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(1) The mammograms shall be transported in a container that protects the film from exposure to light, heat, humidity, radiation, and conditions that may damage the mammograms and processed within 48 hours from the time the mammogram is taken;
(2) A log shall be maintained that includes the name of each patient and unique identification number, date, and time of the first exam of each batch, and date and time of batch processing in accordance with section 30319.20; and
(3) The container used to transport the mammograms shall be cleaned at intervals not to exceed seven days or if mammography is performed at greater intervals, before the mammograms are transported.
(d) Prior to processing mammograms, the provider shall ensure that the test specified in section 30316.20(a) has been met and that the phantom image produced during the test specified in subsection (c) of this section meets the phantom image criteria specified in section 30316.20(b) and if the phantom image fails due to processing problems, the problems shall be corrected prior to processing the mammograms. If the phantom image fails due to a non-processor problem, the provider may process the mammograms, but the lead interpreting physician shall evaluate each mammogram to determine whether any patient must be recalled to have their mammograms repeated. Prior to further clinical use, the mammography system shall be evaluated and problems corrected to ensure that the mammography system is in compliance with all requirements of this article.
(e) Documentation demonstrating compliance with this section shall be maintained in accordance with section 30319.20.
Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.
s 30318.11. Posting Requirements for Mobile Service Providers.
(a) Each mobile service provider shall ensure the following are kept with each radiation machine used to perform mammography in a mobile setting:
(1) All items required to be posted pursuant to section 30255;
(2) The mammographic radiologic technologist's certificate issued pursuant to section 30455.1 to the individual performing the mammographic examination and posted so the patient can view it during the examination;
(3) For facilities performing mammography, the lead interpreting physician's radiology supervisor and operator certificate issued pursuant to section 30466(d) or 30467 and posted so the patient can view it during the examination;
(4) The document required to be posted on the radiation machine pursuant to Health and Safety Code section 115115(b) so the patient can view it during the examination;
(5) A copy of the certificate issued by FDA and posted so the patient can view it during the examination;
(6) The quality assurance records for on-board processors as specified in section 30316.20(a) for at least the last 30 calendar days.
(7) Documentation that, for each location of use visited in the last 30 calendar days, section 30318.10(b) has been met; and
(8) The quality assurance manual as specified in section 30317.10.
(b) Each provider shall maintain a log that identifies the date and physical location where each radiation machine is used.
Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.
s 30319. Notification Requirements.
(a) Within 30 calendar days of the occurrence of any of the following events, each facility that performs mammography shall inform the Department of the event:
(1) Change in the information submitted in response to section 30315.22(a)(1);
(2) Change in the identity of the entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A) that accredited the facility;
(3) Change in certification status with the FDA;
(4) Change in facility personnel and, if adding an interpreting physician, mammographic radiologic technologist, or medical physicist;
(5) Change in location of a radiation machine within the facility;
(6) Change in facility name or owner;
(7) Disassembly and reassembly of any radiation machine or processing equipment;
(8) Change in the accreditation status;
(9) Change in the facility's contact person.
(b) Notifications made pursuant to this section shall be made in writing and contain the name, signature and date of signature of the facility administrator, owner or designee.
Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.
s 30319.20. Record Keeping Requirements.
(a) Each facility shall maintain and make available for inspection by the Department the records specified in Table 1 until Department inspection or the time interval specified which ever is greater:
Table 1. Record Keeping Requirements
Specific Section Type of Record Time Interval for
Record Keeping
30315.50 Personnel Qualifications for At least two years
physicians after the physician
no longer
worked at the
facility
30455.1 Personnel Qualifications for At least two years
mammographic after the
technologist no
longer
radiologic technologists worked at the
facility
30315.52 Personnel Qualifications for medical At least two years
physicists after the medical
physicist no
longer worked at the
facility
30316.20(a) QA logs 3 years
Processor film strips 1 year
30316.20(b) Phantom image score sheets 3 years
Phantom images 1 year
30316.20(c)(1) Fixer retention log sheet 3 years
Fixer retention test film 1 year
30316.20(c)(2) Repeat Analysis 3 years
30316.20(d)(1) Darkroom fog log sheets 3 years
Darkroom test films 1 year
30316.20(d)(2) Screen-film contact log sheets 3 years
Screen-film contact test films 1 year
30316.20(d)(3) Compression test log sheet 3 years
30316.20(f) Darkroom cleaning logs 3 years
Intensifying screen cleaning logs 3 years
View box cleaning logs 3 years
30316.60 Medical Physicist Survey Report, 3 years
evaluations &
instrument calibration reports
30316.10 Evaluations of new or repaired 3 years
equipment
30317.60 Medical Outcomes Audit analysis 3 years
30317.70 Consumer complaints 3 years
30318.10 All mobile service provider documents 3 years
(b) Each facility shall maintain records for inspection by the Department showing calibrations, maintenance, and modifications performed on each radiation machine for three years. These records shall include the date of the calibration, maintenance, or modification performed, the name of the individual making the record, and the manufacturer's model and serial number of the X-ray control.
(c) Each facility shall maintain records showing the receipt, transfer, and disposal of radiation machines pursuant to section 30293. These records shall include the date of receipt, transfers, or disposal, the name and signature of the individual making the record, and the manufacturer's model and serial number from the X-ray control. Records shall be maintained for inspection by the Department until the facility ceases use and disposes of the radiation machine.
Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.
s 30320.90. Grounds for Suspension, Revocation, Amendment or Restriction of a Facility Accreditation Certificate.
(a) A facility accreditation certificate may be revoked, suspended, amended or restricted for any of the following:
(1) Violation of any provision of the Act, any regulation promulgated pursuant to the Act, any provision of the Radiologic Technology Act, as defined in Health and Safety Code section 27, any regulation promulgated pursuant to the Radiologic Technology Act, or any order of the Department;
(2) Failure to pay fees pursuant to sections 30145 or 30145.1;
(3) Refusal to submit to clinical image review or mammography review as directed by the Department;
(4) Failure of clinical images to pass clinical image review or mammography review;
(5) Failure to take corrective action when directed by the Department;
(6) Failure to report changes pursuant to section 30319;
(7) Procuring a facility accreditation certificate by fraud, or misrepresentation, or because of mistake;
(8) Failure to maintain mammograms and reports pursuant to section 30317.50;
(9) Failure to ensure the average glandular dose criteria specified in section 30316.20(e)(10) is not exceeded;
(10) Failure during a Department inspection to obtain the phantom image score specified in section 30316.20(b)(3);
(11) Failure to comply with policies or procedures required to be developed pursuant to section 30317.30; and
(12) Suspension or revocation of the facility's certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(a).
Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100, 115115, 115145, 115165 and 115215, Health and Safety Code.
s 30321. Accountability, Storage, and Transit.
(a) In each hospital and clinic possessing sealed sources, there shall be a custodian of such sources. The custodian or his specified alternate shall keep a permanent record of the issue and return of all such sources.
(b) When not in use, sources and applicators containing sealed sources shall be kept in a protective enclosure of such material and wall thickness as may be necessary to assure compliance with the United States, title 10, Code of Federal Regulations, part 20, subparts C and D as incorporated by reference in section 30253.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30321.1. Confirming Removal of Implants.
The custodian or his specified alternate shall assure that patients treated with removable radioactive source implants remain hospitalized until a source count and a radiation survey of the patient confirm that all implants have been removed.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code; and 10 CFR 35.15(b) (vi) and (vii) (39 FR 26143 and 43 FR 553467).
s 30322. Records and Reports of Misadministration.
(a) When a misadministration involves a therapy procedure, the licensee shall notify the Department. The licensee shall also notify the referring physician of the affected patient and the patient or the responsible relative or guardian, unless the referring physician agrees to inform the patient or believes, based on medical judgment, that telling the patient or the patient's responsible relative or guardian would be harmful to one or the other, respectively. These notifications shall be made within 24 hours after the licensee discovers the misadministration. If the referring physician, patient, or the patient's responsible relative or guardian cannot be reached within 24 hours, the licensee shall notify them as soon as practicable. The licensee is not required to notify the patient or the patient's responsible relative or guardian without first consulting the referring physician; however, the licensee shall not delay medical care for the patient because of this.
(b) Within 15 days after the initial therapy misadministration report to the Department, the licensee shall report, in writing, to the Department and to the referring physician, and furnish a copy of the report to the patient or the patient's responsible relative or guardian if either was previously notified by the licensee, as required by Subsection 30322(a). The written report shall include the licensee's name; the referring physician's name; a brief description of the event; the effect on the patient; the action taken to prevent recurrence; whether the licensee informed the patient or the patient's responsible relative or guardian, and if not, why not. The report shall not include the patient's name or other information that could lead to identification of the patient.
(c) When a misadministration involves a diagnostic procedure, the radiation safety officer shall promptly investigate its cause, make a record for agency review, and retain the record as directed by Subsection 30322(d). The licensee shall also notify the referring physician and the Department, in writing on Department Form DHS 8453 (7/89) (Diagnostic Misadministration Report) within 15 days, if the misadministration involved use of radioactive material not intended for medical use, administration of dosage five-fold different from the intended dosage, or administration of radioactive material such that the patient is likely to receive an organ dose greater than 2 Rem or a whole body dose of greater than 500 millirem (mRem). Licensees shall use the best available dosimetry data, correcting only for amount of radioactivity administered, to determine whether a report is required. Reports and records required pursuant to thissection shall include reference to the source for dosimetry data used to determine whether a report is required.
(d) Each licensee shall retain a record of each misadministration for 10 years. The record shall contain the names of all individuals involved in the event, including the physician, allied health personnel, the patient and the patient's referring physician, the patient's social security number or identification number if one has been assigned, a brief description of the event, the effect on the patient, and the action taken, if any, to prevent recurrence.
(e) Aside from the notification requirement, nothing in Subsections 30322(a) through (d) shall affect any rights or duties of licensees and physicians in relation to each other, patients, or responsible relatives or guardians.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30330. General Provisions.
(a) This article establishes special radiation safety requirements for use of sources of radiation for radiography, which shall be in addition to other applicable provisions of this regulation and of Groups 1 and 2 of this subchapter. Sections 30331 through 30335 shall apply to radiography using radioactive material and Section 30336 shall apply to radiography using radiation machines.
(b) "Radiography," as used in this article, means the examination of the physical structure of materials, other than human beings or animals, by non-destructive methods, utilizing radiation.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801 and 25802, Health and Safety Code.
s 30331. Definitions Specific to Radiography.
(a) As used in Sections 30332 through 30335:
(1) "Permanent radiographic installation" means a shielded installation or structure designed or intended for radiography and in which radiography is regularly performed.
(2) "Radiographer" means any individual who performs radiographic operations or who, while in attendance at the site where radiographic operations are being performed, directly supervises such operations; and who is responsible to the user for assuring compliance with the requirements of radiation control regulations and license conditions.
(3) "Radiographers' assistant" means any individual who assists a radiographer in the performance of radiographic operations.
(4) "Radiographic exposure device" means any device containing a sealed source used for radiography.
(5) "Storage area" means any location, facility, or vehicle which is used to store, to transport, or to secure a radiographic exposure device, a storage container, or a sealed source when it is not in use and which is locked or has a physical barrier to prevent accidental exposure, tampering with, or unauthorized removal of the device, container, or source.
(6) "Storage container" means a container in which sealed sources are transported or stored.
(7) "Source Changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those also used for transporting and storage of sealed sources.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30332. Performance Requirements for Radiographic Exposure Devices, Storage Containers, and Source Changers.
(a) For radiographic exposure devices measuring less than 4 inches from the sealed source position to any exterior surface of the device, the radiation level shall not exceed 50 millirems per hour at 6 inches from any exterior surface, wit the sealed source in the shielded or "off" position.
(b) For all storage containers, source changers and for radiographic exposure devices measuring 4 inches or more from the sealed source storage position to any exterior surface of the device, the radiation level shall not exceed 200 millirems per hour at any exterior surface and 10 millirems per hour at 40 inches from any exterior surface, with the sealed source in the shielded or "off" position.
(c) All radiographic exposure devices and associated equipment manufactured after January 10, 1992 and all radiographic exposure devices and associated equipment used after January 10, 1996 shall comply with the following:
(1) Each radiographic exposure device and all associated equipment shall meet the requirements specified in American National Standard N432-1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography", published as NBS Handbook 136, issued January 1981 (ANSI N432).
(2) Each radiographic exposure device shall have attached to it a durable, legible, clearly visible label bearing the:
(A) Chemical symbol and mass number of the radionuclide in the device;
(B) Activity and date on which this activity was last measured;
(C) Model number and serial number of the sealed source;
(D) Manufacturer of the sealed source; and
(E) Licensee's name, address and telephone number.
(3) Radiographic exposure devices intended for use as Type B transport containers shall meet the applicable requirements of Section 30373.
(4) Modification of any exposure devices and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, controls or guide tubes would not compromise the safety design features of the system.
(5) Also, for radiographic exposure devices and associated equipment that allow the source to be moved out of the device for routine operation:
(A) The coupling between the source assembly and the control cable shall be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling shall be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.
(B) The device shall automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device.
(C) The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device shall be equipped with safety plugs or covers which shall be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter.
(D) Each sealed source or source assembly shall have attached to it or engraved in it, a durable, legible, visible label with the words "Danger -Radioactive." The label shall not interfere with the safe operation of the exposure device or associated equipment.
(E) The guide tube shall have passed the crushing tests for the control tube as specified in ANSI N432 and a kinking resistance test that closely approximates the kinking forces likely to be encountered during use.
(F) Guide tubes shall be used when moving the source out of the device.
(G) An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube shall be attached to the outermost end of the guide tube during radiographic operations.
(H) The guide tube exposure head connection shall be able to withstand the tensile test for control units specified in ANSI N432.
(I) Source changers shall provide a system for assuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.
Note: (1) Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
Note: (2) Copies of American National Standard N432-1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography" (published as NBS Handbook 136, issued January 1981) may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402 and from the American National Standards Institute, Inc., 1430 Broadway, New York, New York 10018.
s 30332.1. Security of Radiographic Exposure Devices, Storage Containers and Source Changers.
(a) Each radiographic exposure device shall be provided with a lock or outer locked container designed to prevent unauthorized or accidental exposure and shall be kept locked at all times except during authorized use or when under the direct surveillance of a radiographer or radiographers' assistant. In addition, during radiographic operations a sealed source assembly shall be secured in the shielded position each time the source is returned to that position.
(b) Each storage container and source changer shall be provided with a lock and kept locked when containing a sealed source except when the container is under the direct surveillance of a radiographer or radiographers' assistant.
(c) Locked radiographic exposure devices, storage containers and source changers shall be physically secured to prevent tampering or unauthorized removal.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30332.2. Security of Permanent Radiographic Installations.
(a) Permanent radiographic installations having high radiation area entrance controls of the types described in Section 30279 shall also meet the following requirements:
(b) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation to which this section applies shall have both visible and audible warning signals to warn of the presence of radiation. The visible signal shall be continuously actuated by radiation whenever a source is exposed. The audible signal shall be actuated when an attempt is made to enter the installation while the source is exposed.
(c) The alarm system shall be tested at intervals not to exceed three (3) months if a source is exposed in the installation during the three month period commencing from the last test. Alarm system testing is not required for inactive installations, provided that the system is tested prior to first exposure of a source in the installation or at three month intervals, whichever period is greater.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30332.3. Radiation Survey Instruments.
(a) Each user shall maintain a sufficient number of calibrated and operable radiation survey instruments, having a range such that 2 milliroentgens per hour through 1 roentgen per hour can be measured, to make physical radiation surveys as required by this regulation.
(b) Each radiation survey instrument shall be calibrated at intervals not to exceed 3 months and after each instrument servicing, and a record of the latest date of calibration shall be maintained and kept available for inspection.
Note: Authority cited: Sections 208 and 25811, Health and Safety Cod. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30332.4. Leak Testing, Repair, Tagging, Opening, Modification, and Replacement of Sealed Sources.
(a) Replacement of any sealed source in a radiographic exposure device, and leak testing, repair, tagging, opening or any other modification of any sealed source shall be performed only by persons specifically authorized by the department to do so pursuant to Group 2 of this subchapter.
(b) Leak testing shall be performed in accordance with the requirements of Section 30275 of this regulation.
(c) Any sealed source which is not mounted in a radiographic exposure device shall have permanently attached to it a durable tag at least 1 inch square bearing the radiation symbol as prescribed in Section 30278, and at least the following instructions: "Danger -Radioactive Material -Do Not Handle -Notify Civil Authorities If Found."
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30332.5. Quarterly Inventory of Sealed Sources.
Each user shall conduct a quarterly physical inventory to account for all sealed sources under his control. Records of the inventories shall be maintained and kept available for inspection and shall include the quantities and kinds of radioactive material, location of sealed sources, and the date of the inventory.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30332.6. Utilization Logs.
(a) Each user shall maintain current logs, which shall be kept available for inspection at the address specified in his license, containing the following information for each radiographic exposure device:
(1) a description (or make, model, and serial number) of the radiographic exposure device or storage container;
(2) the identity of the radiographer to whom assigned; and
(3) locations where used and dates of use.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30332.7. Inspection and Maintenance of Radiographic Exposure Devices, Storage Containers and Source Changers.
(a) The licensee shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers and source changers to assure proper functioning of components important to safety.
(1) The licensee shall check for obvious defects in radiographic exposure devices, storage containers and source changers prior to use each day that the equipment is used.
(2) The licensee shall conduct a program for inspection and maintenance of radiographic exposure devices, storage containers and source changers at intervals not to exceed three months. Exposure devices, storage containers and source changers in storage are not subject to inspection and maintenance, provided that inspection and maintenance is completed prior to first use or at three month intervals, whichever period is greater.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30332.8. Reporting Requirements.
(a) In addition to the reporting requirements specified in 30295 and under other sections of this subchapter, each licensee shall provide a written report to the department within 30 days of the occurrence of any of the following incidents involving radiographic equipment:
(1) Unintentional disconnection of the source assembly from the control cable.
(2) Inability to retract the source assembly to its fully shielded position and secure it in this position.
(3) Failure of any component (critical to safe operation of the device) to properly perform its intended function.
(b) The licensee shall include the following information in each report submitted under subsection (a):
(1) A description of the equipment problem.
(2) Cause of each incident, if known.
(3) Manufacturer and model number of equipment involved in the incident.
(4) Place, time and date of the incident.
(5) Actions taken to establish normal operations.
(6) Corrective actions taken or planned to prevent recurrence.
(7) Qualifications of personnel involved in the incident.
(c) Reports of overexposure submitted under Title 10, Code of Federal Regulations section 20.2203, incorporated by reference in section 30253, which involve failure of safety components of radiography equipment shall also include the information specified in subsection (b).
Note: Authority cited: Sections 100275 and 115000, Health and Safety Code. Reference: Sections 114965, 114970, 115105, 115110, and 115235, Health and Safety Code.
s 30333. Training and Supervision for Radiographers and Radiographers' Assistants.
(a) No user shall permit any individual to act as a radiographer until such individual:
(1) has been instructed in and demonstrated an understanding of the subjects enumerated in Section 30335;
(2) has received copies of, instruction in, and demonstrated understanding of, this regulation, applicable provisions of Group 2 of this subchapter, applicable radioactive material licenses, and the user's operating and emergency procedures; and
(3) has demonstrated competence to use the radiographic exposure devices, sealed sources, related handling tools, and radiation survey instruments which will be employed in his assignments.
(b) No user shall permit any individual to act as a radiographers' assistant until such individual:
(1) has received copies of, instruction in, and demonstrated understanding of, the user's operating and emergency procedures; and
(2) has demonstrated competence to use, under the direct supervision of a radiographer, the radiographic exposure devices, sealed sources, related handling tools, and radiation survey instruments which will be employed in his assignments.
(c) Whenever a radiographer's assistant uses radiographic exposure devices, uses sealed sources or related source handling tools, or conducts radiation surveys required by Section 30334 to determine that the sealed source has returned to the shielded position after an exposure, the radiographer's assistant shall be under the personal supervision of a radiographer. The personal supervision shall include:
(1) The radiographer's personal presence at the site where the sealed sources are being used;
(2) The ability of the radiographer to give immediate assistance if required; and
(3) The radiographer's watching the assistant's performance of the operations referred to in this section.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30333.1. Operating and Emergency Procedures.
(a) Each user shall maintain and keep current written operating and emergency procedures which shall include detailed instructions in at least the following matters:
(1) The handling and use of radiographic exposure devices and the manner of employment to control and limit radiation exposures to individuals.
(2) Methods and occasions for conducting radiation surveys.
(3) Methods and occasions for controlling access to radiography areas.
(4) Methods and occasions for locking and securing radiographic exposure devices and storage containers.
(5) Personnel monitoring and the use of personnel monitoring devices.
(6) Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off scale.
(7) Transporting sealed sources to field locations, including stowage in vehicles, posting of vehicles and control during transportation.
(8) Procedures in the event of an accident, including sealed source handling, minimizing radiation exposure to individuals, and notifying proper persons.
(9) Maintenance of records.
(10) The inspection and maintenance of radiographic exposure devices, storage containers and source changers.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30333.2. Personnel Monitoring Control.
(a) The licensee shall not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operations, each such individual wears a direct reading pocket dosimeter, an alarm ratemeter, and either a film badge or a thermoluminescent dosimeter (TLD) except that for permanent radiography facilities where other appropriate alarming or warning devices are in routine use, the wearing of an alarming ratemeter is not required. Pocket dosimeters shall have a range from zero to at least 200 milliroentgens and shall be recharged at the start of each shift. Each film badge and TLD shall be assigned to and worn by only one individual.
(b) Pocket dosimeters shall be read and exposures recorded daily. The licensee shall retain each record of these exposures for three years after the record is made.
(c) Pocket dosimeters shall be checked at periods not to exceed one year for correct response to radiation. Acceptable dosimeters shall read within plus or minus 30 percent of the true radiation exposure.
(d) If an individual's pocket dosimeter is discharged beyond its range, the individual's film badge or TLD shall be immediately sent for processing.
(e) Reports received from the film badge or TLD processor shall be retained for inspection until the Department terminates each license that authorizes the activity that is subject to the recordkeeping requirement.
(f) Each alarming ratemeter shall:
(1) Be checked to ensure that the alarm functions properly (sounds) prior to use at the start of each shift;
(2) Be set to give an alarm signal at a preset dose rate of 500 mR/hr.;
(3) Require special means to change the preset alarm function; and
(4) Be calibrated at periods not to exceed one year for correct response to radiation.
(g) Acceptable ratemeters shall alarm within plus or minus 20 percent of the true radiation dose rate.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815 and 25876, Health and Safety Code.
s 30334. Precautionary Procedures in Radiographic Operations.
(a) During each radiographic operation the radiographer or radiographers' assistant shall maintain direct surveillance of the operation to protect against unauthorized entry into a high radiation area, except:
(1) where the high radiation area is equipped with a control device or an alarm system as described in the United States, title 10, Code of Federal Regulations, part 20, subpart G as incorporated by reference in section 30253; or
(2) where the high radiation area is locked to protect against unauthorized or accidental entry.
(b) Areas in which radiography is being performed shall be conspicuously posted as required by the United States, title 10, Code of Federal Regulations, part 20, subpart J as incorporated by reference in section 30253. The limits of a "high radiation area" need not be separately defined and posted if the surrounding "radiation area" is posted and controlled as a "high radiation area."
(c) No radiographic operation shall be conducted unless calibrated and operable radiation survey instrumentation per Section 30332.3 is available and used.
(d) A survey with a radiation survey instrument shall be made after each radiographic exposure to determine that the sealed source has been returned to its shielded position. The entire circumferences of the radiographic exposure device shall be surveyed. If the radiographic exposure device has a source guide tube, the survey shall include the guide tube.
(e) A physical radiation survey shall be made to determine that each sealed source is in its shielded condition prior to locking a radiographic exposure device, storage container or source changer pursuant to Section 30332.1. Records of all such surveys shall be maintained and kept available for inspection.
(f) The licensee shall audit the performance of each radiographer and radiographer's assistant at intervals not to exceed (3) months for the pur pose of assessing compliance with Department regulations, license provisions and the licensee's operating and emergency procedures.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815, 25875 and 25876, Health and Safety Code.
s 30335. Minimum Subjects to Be Covered in Training Radiographers.
(a) Fundamentals of Radiation Safety.
(1) Characteristics of gamma radiation.
(2) Units of radiation dose and quantity of radioactivity.
(3) Hazards of excessive exposure to radiation.
(4) Levels of radiation from radiographic exposure devices.
(5) Methods of controlling radiation dose.
(A) working time
(B) working distance
(C) shielding
(b) Radiation Instrumentation.
(1) Use of radiation survey instruments.
(A) operation
(B) calibration
(C) limitations
(2) Radiation survey techniques.
(3) Characteristics and use of personnel monitoring equipment.
(A) film badges
(B) pocket dosimeters
(C) pocket chambers
(D) Thermoluminescent dosimeters
(c) Radiographic Equipment.
(1) Radiographic exposure devices.
(A) using sealed sources
(B) X-ray
(2) Remote handling equipment.
(3) Storage containers.
(d) Inspection and Maintenance Performed by Radiographers.
(e) Case Histories of Radiography Accidents.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811, 25815 and 25876, Health and Safety Code.
s 30336. Radiography Employing Radiation Machines.
Definitions, for purposes of this regulation, and special requirements for various categories of radiography employing radiation machines are as follows:
(a) Cabinet radiography is that which is conducted in an enclosed, interlocked cabinet, such that the radiation machine will not operate unless all openings are securely closed, and the interior of which is so shielded that every location on the exterior meets conditions for an uncontrolled area as specified in the United States, title 10, Code of Federal Regulations, part 20, subpart D as incorporated by reference in section 30253. Cabinet radiography shall be subject to the following special conditions:
(1) No user shall permit any individual to operate a cabinet radiography unit until such individual has received a copy of and instruction in, and demonstrated an understanding of, operating procedures for the unit, and has demonstrated competence in its use.
(b) Shielded room radiography is that which is conducted in an enclosed room, the interior of which is not occupied during radiographic operations, which is so shielded that every location on the exterior meets conditions for an uncontrolled area as specified in the United States, title 10, Code of Federal Regulations, part 20, subpart D as incorporated by reference in section 30253, and the only access to which is through openings which are interlocked so that the radiation machine will not operate unless all openings are securely closed. Shielded room radiography shall be subject to the following special conditions:
(1) No user shall permit any individual to operate a shielded room radiography unit until such individual has received a copy of and instruction in, and demonstrated an understanding of, operating procedures for the unit, and has demonstrated competence in its use.
(2) Each user shall supply appropriate personnel monitoring equipment to, and shall require the use of such equipment by, every individual who operates, who makes "set-ups," or who performs maintenance on a shielded room radiography unit.
(c) Field radiography is all radiography other than cabinet radiography and shielded room radiography. Field radiography shall be subject to the following special conditions, except as may be explicitly exempted by the department or other official agency specifically designated by the department:
(1) No user shall permit any individual to perform field radiography until such individual has been instructed in and demonstrated an understanding of the following subjects:
Characteristics of X-radiation
Units of radiation dose
Radiation hazards
Radiation levels from radiation machines
Methods of controlling radiation exposure: time, distance, shielding
Use of radiation survey instruments: operation, calibration, limitations
Radiation survey techniques
Characteristics and use of personnel monitoring equipment
Use of radiation machines in radiography
(2) Each user shall maintain and keep current written operating procedures for the kinds of radiation machines and the kinds of radiographic procedures employed. Such procedures shall include detailed instructions in at least the following:
(A) Means to be employed to control and limit exposure to individuals.
(B) Methods and occasions for conducting radiation surveys and for controlling access to radiography areas.
(C) The use of radiation survey instruments and personnel monitoring devices.
(3) No user shall permit any individual to perform field radiography until such individual has received a copy of, instruction in, and demonstrated an understanding of, the user's operating procedures and has demonstrated competence in the kinds of radiographic operations which he will perform.
(4) The boundaries of the controlled area for each "setup" shall be determined by a physical radiation survey, and appropriate limitations shall be imposed for controlling access to that area. Such surveys shall be made with a radiation measuring instrument capable of measuring radiation of the energies and at the dose rates to be encountered, which is in good working order, and which has been properly calibrated within the preceding three months or following the last instrument servicing, whichever is later. Survey results and records of boundary locations shall be maintained and kept available for inspection.
(5) Areas in which radiography is being performed shall be conspicuously posted as required by the United States, title 10, Code of Federal Regulations, part 20, subpart J as incorporated by reference in section 30253. The limits of a "high radiation area" need not be separately defined and posted if the surrounding "radiation area" is posted and controlled as a "high radiation area."
(6) During each radiographic operation, the operator shall maintain direct surveillance of the operation to protect against unauthorized entry into a high radiation area unless entry into such area is positively controlled by other suitable means.
(7) Each user shall maintain current utilization logs which shall be kept available for inspection at the address specified on the registration form, containing the following information for each radiation machine:
(A) The identity of the machine.
(B) The location, date, and the identity of the individual operator for each use.
(C) The voltage, current, and exposure time for each use.
(8) Each user shall furnish a film badge and either a pocket dosimeter or pocket chamber to, and require their use at all times during radiographic operations by, every individual who conducts field radiography or who otherwise frequents the area during such operations. Pocket dosimeters and pocket chambers shall be capable of measuring doses to at least 200 millirems. They shall be read and doses recorded daily.
Pocket dosimeters and pocket chambers shall be checked for current leakage and calibrated no less frequently than once a year. Records of such checks and calibrations, showing dates and results, shall be maintained and kept available for inspection.
Each film badge shall be assigned to and worn by only one individual. An individual's film badge shall be immediately processed if his pocket dosimeter or pocket chamber is discharged beyond its range.
The film badge reports received from the film badge processor and records of pocket dosimeter or pocket chamber readings shall be maintained and kept available for inspection.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801 and 25802, Health and Safety Code.
s 30337. Contraband-Detection Fluoroscopy.
When a radiation machine is operated in an occupied area for the purpose of detection of contraband in airline passenger carry-on baggage, it shall meet all of the following requirements:
(a) Radiation emitted from the detection equipment shall not, under any condition of use, exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface, or any door or port.
(b) The detection equipment shall have a physical barrier, photoelectric safety interlock, or other means which will make the insertion of any part of the human body into the primary X-ray beam impossible.
(c) The detection equipment shall have a lock-and-key control which will insure that X-ray generation is not possible with the key removed.
(d) There shall be an illuminated indicator which will show when X-rays are being generated; this indicator shall be prominently visible to operating personnel in their normal working positions:
(e) In systems in which baggage is placed directly onto the fluoroscopy stage through an open port, the operator's X-ray control switch shall be of the deadman type.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30345.1. Scope.
The regulations in this Article shall apply to all licensees or registrants who use sources of radiation for well logging operations including oil, gas, mineral-logging, radioactive markers, or subsurface tracer studies.
Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25815, 25875 and 25876, Health and Safety Code.
s 30345.2. Definitions.
(a) The definitions in section 30100 apply to this article.
(b) As used in this article:
(1) "Energy compensation source" means a small sealed source (not exceeding an activity of 100 microcuries), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use;
(2) "Field station" means a facility where licensed radioactive material or radiation machines may be stored or used and from which equipment is dispatched to temporary jobsites;
(3) "Fresh Water Aquifer" means a geologic formation that is capable of yielding fresh water to a well or spring;
(4) "Injection tool" means a device used for controlled subsurface injection of radioactive tracer material;
(5) "Irretrievable well logging source" means any sealed source containing radioactive material that is pulled off or not connected to the wireline that suspends the source in the well and for which all reasonable effort at recovery has been expended;
(6) "Logging assistant" means any individual who, under the personal supervision of a logging supervisor, handles radiation sources that are not in logging tools or shipping containers or who performs surveys required by section 30348.4;
(7) "Logging supervisor" means any individual who uses radiation sources or provides personal supervision in the use of radiation sources at a temporary jobsite and who is responsible to the user for assuring compliance with the requirements of this regulation and the conditions of the license;
(8) "Logging tool" means a device used subsurface to perform well logging;
(9) "Personal supervision" means guidance and instruction by a logging supervisor who is physically present at a temporary jobsite, who is in personal contact with logging assistants, and who can give immediate assistance;
(10) "Radioactive marker" means radioactive material used for depth determination or direction orientation. The term includes radioactive collar markers and radioactive iron nails;
(11) "Safety review" means a periodic review provided by the user for its employees on radiation safety as it relates to well logging. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, accidents or errors that have been observed, and safety questions by employees;
(12) "Source holder" means a housing or assembly into which a sealed source is placed to facilitate the handling and use of the source in well logging;
(13) "Subsurface tracer study" means the release of unsealed radioactive material or a substance labeled with radioactive material in a single well for the purpose of tracing the movement or position of the material or substance in the well or adjacent formation; (continued)