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ORGANISING QUALITY IN RADIOTHERAPY A MULTIDISCIPLINARY APPROACH
P. Scalliet ICARO 2
Vienna, June 20-23, 2017
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Quality in radiotherapy in the 70’s
• Few patients. • Few curative RT.
• Few imaging. • Few quality control.
• Irreproducible results
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Recurrence rate after mastectomy or conservative surgery with radiotherapy
Variable results in EORTC 10801 No trial quality assurance
0
5
10
15
20
25
30
35
1 2 3 4 5
%
Participants EORTC 10801
TCMRM
1.No dosimetric audit, 2.Variable beam calibration. 3.No understanding of clinical protocol. 4.No respect of inclusion criteria. 5.Frequent violation in dose and time.
Dispersion of outcome
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0
5
10
15
20
25
30
35
A B C D E F G H I J K L M N O P Q
5 ye
ar re
curr
ence
Participating centres
Moyen
Recurrence in EORTC 22881 with quality assurance
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The RT process: radiotherapy is a treatment of cancer
Radiotherapy applies lethal doses that are only tolerated because of a strict framework of application.
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Process control is the basis for quality and safety monitoring systems
Imaging Target
definition Clinical
guidelines
Equipment and quality
control Technical guidelines
Treatment process Clinical
guidelines
Treatment delivery
Online control Deviations?
RTT MPE Dosimetrists RO
RTT MPE Dosimetrists RO
RTT MPE Dosimetrists RO
RTT MPE Dosimetrists RO
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Why process control?
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Assembly QC
Not OK
OK
Process control
800
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Assembly QC
Not OK
OK
30
Process control
Do it well the first time!
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Standard-based quality • Imaging, target definition, clinical guidelines
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Standard-based quality • Imaging, target definition, clinical guidelines • Equipment and quality control,
specification, technical guidelines, periodicity, etc…
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Standard-based quality • Imaging, target definition, clinical guidelines • Equipment and quality control, technical guidelines • Treatment process, clinical guidelines
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Standard-based quality • Imaging, target definition, clinical guidelines • Equipment and quality control, technical guidelines • Treatment process, clinical guidelines • Treatment delivery, on-line control
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Standard-based quality • Imaging, target definition, clinical guidelines • Equipment and quality control, technical guidelines • Treatment process, clinical guidelines • Treatment delivery, on-line control • Process control
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Process control • Prospective
• HFMEA • Other approaches
• Retrospective • Incident registration • Incident root-cause analysis • Return on experience • Communication within the department • Communication between departments
• Internal audit • External audit
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Two approaches
• Standard (or process) based quality
• Safety-based quality
An engine failure is not a safety issue An engine failure is a safety issue
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Radiotherapy is different • We are not free to select or define our level of quality…
Rolls Royce Ford T
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Reference document
ISO 9002 Process-based But patient safety?
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Development of a quality system 1. Select standard. 2. Describe procedures or processes (quality assurance). 3. Use FMEA to refine procedures or processes
proactively. 4. Run processes. 5. Monitor outcome. 6. Register failures (incidents/accidents). 7. Analyse failures and feed-back to
quality system.
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Indicators
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DECISION MAKERS
- Available money - Equipment/plant - Personnel/expertise - Available time
FEEDBACK - Success indicated negatively - Traditional measures noisy and deceptive - Indirect reinforcement value of itself - Only achieves high salience after accident or near-miss
FEEDBACK - Success indicated positively - Readily and reliably gauged - Direct and continuous - Obviously reinforcing - Salient and imperative
RESSOURCES
SAFETY GOALS
PRODUCTION GOALS
Defensive filters
Outcome Relatively uncertain
Outcome Relatively
certain
Injuries Events Outages Accidents Etc.
Rate Range Profit Market share Etc.
Challenge…
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The lifespan of a hypothetical organisation through the production-protection space
Production
Pro
tect
ion
Bankruptcy
Catastrophe incident accident
Better defences converted to increase production
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Breast cancer survival in Belgium • Volume effect
measured in Belgium between centres treating over 150 case/year (14 hospitals) and less than 100 case/year (83 hospitals): 84 vs. 77 % 5y survival
• Corrected for age, stage, grading.
KCE Report 150B
Stage II
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Rate of mastectomy depends on the presence of a RT department in the hospital
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What is the next frontier?