Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 120.000 - The Control of Radiation
SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE REQUIRED
Section 120.558A - Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive

Universal Citation: 105 CMR 120.000 MA Code of Regs 120.558A

Current through Register 1531, September 27, 2024

(A) Except as provided in 105 CMR 120.528, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who:

(1) Is an authorized user under 105 CMR 120.556 for uses listed in 105 CMR 120.556(B)(1)(b)6.c., or equivalent Nuclear Regulatory Commission or Agreement State requirements; or

(2) Is an authorized user under 105 CMR 120.566, 120.587, or equivalent Nuclear Regulatory Commission or Agreement State requirements, and who meets the requirements in 105 CMR 120.558A(B); or

(3) Is certified by a medical specialty board whose certification process has been recognized by the Agency, Nuclear Regulatory Commission or an Agreement State under 105 CMR 120.566 or 120.587, and who meets the requirements in 105 CMR 120.558A(B).

(B) The physician:

(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations listed in 105 CMR 120.556(B)(1)(b)6.c. The training must include:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

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

(e) Radiation biology; and

(2) Has work experience, under the supervision of an authorized user who meets the requirements in 105 CMR 120.528, 120.556, 120.558A, or equivalent Nuclear Regulatory Commission or Agreement State requirements, in the parenteral administrations listed in 105 CMR 120.556(B)(1)(b)6.c. A supervising authorized user who meets the requirements in 105 CMR 120.556, 120.558A, or equivalent Nuclear Regulatory Commission or Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience must involve:

(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 to patients or human research subjects, that include at least three cases of the parenteral administrations as specified in 105 CMR 120.556(B)(1)(b)6.c.; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in 105 CMR 120.558A(B)(1) and (2), 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 must be obtained from either:

(a) A preceptor authorized user who meets the requirements in 105 CMR 120.528, 120.556, 120.558A, or equivalent Nuclear Regulatory Commission or Agreement State requirements. A preceptor authorized user who meets the requirements in 105 CMR 120.556, 120.558A, or equivalent Nuclear Regulatory Commission or Agreement State requirements, must 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 105 CMR 120.528, 120.556, 120.558A, or equivalent Nuclear Regulatory Commission 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 must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 105 CMR 120.558A(B)(1) and (2).

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