Skip to main content
NCBI home page
Reports of Practical Oncology and Radiotherapy logoLink to Reports of Practical Oncology and Radiotherapy
. 2012 Jun 3;17(4):190–199. doi: 10.1016/j.rpor.2012.05.001

Organizational, technical, physical and clinical quality standards for radiotherapy

Marta Bogusz-Czerniewicz a,b,⁎, Daniel Kaźmierczak a
PMCID: PMC3863231  PMID: 24377023

Abstract

Background

Indisputably, radiotherapy has become an entirely interdisciplinary specialty. This situation requires efficient planning, verification, monitoring, quality control and constant improvement of all aspects of service delivery, referring both to patients’ (including diagnosis, prescription and method of treatment, its justification, realization and follow up) and organizational, technical and physics matters.

Aim

The aim of this work was to develop technical, physics and clinical quality standards for radiotherapy. This paper presents chosen standards for each of the aforementioned category.

Materials and methods

For the development of quality standards the comparison analysis of EU and Polish acts of law passed between 1980 and 2010 was conducted, the universal industrial ISO norm 9001:2008 referring to quality management system was reviewed. Recommendations of this norm were completed with detailed quality standards based on the author's 11 year work experience and the review of articles on quality assurance and quality control standards for radiotherapy published between 1984 and 2009 and the review of current recommendations and guidelines of American, International, European and National bodies (associations, societies, agencies such as AAPM, ESTRO, IAEA, and OECI) for quality assurance and quality management in radiotherapy.

Results

As a result 352 quality standards for radiotherapy were developed and categorized into the following three groups: (1) organizational standards, (2) physics and technical standards and (3) clinical standards.

Conclusions

Proposed quality standards for radiotherapy, can be used by any institution using ionizing radiation for medical procedures. Nevertheless standards are only of value if they are implemented, reviewed, audited and improved and if there is a clear mechanism in place to monitor and address failure to meet agreed standards.

Keywords: Quality management, Radiotherapy, Standards

1. Background

The development of radiological technologies that has been going on in the areas of diagnostic imaging, treatment planning systems, high-tech irradiation equipment, has caused radiotherapy to become an interdisciplinary domain involving staff of various backgrounds: physicians, radiotherapists, medical physicists, electronic engineers, dosimetrists, quality experts, and radiation technologists. This allows steady improvement in therapy results, but at the same time the diagnostic and therapeutic process grows more complex and complicated requiring that every stage of it is planned, organized and controlled so as to assure the quality of services provided.1

In its simplest and yet the most meaningful definition, quality is doing the right thing, in the right way and at first go. Simple as it might seem by this definition, quality is, however, a very broad concept applicable to all areas of activity of a health care institution. Quality standards encompass the whole life of a hospital, from nurse's polite approach to management's decisions. It is also a relative concept which does not exist for its own sake. Quality must always be associated with a goal it is meant to serve, be it patients’ satisfaction, prevention of irregularities, errors and adverse events, timely treatment, reduction of in-house infection rate, safe therapy conditions, etc. It would be wrong, therefore, to consider quality only in terms of effects achieved, i.e. treatment efficacy and adequacy, notwithstanding their undeniably crucial role. Other important factors include:

  • •

    conditions in which services are provided (sanitary state of wards, temperature, décor of waiting rooms, type of facilities, medical supplies);availability and flexibility (working hours, waiting time, diagnostic examination, phone and Internet appointments, convenient access roads, car park facilities, clear signs and directions in hospitals),

  • •

    time of response, work organization (consistence, efficiency, personnel accountability, teamwork, legibility of records, process-oriented and systemic approach to tasks performed); action standardization (homogeneity, repetitiveness and reliability), safety (compliance certificates, acceptance tests, equipment controls and measurements, protective clothes, personal safeguards, radiological protection)

  • •

    meeting patients’ needs and expectations (comfort of treatment, continuity of health care, access to information)

  • •

    meeting legal requirements (national and international standards, legal responsibility, directives, regulations)

  • •

    availability of information on services (Internet, bulletins, information boards)

  • •

    psychosocial factors (attitude, reputation, empathy, personnel politeness, respect for personal dignity, trust, friendliness, honesty)2;

  • •

    ethical and cultural factors (consent to be treated, freedom of culture and religion); and

  • •

    competences (professionalism, professional abilities) and personnel reliability (efficiency, punctuality, accuracy).

  • •

    these are all significant components and evaluation criteria of health service quality [3,4].

What health care institutions offer these days are complex services involving professionals of different disciplines and positions, numerous types of specialist equipment, and a wide variety of medical materials, reagents and preparations. In consequence, the final quality of a health service, understood as a therapeutic effect, is a resultant of all necessary components. The bigger an institution, the more components there are and the more complicated it becomes to manage the quality of the diagnostic and therapeutic process. Therefore, quality should be a norm constituting an integral part of organization's activity, rather than an outcome of a series of uncontrolled coincidences.

At present, radiotherapy is an interdisciplinary field using advanced therapeutic and imaging apparatus and computerized therapy planning and simulation systems. This means that both the patient-related aspects (diagnosis, selection, treatment indication, justification, referral, planning, therapy, follow-up) and the control and measurement procedures forming the technical part of the treatment process should be subject to regular planning, verification and, most importantly, constant improvement.

While, as of late, quality assurance in radiotherapy has been believed to play a key role in ensuring safe and effective treatment in the physical and technical context (efficient equipment, in vivo dosimetry, portal imaging), now, a more holistic (systemic) approach to quality is beginning to prevail. This, however, calls for designing, implementing, maintaining and improving formalized quality systems or, in other words, implementing versatile quality management systems to cover all areas of activity (administrative, organizational, physics, technical, and clinical) of a health care unit applying ionizing radiation for medical purposes.

2. Materials and methods

A model of quality management in radiotherapy was proposed and a detailed list of organizational, physics and technical, and clinical standards compiled basing on EU directives5–7 and Polish legal acts published in 2002–2010,8–23 Quality Assurance in Radiotherapy published by the World Health Organization in 1988,24 Recommendations for a quality assurances programme in external radiotherapy published by the European Society for Therapeutic Radiology and Oncology (1995)25 and AAPM Report no 13 on Physical aspects of quality assurances in radiation therapy published by the American Association of Physics in Medicine (1994),26 Requirements for Quality Management System by PN-EN ISO 9001:200127 then 9001:2008,28 International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources Safety series no. 115 published by the International Atomic Energy Agency (1996),29 Guidelines for comprehensive audit of radiotherapy practice: a tool for quality improvement published by the International Atomic Energy Agency (2005)30 Clinical Assessment Guide elaborated by the Organization of European Cancer Institutes in 2003,31 as well as literature of the subject.32–89

3. Results

As a result 352 quality standards for radiotherapy were developed and categorized into the following three groups: (1) organizational standards, (2) physics and technical standards and (3) clinical standards.

Organizational standards were divided into following sub-categories:

  • 1.1.

    Policy and management

  • 1.2.
    Documentation
    • 1.2.1.
      Documentation of quality management system
    • 1.2.2.
      Records and logs
    • 1.2.3.
      Registries (incl. cancer registry)
  • 1.3.
    Resources
    • 1.3.1.
      Human resources
    • 1.3.2.
      Infrastructure, facilities and equipment
    • 1.3.3.
      Environment
      • 1.3.3.1.
        Radiation protection
  • 1.4.

    Interdisciplinary approach

Physics and technical standards were divided into the following sub-categories:

  • 2.1.

    Specification of products

  • 2.2.
    Quality assurance
    • 2.2.1.
      Physics, technical, mechanical and geometrical parameters control of: therapeutic machines, imaging systems (CT, PET, PET–CT), simulators, treatment planning systems, radiotherapy management systems
    • 2.2.2.
      Quality control of gauges and control equipment and tools
  • 2.3.

    Documentation and records

  • 2.4.

    Parameters

  • 2.5.

    Malfunctions

  • 2.6.

    Improvement

  • 2.7.

    Equipment audit

  • 2.8.

    Dosimetrical audit

Clinical standards were divided into the following sub-categories:

  • 3.1

    Patient's referral/treatment prescription

  • 3.2

    Therapeutic protocol

  • 3.3

    Interdisciplinary approach

  • 3.4

    Communication

  • 3.5

    Treatment planning

  • 3.6

    Verification of treatment planning

  • 3.7

    Conduction of treatment

  • 3.8

    Verification of treatment

  • 3.9

    Treatment termination/cancellation

  • 3.10

    Radiological incidents and accidents

  • 3.11

    Quality control of treatment

  • 3.12

    Reference levels of radiation doses

  • 3.13

    Documentation and records

  • 3.14

    Follow-up

  • 3.15

    Clinical audits

For selected organizational, physics and technical, and clinical standards see Tables 1–6.

Table 1.

Organizational standards.

Category Standard
Policy and management
 Quality management system (QMS) 1. The institution has established, documented, implemented and maintained quality management system in radiotherapy and constantly improves its effectiveness in accordance with legal requirements (national and European) and patients’ needs and expectations, as well as other requirements accepted by the institution, e.g. ISO 9001:2008, accreditation program, etc.
2. The institution reviews its management system on a regular basis.



 Organization's goal 1. The institution has defined the goal and extent of its activity (extent of services), with due account taken of other organizational units within the hospital and practicability of performing or coordinating such services within the regional or national network of oncological and clinical centers, in order to provide each patient with best possible radiotherapeutic care and treatment.
2. The organization has defined its goal in the context of its resources (equipment, infrastructure, staff, etc.) and current demographic, social, financial, geographical and epidemiological conditions as well as QMS requirements.
3. The institution's activity shall be consistent with legal requirements and local and national guidelines.
4. The institution has set its short- and long-term quality objectives.
5. The institution's objectives shall be consistent with its policy, systematically reviewed and updated.



 Organization's policy 1. Organization's quality policy has been defined and documented in the context of current demographic, social, financial, geographical and epidemiological conditions as well as QMS requirements. The quality policy is systematically reviewed and updated. QMS development and improvement program (including investment, services, staff training) has been established and documented in line with the quality policy and its objectives.



 Organization's structure 1. The institution has a strictly defined organizational structure, each employee knows and understands his or her position in the structure.
2. The institution has defined its organizational relationships and hierarchy structure, both functional and operational, between particular organizational units and management members.
3. The institution has appointed persons responsible for particular processes (process owners) and responsibilities of process participants.
4. The institution has identified processes covered by QMS and defined and documented systemic relationships between them (process mapping).



 Management's involvement 1. The management has established, maintained and improved QMS in radiotherapy.
2. The management has defined institution's quality policy and objectives.
3. The management ensures necessary resources for the institution to carry out its activity and implement QMS.
4. The management shall monitor institution's costs in the context of annual budget planning.
5. Representative for QMS has been appointed.
6. Committee for QMS in Radiotherapy has been appointed.
7. Representative for QMS shall chair the Committee.
8. Positions (persons) and responsibilities in QMS have been defined.
Open in a new tab

Table 2.

Organizational standards.

Category Standard
Documentation and records
 QMS systemic documentation 1. The institution has put in place a QMS systemic documentation in line with national requirements, i.e.
 (a) quality book including:
  • QMS scope (e.g. radiotherapy),
  • quality policy,
  • quality plan(s),
  • quality objectives,
  • tools to measure achievement of objectives,
  • process map (description of basic and support processes being executed and relationships between them),
  • procedures, instructions and other systemic documents or references thereto;
 (b) general procedures including:
  • supervision over documentation,
  • supervision over records,
  • internal audits,
  • procedure for non-conformities,
  • corrective and preventive actions,
  • code of diagnostic, interventional or therapeutic procedure, applicable to a given organizational unit, developed in compliance with legal requirements,
 (c) handling instructions and user manuals of radiological equipment,
 (d) information concerning testing methods for internal controls of physical parameters of radiological equipment and accessory devices,
 (e) information concerning results of tests of internal controls of physical parameters of radiological equipment and accessory devices, and acceptance tests,
 (f) information concerning personnel qualifications and training,
 (g) description of methodology used for internal clinical audits,
 (h) information concerning results of internal clinical audits and any corrective or preventive measures,
 (i) information concerning interim reviews of quality management system,
 (j) standards for describing examination results and procedures applicable to the results and other documentation,
2. The institution shall develop and document individual record templates (forms, schedules, plans).
3. All systemic documents shall be up-dated, authorized and archived according to QMS requirements and national laws.
4. Out-of-date documents and records shall be withdrawn and destroyed.
5. Archival copies shall be held exclusively by Representative for QMS in Radiotherapy.
6. Systemic documentation shall be systematically reviewed, updated and improved (at least once a year).
7. Documentation updates shall be authorized, dated and numbered.
8. The institution shall hold annual management review schedules – management meetings.
9. Input data for management reviews include:
 • audit results,
 • patient satisfaction survey analyses,
 • process functioning and treatment effectiveness,
 • event and non-conformity reports,
 • corrective and preventive action status,
 • results of follow-up measures,
 • comments, conclusions, points for improvement.
Open in a new tab

Table 3.

Physics and technical standards.

Category Standard
Documentation and records 1. The following shall be subject to detailed documentation:
 (a) results of acceptance tests,
 (b) results of control measurements,
 (c) equipment acceptance protocols,
 (d) equipment failures and repairs,
 (e) equipment exploitation log (including: daily operating conditions, breakdowns, stoppages, repairs, etc.),
 (f) schedule of technical inspections,
 (g) schedule of equipment control tests (daily, weekly, monthly, quarterly, half-yearly, yearly),
 (h) certificates or confirmations of specialist training in operation of specific equipment taken by responsible staff.
2. Head of the radiotherapy unit shall keep a register and documentation of technical and dosimetrical failures and all inconsistencies between physical parameters and indications recorded in an irradiation sheet and actual parameters and indications during irradiation that may lead to A or B category radiological accidents.
3. The institution has implemented and documented:
 (a) control and measurement procedures for physical and technical parameters of radiotherapeutic and accessory equipment (e.g. treatment table, audiovisual communication system, air-conditioning),
 (b) control and measurement procedures for control and measurement equipment,
 (c) emergency procedures in case of detecting faulty operation or technical defects,
 (d) equipment operational instructions.



Physics parameters 1. Equipment physical parameters shall comply with national and international standards as to measured values, required measurement methods and tolerances and safety standards (e.g. IEC, CENELEC, ICRU, IAEA, ICRP, Euratom, national standards).
2. All calibration and dosimetrical operations shall be made or supervised by a qualified expert in medical physics.
3. The institution has introduced a list of tolerances admissible in technical inspection and periodical equipment control tests, as required by national regulations.



Technical failures 1. The institution has defined the technical failure of therapeutic apparatus.
2. The institution has implemented and documented an emergency procedures in case of a defect or faulty operation of therapeutic apparatus/measuring equipment.
3. In case of a technical failure of therapeutic apparatus, a responsible radiation technologist shall report the case to the person responsible for technical quality and efficiency of equipment in the institution.
4. Radiation technologist shall resume operation of the faulty apparatus only after receiving an acceptance protocol signed by head of the institution/authorized person.
5. In case of a technical failure, Head of the institution shall:
 (a) investigate into the cause and circumstances of the failure or non-conformity,
 (b) report the failure or non-conformity to his or her immediate superior.
6. Take measures to eliminate the cause of the failure or non-conformity.
Open in a new tab

Table 4.

Physics and technical standards.

Category Standard
Product specification 1. The institution has developed product specifications including working parameters, tolerances and compatibility of equipment purchased with existing therapeutic machinery.
2. The institutions shall purchase equipment that can be integrated into the existing therapeutic line.
3. The institution has performed and documented technical acceptance of the equipment, confirming that all components delivered by manufacturer are consistent with the specifications.



Quality control of physics, technical, mechanical and geometrical parameters of
 • therapeutic equipment,
 • imaging systems,
 • simulators,
 • radiotherapy planning system,
 • radiotherapy management system.		 1. Control tests shall comply with national regulations in terms of extent and frequency.
2. Medical physics units performing control tests of equipment physical parameters have put in place requirements of PN-EN-ISO 17025.
3. The institution has appointed a person responsible for quality assurance and control as well as technical status and efficiency of the equipment (notwithstanding that particular control tasks are assigned to different persons – physicist, engineer, technician, etc., it is recommended that overall responsibility for the equipment functioning and the QA and CC program be assigned to one person, preferably a medical physicist AAPM, 1994).
4. The institution shall perform acceptance tests of equipment or software (SPL) after its installation and before putting it into operation and clinical use, and after each major defect, repair or modernization, in order to confirm the consistence of its physical and technical parameters with manufacturer or repair specification.
5. Acceptance tests shall cover: calibration and acquisition of beam data, in the case of treatment planning system – entry of beam-related data and testing the system by direct measurements and calculation methods.
6. Acceptance tests shall be made either by manufacturer or in-house medical physicist or medical engineer.
7. The institution shall perform acceptance tests in line with agreed and implemented procedure.
8. The institution shall perform systematic equipment controls and measurements according to requirements of national regulations.
9. The institution has defined the scope of its controls and measurements, as required by national regulations.
10. Controls and measurements shall be made on daily, weekly, monthly and yearly basis and after each repair, ensuring an adequate level of independence between the repairing team and persons responsible for proper functioning of the equipment after repair.
11. The institution shall perform a systematic calibration therapeutic beam.
12. The institution performs systematic authorized maintenance of its equipment (authorized technical inspections).
13. The institution shall perform regular tests of the mechanical and geometrical parameters of simulators (as for therapeutic apparatus, with similar tolerances and frequency of critical parameter assessments).
14. Geometric and mechanical features of simulators shall be compatible with those of therapeutic apparatus.
15. The institution performs regular quality tests of computed tomography units, used to plan radiotherapy,1 planigraphic attachments and other imaging systems, e.g. MRI and USG.
Open in a new tab

Table 5.

Clinical standards.

Category Standard
Referral for treatment/treatment decision/treatment indications 1. Institution's patients shall be subjected to medical exposure for diagnostic or therapeutic purposes, only on recommendation of a medical practitioner.
2. Examination or treatment involving ionizing radiation require a written referral issued by a practitioner authorized to prescribe examination or treatment involving ionizing radiation.
3. Examinations involving ionizing radiation shall be made without doctor's referral only under medical screening projects.
4. Decision on radiotherapy shall be made on the basis of a patient interview, assessment of patient's health and psychosocial status, results of physical and pathological examination results, assessed stage of cancer advancement, and patient's medical documentation.
5. Results of diagnostic tests shall form an integral part of patient's medical documentation and remain available before, during and after treatment.
6. The institution shall evaluate patient's psychosocial condition and accordingly adjust its health care and treatment options.
7. Referral for radiotherapy shall be made in writing and duly authorized (by signature, stamp and date) by a medical practitioner specializing in oncological radiotherapy.
8. Recommendation for radiotherapy shall include planning target volume, gross tumor volume and clinical target volume (PTV, GTV, CTV) according to the rules provided ICRU 50, ICRU 62, and ICRU 38 reports, total dose, method of fractioning, total duration of therapy, planned intervals, and description of treatment techniques pursuant to an applicable therapeutic protocol.
9. Recommendation for radiotherapy shall be forwarded to the team responsible for therapy planning (medical physicist, dosimetrist, radiation technologist) who do the necessary calculations and planning.
10. The institution holds treatment waiting lists.



Therapeutic protocol 1. The institution has established, implemented and documented a therapeutic protocol describing a treatment pattern for each type therapy, tumor location and disease.
2. The therapeutic protocol shall be consistent with the national model of clinical procedures and based on confirmed results of clinical, radiological or physical tests.
3. The institution has indicated sources of the clinical standards it applies (own guidelines, national or international guidelines, etc.).
4. Patients shall be treated in accordance with the established therapeutic protocol; any exemptions need to be accounted for and reasons recorded in patient's medical documentation (e.g. irradiation sheet).
5. Each therapeutic protocol shall provide for lowest possible exposure of healthy tissues (ALARA) and protection of healthy tissues wherever practicable and justified.
6. The institution has implemented and documented a therapeutic protocol for radiotherapy of pregnant women pursuant to national regulations.
7. Therapeutic protocols shall be systematically reviewed and updated to keep in pace with the progress in medical and clinical knowledge.
8. The institution shall hold regular meetings to review therapeutic protocols.
Open in a new tab

Table 6.

Clinical standards.

Category Standard
Conduct of treatment 1. All treatment procedures and related diagnosis shall be performed specializing in oncological radiotherapy or supervised by them (when performed by doctors being trained in this specialty) and radiation technologist.
2. Radiotherapy procedures shall be planned and performed in such a way as to allow for stoppages of therapeutic apparatus causing deviation from accepted treatment standards.
3. The institution shall ensure enough time for a therapeutic session to be performed correctly.
4. One therapeutic apparatus may accommodate the maximum of five radical treatment patients within one hour.
5. Each irradiation fraction shall be preceded with patient identification, including the check-up of name, personal identification number or other identification number, date of birth, patient's photo, irradiation technique, irradiation parameters, irradiated area, tumor location, accessories used, etc.
6. At each stage of treatment, the institution shows full respect for patients’ privacy and personal data protection.
7. Patient's irradiation sheet is available at a given apparatus during each irradiation fraction.
8. First irradiation fraction in radical treatment patients and – in justified cases – in palliative treatment patients is attended by a doctor specializing in oncological radiotherapy to verify patient's positioning and immobilization and provide them with psychological support.
9. Medical physicist participates in the radiation procedure at doctor's or RTT's request.
10. Patients shall be positioned and immobilized by two RTTs.
11. Patients shall be positioned and immobilized as accurately, repetitively and comfortably as possible (in each apparatus used in the treatment process), according to an instruction contained in treatment plan (as a text or diagram).
12. In the case of radical and palliative treatment, doctor specializing in oncological radiotherapy participates in the first irradiation session performed according to a pre-set treatment plan.
13. During radiotherapy, patient shall be monitored by an RTT (audiovisual system).
14. RTT shall confirm the consistence of physical parameters from the irradiation sheet with those actually realized, in particular monitor units (exposure time).
Open in a new tab

4. Conclusion

Proposed quality standards for radiotherapy, can be used by any institution using ionizing radiation for medical procedures. Nevertheless standards are only of value if implemented, reviewed, audited and improved, and if there is a clear mechanism in place to monitor and address a failure to meet agreed standards.

Therefore, it is equally important to develop and implement a quality management system that will also contribute to:

  • (a)

    improvement in work organization,

  • (b)

    improvement of service quality,

  • (c)

    reduction of costs owing to cost-effective supply management,

  • (d)

    patient-oriented approach,

  • (e)

    reduction in the number adverse effects, non-conformities, technical breakdowns and costs of repair,

  • (f)

    increase in patient and staff safety through on-going control of equipment and working place, as well as application of harmonized procedures and documentation,

  • (g)

    legible organizational structure in term of accountability for work outcome,

  • (h)

    strengthening of teamwork and cooperation between individuals and organizational units,

  • (i)

    increased employee involvement in institution's constant improvement and QMS.

Conflict of interest

None declared.

References

  • 1.Bogusz-Osawa M., Kosicka G. The importance of implementing a quality assurance programme for safe irradiation during megavolt radiotherapy. Zdr i Zarz. 2002;4:67–71. [in Polish] [Google Scholar]
  • 2.Bogusz-Osawa M., Kosicka G. The influence of the European and Polish act of law, regulations and standards on the forms and the contents of the informed consent for oncological treatments. Rep Pract Oncol Radiother. 2005;10:67–76. [Google Scholar]
  • 3.Grönroos Ch. Lexington Books; Lexington, MA: 1990. Service management and marketing. [Google Scholar]
  • 4.Nowotarska-Romaniak B. Zakamycze; Kraków: 2002. Marketing of medical services. [in Polish] [Google Scholar]
  • 5.Council Directive 90/641/EURATOM of 04 December 1990 on the operational protection of outside workers exposed to the risk of ionizing radiation during their activities in controlled areas. Official Journal L-349 of 0513/12/90.
  • 6.Council Directive 96/29/EURATOM of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation. Official Journal L-159 from 29/6/96.
  • 7.Council Directive 97/43 Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom. Official Journal L-180 from 09/07/97.
  • 8.Ministry of Labour and Social Policy of 29 November 2002 on the highest admissible concentrations and intensities of health risk factors in work environment. Journal of Laws No. 217, item 1833 [in Polish].
  • 9.Ministry of Health Ordinance of 7 April 2006 on minimum requirements for health care institutions applying for permission conduct activities related to medical exposure to ionising radiation involving the provision of medical services in the area of oncological radiotherapy. Journal of Laws No. 75, item 528 [in Polish].
  • 10.Ordinance of 24 December 2002 on rules for safe application of ionising radiation for medical exposure and methods for internal controls of compliance with those rules. Journal of Laws No. 241, item 2098 [in Polish].
  • 11.Ministry of Health Ordinance of 25 August 2005 on rules of safe application of ionising radiation for all types of medical exposure, pursuant to Article 33c paragraph 9 of the Nuclear Law Act, Journal of Laws from 2004, No. 61, item 1689 and No. 173, item 1808 [in Polish].
  • 12.Council of Ministers Ordinance of 18 January 2005 on contingency plans for radiation events. Journal of Laws No. 20, item 169 [in Polish].
  • 13.Council of Ministers Ordinance of 3 December 2002 on documents required when applying for permission conduct activities related to medical exposure to ionising radiation or when reporting the performance of such activity. Journal of Laws of 24.04.2004 No. 220, item 1851, as amended [in Polish].
  • 14.Council of Ministers Ordinance of 3 December 2002 on radiation waste and burnt nuclear fuel. Journal of Laws No. 230, item 1925 [in Polish].
  • 15.Council of Ministers Ordinance of 5 November 2002 on requirements concerning registration of individual doses. Journal of Laws No. 207, item 1753 [in Polish].
  • 16.Council of Ministers Ordinance of 6 April 2002 on basic requirements concerning controlled and supervised areas. Journal of Laws No. 138, item 1161 [in Polish].
  • 17.Council of Ministers Ordinance of 6 August 2002 on types of positions with high relevance to ensure nuclear safety and radiological protection, and detailed conditions and mode of awarding authorisations to persons holding those positions. Journal of Laws No. 145, item 1217, of 18 January 2005, Journal of Laws No. 21, item 176 [in Polish].
  • 18.Council of Ministers Ordinance of 17 December 2002 on detailed conditions of safe work with sources of ionising radiation. Journal of Laws No. 239, item 2029 [in Polish].
  • 19.Council of Ministers Ordinance of 23 December 2002 on requirements concerning registration of individual doses. Journal of Laws No. 239, item 2032 [in Polish].
  • 20.Council of Ministers Ordinance of 28 May 2002 on border ionising radiation doses, 3 August 2002 of Laws, No. 111, item 969, as amended, of 18.01.2005 [in Polish].
  • 21.Nuclear Law Act of 29 November 2000, Journal of Laws from 2001, No. 3, item 18 [in Polish].
  • 22.Nuclear Law Act of 12 March 2004, Journal of Laws from 2004, No. 70, item 632 [in Polish].
  • 23.Nuclear Law Act of 24 February 2006, Journal Of Laws from 2006, No. 52, item 378 [in Polish].
  • 24.World Health Organization (WHO) WHO; Geneva: 1988. Quality assurance in radiotherapy. [Google Scholar]
  • 25.Aletti P, Bey P. Recommendations for a quality assurance programme in external radiotherapy. ESTRO Booklet No. 2, Wyd. 1. Leuven: Apeldoorn Garant; 1995.
  • 26.American Association of Physics in Medicine (AAPM). Physical aspects of quality assurance in radiation therapy. Report No. 13. New York: American Institute of Physics; 1994. Available at: http://www.aapm.org/pubs/reports/rpt_13.pdf [63 ss. ekranowe].
  • 27.Polish Standardisation Committee (PKN) PKN; Warsaw: 2001. PN-EN ISO 9001:2000 quality management system – requirements. [in Polish] [Google Scholar]
  • 28.Polish Standardisation Committee (PKN) PKN; Warsaw: 2009. PN-EN ISO 9001:2008 quality management system – requirements. [in Polish] [Google Scholar]
  • 29.International Atomic Energy Agency (IAEA) IAEA; Vienna: 1996. International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources Safety series No. 115. [Google Scholar]
  • 30.International Atomic Energy Agency (IAEA) Guidelines for comprehensive audit of radiotherapy practice: a tool for quality improvement – workshop materials, QUATRO. IAEA; Vienna: 2005. [Google Scholar]
  • 31.Organization of European Cancer Institutes (OECI) OECI; 2004. Clinical assessment guide, preliminary document, version 0. [Google Scholar]
  • 32.American Association of Physics in Medicine (AAPM). Phantoms and performance evaluation and quality assurance of CT scanners. Report No. 1. Chicago: American Institute of Physics; 1977. Available at: http://www.aapm.org/pubs/reports/rpt_01.pdf [27 screen pages].
  • 33.American Collage of Radiation Oncology (ACRO). Standards for radiation oncology. Available at: http://www.acro.org/content/internet_resources/acro_practice_accreditation/radiation_standards.cfm [11 screen pages].
  • 34.Nath R., Biggs P.J., Bova F.J. AAPM code of practice for radiotherapy accelerators. Med Phys. 1994;21:1093–1121. doi: 10.1118/1.597398. [DOI] [PubMed] [Google Scholar]
  • 35.Asch D.V. Waiting times for cancer treatment. Clin Oncol. 2000;12:140. doi: 10.1053/clon.2000.9138. [DOI] [PubMed] [Google Scholar]
  • 36.Barthelemy-Brichant N., Sabatier J., Dewé W. Evaluation of frequency and type of errors detected by a computerized record and verify system during radiation treatment. Radiother Oncol. 1999;53:149–154. doi: 10.1016/s0167-8140(99)00141-3. [DOI] [PubMed] [Google Scholar]
  • 37.Belletti S., Dutreix A., Garavaglia G. Quality assurance in radiotherapy: importance of medical physics staffing levels. Recommendations from an ESTRO/EFOMP join task group. Radiother Oncol. 1996;41:89–94. doi: 10.1016/s0167-8140(96)91799-5. [DOI] [PubMed] [Google Scholar]
  • 38.Bentzen S.M., Heeren G., Cottier B. Towards evidence-based guidelines for radiotherapy infrastructure and staffing needs in Europe: the ESTRO QUARTS Project. Radiother Oncol. 2005;75:355–365. doi: 10.1016/j.radonc.2004.12.007. [DOI] [PubMed] [Google Scholar]
  • 39.Bernier J., Horiot J.C., Bartelink H. Profile of radiotherapy departments contributing to the cooperative group pf the European Organization for Research and Treatment of Cancer. Radiat Oncol J Biol Phys. 1996;34:965–967. doi: 10.1016/0360-3016(95)02177-9. [DOI] [PubMed] [Google Scholar]
  • 40.Bernier J., Horiot J.C., Poortmans P. Quality Assurance in radiotherapy: form radiation physics to patient- and trial-oriented control procedures. Eur J Cancer. 2002;38:S155–S158. doi: 10.1016/s0959-8049(01)00438-5. [DOI] [PubMed] [Google Scholar]
  • 41.Bleehen N.M. Department of Health; London: 1991. Quality assurance in radiotherapy. Report of standing sub-committee on Cancer. [Google Scholar]
  • 42.Bogusz-Osawa M., Kierzkowski J., Kubicka M. Practical recommendations for implementation of quality assurance programme in radiotherapy – radiological protection procedures. Współ Onkol. 2002;8:506–514. [in Polish] [Google Scholar]
  • 43.Bogusz-Osawa M. Accreditation standards and nursing care – organisational and practical aspects. Antidotum Zarz Op Zdr. 2002;9:41–47. [Google Scholar]
  • 44.Burnett D. KSC Printers Ltd.; Tunbridge Wells, Kent: 2002. A practical guide to accreditation in laboratory medicine. [Google Scholar]
  • 45.Calandrino R., Cattaneo G.M., Fiorino C. Detection of systematic errors in external radiotherapy before treatment delivery. Radiother Oncol. 1997;45:271–274. doi: 10.1016/s0167-8140(97)00095-9. [DOI] [PubMed] [Google Scholar]
  • 46.Calandrino R., Cattaneo G.M., Del Vecchio A. Human errors in the calculation of monitor units in clinical radiotherapy practice. Radiother Oncol. 1993;28:86–88. doi: 10.1016/0167-8140(93)90193-c. [DOI] [PubMed] [Google Scholar]
  • 47.Crosby P.B. Free Press; New York: 1979. Quality is free. [Google Scholar]
  • 48.Dische S., Saunders M.I., Williams C. Precision in reporting the dose given in a course of radiotherapy. Radiother Oncol. 1993;29:287–293. doi: 10.1016/0167-8140(93)90146-y. [DOI] [PubMed] [Google Scholar]
  • 49.Duggan L., Kron T., Howlett S. An independent check of treatment plan, prescription and dose calculation as a QA procedure. Radiother Oncol. 1997;42:297–301. doi: 10.1016/s0167-8140(97)01906-3. [DOI] [PubMed] [Google Scholar]
  • 50.Society for Therapeutic Oncology and Radiology (ESTRO). Executive summary. ESQUIRE Project: Education, Science and Quality assurance in Radiotherapy in Europe, Grant Agreement/2001CVGG2-005 EC/February 2003. Available at: http://www.estroweb.org/ESTRO/upload/pdfs/Esquire1year1ExecutiveSummary.pdf [5 screen pages].
  • 51.Feigenbaum A.V. McGraw-Hill Cooperation; New York: 1992. Total quality control. [Google Scholar]
  • 52.Ferreira I.H., Dutreix A., Bridier A. Radiotherapy dosimetry audit: a European programme to improve quality and safety in radiation treatments. Proceedings of the international conference on the radiological protection of patients in diagnostic and interventional radiology, nuclear medicine and radiotherapy; Malaga, Spain, 26–30 March; Vienna: IAEA; 2001. [Google Scholar]
  • 53.International Atomic Energy Agency (IAEA) IAEA; Vienna: 2000. Safety Report Series No. 17: lessons learned from accidental exposures in radiotherapy. [Google Scholar]
  • 54.Ito H., Iwasaki S., Nakano Y. Direction of quality improvement activities of health care organizations in Japan. Int J Qual Health Care. 1998;10:361–363. doi: 10.1093/intqhc/10.4.361. [DOI] [PubMed] [Google Scholar]
  • 55.Izewska J., Andreo P. The IAEA/WHO TLD postal program for radiotherapy hospitals. Radiother Oncol. 2000;54:65–72. doi: 10.1016/s0167-8140(99)00164-4. [DOI] [PubMed] [Google Scholar]
  • 56.Karzmark C.J. Procedure and operator error aspects of radiation accidents in radiotherapy. Int J Radiat Oncol Biol Phys. 1987;12:1599–1602. doi: 10.1016/0360-3016(87)90331-2. [DOI] [PubMed] [Google Scholar]
  • 57.Kolitsi Z., Dahl O., Van Loon R. Quality assurance in conformal radiotherapy: DYNARD consensus report on practice guidelines. Radiother Oncol. 1997;45:217–223. doi: 10.1016/s0167-8140(97)00144-8. [DOI] [PubMed] [Google Scholar]
  • 58.Kutcher G.J., Coia L., Gillin M. AAPM American Association of Physicists in Medicine. Comprehensive QA for radiation oncology. Report of AAPM Radiation Therapy Committee Task Group 40. Med Phys. 1994;21:581–618. doi: 10.1118/1.597316. [DOI] [PubMed] [Google Scholar]
  • 59.Leer J.W.H., Corver R., Kraus J.J.A.M. A quality assurance system based on ISO standards: experience in a radiotherapy department. Radiother Oncol. 1995;35:75–81. doi: 10.1016/0167-8140(95)01552-r. [DOI] [PubMed] [Google Scholar]
  • 60.Leer JWH, McKenzie A, Scalliet P, et al. Practical guidelines for the implementation of a quality system in radiotherapy. A project of the ESTRO Quality Assurance Committee, sponsored by Europe Against Cancer, Physics for Clinical Radiotherapy. Booklet No. 4. Brussels: ESTRO; 1998.
  • 61.Luenens G., Verstraete J., Van den Bogaert W. Human errors in data transfer during the preparation and delivery of radiation treatment affecting the final result: “garbage in, garbage out”. Radiother Oncol. 1992;23:217–222. doi: 10.1016/s0167-8140(92)80124-2. [DOI] [PubMed] [Google Scholar]
  • 62.Malicki J., Litoborski M., Kierzkowski J. How the implementation of in vivo dosimetry protocol improved the dose delivery accuracy in head and neck radiotherapy. Neoplasma. 2004;51:155–158. [PubMed] [Google Scholar]
  • 63.Martin C.J., Sutton D.G. Oxford University Press Inc.; New York: 2002. Practical radiation protection in health care. [Google Scholar]
  • 64.McKenzie AL. Would the two most serious radiotherapy accidents in the UK have occurred under ISO 9000? W: Faulkner K, Harrison RM [red.]. Radiation incidents. London: British Institute of Radiology; 1996.
  • 65.McNee S.G. Clinical governance: risks and quality control in radiotherapy. Br J Radiol. 2001;74:209–212. doi: 10.1259/bjr.74.879.740209. [DOI] [PubMed] [Google Scholar]
  • 66.Meunier F., van Oosterom A.T. 40 years of EORTC; the evolution towards a unique network to develop new standards of cancer care. Eur J Cancer. 2002;38:S155–S158. doi: 10.1016/s0959-8049(01)00456-7. [DOI] [PubMed] [Google Scholar]
  • 67.Nolan T.W. System changes to improve patient safety. BMJ. 2000;320:771–773. doi: 10.1136/bmj.320.7237.771. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 68.Proceeding on the symposium, international symposium on practical implementation of clinical audit for exposure to radiation in medical practice; Tempere, Finland, 24–27 May; 2003. [Google Scholar]
  • 69.Radiation and Nuclear Safety Authority (STUK). Quality assurance in radiotherapy. STUK Guide ST 2.1/22 May 2003. Helsinki: STUK; 2003. Dostępne na: http://www.finlex.fi/pdf/normit/22197-ST2-1e.pdf.
  • 70.Reason J. Human error: models and management. BMJ. 2000;320:768–770. doi: 10.1136/bmj.320.7237.768. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 71.Schwappach D., Koeck Ch: What makes an error unacceptable? A factorial survey on the disclosure of medical errors. Int J Qual Health Care. 2004;16:317–326. doi: 10.1093/intqhc/mzh058. [DOI] [PubMed] [Google Scholar]
  • 72.Slotman B.J., Cottier B., Bentzen S. ESTRO; Brussels: 2004. Guidelines for infrastructure and staffing of radiotherapy, ESTRO-QUARTS: work package 1, 27-06-2004, BSL. [DOI] [PubMed] [Google Scholar]
  • 73.Slotman B.J., Cottier B., Bentzen S.M. Overview of national guidelines for infrastructure and staffing of radiotherapy ESTRO-QUARTS: work package 1. Radiother Oncol. 2005;75:349–354. doi: 10.1016/j.radonc.2004.12.005. [DOI] [PubMed] [Google Scholar]
  • 74.Sweeney J., Heaton C. Interpretations and variations of ISO 9000 in acute health care. Int J Qual Health Care. 2000;12:203–209. doi: 10.1093/intqhc/12.3.203. [DOI] [PubMed] [Google Scholar]
  • 75.Teunen D. The European Directive on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure (97/43/Euratom) J Radiol Prot. 1998;18:133–137. doi: 10.1088/0952-4746/18/2/009. [DOI] [PubMed] [Google Scholar]
  • 76.The Netherlands Organization for Applied Scientific Research (TNO) TNO; Leiden: 1994. Quality assurance standards, report on the PACE project. [Google Scholar]
  • 77.Thompson R.E. From quality assurance to continuous improvement. Phys Exec. 1992;17:3–8. [PubMed] [Google Scholar]
  • 78.Thwaites D. Quality assurance into the next century. Radiother Oncol. 2000;54:vii–ix. doi: 10.1016/s0167-8140(00)00144-4. [DOI] [PubMed] [Google Scholar]
  • 79.Thwaites D., Scalliet P., Leer J.W. Quality Assurance in Radiotherapy (European Society for Therapeutic Radiology and Oncology advisory report to the Commission of the European Union for the Europe Against Cancer Programme) Radiother Oncol. 1995;35:61–73. doi: 10.1016/0167-8140(95)01549-v. [DOI] [PubMed] [Google Scholar]
  • 80.Valli M.C., Prina M., Bossi A. Evaluation of most frequent errors in daily compilation and use of a radiation treatment chart. Radiother Oncol. 1994;32:87–89. doi: 10.1016/0167-8140(94)90453-7. [DOI] [PubMed] [Google Scholar]
  • 81.Van der Scheuren E., Horiot J.C., Leunnens G. Quality assurance in cancer treatment. Eur J Cancer. 1993;29A:172–181. doi: 10.1016/0959-8049(93)90168-f. [DOI] [PubMed] [Google Scholar]
  • 82.Van Esch A., Bogaerts R., Kutcher G.J. Quality assurance in radiotherapy by identifying standards and monitoring treatment preparations. Radiother Oncol. 2000;56:109–115. doi: 10.1016/s0167-8140(00)00190-0. [DOI] [PubMed] [Google Scholar]
  • 83.Kowalik A., Konstanty E. Basic tests in mammography as a tool in quality improvement. Rep Pract Oncol Radiother. 2010;15:145–152. doi: 10.1016/j.rpor.2010.08.004. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 84.Van Weert C. Developments in professional quality assurance towards quality improvement: some examples of peer review in the Netherlands and the United Kingdom. Int J Qual Health Care. 2000;12:239–242. doi: 10.1093/intqhc/12.3.239. [DOI] [PubMed] [Google Scholar]
  • 85.Lopez J., Cabrera P., Ordoñez R. Role of radiation therapy in the multidisciplinary management of Ewing's Sarcoma of bone in pediatric patients: an effective treatment for local control. Rep Pract Oncol Radiother. 2011;16:103–109. doi: 10.1016/j.rpor.2011.01.006. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 86.Vincent Ch [red]. Clinical risk management: enhancing patient safety. Wyd. 2. London: BMJ Books; 2001.
  • 87.Weinberg N., Stason W.B. Managing quality in hospital practice. Int J Qual Health Care. 1998;10:295–302. doi: 10.1093/intqhc/10.4.295. [DOI] [PubMed] [Google Scholar]
  • 88.Bogusz-Czerniewicz M. Wyd. Uniwersytetu Medycznego im; K. Marcinkowskiego, Poznań: 2010. Quality management system in radiotherapy, National and EU legal requirements, model, standards, documentation, implementation guidelines based on the example of the Greater Poland Cancer Centre. [Google Scholar]
  • 89.Ślosarek K., Szlag M., Bekman B., Grzadziel A. EPID in vivo dosimetry in RapidArc technique. Rep Pract Oncol Radiother. 2010;15:8–14. doi: 10.1016/j.rpor.2010.01.003. [DOI] [PMC free article] [PubMed] [Google Scholar]

Articles from Reports of Practical Oncology and Radiotherapy are provided here courtesy of Via Medica sp. z o.o. sp. k.

RESOURCES