Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.502 - General Requirements

Current through Reg. 50, No. 138; July 16, 2024
(1)
				Administrative Controls.
(a) Registrant. The
				registrant shall be responsible for directing the operation of the x-ray
				systems which are subject to registration as described in Rule
				 64E-5.511, F.A.C. The registrant
				or the registrant's agent shall assure that the following requirements are met
				in the operation of the x-ray system.
1. Any
				x-ray system which does not meet the provisions of these regulations shall not
				be operated for diagnostic or therapeutic purposes unless the Department
				determines that such operation will not endanger the public health, safety and
				welfare.
2. An x-ray system
				operator shall receive instruction on and be competent in the safe use of the
				x-ray system. A medical x-ray system operator shall also be certified or
				authorized in accordance with Chapter 468, Part IV, F.S.
3. A chart shall be provided in the vicinity
				of the diagnostic x-ray system's control panel, which specifies techniques and
				procedures to be used for all examinations which are performed by that
				system.
4. Except for patients who
				cannot be moved out of the room, only the staff and ancillary personnel
				required for the medical procedure or training shall be in the room during the
				radiographic exposure. Other than the patient being examined:
a. All individuals shall be positioned such
				that no part of the body will be struck by the useful beam unless protected by
				0.5 millimeter lead equivalent.
b.
				Staff and ancillary personnel shall be protected from the direct scatter
				radiation by protective aprons or whole body protective barriers of not less
				than 0.25 millimeter lead equivalent.
c. Other patients who cannot be removed from
				the room shall be protected from the direct scatter radiation by whole body
				protective barriers of 0.25 millimeter lead equivalent or shall be so
				positioned that the nearest portion of the body is at least 2 meters from both
				the tube head and the nearest edge of the useful beam.
d. When a portion of the body of any staff or
				ancillary personnel is potentially subjected to stray radiation which could
				result in that individual receiving one-fourth of the maximum permissible dose
				as defined in Part III, additional protective devices may be required by the
				Department.
5. Gonad
				shields of not less than 0.25 millimeter lead equivalent shall be used for
				patients who have not passed the reproductive age, during radiographic
				procedures in which the gonads are in the useful beam, except for cases in
				which this would interfere with the diagnostic procedure.
6. Individuals shall not be exposed to the
				useful beam except for healing arts purposes and unless such exposure has been
				authorized by a licensed practitioner of the healing arts. This provision
				specifically prohibits the following:
a.
				Exposure of an individual for training, demonstration or other purposes unless
				there are also healing arts requirements and a proper prescription has been
				provided.
b. Exposure of an
				individual for the purpose of a healing arts self-referral program except when
				authorized by subparagraph
				 64E-5.502(1)(a) 
				11., F.A.C.
c. Advertisement of
				free x-ray examinations unless the advertisement states that a determination of
				need will be made prior to the x-ray examination.
7. An x-ray system is exempt from the
				requirements of subparagraph
				 64E-5.502(1)(a) 
				6., F.A.C., only if:
a. The system is a
				stationary, non-mobile system installed and used only in a jail or penal
				institution,
b. The system is used
				only on legal detainees in a jail or penal institution, and never on detainees'
				family members, children, institution employees, contractors, visitors, the
				public, or any other persons,
c.
				The system is manufactured, maintained, and operated solely for security
				screening purposes in strict compliance with, and fully according to, the most
				restrictive standards found in ANSI/HPS N43.17-2009, "Radiation Safety for
				Personnel Security Screening Systems Using X-Ray or Gamma Radiation, " which is
				herein incorporated by reference. This ANSI publication may be examined and
				inspected at the Florida Department of Health, Bureau of Radiation Control at
				Building 4042 Bald Cypress Way, Suite 210, Tallahassee, Florida 32399-1741, and
				at the Florida Department of State, Room 701, The Capitol, Tallahassee, Florida
				32399-0250, and is available from the American National Standards Institute,
				Inc., at
http://www.ansi.org
. The
				agency has determined that posting the publication on the internet for purposes
				of public inspection and examination would constitute a violation of federal
				copyright law; and,
d. The
				institution tracks radiation dose for each detainee, as specified by ANSI/HPS
				N43.17-2009, "Radiation Safety for Personnel Security Screening Systems Using
				X-Ray or Gamma Radiation, " to ensure the detainee does not exceed the
				recommended dose limit.
8. When a patient or film must be provided
				with auxiliary support during a radiation exposure:
a. Mechanical holding devices shall be used
				when the technique permits,
b.
				Written safety procedures shall be available to indicate the requirements for
				selecting a holder, list the individual projections where holding devices
				cannot be used and describe the procedure the holder shall follow,
c. The human holder shall be protected as
				required by subparagraph (1)(a)4., above; and,
d. No individual shall be used routinely to
				hold film or patients.
9.
				Exposure Procedures Designed to Minimize Patient and Personal Exposure.
a. The speed of film or screen and film
				combinations shall be the fastest speed consistent with the diagnostic
				objectives of the examination.
b.
				The radiation exposure to the patient shall be the minimum exposure required to
				produce images of good diagnostic quality.
c. Portable or mobile equipment shall be used
				only for examinations where it is impractical to transfer the patient to a
				stationary radiographic installation.
d. X-ray systems subject to Rule
				 64E-5.505, F.A.C., shall not be
				utilized in procedures where the source to patient distance is less than 30
				centimeters.
e. A person shall not
				perform fluoroscopic imaging or otherwise expose a human to x-rays from a
				fluoroscopic system unless the person is a:
(I) Licensed practitioner as that term is
				defined in Section  468.301, F.S., or
(II) Certified radiologist assistant
				practicing in accordance with the requirements of Chapter 468, Part IV, F.S.,
				or
(III) Certified general
				radiographer practicing in accordance with the requirements of Chapter 468,
				Part IV, F.S.; and,
(A) The general
				radiographer has been trained and authorized in writing by the licensed
				practitioner in charge to perform the specified imaging; and,
(B) The specified imaging does not rely upon
				the general radiographer to provide any diagnostic interpretation, or to
				determine suspicious areas for additional imaging, or to otherwise modify the
				scope of authorization for the imaging; and,
(C) The specified imaging is designed to
				prevent or reduce exposure to patients by facilitating proper location and
				positioning for the authorized radiographic
				imaging.
10. Personnel Monitoring. All individuals who
				are associated with the operation of an x-ray system are subject to the
				occupational exposure limits and the requirements for the determination of the
				doses stated in Rules
				 64E-5.304 and
				 64E-5.308, F.A.C. In addition,
				when protective clothing or devices are worn on portions of the body and a
				personnel monitoring device is required, at least one such device shall be
				utilized as follows:
a. When a protective
				apron is worn, the monitoring device shall be worn at the collar outside of the
				apron.
b. The dose to the whole
				body shall be recorded in the records required by Rule
				 64E-5.339, F.A.C. If more than
				one device is used and a record is made of the data, each dose shall be
				identified with the area where the device was worn on the
				body.
11. Healing arts
				self-referral. Only healing arts self-referral programs for mammography
				screening will be authorized by the Department.