Fla. Admin. Code Ann. R. 64E-5.510 - Mammographic Systems

(1) Mammographic medical x-ray systems shall meet the requirements of Rules 64E-5.502 and 64E-5.503, F.A.C. Registrants who provide mammography services shall:

(a) Have a written quality assurance program specific to mammography imaging that includes an equipment quality control program for performance monitoring and an evaluation of all components of the equipment from the x-ray generator to the image processor.

(b) Establish standards for clinical image evaluations that include breast positioning, compression and overall image quality.

(c) Assign qualified and trained personnel to each part of the quality assurance program.

(d) Conduct a general review of the effectiveness of the quality assurance program annually and maintain a written report of the review.

(e) Have available the services of a medical physicist to furnish diagnostic x-ray physics support who is able to establish and conduct the equipment quality control program and who meets the requirements specified in subsection (12), below. The specific duties of the medical physicist must include:

1. Monitoring equipment performance or verifying the qualifications and training of others to monitor equipment performance.

2. Evaluating the monitoring results to identify problems.

3. Verifying that corrections are effective and meet regulatory requirements.

(2) The film processor shall be optimized for the specific mammography film used by the facility. Its performance shall be checked for consistency of speed, contrast, and base plus fog prior to processing patient films and after being idle more than 6 hours.

(a) Performance checks shall be plotted and compared to established limits. If these limits are exceeded, documented corrective actions including an image quality check as specified in subsection (3), below, are required.

(b) Corrective action shall be taken when:

1. Optical density deviates by more than 0.15 from established operating levels for readings of mid-density or density difference on the sensitometric control charts.

2. Base plus fog exceeds the established operating level by more than 0.03 optical density.

(c) These records for processor optimization, performance, image quality checks and documented corrective actions shall be maintained for inspection by the department for at least 1 year.

(3) Mammographic x-ray systems shall be monitored and evaluated using the following standards:

(a) The image quality shall be checked using a standard phantom approved by the FDA which meets the criteria below at least weekly and whenever service which could affect image quality is performed on the x-ray system or the film processor. The image quality shall be scored on the ability to image fibers, specks, and low density masses. If quality control limits are exceeded, image quality checks also must be performed after any corrective actions have been taken. This standard phantom must be designed to evaluate image quality in the 1.2 to 1.8 optical density range, shall not change more than 0.2 optical density from its previous reading, and must be composed of material that is equivalent to a nominal 4.5 centimeter compressed breast of average density of approximately 50 percent adipose and 50% percent glandular tissue. It shall contain the following objects:

1. Nylon fibers with thicknesses of 1.56 millimeters, 1.12 millimeters, 0.89 millimeters, 0.75 millimeters, 0.54 millimeters, and 0.40 millimeters.

2. Aluminum oxide specks with diameters of 0.54 millimeters, 0.40 millimeters, 0.32 millimeters, 0.24 millimeters, and 0.16 millimeters.

3. Phenolic plastic spherical masses with thicknesses of 2.00 millimeters, 1.00 millimeters, 0.75 millimeters, 0.50 millimeters, and 0.25 millimeters.

(b) Phantom checks which indicate a decrease in image quality shall require immediate investigation of possible corrective actions.

(c) The minimum acceptable image quality of a standard phantom described in paragraph (3)(a), above, shall demonstrate the ability to image at least 0.75 millimeter fibers; 0.32 millimeter specks; and 0.75 millimeter spherical masses. Mammographic examinations shall not be performed on systems which do not meet the minimum image quality standard.

(d) The registrant must document in the annual review required in subsection (1), above, that all equipment quality control items were performed under the direction and approval of the medical physicist.

(e) Mammography system performance must be evaluated regularly. Those components and parameters of the equipment quality control program tested for performance daily, weekly, monthly or quarterly shall be evaluated quarterly. The annual onsite survey by the medical physicist must include a summary of the quarterly evaluations.

(4) The following requirements apply to personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities.

(a) Interpreting physicians shall be licensed to practice medicine in the State of Florida, as specified in Chapters 458 and 459, F.S.

(b) Radiologic technologists shall be certified as a general radiographer in the State of Florida as specified in Chapter 64E-3, F.A.C.

(c) A medical physicist qualified to conduct surveys of mammography facilities and provide oversight of the facility quality assurance program shall be licensed in Florida as a medical physicist as specified in Chapter 483, F.S.

(5) Documentation, records and surveys. Each facility shall maintain records, policies, procedures and documentation to demonstrate compliance with these requirements, including corrective actions taken.

(a) Clinical images. Each facility shall establish and maintain a clinical image quality control program, including:

1. Monitoring of mammograms repeated because of poor image quality; and

2. Maintaining records, analysis of results, and a description of any remedial action taken as a result of this monitoring.

(b) Clinical image interpretation. To ensure that quality clinical images are produced routinely at the facility, each facility shall submit clinical images to the Department for review as required by the Department.

(c) Surveys. A medical physicist who meets the qualifications specified in subsection (4), above, and who establishes, monitors, evaluates, and directs the equipment quality control program must perform an on-site survey of the facility to assure that it meets quality control and equipment standards. These surveys shall be performed at least annually and shall be available for inspection by the department. Each survey report shall be retained by the facility until the next annual survey is completed satisfactorily.

(6) In addition to the above requirements, effective October 1, 1994, no facility can conduct mammography procedures unless the facility also obtains and maintains a certificate issued by the FDA as described in Public Law 102-539, the Mammography Quality Standards Act of 1992, and complies with all requirements of 21 CFR Part 900, April 1, 2014 edition, which is incorporated herein by reference and available from the internet at http://www.gpo.gov/fdsys/pkg/CFR-2014-title21-vol8/pdf/CFR-2014-title21-vol8-chapI-subchapI.pdf, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-05440.

Notes

Fla. Admin. Code Ann. R. 64E-5.510

Rulemaking Authority 404.051, 404.22 FS. Law Implemented 404.051(1), (4), 404.141, 404.22(1), (3), (6) FS.

New 3-17-92, Amended 1-1-94, 11-20-94, Formerly 10D-91.611, Amended 5-18-98, Amended by Florida Register Volume 41, Number 097, May 19, 2015 effective 6/3/2015.