quality criteria and indicators in … criteria and indicators in organ donation del mar, california...
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QUALITY CRITERIA AND INDICATORS IN ORGAN DONATION
Del Mar, California May 23rd, 2012
Martí Manyalich, MD, PhD, TPM, Ass. Prof Hospital Clínic - Universitat de Barcelona
Spain
• To define a
methodology
to evaluate the
performance
of Procurement
– Self-Assessment
– External
Objective
Project
• Call: EAHC 2008-2013
• 1000.000 €, 60% funded by the Commission
• October 2010 - September 2013
• Project leader: Universitat de Barcelona
• Associated
Partners
AT
HR
PT
PL
IT
DE
ES
FR
RO
SE
UK
-MUW
-DSO
-DTI
-SERMAS
-ABM
-MHSW
-FITOT
-Poltransplant
-ASST
-FTR
-KI
-NHSBT
HU
EL MT TR
SI
-HTO -MAHC
-HMBTS
-MDH
-ST
• Collaborating
Partners
Methodology
• Quality Criteria – Key points that make the difference
AND
• Quality Indicators – Measurements of performance of processes or
outcomes used to determine the level achieved
Possible examples • Donors / Deceases
• % of Refusals to donation
• Brain-Deaths / ICU deaths
• Actual Donors / Eligible Donors Possible examples
• Key Donation Professional
• Detection System
• Self-Assessment Program
• Maintenance guidelines
• Follow-up of Living Donors
• Transparent, Equitable Allocation system
1. Train professionals in the creation and implementation of QC and QI
2. Identify standards of best practice (QC) in the 3 types of organ donation
3. Define Quality indicators (QI) in the 3 types of organ donation
4. Implement the QI in selected hospitals
5. Analyse and report results
6. Develop auditing tools and an auditing guide
7. Train professionals in the auditing performance
8. Implement the audits and elaborate recommendations
9. Measure the usefulness and validation of the tools
10. Disseminate the QC/QI, the Auditing tools and results of the project
Specific Objectives
• Legal framework
• Accreditation and certification
• Organization
• Human resources (job description)
• Material resources (office, equipment, etc)
• Finances (sources / payment)
• Services offered
• Media / Dissemination
• Education
• Research
• Access and use of guidelines, protocols and pathways
Organizational Structure
Clinical Processes DBD DCD LD
Donor identification ✔ ✔ ✔
Clinical evaluation ✔ ✔ ✔
Death diagnosis ✔ ✔
Ethical, legal, psychological and economic evaluation ✔
Family / personal consent ✔ ✔ ✔
Donor maintenance ✔ ✔
Organ viability evaluation and placement ✔ ✔
Paired Exchanges ✔
Surgical organ recovery ✔ ✔ ✔
Organ preservation ✔ ✔
Follow-up ✔
Project Development
1st Period (18 months)
• Training program in QC/QI development and implementation
• Creation of information and dissemination tools (website)
• Survey about State of The Art of quality tools utilization
• Development of the QC/QI
• Data Gathering Tools Design (Database)
Communication Plan
Project Development
1st Period (18 months)
• Training program in QC/QI development and implementation
• Creation of information and dissemination tools (website)
• Survey about State of The Art of quality tools utilization
• Development of the QC/QI
• Data Gathering Tools Design (Database)
Survey results Second Report
Barcelona, 2011
Survey Structure
1. General Information 2. Hospital General Overview
3. Quality System
FRANCE 6
ITALY 6
POLAND 35
PORTUGAL 5
ROMANIA 7
SPAIN 12
GERMANY 2
ENGLAND 7
SWEDEN 4
CROATIA 5
AUSTRIA 0
Surveys received: 89
Transplant Center: •Tx from Both living and deceased donation •All type of organs
50 %
100 %
33 %
91,60%
8,30%
2.1 Does your hospital run transplantation programs?
Yes
No
Transplant Center: •Tx from Both living and deceased donation •All type of organs
0,00%
20,00%
40,00%
60,00%
80,00%
100,00%
LD DBD DCD
66,60%
100%
33,30%
2.4 What donation programs does your hospital run?
LD
DBD
DCD
Transplant Center: •Tx from Both living and deceased donation •All type of organs
Transplant Center: •Tx from Both living and deceased donation •Type of organs transplanted: Kidney, Liver, Pancreas, Bowel
0,00%
20,00%
40,00%
60,00%
80,00%
100,00%
LD DBD DCD
57,10%
100% 100%
2,4 What donation programs does your hospital run?
Transplant Center: •Tx from Both living and deceased donation •Type of organs transplanted: Kidney, Liver, Pancreas
Results regarding Hospital General Overview
Hospital General Overview
25,30%
74,60%
Full time and Part Time
One
Results regarding Quality System
Quality Objectives
•Number Actual DBD • % Family consent • Organs Recovered
Quality Plan objectives/s which refer to the organ donation process
Quality in Organ donation part of the Quality program promoted by the National Transplant Organization 63,8 %
% OF HOSPITALS WITH ORGAN DONATION IN QUALITY PLAN
Project Development
1st Period (18 months)
• Training program in QC/QI development and implementation
• Creation of information and dissemination tools (website)
• Survey about State of The Art of quality tools utilization
• Development of the QC/QI
• Data Gathering Tools Design (Database)
Quality Indicators
Final Draft
April 2012
Living Donation
Name of Indicator Expected
result
Evaluation
approach
1. Approval for LD from a council 100% Process
2. Participation of center in living donors registry 100% Process
3. Identification of potential LD (Kidney) 30% Outcome
4. Assessment of organ function for potential live donors 100% Process
5. Long-term follow up of LD 100% Process
6. Information for potential LD 80% Outcome
DBD & DCD Name of Indicator
Expected
result
Evaluation
approach Applicable
FUNCTIONAL ORGANIZATION
1. Donation process procedures Yes/100% Structure DBD /DCD
2. Proactive identification donors protocol Yes/100% Structure DBD/DCD
3. Donation team fulltime availability Yes/100% Structure DBD /DCD
KEY DONATION PERSON (KDP) AND DONATION TEAM REQUIREMENTS
4. Donation team members with ICU background 50% Structure DBD/DCD
5. Dedicated team Key Donation Person (KDP) Yes/100% Structure DBD /DCD
DOCUMENTATION AND REGISTRIES
6. Documentation of the steps of donation process 100% Process DBD/DCD
7. Patient / family opposition <10% Outcome DBD /DCD
DBD & DCD Name of Indicator
Expected
result
Evaluation
approach Applicable
DONOR IDENTIFICATION AND REFERRAL
8. Identification of all possible donors in ICU 75% Process DBD
9. Uncontrolled in-hospital DCD donor identification 100% Process DCD
10. Controlled DCD donor identification 100% Process DCD
11. Existence of controlled DCD donation protocols Yes/100% Structure DCD
12. Referral of DBD possible donors 100% Process DBD
DONOR EVALUATION
13. Discarded organs documented 100% Process DBD /DCD
14. Evaluation of Brain-Dead donors 100% Process DBD
DONOR TREATMENT / MAINTENANCE
15. Donor management >90% Outcome DBD
16. Unexpected cardiac arrest <3% Outcome DBD
17. DCD organ donor preservation >85% Process DCD
DBD & DCD Name of Indicator
Expected
result
Evaluation
approach Applicable
CONFIRMATION OF BRAIN DEATH / DIAGNOSIS OF DEATH
18. Brain death declaration legal framework and protocols
100% Structure DBD
PROMOTION AND EDUCATION
19. Seminars on organ donation 1/year Process DBD /DCD
QUALITY EVALUATION AND OUTCOMES
20. Proper evaluation of potential donors 100% Process DBD /DCD
21. Brain death identification > 50% Outcome DBD
22. Conversion rate in DBD donors > 65% Outcome DBD
23. Conversion rate in uncontrolled DCD donors >75% Outcome DCD
24. Conversion rate in controlled DCD donors >90% Outcome DCD
25. Kidneys transplanted from uncontrolled DCD donors
>65% Outcome DCD
26. Kidneys transplanted from controlled DCD donors >80% Outcome DCD
Project Development
2nd Period (12 months)
• Implementation QC/QI (11 + 5 hospitals)
• Training program in Evaluation System implementation
Project Development
3rd Period (6 months)
• Performance of Evaluations in hospitals
• Validation of the Evaluation System
• Dissemination Plan
Dissemination Proposal
• European Commission support
• Associated and Collaborating partners
• Health authorities and hospitals of the
participating countries
• Congresses
• Mass Media
I INVITE TO ALL GLS ATENDANTS TO
PARTICIPATE IN THIS PROJECT!!
Thank for your attention
Project Meetings
Month Date Meeting Description
2 November 3rd-5th 2010 Kick-off
Leuven
• Project presentation
• Initial training
• Survey design
6 April 4th -5th 2011 1st Lisbon • Consensus on
Quality Standards
13 October 6th-7th 2011 1st Barcelona
Intermediate meeting
• Consensus on
Quality Indicators
18 Mars 2012 2nd Lisbon
• Definite Consensus
• Auditors Training
30 January – Mars 2013 Hospitals • Audits
35 June 2013 2nd Barcelona • Final Meeting
CONCLUSIONS I
1. Almost all hospitals have a Quality Department (80,9%) and Quality Plan (78,2%) 2. 41,4% of the hospitals referred Organ donation in the Quality Plan and The % is higher in transplant hospitals. 3. 71,8% of the hospitals referred at least 3 organ donation objectives in the Quality Plan. (Number Actual DBD, % Family consent and Organs Recovered ) 4. The self assessment survey is the tool more used to measure organ donation process 5. 48,2% of the hospital don’t used quality indicators in organ donation.
CONCLUSIONS II
6. Structural and outcome indicators are the most frequently used. 7. Quality in Organ donation is part of the Quality program promoted by the National Transplant Organization in 63,8 % of the hospitals. 8. 18,9% of the hospitals have quality certification for organ donation.
martí
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