4 20
surgery

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Step six
Evaluate the results – Prioritize
the failure modes

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TOP 10 RPN
N Process Step Potential Failure Mode Potential Effect S O D RPN
Monitoring 13-5 Exposed to Radiation Failure of service - staff harm
1 Complication 4 2 3 24

2 The approval 5-1 Difficult approval from The service will not approved
sends request insurance company from the insurance company 3 4 2 24
to insurance
3 Require 19-1 Severe complication occurs Leads to Death
immediate (CABG) 5 1 4 20
surgery
4 5-2 Approval clerk enters the  The service will not approved
code wrongly into the insurance from the insurance company 2 2 4 16
system
Monitoring 13-1 Crash Cart is not ready Lead the patient to cardiac
5 5 3 1 15
Complication arrest

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TOP 10 RPN
N Process Step Potential Failure Mode Potential Effect S O D RPN
6 Pt Registration 1-1 Delayed patient approval for Procedures case is delayed
4 3 1 12
admission
7 Confirming/cha 8-1 Not reaching the patient for The service will be
nging the confirming the appointment postponed/canceled 2 3 2 12
appointment
8 Nurses 11-1 Non compliance with Transmitting an infection to
connects the infection control precautions the patient
3 2 2 12
patient with
machine
13-2 Lacking of equipment like Lead the patient to cardiac
[Temp PaceMaker] arrest
9 13-3 Lacking of important Medical 4 3 1 12
Consumable [Snare and all size of
Balloon and Stents]
10 Door to PCI 14-1 Difficult engagement of the Triggers some complication
catheter 3 2 2 12
within 60mins

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Step Seven
Use RPNs to plan improvement
efforts

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Plan improvement efforts
Actions to Eliminate/Reduce
N Potential Failure Mode Causes
Failure or Mitigate Effects
1 13-5 Exposed to Radiation Lack of equipment Purchase the required Items
5-1 Difficult approval from Wrong or incomplete data sent Sending complete Medical report
2
insurance company to insurance company with attach latest Investigation.
19-1 Severe complication occurs ------ - Needs to have affiliation with
3 high hospital facilities.
(CABG)
5-2 Approval clerk enters the code Wrong data sent to insurance - Sending complete Medical
report with attach latest
4 wrongly into the insurance system company
Investigation.

13-1 Crash Cart is not ready Lack of training, maintenance and Proper Maintenance, Training
5 equipment and Complete equipment
provided
1-1 Delayed patient approval for ----- Coordinated with the admission
6
admission office.

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Plan improvement efforts
N Potential Failure Mode Causes Actions to Eliminate/Reduce
Failure or Mitigate Effects
8-1 Not reaching the patient for The patient is not answering - Regular follow up on the patient
7 confirming the appointment and families.

11-1 Non compliance with infection Lack of training of the staff - Training Provided
8 control precautions
13-2 Lacking of equipment like Lack of training, maintenance and - Coordinating with the
[Temp PaceMaker] equipment Purchasing Department
9 13-3 Lacking of important Medical
Consumable [Snare and all size of
Balloon and Stents]
14-1 Difficult engagement of the Lacking of sizes of the catheter. - Coordinating with the
10 catheter Purchasing Department

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Action Plan with Progress Checklist

Who checked

Progress
Due
N Action Who What Where Why How
Date

1 Purchase the required Purchasi To Cath Lab Jan 2021 For safety Purchase lead Mr. Ahmed PC
Items ng provided and to gown and Ombabi
Manager the monitor staff radiation
lacking health monitoring
equipmen
t device.

2 Difficult approval 5-1 RCM To admit Admissio Jan 2021 To follow up To send Mr. Amroo C
from insurance company Officer the n Office approval and appropriate Mr. Maned
patient admission data
Approval clerk 5-2 Admittin and get Billing
enters the code wrongly g Officer approved Office
into the insurance by
system insurance
Delayed patient 1-1
approval for admission

Keys for progress check:

G: Good progress. C: Completed. D: Delayed. N: Not implemented.
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Action Plan with Progress Checklist

Who checked

Progress
Due
N Action Who What Where Why How
Date

3 19-1 Severe Quality To July 2021 To improved By follow up Dr. Ayman C

complication occurs Manger provided patient and follow Azoz
good health hospital
(CABG) quality protocols Head of
13-1 Crash Cart is not care To prevent Dept. C
Nursing patient
ready Dept mortality

11-1 Non compliance To prevent C

with infection control transmission
precautions of infection
IPC

8-1 Not reaching the To maintain C

patient for confirming the
Continuity of
the appointment care of
OPD patients

Keys for progress check:

G: Good progress. C: Completed. D: Delayed. N: Not implemented. TREY
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Step Eight
Implement the Action plan
Then Reevaluate the RPN(pilot
test)

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RPN Reevaluation: after implementation of the action plan
Before After
N Process Step Potential Failure Mode Potential Effect RPN S O D RPN
Monitoring 13-5 Exposed to Radiation Failure of service - staff harm
1 24 2 1 2 4
Complication
The approval 5-1 Difficult approval from The service will not approved
2 sends request to insurance company from the insurance company 24 3 1 2 6
insurance
Require 19-1 Severe complication Leads to Death
3 immediate occurs (CABG) 20 3 2 3 18
surgery
5-2 Approval clerk enters the  The service will not approved
4 code wrongly into the insurance from the insurance company 16 3 3 1 9
system
Monitoring 13-1 Crash Cart is not ready Lead the patient to cardiac
5 15 1 1 1 1
Complication arrest

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RPN Reevaluation: after implementation of the action plan
Before After
N Process Step Potential Failure Mode Potential Effect RPN S O D RPN
Pt Registration
1-1 Delayed patient approval for Procedures case is delayed
13 12 1 1 1 1
admission
Confirming/chan 8-1 Not reaching the patient for The service will be
17 ging the confirming the appointment postponed/canceled 12 3 3 1 9
appointment
Nurses connects 11-1 Non compliance with Transmitting an infection to
3 the patient with infection control precautions the patient 12 1 1 1 1
machine
13-2 Lacking of equipment like Lead the patient to cardiac
[Temp PaceMaker] arrest
3 13-3 Lacking of important Medical 12 1 1 1 1
Consumable [Snare and all size of
Balloon and Stents]
Door to PCI 14-1 Difficult engagement of the Triggers some complication
5 catheter 12 5 1 1 5
within 60mins
Total RPN Before and After 159 55

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Conclusion

• Parts of the process that are most in need of change are identified and
action plan done to decrease the risks scores

• Risk priority number decreased from 152 before to 55 after which

represent 83 %

• Continuous follow up implementation of action plan is essential to keep

the progress

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ThankYou
Mrs. Esraa Niazy
Quality and Patient Safety
Manager
Ali Bin Ali HOSPITAL

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