1. B-Quanum: Practical Aspects
Ph. Van Boxem, Ing.
Institute for Radioelements
Fleurus - B
IAEA - Quanum Auditor

2. 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

3. 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

4. Quality Assurance in Health Care
Management
Quality Assurance in Health Care

5. 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

7. QUANUM

8. Comprehensive audit

9. What an audit should be …
Be a multi-disciplinary, multi-professional 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.
Be a systematic and continuing activity
the recommendations given in audit reports are implemented.

10. 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.

11. 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.

12. 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)

13. B-Quanum Procedure

14. B-Quanum: practical How to prepare for internal audit?
How to organize internal audit?
How to execute internal audit with B-Quanum as referential?

15. 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.

16. Comprehensive and well controlled documentation system
...
Contract review
Document control
Purchasing
Process control
Inspection and testing
Test equipment
Quality records
Quality audits
Training
Servicing
Statistical techniques
Quality Manual
Job descriptions, Responsibilities & authority
Procedures
Operating Instructions
Tables
Reports

17. 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

18. 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

19. 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.

20. 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

21. B-Quanum: practical How to prepare for internal audit?
How to organize internal audit?
How to execute internal audit with B-Quanum as referential?

22. 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

23. Example of an audit crew …
Audit leader
Nuclear medicine physician
Radiophysicist
Technologist
Hospital pharmacist // radiopharmacist
Nursing
Hospital administration representative
At least three people

24. 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)

25. Set the agenda … « Starting the audit » briefing Questionnaires review
Minimal requirements review
« End of audit » briefing
Conclusion and report

26. Starting the audit briefing …
Select the process to be reviewed
Audit orientation
Team members to participate
Garantee of confidentiality

27. Questionnaires review
Will cover infrastructure and global nuclear medicin program:
Managment:
goals and objectives,
admin and management,
HR development

28. Questionnaires review
Risk management
People and environment radioprotection
Patient radioprotection
Quality assurance
Quality Control of imaging material
Computers and data processing systems
Acceptance tests

29. 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)

30. Questionnaires review
Examine all process:
Management
Primary
Support

31. Questionnaires review
PROCESSI PRIMARI
Definizione politica e
strategie
Messa a disposizione
delle risorse
PROCESSI DI DIREZIONE
Definizione pianificazione e
monitoraggio obiettivi
Adempimenti
normativi
Gestione
risorse
umane
PROCESSI DI SUPPORTO
tecnologiche
strutturali
approvvigiona
mento
Rifiuti e pulizie
Sistema
informatico
Gestione Sistema qualità
Diagnostica
in vivo
Prenotazione
esame
Accettazione
amministrativa
Valutazione
appropriatezza
Preparazione
radiofarmaco
Somministraz .
Esame
Validazione,
refertazione e
consegna
referto
Terapia
Pianificazione e
stima dosimetrica
Somministrazione ed
eventuale imaging
Raccomandazioni
Referto e
follow up
Ambulatorio
Visita
Prescrizioni
Accettazione amministrativa
Attività di Fisica medica ed EQ
Farmacia Magazzino
SIECIO Ditta esterna
Ufficio pers. Ufficio formazione
Uff. tecnico _ SIA Ing. Clinica - Ditte
Gestore impianti
CQ – Dosimetria
Radioprotezione
Risk management
Audit
Sist. Inform. Az.

32. 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

33. 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

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 7
QC FOR IMAGING EQUIPMENT 75 8
COMPUETR SYSTEM AND DATA HANDLING 65 9
ACCEPTANCE TESTS 88 10
CLINICAL SERVICES_ GENERAL ASPECTS 11
IMAGING PROCEDURES 12
NON IMAGING PROCEDURES 13
RADIONUCLIDE THERAPY 14
THERAPEUTIC PROCEDURES 23 15
HOSPITAL PHARMACY LVL1 16
HOSPITAL PHARMACY LVL 2 45 17
TUMOR MARKER RIA

35. Radar Diagram: A’s through the audit

36. Radar Diagram: what are we good at?

37. Radar Diagram: what do we need to improve?

38. Radar Diagram: what do we need to work?

39. Radar Diagram: global trends of the audit

40. 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

41. 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

42. Minimal requirements review
Minimal educational requirements reviews
Specialized medical doctor
Radiophysicist
Radiopharmacist (for big installations including pet centers)
technologists

43. 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

44. 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

45. QC of equipment

46. IAEA-Operational Guide on Hospital Radiopharmacies

47. B-Quanum: practical How to prepare for internal audit?
How to organize internal audit?
How to execute internal audit with B-Quanum as referential?

48. B-Quanum: audit scheme
Choose team leader
Select the audit team
Prepare agenda
Execute audit
Head of Team
Depart leader Audit team All together

49. B-Quanum: Parties
Auditor
Audited

50. 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

51. Auditors Auditor should: Be quick Be patient Be open minded
Show integrity
Listen well
Respect others

52. 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

53. 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

54. Thank you