Clinical Audits
meaning and strategy
results of the pilot study with
participation of centers
Marleen Vandecapelle
Protection of Health
Federal Agency Nuclear Control
15/06/2011
Round Table and Working Parties
•
27/11/2009: Round Table Radioprotection in Nuclear Medicine:
physicians, medical radiation physicists, radiation experts,
radiopharmacist, auxiliaries, competent authorities,…
WP1 Quality Assurance
and Clinical Audit
WP2 Vigilance system
WP3 Justification
and optimization
•
WP4 Medical
Radiation Physics
WP5 Radionuclide
therapy
WP6 Education and
administrative
simplification
Input for revision/clarification of Chapter VI of RD 20th July 2001
(ARBIS/RGPRI) on application of ionizing radiation in medicine
Marleen Vandecapelle - 15/06/2011
www.fanc.fgov.be/nl/page/werkgroepen-stralingsbescherming-inde-nucleaire-geneeskunde/1291.aspx
What Clinical Audit ?
• Euratom 97/43 “Council Directive on health protection against the
dangers of ionizing radiation in relation to medical exposure”
• RD 20th July 2001 “General Reglementation on the Protection of
Population, Workers and Environment against the Dangers of
Ionizing Radiation” (ARBIS/RGPRI)
“Clinical audit : a systematic examination or review of medical radiological
procedures which seeks
to improve the quality and the outcome of patient care through structured
review not
whereby
2010:
implemented in Belgium and 2/3 of Europe !
radiological practices, procedures and results are examined against agreed
Clear
need
for further
guidance
standards for good
medical
radiological
procedures,
to improve
implementation
and
with modification
of practicesits
where
indicated and the application
of new
if necessary.”
to standards
harmonize
the approaches among the Member States
Clinical audits shall be carried out in radiological installations determined by
the Agency and following the modalities determined or approved by the
Agency.”
Marleen Vandecapelle – 15/06/2011
Clinical Audit: international initiatives
2008
2009
2010
Sufficient guidelines to determine modalities of clinical audit
Marleen Vandecapelle – 15/06/2011
Clinical Audit: national initiative
• WP1 QA and Clinical Audit
– Basis QUANUM
– Timing agreed
– Collaboration ≠ competent authorities
• QUANUM
– Essentially consists of checklists
Y/N questions on 13 ≠ topics
– Audit by peer review of
multi-disciplinary teams
– General because globally applicable
Marleen Vandecapelle – 15/06/2011
Timing Clinical Audits
• Pilot study:
–
–
–
–
performed by 18 NM departments
Belgian version B-QUANUM
suggestions for extra support
01/09/2011 – 01/07/2011
• Auto-evaluation
• Internal CA
• Final destination: external CA in all NM departments with QUANUM
01/09/2010 01/07/2011
Pilot
18 NM
Auto-evaluation + Internal CA
All NM
All NM
Marleen Vandecapelle – 15/06/2011
B
?
+ External CA
All NM
Timing Clinical Audits
• Auto-evaluation : 01/07/2011 - …
– to auto-evaluate and take corrective actions based on B-QUANUM
– continuous process
– by colleagues within the department
• Internal clinical audit : 01/07/2012 - …
– 1x/year
– by colleagues within the hospital
• External clinical audit : 01/07/2013 - …
– 1x/5years
– by colleagues within Belgium
01/09/2010 01/07/2011
Pilot
18 NM
01/07/2012
01/07/2013
Auto-evaluation + Internal CA
All NM
All NM
Marleen Vandecapelle – 15/06/2011
B
+ External CA
All NM
B-QUANUM
AUDIT DE GESTION DE LA QUALITE
EN MEDECINE NUCLEAIRE AUDIT GLOBAL
AUDITS DE GESTION DE LA
QUALITE EN MEDECINE
NUCLEAIRE AUDIT GLOBAL
AUDITS VAN HET
KWALITEITSBEHEER IN DE
NUCLEAIRE GENEESKUNDE UITGEBREIDE AUDIT
Marleen Vandecapelle – 15/06/2011
B-QUANUM annexes
• Annexe 1 Example of annual report 20101
– Practical information on content and format of annual report
• Annexe 2 List of Standard Operating Procedures (SOP’s)
–
–
–
–
•
•
•
•
•
•
1
2
Clinical procedures
Medical radiation physics
Radiopharmacy
Support
If not performed
=
not applicable
Annexe 3 Extract SOP Bone scintigraphy2
Annexe 4 Extract SOP Whole Body 18F-FDG2
Annexe 5 Extract ISO Manual2
Annexe 6 Extract Quality Manual2
Annexes 7-17 Checklists
Annexe 18 Regulatory basis checklists from ARBIS/RGPRI
Courtesy to dr. J. Rutten, AZ Turnhout
Courtesy to dr K. Van Laere, UZ Leuven
Marleen Vandecapelle – 15/06/2011
B-QUANUM checklists
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Strategies and policies
Administration and management
Human resources
Radiation protection of personnel and environment
Radiation protection of the patient and his direct
environment
Quality assurance system
Quality control of imaging equipment and dose
calibrator
Computer systems and data handling
Acceptance tests
General aspects - diagnostics
General aspects - radionuclide therapy
Marleen Vandecapelle – 15/06/2011
B-QUANUM checklists
CHECKLIST 6: QUALITY ASSURANCE SYSTEM
%
Comments
Date
achieved
Component
6.1
Are Standard Operating Procedures
available for all tasks performed by
the department?
A
Required
IAEA technical
Corrective
51.4§3 by0 legislation,
document 25
or other
external
standardactions
?
setting bodies.
50
Urgent corrective
action should be
75
instituted. 100
6.10
Does the department perform selfevaluation or internal audit once a
year?
B
Not compulsory, but are expected to be
reached by all departments.
Corrective action is recommended.
6.11
a. Is the satisfaction of the
patients evaluated?
b. Is the satisfaction of the
referring physicians evaluated?
C
Desirable but not essential.
Corrective action may improve the
overall functioning of the department.
REMARQUE:
Class
ARBIS/
RGPRI
No
Checklists are just the starting point for discussion !
Not applicable is also an answer !
Marleen Vandecapelle – 15/06/2011
B-QUANUM checklists
CHECKLIST 1: STRATEGIES AND POLICY (9 questions)
No
Component
1.3
a. Does the department make a policy plan ?
a.1. Are quality objectives formulated ?
a.2. Is there a system to evaluate the policy
objectives ?
b. Does the department make an annual report ?1
1.7
1
Class
B
plan
Are there written agreements with
a.
other clinical departments
b.
technical department
of the hospital with indication of each tasks and responsibilities ?
Explanation in annexe 1: Example of an annual report
Marleen Vandecapelle – 15/06/2011
and
quality
A
B-QUANUM checklists
CHECKLIST 3: HUMAN RESOURCES (10 questions)
No
Component
Class
3.2
Have all categories of professionally exposed persons active in the department
followed basic education radioprotection ?
A
3.7
Do all categories of professionally exposed persons active in the department
follow continuing education radioprotection ?
A
3.9
Is there a system within the hospital to identify the need for education of its
personel ?
B
3.10
Does all personnel have access to scientific literature through e-learning,
recent books and magazines ?
B
Marleen Vandecapelle – 15/06/2011
B-QUANUM checklists
CHECKLIST 4: RADIATION PROTECTION OF PERSONNEL AND ENVIRONMENT
(21 questions)
No
Component
Class
4.1
a.
b.
Does the department have a authorisation granted by the FANC ?
Is it up to date ?
A
4.12
Are there calibrated, funtioning contamination monitors for all radioisotopes
stated in the authorisation granted by the FANC ?
A
4.14
Do all profesionnaly exposed persons wear a chest dosimeter delivered and
read by a dosimetric service recognised by the FANC ?
A
4.19
Is there a separate toilette for personnel ?
B
Marleen Vandecapelle – 15/06/2011
B-QUANUM checklists
CHECKLIST 5: RADIATION PROTECTION OF PATIENTS AND DIRECT ENVIRONMENT
(12 questions)
No
Component
5.1
Are all applications approved and justified by a nuclear physician authorised
by the FANC for
a. diagnostic procedures ?
b. therapeutic procedures ?
A
5.3
Are all administerd activities conform (inter)national DRL’s for
a. diagnostic procedures ?
b. therapeutic procedures ?
A
5.6
5.7
5.10
5.11
5.12
Class
Are oral/written instructions given to the patient (or his legal guardian) ?
Is before administration of the radiopharmaceutical
a. His/her name and date of birth asked ?
b. asked whether she is pregnant or is lactating ?
c. checked whether he/she had similar imaging procedure ?
Marleen Vandecapelle – 15/06/2011
A
A
B-QUANUM checklists
CHECKLIST 6: QUALITY ASSURANCE SYSTEM (18 questions)
No
Component
6.2
Do al SOP’s for clinical procedures performed by the department contain the
following (if applicable):1,2
a. Clinical question/Purpose of the examination ?
b. Principle ?
c. Indications and contra-indications ?
d. How to make an appointment ?
e. Preparation of the patient ?
f. Planning ?
g. Reception of the patient ?
h. Preparation of the radiopharmacon ?
i. Administration of the radiopharmacon ? j. Execution of the examination ?
k. Reconstruction and processing ?
l. After examination ?
m. Assessment/making protocol ?
n. references ?
o. Version ?
p. Person validating SOP ?
q. Person approving SOP ?
1
2
Class
a list of SOP’s is available in annexe 2
extracts from SOP’s are availabel in annexe 3 and 4
Marleen Vandecapelle – 15/06/2011
B
B-QUANUM checklists
CHECKLIST 7: QUALITY CONTROL OF IMAGING EQUIPMENT AND
DOSECALIBRATORS (21 questions)
No
Component
Class
Based on Quality Assurance Protocols for gamma camera and dosecalibrator
(soon to be published in a degree of the FANC)
and
Feed back from medical radiation physicists nuclear medicine on QUANUM
A
CHECKLIST 9: ACCEPTANCE TESTS (6 questions)
No
Component
Class
Based on feed back from medical radiation physicists nuclear medicine on
QUANUM
Marleen Vandecapelle – 15/06/2011
A
B-QUANUM
• Self-evaluation: 1 coordinator/department
• Audit: Peer review by multi-disciplinary teams of ≥ 3 experts
Internal audit:
External audit:
–
–
–
–
–
–
physician nuclear medicine
(medical radiation physicist)
(technologist medical imaging)
(radio/hospital pharmacist)
(referring physician)
(hospital management)
–
–
–
–
physician nuclear medicine
(medical radiation physicist)
(technologist medical imaging)
(radio/hospital pharmacist)
• Auditors should be independant, have enough knowledge and
experience !
Marleen Vandecapelle – 15/06/2011
B-QUANUM
• First time round: probably not a lot of 100%
Not important !!! If start of corrective actions
• Look for input from:
–
–
–
–
–
–
–
–
Hospital management
Human Resources Management department hospital
Quality coordinator/department hospital
Medical radiation physicist (internal or external)
Health physics department (internal or external)
IAEA, FANC,
Scientific societies (Belnuc, EANM, SNM, NVNG, BSNM, …)
…
• Document management tool:
– MITRAS
– Knowledge tree (www.knowledgetree.com) avaible for free
Marleen Vandecapelle – 15/06/2011
Why Clinical Audit ?
• To assess current status of a NM
department and to identify areas
for future improvement
• Opportunity
to
improve
yourselves based on experience
from peer reviewers
• Stop and think about
“Are we doing the right things ?”
“Are we doing them right ?”
at every level (nuclear physician,
medical radiation physicist,
technologist,…)
Marleen Vandecapelle – 15/06/2011
Why Clinical Audit ?
• Optimization of
– Radiation protection personnel
– (Radiation) protection patient
– Patient care
• Optimization of use of
– resources
– infrastructure
– personnel
• Lower risk (near)incidents
• Protection against potential
damage claims from
patients/personnel
• Proof of quality:
–
–
–
–
–
towards NM community
towards referring physicians
towards patients
towards hospital management
to attract potential (commercial)
partners
Marleen Vandecapelle – 15/06/2011
Who should organize ?
• Federal Authority for Public
Health ?
– Contract
“Coordination
of
quality and patient-safety in
Belgian Hospitals”
– 2004-2012
• College for Medical Imaging of
Federal Authority for Public
Health ?
// RT
• Belnuc ?
// NVNG, BSNM, DGN
Marleen Vandecapelle – 15/06/2011
Timing Clinical Audits
01/07/2011: start of auto-evaluation for all NM departments
• Active mailing to all NM departments
+ corresponding hospital management
• FANC website:
– B-QUANUM (Fr + D)
– Annexes (Fr +D)
– Already available:
• QUANUM (E + Fr + D + G)
• EC159 (E)
• Extracts from quality manual and from SOP’s (Fr + D)
01/09/2010 01/07/2011
Pilot
18 NM
01/07/2012
01/07/2013
Auto-evaluation + Internal CA
All NM
All NM
Marleen Vandecapelle – 15/06/2011
B
+ External CA
All NM
Acknowlegments
• 18 pilot study participants





Dr P. De Bondt (OLV Aalst)
Dr B. Krug (UCL Mont-Godinne)
Dr J. Rutten (AZ Turnhout)
Dr K. Van Laere (UZ Leuven)
G. Lapeirre (AZ Groeninge)
• Pascal Froment (AVC)
• Philippe Van Boxem (EBNM/CANMD +
QUANUM auditor for IAEA)
• Tom Clarijs and Petra Willems (FANC)
Aalst OLV Ziekenhuis
Arlon St-Joseph
Hornu CH Hornu-Frameries
Kortrijk AZ Groeninge
Mons CHR
Oostende AV Serruys
Roeselare Stedelijk Ziekenhuis
St-Truiden St-Trudo
Tienen Stedelijk Ziekenhuis
Tournai A.I.T. Site Union
Turnhout AZ St-Elisabeth
Bruxelles Jules Bordet
Bruxelles CHU St-Pierre
Charleroi CHU de Charleroi
Jette UZ Brussel
La Louvière CHU Tivoli
Leuven UZ Gasthuisberg
Yvoir UCL Mont-Godinne
Marleen Vandecapelle – 15/06/2011
Thank You for listening !
Marleen Vandecapelle
Federal Agency for Nuclear Control
Ravensteinstreet 36
1000 Brussels
marleen.vandecapelle@fanc.fgov.be
++32 (0)2 289 21 78
http://www.fanc.fgov.be/
Marleen Vandecapelle – 15/06/2011