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

B-Quanum: Practical Aspects

Ph. Van Boxem, Ing.Institute for Radioelements

Fleurus - BIAEA - 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

Quality Assurance in Health CareManagement

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 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 recommendation

s 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

Quality Manual

Procedures

Operating Instructions

Reports Tables

...

Contract review

Document control

Purchasing

Process control

Inspection and testing

Test equipment

Quality records

Quality audits

Training

Servicing

Statistical techniques

...

Job descriptions, Responsibilities & authority

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.

• 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

Preparation for internal audit: summary

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 PRIMARI

Definizione politica e strategie

Messa a disposizione delle risorse

PROCESSI DI DIREZIONE

Definizione pianificazione emonitoraggio obiettivi

Adempimentinormativi

Gestione risorseumane

PROCESSI DI SUPPORTO

Gestione risorse

tecnologiche

Gestione risorse

strutturali

Gestione approvvigiona

mento

Gestione Rifiuti e pulizie

Gestione Sistema

informatico

Gestione Sistemaqualità

Diagnostica in vivo

Prenotazioneesame

Accettazioneamministrativa

Valutazione appropriatezza

Preparazione radiofarmaco

Somministraz. radiofarmaco Esame

Validazione, refertazione e

consegna referto

Terapia Valutazione Pianificazione e

stima dosimetrica

Somministrazione ed

eventuale imagingRaccomandazioni Referto e

followup

Ambulatorio Visita Prescrizioni Referto e followupPrenotazione Accettazione amministrativa

Attività diFisica medica

ed EQ

FarmaciaMagazzino

SIECIODitta esterna

Ufficio pers.Ufficio formazione

Uff. tecnico _ SIAIng. Clinica - Ditte

Gestore impianti CQ – Dosimetria

Radioprotezione

Risk management

Audit

Sist. Inform. Az.

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= 6Result 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

Radar Diagram: what are we good at?

Radar Diagram: what do we need to improve?

Radar Diagram: what do we need to work?

Radar Diagram: global trends of the audit

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

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

IAEA-Operational Guide on Hospital Radiopharmacies

http://www-pub.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

Head of Team

Depart leader Audit team 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 departmentAudited 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 youThank you