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The IAC Standards
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1.1D The
report of the therapy must be typed or computer-generated and must accurately
reflect the treatment performed. This must include:
1.1.1D identification
of the name, address and phone number of the facility;
1.1.2D name of the
treatment (type of treatment);
1.1.3.1D patient’s
first and last
name;
1.1.3.3D date of
birth or age;
1.1.4D requesting
health care provider’s name;
1.1.5D treating
physician’s name;
1.1.7D patient’s
diagnosis and justification
for therapy including a summary of relevant clinical history, physical findings, laboratory/pathology results
and imaging data;
1.1.8D a statement that benefits, alternatives, risks (including side effects) and expected
outcomes (including likelihood of success) were discussed with the patient and/or decision maker, and consent was given and documented in writing;
1.1.9D that the
patient was informed of the information above and written consent was obtained;
1.1.10D when
applicable, evidence that the patient is not pregnant;
1.1.11D when
applicable, that the patient is not lactating and/or has been given appropriate breast feeding counseling;
1.1.12D the
specific radiopharmaceutical administered including:
1.1.12.1D specific identity – radionuclide
and chemical form;
1.1.12.2D exact amount (XX.X mCi);
1.1.12.3D route of
administration (e.g.,
oral, intravenous, intra arterial).
1.1.13D any
other relevant procedures that were part of the therapy;
1.1.14D immediate adverse effects of treatment;
1.1.15D post-therapy
instructions given to the patient including planned follow-up (with whom, when
and where or how to arrange the appointment);
1.1.16D any
unusual occurrences or variations from clinic protocols;
1.1.17D report
finalization to include:
1.1.17.1D identification and manual or electronic
signature (password protected) of the treating, qualified physician;
1.1.17.2D date
report finalized and
signed by treating
physician;
1.1.17.3D if the report is amended, the original
report content, author and date of signature must be retained. The content of
the amendment, author and date of amendment must be clearly recorded.
(See Guidelines
below for further recommendations.)
1.2D Therapy
protocols must describe in detail:
1.2.1D requirement
that the treating physician must be an authorized user for and must personally
supervise the administration of the therapeutic radiopharmaceutical;
1.2.2D clinical
indications and contraindications;
1.2.3D patient
preparation and education/instruction such as food/diet restrictions, if any,
withholding or non-withholding of medications or other relevant information;
Comment: If there are no patient
preparations or restrictions, the protocol must specifically state this.
1.2.4D radiopharmaceutical
identity, dosage range or method of calculation and route of administration;
1.2.5D the requirement for a written directive
prior to radiopharmaceutical administration which includes:
1.2.5.2D radiopharmaceutical identity;
1.2.5.3D radiopharmaceutical dosage for the
specific patient;
1.2.5.4D route of
administration;
1.2.5.5D signature of an authorized user, as
defined by the Nuclear Regulatory Commission in 10 CFR §35.217,
for that specific agent and date.
1.2.6D non-radioactive
drugs used in the procedure including identity, dosage, timing of
administration, route of administration and any precautions or restrictions;
1.2.7D Treatment
procedure including:
1.2.7.1D Review of relevant clinical history,
laboratory/pathology results and imaging data.
1.2.7.2D Informed consent with risks, benefits,
alternatives and likelihood of success.
1.2.7.3D Pregnancy and/or lactation status
check. Additionally, if relevant, guidance concerning breast-feeding cessation
must also be included.
1.2.7.4D Immediately prior to dosing,
verification of the patient’s identity with two identifiers (see Standard
4.1.1.2A) by two members of the medical and/or technical staff.
1.2.7.5D Immediately prior to dosing,
verification of the radiopharmaceutical, amount and route of administration
(see Standard 4.1.1.4A) by two members of the medical and/or technical staff
(see Standards 1.1A - 1.4A).
1.2.8D Radiation
precautions following treatment, as appropriate.
Comment:
Guidance concerning breast feeding cessation (if relevant) must also be
included in radiation precautions following treatment.
1.2.8.1D out-patient
instructions, to include, as appropriate:
i. maintaining
distance from others, especially children and pregnant women (including during
sleep and time in public);
ii. travel (including public transportation
and border crossings);
iii. control
of body fluids;
iv. handling
of potentially radioactive household trash;
v. the
duration of these restrictions.
1.2.8.2D in-patient
instructions, to include, as appropriate:
i. radiation
safety instruction to direct care (e.g., nursing) and housekeeping staff;
ii. hospital
room/signage requirements;
iii. radiation
monitoring requirements;
iv. visitation
policy;
v. handling
of materials used by the patient;
vi. release criteria;
vii. response
to medical emergencies or patient death.
1.2.8.3D A description of any imaging required
in conjunction with the therapy (e.g., I131 post-therapy whole body imaging).
If nuclear imaging is needed as part of a therapy protocol, see Standard 2.4.1B
for components of imaging protocols.
1.3D A qualified member of the medical staff (as defined in Standard 1.1.1A and 1.3.1A) must perform or directly supervise all therapies and provide the final written report. The treating physician must be an authorized user for the radiopharmaceutical administered.
Comment: For direct supervision, the qualified member of the medical staff/authorized user must be physically present at the facility for easy contact or to observe the individual(s) administering the therapy.
1.3.1D The
treating physician must review the pertinent elements of the patient’s
clinical history, physical findings, laboratory/pathology results and imaging
data to confirm the patient’s diagnosis and determine the appropriate
treatment. The treating physician must take responsibility for the proper administration
of the therapy and treatment of side effects.
1.3.2D The
written directive must be in accordance with the treatment plan and include all
required elements (see Standard 2.4.1.3B).
1.3.3D The
written directive must be retained according to state or federal regulations
1.3.4D The
treating physician must assure that the facility’s radionuclide therapy (see
Standard 1.2D) and radiation safety protocols (see Standard 4.2A) are followed.
Any deviations from the protocol must be justified and documented in the patient’s
medical record.
1.3.5D Prior to
administration of the therapeutic dosage, the treating physician must
assure:
1.3.5.1D the
patient is fully informed regarding the benefits, risks (including side
effects), alternatives and expected outcome (including likelihood of success)
of the therapy;
1.3.5.2D informed consent is obtained and documented in writing;
1.3.5.3D the
patient is not pregnant;
1.3.5.4D the
patient is not lactating (see Standard 4.1.3.1A);
1.3.5.5D the vial
or syringe is labeled with the desired radiopharmaceutical and dosage and is
not expired.
1.3.6D The
treating physician must personally supervise the administration of the
therapeutic radiopharmaceutical and assure:
1.3.6.1D the
radiopharmaceutical administration is in accordance with the treatment plan and
written directive;
1.3.6.2D immediately
prior to dosing, confirmation of the proper patient, radiopharmaceutical
identity, dosage and route of administration (see Standards 4.1.1.2A and 1.2.7D).
1.3.7D The
treating physician is responsible for post-therapy care including:
1.3.7.1D post-therapy
instructions;
1.3.7.2D follow-up
appointment(s) [with whom (physician or office) and when];
1.3.7.3D transition
of care to the referring or other provider, if appropriate
1.3.8D When
nuclear medicine therapy patients are released rather than being hospitalized
(e.g., when exposure to others is likely to exceed 0.1 rem [1 mSv] but not
likely to exceed 0.5 rem [5 mSv]), a record of basis for the release and
instructions provided must be maintained.
1.1D The report
of therapy should include:
Unique patient identifier (e.g., unique identification number or sufficient
demographic information to identify patient)16
1.2.8D When appropriate written documentation of dose administration should be given to the patient.