1. Planned Exposure Situations Simone Kodlulovich Renha
2016 School on Drafting Regulations. Radiation Safety Stream. IAEA Regional Workshop Vienna, Austria 8 – 19 August 2016
Module 1.5
Planned Exposure Situations
Medical Exposure
(GSR Part 3)
Simone Kodlulovich Renha

2. Content – Lecture Part I
Some Important definitions: medical exposure, patient, Health Professional, Planned exposure situations, Unintended or accidental medical exposures
Requirement 4: Responsibilities for protection and safety
Requirement 34: Responsibilities of government specific to medical exposure
Requirement 35: Responsibilities of the RB specific to medical exposure
Requirement 36: Responsibilities of registrants and licensees specific to medical exposure
1958: the first IAEA Safety Standard
Shortly after its inception in 1957, the Secretariat began developing and setting safety Standards. In 1958, the Agency published its first safety standard, Safety Series No. 1, Safe Handling of Radioisotopes (STI/PUB/1). Over the years, some 200 publications were issued in the Safety Series.

3. Some important definitions!!
Medical exposure:
Exposure incurred by patients for the purposes of their own medical or dental diagnosis or therapeutic exposure; by carers and comforters; and by volunteers subject to exposure as part of a programme of biomedical research.
GSR Part 3 Glossary

4. Patient An individual who is a recipient of services of health
professionals and/or their agents that are directed at:
promotion of health;
prevention of illness and injury;
monitoring of health;
maintaining health; and
medical treatment of diseases/disorders/injuries in order to achieve a cure or, failing that, optimum comfort and function. Some asymptomatic individuals are included

5. Health Professional
An individual who has been formally recognized through appropriate national procedures to practise a profession related to health.
medicine
medical physics
dentistry
radiation and nuclear medical technology
chiropractic
radiopharmacy
paediatrics
occupational health
nursing
MODIFIED
GSR Part 3 Glossary

6. Planned exposure situations
Arises from the planned operation of a source or from a planned activity that results in an exposure due to a source.
The requirements in respect of medical exposure in planned exposure situations apply to all medical exposures, including intended, unintended and accidental exposures
Dose limits do not apply to medical exposures

7. Unintended or accidental medical exposures
Arising from flaws in design, failures of equipment, software or human error
Medical treatment
Wrong individual or tissue/ organ of the patient
radiopharmaceutical
Activity: dose or dose fractionation ≠ values prescribed
DR or IR
Inadvertent exposure of the embryo or fetus
Failure: Equipment/ software/ system. Accident, error, mishap or unusual occurrence, potentially increase substantially the patient medical exposure.

8. Req. 4: Responsibilities for protection and safety
Prime Responsibility:
Person or organization responsible for the facility or activity;
Principal parties responsible:
Registrants or licensees;
Employers (occupational exposure);
Radiological medical practitioners (medical exposure);
Persons or organizations designated to deal with emergency exposure situations or existing exposure situations

9. Specific Responsibilities for protection and safety
ANY MORE!!!
Suppliers of Sources and Equipment;
Radiation Protection Officer
Referring Medical Practitioners
Radiological Medical Practitioners;
Medical Physicists;
Medical Radiation Technologists;
Qualified Experts;
Workers;
Ethics Committees.
And also Government (Req. 34)

10. Suppliers of Sources and Equipment
Responsibilities:
Suppliers of Sources and Equipment
To supply: a safe radiation generator or radioactive source and device meeting quality standards
To demonstrated: compliance tests according to the specifications;
To make information available: performance specifications, instructions for operating and maintenance and for protection and safety;
To ensure: shielding and other protective devices is optimized.
GSR Part 3, Req 17 – 3.49

11. Radiation Protection Officer (RPO)
Responsibilities:
Radiation Protection Officer (RPO)
Definition: Person who is technically competent to provide advice and oversight of the local radiation safety programme.
RPO: crucial component of the radiation safety programme and requires appropriate resources and administrative authority;
“A person technically competent in radiation protection matters relevant for a given type of practice who is designated by the registrant, licensee or employer to oversee the application of relevant requirements” (GSR Part 3 - Definitions)

12. Role of RPO Designation: controlled and supervised areas;
Preparation: local rules;
New staff training: in safe radiation work practices;
Liaison with the RB: on RP matters.
Supervision of the personnel monitoring program;
Maintenance of records: especially worker radiation histories;
Routine surveillance: of radiation areas;
Responding to and investigating: radiation accidents;
Provision: of radiation dosimetry;
General advice: to the licensee and staff regarding radiation safety.

13. Referring medical practitioner
Health professional who, in accordance with national requirements, may refer individuals to a radiological medical practitioner for medical exposure

15. Responsibilities: Radiological Medical Practitioner
A health professional with specialist education and training in the medical uses of radiation, who is competent to perform independently or to oversee procedures involving medical exposure in a given specialty.
Primary responsibility for protection and safety for patients in the planning and delivery of medical exposures including justification and optimization in cooperation with the MP and the Medical Radiation Technologist

16. Responsibilities: Registrants and licensees
Medical exposures: prescribed by a medical practitioner
Medical practitioner: assigned responsibility for ensuring overall patient protection in the prescription and delivery of medical radiation exposures;
Medical and paramedical personnel: trained to discharge their tasks in the conduct of the diagnostic or therapeutic procedure that the medical practitioner prescribes;
GLOSSARY (BSS)
Medical practitioner
An individual who: (a) has been accredited through appropriate national procedures as a health professional; (b) fulfils the national requirements on training and experience for prescribing procedures involving medical exposure; and (c) is a registrant or a licensee, or a worker who has been designated by a registered or licensed employer for the purpose of prescribing procedures involving medical exposure.
Health professional
An individual who has been accredited through appropriate national procedures to practice a profession related to health (e.g. medicine, dentistry, chiropractic, paediatry, nursing, medical physics, radiation and nuclear medical technology, radio pharmacy, occupational health).

17. Medical Physicist (MP)
A health professional with specialist education and training in the concepts and techniques of applying physics in medicine and competent to practise independently in one or more of the subfields (specialties) of MP
GSR Part 3: Definitions

18. MP Responsibilities Goals of quality
Recognized as a health professionals: plays a central role in assuring the safe and effective use of radiation in medicine.
Goals of quality
Achieved through the use of QA/QC protocols applied in radiation-related technologies RT DR
Data
dose planning and verification
optimization
management and analysis
All activities are based on an in depth understanding of radiation physics principles and radiation technology.

19. Medical radiation technologist
Health professional with specialist education and training in medical radiation technology, competent to perform radiological procedures, on delegation from the radiological medical practitioner, in one or more of the specialties of medical radiation technology.
GSR Part 3: Definitions

20. Medical Radiation Technologist Certification
The State should create a mechanism to assess the education, training and competence of any individual proposed by the licensee to act as a medical radiation technologist and to decide, on the basis of either international or national standards where, if such individual could undertake the functions of a medical radiation technologist, within the required specialty.
GSR Part 3 (Definitions)

21. Qualified Expert
An individual who, by virtue of certification by appropriate boards or societies, professional licence or academic qualifications and experience, is duly recognized as having expertise in a relevant field of specialization: medical physics, radiation protection, occupational health, fire safety, quality management or any relevant engineering or safety specialty.

22. Responsibilities: Qualified Experts
Registrants or licensees: must obtain the services of qualified experts (a suitably experienced medical physicist).
Training, competencies and certification of experts: usually a national matter.
Regulatory body: should cooperate with relevant professional organizations in the recognition of such experts.
Professional organizations: are expected to take a lead in defining work practices, certification and accreditation.

23. Req. 34: Government Responsibilities
Shall ensure that:
Relevant parties are authorized to assume their roles and responsibilities
Diagnostic reference levels (DRL), Dose constraints, and Criteria and guidelines for the release of patients are established.

24. Req. 34: Government Responsibilities: Diagnostic reference Level (DRL)
In consultation:
health authority, professional bodies, RB
wide scale surveys or on appropriate published values for the local circumstances.
adequate image quality

25. Req. 34: Government Responsibilities
Dose constraints
Dose constraints is a source related value used in
optimizing the protection of:
PET scan
To identify biomarkers
of Parkinson's Disease.
careers and comforters of patients undergoing radiological procedures
volunteers participating in a programme of biomedical research.

26. Req. 34: Government Responsibilities: Criteria and guidelines for the release of patients who:
have undergone therapeutic radiological procedures using unsealed sources or patients who still retain implanted sealed sources

27. Req. 35: RB responsibilities
RB requirements for health professionals with responsibilities for medical exposure:
Specialized in the appropriate area. Fulfil requirements for education, training and competence in the relevant specialty
Health professionals are authorized to assume the responsibilities for medical exposures, only if: are specialized in the appropriate area, meet the requirements for education, training and competence in RP and are named in a list maintained up to date by the registrant or licensee.
GSR Part 3, Req. 35, 3.150)

28. Req. 36: Registrants and Licensees Responsibilities.
Shall assure that:
No individual incurs a medical exposure…
….as part of a programme of biomedical research unless the exposure has been approved by an ethics committee
….as a carer or comforter unless received/understood relevant information on radiation protection and radiation risks prior to providing care and comfort to an individual undergoing a radiological procedure

29. Req. 36: Registrants and Licensees Responsibilities:
Requested by referring medical practitioner
Clinical information provided
Part of health screening programme
3.151
No patient (symptomatic/asymptomatic), undergoes a medical exposure unless
Justified: radiological and referring medical practitioner
Responsibility for protection and safety: Radiological medical practitioner
Patient or authorized representative informed: benefits x risks of the procedure informed

30. 3.154 Registrants and Licensees Responsibilities . Shall assure that:
Radiological medical practitioner: performing or overseeing the radiological procedure has assumed responsibility for ensuring overall protection and safety for patients in the planning and delivery of the medical exposure, including:
justification of the radiological procedure
optimization of protection and safety, in cooperation with the MP and the medical radiation technologist
3.155–3.161 and 3.162–3.177

31. 3.154 Registrants and Licensees Responsibilities . Shall assure that:
(b) Appropriate specialization: Radiological medical practitioners, MP, medical radiation technologists and other health professionals
(c) Sufficient medical personnel and paramedical personnel: are available as specified by the health authority;
(d) Therapeutic radiological procedures: the requirements for calibration, dosimetry, QA, acceptance and commissioning of medical radiological equipment, are fulfilled by or under the supervision of a MP

32. Registrants and Licensees Responsibilities
(e) Diagnostic radiological procedures and IR: calibration, dosimetry, QA, acceptance and commissioning of medical radiological equipment by or under the oversight of or with the documented advice of a MP, whose degree of involvement is determined by the complexity of the radiological procedures and the associated radiation risks. (f) Any delegation of responsibilities by a principal party is documented.

33. Registrants and licensees Responsibilities: shall ensure that:
There are procedures in place for ascertaining the pregnancy status of a female patient of reproductive capacity before the performance of any radiological procedure that could result in a significant dose to the embryo or fetus, so that this information can be considered in the justification for the radiological procedure and in the optimization of protection and safety.
GSR Part , , , 3.166

34. Registrants and licensees Responsibilities. Shall ensure:
Female patient is not currently breast-feeding before the performance of any radiological procedure involving the administration of a radiopharmaceutical that could result in a significant dose to a breastfed infant, so that this information can be considered in the justification for the radiological procedure and in the optimization of protection and safety.
3.177, 3.155, 3.157, 3.166)

35. To be continued
Medical Exposures – Part 2