Summary of the EANM quality course 27 – 28 March 2010

P. De BondtJ. Rutten

Summary

• EANM-UEMS: accreditation of nm departments (ISO mandatory)

• IAEA: QUANUM: checklist + int and ext audits• EURATOM directive 97/43: clinical audits

The main rules: EURATOM Directive 97/43

Ph. Van Boxem, ING UEMS/EBNM CANMD – Vice Chairman

2010

Where can you find 97/43/Euratom??

• Title:

« Council Directive on health protection against the dangers of ionizing radiation in relation to medical exposure »

• On the web:europa.eu.int/comm/environment/ radprot/legislation/9743.pdf europa.eu.int/comm/environment/radprot/ legislation/9743_fr.pdf

Content of the 97/43/Euratom• Justification:

– Medical exposure shall show a sufficient net benefit (advantages) If no justification, it should be prohibited.

• OptimizationA.L.A.R.A. consistent with obtaining the required diagnostic information.– Diagnostic reference levels should be established

• Responsibilities– Prescriber and the practitioner

• Procedures– Written protocols shall be established for standard practice– Referral criteria are available for prescribers including radiation doses– Medical physics expert are available for NM (optimization , QA, QC, …)– Clinical audits must be carried out

• Inspection:– Competent authorities shall establish a system of inspection.

What does it mean for the NM department?

• All examinations must be justified• ALARA compatible with the set goal• Written protocols to realize examinations• Involved people must be qualified• QA, QC, clinical audit• Continued education

What does it mean for the NM department?

• Equipment must be conform (old and new)• Special care for pediatric exams• Special care for CT examinations• Patient information is important.

The basis:Council Directive 97/43 EURATOM

« Council Directive on health protection against the dangers of ionizing radiation in relation to medical exposure »

Clinical audit in MED DirectiveArticle 6.4.

Clinical audits shall be carried out in accordance with national procedures.

International Workshop on Practical Implementation of Clinical Audit for Medical Exposure to Ionizing Radiation, Tampere, Finland, 7-10 September 2008

EUROPEANCOMMISSION

(Simeonov)

Aim of the EC Guidelines• To provide guidance on clinical audit in order to

improve implementation of Article 6.4 of Council Directive 97/43/ EURATOM.

Clinical audit is...

a systematic examination or review

of medical RADIOLOGICAL

procedures

CANMD goals and achievements

L.Maffioli

AcronymsC. A. N. M. D. Committee for

Accreditation ofNuclearMedicineDepartments

U. E. M. S. / E. B. N. M.

NuclearBoardEuropeanEuropean

MedicalSpecialists

is a permanent committee of

Aims of the Committee

To implement the introduction of an accreditation system in Europe.

To give assistance and help to all nuclear medicine departments in Europe which apply for an accreditation.

To have a Quality Manual with respect to the ISO 9001:2008 standard as a basis to create a specific Quality Management for an individual nuclear medicine facility.

This software package is not intended to do everything for you, or take over your job. It will guide you in the (sometimes unusual) quality vocabulary, explain what a quality system is, show you some examples and templates for documents, and overall help you to implement step by step YOUR quality system.

Download ISO Software

Steps in the QMS

What to do? Documents

1 Read all documents:

“QUALITY INFORMATION”

Quality management principles (TD-001) Quality managements systems (TD-002) Process approach (TD-003) Terms (TD-004)

2 QUALITY MANUAL

2.1 Initiate into the adaptation of Quality Manual in your Nuclear Medicine Department.

Quality Manual (DC-001)

2.2 Quality policy: To define the states of NMD Quality

Policy. Quality Policy (DC-002)

2.3 Organization: Identify the NMD jobs. Design the organization chart.

Organization chart (DC-004)

2.4

Process Map: Identify all NMD processes To classify in:

Management Processes, Key Processes, Support Processes.

Design the Process Map.

Process Map (DC-005)

2.5 Identify the General Procedures General Procedures (GP-xxx)

3 GENERAL PROCEDURES

3.1 Codify documentation of quality system Document control list (F-001)

3.2 Approve procedure’s form General procedure form (F-002)

3.3

Initiate and establish NMD procedures: Determine activities needed to achieve the intended outputs of the process. Purpose. Inputs. Activities. Outputs. Procedure description. Associated documents. Records. Indicators.

General Procedures (GP-xxx)

3.4 To plan the implementation of general procedures

Planning general procedures

3.5 Create general procedures DOCUMENTS CONTROL and RECORD CONTROL

Documents control (GP-001) Record control (GP-002)

GuideISO Software: the “read me”

CANMD ISO Software: “Main Documents”

CANMD ISO Software: General Procedures

18

How to download the software

• www.eanm.org (or http://uems.eanm.org )UEMS/EBNM

Committees Accr. Nuclear Medicine Dept. Download ISO software

• Fill the form and begin the download

The IAEA perspective: introduction to QUANUM

Maurizio Dondi Nuclear Medicine SectionDivision of Human Health

International Atomic Energy Agency

Nuclear Medicine Section• Mission:

– By strengthening quality of practice, to enhance capabilities of Member States to address health needs by the use of nuclear medicine

Many hospital facilities in poor state.Lack of understanding of procedural guidelines.Staff maybe poorly trained and lack appropriate understanding and qualifications.Very little or no end-user QC.Poor radiation hygiene and waste management.

Customer satisfaction rarely taken into account

The need for Quality management (QM) in Nuclear Medicine

• Customer oriented organizations committed to quality care

• Improvements in effectiveness and efficiency

• Continuous educational process

The Quality Management Audits of Nuclear Medicine Practices project

QUANUM is a means by which nuclear medicine facilities can demonstrate the level of patient care they provide by following a process of self- and external evaluation (audits)

QUANUM

http://www-pub.iaea.org/MTCD/publications/PDF/Pub1371_web.pdf

Pre-mission Requests• Internal self appraisal (checklist provided)

• Complete NUMDAB – database http://nucmedicine.iaea.org/– infrastructure & equipment– qualified staff & training – programmes– QA programme

1.STRATEGY AND OBJECTIVES Components:

No Component Class Verifiable – Manual, Reference Documentation, SOP, QC Data, Patient file etc.

Y/N Comments/Planned Action Date achieved.

5.2.1 Is the nuclear medicine service guided by specific objectives developed at the national level?

A IAEA Nuclear Medicine Resources Manual

5.2.2 Is the nuclear medicine service guided by specific objectives developed by the management of the service and is consistent with the overall stated aims of the nation or hospital?

A IAEA Nuclear Medicine Resources Manual

5.2.3 Does hospital management seek the participation of the nuclear medicine staff in decisions which will affect the Department’s role and function?

B IAEA Nuclear Medicine Resources Manual

5.2.4 Is the range of specific nuclear medicine diagnostic imaging and therapeutic services appropriate to the size and scope of the hospital’s clinical service?

B IAEA Nuclear Medicine Resources Manual

5.2.5 Do the objectives of the nuclear medicine service include the provision of services on urgent requests?

B

Type of investigation

Type of study

Clinical problem

Patient preparation

Radio-pharmaceutical and activity

Acquisition parameters

Processing parameters

Images Final report

Recommendations

Planar Thyroid IAEA Nuclear Medicine Resources Manual. e.g. I/II/III

Planar Whole body

Bone IAEA Nuclear Medicine Resources Manual

Dynamic Renography IAEA Nuclear Medicine Resources Manual

SPECT e.g. bone IAEA Nuclear Medicine Resources Manual

Cardiac SPECT

MPS IAEA Nuclear Medicine Resources Manual

IMAGING DIAGNOSTIC PROCEDURES Final summary table

21.04.23

Slide 27

QC of equipment

http://www-pub.iaea.org/MTCD/publications/PDF/Pub1394_web.pdfhttp://www-pub.iaea.org/MTCD/publications/PDF/Pub1393_web.pdf

Slide 28

IAEA-Operational Guide on Hospital Radiopharmacies

http://www-pub.iaea.org/MTCD/publications/PDF/Pub1342/Pub1342_web.pdfhttp://www-pub.iaea.org/MTCD/publications/PDF/Pub1344_web.pdfhttp://www-pub.iaea.org/MTCD/publications/PDF/TCS-39_web.pdf

QC - dose calibrators• constancy test• linearity• accuracy

• For each of different isotopes used

• Closer look behind the lead shield!

Accurate and traceability of actual records of patient dose