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B-Quanum: Practical Aspects

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 ”

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B-Quanum: Practical Aspects

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  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

  5. Quality Management in Health Care Aim • Provide best possible serviceto patients • At the lowest possible risk • At adequate costs for patients and community, including the environment

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

  7. Comprehensive audit

  8. Audit should What an audit should be … Be a multi-disciplinary, multi-professionalactivity. Be a systematic and continuing activity Follow general accepted rules and standards which are based on the recommendations given in audit reports are implemented. international, national or local legal regulations guidelines developed by medical and clinical professional societies.

  9. 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.

  10. 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.

  11. 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)

  12. B-Quanum Procedure

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

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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.

  19. 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

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

  21. 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

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

  23. 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)

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

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

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

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

  28. 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)

  29. Questionnaires review • Examine all process: • Management • Primary • Support

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

  31. 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

  32. 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

  33. Rating tabel

  34. Radar Diagram: A’sthrough the audit

  35. Radar Diagram: what are we good at?

  36. Radar Diagram: what do weneed to improve?

  37. Radar Diagram: what do weneed to work?

  38. Radar Diagram: global trends of the audit

  39. 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

  40. 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

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

  42. 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

  43. 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

  44. 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

  45. 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

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

  47. B-Quanum: audit scheme Head of Team Depart leader Audit team All together

  48. B-Quanum: Parties • Auditor • Audited

  49. 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

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