This rulemaking amends rule language as necessary to ensure that all the rules conform to statutory requirements, federal regulations, and the current x-ray machine registration procedures. The rulemaking updates radiation machine registration ...

 

DEPARTMENT OF HEALTH

Division of Environmental Health

RULE NOS.:RULE TITLES:

64E-5.1602Administrative Requirements

64E-5.220Radioactive Quantities

64E-5.508X-Ray and Electron Therapy Systems with Energies of 1 MeV and Above

64E-5.510Mammographic Systems

64E-5.511Registration of Radiation Machines

64E-5.801Registration Requirements

PURPOSE AND EFFECT: This rulemaking amends rule language as necessary to ensure that all the rules conform to statutory requirements, federal regulations, and the current x-ray machine registration procedures. The rulemaking updates radiation machine registration related applications and forms and updates operational and safety requirements for x-ray and electron therapy systems, as well as diagnostic systems. The rulemaking amends Rule 64E-5.220, F.A.C., to incorporate by reference the modified table of Emergency Plan Isotopes and Quantities and updates the means for enforcing radiation control regulations.

SUMMARY: The rulemaking updates forms related to radiation machine registration, creates an incorporated form table that identifies required Emergency Plan Isotopes and Quantities, deletes obsolete definitions and language related to requirements for x-ray and electron therapy systems, deletes unnecessary language related to mammographic screening system requirements and updates radiation control enforcement rules.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The analysis the department conducted to determine if a SERC is necessary, indicates neither a SERC nor legislative ratification is required. This rulemaking will have minimal impact on the regulated community and is not likely to have an adverse impact on economic growth, private sector job creation or employment, or private sector investment. The rulemaking will have minimal impact on regulatory costs and business competitiveness. This rulemaking will not have an adverse impact or regulatory costs in excess of $1 million within five years as established in Section120.541(2)(a), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 404.022, 404.031, 404.042, 404.051, 404.061, 404.071, 404.081, 404.141, 404.22 FS.

LAW IMPLEMENTED: 404.022, 404.031, 404.042, 404.051, 404.061, 404.071, 404.081, 404.091, 404.101, 404.141, 404.161, 404.162, 404.163, 404.071, 404.081, 404.22 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Brenda Andrews, 4052 Bald Cypress Way, Bin C21, Tallahassee, FL 32399-1741, [phone], [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64E-5.1602 Administrative Requirements.

(1) Registration and Notification.

(a) through (c) No change.

(d) Each person who acquires an electronic brachytherapy device shall apply for registration of the radiation device with the department within 30 days after acquisition. Application for registration shall be on DH Form DH 1107, 09/14 03/07, “Radiation Machine Facility Registration,” as incorporated in subparagraph 64E-5.511(2)(a)1., F.A.C. and is available from the internet at______, and at______. The application must include the following documents:

1. through 6. No change.

(e) No change.

(2) through (3) No change.

Rulemaking Authority 404.051(4), 404.22 FS. Law Implemented 404.051, 404.081(1), 404.22 FS. History–New 3-12-09, Amended.

 

64E-5.220 Radioactive Quantities.

(1) The list of Listed below are quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release as required in Rule 64E-5.219, F.A.C.:, is provided in the Department publication “Emergency Plan Isotopes and Quantities,” July 2014 edition, which is incorporated by reference and can be obtained at http://www.floridahealth.gov/radiation, and at_____.

MaterialRelease FractionCuries

Actinium 228.0014,000

Americium 241.0012

Americium 242.0012

Americium 243.0012

Antimony 124.014,000

Antimony 126.016,000

Barium 133.0110,000

Barium 140.0130,000

Bismuth 207.015,000

Bismuth 210.01600

Cadmium 109.011,000

Cadmium 113.0180

Calcium 45.0120,000

Californium 252.0019

Carbon 14.01 (non CO2)50,000

Cerium 141.0110,000

Cerium 144.01300

Cesium 134.012,000

Cesium 137.013,000

Chlorine 36.5100

Chromium 51.01300,000

Cobalt 60.0015,000

Copper 64.01200,000

Curium 242.00160

Curium 243.0013

Curium 244.0014

Curium 245.0012

Europium 152.01500

Europium 154.01400

Europium 155.013,000

Gadolinium 153.015,000

Germanium 68.012,000

Gold 198.0130,000

Hafnium 172.01400

Hafnium 181.017,000

Holmium 166m.01100

Hydrogen 3.520,000

Iodine 125.510

Iodine 131.510

Indium 114m.011,000

Iridium 192.00140,000

Iron 55.0140,000

Iron 59.017,000

Krypton 851.06,000,000

Lead 210.018

Manganese 56.0160,000

Mercury 203.0110,000

Molybdenum 99.0130,000

Neptunium 237.0012

Nickel 63.0120,000

Niobium 94.01300

Phosphorus 32.5100

Phosphorus 33.51,000

Polonium 210.0110

Potassium 42.019,000

Promethium 145.014,000

Promethium 147.014,000

Radium 226.001100

Ruthenium 106.01200

Samarium 151.014,000

Scandium 46.013,000

Selenium 75.0110,000

Silver 110m.011,000

Sodium 22.019,000

Sodium 24.0110,000

Strontium 89.013,000

Strontium 90.0190

Sulfur 35.5900

Technetium 99.0110,000

Technetium 99m.01400,000

Tellurium 127m.015,000

Tellurium 129m.015,000

Terbium 160.014,000

Thulium 170.014,000

Tin 113.0110,000

Tin 123.013,000

Tin 126.011,000

Titanium 44.01100

Vanadium 48.017,000

Xenon 1331.0900,000

Yttrium 91.012,000

Zinc 65.015,000

Zirconium 93.01400

Zirconium 95.015,000

Any other beta-gamma emitter.0110,000

Mixed fission products.011,000

Mixed corrosion products.0110,000

Contaminated equipment beta-gamma.00110,000

Irradiated material, any form other than

solid noncombustible.011,000

Irradiated material, solid noncombustible.00110,000

Mixed radioactive waste, beta-gamma.011,000

Packaged mixed waste, beta-gamma.00110,000

Any other alpha emitter.0012

 

(2) through (3) No change.

Rulemaking Authority 404.022, 404.042, 404.051, 404.061, 404.071, 404.081 FS. Law Implemented 404.022, 404.042, 404.051(1), (4), (6), (9), (10), 404.061(2), (3), 404.071(1), 404.081(1) FS. History–New 5-12-93, Formerly 10D-91.327, Amended______.

 

64E-5.508 X-Ray and Electron Therapy Systems with Energies of 1 MeV and Above.

(1) Definitions. In addition to the definitions provided in Rule 64E-5.501, F.A.C., the following definitions shall apply be applicable to this section:

(a) through (e) No change.

(f) “Existing equipment” means therapy systems subject to this section which were manufactured on or before January 1, 1985.

(f)(g) “Field-flattening filter” means a filter used to provide dose uniformity over the area of a useful beam of x-rays at a specified depth.

(g)(h) “Field size” means the dimensions along the major axes of an area in a plane perpendicular to the specified direction of the beam of incident radiation at the normal treatment distance and defined by the intersection of the major axes and the 50 percent isodose line. Material shall be placed in the beam such that dose maximum is produced at the normal treatment distance when field size is being determined.

(h)(i) “Gantry” means that part of the system supporting and allowing possible movements of the radiation head.

(i)(j) “Interruption of irradiation” means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.

(j)(k) “Isocenter” means a fixed point in space located at the center of the smallest sphere through which the central axis of the beam passes in all conditions.

(k)(l) “Moving beam therapy” means radiation therapy with relative displacement of the useful beam and the patient during irradiation. It includes arc therapy, skip therapy and rotational therapy.

(m) “New equipment” means systems subject to this section which were manufactured after January 1, 1985.

(l)(n) “Normal treatment distance” means:

1. through 2. No change

(m)(o) “Radiation head” means the structure from which the useful beam emerges.

(n)(p) “Shadow tray” means a device attached to the radiation head to support auxiliary beam limiting material.

(o)(q) “Stationary beam therapy” means radiation therapy without relative displacement of the useful beam or the patient during irradiation.

(p)(r) “Target” means that part of a radiation head which by design intercepts a beam of accelerated particles with subsequent emission of other radiation.

(q)(s) “Virtual source” means a point from which radiation appears to originate.

(2) Requirements for Equipment.

(a) Leakage Radiation to the Patient Area.

1. No change.

2. Existing equipment shall meet the following requirement: For operating conditions producing maximum leakage radiation, the absorbed dose in rads (grays) due to leakage radiation excluding neutrons at any point in a circular plane of 2 meters radius centered on a perpendicular to the central axis of the beam 1 meter from the virtual source, and outside the maximum size useful beam, shall not exceed 0.1 percent of the maximum absorbed dose in rads (grays) of the unattenuated useful beam measured at the point of intersection of the central axis of the beam and the surface of the circular plane. Measurements shall be averaged over an area up to, but not exceeding, 100 square centimeters at the positions specified.

2.3. For each system, Tthe registrant shall determine or obtain from the manufacturer the leakage radiation existing at the positions specified and for the specified operating conditions. Records on radiation leakage shall be maintained for inspection by the Department.

(b) through (e) No change.

(f) Beam Monitors. All therapy systems shall be provided with two radiation detectors in the radiation head.

1. New equipment shall be provided with at least two radiation detectors. The detectors shall be incorporated into two separate dose monitoring systems.

2. Existing equipment shall be provided with at least one radiation detector. This detector shall be incorporated into a primary dose monitoring system.

2.3. The detector and the system into which that detector is incorporated shall meet the following requirements:

a. through d. No change.

3.4. Each dose monitoring system shall have a legible display at the treatment control panel. For new equipment, each display shall:

a.(I) Maintain a reading until intentionally reset to 0;

b.(II) Have only one scale and no scale multiplying factors;

c.(III) Utilize a design such that increasing dose is displayed by increasing numbers and shall be so designed that, in the event of an overdosage of radiation, the absorbed dose may be accurately determined; and

d.(IV) In the event of power failure, the dose monitoring information required to be displayed at the control panel at the time of failure shall be retrievable in at least one system for a 20-minute period of time.

(g) Beam Symmetry. In new equipment inherently capable of producing useful beams with asymmetry exceeding 5 percent, the asymmetry of the radiation beam in two orthogonal directions shall be monitored before the beam passes through the beam limiting device. Facilities shall be provided so that, if the difference in dose rate between one region and another region symmetrically displaced from the central axis of the beam exceeds 5 percent of the central axis dose rate, indication of this condition is made at the control panel; and if this difference exceeds 10 percent, the irradiation is terminated.

(h) Selection and Display of Dose Monitor Units.

1. through 3. No change.

4. For new equipment, Aafter termination of irradiation, it shall be necessary to manually reset the pre-selected dose monitor units before irradiation can be initiated.

(i) Termination of Irradiation by the Dose Monitoring System or Systems During Stationary Beam Therapy.

1. Each primary system shall terminate irradiation when the pre-selected number of dose monitor units has been detected by the system.

2. If original design of the equipment included a second dose monitoring system, that system shall be capable of terminating irradiation when not more than 15 percent or 40 dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the second dose monitoring system.

2.3. For new equipment, a second dose monitoring system shall be present. The That system shall be capable of terminating irradiation when not more than 10 percent or 30 dose monitoring units above the pre-selected number of dose monitor units set at the control panel has been detected by the second dose monitoring system.

3.4. For new equipment, Aan indicator on the control panel shall show which dose monitoring system has terminated irradiation.

(j) through (k) No change.

(l) Timer.

1. through 2. No change.

3. For new equipment, Aafter termination of irradiation and before irradiation can be reinitiated, it shall be necessary to manually reset the preset time selector.

4. No change.

(m) Selection of Radiation Type. Equipment capable of both x-ray therapy and electron therapy shall meet the following additional requirements:

1. through 6. No change.

(n) Selection of Energy. Equipment capable of generating radiation beams of different energies shall meet the following requirements:

1. through 3. No change.

(o) Selection of Stationary Beam Therapy or Moving Beam Therapy. Equipment capable of both stationary beam therapy and moving beam therapy shall meet the following requirements:

1. through 4. No change.

5. For new equipment, Aan interlock system shall be provided to terminate irradiation if:

a. Movement of the gantry occurs during stationary beam therapy; or

b. Movement of the gantry stops during moving beam therapy unless such stoppage is a preplanned function.

6. Moving beam therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental angle of movement.

a. For new equipment, Aan interlock system shall be provided to terminate irradiation if the number of dose monitor units delivered in any 10 degrees of arc differs by more than 20 percent from the selected value.

b. For new equipment, Wwhere gantry angle terminates the irradiation in arc therapy, the dose monitor units shall differ by less than 5 percent from the value calculated from the absorbed dose per unit angle relationship.

7. No change.

(p) Absorbed Dose Rate. For new equipment, Aa system shall be provided from whose readings the absorbed dose rate at a reference point in the treatment volume can be calculated. In addition:

1. The dose monitor unit rate shall be displayed at the treatment control panel;. and,

2. The radiation detectors specified in paragraph (2)(f), above, may form part of this system.

(q) through (r) No change.

(3)  through (4) No change.

Rulemaking Authority 404.031, 404.051, 404.071, 404.081, 404.141, 404.22 FS. Law Implemented 404.022, 404.031, 404.051(1), (4), (5), (6), 404.071(1), 404.081(1), 404.141, 404.22(1), (3) FS. History–New 7-17-85, Amended 4-4-89, Formerly 10D-91.609, Amended_______.

 

64E-5.510 Mammographic Systems.

(1) No change.

(2) Mammographic x-ray examinations shall be performed on systems specifically designed for and used only for mammography. Mammographic medical x-ray systems shall meet the following requirements:

(a) Image receptor. The image receptor systems and their individual components must be designed for mammography.

(b) Target/filter. The x-ray system must be able to provide kVp/target/filter combinations that are compatible with the image receptor systems.

(c) Focal spot size measurement. Focal spot dimensions shall be measured both parallel and perpendicular to the anode-cathode axis with a slit camera or star pattern. Measured focal spot size shall result in minimal acceptable phantom image as specified in paragraph (8)(c) or comply with the manufacturer’s specified nominal focal spot size within the following tolerances:

Nominal Focal Maximum Measured

Spot SizeDimensions*

In MillimetersWidth (mm)Length (mm)

0.100.150.15

0.150.230.23

0.200.300.30

0.300.450.65

0.400.600.85

0.600.901.30

 

*Width is the dimension perpendicular to the anode-cathode axis, length is the dimension parallel to the anode-cathode axis.

(d) Compression. Devices parallel to the imaging plane must be available to immobilize and compress the breast. These devices must be able to compress the breast with a force of at least 25 pounds and be able to maintain this compression for at least 15 seconds. For systems with automatic compression, the maximum force applied without manual assistance shall not be allowed to exceed 40 pounds. The chest wall edge of the compression paddle must be aligned with the chest wall edge of the image receptor to within 1 percent of the SID when the compression paddle is placed 6 centimeters above the patient support device.

(e) Anti-scatter grids. A mammographic x-ray system using screen-film image receptors shall be able to use anti-scatter grids that are integral to the x-ray system and available for all image receptor sizes of the system.

(f) Automatic exposure control. The department recommends that all x-ray equipment installed after September 1, 1993 have automatic exposure control that meets the requirements of subsection 64E-5.503(14), F.A.C. The automatic exposure control shall be able to maintain constant film density within the diagnostic range of 1.05 to 1.60 optical density for 2, 4, and 6 centimeters of acrylic or of BR-12 phantoms. Density selection and kVp can be manually adjusted and recorded on technique charts if necessary to maintain film density.

(3) Beam quality. The useful beam shall have a half-value layer between the values of measured kVp/100 and measured kVp/ 100 + 0.1 millimeter aluminum equivalent when used with screen-film image receptors and the contribution to filtration made by the compression device is included. For xeroradiography, the half-value layer of the useful beam with the compression device in place shall be at least 1.0 and not more than 1.6 millimeters aluminum equivalent, tested at the kVp recommended by the manufacturer. Mammographic units using only rhodium filters and anodes are exempt from these beam quality requirements.

(4) The x-ray system shall meet safety standards and be free from unnecessary hazards to patients, personnel and others. Identified hazards must be corrected promptly. Technique charts, procedures for all equipment use, proper safety precautions for both mechanical and electrical operation, adequate shielding, and emergency procedures must be available to the equipment operator. Staff or a medical physicist as specified in subsection (12), below, shall conduct and document periodic inspections of the equipment and of the adequacy of procedures as part of the annual quality assurance review.

(5) Collimation. The mammographic system shall be able to limit the useful beam so that the x-ray field at the plane of the image receptor at any SID does not extend beyond the left, right, and nipple edges of the image receptor and does not extend beyond the image receptor adjacent to the chest wall by more than 2 percent of the SID. The sum of the collimated light field edges shall not differ from the sum of the respective edges of the x-ray field along either the length or the width of the visually defined field by more than 2 percent of the SID.

(6) Average glandular tissue dose. The average glandular tissue dose for one craniocaudal view of a 4.5 centimeter compressed breast with 50 percent adipose/50 percent glandular tissue shall not exceed the following values:

(a) One hundred millirads (1 milligray) for film/screen without grid.

(b) Three hundred millirads (3 milligray) for film/screen with grid.

(c) Four hundred millirads (4 milligray) for Xeroradiographic systems.

(2)(7)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) These Pperformance 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) (8), 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 and density difference on the sensitometric control charts.

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

(c) No change.

(3)(8) 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 U.S. Food and Drug Administration which meets the criteria below at least weekly monthly 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 1.05 to 1.8 1.60 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. through 3. No change.

(b) No change.

(c) The minimum acceptable image quality of a standard phantom described in (3)(8)(a), above, shall demonstrate the ability to image at least 1.56 millimeter, 1.12 millimeter, 0.89 millimeter, and 0.75 millimeter fibers; 0.54 millimeter, 0.40 millimeter, and 0.32 millimeter specks; and 2.00 millimeter, 1.00 millimeter, 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 the following equipment quality control items were performed under the direction and approval of the medical physicist. when the equipment or components were initially installed or replaced and were performed thereafter at least as often as the frequency specified in paragraph (8)(e), below. When the results of performed tests do not meet established limits, corrective action must be taken and documented. The equipment quality control items which must be monitored are:

1. Processor performance through sensitometric-densitometric means, before processing patient films and as specified in subsection (7), above.

2. Darkroom cleaning, daily.

3. Screen cleaning, weekly.

4. Image quality, monthly and as specified in paragraphs (8)(a), (b) and (c), above.

5. Equipment observation check, monthly.

6. Analysis of fixer retention in film, quarterly.

7. Compression device performance, semiannually.

8. Screen film contact and screen artifact detection, semiannually.

9. Uniformity of screen speed, annually.

10. Beam limiting device alignment, annually.

11. Accuracy of kVp, annually.

12. Output reproducibility and linearity, annually.

13. Automatic exposure control reproducibility, kVp response and phantom thickness response, annually.

14. Half-value layer, annually.

15. Average glandular tissue dose, annually.

16. Focal spot size, annually.

17. Analysis of clinical images repeated or rejected, quarterly. Corrective action shall be taken and documented if the retake rate of the facility exceeds 5 percent.

18. Viewbox uniformity and integrity of devices used to block extraneous light, semiannually. A means shall be provided to block extraneous light from the viewer’s eye when the illuminated surface of the viewbox is larger than the film size or area of clinical interest.

19. Darkroom integrity, semiannually. Darkroom fog shall not exceed 0.05 optical density when sensitized film is exposed to darkroom conditions with the safelight on for 2 minutes.

(e) Mammography system performance must be evaluated regularly. The registrant must document the evaluation of the equipment quality control tests in the annual review specified in subsection (1), above. 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 evaluation by the medical physicist must include a summary of the quarterly evaluations. and the following:

1. Unit assembly.

2. Collimation assessment.

3. Focal spot size measurement.

4. Accuracy and reproducibility of the kVp.

5. Beam quality assessment.

6. Automatic exposure control system performance.

7. Uniformity of screen speed.

8. Breast entrance exposure and average glandular tissue dose.

9. Image quality.

10. Artifacts.

(f) The registrant shall document the qualifications and training of the personnel responsible for each part of the mammography quality assurance program, including the clinical image review, the establishment, monitoring, and evaluation of the equipment quality control program, and the annual review of the quality assurance program effectiveness.

(9) All image receptors shall be clearly marked to indicate on the film which receptor was used on any given examination to facilitate the detection and removal of artifacts.

(10) Xerox mammography systems shall be exempt from the requirements of paragraphs (2)(e), (2)(f), (7), (8)(d)1., 2., 3., 6., 8., 9., 13., 18., 19., (8)(e)6., and 7.

(11) Xerox mammography systems which exceed an average glandular dose for one craniocaudal view of a 4.5 centimeter compressed breast with a 50/50 percent ratio of glandular/fat tissue of 400 mrads (4 mGy) shall have the exposure techniques, processing, and image quality of the system investigated by a medical physicist, as specified in subsection (12), below.

(4)(12) 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 meet the following requirements:1. lLicensed to practice medicine in the State of Florida, as specified in Chapters 458 and 459, F.S.

2.a. Certified by a certifying body approved by the U.S. Food and Drug Administration; or

b.(I) Have 2 months of documented full-time training in the interpretation of mammograms, including instruction in radiation physics, radiation effects, and radiation protection; and

(II) Have 40 hours of documented continuing medical education in mammography. Time spent in residency specifically devoted to mammography is acceptable if documented in writing by the physician.

3.a. Have read and interpreted mammograms from the examinations of at least 240 patients in the last 6 months; or

b. Have read and interpreted mammograms as specified above under the direct supervision of a fully qualified interpreting physician.

4.a. Read and interpret mammograms from the examinations of an average of at least 40 patients per month over 24 months; and

b. Teach or complete an average of at least five continuing medical education credits in mammography per year.

(b) Radiologic technologists shall be meet the following requirements:1. cCertified as a general radiographer in the State of Florida as specified in Chapter 64E-3, F.A.C.

2. Obtain training specific to mammography, either through a training curriculum or special mammography course.

3. Accumulate an average of 5 continuing education hours in mammography per year.

(c)1. Prior to April 28, 1999, Aa medical physicist qualified to conduct surveys of mammography facilities and provide oversight of the facility quality assurance program shall be meet the criteria specified in a. and b. and c., below:a. lLicensed in Florida as a medical physicist as specified in Chapter 483, Florida Statutes.; and

b.(I) Holds a Master of Science, Master of Arts, or a higher degree in an appropriate field from an accredited institution. Appropriate fields include physics, applied physics, radiological physics, biophysics, health physics, engineering, and public health when the Bachelor’s degree is in a physical science; and

(II) Has had training in biological sciences; and

(III) Has had at least 1 year of training in medical physics in the area of diagnostic radiological physics; and

(IV) Has had at least 2 years of experience conducting mammography equipment performance evaluations.

c. Has received or taught at least an average of 5 hours of documented continuing education related to mammography per year.

2. After April 28, 1999, the medical physicist must meet the criteria specified in 1.a. and 1.b.(I), above, and the qualifications and experience specified in 21 CFR 900.12(a) (3) (i), (iii), and (iv), which is herein incorporated by reference and which is available from the department.

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

(a) No change.

(b) Clinical image interpretation. To ensure that quality clinical images are produced routinely at the facility, each facility shall submit clinical images to the Ddepartment for review as required by the Ddepartment. Each facility also will establish a system to review outcome data from all mammography performed, including follow-up on the disposition of positive mammograms and correlation of surgical biopsy results with mammogram reports.

(c) Surveys. A medical physicist who meets the qualifications specified in subsection (4) (12), 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.

(d) Medical records.

1. Each facility shall maintain mammograms and associated records in a permanent medical record of the patient as follows:

a. For at least 5 years, or, if no additional mammograms of the patient are performed at the facility, for at least 10 years; or

b. Until the records are transferred as requested by the patient to a medical institution, to a physician of the patient, or to the patient.

2. Each facility shall prepare a written report of the results of each mammography examination. This report shall be completed as soon as reasonably possible and shall:

a. Be signed by the interpreting physician; and

b. Be provided to the patient’s physician or to the patient if the patient’s physician is not available or if the patient does not have a physician. If this report is sent to the patient, it shall include a summary written in language easily understood by a lay person. A copy of the report shall be maintained in the patient’s medical record.

(6)(14) 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 U.S. Food and Drug Administration 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______.

Rulemaking Authority 404.051, 404.22 FS. Law Implemented 404.051(1),(4), 404.141, 404.22(1), (3), (6) FS. History–New 3-17-92, Amended 1-1-94, 11-20-94, Formerly 10D-91.611, Amended 5-18-98,______.

 

64E-5.511 Registration of Radiation Machines.

(1) Exemptions.

(a) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from registration and notification requirements if the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 0.5 mR millirem (5 µSv) per hour at 5 centimeters from any accessible surface of the equipment. The production, testing or factory servicing of such equipment shall not be exempt.

(b) No change.

(2) Application and Fees for Registration of Radiation Machines.

(a) Each person who acquires a radiation machine or an additional radiation machine shall:

1. Apply for registration of the radiation machine with the department within 30 days after acquisition and before use. Application for registration shall be on DH Form 1107, 09/14 3/07, “Radiation Machine Facility Registration,” which is herein incorporated by reference and available from the internet department at http://www.floridahealth.gov/radiation, or at ________ http://www.doh.state.fl.us/environment/radiation/.

2. through 3. No change.

(b) Registration fees are due within 30 days after acquiring a radiation machine. If the machine is acquired within 120 days before the October 28 annual renewal date, the registration fee will be due on or before  October 28 and will be the annual renewal fee. Otherwise, the renewal fee is due annually on or before October 28.

(c) (b) An annual fee for the registration and inspection of radiation machines shall be paid according to the following schedule:

First Tube/Unit EachAdditional Tube/Unit

Medical or Chiropractic or Osteopathic  One Tube$145$85

Each Additional Tube $85

or Naturopathic Veterinary                       One Tube$50$34

Each Additional Tube$34

Educational or Industrial                         One Tube$47             $23

Each Additional Tube$23

Dental or Podiatry                                     One Tube$31$11

Each Additional Tube$11

Medical Accelerator                                  One Unit$258$148

Each Additional Unit$148

Non-Medical Accelerator                          One Unit$81$48

Each Additional Unit$48

1. Renewal fees are due before October 28 annually.

2. Registration fees are due within 30 days after acquiring a radiation machine. If the machine is acquired within 120 days before the October 28 annual renewal date, the registration fee will be due on October 28 and shall be the annual renewal fee.

(3) Application for Registration of Servicing and Services.

(a) Each person who installs or offers to install radiation machines or furnishes or offers to furnish radiation machine servicing or services in Florida shall apply to the Ddepartment to register such services before furnishing or offering to furnish such services.

(b) Application for registration shall be completed on DH DOH Form 1113, 09/14, “Radiation Machine Vendor Registration Form,” which is herein incorporated by reference and which is available from the internet department at http://www.floridahealth.gov/radiation, and at_______.

(c) No change.

(4) No change.

(5) Assembler or Transferor Obligation.

(a) Any person who sells, leases, transfers, relocates, lends, assembles, installs or disposes of radiation machines or major components of such machines shall notify the Ddepartment within 15 days after such action. Notification shall be made on DH DOH Form 1114, 09/14, “Report of Assembly of Non-Certified X Ray Systems,” which is herein incorporated by reference and available from the internet department; at http://www.floridahealth.gov/radiation and at ______, or if the system contains certified components, on Form FDA 2579, which is herein incorporated by reference and which is available from the FDA department at http://www.fda.gov/aboutfda/reportsmanualsforms/forms/default.htm.

(b) No person shall sell, offer to sell, lease, transfer, lend or install radiation machines unless such machines meet the requirements of these regulations.

(6) Out-of-State Radiation Machines.

(a) Any person proposing to bring a radiation machine into Florida shall notify the Ddepartment in writing at least 10 days before the machine is to be used in the state. The notice shall include the type of radiation machine; the nature, duration and scope of use; and the exact location where the radiation machine will be used. If the 10-day period is an undue hardship, the department can grant permission to proceed sooner.

(b) Any person proposing to bring a radiation machine into Florida shall register the machine with the department and pay the registration fee.

(c) No change.

(7) Enforcement. The General Statement of Policy and Procedure for Radiation Machine Enforcement Actions, September 2014 1996, which is available from the department and which is herein incorporated by reference, will be used to determine enforcement actions to be taken. This publication can be obtained from the internet at http://www.floridahealth.gov/radiation, and at _______.

Rulemaking Authority 404.051 FS. Law Implemented 404.071, 404.091, 404.101, 404.141, 404.161, 404.162, 404.163, 404.22 FS. History–New 12-12-96, Formerly 10D-91.612, Amended 8-16-07,______.

 

64E-5.801 Registration Requirements.

(1) No person shall receive, possess, use, transfer, or acquire a particle accelerator facility or a particle accelerator except as authorized by a registration certificate issued by the Department pursuant to these rules.

(2) Application for registration shall be made on DH DOH Form 1107, 09/14, “Radiation Machine Facility Registration,” which is incorporated by reference herein effective 7-17-85, and is available from the internet at http://www.floridahealth.gov/radiation, and at______, furnished by the Department, and shall contain all information required by the form and accompanying instructions. Part V contains rules concerning registration and the payment of registration fees.

Rulemaking Authority 404.051, 404.22 FS. Law Implemented 404.022, 404.051(1), (4), (9), 404.22(1) FS. History–New 7-17-85, Amended 5-15-96, Formerly 10D-91.902, Amended              _______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Cynthia Becker, Bureau Chief, Bureau of Radiation Control

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: John H. Armstrong, MD, FACS, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 14, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 19, 2014