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 paragraph (E) of this rule. In addition to Chapters 3701:1-38 and 3701:1-66 of the Administrative Code, a handler of mammography radiation-generating equipment that uses either stationary or mobile installations, other than dedicated stereotactic systems, shall comply with all applicable standards in 21 C.F.R. 1020 (as published in the April 1, 2008, Code of Federal Regulations) and the following:

(A) In addition to meeting the applicable equipment standards in rule 3701:1-66-02 of the Administrative Code, mammography radiation-generating equipment shall be specifically designed for mammography in accordance with all applicable standards of 21 C.F.R. 1020, and comply with applicable standards in Mammography Quality Standards Act(MQSA) regulations, 21 C.F.R. 900.12(b) (as published in the April 1, 2008, Code of Federal Regulations).

(B) A handler of all types of mammography radiation-generating equipment shall comply with the shielding requirements in paragraph (I) of rule 3701:1-66-02 of the Administrative Code.

(C) In addition to applicable radiation safety requirements 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 shall comply with the following:

(1) When a film/screen mammography system is used, clinical films shall 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 shall:

(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) An individual, other than a licensed practitioner, operating any type of mammography or stereotactically-guided biopsy equipment shall possess an Ohio radiographer license in accordance with rules in Chapter 3701-72 of the Administrative Code and meet the training and continuing education requirements of 21 C.F.R. 900.12(a)(2) and to include at least one of the following:

(a) Documented evidence of having completed twelve classroom hours of educational courses in mammography as accepted by the department; or

(b) Proof of advanced certification in mammography issued to the operator by the "American Registry of Radiologic Technology."

(D) In addition to all applicable quality assurance requirements in rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, a handler of screening and diagnostic mammography radiation-generating equipment shall comply with the following:

(1) Designate and utilize a medical physicist who meets the qualifications under 21 C.F.R. 900.12(a)(3) who shall:

(a) Document and verify that the facility is taking proper corrective actions when results of the quality control tests indicate the need;

(b) Conduct surveys of the equipment in accordance with 21 C.F.R. 900 ; and

(c) Provide oversight and maintenance over the quality assurance program; For hospitals registered under division (A) of section 3701.07 of the Revised Code, the medical physicist also shall be certified as a radiation expert under paragraph (E)(3) of rule 3701:1-66-03 of the Administrative Code.

(2) The facility shall conduct testing procedures and maintain written records of all MQSA quality assurance and quality control tests between inspections in accordance with 21 C.F.R. 900, and phantom and quality control films for three months.

(E) Mammography radiation-generating equipment used exclusively for radiography of breast tissue from a biopsy, shall be exempt from paragraphs (A) to (D) of this rule, and shall comply with the requirements set forth in paragraphs (A), (D)(2), (F), (G)(2), (H)(1), (I) and (J) of rule 3701:1-66-02 of the Administrative Code.

(F) Testing by a medical physicist shall be conducted on mammography radiation-generating equipment having stereotactically-guided breast biopsy capability and shall follow the "American College of Radiology (ACR) Guideline for the Performance of Stereotactically Guided Breast Interventional Procedures" (as amended in 2006). This document is available from the "American College of Radiology, 1891 Preston White Drive, Reston, Virginia 20191, telephone (703) 648-8900." The medical physicist shall meet the requirements of the aforementioned ACR document.

Replaces: 3701:1-66-08

Effective: 04/15/2009
R.C. 119.032 review dates: 04/15/2014
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 2/15/2001, 2/01/05