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Standard 57
Radiotherapy
Radiotherapy: each course justified and independently checked before the first fraction, patient and site verified before every treatment, treatment machines under quality assurance, staff and visitors protected, and patients informed about side effects and follow-up.
Every course of radiotherapy has a documented justification and a prescription signed by the clinician. The treatment plan is checked independently by a second qualified person before the first fraction is given.
How the surveyor verifies this criterion
Sample. Review the justification, prescription and plan check records for every course of radiotherapy started in the last 6 months.
1. Every course has a documented justification and a clinician-signed prescription.
Method. Check each sampled course for the justification record and the signed prescription.
Evidence to show. Radiation justification and dose optimisation (RAD-POL-001, existing, reused); radiation justification record (RAD-FRM-001, existing, reused).
Pass when. Every sampled course has the justification and a signed prescription.
2. The plan is checked by a second qualified person before the first fraction.
Method. Check each sampled plan for the independent check entry dated before the first fraction.
Evidence to show. Treatment plan verification before the first fraction (RTH-SOP-001); treatment plan verification record (RTH-FRM-001).
Pass when. Every sampled plan has an independent check recorded before the first fraction.
3. Any discrepancy found in the check is resolved and the plan is re-checked.
Method. Check each recorded discrepancy for the correction and the re-check.
Evidence to show. Treatment plan verification record (RTH-FRM-001).
Pass when. Every recorded discrepancy has a correction and a re-check.
Immediate fail (any one means the criterion is not met)
- A plan with the wrong target volume starts treatment without an independent check, and the error is found after ten fractions.
Documents
No documents yet.
E-learning
References
- International Atomic Energy Agency. Radiation Protection and Safety in Medical Uses of Ionizing Radiation. Specific Safety Guide SSG-46. Vienna: IAEA; 2018.
Before every fraction, the patient identity, the treatment site and the set-up are verified against the plan, and the treatment is paused for a check when the set-up differs from the plan.
How the surveyor verifies this criterion
Sample. Observe a sample of treatment sessions on several days and audit the daily verification records for the sample period.
1. Patient identity is verified before every fraction.
Method. Observe the identity check for each sampled fraction against the record.
Evidence to show. Patient identity and site verification before each fraction (RTH-SOP-002); daily treatment verification record (RTH-FRM-002).
Pass when. Every observed fraction has identity verified.
2. Treatment site and set-up are verified against the plan.
Method. Check the set-up record for each sampled fraction against the plan.
Evidence to show. Daily treatment verification record (RTH-FRM-002).
Pass when. Every sampled fraction has the set-up verified against the plan.
3. Treatment is paused for review when the set-up differs from the plan.
Method. Check each sampled set-up difference for the pause and the review recorded.
Evidence to show. Patient identity and site verification before each fraction (RTH-SOP-002).
Pass when. Every sampled set-up difference has a pause and review recorded.
Immediate fail (any one means the criterion is not met)
- A patient is treated on the wrong side because the set-up was not checked against the plan on that day.
Documents
No documents yet.
E-learning
References
- International Atomic Energy Agency. Radiation Protection and Safety in Medical Uses of Ionizing Radiation. Specific Safety Guide SSG-46. Vienna: IAEA; 2018.
Linear accelerators and other treatment equipment are checked on a documented quality assurance schedule, including output and safety interlocks. A machine that fails a check is taken out of clinical use until it is repaired and re-tested.
How the surveyor verifies this criterion
Sample. Review the quality assurance register and the output and safety checks for every treatment machine in the last 12 months.
1. Each machine is checked on the documented schedule.
Method. Compare each machine check date with the schedule.
Evidence to show. Linear accelerator quality assurance (RTH-SOP-003); machine quality assurance register (RTH-REG-001).
Pass when. Every scheduled check is recorded on time.
2. Output and safety interlocks are checked and within tolerance.
Method. Check each recorded output and interlock result against the tolerance.
Evidence to show. Machine quality assurance register (RTH-REG-001); imaging equipment quality assurance and calibration (IMG-SOP-001, existing, reused, applied to treatment imaging).
Pass when. Every recorded result is within tolerance or the machine is recorded as out of use.
3. A machine that fails a check is taken out of use until re-tested.
Method. Check each failed result for the out-of-use record and the re-test.
Evidence to show. Machine quality assurance register (RTH-REG-001).
Pass when. Every failed result has the out-of-use entry and a passed re-test before return.
Immediate fail (any one means the criterion is not met)
- A linear accelerator with a faulty interlock treats patients for a week before the failure is noticed.
Documents
No documents yet.
E-learning
References
- Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation. Official Journal of the European Union, L 13, 17 January 2014.
Treatment rooms have controlled areas and shielding that meet the design, and staff wear personal dosimeters whose readings are reviewed at the set interval. Visitors and pregnant staff are managed under a written policy.
How the surveyor verifies this criterion
Sample. Review the dosimetry records and the shielding and controlled area checks for the last 12 months.
1. Staff wear personal dosimeters and the readings are reviewed at the set interval.
Method. Compare each sampled staff member with the dosimetry register and the review dates.
Evidence to show. Personal dosimetry register (RTH-REG-002); radiation protection in the treatment room (RTH-POL-001).
Pass when. Every sampled staff member has readings reviewed at the interval.
2. Treatment rooms have shielding and controlled areas that meet the design.
Method. Inspect the shielding and the controlled area signs on the sampled days.
Evidence to show. Radiation protection in the treatment room (RTH-POL-001).
Pass when. Every inspected room has the shielding and controlled area in place.
3. Pregnant staff and visitors are managed under the written policy.
Method. Check the records for each pregnant staff member and visitor entry in the sample.
Evidence to show. Radiation protection in the treatment room (RTH-POL-001).
Pass when. Every sampled case follows the written policy.
Immediate fail (any one means the criterion is not met)
- A staff member receives a dose above the set limit, and the reading is not reviewed for six months.
Documents
No documents yet.
E-learning
References
- Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation. Official Journal of the European Union, L 13, 17 January 2014.
Each patient receives written information on expected side effects, skin care and warning signs before the first fraction, with a follow-up review of toxicity recorded during and after treatment.
How the surveyor verifies this criterion
Sample. Review the written information and toxicity follow-up records for a sample of patients who started treatment in the last 6 months.
1. Each patient receives written information on side effects, skin care and warning signs before the first fraction.
Method. Check each sampled record for the information sheet given before the first fraction.
Evidence to show. Informed consent before significant care (CON-SOP-001, existing, reused); consent record (CON-FRM-001, existing, reused).
Pass when. Every sampled patient has the written information recorded before the first fraction.
2. Toxicity is reviewed during and after treatment and recorded.
Method. Check each sampled patient for the toxicity review entries during and after treatment.
Evidence to show. Treatment toxicity and follow-up record (RTH-FRM-003).
Pass when. Every sampled patient has toxicity reviewed and recorded during and after treatment.
3. Patients with severe toxicity are reviewed the same week.
Method. Check each sampled severe toxicity for the review date.
Evidence to show. Treatment toxicity and follow-up record (RTH-FRM-003).
Pass when. Every sampled severe toxicity was reviewed within the week.
Immediate fail (any one means the criterion is not met)
- A patient with severe skin reaction is not reviewed, and the wound becomes infected.
Documents
No documents yet.
E-learning
References
- World Health Organization Regional Office for Europe. Declaration on the Promotion of Patients’ Rights in Europe. Copenhagen: WHO Regional Office for Europe; 1994.
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