Iowa Administrative Code

39.15(1) In addition to the rules of this chapter, RAM facilities shall comply with the requirements of 10 CFR Part 40 unless specific exemptions apply. 39.15(2) The provisions of 10 CFR Part 40 are hereby adopted by reference and are subject to the following conditions: a. Not a…

39.16(1) In addition to the rules of this chapter, RAM facilities shall comply with the requirements of 10 CFR Part 70, “Domestic Licensing of Special Nuclear Material,” unless specific exemptions apply. 39.16(2) The provisions of 10 CFR Part 70 are hereby adopted by reference an…

39.17(1) In addition to the rules of this chapter, RAM facilities shall comply with the requirements of 10 CFR Part 71, “Packaging and Transportation of Radioactive Material,” unless specific exemptions apply. 39.17(2) The provisions of 10 CFR Part 71 are hereby adopted by refere…

39.18(1) In addition to the rules of this chapter, RAM facilities shall comply with the requirements of 10 CFR Part 150, “Packaging and Transportation of Radioactive Material,” unless specific exemptions apply. 39.18(2) The provisions of 10 CFR Part 150 are hereby adopted by refe…

36, 37, 39, 40, 70, 71, and 150 as amended to August 1, 2025, and adopted by reference, apply to the provisions of this chapter. The definitions provided in 641—Chapters 37, 38, 40, and 42 may also apply. Additionally, the definitions set forth below are specific to this chapter.…

39.3(1) Congress authorized the NRC in Section 274b of the Atomic Energy Act to enter into agreements that allow states to assume, and the NRC to discontinue, regulatory authority over byproduct, source, and small quantities of special nuclear material. The state can then regulat…

39.4(1) In addition to the rules of this chapter, RAM facilities as defined in rule 641—37.2(136C) shall comply with the requirements of 10 CFR Part 19, “Notices, Instructions and Reports to Workers; Inspection and Investigations,” except where specific exemptions apply. 39.4(2) …

RAM facilities shall comply with the requirements of 10 CFR Part 20, “Standards for Protections Against Radiation,” unless specific exemptions apply. 39.5(1) The provisions of 10 CFR Part 20 are hereby adopted by reference and are subject to the following conditions: a. Not adopt…

rules of this chapter, RAM facilities shall comply with the requirements of 10 CFR Part 30, “Rules of General Applicability to Domestic Licensing of Byproduct Material,” unless specific exemptions apply. Information and records, including applications and supporting documents sub…

39.7(1) In addition to the rules of this chapter, RAM facilities shall comply with the requirements of 10 CFR Part 31, “General Domestic Licenses for Byproduct Material,” unless specific exemptions apply. 39.7(2) The provisions of 10 CFR Part 31 are hereby adopted by reference an…

byproduct material. 39.8(1) In addition to the rules of this chapter, RAM facilities shall comply with the requirements of 10 CFR Part 32, “Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material,” unless specific exemptions apply. 39.8(2…

39.9(1) In addition to the rules of this chapter, RAM facilities shall comply with the requirements of 10 CFR Part 33, “Specific Domestic Licenses of Broad Scope for Byproduct Material,” unless specific exemptions apply. 39.9(2) The provisions of 10 CFR Part 33 are hereby adopted…

“Anonymized specimen” means a specimen that cannot be traced back to or linked with the particular individual from whom the specimen was obtained. “Attending health care provider” means the same as defined in Iowa Code section 136A.2. “Birth defect” means any major structural abn…

newborn screening services for hereditary and congenital disorders for the state. 4.2(1) Newborn screening policy. a. All newborns and infants born in the state of Iowa shall be screened for all congenital and inherited disorders on the Iowa newborn screening panel as specified b…

comprehensive maternal prenatal screening services for the state. 4.3(1) Maternal screening. The IMPSP provides a risk assessment for certain congenital or inherited conditions and disorders of a newborn. The department will identify the minimum conditions included in the assessm…

genetic and genomic services statewide through outreach clinics. 4.4(1) Provision of comprehensive genetic and genomic services. The department will contract with the division of medical genetics and genomics within the department of pediatrics at the University of Iowa to provid…

provides comprehensive services statewide for individuals and families with neuromuscular disorders through outreach clinics and statewide, active surveillance for selected neuromuscular disorders. 4.5(1) Comprehensive service provision. The department will contract with the depa…

active statewide surveillance for congenital and inherited conditions and disorders. These may include birth defects, neuromuscular disorders, metabolic disorders, and all stillbirths. The program also may conduct active statewide surveillance of live births without a reportable …

of diagnostic X-ray equipment and imaging systems. Such equipment shall be used only by, or under the supervision of, an individual who is authorized to operate the equipment and is licensed in accordance with state statutes to practice in the healing arts, including medicine, po…

accordance with 641—subrule 37.8(2) and maintained and operated, at a minimum, in accordance with the manufacturer’s specifications. 40.10(1) Equipment. All veterinary equipment shall follow the general requirements as specified in rule 641—40.5(136C). 40.10(2) Operator and ancil…

provisions of this chapter. Additionally, the following definitions set forth below are specific to this chapter. “Accessible surface” means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer. “Attenuation block” me…

40.3(1) The registrant shall be responsible for directing the operation of the X-ray system(s) under the registrant’s administrative control and shall ensure that the requirements of these regulations are met in the operation of the X-ray system(s). 40.3(2) In addition to the rul…

40.4(1) Registrant. The registrant shall be responsible for: a. Maintaining and directing the operation of the X-ray system(s) under the registrant’s administrative control for ensuring that the requirements of these rules are met in the operation of the X-ray system(s). b. Ensur…

requirements of this chapter, all diagnostic X-ray systems shall meet the requirements for manufacture as specified in 21 CFR 1020.30 and 1020.31. 40.5(1) Warning label. Diagnostic registrants shall comply with the warning label requirements of 21 CFR 1020.30(j). 40.5(2) Leakage …

addition to the applicable requirements of this chapter, all fluoroscopic and interventional X-ray systems shall meet the requirements for manufacture as specified in 21 CFR 1020.32 to include all of the following minimum requirements. 40.6(1) Fluoroscopic equipment. Only image-i…

volumetric dental imaging equipment. 1. In addition to the applicable requirements of this chapter, all dental intraoral, panoramic, cephalometric, and volumetric imaging X-ray systems shall meet the requirements for manufacture as specified in 21 CFR 1020.31, as well as the requ…

this chapter, all computed tomography X-ray systems, except CT used exclusively for radiation therapy, shall meet the requirements for manufacture as specified in 21 CFR 1020.33 and the requirements set forth in this chapter at the time of installation and at all times when in us…

accordance with 641—subrule 37.8(2) and maintained and operated, at a minimum, in accordance with the manufacturer’s specifications. 40.9(1) Shielding. No additional shielding for the room is required. 40.9(2) Operator requirements. Operators shall meet the requirements of 641—Ch…

biopsy. The following provisions of 21 CFR 900 as amended to August 1, 2025, for mammography are hereby adopted by reference: 41.1(1) 21 CFR 900.2 Definitions. 41.1(2) 21 CFR 900 Subpart B—Quality Standards and Certification. [ARC 0181D, IAB 4/1/26, effective 7/1/26]

the quality assurance requirements of 21 CFR 900.12(d), 21 CFR 900.12(e), 21 CFR 900.12(f) and the requirements of this chapter. 41.10(1) Mammography facilities shall comply with the general quality assurance requirements of 21 CFR 900.12(d). a. Mammography facilities shall compl…

41.11(1) Revocation of accreditation and revocation of accreditation body approval. Mammography facilities shall comply with the revocation of accreditation and revocation of accreditation body approval requirements of 21 CFR 900.13. 41.11(2) Suspension or revocation of certifica…

facilities may also comply with the alternative quality standard requirements of 21 CFR 900.12 and 21 CFR 900.18. [ARC 0181D, IAB 4/1/26, effective 7/1/26]

certified to perform stereotactic breast biopsies shall comply with the applicable requirements of this chapter and the applicable provisions in 641—Chapters 37 and 40. [ARC 0181D, IAB 4/1/26, effective 7/1/26]

biopsy. Each radiation machine used to perform stereotactically guided breast biopsies shall be registered according to the requirements set forth in 641—subrule 37.8(2). 41.14(1) Each facility wishing to perform stereotactically guided breast biopsies shall apply to the departme…

be qualified according to the setting and their role in performing stereotactically guided breast biopsies. 41.15(1) Requirements for stereotactic breast biopsies for radiologists in collaborative settings. a. Initial training and qualifications for radiologists in collaborative …

41.16(1) Radiologic technologists shall be qualified according to the rules of this chapter. 41.16(2) An Iowa permit to practice radiography as a general radiologic technologist shall be in effect whenever stereotactic procedures are performed by the radiologic technologist and s…

biopsy systems. 41.17(1) Qualified medical physicists, as outlined in this chapter, shall have performed three hands-on stereotactically guided breast biopsy system physics surveys prior to July 1, 1998; or one hands-on stereotactically guided breast biopsy system physics survey …

retained for a minimum of ten years. The facility shall make, for each procedure, a record of the services provided, including all of the following: 41.18(1) The date of the procedure; 41.18(2) The name of the patient and one additional patient identifier; 41.18(3) The names of t…

equipment quality assurance program specific to stereotactically guided breast biopsy systems to ensure high-quality images with minimum patient exposure. 41.19(1) The facility shall name a supervising stereotactic breast biopsy physician who shall be responsible for all of the f…

to the mammography provisions of this chapter. The definitions provided in 641—Chapters 37 and 40 may also apply. Additionally, the definitions set forth below are specific to this chapter. “Annually” means within 10 to 14 months of previous occurrence. “Authorization” means the …

specifically designed for stereotactically guided breast biopsy. 41.20(1) Stereotactic facilities shall comply with the requirements of 641—Chapters 37 and 40. 41.20(2) Annual inspections shall be conducted by an inspector from the department to ensure compliance with these rules…

breast biopsy. 41.21(1) Suspension, revocation, or denial of authorization. Authorization may be suspended or revoked with cause if any machine does not meet one or more of the standards of these rules. a. Stereotactic facilities shall comply with the administrative enforcement a…

personnel shall comply with the applicable regulations of 21 CFR 900 as adopted in rule 641—41.1(136C). In addition, compliance with the requirements of 641—Chapters 37 and 40 and the rules contained herein are required. Where differences exist, compliance with the most stringent…

the rules of this chapter, mammography facilities shall comply with the requirements of 21 CFR 900.11. 41.4(1) Registration and certificates. Each radiation machine used to perform mammography shall be registered according to 641—subrule 37.8(2). a. A certificate issued by the FD…

personnel shall comply with the requirements of 21 CFR 900.12. The following requirements apply to all personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities. 41.5(1) Interpr…

comply with the retention of personnel records requirements of 21 CFR 900.12(a)(4). [ARC 0181D, IAB 4/1/26, effective 7/1/26]

shall comply with the equipment requirements of 21 CFR 900.12(b). [ARC 0181D, IAB 4/1/26, effective 7/1/26]

comply with the requirements for medical records and mammography reports of 21 CFR 900.12(c) and of this chapter. [ARC 0181D, IAB 4/1/26, effective 7/1/26]

with the contents and terminology requirements of 21 CFR 900.12(c)(1) and this chapter. 41.9(1) A separate and distinct section entitled “Assessment” with the appropriate assessment term or an approved equivalent shall be included. 41.9(2) The breast density information as design…

registrant for the use of therapeutic radiation machines. 42.1(1) The use of therapeutic radiation machines shall be by, or under the supervision of, a physician who meets the training and experience criteria established by rule 641—42.5(136C). 42.1(2) Unless otherwise specified …