A 15-minutes oral presentation that was given in ISQua's 32nd International Conference, Doha, October 2015 by Dr. Yasser Amer under the track: "Quality and Safety in Developing Countries"

1. FAILURE MODE AND EFFECT ANALYSIS (FMEA)
FOR IMPLEMENTATION OF CLINICAL PRACTICE
GUIDELINES AT A TERTIARY CARE TEACHING
HOSPITAL IN SAUDI ARABIA
(ISQUA15-1434)
Amir Babiker, Yasser Amer, Hayfaa Wahabi, Khalid Alswat
Mohamed El-Faki, Sarar Mohamed, Abdulrahman Al-Nemri, Ayman Aleyadi,
Solafa Fatani, Fadi El-Jardali, Farheen Shaikh, Lubna Al-Ansary, Fahad Al-Zamil
King Saud University College of Medicine
University Medical City, Riyadh, Saudi Arabia
Quality and Safety in Developing Countries
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2. Statement of disclosure
Dr. Yasser S. Amer
MBBCh, MPed, MHCI, CPHQ
I have no actual or potential, commercial or
academic conflict of interest to declare in relation
to this presentation/ project.
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3. CPGs Definition
“Statements that include Recommendations intended
to optimize patient care that are informed by a
Systematic Review of evidence and an assessment of
the benefits and harms of alternative care options”
Committee on Standards for Developing Trustworthy CPG
(IOM-AHRQ 2011)
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Introduction

4. CPG Implementation
“The concrete activities and interventions
undertaken to turn policies into desired results“
Guidelines for clinical practice: from development to use. IOM, 1992
CPGs Practice
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5. KSUMC CPG PROGRAM
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6. 6
Modified ADAPTE Process

7. Clinical Practice Guidelines (CPGs) Program of King Saud
University Medical City
KSUMC CPG Program Partners:-
• KSUMC-Wide CPGs Steering Committee;
• Clinical Departments (20 CPGs Depart. Committees);
• Research Chair for Evidence-Based Health Care and
Knowledge Translation (CEBHC-KT);
• Quality Management Department; DQTs
• Top Management & Leadership of KSU College of
Medicine and KSU Medical City
IMPLEMENT
QIP
ADAPT
Methods
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8. Guidelines International Network (G-I-N)
www.g-i-n.net
EBHC-KT Chair, King Saud University: Org. Member since 2009
(1st Member from Gulf & 3rd Member from MENA Countries)
Founded in Nov.
2002
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9. Historical background - FMEA
• 1940s – US Armed Forces Military Procedures (FMECA: Failure
mode, effects, and criticality analysis)
• 1960s –
NASA
Civil aviation industry
• 1970s – Automotive industry
• 1999 – Healthcare adaptation (HFMEA™): VA National Center
for Patient Safety, US Department of Veterans Affairs
• 2000s – Promoted in the Joint Commission PS Standards.
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10. Definition of FMEA
“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 (failure
modes), in order to identify the parts of the process
that are most in need of change” (2015)
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11. What does FMEA include?
FMEA includes review of the following:-
• Steps in the process
• Failures modes (what could go wrong?)
• Failure causes (Why would failure happen?)
• Failure effects (What would be the consequences of each
failure?)
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12. METHODS
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13. RESULTS
The KSUMC CPG program resulted in the adaptation
of 28 CPGs in different departments with different
progress in implementation (including 7 CPGs
finalized & 4 in progress in the department of
Pediatrics).
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14. 5 Steps of HFMEA
STEP 1 - Define the HFMEA Topic CPG Implementation
STEP 2 - Assemble a multidisciplinary
team
Pilot in Pedia. DQT/ CGC
(phys., pharm., nurs.)
STEP 3 - Graphically describe the
process
STEP 4 - Conduct a hazard analysis Failure modes, causes,
effects and RPN Matrix &
evaluate results
STEP 4 - Actions & outcome measures Assign responsible team for
actions then monitor
afterwards for risk reduction
Re-calculate the RPN to compare/ evaluate any
change in the process (residual risk) “We are here now!”14

15. Steps: CPGs Implementation
CPG Lifecycle – The ‘living’ CPG !
1. Adaptation of Evidence-Based Clinical Practice Guidelines (EBCPGs)
2. Dissemination of 'Approved' EBCPGs
3. Implementation of 'Approved' EBCPGs
4. Measurement / Evaluation of EBCPGs (M&E)
5. Networking and linking with existing projects in KSUMC
6. Sharing the experience with similar EBCPGs programs/ Initiatives
(nationally/ internationally)15

16. • Set Up Phase: CPG topic selection, team formation, leadership support
• Adaptation phase: search/screen/select of CPGs, Evaluation (AGREE),
• Finalization Phase: External review, response to reviewers' comments, implementation sectionCPG Adaptation
•Awareness of the approved CPGs
•Available implementation tools (printed/ electronic)
•Educational/ training activities
CPG Dissemination
•Implementation tools
•implementation strategies
•HIS/ EMR/ CPOE/ Order Sets/ CDS
CPG Implementation
•Performance/ quality measures/ indicators
•Data management (collection, cleaning, analysis)
•Post-auditing actions
CPG Monitoring/ Evaluation
•Local
•National
•International
Networking with existing
projects
•Collaboration with national CPG programs & iniatives
•Collaboration with international CPG programs & iniatives
Sharing the experience with similar CPG
programs
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18. RPN Calculation
(1 – 10)Likelihood of
Occurrence (Occ.)
(1 – 10)
Note:
1 = very likely it WILL be detected
10 = very likely it WILL NOT be detected
Likelihood of Detection
(Det.)
(1 – 10)Severity (Sev.)
(Occ × Det × Sev)Risk Priority Number
(RPN)
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19. IHI – Online FMEA Tool
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20. IHI – Online FMEA Tool
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21. RESULTS – Major Failure Modes
The identified potential failure modes in CPGs
implementation with the highest RPN (≥ 80):-
1. Auditing of the CPGs (e.g. data management process).
2. Adaptation process (e.g. AGREE appraisal, Ext. review).
3. Networking with existing projects.
4. Awareness/training activities.
5. Accessible printed & electronic implementation tools
6. Advocates from clinical/ quality champions
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22. RESULTS - Actions taken
1. Auditing: supported by Pedia. CGC, DQT & QMD as a part
of Quality sustainability plan and CPG Program.
2. Adaptation: (e.g. AGREE: 4 appraisers, Review: all
Stakeholders)
3. Networking: (e.g. Dept. QIP, CPD, Accreditation, Research)
4. Awareness/ training activities: organized regularly.
5. Printed & electronic copies*: Available and accessible to
HC providers at points of care. *eSiHi!
6. Champions: Consultants/ senior practitioners encouraged
to get involved in CPG adaptation/ implementation.22

23. “Paper-to-Electronic Challenge!”
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24. Poster presentation
Quality and Safety in Developing Countries
# 1439
Clinical Documentation Success Story in Department
of Medicine, KKUH, KSUMC
“Paper-to-Electronic Challenge!”
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25. Conclusion - Application of HFMEA …
1) Identifies potential failures and monitor
barriers in CPGs implementation.
2) identifies the most important and relevant
critical activities that need to be adopted in
order to achieve a successful outcome
3) It is vital to address these recommendations
and actions that result from the FMEA.
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26. KSUMC CPG Program
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Thank you!
Email: yamer@ksu.edu.sa;
yasser3amer@yahoo.com