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Audit Regulation Consolidated Reference Sheet

Audit History

A. Were previous audits conducted annually [20.1101]?

Subpart B--Radiation Protection Programs

§ 20.1101 Radiation protection programs.

(a) Each licensee shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities and sufficient to ensure compliance with the provisions of this part. (See § 20.2102 for recordkeeping requirements relating to these programs.)

(b) The licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).

(c) The licensee shall periodically (at least annually) review the radiation protection program content and implementation.

(d) To implement the ALARA requirements of § 20.1101 (b), and notwithstanding the requirements in § 20.1301 of this part, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees other than those subject to § 50.34a, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in § 20.2203 and promptly take appropriate corrective action to ensure against recurrence.

B: Were records of previous audits maintained (3 years)

§20.2102 Records of radiation protection programs.

(a) Each licensee shall maintain records of the radiation protection program, including:

(1) The provisions of the program; and

(2) Audits and other reviews of program content and implementation.

(b) The licensee shall retain the records required by paragraph (a)(1) of this section until the Commission terminates each pertinent license requiring the record. The licensee shall retain the records required by paragraph (a)(2) of this section for 3 years after the record is made.

C. Were any deficiencies identified during previous audit?

D. Were corrective actions taken? (Look for repeated deficiencies.)

Organization and Scope of Program

A. Radiation Safety Officer:

1. If the RSO was changed, was the license amended (30 days) [35.13]?

§ 35.13 License amendments.

A licensee shall apply for and must receive a license amendment—

(a) Before it receives, prepares, or uses byproduct material for a type of use that is permitted under this part, but is not authorized on the licensee's current license issued under this part; except that—

(1) A Government agency or a Federally recognized Indian Tribe licensee who possesses and uses accelerator-produced radioactive material or discrete sources of radium-226 may continue to use such material for medical uses permitted under this part until the date of the NRC's final licensing determination, provided that the licensee submits an amendment application on or before June 2, 2008. (see CFR 35.13 License amendments).

(2) Except as provided in paragraph (a)(1) of this section, all other licensees who possess and use accelerator-produced radioactive material or discrete sources of radium-226 may continue to use those materials for medical uses permitted under this part until the date of the NRC's final licensing determination, provided that the person submits a medical use license amendment request within 6 months from the waiver expiration date of August 7, 2009 or within 6 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever date is earlier. (see CFR 35.13 License amendments).

(b) Before it permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except—

(1) For an authorized user, an individual who meets the requirements in §§ 35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a);

(2) For an authorized nuclear pharmacist, an individual who meets the requirements in §§ 35.55(a) and 35.59;

(3) For an authorized medical physicist, an individual who meets the requirements in §§ 35.51(a) and (c) and 35.59;

(4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, or authorized medical physicist (see CFR 35.50 Training for Radiation Safety Officer).—

(i) On a Commission or Agreement State license or other equivalent permit or license recognized by NRC that authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy;

(ii) On a permit issued by a Commission or Agreement State specific license of broad scope that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy;

(iii) On a permit issued by a Commission master material licensee that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy; or

(iv) By a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists.

(5) A physician, podiatrist, or dentist who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses or a nuclear pharmacist who used only accelerator-produced radioactive materials in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, and for only those materials and uses performed before these dates. (see CFR 35.13 License amendments).

(d) Before it receives byproduct material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;

(e) Before it adds to or changes the areas of use identified in the application or on the license, including areas used in accordance with either § 35.100 or § 35.200 if the change includes addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area. Other areas of use where byproduct material is used only in accordance with either § 35.100 or § 35.200 are exempt;

(f) Before it changes the address (es) of use identified in the application or on the license; and

(g) Before it revises procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable, where such revision reduces radiation safety.

2. Does the new RSO meet NRC training requirements (313a) [35.50, 35.57, and 35.59]?

§ 35.50 Training for Radiation Safety Officer.

Except as provided in § 35.57, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in § 35.24 to be an individual who—

(a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraphs (d) and (e) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1)(i) Hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science; (see CFR 35.50 Training for Radiation Safety Officer).

(ii) Have 5 or more years of professional experience in health physics (graduate training may be substituted for no more than 2 years of the required experience) including at least 3 years in applied health physics; and

(iii) Pass an examination administered by diplomates of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or

(2)(i) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; (see CFR 35.51 Training for an authorized medical physicist)

(ii) Have 2 years of full-time practical training and/or supervised experience in medical physics-

(A) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the Commission or an Agreement State; or

(B) In clinical nuclear medicine facilities providing diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users in §§ 35.57, 35.290, or 35.390; and

(iii) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or

(b)(1) Has completed a structured educational program consisting of both:

(i) 200 hours of classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(D) Radiation biology; and

(E) Radiation dosimetry; and

(ii) One year of full-time radiation safety experience under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license or permit issued by a Commission master material licensee that authorizes similar type(s) of use(s) of byproduct material involving the following—

(A) Shipping, receiving, and performing related radiation surveys;

(B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;

(D) Using administrative controls to avoid mistakes in the administration of byproduct material;

(E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;

(F) Using emergency procedures to control byproduct material; and

(G) Disposing of byproduct material; or

(2) [Reserved] (see CFR 35.50 Training for Radiation Safety Officer).

(c)(1) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State under § 35.51(a) and has experience in radiation safety for similar types of use of byproduct material for which the licensee is seeking the approval of the individual as Radiation Safety Officer and who meets the requirements in paragraphs (d) and (e) of this section; or

(2) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual has Radiation Safety Officer responsibilities. (see CFR 35.50 Training for Radiation Safety Officer).

; and,

(d) Has obtained written attestation, signed by a preceptor Radiation Safety Officer, that the individual has satisfactorily completed the requirements in paragraph (e) and in paragraphs (a)(1)(i) and (a)(1)(ii) or (a)(2)(i) and (a)(2)(ii) or (b)(1) or (c)(1) or (c)(2) of this section, and has achieved a level of radiation safety knowledge sufficient to function independently as a Radiation Safety Officer for a medical use licensee; and

(e) Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval.

§ 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

(a)(1) An individual identified as a Radiation Safety Officer, a teletherapy or medical physicist, or a nuclear pharmacist on a Commission or Agreement State license or a permit issued by a Commission or Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope before October 24, 2002, need not comply with the training requirements of §§ 35.50, 35.51, or 35.55, respectively. (see § 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist).

(2) An individual identified as a Radiation Safety Officer, an authorized medical physicist, or an authorized nuclear pharmacist on a Commission or Agreement State license or a permit issued by a Commission or Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope between October 24, 2002 and April 29, 2005 need not comply with the training requirements of §§ 35.50, 35.51, or 35.55, respectively. (see § 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist).

(3) A Radiation Safety Officer, a medical physicist, or a nuclear pharmacist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of § 35.50, § 35.51 or § 35.55, respectively, when performing the same uses. A nuclear pharmacist, who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist, who used only accelerator-produced radioactive materials, at the locations and time period identified in this paragraph, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for purposes of this chapter, as specified in § 35.57.

(b)(1) Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the Commission or Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or Agreement State broad scope licensee, or a permit issued by a Commission master material license broad scope permittee before October 24, 2002, who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of Subparts D through H of this part as specified in § 35.57.

(2) Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the Commission or Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or Agreement State broad scope licensee, or a permit issued by a Commission master material license broad scope permittee who perform only those medical uses for which they were authorized between October 24, 2002 and April 29, 2005, need not comply with the training requirements of Subparts D through H of this part, as specified in § 35.57.

(3) Physicians, dentists, or podiatrists who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses performed at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of subparts D through H of this part when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses at the locations and time period identified in this paragraph, qualifies as an authorized user for those materials and uses performed before these dates, for purposes of this chapter. § 35.57

(c) Individuals who need not comply with training requirements as described in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on NRC licenses for the same uses for which these individuals are authorized.

§ 35.59 Recentness of training.

The training and experience specified in Subparts B, D, E, F, G, and H of this part must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed

3. If the scope of the program expands, does the RSO have training in radiation safety, regulatory issues, and emergency procedures for the new uses [35.50(e)]?

35.50 Training for Radiation Safety Officer.

4. Is the RSO fulfilling all duties [35.24]?

§ 35.24 Authority and responsibilities for radiation for radiation protection program

Subpart B--General Administrative Requirements

§ 35.24 Authority and responsibilities for the radiation protection program.

(a) In addition to the radiation protection program requirements of § 20.1101 of this chapter, a licensee's management shall approve in writing—

(1) Requests for a license application, renewal, or amendment before submittal to the Commission; (see § 35.24 Authority and responsibilities for the radiation protection program).

(2) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and (see § 35.24 Authority and responsibilities for the radiation protection program)

(3) Radiation protection program changes that do not require a license amendment and are permitted under § 35.26;

(b) A licensee's management shall appoint a Radiation Safety Officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements.

(c) For up to 60 days each year, a licensee may permit an authorized user or an individual qualified to be a Radiation Safety Officer, under §§ 35.50 and 35.59, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in paragraph (g) of this section, if the licensee takes the actions required in paragraphs (b), (e), (g), and (h) of this section and notifies the Commission in accordance with § 35.14(b).

(d) A licensee may simultaneously appoint more than one temporary Radiation Safety Officer in accordance with paragraph (c) of this section, if needed to ensure that the licensee has a temporary Radiation Safety Officer that satisfies the requirements to be a Radiation Safety Officer for each of the different types of uses of byproduct material permitted by the license.

(e) A licensee shall establish the authority, duties, and responsibilities of the Radiation Safety Officer in writing.

(f) Licensees that are authorized for two or more different types of uses of byproduct material under Subparts E, F, and H of this part, or two or more types of units under Subpart H of this part, shall establish a Radiation Safety Committee to oversee all uses of byproduct material permitted by the license. The Committee must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. The Committee may include other members the licensee considers appropriate.

(g) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to—

(1) Identify radiation safety problems; (see § 35.24 Authority and responsibilities for the radiation protection program)

(2) Initiate, recommend, or provide corrective actions; (see § 35.24 Authority and responsibilities for the radiation protection program)

(3) Stop unsafe operations; and, (see § 35.24 Authority and responsibilities for the radiation protection program)

(4) Verify implementation of corrective actions. (see § 35.24 Authority and responsibilities for the radiation protection program)

(h) A licensee shall retain a record of actions taken under paragraphs (a), (b), and (e) of this section in accordance with § 35.2024.

5. Is the written agreement in place for a new RSO (appointment orders) [35.24(b)]?

35.24 Authority and responsibilities for the radiation protection program.

B. Multiple places of use? If yes, list locations.

C. Are all locations listed on license? Includes locations of accelerator-produced radioactive materials and discrete sources of radium-226?

D. Were annual audits performed at each location? If no, explain.

E. Describe the scope of the program (staff size, number of procedures performed, etc.).

F. Licensed Material:

1. Isotope, chemical form, quantity, and use as authorized? Includes accelerator-produced radioactive materials and discrete sources of radium-226?

2. Does the total amount of radioactive material possessed require financial assurance [30.35(a)]? If so, is the financial assurance adequate?

30.35 Financial assurance and recordkeeping for decommissioning.

(a)(1) Each applicant for a specific license authorizing the possession and use of unsealed byproduct material of half-life greater than 120 days and in quantities exceeding 105 times the applicable quantities set forth in appendix B to part 30 shall submit a decommissioning funding plan as described in paragraph (e) of this section. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 105 is greater than 1 (unity rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in appendix B to part 30. (see § 30.35 Financial assurance and recordkeeping for decommissioning).

(2) Each holder of, or applicant for, any specific license authorizing the possession and use of sealed sources or plated foils of half-life greater than 120 days and in quantities exceeding 1012 times the applicable quantities set forth in appendix B to part 30 (or when a combination of isotopes is involved if R, as defined in § 30.35(a)(1), divided by 1012 is greater than 1), shall submit a decommissioning funding plan as described in paragraph (e) of this section. The decommissioning funding plan must be submitted to NRC by December 2, 2005. (see § 30.35 Financial assurance and recordkeeping for decommissioning).

3. Calibration, transmission, and reference sources [35.65]?

35.65 Authorization for calibration, transmission, and reference sources.

Any person authorized by § 35.11 for medical use of byproduct material may receive, possess, and use any of the following byproduct material for check, calibration, transmission, and reference use

a. Sealed sources manufactured and distributed by a person licensed pursuant to 10 CFR 32.74, equivalent Agreement State regulations, or redistributed by a licensee authorized to redistribute sealed sources, and sources do not exceed 30 millicuries each [35.65(a) and (b)]?

§ 32.74 suppliers for sealed sources or devices

(a) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under § 32.74 of this chapter or equivalent Agreement State regulations.

(b) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under § 32.74 of this chapter or equivalent Agreement State regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.

b. Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 15 millicuries [35.65(c)]?

§ 35.65 medical use of byproduct material

(c) Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 0.56 GBq (15 mCi).

c. Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 200 microcuries or 1000 times the quantities in Appendix B of Part 30 [35.65(d)]?

§ 35.65 medical use of byproduct

(d) Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 μCi) or 1000 times the quantities in Appendix B of Part 30 of this chapter.

d. Technetium-99m in individual amounts as needed [35.65(e)]?

(e) Technetium-99m in amounts as needed.

4. Unsealed materials used under 10 CFR 35.100, 35.200, and 35.300 are:

§ 35.290 Training for imagining and localization studies

a. Obtained from a manufacturer or preparer licensed under 10 CFR 32.72?

32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35

(a) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing byproduct material for use by persons authorized pursuant to part 35 of this chapter will be approved if:

(1) The applicant satisfies the general requirements specified in 10 CFR 30.33; (see § 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35):

(i) Registered with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a);

(ii) Registered or licensed with a state agency as a drug manufacturer;

(iii) Licensed as a pharmacy by a State Board of Pharmacy;

(iv) Operating as a nuclear pharmacy within a Federal medical institution; or

(v) A Positron Emission Tomography (PET) drug production facility registered with a State agency.

The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees. (See § 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35); and

(4) The applicant satisfies the following labeling requirements (See § 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35):

(i) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than 100 days, the time may be omitted.

(ii) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

(b) A licensee described by paragraph (a) (2) (iii) or (iv)of this section:

(1) May prepare radioactive drugs for medical use, as defined in 10 CFR 35.2, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraph (b)(2) and (b)(4) of this section, or an individual under the supervision of an authorized nuclear pharmacist as specified in 10 CFR 35.27.

(2) May allow a pharmacist to work as an authorized nuclear pharmacist as specified in § 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35) if:

(i) This individual qualifies as an authorized nuclear pharmacist as defined in 10 CFR 35.2,

(ii) This individual meets the requirements specified in § 35.55(b) and 35.59 of this chapter, and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or

(iii) This individual is designated as an authorized nuclear pharmacist in accordance with paragraph (b) (4) of this section.

(3) The actions authorized in paragraphs (b) (1) and (b)(2) of this section are permitted in spite of more restrictive language in license conditions.

(4) May designate a pharmacist (as defined in § 35.2 of this chapter) as an authorized nuclear pharmacist if:

(i) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, as specified § 35.2 and

(ii) The individual practiced at a pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC § 35.2.

(5) Shall provide to the Commission: (see § 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35)

(i) A copy of each individual's certification by a specialty board whose certification process has been recognized by the Commission or an Agreement State as specified in § 35.55(a) of this chapter with the written attestation signed by a preceptor as required by § 35.55(b)(2) of this chapter; or

(ii) The Commission or Agreement State license, or

(iii) Commission master materials licensee permit, or

(iv) The permit issued by a licensee or Commission master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist, under § 35.65 or

(v) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; (see § 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35)

and

(vi) A copy of the State pharmacy licensure or registration, no later than 30 days after the date that the licensee allows, under paragraphs (b)(2)(i) and (b)(2)(iii) of this section, the individual to work as an authorized nuclear pharmacist.

(c) A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution § 32.72. In addition, the licensee shall:

(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary (see § 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35); and

(2) Check each instrument for constancy and proper operation at the beginning of each day of use. (see § 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35)

(d) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs § 32.72.

b. Obtained from a producer of PET radioactive drugs under 10 CFR 30.32(j)?

§ 30.32 Application for specific licenses

(j) An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under part 35 of this chapter or equivalent Agreement State requirements (see § 30.32 Application for specific licenses)

Shall include:

c. Prepared by a physician AU, an ANP, or an individual under the supervision of an ANP or physician AU?

d. Obtained and prepared for research in accordance with 10 CFR 35.100, 10 CFR 35.200, and 10 CFR § 35.300, as applicable?

Subpart D—Unsealed Byproduct Material—Written Directive Not Required

§ 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required. (see CFR Part 35—Medical Use of Byproduct Material )

Except for quantities that require a written directive under § 35.40(b), a licensee may use any unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is—

(a) Obtained from:

(1) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(2) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in §§ 35.290, or 35.390 and 35.290(c)(1)(ii)(G); or

(c) Obtained from and prepared by an NRC or Agreement State licensee as specified in § 35.200 for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA. (see § 35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.)

35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.

Except for quantities that require a written directive under § 35.40(b), a licensee may use any unsealed byproduct material prepared for medical use for imaging and localization studies that is—

(a) Obtained from:

(1) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(2) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in § 35.290, or 35.390 and 35.290(c)(1)(ii)(G); or

Subpart E—Unsealed Byproduct Material—Written Directive Required

§ 35.300 Use of unsealed byproduct material for which a written directive is required.

A licensee may use any unsealed byproduct material prepared for medical use and for which a written directive is required that is—

(a) Obtained from:

(1) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(2) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in §35.290, 35.390, or

(3) An individual under the supervision, as specified in § 35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this section or the physician who is an authorized user in paragraph (b)(2) of this section (see § 35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required).; or

(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA § 35.200; or

(d) Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA § 35.200.

(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA § 35.200.

5. Production of PET radioactive drugs

a. Authorized under 10 CFR 30.32(j)?

§ 30.32 application for specific licenses

(1) A request for authorization for the production of PET radionuclides or evidence of an existing license issued under part 30 of this chapter or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides § 32.72.

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in § 32.72(a)(2) of this chapter.

(3) Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in § 32.72(b)(2) of this chapter.

(4) Information identified in § 32.72(a)(3) of this chapter on the PET drugs to be noncommercially transferred to members of its consortium

b. For internal use from licensee’s PET radionuclide production facility as authorized in 10 CFR 35.100(b), 35.200(b), or 35.300(b)?

35.100 (b) excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in §35.290, or 35.390 and 35.290(c) (1)(ii)(G); or

35.200(b)

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in § 35.290, or 35.390 and 35.290(c)(1)(ii)(G); or

35.300(b)

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in §§ 35.290, 35.390, or

G. Are the sealed sources possessed and used as described in the Sealed Source and Device Registry (SSDR) certificate in 10 CFR 32.210, 35.400, 35.500, 35.600?

10 CFR 32.210

Subpart D—Sealed Source and Device Registration

§ 32.210 Registration of product information.

(a) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the NRC for evaluation of radiation safety information about its product and for its registration.

(b) The request for review must be sent to the NRC's Office of Nuclear Material Safety and Safeguards, ATTN: SSDR by an appropriate method listed in § 30.6(a) of this chapter.

(c) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

(d) The NRC normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the NRC formulates reasonable standards and criteria with the help of the manufacturer or distributor. The NRC shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. Subpart A of this part includes specific criteria that apply to certain exempt products and subpart B includes specific criteria applicable to certain generally licensed devices. Subpart C includes specific provisions that apply to certain specifically licensed items. ( see § 32.210 Registration of product information).

(e) After completion of the evaluation, the Commission issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate. (see CFR §32.210 Registration of product information).

(f) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with § 32.210—

(1) The statements and representations, including quality control program, contained in the request § 32.210; and

(2) The provisions of the registration certificate. (see CFR § 32.210 Registration of product information).

(g) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases § 32.210:

(1) Calibration and reference sources containing no more than:

(i) 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; or

(ii) 0.37 MBq (10 μCi), for alpha emitting radionuclides; or

(2) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; ( see § 32.210 Registration of product information).

and

(i) The intended recipients are licensed under part 33 of this chapter or comparable provisions of an Agreement State § 32.210; or

(ii) The recipients are authorized for research and development; or

(iii) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide § 32.210.

(h) After the certificate is issued, the Commission may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Commission will complete its evaluation in accordance with criteria specified in this section. The Commission may request such additional information as it considers necessary to conduct its review and the certificate holder shall provide the information as requested.

(See CFR § 32.210 Registration of product information).

10 CFR 35.400

Subpart F--Manual Brachytherapy

§ 35.400 Use of sources for manual brachytherapy.

A licensee shall use only brachytherapy sources for therapeutic medical uses:

(a) As approved in the Sealed Source and Device Registry; or

(b) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of § 35.49(a) are met. (see CFR §35.400 Use of sources for manual brachytherapy).

10 CFR 35.500

Subpart G--Sealed Sources for Diagnosis

§ 35.500 Use of sealed sources for diagnosis.

A licensee shall use only sealed sources for diagnostic medical uses as approved in the Sealed Source and Device Registry.

10 CFR 35.600

Subpart H--Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

§ 35.600 Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.

A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses:

(a) As approved in the Sealed Source and Device Registry § 35.400; or

(b) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of § 35.49(a) are met. (See CFR 35.400 Use of sources for manual brachytherapy. )

a. Are copies of (or access to) SSDR certificates possessed?

b. Are manufacturers’ manuals for operation and maintenance of medical devices possessed?

H. Are there sealed sources containing accelerator-produced radioactive materials or discrete sources of radium-226 that do not have an SSDR certificate? If the sealed source is not generally licensed or exempt from licensing, seek a license amendment providing information under 10 CFR 32(g) (2) or (3).

I. Are the actual uses of medical devices consistent with the authorized uses listed on the license?

J. If places of use changed, was the license amended [35.13(e)]?

35.13 License amendments

K. If control of the license was transferred or bankruptcy filed, was NRC’s prior consent obtained or notification made [30.34(b) and 30.34(h) respectively]?

30.34 terms and conditions of licenses.

Radiation Safety Program

A. Minor changes to program [10 CFR 35.26 or license condition for 10 CFR 35.1000 medical uses]?

§ 35.26 Radiation protection program changes.

(a) A licensee may revise its radiation protection program without Commission approval if--

(1) The revision does not require a license amendment under § 35.13;

(2) The revision is in compliance with the regulations and the license;

(3) The revision has been reviewed and approved by the Radiation Safety Officer and licensee management; and

(4) The affected individuals are instructed on the revised program before the changes are implemented.

(b) A licensee shall retain a record of each change in accordance with § 35.2026.

§ 35.1000 Other medical uses of byproduct material or radiation from byproduct material.

A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in subparts D through H of this part if—

(a) The applicant or licensee has submitted the information required by § 35.12(b) through (d); and

(b) The applicant or licensee has received written approval from the Commission in a license or license amendment and uses the material in accordance with the regulations and specific conditions the Commission considers necessary for the medical use of the material.

B. Records of changes maintained for 5 years [35.2026]?

§ 35.2026 Records of radiation protection program changes.

A licensee shall retain a record of each radiation protection program change made in accordance with § 35.26(a) for 5 years. The record must include a copy of the old and new procedures; the effective date of the change; and the signature of the licensee management that reviewed and approved the change.

C. Content and implementation reviewed annually by the licensee [20.1101(c)]?

§ 20.1101 Radiation protection programs

(c) The licensee shall periodically (at least annually) review the radiation protection program content and implementation.

E. Changes include addition of accelerator-produced radioactive materials or discrete sources of radium-226 to NRC-regulated Radiation Safety Program?

F. Changes include authorization to produce PET radioactive drugs for noncommercial distribution to other medical use licensees in the consortium [10 CFR 30.32(j)]?

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in § 32.72(a)(2) of this chapter.

(4) Information identified in § 32.72(a)(3) of this chapter on the PET drugs to be noncommercially transferred to members of its consortium.

Use by Authorized Individuals: Compliance is established by meeting at least one criterion under each category.

A. Authorized Nuclear Pharmacist [35.55, 35.57, 35.59]

(Note: Does not apply to facilities that are registered with FDA as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a) or registered with the State as a drug manufacturer or PET drug production facility with distribution regulated under 10 CFR 32.72):

35.55 Training for an authorized nuclear pharmacist.

Except as provided in § 35.57, the licensee shall require the authorized nuclear pharmacist to be a pharmacist who--

(a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (b)(2) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Have graduated from a pharmacy program accredited by the American Council on Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;

(2) Hold a current, active license to practice pharmacy;

(3) Provide evidence of having acquired at least 4000 hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and

(4) Pass an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development; or

(b)(1) Has completed 700 hours in a structured educational program consisting of both:

(i) 200 hours of classroom and laboratory training in the following areas-

(A) Radiation physics and instrumentation;

(B) Radiation protection;

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

(E) Radiation biology; and

(ii) Supervised practical experience in a nuclear pharmacy involving--

(A) Shipping, receiving, and performing related radiation surveys;

(B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;

(D) Using administrative controls to avoid medical events in the administration of byproduct material; and

(E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

(2) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraphs (a)(1), (a)(2), and (a)(3) or (b)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist. (See Radiation Safety Officer: for § 35.57 35.59)

1. Certified by specialty board?

2. Identified on NRC or Agreement State license?

3. Identified on permit issued by broad-scope or master materials licensee?

4. Identified on permit issued by master materials permittee of broad scope?

5. Identified as an ANP by a commercial nuclear pharmacy that has been authorized to identify ANPs?

6. Designated as an ANP in accordance with 10 CFR 32.72(b) (4)?

(b) A licensee described by paragraph (a) (2)(iii) or (iv) of this section:

(4) May designate a pharmacist (as defined in § 35.2 of this chapter) as an authorized nuclear pharmacist if:

(i) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and

7. Meets requirements in 35.57(a) (3)?

8. Listed on facility license?

B. Authorized User [35.57, 35.59, and 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.491, 35.590, 35.690]: (See #2-does the new RSO meet NRC training requirements (313a) for §35.57and 35.59)

§ 35.190 Training for uptake, dilution, and excretion studies

Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.100 to be a physician who—

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (c)(2) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies as described in paragraphs (c)(1)(i) through (c)(1)(ii)(F) of this section; and

(2) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

(b) Is an authorized user under §35.290, 35.390, or equivalent Agreement State requirements; or (c)(1)*

(c)(1) Has completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies. The training and experience must include-

(i) Classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

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

(E) Radiation biology; and

(ii) Work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.190, 35.290, 35.390, or equivalent Agreement State requirements, involving—

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

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

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

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

(F) Administering dosages of radioactive drugs to patients or human research subjects; and

(2) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in §§ 35.57, 35.190, 35.290, or 35.390, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under § 35.100.

§ 35.290 Training for imaging and localization studies.

Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.200 to be a physician who—

(1) Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for imaging and localization studies as described in paragraphs (c)(1)(i) through (c)(1)(ii)(G) of this section; and

(2) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

(b) Is an authorized user under § 35.390 and meets the requirements in § 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements; or

(c)(1) Has completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for imaging and localization studies. The training and experience must include, at a minimum-

(i) Classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(D) Chemistry of byproduct material for medical use;

(E) Radiation biology; and

(ii) Work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, involving—

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

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

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

(E) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;

(F) Administering dosages of radioactive drugs to patients or human research subjects; and

(G) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

(2) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in §§ 35.57, 35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under §§ 35.100 and 35.200.

§ 35.390 Training for use of unsealed byproduct material for which a written directive is required.

Except as provided in § 35.57, the licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.300 to be a physician who—

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraphs (b)(1)(ii)(G) and (b)(2) of this section. (Specialty boards whose certification processes have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To be recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include 700 hours of training and experience as described in paragraphs (b)(1)(i) through (b)(1)(ii)(E) of this section. Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate Training of the American Osteopathic Association; and

(2) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material for which a written directive is required; or

(b)(1) Has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive. The training and experience must include-

(i) Classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

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

(E) Radiation biology; and

(ii) Work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.390, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in § 35.390(b), must also have experience in administering dosages in the same dosage category or categories (i.e., § 35.390(b)(1)(ii)(G)) as the individual requesting authorized user status. The work experience must involve—

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

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

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

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

(F) [Reserved]

(G) Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status—

(1) Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131, for which a written directive is required;

(2) Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-1312;

(3) Parenteral administration of any beta emitter, or a photon- emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required; and/or

(4) Parenteral administration of any other radionuclide, for which a written directive is required; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) and (b)(1)(ii)(G) or (b)(1) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under § 35.300. The written attestation must be signed by a preceptor authorized user who meets the requirements in §§ 35.57, 35.390, or equivalent Agreement State requirements. The preceptor authorized user, who meets the requirements in § 35.390(b) must have experience in administering dosages in the same dosage category or categories (i.e., § 35.390(b)(1)(ii)(G)) as the individual requesting authorized user status.

§ 35.392 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries).

Except as provided in § 35.57, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who—

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraphs (c)(1) and (c)(2) of this section and whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (c)(3) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.); or

(b) Is an authorized user under § 35.390 for uses listed in § 35.390(b)(1)(ii)(G)(1) or (2), § 35.394, or equivalent Agreement State requirements; or

(c)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. 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, 35.392, 35.394, or equivalent Agreement State requirements. A supervising authorized user who meets the requirements in § 35.390(b) must also have experience in administering dosages as specified in §§ 35.390(b)(1)(ii)(G)(1) or 35.390(b)(1)(ii)(G)(2). 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 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 includes at least 3 cases involving the oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under § 35.300. The written attestation must be signed by a preceptor authorized user who meets the requirements in §§ 35.57, 35.390, 35.392, 35.394, or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirement in § 35.390(b), must also have experience in administering dosages as specified in §§ 35.390(b)(1)(ii)(G)(1) or 35.390(b)(1)(ii)(G)(2).

§ 35.394 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).

Except as provided in 35.57, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to be a physician who—

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraphs (c)(1) and (c)(2) of this section, and whose certification has been recognized by the Commission or an Agreement State, and who meets the requirements in paragraph (c)(3) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.); or

(b) Is an authorized user under § 35.390 for uses listed in § 35.390(b)(1)(ii)(G)(2) or equivalent Agreement State requirements; or

(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, 35.394, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in § 35.390(b), must also have experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(2). 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 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 includes at least 3 cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under § 35.300. The written attestation must be signed by a preceptor authorized user who meets the requirements in §§ 35.57, 35.390, 35.394, or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirements in § 35.390(b), must also have experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(2).

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

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) 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) Is an authorized user under §§ 35.490, 35.690, or equivalent Agreement State requirements and who meets the requirements in paragraph (d) of this section; or

(c) 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) of this section.

(d)(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. 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 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). 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 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; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (b) or (c) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation must be signed by 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, 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).

§ 35.490 Training for use of manual brachytherapy sources.

Except as provided in § 35.57, the licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under § 35.400 to be a physician who—

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State, and who meets the requirements in paragraph (b)(3) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete a minimum of 3 years of residency training in a radiation oncology program 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 Committee on Post-Graduate Training of the American Osteopathic Association; and

(2) Pass an examination, administered by diplomates of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy; or

(b)(1) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes—

(i) 200 hours of classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(D) Radiation biology; and

(ii) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.490, or equivalent Agreement State requirements at a medical institution, involving—

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

(B) Checking survey meters for proper operation;

(D) Maintaining running inventories of material on hand;

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

(F) Using emergency procedures to control byproduct material; and

(2) Has completed 3 years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in §§ 35.57, 35.490, or equivalent Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (b)(1)(ii) of this section; and

(3) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in §§ 35.57, 35.490, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (a)(1), or paragraphs (b)(1) and (b)(2), of this section and has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized under § 35.400.

§ 35.491 Training for ophthalmic use of strontium-90.

Except as provided in § 35.57, the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who—

(a) Is an authorized user under § 35.490 or equivalent Agreement State requirements; or

(b)(1) Has completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

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

(iv) Radiation biology; and

(2) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training must involve—

(i) Examination of each individual to be treated;

(ii) Calculation of the dose to be administered;

(iii) Administration of the dose; and

(iv) Follow up and review of each individual's case history; and

(3) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in §§ 35.57, 35.490, 35.491, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (b) of this section and has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic use.

§ 35.590 Training for use of sealed sources for diagnosis.

Except as provided in § 35.57, the licensee shall require the authorized user of a diagnostic sealed source for use in a device authorized under § 35.500 to be a physician, dentist, or podiatrist who--

(a) Is certified by a specialty board whose certification process includes all of the requirements in paragraphs (b) and (c) of this section and whose certification has been recognized by the Commission or an Agreement State. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.); or

(b) Has completed 8 hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include-

(1) Radiation physics and instrumentation;

(2) Radiation protection;

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

(4) Radiation biology; and

§ 35.690 Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

Except as provided in § 35.57, the licensee shall require an authorized user of a sealed source for a use authorized under § 35.600 to be a physician who—

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraphs (b)(3) and (c) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete a minimum of 3 years of residency training in a radiation therapy program 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 Committee on Post-Graduate Training of the American Osteopathic Association; and

(2) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy; or

(b)(1) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes—

(i) 200 hours of classroom and laboratory training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(D) Radiation biology; and

(ii) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.690, or equivalent Agreement State requirements at a medical institution, involving—

(A) Reviewing full calibration measurements and periodic spot-checks;

(B) Preparing treatment plans and calculating treatment doses and times;

(D) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;

(E) Checking and using survey meters; and

(F) Selecting the proper dose and how it is to be administered; and

(2) Has completed 3 years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in §§ 35.57, 35.690, or equivalent Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (b)(1)(ii) of this section; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (a)(1) or paragraphs (b)(1) and (b)(2), and paragraph (c), of this section, and has achieved a level of competency sufficient to function independently as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written attestation must be signed by a preceptor authorized user who meets the requirements in §§ 35.57, 35.690, or equivalent Agreement State requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status; and

(c) Has received training in device operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type(s) of use for which the individual is seeking authorization.

1. Certified by specialty board?

2. Identified on NRC or Agreement State license?

3. Identified on permit issued by broad-scope or master materials licensee?

4. Identified on permit issued by master materials permittee of broad scope?

5. Meets requirements in 35.57(b) (3)?

6. Listed on facility license?

C. Authorized Medical Physicist [35.51, 35.57, and 35.59]: (See #2-does the new RSO meet NRC training requirements (313a) for §35.57and 35.59)

1. Certified by specialty board?

2. Identified on NRC or Agreement State license?

3. Identified on permit issued by broad-scope or master materials licensee?

4. Identified on permit issued by master materials permittee of broad scope?

5. Meets requirements in 35.57(a) (3)? See below.

6. Listed on facility license?

§ 35.51 Training for an authorized medical physicist.

Except as provided in § 35.57, the licensee shall require the authorized medical physicist to be an individual who—

(a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraphs (b)(2) and (c) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

(2) Have 2 years of full-time practical training and/or supervised experience in medical physics-

(i) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the Commission or an Agreement State; or

(ii) In clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements in § 35.57, 35.490, or 35.690; and

(3) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery; or

(b)(1) Holds a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and has completed 1 year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type(s) of use for which the individual is seeking authorization. This training and work experience must be conducted in clinical radiation facilities that provide high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services and must include:

(i) Performing sealed source leak tests and inventories;

(ii) Performing decay corrections;

(iii) Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

(iv) Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c) and (a)(1) and (a)(2), or (b)(1) and (c) of this section, and has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in §§ 35.51, 35.57, or equivalent Agreement State requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; and

(c) Has training for the type(s) of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type(s) of use for which the individual is seeking authorization.

D. Nonmedical use authorized users [30.33(a) (3)]:

Listed on facility license for same materials and uses?

§ 30.33 General requirements for issuance of specific licenses.

(a) An application for a specific license will be approved if:

(3) The applicant is qualified by training and experience to use the material for the purpose requested in such manner as to protect health and minimize danger to life or property;

Mobile Medical Service

A. Operates services per 35.80, 35.647?

§ 35.80 Provision of mobile medical service.

(a) A licensee providing mobile medical service shall--

(1) Obtain a letter signed by the management of each client for which services are rendered that permits the use of byproduct material at the client's address and clearly delineates the authority and responsibility of the licensee and the client;

(2) Check instruments used to measure the activity of unsealed byproduct material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this paragraph must include a constancy check;

(3) Check survey instruments for proper operation with a dedicated check source before use at each client's address; and

(4) Before leaving a client's address, survey all areas of use to ensure compliance with the requirements in Part 20 of this chapter.

(b) A mobile medical service may not have byproduct material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the byproduct material. Byproduct material delivered to the client must be received and handled in conformance with the client's license.

(c) A licensee providing mobile medical services shall retain the letter required in paragraph (a)(1) and the record of each survey required in paragraph (a)(4) of this section in accordance with § 35.2080(a) and (b), respectively.

§ 35.647 Additional technical requirements for mobile remote afterloader units.

(a) A licensee providing mobile remote afterloader service shall--

(1) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and

(2) Account for all sources before departure from a client's address of use.

(b) In addition to the periodic spot-checks required by § 35.643, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of--

(1) Electrical interlocks on treatment area access points;

(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

(3) Viewing and intercom systems;

(4) Applicators, source transfer tubes, and transfer tube-applicator interfaces;

(5) Radiation monitors used to indicate room exposures;

(6) Source positioning (accuracy); and

(7) Radiation monitors used to indicate whether the source has returned to a safe shielded position.

(c) In addition to the requirements for checks in paragraph (b) of this section, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

(d) If the results of the checks required in paragraph (b) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(e) A licensee shall retain a record of each check required by paragraph (b) of this section in accordance with § 35.2647.

B. Compliance with 20.1301 evaluated and met? (See below)

C. Letter signed by management of each client [35.80(a)]? (See below)

D. Licensed material not delivered to client’s address (unless client was authorized) [35.80(b)]? (See below)

E. Dosage measuring instruments checked for proper function before use at each address of use or on each day of use, if more frequent [35.80(a)]? (See below)

F. Survey instruments checked for proper operation before use at each address of use [35.80(a)]? (See below)

G. Survey of all areas of use prior to leaving each client address [35.80(a)]? (See below)

§ 20.1301 Dose limits for individual members of the public

(a) Each licensee shall conduct operations so that -

(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contributions from background radiation, from any administration the individual has received, from exposure to individuals administered radioactive material and released under § 35.75, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with § 20.2003, and

(2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with § 35.75, does not exceed 0.002 rem (0.02 millisievert) in any one hour.

(b) If the licensee permits members of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.

(c) Notwithstanding paragraph (a)(1) of this section, a licensee may permit visitors to an individual who cannot be released, under § 35.75, to receive a radiation dose greater than 0.1 rem (1 mSv) if-

(1) The radiation dose received does not exceed 0.5 rem (5 mSv); and

(2) The authorized user, as defined in 10 CFR Part 35, has determined before the visit that it is appropriate.

(d) A licensee or license applicant may apply for prior NRC authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv). The licensee or license applicant shall include the following information in this application:

(1) Demonstration of the need for and the expected duration of operations in excess of the limit in paragraph (a) of this section;

(2) The licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and

(3) The procedures to be followed to maintain the dose as low as is reasonably achievable.

(e) In addition to the requirements of this part, a licensee subject to the provisions of EPA's generally applicable environmental radiation standards in 40 CFR part 190 shall comply with those standards.

(f) The Commission may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

H. Additional technical requirements for mobile remote after loaders per 35.647? (See above)

Amendments Since Last Audit [35.13]

A. Any Amendments since last audit [35.13]?

B. Security-related sensitive information was properly marked?

§ 35.13 License amendments.

A licensee shall apply for and must receive a license amendment—

(b) Before it permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except—

(1) For an authorized user, an individual who meets the requirements in §§ 35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a);

(2) For an authorized nuclear pharmacist, an individual who meets the requirements in §§ 35.55(a) and 35.59;

(3) For an authorized medical physicist, an individual who meets the requirements in §§ 35.51(a) and (c) and 35.59;

(4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, or authorized medical physicist—

(iii) On a permit issued by a Commission master material licensee that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy; or

(iv) By a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists.

(d) Before it receives byproduct material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;

(f) Before it changes the address(es) of use identified in the application or on the license; and

(g) Before it revises procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable, where such revision reduces radiation safety.

Notifications Since Last Audit [35.14]

A. Any Notifications since last audit [35.14]?

§ 35.14 Notifications.

(a) A licensee shall provide the Commission a copy of the board certification and the written attestation(s), signed by a preceptor, the Commission or Agreement State license, the permit issued by a Commission master material licensee, the permit issued by a Commission or Agreement State licensee of broad scope, the permit issued by a Commission master material license broad scope permittee, or documentation that only accelerator-produced radioactive materials, discrete sources of radium-226, or both, were used for medical use or in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, and for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist, under § 35.13(b). For individuals permitted to work under § 35.13(b)(4), within the same 30-day time frame, the licensee shall also provide, as appropriate, verification of completion of;

(1) Any additional case experience required in § 35.390(b)(1)(ii)(G) for an authorized user under § 35.300;

(2) Any additional training required in § 35.690(c) for an authorized user under § 35.600; and

(3) Any additional training required in § 35.51(c) for an authorized medical physicist.

(b) A licensee shall notify the Commission no later than 30 days after:

(1) An authorized user, an authorized nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change;

(2) The licensee permits an authorized user or an individual qualified to be a Radiation Safety Officer, under §§ 35.50 and 35.59, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer in accordance with § 35.24(c).

(3) The licensee's mailing address changes;

(4) The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in § 30.34(b) of this chapter; or

(5) The licensee has added to or changed the areas of use identified in the application or on the license where byproduct material is used in accordance with either § 35.100 or § 35.200 if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area.

(c) The licensee shall send the documents required in this section to the appropriate address identified in § 30.6 of this chapter.

B. Appropriate documentation provided to NRC, for ANP, AMP, or AU, no later than 30 days after the individual starts work [35.14(a), (see above) 30.34(j)(4)]?

§ 30.34 Terms and conditions of licenses

(j)(1) Authorization under § 30.32(j) to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs.

(4) A pharmacy, authorized under § 30.32(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of § 32.72(b)(5) of this chapter.

C. NRC notified within 30 days after: AU, ANP, AMP, or RSO stops work or changes name; licensee’s mailing address changes; licensee’s name changes without a transfer of control of the license; or licensee has added to or changed an area of use for 10 CFR 35.100 or 35.200 use, if the change does not include addition or relocation of either an area where PET radionuclides are produced or a radionuclide delivery line from a PET radionuclide production area [35.14(b)] (see above)?

Training, Retraining, and Instructions to Workers

A. Have workers been provided with required instructions [19.12, 35.27, 35.310, 35.410, and 35.610]?

§ 19.12 Instruction to workers.

(a) All individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv) shall be--

(1) Kept informed of the storage, transfer, or use of radiation and/or radioactive material;

(2) Instructed in the health protection problems associated with exposure to radiation and/or radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

(3) Instructed in, and required to observe, to the extent within the workers control, the applicable provisions of Commission regulations and licenses for the protection of personnel from exposure to radiation and/or radioactive material;

(4) Instructed of their responsibility to report promptly to the licensee any condition which may lead to or cause a violation of Commission regulations and licenses or unnecessary exposure to radiation and/or radioactive material;

(5) Instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and/or radioactive material; and

(6) Advised as to the radiation exposure reports which workers may request pursuant to § 19.13.

(b) In determining those individuals subject to the requirements of paragraph (a) of this section, licensees must take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and/or radioactive material which can reasonably be expected to occur during the life of a licensed facility. The extent of these instructions must be commensurate with potential radiological health protection problems present in the work place.

Subpart B—General Administrative Requirements

§ 35.27 Supervision.

(a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user, as allowed by § 35.11(b)(1), shall--

(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of this chapter, and license conditions with respect to the use of byproduct material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of byproduct material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this chapter, and license conditions with respect to the medical use of byproduct material.

(b) A licensee that permits the preparation of byproduct material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by § 35.11(b)(2), shall--

(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the preparation of byproduct material for medical use, as appropriate to that individual's involvement with byproduct material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of byproduct material for medical use, written radiation protection procedures established by the licensee, the regulations of this chapter, and license conditions.

(c) A licensee that permits supervised activities under paragraphs (a) and (b) of this section is responsible for the acts and omissions of the supervised individual.

Subpart E—Unsealed Byproduct Material—Written Directive Required

§ 35.310 Safety instruction.

In addition to the requirements of § 19.12 of this chapter,

(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include—

(1) Patient or human research subject control;

(2) Visitor control, including—

(i) Routine visitation to hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and

(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter;

(3) Contamination control;

(4) Waste control; and

(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.

(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.

Subpart F—Manual Brachytherapy

§ 35.410 Safety instruction.

In addition to the requirements of § 19.12 of this chapter,

(a) The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include the--

(1) Size and appearance of the brachytherapy sources;

(2) Safe handling and shielding instructions;

(3) Patient or human research subject control;

(4) Visitor control, including both:

(i) Routine visitation of hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and

(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter; and

(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.

(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.

Subpart H—Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

§ 35.610 Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

(a) A licensee shall--

(1) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

(2) Permit only individuals approved by the authorized user, Radiation Safety Officer, or authorized medical physicist to be present in the treatment room during treatment with the source(s);

(3) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

(4) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include--

(i) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

(ii) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

(iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.

(b) A copy of the procedures required by paragraph (a)(4) of this section must be physically located at the unit console.

(1) The location of the procedures required by paragraph (a)(4) of this section; and

(2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.

(d) A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual's assigned duties, in--

(1) The procedures identified in paragraph (a)(4) of this section; and

(2) The operating procedures for the unit.

(e) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.

(f) A licensee shall retain a record of individuals receiving instruction required by paragraph (d) of this section, in accordance with § 35.2310.

(g) A licensee shall retain a copy of the procedures required by §§ 35.610(a)(4) and (d)(2) in accordance with § 35.2610.

B. Have workers been informed of NRC’s regulatory authority for accelerator-produced radioactive materials and discrete sources of radium-226?

C. Is the individual’s understanding of current procedures and regulations adequate?

D. Is the training program implemented?

1. Operating procedures [35.27, 35.310, 35.410, 35.610]? (See above.)

2. Emergency procedures [35.27, 35.310, 35.410, 35.610]? (See above.)

3. Periodic training required and implemented [35.310, 35.410, 35.610]? (See above.)

4. Were all workers who are likely to exceed 1 mSv (100 mrem) in a year instructed and was refresher training provided, as needed [19.12]? (See above.)

5. Was each supervised user instructed in the licensee’s written radiation protection procedures and administration of written directives, as appropriate [35.27]? (See above.)

6. Are initial and periodic training records maintained for each individual [35.2310]?

§ 35.2310 Records of safety instruction.

A licensee shall maintain a record of safety instructions required by §§ 35.310, 35.410, and 35.610 for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.

7. Briefly describe training program.

E. Do additional therapy device instructions/training include?

1. Unit operation, inspection, associated equipment, survey instruments?

2. License conditions applicable to the use of the unit?

3. Emergency drills [35.610]? (See above.)

F. 10 CFR Part 20 – Are workers cognizant of requirements for:

1. Radiation Safety Program [35.24, 35.26, 20.1101]?

Subpart B—General Administrative Requirements

35.24 Authority and responsibilities for the radiation protection program.

(a) In addition to the radiation protection program requirements of § 20.1101 of this chapter, a licensee's management shall approve in writing--

(1) Requests for a license application, renewal, or amendment before submittal to the Commission;

(2) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and

(3) Radiation protection program changes that do not require a license amendment and are permitted under § 35.26;

(e) A licensee shall establish the authority, duties, and responsibilities of the Radiation Safety Officer in writing.

(g) A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to--

(1) Identify radiation safety problems;

(2) Initiate, recommend, or provide corrective actions;

(3) Stop unsafe operations; and,

(4) Verify implementation of corrective actions.

(h) A licensee shall retain a record of actions taken under paragraphs (a), (b), and (e) of this section in accordance with § 35.2024.

§ 35.26 Radiation protection program changes.

(a) A licensee may revise its radiation protection program without Commission approval if--

(1) The revision does not require a license amendment under § 35.13;

(2) The revision is in compliance with the regulations and the license ;

(3) The revision has been reviewed and approved by the Radiation Safety Officer and licensee management; and

(4) The affected individuals are instructed on the revised program before the changes are implemented.

(b) A licensee shall retain a record of each change in accordance with § 35.2026.

§ 20.1101 Radiation protection programs.

(c) The licensee shall periodically (at least annually) review the radiation protection program content and implementation.

2. Annual dose limits [20.1201, 20.1301, and 20.1302]?

Subpart C--Occupational Dose Limits

§ 20.1201 Occupational dose limits for adults.

(a) The licensee shall control the occupational dose to individual adults, except for planned special exposures under § 20.1206, to the following dose limits.

(1) An annual limit, which is the more limiting of--

(i) The total effective dose equivalent being equal to 5 rems (0.05 Sv); or

(ii) The sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rems (0.5 Sv).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(i) A lens dose equivalent of 15 rems (0.15 Sv), and

(ii) A shallow-dose equivalent of 50 rem (0.5 Sv) to the skin of the whole body or to the skin of any extremity.

(b) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, must be subtracted from the limits for planned special exposures that the individual may receive during the current year (see § 20.1206(e)(1)) and during the individual's lifetime (see § 20.1206(e)(2)).

(c) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the NRC. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure. The assigned shallow-dose equivalent must be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable.

(d) Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in table 1 of appendix B to part 20 and may be used to determine the individual's dose (see § 20.2106) and to demonstrate compliance with the occupational dose limits.

(e) In addition to the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity (see footnote 3 of appendix B to part 20).

(f) The licensee shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person (see § 20.2104(e)).

Subpart D--Radiation Dose Limits for Individual Members of the Public

§ 20.1301 Dose limits for individual members of the public.

(a) Each licensee shall conduct operations so that -

(b) If the licensee permits members of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.

(1) The radiation dose received does not exceed 0.5 rem (5 mSv); and

(2) The authorized user, as defined in 10 CFR Part 35, has determined before the visit that it is appropriate.

(1) Demonstration of the need for and the expected duration of operations in excess of the limit in paragraph (a) of this section;

(2) The licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and

(3) The procedures to be followed to maintain the dose as low as is reasonably achievable.

3. NRC Forms 4 and 5?

4. 10% monitoring threshold [20.1502]?

§ 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.

Each licensee shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of this part. As a minimum—

(a) Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by—

(1) Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in § 20.1201(a),

(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);

(3) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);2 and

(4) Individuals entering a high or very high radiation area.

(b) Each licensee shall monitor (see § 20.1204) the occupational intake of radioactive material by and assess the committed effective dose equivalent to—

(1) Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALI(s) in table 1, Columns 1 and 2, of appendix B to §§ 20.1001-20.2402;

(2) Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 rem (1 mSv); and

(3) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 mSv).

5. Dose limits to embryo/fetus and declared pregnant worker [20.1208]?

§ 20.1208 Dose equivalent to an embryo/fetus.

(a) The licensee shall ensure that the dose equivalent to the embryo/fetus during the entire pregnancy, due to the occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). (For recordkeeping requirements, see § 20.2106.)

(b) The licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (a) of this section.

(1) The deep-dose equivalent to the declared pregnant woman; and

(2) The dose equivalent to the embryo/fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.

(d) If the dose equivalent to the embryo/fetus is found to have exceeded 0.5 rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee, the licensee shall be deemed to be in compliance with paragraph (a) of this section if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.

6. “Grave Danger” Posting [20.1902(c)]?

§ 20.1902 Posting requirements.

(a) Posting of radiation areas. The licensee shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."

(b) Posting of high radiation areas. The licensee shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."

(c) Posting of very high radiation areas. The licensee shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA."

(d) Posting of airborne radioactivity areas. The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA."

(e) Posting of areas or rooms in which licensed material is used or stored. The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding 10 times the quantity of such material specified in appendix C to part 20 with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."

7. Procedures for opening packages [20.1906]?

§ 20.1906 Procedures for receiving and opening packages.

(a) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in § 71.4 and appendix A to part 71 of this chapter, shall make arrangements to receive—

(1) The package when the carrier offers it for delivery; or

(2) Notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.

(b) Each licensee shall—

(1) Monitor the external surfaces of a labeled3a package for radioactive contamination unless the package contains only radioactive material in the form of a gas or in special form as defined in 10 CFR 71.4;

(2) Monitor the external surfaces of a labeled3a package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in § 71.4 and appendix A to part 71 of this chapter; and

(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.

(c) The licensee shall perform the monitoring required by paragraph (b) of this section as soon as practical after receipt of the package, but not later than 3 hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours, or not later than 3 hours from the beginning of the next working day if it is received after working hours.

(d) The licensee shall immediately notify the final delivery carrier and the NRC Operations Center (301-816-5100), by telephone, when—

(1) Removable radioactive surface contamination exceeds the limits of § 71.87(i) of this chapter; or

(2) External radiation levels exceed the limits of § 71.47 of this chapter.

(e) Each licensee shall—

(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

(f) Licensees transferring special form sources in licensee-owned or licensee-operated vehicles to and from a work site are exempt from the contamination monitoring requirements of paragraph (b) of this section, but are not exempt from the survey requirement in paragraph (b) of this section for measuring radiation levels that is required to ensure that the source is still properly lodged in its shield.

G. Is supervision of individuals by AU and/or ANP in accordance with 10 CFR 35.27? (See Training, Retraining, and Instructions to Workers above)

Training for Manual Brachytherapy and Use of Unsealed Byproduct Material for Which a Written Directive Is Required

A. Does safety instruction to personnel include [35.310, 35.410]: (See above)

1. Control of patient and visitors?

2. Routine visitation to patients in accordance with 10 CFR 20.1301? (See above)

3. Contamination control and size/appearance of sources?

4. Safe handling and shielding instructions?

5. Waste control?

6. RSO and AU notification if patient had a medical emergency or died?

7. Records retained [35.2310]? (See above)

Facilities

A. Facilities as described in license application?

B. Therapy device facilities provided with electrical interlock system, viewing and intercom systems, radiation monitor, source retraction mechanism, and source indicator lights?

C. Emergency source recovery equipment available [35.415, 35.615]?

§ 35.415 Safety precautions.

(a) For each patient or human research subject who is receiving brachytherapy and cannot be released under § 35.75, a licensee shall--

(1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving brachytherapy;

(2) Visibly post the patient's or human research subject's room with a "Radioactive Materials" sign; and

(3) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.

(b) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source--

(1) Dislodged from the patient; and

(2) Lodged within the patient following removal of the source applicators.

(c) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

§ 35.615 Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

(a) A licensee shall control access to the treatment room by a door at each entrance.

(b) A licensee shall equip each entrance to the treatment room with an electrical interlock system that will--

(1) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

(2) Cause the source(s) to be shielded when an entrance door is opened; and

(3) Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source(s) on-off control is reset at the console.

(c) A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

(d) Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

(e) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.

(f) In addition to the requirements specified in paragraphs (a) through (e) of this section, a licensee shall--

(1) For medium dose-rate and pulsed dose-rate remote afterloader units, require--

(i) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and

(ii) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.

(2) For high dose-rate remote afterloader units, require--

(i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

(ii) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.

(3) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.

(4) Notify the Radiation Safety Officer, or his/her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

(g) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source--

(1) Remaining in the unshielded position; or

(2) Lodged within the patient following completion of the treatment.

D. Storage areas:

1. Materials secured from unauthorized removal or access [20.1801]?

Subpart I--Storage and Control of Licensed Material

§ 20.1801 Security of stored material.

The licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas

2. Licensee controls and maintains constant surveillance of licensed material not in storage [20.1802]?

§ 20.1802 Control of material not in storage.

The licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.

E. Therapy unit operation:

1. Unit, console, console keys, and treatment room controlled adequately [20.1801, 35.610(a)(1)]? (See Above)

2. Restricted to certain source orientations and/or gantry angles?

3. Ceases to operate in restricted orientation(s)?

4. Only one radiation device can be placed in operation at a time within the treatment room [35.610(a)(3)]? (See above)

Dose or Dosage Measuring Equipment

A. Possession, use, and calibration of instruments to measure activities of unsealed radionuclides [35.60] or PET radioactive drugs produced by licensee [30.34(j) (See above)]:

Subpart C--General Technical Requirements

§ 35.60 Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material

(a) For direct measurements performed in accordance with § 35.63, a licensee shall possess and use instrumentation to measure the activity of unsealed byproduct material before it is administered to each patient or human research subject.

(b) A licensee shall calibrate the instrumentation required in paragraph (a) of this section in accordance with nationally recognized standards or the manufacturer's instructions.

(c) A licensee shall retain a record of each instrument calibration required by this section in accordance with § 35.2060.

1. Types of equipment listed?

2. Approved procedures for use of instrumentation followed?

3. Constancy, accuracy, linearity, and geometry dependence tests performed in accordance with nationally recognized standards or the manufacturer’s instructions?

4. Instrument repaired or replaced or dosages mathematically corrected, as required, when tests do not meet the performance objectives provided in the nationally recognized standard or manufacturer’s instructions (e.g., ±10%)?

5. Records maintained and include required information [35.2060]?

§ 35.2060 Records of calibrations of instruments used to measure the activity of unsealed byproduct material.

A licensee shall maintain a record of instrument calibrations required by § 35.60 for 3 years. The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

B. Determination of dosages of unsealed byproduct material [35.63, 30.34(j) (See above)]?

§ 35.63 Determination of dosages of unsealed byproduct material for medical use.

(a) A licensee shall determine and record the activity of each dosage before medical use.

(b) For a unit dosage, this determination must be made by—

(1) Direct measurement of radioactivity; or

(2) A decay correction, based on the activity or activity concentration determined by—

(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(ii) An NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(iii) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.

(1) Direct measurement of radioactivity;

(2) Combination of measurement of radioactivity and mathematical calculations; or

(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(ii) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.

(d) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.

(e) A licensee shall retain a record of the dosage determination required by this section in accordance with § 35.2063.

1. Each dosage determined and recorded prior to medical use [35.63(a)]? Or transfer [30.34(j)]? (See above)

2. Measurement of unit dosages of photon- or beta-emitting radionuclides made either by direct measurement or by decay correction [35.63(b), 30.34(j)(2)(ii)]? (See above)

3. Measurement of unit dosage of alpha-emitting radionuclide by decay correction of the activity provided by the producer licensed in accordance with 10 CFR 32.72 or 30.32(j)? (See above)

4. For other than unit dosages of photon- or beta-emitting radionuclides, measurement made by direct measurement of radioactivity or by combination of radioactivity or volumetric measurement and calculation [35.63(c), 30.34(j)(2)(ii) (See above)]?

5. For other than unit dosages of alpha-emitting radionuclide, measurement made by combination using the activity provided by the producer licensed in accordance with 10 CFR 32.72, or 30.32(j) volumetric measurement, and calculation [35.63(c)]? (See above)

C. Licensee uses generators?

1. First eluate after receipt tested for Mo-99 breakthrough [35.204(b)]?

35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

(b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with paragraph (a) of this section.

2. No radiopharmaceuticals administered with Mo-99 concentrations over 0.15 μCi per mCi of Tc-99m [35.204(a)(1)]?

35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

(a) A licensee may not administer to humans a radiopharmaceutical that contains:

(1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m); or

3. First eluate after receipt tested for strontium-82 and strontium-85 when eluting rubidium-82 [35.204(c)]?

35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

(c) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with paragraph (a) of this section.

4. No radiopharmaceuticals administered with strontium-82 concentrations over

0.02 μCi per mCi of rubidium-82 or strontium-85 concentrations over 0.2 μCi per mCi of rubidium-82 [35.204(a)(2)]?

§ 35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

(a) A licensee may not administer to humans a radiopharmaceutical that contains

(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).

5. Records maintained [35.2204]?

§ 35.2204 Records of molybdenum-99, strontium-82, and strontium-85 concentrations.

A licensee shall maintain a record of the molybdenum-99 concentration or strontium-82 and strontium-85 concentration tests required by § 35.204(b) and (c) for 3 years. The record must include:

(a) For each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (or microcuries of molybdenum per millicurie of technetium), the time and date of the measurement, and the name of the individual who made the measurement; or

(b) For each measured elution of rubidium-82, the ratio of the measures expressed as kilobecquerel of strontium-82 per megabecquerel of rubidium-82 (or microcuries of strontium-82 per millicurie of rubidium), kilobecquerel of strontium-85 per megabecquerel of rubidium-82 (or microcuries of strontium-85 per millicurie of rubidium), the time and date of the measurement, and the name of the individual who made the measurement.

D. Dosimetry Equipment [35.630]:

§ 35.630 Dosimetry equipment.

(a) Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met.

(1) The system must have been calibrated using a system or source traceable to the National Institute of Standards and Technology (NIST) and published protocols accepted by nationally recognized bodies; or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous 2 years and after any servicing that may have affected system calibration; or

(2) The system must have been calibrated within the previous 4 years. Eighteen to thirty months after that calibration, the system must have been intercompared with another dosimetry system that was calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the AAPM. The results of the intercomparison must indicate that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

(b) The licensee shall have a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section.

1. Calibrated system available for use [35.630(a)]?

§ 35.630 Dosimetry equipment.

2. Calibrated by NIST or an AAPM-accredited lab within previous 2 years and after servicing [35.630(a)(1)] OR calibrated by intercomparison per 10 CFR 35.630(a)(2)?

§ 35.630 Dosimetry equipment.

(c) The licensee shall retain a record of each calibration, intercomparison, and comparison in accordance with § 35.2630.

3. Calibrated within the previous 4 years [35.630(a)(2)]? (See above)

4. Licensee has available for use a dosimetry system for spot-check measurements [35.630(b)]? (See above)

5. Record of each calibration, intercomparison, and comparison maintained [35.2630]?

§ 35.2630 Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

(a) A licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with § 35.630 for the duration of the license.

(b) For each calibration, intercomparison, or comparison, the record must include--

(1) The date;

(2) The manufacturer's name, model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of § 35.630;

(3) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and

(4) The names of the individuals who performed the calibration, intercomparison, or comparison.

Radiation Protection And Control of Radioactive Material (this now includes accelerator-produced radioactive materials and discrete sources of radium-226)

A. Use of radiopharmaceuticals and production of PET radioactive drugs:

1. Protective clothing worn?

2. Personnel routinely monitor their hands?

3. No eating/drinking in use/storage areas?

4. No food, drink, or personal effects kept in use/storage areas?

5. Proper dosimetry worn?

6. Radioactive waste disposed of in proper receptacles?

7. Syringe shields and vial shields used?

8. Proper use of remote handling tools and radiation shields?

B. Leak tests and inventories:

1. Leak test performed on sealed sources and brachytherapy sources [35.67(b)(1) or leak test license condition]?

§ 35.67 Requirements for possession of sealed sources and brachytherapy sources

(b) A licensee in possession of a sealed source shall—

(1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and

2. Inventory of sealed sources and brachytherapy sources performed semiannually [35.67(g)]?

(g) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. The licensee shall retain each inventory record in accordance with § 35.2067(b).

3. Records maintained [35.2067]?

§ 35.2067 Records of leaks tests and inventory of sealed sources and brachytherapy sources.

(a) A licensee shall retain records of leak tests required by § 35.67(b) for 3 years. The records must include the model number, and serial number if one has been assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of the test; the date of the test; and the name of the individual who performed the test.

(b) A licensee shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by § 35.67(g) for 3 years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source by radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.

Radiation Survey Instruments

A. Survey instruments used to show compliance with 10 CFR Part 20 and 10 CFR 30.33(a)(2):

§ 30.33 General requirements for issuance of specific licenses.

(a) An application for a specific license will be approved if:

(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property;

1. Appropriate operable survey instruments possessed or available [10 CFR Part 20]?

2. Calibrations [35.61(a) and (b)]: § 35.61 Calibration of survey instruments.

(a) A licensee shall calibrate the survey instruments used to show compliance with this part and 10 CFR Part 20 before first use, annually, and following a repair that affects the calibration. A licensee shall--

(1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source;

(2) Calibrate two separated readings on each scale or decade that will be used to show compliance; and

(3) Conspicuously note on the instrument the date of calibration.

(b) A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20 percent.

a. Before first use, annually, and after repairs?

b. Within 20% on each scale or decade of interest?

3. Records maintained [35.2061]?

§ 35.2061 Records of radiation survey instrument calibrations.

A licensee shall maintain a record of radiation survey instrument calibrations required by § 35.61 for 3 years. The record must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

B. Radiation surveys performed in accordance with the licensee’s procedures and the regulatory requirements [20.1501, 35.70]? If producing PET radioactive drugs under 10 CFR 30.32(j) or 35.100(b), 35.200(b), or 35.300(b) (See above), the survey frequencies described below should be reviewed and adjusted as necessary.

Subpart F--Surveys and Monitoring

§ 20.1501 General.

(a) Each licensee shall make or cause to be made, surveys of areas, including the subsurface, that —

(1) May be necessary for the licensee to comply with the regulations in this part; and

(2) Are reasonable under the circumstances to evaluate--

(i) The magnitude and extent of radiation levels; and

(ii) Concentrations or quantities of residual radioactivity; and

(iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.

(b) Notwithstanding § 20.2103(a) of this part, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with §§ 30.35(g), 40.36(f), 50.75(g), 70.25(g), or 72.30(d), as applicable.

(c) The licensee shall ensure that instruments and equipment used for quantitative radiation measurements (e.g., dose rate and effluent monitoring) are calibrated periodically for the radiation measured.

(d) All personnel dosimeters (except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities) that require processing to determine the radiation dose and that are used by licensees to comply with § 20.1201, with other applicable provisions of this chapter, or with conditions specified in a license must be processed and evaluated by a dosimetry processor--

(1) Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and

(2) Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.

§ 35.70 Surveys of ambient radiation exposure rate.

(a) In addition to the surveys required by Part 20 of this chapter, a licensee shall survey with a radiation detection survey instrument at the end of each day of use. A licensee shall survey all areas where unsealed byproduct material requiring a written directive was prepared for use or administered.

(b) A licensee does not need to perform the surveys required by paragraph (a) of this section in an area(s) where patients or human research subjects are confined when they cannot be released under § 35.75.

1. Daily in all areas where radiopharmaceuticals requiring a written directive are prepared or administered (except patient rooms) [35.70]? (See above)

2. Weekly in all areas where radiopharmaceuticals or waste are stored?

3. Weekly for wipes in all areas where radiopharmaceuticals are routinely prepared, administered, or stored?

4. Trigger levels established?

5. Corrective action taken and documented if trigger level exceeded?

6. Techniques can detect 0.1 mR/hr, 2000dpm?

7. Surveys made to assure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the sources(s) in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry [35.652(a)] and records maintained [35.2652]?

§ 35.652 Radiation surveys.

(a) In addition to the survey requirement in § 20.1501 of this chapter, a person licensed under this subpart shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.

§ 35.2652 Records of surveys of therapeutic treatment units.

(a) A licensee shall maintain a record of radiation surveys of treatment units made in accordance with § 35.652 for the duration of use of the unit.

(b) The record must include--

(1) The date of the measurements;

(2) The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels;

(3) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and

(4) The signature of the individual who performed the test.

a. After new source installation?

b. Following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical mechanism that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s)?

Public Dose (this now includes dose from accelerator-produced radioactive materials and discrete sources of radium-226)

A. Is licensed material used in a manner to keep doses below 1mSv (100 mrem) in a year [20.1301(a)(1)]?

§ 20.1301 Dose limits for individual members of the public.

(a) Each licensee shall conduct operations so that -

B. Has a survey or evaluation been performed per 20.1501(a)?

Subpart F--Surveys and Monitoring

§ 20.1501 General.

(a) Each licensee shall make or cause to be made, surveys of areas, including the subsurface, that —

C. Have there been any additions or changes to the storage, security, or use of surrounding areas that would necessitate a new survey or evaluation?

D. Do unrestricted area radiation levels exceed 0.02 mSv (2 mrem) in any 1 hour [20.1301(a)(2)]?

Subpart D--Radiation Dose Limits for Individual Members of the Public

§ 20.1301 Dose limits for individual members of the public.

(a) Each licensee shall conduct operations so that -

E. Is licensed material used or stored in a manner that would prevent unauthorized access or removal [20.1801 and 20.1802]?

§ 20.1801 Security of stored material.

The licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas.

§ 20.1802 Control of material not in storage.

The licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.

F. Are records maintained [20.2103, 20.2107]?

§ 20.2103 Records of surveys.

(a) Each licensee shall maintain records showing the results of surveys and calibrations required by §§ 20.1501 and 20.1906(b). The licensee shall retain these records for 3 years after the record is made.

(b) The licensee shall retain each of the following records until the Commission terminates each pertinent license requiring the record:

(1) Records of the results of surveys to determine the dose from external sources and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents. This includes those records of results of surveys to determine the dose from external sources and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents required under the standards for protection against radiation in effect prior to January 1, 1994; and

(2) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose. This includes those records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose required under the standards for protection against radiation in effect prior to January 1, 1994; and

(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to § 20.1703(c) (1) and (2). This includes those records showing the results of air sampling, surveys, and bioassays required under the standards for protection against radiation in effect prior to January 1, 1994; and

(4) Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment. This includes those records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment required under the standards for protection against radiation in effect prior to January 1, 1994.

§ 20.2107 Records of dose to individual members of the public.

(a) Each licensee shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public (see § 20.1301).

(b) The licensee shall retain the records required by paragraph (a) of this section until the Commission terminates each pertinent license requiring the record.

Patient Release

A. Individuals released when TEDE is less than 0.5 rem [35.75(a)]?

§ 35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material.

(a) A licensee may authorize the release from its control of any individual who has been administered unsealed byproduct material or implants containing byproduct material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem).1

1The current revision of NUREG–1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Licenses" describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 rem).

B. Instructions to the released individual, including breast-feeding women, include required information [35.75(b)]?

(b) A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). If the total effective dose equivalent to a nursing infant or child could exceed 1 mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions must also include—

(1) Guidance on the interruption or discontinuation of breast-feeding; and

(2) Information on the potential consequences, if any, of failure to follow the guidance.

C. Release records maintained [35.2075(a)]?

§ 35.2075 Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material.

(a) A licensee shall retain a record of the basis for authorizing the release of an individual in accordance with § 35.75, if the total effective dose equivalent is calculated by--

(1) Using the retained activity rather than the activity administered;

(2) Using an occupancy factor less than 0.25 at 1 meter;

(3) Using the biological or effective half-life; or

(4) Considering the shielding by tissue.

D. Records of instructions given to breast-feeding women maintained, if required [35.2075(b)]?

(b) A licensee shall retain a record that the instructions required by § 35.75(b) were provided to a breast-feeding female if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem).

Unsealed Byproduct Material for Which a Written Directive Is Required (this now includes written directives for accelerator-produced radioactive materials and discrete sources of radium-226)

A. Safety precautions implemented to include patient facilities, posting, stay times, patient safety guidance, release, and contamination controls [35.315(a)]?

§ 35.315 Safety precautions.

(a) For each patient or human research subject who cannot be released under § 35.75, a licensee shall—

(1) Quarter the patient or the human research subject either in—

(i) A private room with a private sanitary facility; or

(ii) A room, with a private sanitary facility, with another individual who also has received therapy with unsealed byproduct material and who also cannot be released under § 35.75;

B. RSO and AU promptly notified if patient had a medical emergency or died [35.315(b)]?

(b) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

Brachytherapy or Brachytherapy Source Use

A. Safety precautions implemented to include patient facilities, posting, stay times, and emergency response equipment [35.415]?

§ 35.415 Safety precautions.

(a) For each patient or human research subject who is receiving brachytherapy and cannot be released under § 35.75, a licensee shall--

(1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving brachytherapy;

(2) Visibly post the patient's or human research subject's room with a "Radioactive Materials" sign; and

(3) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.

(b) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source--

(1) Dislodged from the patient; and

(2) Lodged within the patient following removal of the source applicators.

(c) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

B. Survey immediately after implant [35.404(a)]?

C. Patients surveyed immediately after removing the last temporary implant source [35.404(b)]?

§ 35.404 Surveys after source implant and removal.

(a) Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.

(b) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.

D. RSO and AU promptly notified if patient had a medical emergency or died [35.415(c)]?

§ 35.415 Safety precautions

(c) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

E. Records maintained [35.2404]?

§ 35.2404 Records of surveys after source implant and removal.

A licensee shall maintain a record of the surveys required by §§ 35.404 and 35.604 for 3 years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.

Radioactive Waste (this now includes waste containing accelerator-produced radioactive materials and discrete sources of radium-226)

A. Disposal:

1. Decay-in-storage [35.92]?

§ 35.92 Decay-in-storage.

(a) A licensee may hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if it—

(1) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and

(2) Removes or obliterates all radiation labels, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee.

(b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section in accordance with § 35.2092.

2. Procedures followed?

3. Labels removed or defaced [20.1904, 35.92]?

§ 20.1904 Labeling containers.

(a) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label must also provide sufficient information (such as the radionuclide(s) present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment) to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

(b) Each licensee shall, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

§ 35.92 Decay-in-storage.

(a) A licensee may hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if it—

(b) A licensee shall retain a record of each disposal permitted under paragraph (a) of this section in accordance with § 35.2092.

B. Special procedures performed as required?

C. Authorized disposals [20.2001]?

Subpart K--Waste Disposal

§ 20.2001 General requirements.

(a) A licensee shall dispose of licensed material only--

(1) By transfer to an authorized recipient as provided in § 20.2006 or in the regulations in parts 30, 40, 60, 61, 63, 70, and 72 of this chapter;

(2) By decay in storage; or

(3) By release in effluents within the limits in § 20.1301; or

(4) As authorized under §§ 20.2002, 20.2003, 20.2004, 20.2005, or 20.2008.

(b) A person must be specifically licensed to receive waste containing licensed material from other persons for:

(1) Treatment prior to disposal; or

(2) Treatment or disposal by incineration; or

(3) Decay in storage; or

(4) Disposal at a land disposal facility licensed under part 61 of this chapter; or

(5) Disposal at a geologic repository under part 60 or part 63 of this chapter.

D. Records maintained [20.2103(a), 20.2108, 35.2092]?

§ 20.2103 Records of surveys.

§ 20.2108 Records of waste disposal.

(a) Each licensee shall maintain records of the disposal of licensed materials made under §§ 20.2002, 20.2003, 20.2004, 20.2005, 10 CFR part 61 and disposal by burial in soil, including burials authorized before January 28, 1981.6

(b) The licensee shall retain the records required by paragraph (a) of this section until the Commission terminates each pertinent license requiring the record. Requirements for disposition of these records, prior to license termination, are located in §§ 30.51, 40.61, 70.51, and 72.80 for activities licensed under these parts.

§ 35.2092 Records of decay-in-storage.

A licensee shall maintain records of the disposal of licensed materials, as required by § 35.92, for 3 years. The record must include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.

E. Effluents:

1. Release to sanitary sewer [20.2003]?

§ 20.2003 Disposal by release into sanitary sewerage.

(a) A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:

(1) The material is readily soluble (or is readily dispersible biological material) in water; and

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table 3 of appendix B to part 20; and

(3) If more than one radionuclide is released, the following conditions must also be satisfied:

(i) The licensee shall determine the fraction of the limit in table 3 of appendix B to part 20 represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table 3 of appendix B to part 20; and

(ii) The sum of the fractions for each radionuclide required by paragraph (a)(3)(i) of this section does not exceed unity; and

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage system in a year does not exceed 5 curies (185 GBq) of hydrogen-3, 1 curie (37 GBq) of carbon-14, and 1 curie (37 GBq) of all other radioactive materials combined.

(b) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in paragraph (a) of this section.

a. Material is readily soluble or readily dispersible [20.2003(a)(1)]? (See above)

b. Monthly average release concentrations do not exceed 10 CFR Part 20, Appendix B, Table 2 values?

c. No more than 5 Ci of H-3, 1 Ci of C-14, and 1 Ci of all other radionuclides combined, released in a year [20.2003]? (See above)

d. Procedures to ensure representative sampling and analysis implemented [20.1501]? (See Above)

2. Release to septic tanks [20.2003]? Within unrestricted limits [10 CFR Part 20, Appendix B, Table 2]? (See above)

3. Waste incinerated?

a. License authorizes [20.2004(a)(3)]?

§ 20.2004 Treatment or disposal by incineration.

(a) A licensee may treat or dispose of licensed material by incineration only:

(3) As specifically approved by the Commission pursuant to § 20.2002.

b. Exhaust directly monitored?

c. Airborne releases evaluated and controlled [20.1302, 20.1501]?

§ 20.1302 Compliance with dose limits for individual members of the public.

(a) The licensee shall make or cause to be made, as appropriate, surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in § 20.1301.

(b) A licensee shall show compliance with the annual dose limit in § 20.1301 by--

(1) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual dose limit; or

(2) Demonstrating that--

(i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in table 2 of appendix B to part 20; and

(ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year.

(c) Upon approval from the Commission, the licensee may adjust the effluent concentration values in appendix B to part 20, table 2, for members of the public, to take into account the actual physical and chemical characteristics of the effluents (e.g., aerosol size distribution, solubility, density, radioactive decay equilibrium, chemical form).

Subpart F--Surveys and Monitoring

§ 20.1501 General.

(a) Each licensee shall make or cause to be made, surveys of areas, including the subsurface, that —

(1) May be necessary for the licensee to comply with the regulations in this part; and

(2) Are reasonable under the circumstances to evaluate--

(i) The magnitude and extent of radiation levels; and

(ii) Concentrations or quantities of residual radioactivity; and

(iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.

(1) Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and

4. Air effluents and ashes controlled [20.1101 (See above), 20.1201 (See above), 20.1301 (See above), 20.1501 (See above), 20.2001(See above)]? (See also IP 87102, RG 8.37.) If applicable, includes air effluent releases from production of PET radioactive drugs?

a. Air effluent less than 10 mrem constraint limit [20.1101]?

§ 20.1101 Radiation protection programs.

(c) The licensee shall periodically (at least annually) review the radiation protection program content and implementation.

d) To implement the ALARA requirements of § 20.1101 (b), and notwithstanding the requirements in § 20.1301 of this part, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees other than those subject to § 50.34a, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in § 20.2203 and promptly take appropriate corrective action to ensure against recurrence.

i. If no, reported appropriate information to NRC?

ii. If no, corrective actions implemented and on schedule?

b. Description of effluent program:

i. Monitoring system hardware adequate?

ii. Equipment calibrated, as appropriate?

iii. Air samples/sampling technique (e.g., charcoal, HEPA) analyzed with appropriate instrumentation?

F. Waste storage:

1. Protection from elements and fire?

2. Control of waste maintained [20.1801]?

Subpart I--Storage and Control of Licensed Material

Source: 56 FR 23401, May 21, 1991, unless otherwise noted.

§ 20.1801 Security of stored material.

The licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas.

3. Containers properly labeled and area properly posted [20.1902, 20.1904]?

Subpart J—Precautionary Procedures

§ 20.1902 Posting requirements.

(a) Posting of radiation areas. The licensee shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."

§ 20.1904 Labeling containers.

4. Package integrity adequately maintained?

G. Waste disposal:

1. Sources transferred to authorized individuals [20.2006, 20.2001, 30.41]?

§ 20.2006 Transfer for disposal and manifests.

(a) The requirements of this section and appendix G to 10 CFR Part 20 are designed to--

(1) Control transfers of low-level radioactive waste by any waste generator, waste collector, or waste processor licensee, as defined in this part, who ships low-level waste either directly, or indirectly through a waste collector or waste processor, to a licensed low-level waste land disposal facility (as defined in Part 61 of this chapter);

(2) Establish a manifest tracking system; and

(3) Supplement existing requirements concerning transfers and recordkeeping for those wastes.

(b) Any licensee shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility must document the information required on NRC's Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee in accordance with appendix G to 10 CFR Part 20.

(c) Each shipment manifest must include a certification by the waste generator as specified in section II of appendix G to 10 CFR Part 20.

(d) Each person involved in the transfer for disposal and disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in section III of appendix G to 10 CFR Part 20.

(e) Any licensee shipping byproduct material as defined in paragraphs (3) and (4) of the definition of Byproduct material set forth in § 20.1003 intended for ultimate disposal at a land disposal facility licensed under part 61 of this

chapter must document the information required on the NRC’s Uniform Low-Level Radioactive Waste Manifest and

transfer this recorded manifest information to the intended consignee in accordance with appendix G to this part.

Subpart K--Waste Disposal

§ 20.2001 General requirements.

(a) A licensee shall dispose of licensed material only--

(1) By transfer to an authorized recipient as provided in § 20.2006 or in the regulations in parts 30, 40, 60, 61, 63, 70, and 72 of this chapter;

(2) By decay in storage; or

(3) By release in effluents within the limits in § 20.1301; or

(4) As authorized under §§ 20.2002, 20.2003, 20.2004, 20.2005, or 20.2008.

(b) A person must be specifically licensed to receive waste containing licensed material from other persons for:

(1) Treatment prior to disposal; or

(2) Treatment or disposal by incineration; or

(3) Decay in storage; or

(4) Disposal at a land disposal facility licensed under part 61 of this chapter; or

(5) Disposal at a geologic repository under part 60 or part 63 of this chapter.

§ 30.41 Transfer of byproduct material.

(a) No licensee shall transfer byproduct material except as authorized pursuant to this section.

(b) Except as otherwise provided in his license and subject to the provisions of paragraphs (c) and (d) of this section, any licensee may transfer byproduct material:

(1) To the Department;

(2) To the agency in any Agreement State which regulates radioactive material pursuant to an agreement under section 274 of the Act;

(3) To any person exempt from the licensing requirements of the Act and regulations in this part, to the extent permitted under such exemption;

(4) To any person in an Agreement State, subject to the jurisdiction of that State, who has been exempted from the licensing requirements and regulations of that State, to the extent permitted under such exemption;

(5) To any person authorized to receive such byproduct material under terms of a specific license or a general license or their equivalents issued by the Atomic Energy Commission, the Commission, or an Agreement State;

(6) To a person abroad pursuant to an export license issued under part 110 of this chapter; or

(7) As otherwise authorized by the Commission in writing.

(c) Before transferring byproduct material to a specific licensee of the Commission or an Agreement State or to a general licensee who is required to register with the Commission or with an Agreement State prior to receipt of the byproduct material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of byproduct material to be transferred.

(d) The following methods for the verification required by paragraph (c) of this section are acceptable:

(1) The transferor may have in his possession, and read, a current copy of the transferee's specific license or registration certificate;

(2) The transferor may have in his possession a written certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of byproduct material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date;

(3) For emergency shipments the transferor may accept oral certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of byproduct material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date: Provided, That the oral certification is confirmed in writing within 10 days;

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the Commission or the licensing agency of an Agreement State as to the identity of licensees and the scope and expiration dates of licenses and registration; or

(5) When none of the methods of verification described in paragraphs (d)(1) to (4) of this section are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the Commission or the licensing agency of an Agreement State that the transferee is licensed to receive the byproduct material

2. Name of organization:

H. Records of surveys and material accountability maintained [20.2103, 20.2108, 35.2092]?

§ 20.2103 Records of surveys.

(b) The licensee shall retain each of the following records until the Commission terminates each pertinent license requiring the record:

(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to § 20.1703(c)(1) and (2). This includes those records showing the results of air sampling, surveys, and bioassays required under the standards for protection against radiation in effect prior to January 1, 1994; and

§ 20.2108 Records of waste disposal.

§ 35.2092 Records of decay-in-storage.

Receipt and Transfer of Radioactive Material (this now includes receipt and transfer of accelerator-produced radioactive materials and discrete sources of radium-226)

A. Description of how packages are received and by whom?

B. Written package-opening procedures established and followed [20.1906(e)]?

§ 20.1906 Procedures for receiving and opening packages.

(e) Each licensee shall—

(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

C. All incoming packages with a DOT label monitored for radioactive contamination, unless exempted (gases and special form) [20.1906(b)(1)]?

§ 20.1906 Procedures for receiving and opening packages.

(b) Each licensee shall—

D. Incoming packages surveyed [20.1906(b)(2)]? When authorized for return, includes “empty” transport radiation shields from other consortium members receiving PET radioactive drugs under 10 CFR 30.32(j) authorization?

E. Monitoring in (C) and (D) performed within time specified [20.1906(c)]?

F. Transfer(s) performed per [30.41]?

G. If authorized under 10 CFR 30.32(j) for production and noncommercial transfer of PET radioactive drugs, all transfers of these drugs for medical use are to medical use licensees within the consortium?

H. All sources surveyed before shipment and transfer [20.1501(a)]?

I. Records of surveys and receipt/transfer maintained [20.2103(a), 30.51]?

J. Package receipt/distribution activities evaluated for compliance with 20.1301?

Transportation (10 CFR 71.5(a) and 49 CFR 171-189)

A. Shipments, including shipments of accelerator-produced radioactive materials and discrete sources of radium-226, and PET radioactive drugs produced for noncommercial transfer to other medical use licensees in the consortium, are:

1. Delivered to common carriers?

2. Transported in own private vehicle?

3. Both?

4. No shipments since last audit?

B. Return radiopharmacy doses to drug manufacture or commercial nuclear pharmacy or sealed sources to source or device manufacturer?

Note: Licensees authorized under 10 CFR 30.32(j) for production and noncommercial transfer of PET radioactive drugs are not authorized to receive unused dosages or empty syringes and vials back from consortium members.

§ 30.32 Application for specific licenses.

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in § 32.72(a)(2) of this chapter.

(4) Information identified in § 32.72(a)(3) of this chapter on the PET drugs to be noncommercially transferred to members of its consortium.

1. Licensee assumes shipping responsibility?

2. If “NO,” describe arrangements made between licensee and radiopharmacy for shipping responsibilities.

C. Packages:

1. Authorized packages used?

2. Performance test records on file?

a. DOT-7A packages

b. Special form sources

3. Two labels (White-I, Yellow-II, Yellow-III) with Transport Index (TI), Nuclide, Activity, and Hazard Class?

4. Properly marked (Shipping Name, UN Number, Package Type, Reportable Quantity, “This End Up” (liquids), Name and Address of consignee)?

5. Closed and sealed during transport?

D. Shipping Papers:

1. Prepared and used?

2. Contain proper entries (Shipping Name; Hazard Class; Identification Number (UN Number); Total Quantity; Package Type; Nuclide; Reportable Quantity; Physical and Chemical Form; Activity; Category of Label; TI; Shipper’s Name, Certification and Signature; Emergency Response Telephone Number; “Limited Quantity” (if applicable); “Cargo Aircraft Only” (if applicable))?

3. Readily accessible during transport?

Teletherapy and Gamma Stereotactic Radiosurgery Servicing

A. Inspection and servicing performed following source replacement or at intervals not to exceed 5 years [35.655(a)]?

§ 35.655 Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.

(a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first, to assure proper functioning of the source exposure mechanism.

B. Needed service arranged for as identified during the inspection?

C. Service performed by persons specifically authorized to do so [35.655(b)]?

§ 35.655 Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.

(b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State.

Full Calibration-Therapeutic Medical Devices

A. Proper protocol(s) used (e.g., TG-21, AAPM 54, TG-56, TG-40)?

B. Performed prior to first patient use [35.632(a)(1), 35.633(a)(1), 35.635(a)(1)]?

§ 35.632 Full calibration measurements on teletherapy units.

(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit--

(1) Before the first medical use of the unit; and

§ 35.633 Full calibration measurements on remote afterloader units.

(a) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit--

(1) Before the first medical use of the unit;

§ 35.635 Full calibration measurements on gamma stereotactic radiosurgery units.

(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit--

(1) Before the first medical use of the unit;

C. At intervals not to exceed 1 year for teletherapy, gamma stereotactic, and LDR remote afterloader; at intervals not exceeding 1 quarter for HDR, MDR, and PDR remote afterloaders [35.632(a)(3)], 35.633(a)(3) and (4), 35.635(a)(3)]?

§ 35.632 Full calibration measurements on teletherapy units.

(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit—

(3) At intervals not exceeding 1 year.

§ 35.633 Full calibration measurements on remote afterloader units.

(a) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit--

(3) At intervals not exceeding 1 quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and

§ 35.635 Full calibration measurements on gamma stereotactic radiosurgery units.

(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit—

(3) At intervals not exceeding 1 year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

D. Whenever spot-checks indicate output differs from expected by ±5% [35.632(a)(2)(i), 35.635(a)(2)(i)]?

§ 35.632 Full calibration measurements on teletherapy units.

(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit--

(2) Before medical use under the following conditions:

(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

§ 35.635 Full calibration measurements on gamma stereotactic radiosurgery units.

(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit--

(2) Before medical use under the following conditions--

(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

E. After source exchange, relocation, and major repair or modification [35.632(a)(2), 35.633(a)(2), 35.635(a)(2)]?

§ 35.632 Full calibration measurements on teletherapy units.

(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit--

(2) Before medical use under the following conditions:

(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location;

(iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

§ 35.633 Full calibration measurements on remote afterloader units.

(a) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit--

(2) Before medical use under the following conditions:

(i) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

(ii) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

§ 35.635 Full calibration measurements on gamma stereotactic radiosurgery units.

(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit--

(2) Before medical use under the following conditions--

(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(ii) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

(iii) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

F. Performed with properly calibrated instrument [35.632(c), 35.633(c), 35.635(c)]?

§ 35.632 Full calibration measurements on teletherapy units.

c) A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.

§ 35.633 Full calibration measurements on remote afterloader units.

§ 35.635 Full calibration measurements on gamma stereotactic radiosurgery units.

(c) A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.

G. Includes:

1. For teletherapy: (See below for all)

a. Output measured within ±3% of expected for the range of field sizes, range of distances [35.632(b)(1)]?

b. Coincidence of radiation field and field light localizer [35.632(b)(2)]?

c. Uniformity of radiation field and beam angle dependence [35.632(b)(3)]?

d. Timer accuracy and linearity over the range of use [35.632(b)(4)]?

e. On-off error [35.632(b) (5)]?

f. Accuracy of all measuring and localization devices [35.632(b)(6)]?

§ 35.632 Full calibration measurements on teletherapy units.

(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of--

(1) The output within +/-3 percent for the range of field sizes and for the distance or range of distances used for medical use;

(2) The coincidence of the radiation field and the field indicated by the light beam localizing device;

(3) The uniformity of the radiation field and its dependence on the orientation of the useful beam;

(4) Timer accuracy and linearity over the range of use;

(5) On-off error; and

(6) The accuracy of all distance measuring and localization devices in medical use.

2. For remote after loaders: (See below)

a. Output measured within ±5% of expected [35.633(b)(1)]?

b. Source positioning accuracy within ±1 millimeter [35.633(b)(2)]?

c. Source retraction with backup battery upon power failure [35.633(b)(3)]?

d. Length of source transfer tubes [35.633(b)(4)]?

e. Timer accuracy and linearity over the typical range of use [35.633(b)(5)]?

f. Length of the applicators [35.633(b)(6)]?

g. Function of source transfer tubes, applicators, and transfer tube-applicator interfaces [35.633(b)(7)]?

§ 35.633 Full calibration measurements on remote afterloader units.

(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include, as applicable, determination of:

(1) The output within ± 5 percent;

(2) Source positioning accuracy to within ±1 millimeter;

(3) Source retraction with backup battery upon power failure;

(4) Length of the source transfer tubes;

(5) Timer accuracy and linearity over the typical range of use;

(6) Length of the applicators; and

(7) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

h. Autoradiograph quarterly of the LDR source(s) to verify source(s) arrangement and inventory [35.633(e)]?

§ 35.633 Full calibration measurements on remote afterloader units.

(e) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in paragraph (b) of this section, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding 1 quarter.

3. For gamma stereotactic radiosurgery: (See below)

a. Output measured within ±3% of expected [35.635(b)(1)]?

b. Helmet factors [35.635(b)(2)]?

c. Isocenter coincidence [35.635(b)(3)]?

d. Timer accuracy and linearity over the range of use [35.635(b)(4)]?

e. On-off error [35.635(b)(5)]?

f. Trunnion centricity [35.635(b)(6)]?

g. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off [35.635(b)(7)]?

h. Helmet microswitches [35.635(b)(8)]?

i. Emergency timing circuit [35.635(b)(9)]?

j. Stereotactic frames and localizing devices (trunnions) [35.635(b)(10)]?

§ 35.635 Full calibration measurements on gamma stereotactic radiosurgery units.

(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of--

(1) The output within ±3 percent;

(2) Relative helmet factors;

(3) Isocenter coincidence;

(4) Timer accuracy and linearity over the range of use;

(5) On-off error;

(6) Trunnion centricity;

(7) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(8) Helmet microswitches;

(9) Emergency timing circuits; and

(10) Stereotactic frames and localizing devices (trunnions).

H. Output corrected mathematically for decay [35.632(e), 35.633(g), 35.635(e)]?

§ 35.632 Full calibration measurements on teletherapy units.

(e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding 1 month for cobalt-60, 6 months for cesium-137, or at intervals consistent with 1 percent decay for all other nuclides.

§ 35.633 Full calibration measurements on remote afterloader units.

(g) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay at intervals consistent with 1 percent physical decay.

§ 35.635 Full calibration measurements on gamma stereotactic radiosurgery units.

(e) A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.

I. Records maintained [35.2632]?

§ 35.2632 Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.

(a) A licensee shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by §§ 35.632, 35.633, and 35.635 for 3 years.

(b) The record must include--

(1) The date of the calibration;

(2) The manufacturer's name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit(s), the source(s), and the instruments used to calibrate the unit(s);

(3) The results and an assessment of the full calibrations;

(4) The results of the autoradiograph required for low dose-rate remote afterloader units; and

(5) The signature of the authorized medical physicist who performed the full calibration.

Periodic Spot Checks For Therapeutic Devices (See below)

A. Performed at required frequency [35.642(a), 35.643(a), 35.645(a)]?

B. Procedures established by AMP [35.642(b), 35.643(b), 35.645(b)]?

C. Procedures followed?

D. Medical physicist reviews results within 15 days [35.642(c), 35.643(c), 35.645(b)]?

E. Performed with properly calibrated instrument [35.642(a)(5), 35.645(c)(2)(i)]?

F. Output and safety spot checks include:

1. For teletherapy: (See below)

a. Timer accuracy and linearity over the range of use [35.642(a)(1)]?

b. On-off error [35.642(a)(2)]?

c. Coincidence of radiation field and field light localizer [35.642(a)(3)]?

d. Accuracy of all measuring and localization devices [35.642(a)(4)]?

e. The output for one typical set of operating conditions [35.642(a)(5)]?

f. Difference between measured and expected output [35.642(a)(6)]?

g. Interlock systems [35.642(d)(1)]?

h. Beam stops [35.642(d)(2)]?

i. Source exposure indicator lights [35.642(d)(3)]?

j. Viewing and intercom systems [35.642(d)(4)]?

k. Treatment room doors, inside and out [35.642(d)(5)]?

l. Electrical treatment doors with power shut off [35.642(d)(6)]?

2. For remote afterloaders: (See below)

a. Interlock systems [35.643(d)(1)]?

b. Source exposure indicator lights [35.643(d)(2)]?

c. Viewing and intercom systems, except for low dose-rate (LDR) [35.643(d)(3)]?

d. Emergency response equipment [35.643(d)(4)]?

e. Radiation monitors used to indicate source position [35.643(d)(5)]?

f. Timer accuracy [35.643(d)(6)]?

g. Clock (date and time) in the unit’s computer [35.643(d)(7)]?

h. Decayed source(s) activity in the unit’s computer [35.643(d)(8)]?

3. For gamma stereotactic radiosurgery: (See below)

a. Treatment table retraction mechanism [35.645(c) (1)(i)]?

b. Helmet microswitches [35.645(c) (1)(ii)]?

c. Emergency timing circuits [35.645(c) (1) (iii)]?

d. Stereotactic frames and localizing devices [35.645(c)(1)(iv)]?

e. The output for one typical set of operating conditions [35.645(c)(2)(i)]?

f. Difference between measured and expected output [35.645(c)(2)(ii)]?

g. Source output compared against computer calculation of output [35.645(c)(2)(iii)]?

h.Timer accuracy and linearity over the range of use [35.645(c)(2)(iv)]?

i. On-off error [35.645(c)(2)(v)]?

j. Trunnion centricity [35.645(c)(2)(vi)]?

k. Interlock systems [35.645(d)(1)]?

l. Source exposure indicator lights [35.645(d)(2)]?

m. Viewing and intercom systems [35.645(d)(3)]?

n. Timer termination [35.645(d)(4)]?

o. Radiation monitors used to indicate room exposures [35.645(d)(5)]?

p. Emergency off buttons [35.645(d) (6)]?

G. Licensee promptly repaired items found to be not operating properly and did not use unit until repaired, if required [35.642(e), 35.643(e), 35.645(f)]? (See below)

§ 35.642 Periodic spot-checks for teletherapy units.

(a) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of--

(1) Timer accuracy, and timer linearity over the range of use;

(2) On-off error;

(3) The coincidence of the radiation field and the field indicated by the light beam localizing device;

(4) The accuracy of all distance measuring and localization devices used for medical use;

(5) The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b); and

(6) The difference between the measurement made in paragraph (a)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

(b) A licensee shall perform measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.

(c) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

(d) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of--

(1) Electrical interlocks at each teletherapy room entrance;

(2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);

(3) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

(4) Viewing and intercom systems;

(5) Treatment room doors from inside and outside the treatment room; and

(6) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

(e) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(f) A licensee shall retain a record of each spot-check required by paragraphs (a) and (d) of this section, and a copy of the procedures required by paragraph (b), in accordance with § 35.2642.

§ 35.643 Periodic spot-checks for remote afterloader units.

(a) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit--

(1) Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit on a given day;

(2) Before each patient treatment with a low dose-rate remote afterloader unit; and

(3) After each source installation.

(b) A licensee shall perform the measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

(d) To satisfy the requirements of paragraph (a) of this section, spot-checks must, at a minimum, assure proper operation of--

(1) Electrical interlocks at each remote afterloader unit room entrance;

(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

(3) Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility;

(4) Emergency response equipment;

(5) Radiation monitors used to indicate the source position;

(6) Timer accuracy;

(7) Clock (date and time) in the unit's computer; and

(8) Decayed source(s) activity in the unit's computer.

(f) A licensee shall retain a record of each check required by paragraph (d) of this section and a copy of the procedures required by paragraph (b) of this section in accordance with § 35.2643.

§ 35.645 Periodic spot-checks for gamma stereotactic radiosurgery units.

(a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit--

(1) Monthly;

(2) Before the first use of the unit on a given day; and

(3) After each source installation.

(b) A licensee shall--

(1) Perform the measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

(2) Have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

(1) Assure proper operation of--

(i) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(ii) Helmet microswitches;

(iii) Emergency timing circuits; and

(iv) Stereotactic frames and localizing devices (trunnions).

(2) Determine--

(i) The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b);

(ii) The difference between the measurement made in paragraph (c)(2)(i) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

(iii) Source output against computer calculation;

(iv) Timer accuracy and linearity over the range of use;

(v) On-off error; and

(vi) Trunnion centricity.

(d) To satisfy the requirements of paragraphs (a)(2) and (a)(3) of this section, spot-checks must assure proper operation of--

(1) Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

(2) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

(3) Viewing and intercom systems;

(4) Timer termination;

(5) Radiation monitors used to indicate room exposures; and

(6) Emergency off buttons.

(e) A licensee shall arrange for the repair of any system identified in paragraph (c) of this section that is not operating properly as soon as possible.

(f) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(g) A licensee shall retain a record of each check required by paragraphs (c) and (d) and a copy of the procedures required by paragraph (b) of this section in accordance with § 35.2645.

H. Records maintained [35.2642, 35.2643, and 35.2645]?

§ 35.2642 Records of periodic spot-checks for teletherapy units.

(a) A licensee shall retain a record of each periodic spot-check for teletherapy units required by § 35.642 for 3 years.

(b) The record must include--

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number of the teletherapy unit, source and instrument used to measure the output of the teletherapy unit;

(3) An assessment of timer linearity and constancy;

(4) The calculated on-off error;

(5) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;

(6) The determined accuracy of each distance measuring and localization device;

(7) The difference between the anticipated output and the measured output;

(8) Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and

(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(c) A licensee shall retain a copy of the procedures required by § 35.642(b) until the licensee no longer possesses the teletherapy unit.

§ 35.2643 Records of periodic spot-checks for remote afterloader units.

(a) A licensee shall retain a record of each spot-check for remote afterloader units required by § 35.643 for 3 years.

(b) The record must include, as applicable--

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number for the remote afterloader unit and source;

(3) An assessment of timer accuracy;

(4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and

(5) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(c) A licensee shall retain a copy of the procedures required by § 35.643(b) until the licensee no longer possesses the remote afterloader unit.

§ 35.2645 Records of periodic spot-checks for gamma stereotactic radiosurgery units.

(a) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by § 35.645 for 3 years.

(b) The record must include--

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;

(3) An assessment of timer linearity and accuracy;

(4) The calculated on-off error;

(5) A determination of trunnion centricity;

(6) The difference between the anticipated output and the measured output;

(7) An assessment of source output against computer calculations;

(8) Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and

(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(c) A licensee shall retain a copy of the procedures required by § 35.645(b) until the licensee no longer possesses the gamma stereotactic radiosurgery unit.

Installation, Maintenance, and Repair of Therapy Devices

A. Only authorized individuals perform installation, maintenance, adjustment, repair, and inspection [35.605, 35.655]? Name of organization/individual.

§ 35.605 Installation, maintenance, adjustment, and repair.

(a) Only a person specifically licensed by the Commission or an Agreement State shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

(b) Except for low dose-rate remote afterloader units, only a person specifically licensed by the Commission or an Agreement State shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

(c) For a low dose-rate remote afterloader unit, only a person specifically licensed by the Commission or an Agreement State or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.

(d) A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units in accordance with § 35.2605.

§ 35.655 Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.

(b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State.

B. Records maintained [35.2605, 35.2655]?

§ 35.2605 Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by § 35.605 for 3 years. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.

§ 35.2655 Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units.

(a) A licensee shall maintain a record of the 5-year inspections for teletherapy and gamma stereotactic radiosurgery units required by § 35.655 for the duration of use of the unit.

(b) The record must contain--

(1) The inspector's radioactive materials license number;

(2) The date of inspection;

(3) The manufacturer's name and model number and serial number of both the treatment unit and source;

(4) A list of components inspected and serviced, and the type of service; and

(5) The signature of the inspector.

Operating Procedures For Therapy Devices (See below)

A. Instructions on location of emergency procedures and emergency response telephone numbers posted at the device console [35.610(c)]?

B. Copy of the entire procedures physically located at the device console [35.610(b)]?

C. Procedures include:

1. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions [35.610(a)(4)]?

2. The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure [35.610(a)(4)]?

3. The names and telephone numbers of the AUs, the AMP, and the RSO to be contacted if the unit or console operates abnormally [35.610(a)(4)]?