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HPPOS-314 PDR-9306250188

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