Standards › ASF Health Standards v10 › Standard 50
Standard 50
Diagnostic Imaging
Diagnostic imaging: radiation justified and dose optimised, equipment quality assured, reports timely with critical findings escalated, contrast media and MRI safety controlled, images retrievable, and resuscitation equipment ready.
Every imaging study involving ionising radiation is clinically justified before ordering, with dose optimised to the lowest level consistent with diagnostic quality, not a default protocol applied regardless of patient size, age, or clinical indication.
Why it matters. Ionising radiation can harm the patient, so each scan must be justified, and the dose kept as low as the result allows. Both are required for every study.
How the surveyor verifies this criterion
Sample. Review a sample of imaging studies that use ionising radiation from the last 6 months, with their justification and dose records.
1. Every radiation study is clinically justified before it is ordered.
Method. Check each sampled study for a recorded justification dated before the study.
Evidence to show. Radiation justification and dose optimisation (RAD-POL-001); radiation justification record (RAD-FRM-001).
Pass when. Every sampled study has a justification recorded before it was performed.
2. Dose is optimised to the lowest level that gives diagnostic quality.
Method. Compare the dose set for each sampled study with the reference level and the protocol.
Evidence to show. Radiation justification record (RAD-FRM-001); dental radiography justification and dose optimisation (DEN-POL-002, existing, reused) for dental studies.
Pass when. Every sampled dose is within the reference level, or a reason above it is recorded.
3. Dose is audited each year, and any dose above the reference level is reviewed.
Method. Check the annual dose audit and the review of each dose above the reference level.
Evidence to show. Radiation justification and dose optimisation (RAD-POL-001).
Pass when. The annual audit is recorded and every dose above the reference level has a review.
Immediate fail (any one means the criterion is not met)
- A patient has a repeat CT scan within a week with no recorded justification, and the dose is never reviewed.
Documents
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E-learning
References
- International Commission on Radiological Protection. The 2007 Recommendations of the ICRP. ICRP Publication 103. Ann ICRP. 2007;37(2-4).
- 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.
All imaging equipment undergoes documented quality assurance testing and calibration on a defined schedule by qualified personnel, with any equipment failing to meet standards immediately removed from clinical use until corrected.
Why it matters. An imaging machine out of calibration gives wrong pictures, and wrong pictures lead to wrong decisions. Quality testing and calibration on schedule keep the images reliable.
How the surveyor verifies this criterion
Sample. Review quality assurance records for all imaging equipment for the last 12 months.
1. All imaging equipment has documented quality assurance testing on a defined schedule.
Method. Compare the register with the schedule for each piece of equipment.
Evidence to show. Imaging equipment quality assurance (IMG-SOP-001); imaging equipment quality assurance register (IMG-REG-002).
Pass when. Every piece of equipment was tested within its schedule.
2. Testing and calibration are carried out by qualified personnel.
Method. Check the person who carried out each test against the qualification list.
Evidence to show. Imaging equipment quality assurance register (IMG-REG-002).
Pass when. Every test was carried out by a qualified person.
3. Equipment that fails is taken out of use until it passes.
Method. Check each failed test for the out-of-use date and the return-to-use date.
Evidence to show. Imaging equipment quality assurance (IMG-SOP-001).
Pass when. No equipment was used between a failed test and its passing retest.
Immediate fail (any one means the criterion is not met)
- An X-ray unit fails its calibration test, and patients are scanned on it for three weeks.
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.
Imaging studies are reported within a defined time frame appropriate to clinical urgency, with a documented, functioning critical finding communication protocol ensuring an urgent result reaches the ordering clinician directly, not left in a queue for routine review.
Why it matters. A critical finding on a scan, such as a bleed, must reach the clinician in time to act. A set reporting time and an escalation route for critical results protect the patient.
How the surveyor verifies this criterion
Sample. Review the reporting time and critical finding log for a sample of studies from the last 6 months, against each urgency band.
1. Studies are reported within the time frame for their clinical urgency.
Method. Compare the reporting time of each sampled study with its time frame.
Evidence to show. Imaging report turnaround and critical finding log (IMG-REG-001).
Pass when. Every sampled study was reported within its time frame, or the reason is recorded.
2. A critical finding is communicated to the responsible clinician, and the time is recorded.
Method. Check each critical finding in the log for the recipient and the time.
Evidence to show. Critical result reporting (HOS-SOP-009, existing, reused); imaging report turnaround and critical finding log (IMG-REG-001).
Pass when. Every critical finding has a recorded recipient and time.
3. The communication protocol works.
Method. Test the protocol with a sample call to the responsible clinician and record the time to reach them.
Evidence to show. Imaging report turnaround and critical finding log (IMG-REG-001).
Pass when. The responsible clinician is reached within the time set in the protocol.
Immediate fail (any one means the criterion is not met)
- A critical pneumothorax is reported on a Friday evening and not communicated until Monday.
Documents
No documents yet.
E-learning
References
- World Health Organization (2021). Global Patient Safety Action Plan 2021–2030: Towards Eliminating Avoidable Harm in Health Care. Geneva: WHO. https://www.who.int/publications-detail-redirect/9789240032705
A written protocol governs contrast media use, including pre-screening for allergy and renal function, informed consent, and a documented, immediately accessible emergency response plan for a contrast reaction — not a generic allergy question treated as sufficient screening.
Why it matters. Contrast media can cause severe allergic reactions and kidney damage. A protocol that screens for allergy and kidney function before use reduces these risks.
How the surveyor verifies this criterion
Sample. Review contrast media records for a sample of contrast studies in the last 6 months, and the emergency kit checks.
1. A written protocol governs contrast media use.
Method. Check the protocol for the screening, consent and emergency steps.
Evidence to show. Contrast media safety protocol (CTR-SOP-001).
Pass when. The protocol covers allergy, renal function, consent and emergency steps.
2. Every patient is pre-screened for allergy and renal function before contrast is given.
Method. Check each sampled study for the pre-screen record before the contrast was given.
Evidence to show. Contrast media pre-screen and consent record (CTR-FRM-001).
Pass when. Every sampled study has a pre-screen recorded before the contrast was given.
3. An emergency response for reaction is documented and immediately accessible.
Method. Check the emergency kit and the daily check record, and trace the reaction response.
Evidence to show. Adverse reaction record (PRO-FRM-006, existing, reused); contrast media safety protocol (CTR-SOP-001).
Pass when. The emergency kit was checked each day and any reaction has a recorded response.
Immediate fail (any one means the criterion is not met)
- A patient with a known contrast allergy receives contrast, and the emergency kit is empty.
Documents
No documents yet.
E-learning
References
- World Health Organization (2021). Global Patient Safety Action Plan 2021–2030: Towards Eliminating Avoidable Harm in Health Care. Geneva: WHO. https://www.who.int/publications-detail-redirect/9789240032705
Every patient and accompanying individual is screened for MRI contraindications before entering the magnetic field, with physical zone control preventing unscreened access — not a screening form completed but not verified before entry.
Why it matters. A metal implant or device can move or heat up in an MRI scanner and injure the patient or the person accompanying them. Screening everyone before they enter the scanner prevents that.
How the surveyor verifies this criterion
Sample. Observe MRI sessions on several days and check the screening records for a sample of studies in the last 6 months.
1. Every patient and accompanying person is screened for MRI contraindications before entry.
Method. Observe entry on several days and check the screening record for each sampled study.
Evidence to show. MRI safety screening and zone control (MRI-SOP-001); MRI safety screening record (MRI-FRM-001).
Pass when. Every observed and sampled entry has a screening record before entry.
2. Physical zone control prevents unscreened access to the magnetic field.
Method. Observe the zone entry on several days, and test it with an unscreened person.
Evidence to show. MRI safety screening and zone control (MRI-SOP-001).
Pass when. The zone entry stops every unscreened person, and no unscreened entry is observed.
3. Implants and devices are checked against the MRI-conditional list.
Method. Check the record of each sampled implant or device for the check.
Evidence to show. MRI safety screening record (MRI-FRM-001).
Pass when. Every sampled implant or device has a recorded check against the list.
Immediate fail (any one means the criterion is not met)
- A patient with an unknown metal implant enters the MRI room unscreened.
Documents
No documents yet.
E-learning
References
- World Health Organization (2021). Global Patient Safety Action Plan 2021–2030: Towards Eliminating Avoidable Harm in Health Care. Geneva: WHO. https://www.who.int/publications-detail-redirect/9789240032705
Imaging studies and reports are retained for the required period and retrievable for comparison with prior studies, not archived in a way that makes practical retrieval difficult or unreliable.
Why it matters. Images and reports are needed for comparison, for follow-up and for the law. Keeping them for the required period, and finding them when asked, is part of safe imaging.
How the surveyor verifies this criterion
Sample. Retrieve a sample of prior imaging studies and reports from the archive, and check the retention schedule.
1. Imaging studies and reports are retained for the required period.
Method. Check the archive against the retention period for a sample of studies.
Evidence to show. Image and report retention and retrieval (ARC-POL-001).
Pass when. Every sampled study is retained for the required period.
2. Each study can be retrieved for comparison with prior studies.
Method. Retrieve a sample of studies by patient and date and time the retrieval.
Evidence to show. Image retrieval test register (ARC-REG-001).
Pass when. Every sampled study is retrieved within the set time.
3. Archiving does not make practical retrieval difficult.
Method. Check the retrieval tests for failures and any action taken.
Evidence to show. Image retrieval test register (ARC-REG-001); records audit tool (REC-FRM-002, existing, reused).
Pass when. No retrieval test fails without a recorded corrective action.
Immediate fail (any one means the criterion is not met)
- A prior study is archived with the wrong patient identifier and cannot be retrieved for a comparison scan.
Documents
No documents yet.
E-learning
References
- International Organization for Standardization. ISO 15189:2022 Medical laboratories: requirements for quality and competence. Geneva: ISO; 2022.
Resuscitation equipment is checked every shift, fully stocked and working, and staff holding life support certification are current.
Why it matters. When a patient stops breathing, minutes matter. Equipment that is missing or broken, or staff without current life-support training, cost lives.
How the surveyor verifies this criterion
Sample. Check resuscitation equipment on every shift for a sample of days in the last 3 months, and the life support certificates of staff on those shifts.
1. Resuscitation equipment is checked every shift.
Method. Check the shift check record for each sampled shift.
Evidence to show. Resuscitation equipment checks (HOS-SOP-015, existing, reused); daily resuscitation check record (HOS-FRM-013, existing, reused).
Pass when. Every sampled shift has a recorded equipment check.
2. Resuscitation equipment is fully stocked and working.
Method. Inspect the equipment on the sampled shifts and test the working items.
Evidence to show. Resuscitation area readiness (ED-POL-002, existing, reused); resuscitation area readiness register (ED-REG-001, existing, reused).
Pass when. Every item is present and working on each sampled shift.
3. Staff holding life support certification are current.
Method. Check the certificate and its expiry date for the staff on each sampled shift.
Evidence to show. Resuscitation area readiness register (ED-REG-001, existing, reused).
Pass when. Every staff member on the sampled shifts holds a current certificate.
Immediate fail (any one means the criterion is not met)
- The defibrillator pads are expired on the night of a cardiac arrest, and no one has checked the shift record.
Documents
No documents yet.
E-learning
References
- Panchal AR, et al. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020;142(16 Suppl 2):S366-S468.
- World Health Organization (2016). Emergency care systems for universal health coverage: ensuring timely care for the sick and injured. Report of the Director-General, A69/21. Geneva: WHO.
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