§ 35.396 - Training for the parenteral administration of unsealed byproduct material requiring a written directive.

§ 35.396 Training for the parenteral administration of unsealed byproduct material requiring a written directive.

Cross Reference

Link to an amendment published at 83 FR 33108, July 16, 2018.

(a) Except as provided in § 35.57, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who -

(

a

1) Is an authorized user under § 35.390 for uses listed in

§§

§ 35.390(b)(1)(ii)(G)(3)

or 35.390(b)(1)(ii)(G)(4)

, or equivalent Agreement State requirements; or

(

b

2) Is an authorized user under

§§

§ 35.490, § 35.690, or equivalent Agreement State requirements, and who meets the requirements in paragraph (

d

b) of this section; or

(

c

3) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State under

§§

§ 35.490 or § 35.690, and who meets the requirements in paragraph (

d

b) of this section.

(

d

b) The physician -

(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations

, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required.

listed in § 35.390(b)(1)(ii)(G)(3). The training must include -

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of byproduct material for medical use; and

(v) Radiation biology; and

(2) Has work experience, under the supervision of an authorized user who meets the requirements in

§§

§ 35.57, § 35.390, § 35.396, or equivalent Agreement State requirements, in the parenteral

administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements

administrations listed in § 35.390

must have experience in administering dosages as specified in §§ 35.390

(b)(1)(ii)(G)(3)

and/or 35.390(b)(1)(ii)(G)(4).

. A supervising authorized user who meets the requirements in § 35.390, § 35.396, or equivalent Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience must involve -

(i) Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(v) Using procedures to contain spilled byproduct material safely, and using proper decontamination procedures; and

(vi) Administering dosages to patients or human research subjects, that include at least

3

three cases

involving the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV and/or at least 3 cases involving the parenteral administration of any other radionuclide, for which a written directive is required

of the parenteral administrations as specified in § 35.390(b)(1)(ii)(G)(3); and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in

paragraph

paragraphs (b)

or

(

c

1) and (2) of this section, and

has achieved a level of competency sufficient to function independently

is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The

written

attestation must be

signed by a

obtained from either:

(i) A preceptor authorized user who meets the requirements in

§§

§ 35.57, § 35.390, § 35.396, or equivalent Agreement State requirements. A preceptor authorized user

,

who meets the requirements in § 35.390, § 35.396, or equivalent Agreement State requirements, must have experience in administering dosages

as specified in §§ 35.390(b)(1)(ii)(G)(3) and/or 35.390

in the same category or categories as the individual requesting authorized user status; or

(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, § 35.390, § 35.396, or equivalent Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (b)(1) and (

ii)(G)(4)

2) of this section.

[70 83 FR 16365, Mar. 30, 2005, as amended at 71 FR 15010, Mar. 27, 2006; 74 FR 33906, July 14, 200933108, July 16, 2018]