Basics of Quality Management for Nuclear Medicine Practices

Basics of

Quality Management for

Nuclear Medicine Practices

Human Health Series No. 43

Basics of

Quality Management for

Nuclear Medicine Practices

INTERNATIONAL ATOMIC ENERGY AGENCY

VIENNA, 2023

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Printed by the IAEA in Austria

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STI/PUB/1984

IAEA Library Cataloguing in Publication Data

Names: International Atomic Energy Agency.

Title: Basics of Quality Management for Nuclear Medicine Practices / International Atomic Energy Agency.

Description: Vienna : International Atomic Energy Agency, 2023. | Series: Human Health Series, ISSN 2075–3772 ; no. 43 | Includes bibliographical references.

Identifiers: IAEAL 23-01593 | ISBN 978–92–0–130022–5 (paperback : alk. paper) | ISBN 978–92–0–130122–2 (pdf) | ISBN 978–92–0–130222–9 (epub)

Subjects: LCSH: Nuclear medicine — Quality assurance. | Nuclear medicine — Quality control. | Nuclear medicine — Safety measures. | Nuclear medicine — Employees — Training of.

Classification: UDC 615.849 | STI/PUB/1984

FOREWORD

Quality improvement poses challenges to many countries striving to deliver optimal patient care that meets international standards for clinical care, safety and other areas. Public expectations of health care are now much higher than previously, in line with improving health care standards globally. These expectations have to be met amid the challenges of rising costs of health care, skill shortages in some areas of medicine and increasing patient activity.

Health care systems have a complex socioeconomic structure with various stakeholders, each with its own roles, interests and multiple interactions. All countries have health care professionals, managers, patients, financers and others who are invested in improving safety and quality in health care practices.

This publication is built upon the experience gained from implementing the Quality Management Audits in Nuclear Medicine Practices (QUANUM) programme, which was developed by the IAEA more than a decade ago and has been successfully implemented in more than 80 countries worldwide.

The purpose of this publication is to assist nuclear medicine professionals, middle management and executive teams at the hospital level in developing strategies that support quality improvement in nuclear medicine practices and help protect the public from unsafe or substandard practices.

The technical officers responsible for this publication were M. Dondi and D. Paez of the Division of Human Health.

EDITORIAL NOTE

Although great care has been taken to maintain the accuracy of information contained in this publication, neither the IAEA nor its Member States assume any responsibility for consequences which may arise from its use.

This publication does not address questions of responsibility, legal or otherwise, for acts or omissions on the part of any person.

Guidance and recommendations provided here in relation to identified good practices represent expert opinion but are not made on the basis of a consensus of all Member States.

The use of particular designations of countries or territories does not imply any judgement by the publisher, the IAEA, as to the legal status of such countries or territories, of their authorities and institutions or of the delimitation of their boundaries.

The mention of names of specific companies or products (whether or not indicated as registered) does not imply any intention to infringe proprietary rights, nor should it be construed as an endorsement or recommendation on the part of the IAEA.

The IAEA has no responsibility for the persistence or accuracy of URLs for external or third party Internet web sites referred to in this book and does not guarantee that any content on such web sites is, or will remain, accurate or appropriate.

The authoritative versions of the publications are the hard copies issued and available as PDFs on www.iaea.org/publications.To create the versions for e-readers, certain changes have been made, including the movement of some figures and tables.

CONTENTS

1. INTRODUCTION

1.1. Background

1.2. Objective

1.3. Scope

1.4. Structure

1.5. Clinical governance

2. RISK MANAGEMENT

2.1. Education, training and continuing professional development

2.2. Evidence based care and effectiveness

2.3. Experience and involvement of patients, referrers and carers

2.4. Staffing and staff management

2.5. Indicators

2.6. Internal reviews

2.7. Audits

3. CULTURE OF QUALITY

3.1. Fostering a culture of quality

3.2. Engaging staff in implementing a quality programme in a culture of quality

3.3. Leadership and responsibility for quality

3.4. Quality committee

3.5. Tasks in quality management for the quality committee

3.6. Supporting senior management

4. MANAGEMENT AND STRUCTURE OF A QUALITY MANAGEMENT SYSTEM

4.1. Quality manual

4.2. Mission and vision

4.3. Process identification and process map

4.4. Short and long term strategic planning

4.5. Documentation system and document control

5. LICENSING AND COMPLIANCE

5.1. Licensing

5.2. Authorization for the use of radioactive materials and radiation protection

5.3. Waste management

6. HUMAN RESOURCES MANAGEMENT

6.1. Professional responsibility and authority

6.2. Organizational chart

6.3. Job description

6.4. Personnel evaluation

6.5. Personnel development

6.6. Nms quality manager

7. RISK ASSESSMENT

7.1. Retrospective (or reactive) risk analysis methods

7.2. Prospective risk analysis methods

7.3. Failure modes and effects analysis

7.4. Fault tree analysis

7.5. Incidents

8. STANDARD OPERATING PROCEDURES

8.1. How to write a standard operating procedure

8.2. Sops for clinical activity

8.3. Procedural sops

8.4. Sop for radionuclide therapy

8.5. Sop for identification of patients

8.6. Sop for traceability

8.7. Formalization of coordination and interactions: ‘contracts’

8.8. Sops for staff radiation protection and safety

8.9. Sops for radiation protection of patients

8.10. Sops for radiopharmacy

9. DETECTION AND MANAGEMENT OF NON-CONFORMANCES

9.1. Management of non-conformance

9.2. Categorization of non-conformance

9.3. Corrective and preventive actions

10. MANAGEMENT OF EQUIPMENT AND OTHER MEDICAL DEVICES

10.1. Generalities

10.2. Equipment inventory

10.3. Management of the equipment life cycle

10.4. Maintenance and its evaluation

10.5. The cycle of qa/qc

10.6. Roles and responsibilities in equipment management

10.7. End of service life and equipment disposal

10.8. Provision and management of resources

11. MEASUREMENT, ASSESSMENT AND IMPROVEMENT IN QMS

11.1. Definition of indicators and recording methods

11.2. Sample parameter and indicator vaules

11.3. Customer satisfaction

11.4. Performing managerial review

REFERENCES

Annex I: SAMPLE TABLE OF CONTENTS FOR A QUALITY MANUAL

Annex II: SAMPLE SOP FORM FOR DIAGNOSTIC PROCEDURES

ANNEX IV: SAMPLE CLINICAL SOPS FOR DIAGNOSTICS WITH SINGLE PHOTON EMITTERS

ANNEX III: SAMPLE SOP FORM FOR THERAPY PROCEDURES

Annex V: SAMPLE CLINICAL SOP FOR PET/CT

Annex VI: SAMPLE CLINICAL SOP FOR THERAPY

Contributors to Drafting and Review

1. INTRODUCTION

1.1. Background

The definition of quality health service, as set out by the World Health Organization (WHO) [1], recognizes the need for safe care and the requirement for stringent laws demanding a high level of standards and human rights in the context of health care. It also covers the following three perspectives on quality:

— Patient quality (what patients want and experience);

— Professional quality (what patients need, in line with best practice);

— Management quality (efficiency and meeting regulations).

Quality improvement contributes to addressing the challenges confronting health systems in many countries. Patients expect more from health care than previously and have changing health needs. Improvement means defining and measuring aspects of each of the above perspectives and setting appropriate standards. There is indeed evidence that some health care might be ineffective [2, 3] and that resources are often wasted [4, 5].

1.2. Objective

The objective of this publication is to provide a framework for quality management systems (QMSs) to be holistically implemented and managed in an ongoing fashion in nuclear medicine departments, keeping in mind that nuclear medicine has always taken quality aspects into account, although often limited to equipment management and radiopharmaceutical preparations.

This publication is pertinent to the following audiences:

— Key players in delivering health care, such as hospital managers; professionals such as physicians, physicists, radiopharmacists, technologists, radiographers and nurses; and allied health professionals involved in nuclear medicine services (NMSs).

— Customers (patients and / or referring clinicians) requesting or requiring the services provided by professionals and organizations, on the basis of a common understanding of illness and disease and using accepted medical interventions to help patients stay healthy or get better, or to prevent further disabilities or deterioration of patients.

Guidance and recommendations provided here in relation to identified good practices represent expert opinion but are not made on the basis of a consensus of all Member States.

1.3. Scope

This publication covers the basics of a QMS as applied to NMS and is based on the methodology, the reasoning and assumptions underlying the IAEA’s QUANUM programme [6].

1.4. Structure

The publication is separated into eleven sections and six annexes, beginning with an explanation of the concept of clinical governance as a strategy to keep clinical services and their quality under control, and covering all activities involved, from promoting the culture of quality to measuring the QMS. Insight is provided on how to structure the QMS and how to manage human resources, risks and radiation protection as well as the safety of patients and personnel. Advice is also provided on the preparation and control of the documentation system, including the preparation of a quality manual,