Frequently asked questions

Frequently asked questions

1. Related to Question 1.3: Why is it necessary to define the coordination with other Departments, such as Cardiology, Radiology, etc.?
2. Related to Question 2.1: What is a process map? Why is it requested?
3. Related to Question 3.8: What is the internal review of competences? Can you give an example?
4. Related to Questions 4.19 and 4.21: Do risk assessments include aspects not related to radiation?
5. Related to Question 5.5 : We have a table with the definition of the levels of activity that should normally be injected for each type of examination. Is it sufficient for conformance with the requisite?
6. Related to Question 5.11: What is the meaning of “non-compliance in patient exposures”? Please provide an example.
7. Related to Question 7.4 – 7.8: Are acceptance tests really necessary? Why should they be performed by someone that is independent of the manufacturer?
8. Related to question 9.21: What do you mean with adverse events?
9. Related to question 9.1: Please clarify the concept of SOP and what is the difference between acquisition protocol, guideline and SOP.
10. Related to the scoring: What is the difference between score 3 and 4 ? I just completed the whole set of SOPs, but the internal auditors claim this is not sufficient to obtain full conformity.

1. Related to Question 1.3: Why is it necessary to define the coordination with other Departments, such as Cardiology, Radiology, etc.?

Nuclear Medicine professionals naturally and synergistically interact with other specialties within a Hospital. Some Departments commonly refer their patients to Nuclear Medicine for procedures, examples include Oncology or Nephrology.

On the other hand, we have areas (such as Medical Physics; Information Technology; Pharmacy; Biomedical Engineering) that play central supportive roles in the processes performed within the Nuclear Medicine (i.e. they contribute to the delivery of “products”) Dept., itself, and therefore the interactions are more complex and require a formal definition of the relationship (a so-called “contract”) for reasons such as, but not limited to:

• ensuring the quality and continuity of provided services; through the presence of qualified specialists and personnel, according to a roaster, agreed among the Heads of Departments;
• overseeing patients’ safety, ensuring that they are under the continuous observation of a single specific Department and under the responsibility of a defined Medical Doctor (e.g. cardiac patients under stress tests).

There are various means to ensure this formal agreement, and it is not necessary to sign a real contract, like in business interactions. An exchange of letters between the Heads of the involved Departments is sufficient evidence of the level of definition requested.

2. Related to Question 2.1: What is a process map? Why is it requested?

Question 2.1 requires that, within a Nuclear Medicine Department, the primary processes as well as the supporting and management processes, are defined. The primary processes (diagnostic procedures, in our case) are those which contribute towards the end product (the report) that can be billed. Supporting processes, such as radiopharmaceutical preparations or QA/QC of equipment, are necessary for a successful primary process. Managerial processes are necessary for the orderly delivery of all processes.

This definition can be made using a graphical representation (a “process map”), but alternatives are possible.

Examples of primary processes are “diagnostic scans” or “clinical procedures”. They are the general process aimed at producing the final product, i.e. the report; or “Therapeutic procedures with radiopharmaceuticals”, aimed at administering radiopharmaceuticals for therapeutic purposes..

Examples of supporting processes are the preparation of radiopharmaceuticals, or QA/QC programs for diagnostic equipment.

Log books with daily schedules of the different procedures, reporting daily activities and workload, or calendars of staff shifts and holidays are examples of managerial processes.

3. Related to Question 3.8: What is the internal review of competences? Can you give an example?

Example 1: Let us consider a NM Department performing PET-CT, SPECT and SPECT-CT as well as planar imaging. Several qualified NM Physicians are available. The fact that a physician holds a qualification (a university degree or a board certification) does not guarantee that he is well trained in ALL procedures; e.g. a NM physician may be very well trained in Nuclear Cardiology but not in PET-CT in Oncology, at least according to the required standards of the institution.

In order to be dedicated to a specific activity it is requested that a professional has the qualification AND the specific competencies required for the procedure: e.g. to have reported under supervision of an already qualified NM Physician a pre-fixed number of the type of scans of interest.

Example 2: A board-certified Nuclear Medicine Technologist after a long maternity leave comes back on duty. She may have lost confidence with operations in radiopharmacy, so a short re-training may be recommended in order to ensure her competence in the specific field of activity.

The periodical review of competences (in many cases managed at the institutional level) is necessary in order to grant that a professional or staff member can be dedicated to a specific task, safe for him and for the patients.

4. Related to Questions 4.19 and 4.21: Do risk assessments include aspects not related to radiation?

Yes. Even if radiation is in general the most important risk factor in a Nuclear Medicine facility, risk assessment should consider other “conventional” aspects related to safety of the staff as well.

Examples include:

• Electrical safety: In NM we manage a lot of electronic equipment, frequently operating at high voltage;
• Mechanical safety: Lead bricks are very useful to build shielding barriers, but must be properly secured to ensure that they do not fall;
• Microbiological safety: Biohazards should be carefully considered, being frequently even more relevant than radioactive contamination. After injection, syringes should never be recapped; sharps containers should be widely available, in regular use, and receptacles be emptied or replaced regularly per protocol;
• Misadministration is also another important risk that should be carefully considered and preventive actions put in place.

5. Related to Question 5.5 : We have a table with the definition of the levels of activity that should normally be injected for each type of examination. Is it sufficient for conformance with the requisite?

Unfortunately not, unless there is no specific Standard Operating Procedure in place prescribing measurements of each single dose just before injection, granted not only that the nominal values of activity are in line with the Diagnostic Reference Levels reported in the BSS or in national and international guidelines, but also that the real levels of activity routinely dispensed and effectively administered are conforming. This is easy to obtain if there is a recording of each unit dose dispensed or acquired; a retrospective analysis performed periodically (e.g. once or twice per year) in a sample time interval, can ensure that the prescription of the nominal activity levels in the table is consistently achieved.

For an interesting multi-national overview on diagnostic reference levels, refer to the European document Radiation Protection series no. 180 (free download →).

6. Related to Question 5.11: What is the meaning of “non-compliance in patient exposures”? Please provide an example.

Non-compliances in patient exposure could be:

• a wrong radiopharmaceutical given to a patient;
• wrong administered activity (e.g. 800 MBq instead of 700 Mbq);
• detection of an unexpected bio-distribution (most likely due to extravasation);
• All of the above should be considered mis-administrations.

A further example could be the use of incorrect parameters for the X-ray component of a PET-CT or SPECT-CT scan which may either lead to scan repetition, or the excessive unjustified patient radiation exposure.

Considering therapy, a very serious non-compliance can be the extravasation in the administration of Y-90 or Ra-223 radiopharmaceuticals. These will determine a high and unjustified dose to the tissues surrounding the administration site.

There should be a mechanism (and a formal, specific SOP) aimed at preventing the above incidents, report the latter in case they occur, and activate corrective actions to limit the likelihood of further occurrences.

7. Related to Question 7.4 – 7.8: Are acceptance tests really necessary? Why should they be performed by someone that is independent of the manufacturer?

Imaging equipment is highly sophisticated technology; these complex systems may very frequently show defects from the beginning (e.g. hydrated crystal in SPECT scanners; modules not acquiring correctly in PET detectors, etc.). If not revealed at the time of installation, these defects may extend with time and produce consequences in clinical images.

Moreover, even if structural defects are not present, it may happen that some relevant parameters of performance do not meet the specifications. With what level of confidence can a NM Physician report on the detectability of lesions if the spatial resolution and the sensitivity of the scanner have not been checked and verified?

These aspects were considered when the International Electrotechnical Commission (IEC) issued the standards of the series IEC 61223 “Evaluation and routine testing in medical imaging departments”. They have been recognized by the IAEA not only in the QUANUM programme but also into the publications Human Health Series No. 1 “Quality assurance for PET and PET/CT systems” and No. 6 “Quality assurance for SPECT systems”.

To avoid any conflict of interest, acceptance tests should be performed by a third party. .Acceptance testing performance and minimum acceptable performance characteristics must be established during negotiations before purchase,., . Acceptance testing is meant to verify that those standards are met.

8. Related to question 9.21: What do you mean with adverse events?

A Quality System is aimed to improve performance and to prevent undesirable situations and, once something unplanned occurs, to have the capacity of reacting effectively and appropriately.

Adverse or unexpected events are frequently termed as incidents/accidents. This specific question deals with the existence of a planned procedure in the case of similar events and if there is a mechanism of incident reporting.

Incident reporting should be consistently applied to all types of situations, like mis-administration or adverse reaction for both radioactive AND non-radioactive drugs. Not only events involving radiation should be considered; as a further example, a relatively frequent incident in diagnostic imaging facilities is the fall of a patient form the bed of the imaging equipment.

A Standard Operating Procedure can guide a Department in preventing or reacting to all of these undesired situations.

9. Related to question 9.1: Please clarify the concept of SOP and what is the difference between acquisition protocol, guideline and SOP.

In very general terms, a procedure is a written description of how a particular process is carried out.

• Clinical guidelines are part of the process of evidence-based medicine (EBM); they collect current opinions from relevant scientists and associations and define the “state of the art” on a certain topic, e.g. you may have a guideline on the appropriate use of FDG PET in oncology or on thyroid scintigraphy in nodular goitre, etc. Note that guidelines may be issued by different bodies / organizations and may have different levels of recognition by law in different countries.
• The term “protocol” is used in several different contexts. In clinical practice the notion “protocol” refers to the operating procedure adopted to perform a given task, e.g. thyroid scintigraphy. In this sense, an internal protocol reflects only a convention inside that specific Department. It should however comply with international standards as well national laws and regulations, for instance as regards administered dose. Another frequent use is in research or in multi-centre trials. In this context, “protocol” represents an agreement on how to perform a detailed series of operations. It does not necessarily have any legal recognition and it is not a common base for the definition of the “state of the art”, but simply an agreed working program.
• In particular, in Nuclear Medicine, the acquisition protocol is intended as the set of parameters to perform a specific type of examination; e.g. we typically have different acquisition protocols for 99mTc whole body scan, or for myocardial gated SPECT or for 18F-FDG scans. The acquisition protocol only deals with the acquisition parameter on the camera, and not with the whole procedure, e.g. it does not account for patient preparation, any possible interference from other drugs or medication, counter-indications etc. Therefore, the acquisition protocol is only one of the components of the whole procedure, and is not exhaustive of all aspects involved.
• A Standard Operating Procedure (SOP) is a formal document, whose format, revision, distribution, as well as its content, are maintained under control.. A SOP is used to define how a task or series of operations is performed inside an organization (a Department). In this context, a SOP has (at least superficially) the same function as an “internal protocol”.. However an SOP is intended as a formal document and thus needs to be traceable to reference documents (i.e. guidelines form professional bodies) and in relation with the full set of SOPs dealing with other related subjects inside the organization. SOPs should also be distributed to all involved staff, be easily reachable in the site of use and a distribution list should be signed by receiving staff and kept as evidence of distribution.

10. Related to the scoring: What is the difference between score 3 and 4 ? I just completed the whole set of SOPs, but the internal auditors claim this is not sufficient to obtain full conformity.

Documents such as SOPs are a fundamental component of any Quality System, however their mere existence does not prove by itself that the Quality System is working.

Other components are requested, and particularly:

• evidence that the Quality System is operationally used to keep track of departmental performance;
• evidence that the improvement (Deming) cycle was applied: i.e. learning from the experience and checking planned activities towards results,
• planning and implementation of corrective actions

Therefore, for level 4 or full conformance, it is requested to prove that requirements of any particular item are not only met and included in the overall Quality System, but they are also (1) used and, (2) that the results were reviewed and used to plan further improvement.