B-Quanum: Practical Aspects
Ph. Van Boxem, Ing.
Institute for Radioelements
Fleurus - B
IAEA - Quanum Auditor
The origin of Quanum
IAEA
“The Agency shall seek to
accelerate and enlarge the
contribution of atomic energy to
peace, health and prosperity
throughout the world”
Article II of the Statutes of IAEA
Nuclear Medicine Section of IAEA
•
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
Management
Quality Assurance in Health Care
Quality Management in Health Care
Aim
• Provide best possible service to patients
• At the lowest possible risk
• At adequate costs for patients and community,
including the environment
QUANUM
http://www-pub.iaea.org/MTCD/publications/PDF/Pub1371_web.pdf
Comprehensive audit
What an audit should be …
Audit
should
Be a multidisciplinary,
multiprofessional
activity.
Be a systematic
and continuing
activity
Follow general
accepted rules
and standards
which are based
on
international,
national or local
legal regulations
guidelines developed
by medical and
clinical professional
societies.
the
recommendations
given in audit
reports are
implemented.
B-Quanum: base for audits
• Legal requirement since
2001
• Internal self appraisal
since July 2011
• Internal audits starting
in July 2012
• External audits starting
in July 2013.
Need to remember ...
Going through an audit is:
Demonstrating how good the
patient care level in the
department is at the time of the
audit ...
and ...
How the patient care level is
enhanced through managed
actions and structured process.
Need to remember ...
Audit must:
• Happen with a Yearly frequency
• Cover all aspects
• policies
•Human resources
•Risk management
•Clinical procedures
• or be specific (follow up audit)
B-Quanum Procedure
B-Quanum: practical
• How to prepare for internal audit?
• How to organize internal audit?
• How to execute internal audit with B-Quanum
as referential?
Essential Internal preparation
• Re-visit underlying reasons for the audit with all the stakeholders
• Sensitize team and prepare them for external review process
– Re-establish objectives for the team
– Ensure team efforts
– Commitment and openness of the team
• Update data and cross check information submitted
• Review previous audits and insure required actions have been
undertaken.
Comprehensive and well controlled
documentation system
...
Contract review
Quality Manual
Job descriptions,
Responsibilities &
authority
Document control
Purchasing
Process control
Inspection and
testing
Procedures
Test equipment
Quality records
Operating Instructions
Quality audits
Training
Reports
Tables
Servicing
Statistical
techniques
...
Guide to audit questionnaires
• Yes or no is not sufficient
• “Comments/Planned Action”- Documentation reference
• non-compliances should be noted, however, prioritization
is based on the implication for patients
• priority can be defined as ‘Critical, Major, or Minor’
• Agree action and timely follow-up
Address each element of the audit
• Complete all the tables
• What is done in practice rather than what is expected
• Proof of practice
• Tidy all areas of concerns before external audit
• Contingencies and Realistic programme
• Demonstrate ongoing continuous development
Immediately before external audit
• Check and Confirm that appointments are acceptable
• Be pro-active and tidy up
• Book rooms and assemble documentation, cases studies etc.
• Agree a programme with senior managers- allow time for formal and informal
discussions
• Maintain reasonable routine work load so that auditors can observe practices
• Aim to get maximum benefit and leverage out from the audit.
Preparation for internal audit:
summary
Have gone through self evaluation before internal audit
•
• Have the material of the audited process ready:
– Records, files, clinical data
– Quality manual
– Useful documentation
• Have the prepared material transferred to the audit team
• Inform the department , the hospital and other people that the audit
happens
• Organize the availability of the needed people
• Organize the required meetings
• Organize the access to the different places where the audit must happen
 An audit must be prepared; one should participate to an audit and not
afford or suffer an audit
B-Quanum: practical
• How to prepare for internal audit?
• How to organize internal audit?
• How to execute internal audit with B-Quanum
as referential?
How to organize …
• An audit leader must be chosen
• Audit leader selects the other team members:
– Independant people
– Having knowledge of the procedures and
protocols
– Having gained respect from the other team
members
– One external person representing users
Example of an audit crew …
•
•
•
•
•
•
•
Audit leader
Nuclear medicine physician
Radiophysicist
Technologist
Hospital pharmacist // radiopharmacist
Nursing
Hospital administration representative
• At least three people
Set the agenda …
• An agenda of the audit must be defined
• Proposed by the audit team to the audited
department
• Depending on the material delivered upfront
• Depending on the type of audit (follow up or
first)
Set the agenda …
• « Starting the audit » briefing
• Questionnaires review
• Minimal requirements review
• « End of audit » briefing
• Conclusion and report
Starting the audit briefing …
•
•
•
•
Select the process to be reviewed
Audit orientation
Team members to participate
Garantee of confidentiality
Questionnaires review
• Will cover infrastructure and global nuclear
medicin program:
– Managment:
• goals and objectives,
• admin and management,
• HR development
Questionnaires review
– Risk management
•
•
•
•
•
•
People and environment radioprotection
Patient radioprotection
Quality assurance
Quality Control of imaging material
Computers and data processing systems
Acceptance tests
Questionnaires review
– Clinical procedures:
• General aspects
• Diagnostic
– Imaging procedures: what is the clinical problem? How to
prepare the patient? Which product? Acquisition parameters?
Processing parameters? Images? Final report? Feed-back?
Grade I, II (4 weeks), III (six months)
– Non-imaging procedures: idem + calculation method
• Therapy
– Idem + calculation and treatment validity? Grade I, II
(immediate) and III (six months)
Questionnaires review
• Examine all process:
– Management
– Primary
– Support
Questionnaires review
PROCESSI DI DIREZIONE
Adempimenti
normativi
Definizione politica e
strategie
Definizione pianificazione e
monitoraggio obiettivi
Messa a disposizione
delle risorse
PROCESSI PRIMARI
Diagnostica
in vivo
Prenotazione
esame
Terapia
Ambulatorio
Accettazione
amministrativa
Valutazione
Prenotazione
Valutazione
appropriatezza
Preparazione
radiofarmaco
Pianificazione e
Somministrazione ed
stima dosimetrica
eventuale imaging
Accettazione amministrativa
Somministraz
.
radiofarmaco
Esame
Raccomandazioni
Visita
Prescrizioni
Validazione,
refertazione e
consegna
referto
Referto e
followup
Referto e
followup
PROCESSI DI SUPPORTO
Gestione
risorse
umane
Gestione
risorse
tecnologiche
Ufficio pers.
Uff. tecnico _ SIA
Ufficio formazione Ing. Clinica - Ditte
Gestione
risorse
strutturali
Gestione
approvvigiona
mento
Gestore impianti
Farmacia
Magazzino
Attività di
Fisica medica
ed EQ
CQ – Dosimetria
Radioprotezione
Gestione
Rifiuti e pulizie
SIECIO
Ditta esterna
Gestione
Sistema
informatico
Gestione
Sistema
qualità
Sist. Inform. Az.Risk management
Audit
Questionnaires review
•
•
•
•
A: legal or international standards
B: normally present
C: desirable but not essential
%: if not 100%, there should be remarks,
action plan
• RATING PROPOSAL
–
–
–
–
–
0 %NOT YET THOUGHT ABOUT/ NOTHING IS DONE
25 % PLANNED
50 % PLANNED AND START IMPLEMENT
75% PLANNED AND IMPLEMENTED
100 % HAS GONE THROUGH A FULL DEHMING CYCLE / REVIEWED AND ENHANCED / CLEARLY DOCUMENTED
Tabel calculation
VALUES CALCULATED in the tabel
• Adm and Mgmt = (SUM OF THE POINTS OF
THE A's : NUMBER A's *4) * 100
Example: number of A’s in checklist #2= 6
Result obtained in the A’s questions: 8
  (8 / 6*4) * 100 = 34
Rating tabel
# checklist
NAME OF THE CHECKLIST
A
1
STRATEGY AND OBJECTIVES
82
2
ADMINISTRATION ANDS MANAGEMENT
34
3
HUMAN RESSOURCES DEVELOPMENT
35
4
RADIATION, REGULATORY ADN SAFETY
55
5
RADIATION PROTECTION OF THE PATIENT
67
6
EVALUATION AND ASSURANCE OF THE QS
34
7
QC FOR IMAGING EQUIPMENT
75
8
COMPUETR SYSTEM AND DATA HANDLING
65
9
ACCEPTANCE TESTS
88
10
CLINICAL SERVICES_ GENERAL ASPECTS
0
11
IMAGING PROCEDURES
0
12
NON IMAGING PROCEDURES
0
13
RADIONUCLIDE THERAPY
12
14
THERAPEUTIC PROCEDURES
23
15
HOSPITAL PHARMACY LVL1
13
16
HOSPITAL PHARMACY LVL 2
45
17
TUMOR MARKER RIA
35
Radar Diagram: A’s through the audit
STRATEGY AND OBJECTIVES
ADMINISTRATION ANDS
90
TUMOR MARKER RIA
MANAGEMENT
80
HUMAN RESSOURCES
70
HOSPITAL PHARMACY LVL 2
DEVELOPMENT
60
50
HOSPITAL PHARMACY LVL1
RADIATION, REGULATORY ADN
SAFETY
40
30
20
RADIATION PROTECTION OF THE
PATIENT
10
THERAPEUTIC PROCEDURES
0
Series1
Series2
Series3
EVALUATION AND ASSURANCE OF
THE QS
RADIONUCLIDE THERAPY
NON IMAGING PROCEDURES
IMAGING PROCEDURES
CLINICAL SERVICES_ GENERAL
ASPECTS
QC FOR IMAGING EQUIPMENT
COMPUETR SYSTEM AND DATA
HANDLING
ACCEPTANCE TESTS
Radar Diagram: what are we good at?
STRATEGY AND OBJECTIVES
ADMINISTRATION ANDS
90
TUMOR MARKER RIA
MANAGEMENT
80
HUMAN RESSOURCES
70
HOSPITAL PHARMACY LVL 2
DEVELOPMENT
60
50
HOSPITAL PHARMACY LVL1
RADIATION, REGULATORY ADN
SAFETY
40
30
20
RADIATION PROTECTION OF THE
PATIENT
10
THERAPEUTIC PROCEDURES
0
Series1
Series2
Series3
EVALUATION AND ASSURANCE OF
THE QS
RADIONUCLIDE THERAPY
NON IMAGING PROCEDURES
IMAGING PROCEDURES
CLINICAL SERVICES_ GENERAL
ASPECTS
QC FOR IMAGING EQUIPMENT
COMPUETR SYSTEM AND DATA
HANDLING
ACCEPTANCE TESTS
Radar Diagram: what do we need to
improve?
STRATEGY AND OBJECTIVES
ADMINISTRATION ANDS
90
TUMOR MARKER RIA
MANAGEMENT
80
HUMAN RESSOURCES
70
HOSPITAL PHARMACY LVL 2
DEVELOPMENT
60
50
HOSPITAL PHARMACY LVL1
RADIATION, REGULATORY ADN
SAFETY
40
30
20
RADIATION PROTECTION OF THE
PATIENT
10
THERAPEUTIC PROCEDURES
0
Series1
Series2
Series3
EVALUATION AND ASSURANCE OF
THE QS
RADIONUCLIDE THERAPY
NON IMAGING PROCEDURES
IMAGING PROCEDURES
CLINICAL SERVICES_ GENERAL
ASPECTS
QC FOR IMAGING EQUIPMENT
COMPUETR SYSTEM AND DATA
HANDLING
ACCEPTANCE TESTS
Radar Diagram: what do we need to
work?
STRATEGY AND OBJECTIVES
ADMINISTRATION ANDS
90
TUMOR MARKER RIA
MANAGEMENT
80
HUMAN RESSOURCES
70
HOSPITAL PHARMACY LVL 2
DEVELOPMENT
60
50
HOSPITAL PHARMACY LVL1
RADIATION, REGULATORY ADN
SAFETY
40
30
20
RADIATION PROTECTION OF THE
PATIENT
10
THERAPEUTIC PROCEDURES
0
Series1
Series2
Series3
EVALUATION AND ASSURANCE OF
THE QS
RADIONUCLIDE THERAPY
NON IMAGING PROCEDURES
IMAGING PROCEDURES
CLINICAL SERVICES_ GENERAL
ASPECTS
QC FOR IMAGING EQUIPMENT
COMPUETR SYSTEM AND DATA
HANDLING
ACCEPTANCE TESTS
Radar Diagram: global trends of the
audit
STRATEGY AND OBJECTIVES
ADMINISTRATION ANDS
90
TUMOR MARKER RIA
MANAGEMENT
80
HUMAN RESSOURCES
70
HOSPITAL PHARMACY LVL 2
DEVELOPMENT
60
50
HOSPITAL PHARMACY LVL1
RADIATION, REGULATORY ADN
SAFETY
40
30
20
RADIATION PROTECTION OF THE
PATIENT
10
THERAPEUTIC PROCEDURES
0
Series1
Series2
Series3
EVALUATION AND ASSURANCE OF
THE QS
RADIONUCLIDE THERAPY
NON IMAGING PROCEDURES
IMAGING PROCEDURES
CLINICAL SERVICES_ GENERAL
ASPECTS
QC FOR IMAGING EQUIPMENT
COMPUETR SYSTEM AND DATA
HANDLING
ACCEPTANCE TESTS
Questionnaires review…
• Additonnal instruments for the audit:
– Location visit
– Review and evaluation of the documentation
– Practical application of the working procedures
– Team members interviews
– Meeting with the management of the hospital
Minimal requirements review
• Hot and cold areas clearly separated
– Hot laboratory
– Injection area
– Waiting room with WC for injected patients
– Waste management room
– Stress test room (if needed)
– In vitro room (if applicable)
– Diagnostic room
– Technologists / nurses room
Minimal requirements review
• Minimal educational requirements reviews
– Specialized medical doctor
– Radiophysicist
– Radiopharmacist (for big installations including
pet centers)
– technologists
End of audit briefing
• Present the feedback of the
auditors
• All points discovered by the
auditors might be discussed
• Direct reaction to the
discovered points
• Prepare corrective plan
• Evaluate and immediate
answer to the A’s problems
Conclusion and report
• Patient oriented priority setting
• Clear statement and recommandations
– « Low hanging fruits » (inside the department)
– Important points to be solved on high level
(outside the department)
• Addressed to the head of the department /
hospital management
• Confirmation of the CAPA’s
QC of equipment
http://wwwpub.iaea.org/MTCD/publications/PDF/Pub1394_web.pdf
http://wwwpub.iaea.org/MTCD/publications/PDF/Pub1393_web.pdf
IAEA-Operational Guide on
Hospital Radiopharmacies
http://wwwpub.iaea.org/MTCD/publications/PDF/Pub1342/Pub1342_web.pdf
http://www-pub.iaea.org/MTCD/publications/PDF/Pub1344_web.pdf
http://www-pub.iaea.org/MTCD/publications/PDF/TCS-39_web.pdf
B-Quanum: practical
• How to prepare for internal audit?
• How to organize internal audit?
• How to execute internal audit with B-Quanum
as referential?
B-Quanum: audit scheme
Choose
team leader
Select the
audit team
Head of
Team
Depart
leader
Prepare
agenda
Audit team
Execute
audit
All together
B-Quanum: Parties
• Auditor
• Audited
Auditors
• Auditor should:
– Create a favorable climate
– Question without being aggressive
– Leave no place for doubt or uncertainties
– Use adequate and sufficient sampling
– Keep his audit under control
Auditors
• Auditor should:
– Be quick
– Be patient
– Be open minded
– Show integrity
– Listen well
– Respect others
Auditors
• Audit is a dialog (questions and answers)  need to listen
– Stop to read or speak with other auditors
– Show interest for the subject
– Be patient
– No argument, no criticism
Audited department
Audited people (department) should:
• Be aware of the audit
• Be prepared
• Be honnest
• Provide evidence of the answers
• Provide access to the facilities
• Prepare the necessary meetings
Thank you