Concept of operation

In a nuclear medicine facility, following operational flow should be planned in accordance with IAEA quality assurance in nuclear medicine (QUANUM) methodology [4]. In deciding upon the performance of a particular test, one should be aware of the contribution of the test result to patient management and be cognizant of appropriate use criteria and of possible alternatives where no radiation is involved. Relevant details include clinical history, pregnancy, breast-feeding allergies, medication and urinary continence as specified in facility protocols. Proper communication, at an early stage, concerning specific preparations for certain procedures is essential. Local guidelines about informed consent must be followed.

The radiopharmaceutical is administered (oral, inhalation, intravenous or intracavity) to the patient in a designated room. Some procedures require immediate imaging, while in other cases a distribution or incorporation phase is required prior to data acquisition. In the latter case, the patient needs to wait in a controlled area or may be sent home for later attendance.

Data acquisition may involve imaging, counting with a probe, or collection of biological samples for later analysis. Due to the nature of nuclear medicine procedures, some may be completed within minutes; others may require repeated acquisitions over several days.

Before discharging the patient, quality analysis of the study should be performed by the technologist and nuclear medicine specialist to ensure proper completion. All exams must be reported by trained specialists in a timely manner.

Critical findings demanding urgent medical attention should be communicated immediately to the referring physician. The report should record the clinical indication for the procedure, the description of methodology (ideally in a template

format), a description of results with a highlighting of important positive and negative findings and then a concise conclusion that addresses the key clinical questions. The report should be signed (electronically or with a formal signature) and delivered to the referring clinician in a timely manner.

The end result of establishing a nuclear medicine service is to ultimately provide a clinical application that will benefit and impact on patient management.

Specific arrangements are necessary for particular categories of patients (elder or bed ridden, paediatric). Paediatric patients are particularly relevant given the role of nuclear medicine studies in this field. Purpose built areas of the facility, including waiting areas, toilets and diagnostic rooms, specifically adapted to children needs should be considered. Specific training should be given to staff.

3.2.2. Patient scheduling

The daily work schedule should match the facility throughput capacity and consider available resources including personnel, equipment and radiopharmaceuticals. The number and type of procedures performed each day can be adapted to suit local demand. An administrative system that allows patients and referring clinicians ready access to clerical staff to ensure optimal appointment scheduling is strongly encouraged:

(a) Referring physician fills a request form for a nuclear medicine test including short clinical information (history, medical records, medication, results of relevant diagnostic investigation).

(b) Request form is received in nuclear medicine reception and assessed for completeness and any possible additional information.

(c) Nuclear medicine specialist, as per requirements in GSR Part 3 [9] and regulations (e.g. EU directives) is consulted about the justification for the procedure.

(d) If request is approved, the appointment is scheduled and instructions for patient preparation are provided.

(e) Information on the study procedure and relevant illustrated material is made available to the patient.

(f) If applicable by local regulation, the patient is asked to sign an inform consent.

3.2.3. Registration

Patient registration is essential for correct patient identification, efficient storage and retrieval of information, reporting and billing. Most countries have

statutory requirement for reports and images to be retained for determined periods of time:

(a) The patient’s entry is activated on the day of the appointment.

(b) Any available previous patient’s study is retrieved.

(c) The patient’s data are entered in the workflow for the nuclear medicine procedure (nuclear medicine information system).

3.2.4. Procedure

With regard to the procedure:

(a) Before radiopharmaceutical administration, patients wait in general waiting areas or a quiet area for PET-fluorodeoxyglucose (FDG) studies.

(b) Radiopharmacy receives the related patient information (body weight, age, height, procedure) and prepares the requested radiopharmaceutical in the desired activity.

(c) Radiopharmacy transfers the patient information to the technologist (or nurse) when the product is ready.

(d) The technologist (or nurse), under the supervision of attending physicians, deals with patient preparation (hydration, appropriate medication, intravenous line, proper patient position) in line with standard operating procedures (SOP).

(e) Qualified staff administer the radiopharmaceutical and start procedure as for the appropriate SOP. Note that in some PET studies, an automatic injector could be used.

(f) The technologist consults the acquisition protocol with the nuclear medicine resident or specialist, sets the imaging equipment for that specific procedure.

(g) The technologist places the patient according to the relevant SOP.

(h) Upon completion of the acquisition, the technologist consults with the nuclear medicine qualified physician to decide on further actions.

(i) Before discharging the patient, the attending physician should carefully assess the quality of the images in relation to the clinical questions and the SOP.

3.2.5. Data processing and management

Data processing is a necessary part of many procedures. This is usually accomplished by a trained technologist using a standard workstation. Data archiving and storage is a legal requirement and essential for clinical follow-up,

education and research. Archiving can take the form of print or digital media (PACS if available).

3.2.6. Reporting and approval of reports With regard to reporting:

(a) A nuclear medicine qualified physician reviews the patient information and images.

(b) Studies should be reported according to the relevant SOP.

(c) Before signing the report, the nuclear medicine specialist reviews images and findings.

(d) A final diagnosis is set for the patient and the final report is signed off to appear in hospital’s intranet (if available) and to be retrieved by the patient or sent to the referring physician.

3.2.7. Additional requirements for radionuclide therapy

Therapy can be administered on an outpatient or inpatient basis depending upon procedure complexity, administered activity and statutory requirements for radiation protection, in addition to patient specific clinical considerations.

Radionuclide therapy places additional, specific demands, which should be reflected in the SOP:

(a) The indication of radionuclide therapy should be the result of a multidisciplinary decision.

(b) Clinical history, histological reports, concomitant treatments, hormonal status and possible medical interactions relating directly to therapy should be available to confirm appropriate indication.

(c) Pregnancy tests are of particular importance before the radionuclide therapy.

(d) Information should be given in case of breast-feeding patients.

(e) The administered activity should be prescribed taking into account targets and critical organs’ absorbed dose by the nuclear medicine physician and medical physicist.

(f) A summary of radiation protection advice provided, a record of activity administered and arrangements for medical follow-up after treatment.

(g) Documentation needs to include confirmation of patient identity, written information about the treatment provided and, in accordance with local regulation, a record of signed informed consent to the particular treatment.

(h) Arrangement for admission, staying and discharge from therapy ward should be taken.