U.S. Nuclear Regulatory Commission

Technical Assistance Request, Community Memorial Hospital, Toms River, NJ, Regarding Exemption from 10 CFR 35.75 (b)

HPPOS-314 PDR-9306250188

Title: Technical Assistance Request, Community Memorial

Hospital, Toms River, NJ, Regarding Exemption from 10 CFR

35.75 (b)

See the memorandum from J. E. Glenn to R. R. Bellamy dated

February 26, 1991. This memo responds to the TAR dated

November 21, 1988, regarding an exemption request by

Community Memorial Hospital, Toms River, New Jersey. The

licensee requests an exemption from 10 CFR 35.75 (b) in

order to release patients containing iodine-125 (I-125)

permanent implants with shielded dose rates of 5 mR/hr or

less at one meter. An exemption from the current rule is

necessary for this practice since the intention of the rule

is to require a dose rate measurement with a survey

measurement instrument without the presence of interposed

shielding at the time of that measurement.

NMSS used the assistance of four NRC medical consultants,

including two physicists and two radiation therapists, in

evaluating this exemption request. Per our request, the

licensee submitted additional information in a letter dated

December 3, 1990, regarding patient treatment areas and

shielding construction. In addition, the licensee proposed

the use of palladium-103 (Pd-103) permanent implants.

Based on reviews of information submitted by the licensee,

NMSS believes that the exemption request may be granted for

the use of I-125 and Pd-103 for the treatment of head and

neck soft tissue sarcomas. The use of I-125 or Pd-103

implants for the treatment of sarcomas located in other

body parts, as proposed by the licensee, should not be

authorized based on the impracticality of attempting to

design shielding devices that the patient would find

comfortable for the duration of the treatment.

Safety regulations regarding the medical use of byproduct

material should not unduly infringe on the practice of

medicine nor severely impact upon patients. However, The

licensee must comply with requirements in the following

sections of 10 CFR Part 35 Subpart G: Section 35.400, "Use

of sources for brachytherapy"; Section 35.406,

"Brachytherapy source inventory"; Section 35.410, "Safety

instruction"; Section 35.415, "Safety precautions"; and

Section 35.420, "Possession of survey instruments". In

addition, NMSS recommends that the following radiation

safety guidance be sufficiently addressed by the licensee

prior to granting an exemption for the use of interposed

shielding to meet the release criteria described in 10 CFR

35.75 (b):

1. The licensee should agree to provide the patient

with an identification bracelet and a wallet card. The

bracelet must contain plain wording to indicate that the

patient has been implanted with radioactive material and a

reference to the wallet card which would contain the

following information: a) radionuclide and activity

implanted; (b) exposure rate at the time of release; (c) a

24-hour emergency telephone number; and (d) a contact

person in the event of a medical emergency or dislodged

source.

Explicit information regarding the implanted radioactive

material could be essential to medical personnel in the

event of an emergency. A physicist or radiation safety

officer could determine any necessary radiation safety

protection measures to be taken by the medical personnel,

as well as, the significance of any possible radiation

exposure received by a member of the public from the

patient if the appropriate radionuclide information is

promptly available. In addition, identification of

patients implanted with radioactive material could also

decrease the chance of accidental burial of a radioactive

source in the event of an unexpected death.

2. Prior to release from hospitalization, the licensee

should agree to provide the patient with safety instruction

equivalent to the instruction required for licensee

personnel described in 10 CFR 35.410, and safety

precautions as described in 35.415 (a) (5) and 35.415 (b).

In addition, the instruction should include the following

radiation safety guidance: (a) the purpose and proper use

of the lead shield; (b) the conditions under which it must

be worn; and (c) the importance of wearing the ID bracelet

and carrying the wallet card.

The instruction should be in oral and written form so that

the patient has a copy of the radiation safety guidelines

available after release from hospitalization. It is

recommended that the instruction be routinely conducted by

an individual that is knowledgeable of brachytherapy

procedures and associated regulatory requirements, such as,

the radiation therapy physician, radiation safety officer,

or a qualified designee that is knowledgeable of

brachytherapy procedures and associated regulatory

requirements. It is also recommended that a responsible

member of the patient's household be present at the time of

instruction so that an individual, other than the patient,

has received instructions and can assist the patient in

complying with the radiation safety guidance.

3. The licensee should develop methods of compliance

with radiation safety guidance. For example: (a) the

interposed shielding device should be in a configuration to

provide for maximum comfort and radiation protection for

the duration of the treatment period; (b) prior to

implantation, the licensee must reach a conclusion based on

available information that the patient is reasonably able

to comply with the radiation safety instruction given prior

to release from hospitalization; and (c) the licensee

should provide some follow-up mechanism (s), such as,

conducting (1) periodic visits to the patient's residence,

(2) periodic telephone contacts with the patient, or (3)

periodic follow-up evaluations to ensure regulatory

compliance. These periodic checks may be performed by the

RSO or a qualified individual designated by the RSO.

4. The exemption should be limited to a set number of

patients and re-evaluated after a portion has been treated

and released under this practice. In addition, the

licensee needs to evaluate patient compliance and report

the results of the evaluations to the Regional office on a

periodic basis.

By requiring licensees to address these radiation safety

concerns, when releasing patients treated with permanent

implants with shielded dose rates of 5 mR/hr or less at one

meter, we can ensure public health and safety without

significantly infringing on the medical use of byproduct

material. Further, we believe this practice should be the

exception rather than the rule.

Regulatory references: 10 CFR 20.1301, 10 CFR 35, License

Conditions

Subject codes: 3.6, 11.1

Applicability: Byproduct Material