A brief description of both the event and the consequences as they may affect the person.
Aside from the notification requirement, nothing in this subsection affects any rights or duties of a licensee or physician in relation to each other, to any person affected by the medical event or to any individual's responsible relatives or guardians.
A licensee shall retain a record of a medical event under s. DHS 157.71 (4)
. A copy of the record required under s. DHS 157.71 (4)
shall be provided to the referring physician, if other than the licensee, no later then 15 days after the discovery of the event.
(2) Report of a dose to an embryo or fetus or a nursing child. DHS 157.72(2)(a)(a)
A licensee shall report to the department any dose to an embryo or fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo or fetus was specifically approved, in advance, by the authorized user.
A licensee shall report to the department any dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that meets either of the following criteria:
Resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.
A licensee shall notify the department by telephone no later than the next calendar day after discovery of a dose to the embryo, fetus or nursing child that requires a report in par. (a)
A licensee shall submit a written report to the department within 15 days after discovery of a dose to the embryo, fetus or nursing child that requires a report in par. (a)
. The written report shall include all of the following information:
What actions, if any, have been taken or are planned to prevent recurrence.
Certification that the licensee notified the pregnant individual or mother or the mother's or child's responsible relative or guardian, and if not, why not.
The report may not contain the individual's or child's name or any other information that could lead to identification of the individual or child.
A licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under par. (a)
, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. A licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, a licensee shall make the appropriate notifications as soon as possible thereafter. A licensee may not delay any appropriate medical care for the embryo, fetus or nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. A licensee shall provide such a written description if requested.
Annotate a copy of the report provided to the department with all of the following information:
Name of the pregnant individual or the nursing child who is the subject of the event.
Social security number or other identification number, if one has been assigned, of the pregnant individual or the nursing child who is the subject of the event.
Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.
(3) Reports of leaking sources.
A licensee shall submit a written report to the department within 5 working days if a leakage test required by s. DHS 157.62 (5)
reveals the presence of 185 Bq (0.005 mCi) or more of removable contamination. The written report shall include the model number and serial number, if assigned, of the leaking source, the radionuclide and its estimated activity, the results of the test, the date of the test and the action taken.
DHS 157.72 History
History: CR 01-108
: cr. Register July 2002 No. 559
, eff. — see Note at the start of the chapter; CR 06-021
: r. and recr. (1) (a) 3., (h) and (2) Register October 2006 No. 610
, eff. 11-1-06.
Radiation safety requirements. DHS 157.73(1)(a)(a)
A sealed source installed in an irradiator shall meet all of the following requirements:
Use radioactive material that is as nondispersible and insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator.
Be encapsulated in a material resistant to general corrosion and to localized corrosion such as 316L stainless steel or other material with equivalent resistance if the sources are for use in irradiator pools.
In prototype testing of the sealed source, be leak tested and found leak-free after each of the tests in par. (b)
A sealed source used in an irradiator shall be subjected to all of the following tests prior to use:
The test source shall be held at -40°C for 20 minutes, 600°C for one hour, and then be immediately subjected to thermal shock test with a temperature drop from 600°C to 20°C within 15 seconds.
The test source shall be twice subjected for at least 5 minutes to an absolute external pressure of 2 million newtons per square meter.
A 2 kilogram steel weight, 2.5 centimeters in diameter, shall be dropped from a height of one meter on to the test source.
The test source shall be subjected 3 times for 10 minutes each to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of 5 times the acceleration of gravity. In addition, each test source shall be vibrated for 30 minutes at each resonant frequency found.
A 50 gram weight and pin, 0.3 centimeter pin diameter, shall be dropped from a height of one meter on to the test source.
If the length of the source is more than 15 times larger than the minimum cross-sectional dimension, the test source shall be subjected to a force of 2000 newtons at its center equidistant from 2 support cylinders, the distance between which is 10 times the minimum cross-sectional dimension of the source.
Each entrance to a radiation room at a panoramic irradiator shall have a door or other physical barrier to prevent inadvertent entry of personnel when the sources are not in the shielded position. Product conveyor systems may serve as barriers as long as they reliably and consistently function as a barrier. It shall be impossible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed shall cause the sources to return promptly to the shielded position. The personnel entrance door or barrier shall have a lock that is operated by the same key used to move the sources. The control panel lock shall be designed so that the key cannot be removed unless the sources have been returned to the shielded position. The doors and barriers may not prevent any person in the radiation room from leaving.
Each entrance to a radiation room at a panoramic irradiator shall have an independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed shall cause the sources to return to their fully shielded position and shall activate a visible and audible alarm to make the person entering the room aware of the hazard. The alarm shall also alert at least one other person who is on-site of the entry. The person alerted shall be trained on how to respond to the alarm and prepared to promptly render or summon assistance.
A radiation monitor shall be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor shall be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted personnel entry while the monitor measures high radiation levels shall activate the alarm described in par. (b)
. The monitor may be located in the entrance, normally referred to as the maze, but not in the direct radiation beam.
Before the sources move from their shielded position in a panoramic irradiator, the source control shall automatically activate conspicuous visible and audible alarms to alert people in the radiation room that the sources will be moved from their shielded position. The alarms shall give persons enough time to leave the room before the sources leave the shielded position.
Each radiation room of a panoramic irradiator shall have a clearly visible and readily accessible control that allows a person in the room to make the sources return to their fully shielded position.
Each radiation room of a panoramic irradiator shall contain a control that prevents the sources from moving from the shielded position unless the control has been activated and the door or barrier to the radiation room has been closed within a preset time after activation of the control.
Each entrance to the radiation room of a panoramic irradiator and each entrance to the area within the personnel access barrier of an underwater irradiator shall have a sign bearing the radiation symbol and the words, "Caution (or danger), radioactive material." A panoramic irradiator shall have a sign stating "Grave (or Extreme) danger, very high radiation area," but the sign may be removed, covered or otherwise made inoperative when the sources are fully shielded.
If the radiation room of a panoramic irradiator has roof plugs or movable shielding, no person may operate the irradiator unless the shielding is in its proper location. The requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating.
An underwater irradiator shall have a personnel access barrier around the pool that shall be locked to prevent access when the irradiator is not attended. Only operators or facility management may have access to keys that operate the personnel access barrier. There shall be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm shall alert a person who is not necessarily on-site but who is prepared to respond or summon assistance.
The radiation dose rate in areas that are normally occupied during operation of a panoramic irradiator may not exceed 0.02 millisievert (2 mrem) per hour at any location 30 centimeters or more from the wall of the room when the sources are exposed. The dose rate shall be averaged over an area not to exceed 100 square centimeters having no linear dimension greater than 20 centimeters. Any area where the radiation dose rate exceeds 0.02 millisievert (2 mrem) per hour shall be locked, roped off or posted.
The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not exceed 0.02 millisievert (2 mrem) per hour when the sources are in the fully shielded position.
The radiation dose rate at one meter from the shield of a dry-source-storage panoramic irradiator when the source is shielded may not exceed 0.02 millisievert (2 mrem) per hour and at 5 centimeters from the shield may not exceed 0.2 millisievert (20 mrem) per hour.
The radiation room of a panoramic irradiator shall have heat and smoke detectors. The detectors shall activate an audible alarm. The alarm shall be capable of alerting a person who is prepared to summon assistance promptly. The sources shall automatically become fully shielded if a fire is detected.
The radiation room of a panoramic irradiator shall be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room shall have a shut-off valve to control flooding into unrestricted areas.
An irradiator with an automatic product conveyor system shall have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm shall sound and product conveyors shall stop automatically. The alarm shall be capable of alerting a person in the facility who is prepared to summon assistance. An underwater irradiator in which the product moves within an enclosed stationary tube is exempt from the requirements of this paragraph.
An underwater irradiator that is not in a shielded radiation room shall have a radiation monitor over the pool to detect abnormal radiation levels. The monitor shall have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The audible alarm may have a manual shut-off. The alarm shall be capable of alerting a person who is prepared to respond promptly.
The mechanism that moves the sources of a panoramic irradiator shall require a key to actuate. Actuation of the mechanism shall cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any time, and only operators or facility management may possess it. The key shall be attached to a portable radiation survey meter by a chain or cable. The lock for source control shall be designed so that the key may not be removed if the sources are in an unshielded position. The door to the radiation room shall require the same key.
The console of a panoramic irradiator shall have a source position indicator that indicates when the sources are in the fully shielded position, in transit and exposed.
The control console of a panoramic irradiator shall have a control that promptly returns the sources to the shielded position.
The function of each control for a panoramic irradiator shall be clearly marked.
Constructed with a water-tight stainless steel liner or a liner metallurgically compatible with other components in the pool.
Constructed so that there is a low likelihood of substantial leakage and with a surface designed to facilitate decontamination.
A licensee shall have a method to safely store the sources during repairs of the pool.
An irradiator pool shall have no outlets more than 0.5 meter below the normal low water level that may allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that may act as siphons shall have siphon breakers to prevent the siphoning of pool water.
A method shall be available to replenish water losses from the pool.
A visible indicator shall be provided in a clearly observable location to indicate if the pool water level is below the normal low water level or above the normal high water level.
An irradiator pool shall be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of 20 microsiemens per centimeter or less and with a clarity so that the sources are clearly visible.
A physical barrier, such as a railing or cover, shall be used around or over irradiator pools during normal operation to prevent personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection and service operations.
If long-handled tools or poles are used in an irradiator pool, the radiation dose rate to the operator at the handling areas of the tools may not exceed 0.02 millisievert (2 mrem) per hour.
(8) Source rack protection.
If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack shall be protected by a carrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.
If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources shall automatically return to the shielded position.
The lock on the door of the radiation room of a panoramic irradiator shall remain locked in the event of a power failure.
During a power failure, the area of any irradiator where sources are located may be entered only when using an operable and calibrated radiation survey meter.
(10) Design requirements.
An irradiator shall meet all of the following design requirements:
For a panoramic irradiator, a licensee shall design shielding walls to meet generally accepted building code requirements for reinforced concrete and design the walls, wall penetrations, and entranceways to meet the radiation shielding requirements of sub. (3)
. If the irradiator will use more than 2 x 1017 becquerels (5 million Ci) of activity, a licensee shall evaluate the effects of heating of the shielding walls by the irradiator sources.
For a panoramic irradiator, a licensee shall design the foundation, with consideration given to soil characteristics, to ensure that the foundation is adequate to support the weight of the facility shield walls.
For a pool irradiator, a licensee shall design the pool to ensure all of the following: