Clinical Audits meaning and strategy results of the pilot study with participation of centers

Clinical Auditsmeaning and strategy

results of the pilot study withparticipation of centers

Marleen VandecapelleProtection 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,…

• Input for revision/clarification of Chapter VI of RD 20th July 2001 (ARBIS/RGPRI) on application of ionizing radiation in medicine

WP6 Education and

administrative simplification

WP4 Medical Radiation Physics

WP3 Justification and optimization

WP1 Quality Assurance and Clinical Audit

WP2 Vigilance system

WP5 Radionuclide therapy

Marleen Vandecapelle - 15/06/2011

www.fanc.fgov.be/nl/page/werkgroepen-stralingsbescherming-in-de-nucleaire-geneeskunde/

1291.aspx

• 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 whereby radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices where indicated and the application of new standards if necessary.”Clinical audits shall be carried out in radiological installations determined by the Agency and following the modalities determined or approved by the Agency.”

2010: not implemented in Belgium and 2/3 of Europe !Clear need for further guidance

to improve its implementation and to harmonize the approaches among the Member States

What Clinical Audit ?

Marleen Vandecapelle – 15/06/2011

2009 2010


Clinical Audit: international initiatives

2008

Sufficient guidelines to determine modalities of clinical audit

• 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


Clinical Audit: national initiative

• 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

?

Timing Clinical Audits

+ External CA

All NM

B


01/09/2010

Pilot

18 NM

01/07/2011

+ Internal CAAuto-evaluation

All NMAll NM


• 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

+ External CA+ Internal CAAuto-evaluation

01/07/201301/07/2012

All NMAll NMAll NM

01/07/201101/09/2010

Pilot

18 NM


B

AUDITS VAN HET KWALITEITSBEHEER IN DE NUCLEAIRE GENEESKUNDE -UITGEBREIDE AUDIT

AUDIT DE GESTION DE LA QUALITEEN MEDECINE NUCLEAIRE -AUDIT GLOBAL

AUDITS DE GESTION DE LA QUALITE EN MEDECINE NUCLEAIRE -AUDIT GLOBAL


B-QUANUM

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)– Clinical procedures– Medical radiation physics– Radiopharmacy– Support

• 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/RGPRI1 Courtesy to dr. J. Rutten, AZ Turnhout2 Courtesy to dr K. Van Laere, UZ Leuven

If not performed =

not applicable


B-QUANUM checklists

1. Strategies and policies2. Administration and management3. Human resources4. Radiation protection of personnel and

environment5. Radiation protection of the patient and his direct

environment6. Quality assurance system7. Quality control of imaging equipment and dose

calibrator8. Computer systems and data handling9. Acceptance tests10. General aspects - diagnostics11. General aspects - radionuclide therapy


No Component Clas

s ARBIS/RGPRI

% CommentsDate

achieved

6.1 Are Standard Operating Procedures available for all tasks performed by the department?

A 51.4§3

6.10

Does the department perform self-evaluation or internal audit once a year?

B

6.11

a. Is the satisfaction of the patients evaluated?

b. Is the satisfaction of the referring physicians evaluated?

C

B-QUANUM checklists

Required by legislation, IAEA technical document or other external standard-setting bodies.Urgent corrective action should be instituted.

Desirable but not essential. Corrective action may improve the overall functioning of the department.

Not compulsory, but are expected to be reached by all departments. Corrective action is recommended.


REMARQUE: Checklists are just the starting point for discussion !

Not applicable is also an answer !

0255075

100

Corrective actions ?

CHECKLIST 6: QUALITY ASSURANCE SYSTEM

No ComponentClas

s

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 plan and quality objectives ?b. Does the department make an annual report ?1

B

1.7 Are there written agreements witha. other clinical departmentsb. technical departmentof the hospital with indication of each tasks and responsibilities ?

A


B-QUANUM checklists

CHECKLIST 1: STRATEGIES AND POLICY (9 questions)

1 Explanation in annexe 1: Example of an annual report

No ComponentClas

s

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


B-QUANUM checklists

CHECKLIST 3: HUMAN RESOURCES (10 questions)


B-QUANUM checklists

CHECKLIST 4: RADIATION PROTECTION OF PERSONNEL AND ENVIRONMENT(21 questions)

No ComponentClas

s

4.1 a. Does the department have a authorisation granted by the FANC ?

b. 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


B-QUANUM checklistsCHECKLIST 5: RADIATION PROTECTION OF PATIENTS AND DIRECT ENVIRONMENT(12 questions)

No ComponentClas

s

5.1 Are all applications approved and justified by a nuclear physician authorised by the FANC fora. diagnostic procedures ?b. therapeutic procedures ?

A

5.3 Are all administerd activities conform (inter)national DRL’s fora. diagnostic procedures ?b. therapeutic procedures ?

A

5.65.7

Are oral/written instructions given to the patient (or his legal guardian) ?

A

5.105.115.12

Is before administration of the radiopharmaceuticala. 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 ?

A


B-QUANUM checklists

CHECKLIST 6: QUALITY ASSURANCE SYSTEM (18 questions)

No ComponentClas

s

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 ?

B

1 a list of SOP’s is available in annexe 22 extracts from SOP’s are availabel in annexe 3 and 4


B-QUANUM checklists

CHECKLIST 7: QUALITY CONTROL OF IMAGING EQUIPMENT AND DOSECALIBRATORS (21 questions)

No ComponentClas

s

Based on Quality Assurance Protocols for gamma camera and dosecalibrator (soon to be published in a degree of the FANC)andFeed back from medical radiation physicists nuclear medicine on QUANUM

A

No ComponentClas

s

Based on feed back from medical radiation physicists nuclear medicine on QUANUM

A

CHECKLIST 9: ACCEPTANCE TESTS (6 questions)

B-QUANUM

• Self-evaluation: 1 coordinator/department• Audit: Peer review by multi-disciplinary teams of ≥ 3 experts

Internal audit: External audit:– physician nuclear medicine – physician nuclear medicine– (medical radiation physicist) – (medical radiation physicist)– (technologist medical imaging) – (technologist medical imaging)– (radio/hospital pharmacist) – (radio/hospital pharmacist)– (referring physician)– (hospital management)

• Auditors should be independant, have enough knowledge and experience !


• 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

B-QUANUM


• 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,…)


Why Clinical Audit ?

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


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



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)

+ External CA+ Internal CAAuto-evaluation

01/07/201301/07/2012

All NMAll NMAll NM

01/07/201101/09/2010

Pilot

18 NM


B

AcknowlegmentsAalst OLV ZiekenhuisArlon St-Joseph Hornu CH Hornu-FrameriesKortrijk AZ GroeningeMons CHROostende AV SerruysRoeselare Stedelijk ZiekenhuisSt-Truiden St-TrudoTienen Stedelijk ZiekenhuisTournai A.I.T. Site UnionTurnhout AZ St-Elisabeth

Bruxelles Jules BordetBruxelles CHU St-PierreCharleroi CHU de CharleroiJette UZ BrusselLa Louvière CHU TivoliLeuven UZ GasthuisbergYvoir UCL Mont-Godinne


• 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)

Thank You for listening !

Marleen VandecapelleFederal Agency for Nuclear

ControlRavensteinstreet 36

1000 [email protected].

be++32 (0)2 289 21 78

http://www.fanc.fgov.be/Marleen Vandecapelle – 15/06/2011

Documents

Clinical Audits meaning and strategy results of the pilot study with participation of centers