La. Admin. Code tit. 33, § XV-763 - Training

Current through Register Vol. 48, No. 3, March 20, 2022

A. Training for a Radiation Safety Officer and Associate Radiation Safety Officer. Except as provided in Subsection B of this Section, the licensee shall require an individual fulfilling the responsibilities of the radiation safety officer or an individual assigned duties and tasks as an associate radiation safety officer as provided in LAC 33:XV.706 to be an individual:
1. who is certified by a specialty board whose certification process has been recognized by the NRC or an agreement state, and who meets the requirements in Paragraph A.4 of this Section. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
a. meet the requirements of Clauses A.1.a.i-iii of this Section, as follows:
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;
ii. have five or more years of professional experience in health physics (graduate training may be substituted for no more than two years of the required experience) including at least three 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
b. meet the requirements of Clauses A.1.b.i-iii of this Section, as follows:
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;
ii. have two 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 Nuclear Regulatory Commission or an agreement state; or
(b). in clinical nuclear medicine facilities providing diagnostic or therapeutic services under the direction of physicians who meet the requirements for authorized users in Subsection B or D, or Paragraph E.1 of this Section; 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
2. who has completed a structured educational program consisting of both:
a. 200 hours of classroom and laboratory training in the following areas:
i. radiation physics and instrumentation;
ii. radiation protection;
iii. mathematics pertaining to the use and measurement of radioactivity;
iv. radiation biology; and
v. radiation dosimetry; and
b. one year of full-time radiation safety experience under the supervision of the individual identified as the radiation safety officer on a NRC or agreement state license or permit issued by a NRC master material licensee that authorizes similar type(s) of use(s) of byproduct material. An associate radiation safety officer may provide supervision for those areas for which the associate radiation safety officer is authorized on a NRC or an agreement state license or permit issued by a NRC master material licensee. The full-time radiation safety experience shall involve the following:
i. shipping, receiving, and performing related radiation surveys;
ii. using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;
iii. securing and controlling byproduct material;
iv. using administrative controls to avoid mistakes in the administration of byproduct material;
v. using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;
vi. using emergency procedures to control byproduct material; and
vii. disposing of byproduct material; and
c. this individual shall obtain a written attestation, signed by a preceptor radiation safety officer or associate radiation safety officer who has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual is seeking approval as a radiation safety officer or an associate radiation safety officer. The written attestation shall state that the individual has satisfactorily completed the requirements in Paragraphs A.2 and A.4 of this Section, and is able to independently fulfill the radiation safety-related duties as a radiation safety officer or as an associate radiation safety officer for a medical use license; or
3. ...
a. is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the NRC or an agreement state in accordance with Subsection J of this Section, has experience with the radiation safety aspects of similar types of use of byproduct material for which the licensee is seeking the approval of the individual as radiation safety officer or an associate radiation safety officer, and who meets the requirements in Paragraph A.4 of this Section; or
b. is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on a NRC or an agreement state license, or a permit issued by a NRC or an agreement state licensee of broad scope, or a permit issued by the NRC master material license broad scope permittee, has experience with the radiation safety aspects of similar types of use of byproduct material for which the licensee seeks the approval of the individual as the radiation safety officer or associate radiation safety officer, and meets the requirements in Paragraph 4 of this Section; or
c. has experience with the radiation safety aspects of the types of use of byproduct material for which the individual is seeking simultaneous approval both as the radiation safety officer and the authorized user on the same new medical use license or new medical use permit issued by a NRC master material license. The individual shall also meet the requirements in Paragraph A.4 of this Section.
4. The individual shall have 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, an associate 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.
B. ...
1. An individual identified on an agreement state or a NRC license or a permit issued by a NRC or an agreement state broad scope licensee or master material license permit or by a master material license permittee of broad scope as a radiation safety officer, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist, or an authorized nuclear pharmacist on or before January 14, 2019, need not comply with the training requirements of Subsections A, J, or K of this Section, respectively, except the radiation safety officers and authorized medical physicists identified in this Paragraph shall meet the training requirements in Paragraphs A.4 or J.3 of this Section as appropriate, for any material or uses for which they were not authorized prior to this date.
2. Any individual certified by the American Board of Health Physics in Comprehensive Health Physics; American Board of Radiology; American Board of Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical Physics in radiation oncology physics; Royal College of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, need not comply with the training requirements of Subsection A of this Section to be identified as a radiation safety officer or as an associate radiation safety officer on a NRC or an agreement state license or NRC master material license permit for those materials and uses that these individuals performed on or before October 24, 2005.
3. Any individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, X-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, need not comply with the training requirements for an authorized medical physicist described in Subsection J of this Section, for those materials and uses that these individuals performed on or before October 24, 2005.
4. 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 any other location of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of Subsections A, J, or K of this Section, 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 during the 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.
5. Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the NRC or agreement state, a permit issued by a NRC master material licensee, a permit issued by a NRC or an agreement state broad scope licensee, or a permit issued by a commission master material license broad scope permittee on or before January 14, 2019, who perform only those medical uses for which they were authorized on or before that date need not comply with the training requirements of this Chapter.
6. Physicians, dentists, or podiatrists not identified as authorized users for the medical use of byproduct material on a license issued by the NRC or agreement state, a permit issued by a NRC master material licensee, a permit issued by a NRC or an agreement state broad scope licensee, or a permit issued by a NRC master material license of broad scope on or before October 24, 2005, need not comply with the training requirements of this Chapter for those materials and uses that these individuals performed on or before October 24, 2005, as follows:
a. for uses authorized under LAC 33:XV.729 or 731, or oral administration of sodium iodide I-131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine;
b. for uses authorized under LAC 33:XV.735.C, a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine; the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or the American Osteopathic Board of Radiology after 1984;
c. for uses authorized under LAC 33:XV.741, a physician who was certified on or before October 24, 2005, in radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; radiation oncology by the American Osteopathic Board of Radiology; radiology, with specialization in radiotherapy, as a British -SFellow of the Faculty of Radiology-S or -SFellow of the Royal College of Radiology-S; or therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; and
d. for uses authorized under LAC 33:XV.739, a physician who was certified on or before October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or nuclear medicine by the Royal College of Physicians and Surgeons of Canada.
7. 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 this Chapter 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.
8. Individuals who need not comply with training requirements as described in this Section may serve as preceptors for, and supervisors of, applicants seeking authorizations on Agreement State or NRC licenses for the same uses for which these individuals are authorized.
C. Training for Uptake, Dilution, and Excretion Studies. Except as provided in Subsection B of this Section, the licensee shall require the authorized user of unsealed byproduct material for the uses authorized in LAC 33:XV.729 to be a physician:
1. who is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensees Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
a. 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 Clauses C.3.a.i-ii of this Section; and
b. pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or
2. who is an authorized user under Subsection D or Paragraph E.1 of this Section, or equivalent agreement state requirements, or NRC requirements; or
3. who meets the following requirements:
a. has completed 60 hours of training and experience, including a minimum of eight 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 shall include:
i. classroom and laboratory training in the following areas:
(a). radiation physics and instrumentation;
(b). radiation protection;
(c). mathematics pertaining to the use and measurement of radioactivity;
(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 Subsection B or C or D or Paragraph E.1 of this Section, or equivalent agreement state requirements, or Nuclear Regulatory Commission 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;
(c). calculating, measuring, and safely preparing patient or human research subject dosages;
(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
b. has obtained written attestation that the individual has satisfactorily completed the requirements in Subparagraph C.3.a of this Section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized in LAC 33:XV.729. The attestation shall be obtained from either:
i. a preceptor authorized user who meets the requirements in Subsections B, C, D, or Paragraph E.1 of this Section, or equivalent NRC or agreement state requirements; or
ii. a residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in Subsections B, C, D, or Paragraph E.1 of this Section, or equivalent NRC or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in Subparagraph C.3.a of this Section.
D. Training for Imaging and Localization Studies. Except as provided in Subsection B of this Section, the licensee shall require the authorized user of unsealed byproduct material for the uses authorized in LAC 33:XV.731.H to be a physician:
1. who is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
a. 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 that includes the topics listed in Clauses D.3.a.i-ii of this Section; and
b. pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or
2. who is an authorized user under Paragraph E.1 of this Section, and meets the requirements in Subclause D.3.a.ii.(f) of this Section, or equivalent agreement state requirements; or
3. who meets the following requirements:
a. 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 shall include, at a minimum:
i. classroom and laboratory training in the following areas:
(a). radiation physics and instrumentation;
(b). radiation protection;
(c). mathematics pertaining to the use and measurement of radioactivity;
(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 this Subsection, Subsection B, or Subclause D.3.a.ii.(g) and Paragraph E.1 of this Section, or equivalent agreement state requirements, or NRC requirements. An authorized nuclear pharmacist who meets the requirements in Subsections B or K of this Section may provide the supervised work experience for Subclause D.3.a.ii.(g) of this Section. Work experience shall 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;
(c). calculating, measuring, and safely preparing patient or human research subject dosages;
(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). 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
(g). administering dosages of radioactive drugs to patients or human research subjects; and
b. has obtained written attestation that the individual has satisfactorily completed the requirements in Subparagraph D.3.a of this Section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized in LAC 33:XV.729 and LAC 33:XV.731.H. The attestation shall be obtained from either:
i. a preceptor authorized user who meets the requirements in this Subsection, Subsection B, or Paragraph E.1 and Subclause D.3.a.ii.(g) of this Section, NRC or equivalent agreement state requirements; or
ii. a residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Subsection, Subsection B, or Paragraph E.1 and Subclause D.3.a.ii.(g), or equivalent NRC or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in Subparagraph D.3.a of this Section.
E. Therapeutic Use of Radiopharmaceuticals
1. Training for Use of Unsealed Byproduct Material for Which a Written Directive Is Required. Except as provided in Subsection B of this Section, the licensee shall require the authorized user of unsealed byproduct material for the uses authorized in LAC 33:XV.735.C to be a physician:
a. who is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state, and who meets the requirements in Division E.1.b.i.(b).(vii) of this Section. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To be recognized, a specialty board shall require all candidates for certification to:
i. 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 shall include 700 hours of training and experience as described in Subclause E.1.b.i.(a) through Division E.1.b.i.(b).(v) of this Section. Eligible training programs shall 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 Council on Postdoctoral Training of the American Osteopathic Association; and
ii. pass an examination, administered by diplomates of the specialty board, that 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. who meets the following requirements:
i. 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 shall include:
(a). classroom and laboratory training in the following areas:
(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
(b). work experience, under the supervision of an authorized user who meets the requirements in this Paragraph, Subsection B of this Section, or equivalent agreement state requirements or NRC requirements. A supervising authorized user, who meets the requirements in Subparagraph E.1.b of this Section, shall also have experience in administering dosages in the same dosage category or categories (i.e., Division E.1.b.i.(b).(vii) of this Section) as the individual requesting authorized user status. The work experience shall 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;
(vi). Reserved.
(vii). administering dosages of radioactive drugs to patients or human research subjects from the three categories in this Division. Radioactive drugs containing radionuclides in categories not included in this Division are regulated elsewhere in this Chapter. This work experience shall involve a minimum of three cases in each of the following categories for which the individual is requesting authorized user status:
[a]. oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I131, for which a written directive is required;
[b]. oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 (Experience with at least three such cases also satisfies the requirement in Subdivision E.1.b.i.(b).(vii).[a] of this Section.);
[c]. parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required; and
ii. has obtained written attestation that the individual has satisfactorily completed the requirements in Clause E.1.b.i of this Section, and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized in LAC 33:XV.735.C for which the individual is requesting authorized user status. The attestation shall be obtained from either:
(a). a preceptor authorized user who meets the requirements in this Paragraph, Subsection B of this Section, equivalent agreement state requirements, or NRC requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or
(b). a residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Paragraph, Subsection B of this Section, equivalent agreement state requirements, or NRC requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in Clause E.1.b.i of this Section.
2. 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 Subsection B of this Section, 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:
a. who is certified by a medical specialty board whose certification process includes all of the requirements in Clauses E.2.c.i and ii of this Section and whose certification process has been recognized by the NRC or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page; or
b. who is an authorized user in accordance with Paragraph E.1 of this Section for uses listed in Subdivision E.1.b.i.(b).(vii).[a] or [b] of this Section, Paragraph E.3 of this Section, or equivalent agreement state requirements or Nuclear Regulatory Commission requirements; or
c. who meets the following requirements:
i. 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 shall include:
(a). radiation physics and instrumentation;
(b). radiation protection;
(c). mathematics pertaining to the use and measurement of radioactivity;
(d). chemistry of byproduct material for medical use; and
(e). radiation biology; and
ii. has work experience, under the supervision of an authorized user who meets the requirements in this Paragraph, Subsection B of this Section, or Paragraphs E.1 or E.3 of this Section, or equivalent agreement state requirements or NRC requirements. A supervising authorized user who meets the requirements in Subparagraph E.1.b of this Section shall also have experience in administering dosages as specified in Subdivision E.1.b.i.(b).(vii).[a] or [b] of this Section. The work experience shall 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;
(c). calculating, measuring, and safely preparing patient or human research subject dosages;
(d). using administrative controls to prevent a medical event involving the use of byproduct material;
(e). using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(f). administering dosages to patients or human research subjects that includes at least three cases involving the oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131; and
iii. has obtained written attestation that the individual has satisfactorily completed the requirements in Clauses E.2.c.i and ii of this Section, and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized in LAC 33:XV.735.C. The attestation shall be obtained from either:
(a) . a preceptor authorized user who meets the requirements in this Paragraph, Subsection B of this Section, Paragraphs E.1 or E.3 of this Section, equivalent NRC or agreement state requirements, and has experience in administering dosages as specified in Subdivision E.1.b.i.(b).(vii).[a] or [b] of this Section; or
(b). a residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Paragraph, Subsection B of this Section, Paragraphs E.1 or E.3 of this Section, or equivalent NRC or agreement state requirements, has experience in administering dosages as specified in Subdivision E.1.b.i.(b).(vii).[a] or [b] of this Section, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in Clauses E.2.c.i and ii of this Section.
3. 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 Subsection B of this Section, 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:
a. who is certified by a medical specialty board whose certification process includes all of the requirements in Clauses E.3.c.i and ii of this Section, and whose certification process has been recognized by the NRC or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page; or
b. who is an authorized user in accordance with Paragraph E.1 of this Section for uses listed in Subdivision E.1.b.i.(b).(vii).[b] of this Section, or equivalent agreement state requirements or Nuclear Regulatory Commission requirements; or
c. who meets the following requirements:
i. 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 shall include:
(a). radiation physics and instrumentation;
(b). radiation protection;
(c). mathematics pertaining to the use and measurement of radioactivity;
(d). chemistry of byproduct material for medical use; and
(e). radiation biology; and
ii. has work experience, under the supervision of an authorized user who meets the requirements in this Paragraph of this Section, Subsection B of this Section, Paragraph E.1 of this Section, or equivalent agreement state requirements or NRC requirements. A supervising authorized user who meets the requirements in Subparagraph E.1.b of this Section shall also have experience in administering dosages as specified in Subdivision E.1.b.i.(b).(vii).[b] of this Section. The work experience shall 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;
(c). calculating, measuring, and safely preparing patient or human research subject dosages;
(d). using administrative controls to prevent a medical event involving the use of byproduct material;
(e). using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(f). administering dosages to patients or human research subjects that includes at least three cases involving the oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131; and
iii. has obtained written attestation that the individual has satisfactorily completed the requirements in Clauses E.3.c.i and ii of this Section, and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized in LAC 33:XV.735.C. The attestation shall be obtained from either:
(a). a preceptor authorized user who meets the requirements in this Paragraph, Subsection B of this Section, Paragraphs E.1 of this Section, equivalent NRC or agreement state requirements, and has experience in administering dosages as specified in Subdivision E.1.b.i.(b).(vii).[b] of this Section; or
(b). a residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Paragraph, Subsection B of this Section, Paragraphs E.1 of this Section, or equivalent NRC or agreement state requirements, has experience in administering dosages as specified in Subdivision E.1.b.i.(b).(vii).[b] of this Section, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in Clauses E.3.c.i and ii of this Section.
4. Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive. Except as provided in Subsection B of this Section, the licensee shall require an authorized user for the parenteral administration requiring a written directive to be a physician:
a. who is an authorized user in accordance with Paragraph E.1 of this Section for uses listed in Subdivision E.1.b.i.(b).(vii).[c] of this Section, or equivalent agreement state requirements or NRC requirements; or
b. who is an authorized user in accordance with Subsections F or I of this Section, or equivalent agreement state requirements, NRC requirements, and who meets the requirements in Subparagraph E.4.d of this Section; or
c. who is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state in accordance with Subsections F or I of this Section, and who meets the requirements in Subparagraph E.4.d of this Section; or
d. who meets the following requirements:
i. has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations listed in Subdivision E.1.b.i.(b).(vii).[c]. The training shall include:
(a). radiation physics and instrumentation;
(b). radiation protection;
(c). mathematics pertaining to the use and measurement of radioactivity;
(d). chemistry of byproduct material for medical use; and
(e). radiation biology; and
ii. has work experience, under the supervision of an authorized user who meets the requirements in this Paragraph, Subsection B, or Paragraph E.1 of this Section, or equivalent agreement state requirements, or NRC requirements in the parenteral administration listed in Subdivision E.1.b.i.(b).(vii).[c]. A supervising authorized user who meets the requirements in this Paragraph, Paragraph E.1 of this Section, or equivalent NRC or agreement state requirements, shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience shall 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;
(c). calculating, measuring, and safely preparing patient or human research subject dosages;
(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 to patients or human research subjects, that include at least three cases of the parenteral administrations as specified in Subdivision E.1.b.i.(b).(vii).[c]; and
iii. has obtained written attestation that the individual has satisfactorily completed the requirements in Clauses E.4.d.i and ii of this Section, and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The attestation shall be obtained from either:
(a). a preceptor authorized user who meets the requirements in this Paragraph, Subsection B of this Section, Paragraph E.1 of this Section, or equivalent NRC or agreement state requirements. A preceptor authorized user who meets the requirements in this Paragraph, Paragraph E.1 of this Section, or equivalent NRC or agreement state requirements, shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or
(b). a residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Paragraph, Subsection B of this Section, Paragraph E.1 of this Section, or equivalent NRC or agreement state requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in Clauses 4.d.i and ii of this Section.
F. Training for Use of Manual Brachytherapy Sources. Except as provided in Subsection B of this Section, the licensee shall require the authorized user of a manual brachytherapy source for the uses authorized in LAC 33:XV.741.B to be a physician:
1. who is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
a. successfully complete a minimum of three 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 Council on Postdoctoral Training of the American Osteopathic Association; and
b. 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
2. who meets the following requirements:
a. 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;
(c). mathematics pertaining to the use and measurement of radioactivity; and
(d). radiation biology; and
ii. 500 hours of work experience under the supervision of an authorized user who meets the requirements in this Subsection, Subsection B of this Section or equivalent agreement state requirements or NRC requirements at a medical facility authorized to use byproduct materials in accordance with LAC 33:XV.741.B, involving:
(a). ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(b). checking survey meters for proper operation;
(c). preparing, implanting, and removing brachytherapy sources;
(d). maintaining running inventories of material on hand;
(e). using administrative controls to prevent a medical event involving the use of byproduct material; and
(f). using emergency procedures to control byproduct material; and
b. has completed three years of supervised clinical experience in radiation oncology under an authorized user who meets the requirements in this Subsection, Subsection B of this Section or equivalent agreement state requirements, or NRC 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 Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required in Subparagraph F.2.a.ii of this Section; and
c. has obtained written attestation that the individual has satisfactorily completed the requirements in Subparagraphs F.2.a and b of this Section, and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized in LAC 33:XV.741.B. The attestation shall be obtained from either:
i. a preceptor authorized user who meets the requirements in this Subsection, Subsection B of this Section, or equivalent NRC or agreement state requirements; or
ii. a residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Subsection, Subsection B of this Section or equivalent NRC or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in Subparagraphs 2.a and b of this Section.
G. Training for Ophthalmic Use of Strontium-90. Except as provided in Subsection B of this Section, the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician:
1. who is an authorized user in accordance with Subsection F of this Section, or equivalent agreement state requirements or Nuclear Regulatory Commission requirements; or
2. who meets the following requirements:
a. has completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training shall include:
i. radiation physics and instrumentation;
ii. radiation protection;
iii. mathematics pertaining to the use and measurement of radioactivity; and
iv. radiation biology; and
b. 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 shall 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
c. has obtained written attestation, signed by a preceptor authorized user who meets the requirements in Subsections B or F and G of this Section, or equivalent agreement state requirements, or NRC requirements that the individual has satisfactorily completed the requirements in Subparagraphs G.2.a and b of this Section and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.
H. Training for Use of Sealed Sources and Medical Devices for Diagnosis. Except as provided in Subsection B of this Section, the licensee shall require the authorized user of a diagnostic sealed source or a device authorized in LAC 33:XV.739 to be a physician, dentist, or podiatrist:
1. who is certified by a specialty board whose certification process includes all of the requirements in Paragraphs H.3 and 4 of this Section and whose certification has been recognized by the NRC or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state will be posted on the NRC's Medical Uses Licensee Toolkit web page; or
2. who is an authorized user for uses listed in LAC 33:XV.731.H, or equivalent NRC or agreement state requirements; or
3. who has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training shall include:
a. radiation physics and instrumentation;
b. radiation protection;
c. mathematics pertaining to the use and measurement of radioactivity; and
d. radiation biology; and
4. who has completed training in the use of the device for the uses requested.
I. Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units. Except as provided in Subsection B of this Section, the licensee shall require the authorized user of a sealed source for a use authorized in LAC 33:XV.747 to be a physician:
1.who is certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state, and who meets the requirements in Paragraph I.3 of this Section. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
a. successfully complete a minimum of three 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 Council on Postdoctoral Training of the American Osteopathic Association; and
b. 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 stereotactic radiosurgery, remote afterloaders, and external beam therapy; or
2. who meets the following requirements:
a. 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;
(c). mathematics pertaining to the use and measurement of radioactivity; and
(d). radiation biology; and
ii. 500 hours of work experience under the supervision of an authorized user who meets the requirements in this Subsection, or Subsection B of this Section or equivalent agreement state requirements or NRC requirements at a medical facility that is authorized to use byproduct materials in LAC 33:XV.747 involving:
(a). reviewing full calibration measurements and periodic spot-checks;
(b). preparing treatment plans and calculating treatment doses and times;
(c). using administrative controls to prevent a medical event involving the use of byproduct material;
(d). implementing emergency procedures to be followed in the event of the abnormal operation of a medical unit or console;
(e). checking and using survey meters; and
(f). selecting the proper dose and how it is to be administered; and
b. has completed three years of supervised clinical experience in radiation therapy under an authorized user who meets the requirements in this Subsection, or Subsection B of this Section or equivalent agreement state requirements, or NRC 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 Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required in Clause I.2.a.ii of this Section; and
c. has obtained written attestation that the individual has satisfactorily completed the requirements in Subparagraphs I.2.a and b and Paragraph I.3 of this Section, and is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The attestation shall be obtained from either:
i. a preceptor authorized user who meets the requirements in this Subsection or Subsection B of this Section or equivalent agreement state requirements or NRC requirements for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status; or
ii. a residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this Subsection, Subsection B of this Section, or equivalent NRC or agreement state requirements, for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program shall be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and shall include training and experience specified in Subparagraphs 2.a and b of this Section.
3. who 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.
J. Training for an Authorized Medical Physicist. Except as provided in Subsection B of this Section, the licensee shall require the authorized medical physicist to be an individual:
1. who is certified by a specialty board whose certification process has been recognized by the NRC or an agreement state, and who meets the requirements in Paragraph J.3 of this Section. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
a. 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;
b. have two 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 whose certification process has been recognized under this Section by the NRC 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 for an authorized user in Subsection B, F or I of this Section; and
c. 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
2. who meets the following requirements:
a. 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 one 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 shall 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 shall 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
b. has obtained written attestation that the individual has satisfactorily completed the requirements in Subparagraph J.2.a and Paragraph J.3 of this Section, and is able to independently fulfill the radiation safety-related duties 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 shall be signed by a preceptor authorized medical physicist who meets the requirements in this Subsection, Subsection B of this Section or equivalent agreement state requirements or NRC requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; and
3. who 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.
K. Training for an Authorized Nuclear Pharmacist. Except as provided in this Subsection the licensee shall require the authorized nuclear pharmacist to be a pharmacist:
1.who is certified by a specialty board whose certification process has been recognized by the NRC or an agreement state, and who meets the requirements in Subparagraph K. 2.b of this Section. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
a. 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;
b. hold a current, active license to practice pharmacy;
c. provide evidence of having acquired at least 4000 hours of training and experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and
d. 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
2. who meets the following requirements:
a. 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;
(c). mathematics pertaining to the use and measurement of radioactivity;
(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-emitting or beta-emitting radionuclides;
(c). calculating, assaying, and safely preparing dosages for patients or human research subjects;
(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
b. has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in Subparagraph K.2.a, of this Section and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.
L. Reserved.
M. Recentness of Training. The training and experience specified in Subsections A-K of this Section shall have been obtained within the seven years preceding the date of application, or the individual shall have had continuing applicable experience since the required training and experience was completed.

Notes

La. Admin. Code tit. 33, § XV-763
Promulgated by the Department of Environmental Quality, Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), amended LR 24:2106 (November 1998), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2590 (November 2000), LR 30:1186 (June 2004), amended by the Office of Environmental Assessment, LR 31:1061 (May 2005), amended by the Office of the Secretary, Legal Affairs Division, LR 32:814 (May 2006), LR 34:983 (June 2008), LR 34:2121 (October 2008), LR 36:1772 (August 2010), amended by the Office of the Secretary, Legal Division, LR 38:2748 (November 2012), LR 40:1342 (July 2014), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 442138 (12/1/2018), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 451179 (9/1/2019), Amended LR 471860 (12/1/2021).
AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq., and 2104.B.

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