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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Rule 3701:1-66-08 | Mammography radiation-generating equipment.

 

This rule provides standards for radiation-generating equipment used for screening and diagnostic mammography, and mammography equipment used for invasive localization and stereotactically-guided breast biopsy purposes, except as provided by paragraphs (E) and (F) of this rule. In addition, a handler of mammography radiation-generating equipment that uses either stationary or mobile installations, will comply with all applicable standards in 21 C.F.R. part 1020 (as effective on the effective date of this rule).

(A) In addition to meeting the applicable equipment standards in rule 3701:1-66-02 of the Administrative Code, a handler performing screening or diagnostic mammography will have a valid certificate issued by the U.S. department of health and human services, pursuant to the Mammography Quality Standards Reauthorization Act of 1998, Public Law 105-248, and 21 C.F.R. Part 900 (as effective on the effective date of this rule).

(B) A handler of all types of mammography radiation-generating equipment will comply with the shielding obligations in paragraphs (H)(2) to (H)(4) of rule 3701:1-66-02 of the Administrative Code.

(C) In addition to applicable radiation safety obligations in rules adopted pursuant to Chapter 3748. of the Revised Code and rule 3701:1-66-02 of the Administrative Code, a handler of all types of screening and diagnostic mammography radiation-generating equipment will comply with the following:

(1) When a film/screen mammography system is used, clinical films will be processed as soon as possible, but not to exceed twenty-four hours from the time the first clinical image is taken. Facilities utilizing batch processing will:

(a) Use a container to transport clinical films that will protect the film from exposure to light, excessive heat and radiation; and

(b) Maintain a log to include date and identification of each patient, time of first exposure of each batch, and date and time of each batch processing;

(2) Individuals who perform mammography procedures on human beings will hold an Ohio radiographer license in accordance with Chapter 3701-72 of the Administrative Code and will meet at least one of the following qualifications:

(a) Documented evidence of having completed the forty contact hours of training obligated by 21 C.F.R. 900.12(a)(2)(ii); or

(b) Hold advanced certification in mammography issued by the "American Registry of Radiologic Technologists."

(D) In addition to all applicable quality assurance obligations in rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, the facility will maintain phantom and quality control images for three months.

(E) Radiation-generating equipment designed for mammography, but used exclusively for radiography of tissue from a biopsy, will be exempt from paragraphs (A) to (D) of this rule, and will comply with paragraphs (E), (H)(2), (H)(3) and (J) of rule 3701:1-66-02 of the Administrative Code.

(F) Radiation-generating equipment used for radiography of tissue from a biopsy and equipped with an x-ray tube enclosure designed to exclude personnel from its interior during x-ray generation will be exempt from paragraphs (A) to (E) of this rule, and will comply with the obligations set forth in rule 3701:1-68-06 of the Administrative Code.

(G) Quality control testing by a radiation expert will be conducted on mammography radiation-generating equipment used for invasive localization or having stereotactically-guided breast biopsy capability. Quality control testing for stereotactically-guided breast biopsy equipment will follow the "American College of Radiology (ACR) Practice Parameter for the Performance of Stereotactic-Guided Breast Interventional Procedures" (as revised in 2016). This document is available from the "American College of Radiology, 1891 Preston White Drive, Reston, Virginia 20191, telephone (703) 648-8900."

(1) The radiation expert will meet the obligations of the aforementioned ACR guideline; and

(2) The radiation expert will document and verify that the facility is taking proper corrective actions when results of the quality control tests indicate the need.

Last updated December 13, 2024 at 7:32 AM

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.01, 3748.02, 3748.04, 3748.05, 3748.06, 3748.07, 3748.12, 3748.121, 3748.13, 3748.14, 3748.15, 3748.17, 3748.18, 3748.19, 3748.20, 3748.22, 3748.99
Five Year Review Date: 12/13/2029
Prior Effective Dates: 2/15/2001, 2/1/2005, 4/15/2009, 2/1/2014, 12/20/2019