Permanent Implant Patient Info

[Jeff Mason <JMASON@WPO.IUPUI.EDU>]

Hopefully, the following will be of interest to RADSAFERs who deal with
patients.  According to 10CFR35.410 ," (a) The licensee shall provide
radiation safety instruction to all personnel caring for the patient or
human research subject undergoing implant therapy..." and  10CFR35.415,
"(a) For each patient or human research subject receiving implant
therapy, a licensee shall: (1) Not quarter the patient or human research
subject in the same room . . . (2) Post the patient's or human research
subjects door with . . . (3) Authorize visits by individuals under age
18 . . . (4) Promptly after implanting the material, survey the doses .
. .  (5) Provide the patient or human research subject with radiation
safety guidance. . . " regardless if the person is hospitalized based on
the release criteria or if they are hospitalized for other reasons
(e.g., other illness, recovery from surgery, etc.).  According to
10CFR35.310 and 35.315, you do not have to do the same for
radiopharmaceutical therapy patients who can be released but are
hospitalized for other reasons.  We asked the NRC whether implant
patients that are hospitalized but MAY be released based on exposure
rates may be exempt from 35.410 and 35.415.  They replyed with the
following:

"This is in response to your letter dated March 4, 1996, requesting an
interpretation to the regulations (10CFR35.410 and 35.415) as they apply
to patients who receive permanent implants and meet the release criteria
as described in 10CFR35.75.

The NRC staff has concluded that all of the requirements of 10CFR35.410
and 35.415 must be met up to the point where confinement is no longer
required.  Be reminded that 10CFR35.415(a)(5) requires that you provide
implant patients with "radiation safety guidance that will help to keep
radiation dose to household members and the public as low as reasonably
achievable before releasing the patient (in accordance with 10CFR35.75)
if the individual was administered a permanent implant' (emphasis
added).  Once the patient is released from confinement pursuant to
10CFR35.75, and does not require confinement to a private room under
10CFR35.415(a)(1), the regulations in 10CFR35.410 or 35.415 are no
longer applicable.  You may want to consider providing guidance to
implant patients prior to surgery if you plan to 'release' the patient
prior to transferring the patient to the recovery room.  If instructions
have not been given prior to surgery, you should continue to follow
10CFR35.410 and 35.415 restrictions until the instructions have been
given to the patient.

According to the October 31, 1986, 'Statements of Consideration' for
10CFR Part 35, 10CFR35.415 was modified to require licensees to provide
radiation safety guidance in response to comments that the release of
patients, pursuant to 10CFR35.75, may cause unnecessary radiation dose
to members of the public.  Hence, radiation safety guidance must be
provide upon the patients release from confinement . .  ."