Re: Radioisotope misadministrations

[Robert Yoss <ryoss@post.its.mcw.edu>]

Excerpted from the current 10 CFR 35.2 Definitions

Misadministration means the administration of:

(1) A radiopharmaceutical dosage greater than 30 microcuries of either sodium
iodide I - 125 or I - 131:

(i) Involving the wrong individual, or wrong radiopharmaceutical; or

(ii) When both the administered dosage differs from the prescribed dosage by
more than 20 percent of the prescribed dosage and the difference between the
administered dosage and prescribed dosage exceeds 30 microcuries.

(2) A therapeutic radiopharmaceutical dosage, other than sodium iodide I - 125
or I - 131:

(i) Involving the wrong individual, wrong radiopharmaceutical, or wrong route of
administration; or

(ii) When the administered dosage differs from the prescribed dosage by more
than 20 percent of the prescribed dosage.

(3) A gamma stereotactic radiosurgery radiation dose:

(i) Involving the wrong individual, or wrong treatment site; or

(ii) When the calculated total administered dose differs from the total
prescribed dose by more than 10 percent of the total prescribed dose.

(4) A teletherapy radiation dose:

(i) Involving the wrong individual, wrong mode of treatment, or wrong treatment
site;

(ii) When the treatment consists of three or fewer fractions and the calculated
total administered dose differs from the total prescribed dose by more than 10
percent of the total prescribed dose;

(iii) When the calculated weekly administered dose exceeds the weekly prescribed
dose by 30 percent or more of the weekly prescribed dose; or

(iv) When the calculated total administered dose differs from the total
prescribed dose by more than 20 percent of the total prescribed dose.

(5) A brachytherapy radiation dose:

(i) Involving the wrong individual, wrong radioisotope, or wrong treatment site
(excluding, for permanent implants, seeds that were implanted in the correct
site but migrated outside the treatment site);

(ii) Involving a sealed source that is leaking;

(iii) When, for a temporary implant, one or more sealed sources are not removed
upon completion of the procedure; or

(iv) When the calculated administered dose differs from the prescribed dose by
more than 20 percent of the prescribed dose.

(6) A diagnostic radiopharmaceutical dosage, other than quantities greater than
30 microcuries of either sodium iodide I - 125 or I - 131, both:

(i) Involving the wrong individual, wrong radiopharmaceutical, wrong route of
administration, or when the administered dosage differs from the prescribed
dosage; and

(ii) When the dose to the individual exceeds 5 rems effective dose equivalent or
50 rems dose equivalent to any individual organ.

Bob Yoss
ryoss@mcw.edu

> The seven cases in Nuclear Medicine are the following:
> http://www.nrc.gov/NRC/COMMISSION/SECYS/1997-023scy.html
>
> 1)  Radiopharmaceutical Misadministration  Administering a
> radiopharmaceutical other than the one intended, where the actual dose is
> greater than five times the prescribed dose.
>
>  2) Radiopharmaceutical Misadministration  -  An actual diagnostic dose of a
> radiopharmaceutical is greater than five times the prescribed dose.
>
> 3)  Radiopharmaceutical Misadministration  - An actual diagnostic dose of a
> radiopharmaceutical is greater than five times the prescribed dose.
>
> 4) Radiopharmaceutical Misadministration  - A therapeutic dose such that the
> actual dose is less than 0.5 times the prescribed dose.
>
> 5) Radiopharmaceutical Misadministration  - A therapeutic dose of a
> radiopharmaceutical differing from the prescribed dose by more than 10
> percent, and the actual dose is less than 0.5 times the  prescribed dose.
>
> 6) Radiopharmaceutical Misadministration - Administering a diagnostic dose
> of a radiopharmaceutical  differing from the prescribed dose by more than 50
> percent, and the actual dose is greater than five times the prescribed dose.
>
> 7)  Radiopharmaceutical Misadministration  - Administering a therapeutic
> dose such that the actual dose is less than 0.5 times the prescribed dose.
>
> J. J. Rozental
> josrozen@netmedia.net.il
> Israel
>
> jjrozental
>
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