Radiation Protection in Radiotherapy

Radiation Protection inRadiotherapy IAEA Training Material on Radiation Protection in Radiotherapy Part 12 Quality Assurance

QUALITY as a goal • “The totality of features or characteristics that bear on our ability to satisfy the stated or implied goal of effective patient care.” Comprehensive QA for Radiation Oncology, AAPM Task Group 40, 1994 • To ensure the goal is reached requires a fully implemented Quality Assurance program throughout the facility. Part 12: Quality assurance

What is Quality Assurance? • “All those planned and systematic actions necessary to provide confidence that a product or service will satisfy given requirements for quality.” ISO 9000 Part 12: Quality assurance

Quality Assurance • In the BSS seen in the context of medical exposure as essential for radiation protection of the patient • Quality Assurance and Control is also important to assess the overall effectiveness of protection and safety measures Part 12: Quality assurance

Objectives • To be familiar with the concepts of Quality Assurance as a multidisciplinary activity and its interrelation with radiation protection in radiotherapy. • To be familiar with Quality Assurance procedures as a tool for reviewing and assessing the overall effectiveness of a radiation protection program. • To be able to understand the need for and role of specific tests in the context of Quality Control and be able to identify appropriate national and international protocols for this task • To be aware of the need for involvement of professionals in a Quality Assurance program and for radiation protection Part 12: Quality assurance

Contents 1. Quality Assurance and the BSS 2. QA systems 3. Quality Control in radiotherapy External Beam RT Brachytherapy 4. QA and radiation protection Part 12: Quality assurance

1. Quality Assurance and the BSS (Managerial Requirements) BSS 2.29. “Quality assurance programmes shall be established that provide, as appropriate: (a) adequate assurance that the specified requirements relating to protection and safety are satisfied; and (b) quality control mechanisms and procedures for reviewing and assessing the overall effectiveness of protection and safety measures.” Part 12: Quality assurance

QA and QC • Quality Assurance is the overall process which is supported by Quality Control activities • Quality Control describes the actual mechanisms and procedures by which one can assure quality Part 12: Quality assurance

Quality Assurance and Medical Exposure BSS appendix II.22. “Registrants and licensees, in addition to applying the relevant requirements for quality assurance specified elsewhere in the Standards, shall establish a comprehensive quality assurance programme for medical exposures with the participation of appropriate qualified experts in the relevant fields, such as radiophysics or radiopharmacy, taking into account the principles established by the WHO and the PAHO.” You must establish a QA program! Part 12: Quality assurance

Relevant for radiotherapy • WORLD HEALTH ORGANIZATION, Quality Assurance in Radiotherapy, WHO, Geneva (1988). • PAN AMERICAN HEALTH ORGANIZATION, Publicación Cientifica No. 499, Control de Calidad en Radioterapia: Aspectos Clínicos y Físicos, PAHO, Washington, DC (1986). Part 12: Quality assurance

BSS appendix II.23 • “Quality assurance programmes for medical exposures shall include: (a) measurements of the physical parameters of the radiation generators, imaging devices and irradiation installations at the time of commissioning and periodically thereafter; (b) verification of the appropriate physical and clinical factors used in patient diagnosis or treatment; …” Check machine and data! Part 12: Quality assurance

Consequences for radiotherapy • A good acceptance testing and commissioning program is fundamental for any QA activities • QA activities are typically a subset of the tests and procedures used for the commissioning of a unit • QA applies to both physical and clinical aspects of the treatment Part 12: Quality assurance

BSS appendix II.23 • “Quality assurance programmes for medical exposures shall include: ... (c) written records of relevant procedures and results; (d) verification of the appropriate calibration and conditions of operation of dosimetry and monitoring equipment; .…” Part 12: Quality assurance

Consequences for radiotherapy • Treatment records must be kept of all relevant aspects of the treatment - including • Session and Summary Record information • Records all treatment parameters • Dose Calculations • Dose Measurements • Particular emphasis is placed on QA of dosimetry Part 12: Quality assurance

Treatment records • Must contain all relevant information • Can be in electronic format Part 12: Quality assurance

BSS appendix II.23 • “Quality assurance programmes for medical exposures shall include: ... and (e) as far as possible, regular and independent quality audit reviews of the quality assurance programme for radiotherapy procedures” Part 12: Quality assurance

Consequences for radiotherapy • A QA system itself and its outcomes must be critically reviewed • External audits are recommended to verify that the checks are not only done but that they also achieve what they are supposed to do • Every good system requires an independent look at times Part 12: Quality assurance

2. QA systems • Many QA systems exist - one important example is the ISO 9000 system • They are highly successful in manufacturing industry because they do improve productivity and avoid costly mistakes Part 12: Quality assurance

Good QA systems in radiotherapy • Improves work practices • Would have prevented most of the major accidents Part 12: Quality assurance

ISO 9000 • Comprehensive set of standards for QA (mainly in manufacturing and service industry) • Adapted e.g. by ESTRO to the radiotherapy environment • European Society for Therapeutic Radiology and Oncology (ESTRO) Advisory Report to the Commission of the European Union for the 'Europe Against Cancer Programme'. Quality Assurance in radiotherapy. Radiother. Oncol. 35: 61-73; 1995. Part 12: Quality assurance

A Comprehensive Quality Assurance Program • The details of such a program are often wrapped up in a “Code of Practice”. • “Quality Assurance in Radiotherapy”, ESTRO Advisory Report, 1995 • “Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group 40”, 1994 • “Quality Assurance in Radiotherapy”, WHO, 1988 Part 12: Quality assurance

A Comprehensive QA Program typically comprises • Quality Assurance Committee • Policies and Procedures Manual • Quality Assurance team • Quality audit • Resources Part 12: Quality assurance

QA Committee Membership • Must represent the many disciplines within the department • Should be chaired by the Head of Department • As a minimum must include a medical doctor, a physicist, a radiotherapy technologist and an engineer responsible for service and maintenance • Must be appointed and supported by senior management • Must have sufficient depth of experience to understand the implications of the process • Must have the authority and access to the resources to instigate and carry out the QA process Part 12: Quality assurance

Quality Assurance Committee • Should ‘represent’ the department • Should be ‘visible’ AND accessible to staff • Oversees the entire Quality Assurance program • Writes policies to ensure the quality of patient care • Assists staff in tailoring the program to meet the needs of the Department (using published reports as a guide) • Monitor and audit the program to ensure that each component is being performed and documented Part 12: Quality assurance

Quality Assurance Committee • Set agreed “Action Levels” • Example: Physics is given the authority to ensure correct accelerator output • For the daily output check two “Action Levels” are set • For any daily measurement which exceeds 2% but less than 4%, treatment may continue but the Senior Physicist responsible must be notified (immediately) • For any daily measurement which exceed 4%, treatment must STOP immediately and the problem investigated by the Senior Physicist responsible Part 12: Quality assurance

Action levels • Are quantitative • Reflect the required outcome • Are informed by the achievable outcome • Must be unambiguous • Should be easy to understand Part 12: Quality assurance

QA Committee review • Where “Action Levels” have been exceeded • Where set procedures have been discovered to be faulty • After a review, recommendations must be formulated in writing for improving the QA program • When errors are discovered the fault often lies in the process rather than in the action of individuals Part 12: Quality assurance

Documentation for the Quality Assurance Committee • Terms of Reference • The Committee must meet at established intervals and retain for audit purposes the minutes of its meetings, actions recommended and the results attained. • In short, there is a QA program for the QA Committee Part 12: Quality assurance

Policies and Procedures Manual • This manual contains clear and concise statements of all the policies and procedures carried out in the Department • Reviewed (typically) yearly • Updated as procedures change Policies and Procedures Manual Part 12: Quality assurance

Policies and Procedures Manual • As a minimum, sections should exist for • Administrative procedures • Clinical procedures • Treatment procedures • Physics procedures • Radiation safety Part 12: Quality assurance

Policies and Procedures Manual • It must be “signed off” by the Head of Department and appropriate section heads • It is important that all staff have “ownership” to the manual - it should reflect the opinions of all and be agreed to by all • A list of all copies of the Manual and their locations must be kept to ensure that each copy is updated Part 12: Quality assurance

Quality Assurance Team • Includes all disciplines • Well defined responsibility and reporting structure • Each member of the team must • Know his/her responsibility • Be trained to perform them • Know what actions are to be taken should a test or action be outside the preset “action levels” Part 12: Quality assurance

Responsibility Chart Leer Professional Area Part 12: Quality assurance

Quality Assurance Team • Each member of the team must also • Have at least some understanding of the consequences when tests or actions are outside the “action levels” • Maintain records documenting the frequency of performance, the results and the corrective action taken if necessary Part 12: Quality assurance

Quality Audit • “A systematic and independent examination and evaluation to determine whether quality activities and results comply with planned arrangements and whether the arrangements are implemented effectively and are suitable to achieve the objectives.” “Quality assurance in radiotherapy.”, Radiother. Oncol., 1995 Do you do what you say you do? Part 12: Quality assurance

Quality Audit • Ideally performed by someone outside of the organisation • Examples • IAEA/WHO TLD program for check of dose in therapy units • EQUAL program in Europe • Audits of clinical trials participation Part 12: Quality assurance

Quality Assurance does not stop here! The Quality Assurance Committee and the Quality Assurance team must continuously monitor new information and implement this in their procedures

Continuous Quality Improvement • CQI - many other acronyms are available for this • Part of virtually all QA systems • Improved methods on cancer patient management are documented in clinical trial reports. • Quality assurance protocols are continuously under development in many countries • Regular Quality Assurance meeting for all members of a Section • Continuing education - lectures, workshops, journal clubs and must be available for all staff Part 12: Quality assurance

And finally: QA is not a threat, it is an opportunity • It is essential in a QA program that all staff feel free to report errors • A non threatening environment must exist • Reward honesty with encouragement • Education is the key, not punishment Part 12: Quality assurance

3. Quality Control in radiotherapy • Many documents exist that specify what QC activities should be performed in radiotherapy… Part 12: Quality assurance

QC should ensure every step in the treatment chain... e.g.: check source activity e.g.: hand calculation of treatment time Part 12: Quality assurance

Radiother. Oncol. 1992: > 50 occasions of data transfer from one point to another for each patient! If one of them is wrong - the overall outcome is affected Part 12: Quality assurance

QC activities in radiotherapy • Three general areas: • Physical dosimetry • Treatment planning (dealt with part 10 lecture 3C of the course) • Patient treatment Part 12: Quality assurance

QC activities • Must be planned prospectively • daily • weekly • monthly • annually • whenever needed… • The following is only a suggestion! Part 12: Quality assurance

External Beam RadiotherapyExamples for daily QC • Safety • door and other interlocks • radiation warning lights • audiovisual • radiation area monitor • Radiation constancy check • Mechanical/optical “pointers” PTW Linacheck Part 12: Quality assurance

Test of optical components • Used for patient set-up • Essential • Easy to perform • Jigs available RMI test tool Part 12: Quality assurance

Alignment of lasers for patient set-up • Should point to the isocentre • Check also line width • Check line alignment at least 20cm beyond isocentre Gammex laser and test tool Part 12: Quality assurance

Quality Control - Weekly • Check of source positioning (cobalt 60) • Couch movements (lateral, vertical, longitudinal) Part 12: Quality assurance

Example for weekly QC summary From Constantinou 1992 Part 12: Quality assurance

Quality Control - Monthly • Dosimetry • Output constancy • Backup monitors • Central axis %DD constancy • Flatness/symmetry constancy • Timer end effect Part 12: Quality assurance

Radiation Protection in Radiotherapy