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(continued)
(5) The X-ray tube shall be so mounted that it cannot turn or slide with respect to the aperture.
(6) Means shall be provided to immobilize the tube housing during stationary portal treatment.
(7) A suitable exposure control device such as an automatic timer, exposure meter, or dose meter shall be provided to terminate the exposure after a preset time interval or preset exposure or dose limit. A timer shall be provided to terminate the exposure after a preset time regardless of what other exposure limiting devices are present. Means shall be provided for the operator to terminate the exposure at any time.
(8) Equipment utilizing shutters to control the useful beam shall have a shutter position indicator on the control.
(9) An easily discernible indicator which shows whether or not X-rays are being produced shall be on the control panel.
(10) Mechanical and/or electrical stops shall be provided on X-ray machines capable of operating at 150 kVp or above to insure that the useful beam is oriented only toward primary barriers.
(11) When the relationship between the beam interceptor (when present) and the useful beam is not permanently fixed, mechanical or electrical stops shall be provided to insure that the beam is oriented only toward primary barriers.
(b) Operating Procedures.
(1) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used.
(2) No patient other than the one being treated shall be in the treatment room during exposure.
(3) No person other than the patient shall be in the treatment room when the tube is operated at potentials exceeding 150 kVp. At operating potentials of 150 kVp or below, persons other than the patient and operator may be in the treatment room for good reason but only if they are adequately protected and their radiation exposure is appropriately monitored.
(4) A calibration of the output of each radiation therapy system shall be performed before the system is first used for irradiation of a patient, and thereafter at intervals not to exceed 24 months. Therapy equipment shall not be used for any therapy treatments except at those combinations of effective energy, field size, and treatment distance for which the equipment has been calibrated. The calibration shall be performed by or under the direct supervision of a person who has been determined by the Department to have adequate training, experience and knowledge in radiation therapy physics, and who shall be present at the facility during such calibration. After any change which might significantly alter the output, spatial distribution, or other characteristics of the therapy beam, the parameters which might be affected shall be measured.
(A) For therapy systems operating at potentials above 500 kVp, the determinations included in the calibration shall be provided in sufficient detail so that the absorbed dose in tissue in the useful beam may be calculated to within 5 percent. The calibration shall include, but shall not be limited to, the following determinations:
1. Verification that the equipment is operating in compliance with the design specifications concerning the light localizer, the side light and back-pointer alignment with the isocenter when these specifications are known and applicable, variation in the axis of rotation for the table, gantry and jaw system, and beam flatness and symmetry at specified depths.
2. The relative dose at various depths in a tissue equivalent phantom for each effective energy and the ranges of field sizes and treatment distances used for radiation therapy.
3. The congruence between the radiation field and the field indicated by the localizing device.
4. The uniformity of the radiation field and its dependency upon the direction of the useful beam.
5. The absolute dose per unit time and dose per monitor setting.
(B) For therapy systems operating at potentials between 150 kVp and 500 kVp inclusive, the calibration shall include, but shall not be limited to, the following determinations:
1. The exposure rates and/or dose rates for each combination of field size, technique factors, filter, and treatment distance used.
2. The degree of congruence between the radiation field and the field indicated by the localizing device if such device is present.
3. An evaluation of the uniformity of the radiation field symmetry for the field sizes used, and any dependence upon tube housing assembly orientation.
(5) All new installations and existing installations not previously surveyed shall have a radiation protection survey performed by or under the direction of a person determined by the Department to have adequate knowledge and training to advise regarding radiation protection needs, to measure ionizing radiation and to evaluate safety techniques. If the survey shows that supplementary shielding is required a resurvey shall be performed after its installation. In addition, a resurvey shall be made after every change which might decrease radiation protection significantly. The surveyor shall report his findings in writing to the user. The report shall indicate whether or not the installation is in compliance with all applicable radiation protection requirements of this section. The user shall report the findings of the survey in writing to the Department within 15 days of his receipt of the survey report.
(6) The exposure rate or dose rate of the useful beam and the size and shape of the useful beam shall be known with reasonable certainty at all times during operation of the radiation therapy apparatus for medical purposes.
(7) Spot checks shall be performed at least once each week for therapy systems operating at potentials above 500 kVp, and at least once each month for therapy systems operating at 500 kVp or below.
(A) The measurements taken during spot checks shall demonstrate the degree of consistency of the operating characteristics which can affect the radiation output of the system or the radiation delivered to a patient during a therapy procedure.
(B) For systems in which the calibrating person believes beam quality can vary significantly, spot checks shall include beam quality checks.
(C) The spot check procedures shall be in writing and shall have been developed or approved by the individual who made the most recent calibration of the system pursuant to Section 30312(b)(4). The written spot check procedures shall specify when measurements and determinations indicate an inconsistency or potential change in radiation output. When more than the minimum frequency of spot checking is necessary, the spot check procedures shall specify the frequency at which spot checks are to be performed.
(D) When spot check results are erratic or inconsistent with calibration data, the person who designed the spot check procedures, or a person of equivalent competence, shall be consulted immediately and the reason(s) for the inconsistency corrected before the system is used for patient irradiation.
(8) Calibration of the therapy beam shall be performed with a measurement instrument which has been calibrated within the preceding two years directly, or through no more than one exchange, at the National Institute of Standards and Technology, or facility determined acceptable by the Department. In addition, indirect spot checks or intercomparisons of measurement instruments with secondary standards shall be made at least each six months.
(9) Reports of each radiation safety survey spot check and calibration performed pursuant to this section shall be maintained at the facility for at least three years. A copy of the treatment data developed from the latest calibration shall be available for use by the operator at the treatment control station.


Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.


s 30313. Special Requirements for X-Ray Therapy Equipment Operated at Potentials of 50 kV and Below.
(a) Equipment.
(1) All provisions of Section 30312(a) apply.
(2) A therapeutic-type protective tube housing shall be used. Contact therapy machines shall meet the additional requirement that the leakage radiation at 2 inches from the surface of the housing not exceed 0.1 R/hr.
(3) Automatic timers shall be provided which will permit accurate presetting and determination of exposures as short as one second.
(b) Operating Procedures.
(1) All provisions of Section 30312(b) apply except 30312(b)(1) and 30312(b)(7).
(2) In the therapeutic application of apparatus constructed with beryllium or other low-filtration windows adequate shielding shall be required to protect against unnecessary exposure from the useful beam, and special safeguards are essential to avoid accidental exposures to the useful beam. There shall be on the control panel some easily discernible device which will give positive information as to whether or not the tube is energized.
(3) Machines having an output of more than 1,000 roentgens per minute at any accessible place shall not be left unattended without the power being shut off at the primary disconnecting source.
(4) If the X-ray tube of a contact therapy machine is hand-held during irradiation, the operator shall wear protective gloves and apron.


Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.


s 30314. Veterinary Medicine Radiographic Installations.
(a) Equipment.
(1) The tube housing shall be of diagnostic type.
(2) Diaphragms or cones shall be provided for collimating the useful beam to the area of clinical interest and shall provide the same degree of protection as is required of the housing.
(3) The total filtration permanently in the useful beam shall not be less than 1.5 millimeters aluminum-equivalent for equipment operating up to 70 kvp and 2.0 millimeters aluminum-equivalent for machines operated in excess of 70 kvp.
(4) A device shall be provided to terminate the exposure after a pre-set time or exposure.
(5) A dead-man type of exposure switch shall be provided, together with an electrical cord of sufficient length so that the operator can stand out of the useful beam and at least 6 feet from the animal during all X-ray exposures.
(b) Operating Procedures.
(1) The operator shall stand well away from the tube housing and the animal during radiographic exposures. The operator shall not stand in the useful beam. If film must be held, it shall be held by individuals not occupationally exposed to radiation. Hand-held fluoroscopic screens shall not be used. The tube housing shall not be held by the operator. No individuals other than the operator shall be in the X-ray room while exposures are being made unless such person's assistance is required.
(2) In any application in which the operator is not located behind a protective barrier, clothing consisting of a protective apron having a lead-equivalent of not less than 0.25 millimeter shall be worn by the operator and any other individuals in the room during exposures.
(3) No individual shall be regularly employed to hold or support animals during radiation exposures. Operating personnel shall not perform this service except very infrequently and then only in cases in which no other method is available. Any individual holding or supporting an animal during radiation exposure shall wear protective gloves and apron having a lead-equivalent of not less than 0.25 millimeter.


Note: Authority cited: Sections 208 and 25811, Health and Safety Code. Reference: Sections 25801, 25802, 25811 and 25815, Health and Safety Code.


s 30315.10. Definitions.
(a) The definitions in section 30100 shall apply to this article.
(b) As used in this article:
(1) "Action limit" means the minimum or maximum value of a quality assurance measurement representing acceptable performance.
(2) "Activities" means the operation of a mammography system to produce the mammogram, the initial interpretation of the mammogram, and the maintenance of the viewing conditions for that interpretation.
(3) "Adverse event" means an undesirable experience associated with mammography activities such as:
(A) Poor image quality;
(B) Failure to send mammography reports within 30 calendar days from the date of the mammographic examination to the referring physician or to the patient; and
(C) Use of personnel that do not meet the applicable requirements of sections 30315.50, 30315.51 or 30315.52.
(4) "Air kerma" means the kerma, measured in Gray (Gy), in a given mass of air.
(5) "Automatic exposure control" (AEC) means a device that automatically controls one or more technique factors in order to obtain at pre-selected locations a required quantity of radiation.
(6) "Average glandular dose" means the value in millirad (mrad) or milligray (mGy) for a given breast or phantom thickness that estimates the average absorbed dose to the glandular tissue extrapolated from free air exposures and based on fixed filter thickness and target material.
(7) "Category I" means medical educational activities that have been designated as Category I by the Accreditation Council for Continuing Medical Education, the American Osteopathic Association, or a state medical society.
(8) "Clinical image review" means the process whereby the mammograms produced by a specific mammography system are evaluated for image quality.
(9) "Consumer" means an individual who chooses to comment on or complain in reference to a mammographic examination, including the patient or representative of the patient, such as a family member or referring physician.
(10) "Continuing education unit" means one hour of training received through either:
(A) Face-to-face interaction between instructor(s) and student(s), as when the instructor provides a lecture, conducts demonstrations, or reviews student performance; or
(B) The administration and correction of student examinations by an instructor(s) with subsequent feedback to the student(s).
(11) "Direct supervision" means the oversight of operations that include the following:
(A) During joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the diagnosis of the physician being supervised and signs the resulting report before it is entered into the patient's record.
(B) During performance of a mammographic examination, the supervising mammographic radiologic technologist is physically present to observe, and correct, as needed, the performance of the individual who is performing the mammographic examination.
(C) During performance of a survey, the supervising medical physicist is physically present to observe, and correct, as needed, the performance of the individual who is performing the survey.
(12) "Established operating level" means the value of a particular quality assurance parameter that has been established as an acceptable normal level by the facility's quality assurance program.
(13) "Facility" means a hospital, outpatient department, clinic, radiology practice, an office of a physician, mobile setting, or other place or building in which a person conducts:
(A) Mammography activities; and/or
(B) Interventional mammography or research mammography.
(14) "Facility accreditation certificate" means a document issued by the Department authorizing a facility to perform mammography.
(15) "FDA" means the United States Food and Drug Administration.
(16) "Image receptor" means any device that transforms incident X-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.
(17) "Interpreting physician" means a licensed physician who interprets mammograms and meets the requirements of section 30315.50.
(18) "Interim Facility Accreditation Certificate" means a document issued by the Department pursuant to section 30315.24.
(19) "Interventional mammography" means the creation of a mammogram during invasive interventions for localization, biopsy procedures, or therapeutic procedures.
(20) "Kerma" means the sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.
(21) "Lead interpreting physician" means the interpreting physician designated either by the person who owns or leases the facility, or an authorized agent of that person to ensure that the facility's quality assurance program meets all of the requirements of this article.
(22) "Mammogram" means an X-ray image of the human breast.
(23) "Mammographic examination" means the performance of mammography on a human being.
(24) "Mammographic modality" means a technology for radiography of the breast such as screen-film mammography, digital mammography and xeromammography.
(25) "Mammography" means the procedure for creating a mammogram.
(26) "Mammography medical outcomes audit" means a systematic collection of mammography results and the comparison of those results with outcome data.
(27) "Mammography system" means a system that includes all of the following:
(A) A radiation machine used as a source of radiation to produce a mammogram;
(B) An imaging receptor used for the formation of a latent image of a mammogram or for converting X-ray photons to a digital signal;
(C) A processing device for changing a latent image of a mammogram or a digital signal to a visual image that can be used for diagnostic or therapeutic purposes; and
(D) A viewing device, such as a view box or computer monitor, used to visually evaluate a mammogram.
(28) "Mammography system evaluation" means an evaluation of the mammography system by a medical physicist to ensure the system is in compliance with sections 30316 and 30316.20(e).
(29) "Medical physicist" means an individual trained in performing mammography system evaluations, quality assurance testing evaluations and surveys.
(30) "Mobile service provider" means a person who performs mammography in a mobile setting.
(31) "Mobile setting" means a setting in which mammography is performed with a radiation machine that is fixed or used exclusively in a mobile vehicle or unit, or is transported to a different location for the purpose of providing mammography, but does not include a radiation machine moved from room to room within a facility.
(32) "Multi-reading" means two or more physicians interpreting the same mammogram, at least one of whom meets the requirements of section 30315.50.
(33) "Overall assessment of findings" means the results of an interpreting physician's evaluation of mammograms produced during a mammographic examination and categorized using the assessment categories specified in section 30317.40(a)(4).
(34) "Phantom" means a test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer.
(35) "Phantom image" means a radiographic image of a phantom.
(36) "Physical science" means physics, chemistry, radiation science (including medical physics and health physics), and engineering.
(37) "Positive mammogram" means a mammogram that has an overall assessment of findings that are either "suspicious" or "highly suggestive of malignancy."
(38) "Quality assurance technologist" means an individual who meets the requirements of section 30315.51 and has experience performing or assisting in the performance of quality assurance tests specified in section 30316.20(a) through (d) and (f)
(39) "Quality assurance testing evaluation" means an evaluation of a facility's quality assurance testing by a medical physicist to ensure quality assurance testing is performed in accordance with section 30316.20 excluding subsection (e) of section 30316.20.
(40) "Research mammography" means the creation of a mammogram with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations in part 812 of title 21, Code of Federal Regulations.
(41) "Serious adverse event" means an adverse event that may significantly compromise clinical outcomes, or an adverse event for which appropriate corrective action was not taken in a timely manner.
(42) "Serious complaint" means a report of a serious adverse event.
(43) "Source-to-image receptor distance" (SID) means the distance from the X-ray source to the center of the input surface of the image receptor.
(44) "Standard breast" means a 4.2 cm thick compressed breast consisting of 50 percent glandular and 50 percent adipose tissue.
(45) "Survey," in lieu of the definition found in title 10, Code of Federal Regulations, section 20.1001 incorporated by reference in section 30253, means the on-site performance of a mammography system evaluation and a quality assurance testing evaluation by a medical physicist.
(46) "Traceable to a national standard" means that the instrument used to quantitatively measure radiation has been calibrated at:
(A) The National Institute of Standards and Technology (NIST); or
(B) A calibration laboratory that participates in a proficiency program with NIST at least once every two years during which the calibration laboratory achieves agreement within plus or minus 3.0 percent of the NIST standard at mammography energy levels.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.


s 30315.20. Facility Accreditation Certificate and Interim Facility Accreditation Certificate.
(a) Except for persons only performing interventional mammography or research mammography, a person shall not perform mammography activities unless performed in a facility that:
(1) Possesses a current and valid Facility Accreditation Certificate or an Interim Facility Accreditation Certificate; and
(2) Meets the requirements of this subchapter.
(b) An Interim Facility Accreditation Certificate shall be valid for six months beginning on the date of issuance.
(c) A Facility Accreditation Certificate shall be valid for three years beginning on the date of issuance.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.


s 30315.22. Eligibility for a Facility Accreditation Certificate.
(a) To be eligible for a Facility Accreditation Certificate a facility shall:
(1) Submit the application described in section 30315.33;
(2) Comply with section 30108;
(3) Pass a Department inspection verifying that:
(A) Physicians interpreting mammograms meet the requirements of section 30315.50;
(B) Mammographic radiologic technologists meet the requirements of section 30315.51;
(C) Medical physicists meet the requirements of section 30315.52;
(D) Mammography systems meet the requirements of section 30316;
(E) The mammography quality assurance program is capable of meeting the requirements of section 30317.10;
(F) By following the procedure specified in section 30316.20(b), phantom images of a phantom that meets the requirements of section 30316.22 produced by all mammography systems, meet the criteria specified in section 30316.20(b)(1) through (3);
(G) By use of the facility's proposed technique factors for a standard breast, the average glandular dose for each radiation machine used for mammography does not exceed the value specified in section 30316.20(e)(10);
(H) The quality assurance manual meets the requirements of section 30317.20;
(I) The mammography procedures manual meets the requirements of section 30317.30;
(J) The facility is capable of ensuring mammograms and mammographic examination reports meet the requirements of sections 30316.50 and 30317.40;
(K) The facility is capable of conducting a mammography medical outcomes audit that meets the requirements of section 30317.60;
(L) The facility has a consumer complaint procedure that meets the requirements of section 30317.70; and
(M) The requirements of Group 3 of this regulation are met.
(4) After receipt of an interim facility accreditation certificate issued pursuant to section 30315.24, for each machine that will be used to perform mammography, pass a clinical image review conducted by the Department pursuant to section 30315.35, or conducted by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A); and
(5) After receipt of an interim facility accreditation certificate issued pursuant to section 30315.24, possess a current and valid certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(b).


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.


s 30315.23. Renewal of a Facility Accreditation Certificate.
(a) To renew a Facility Accreditation Certificate, a facility shall:
(1) Seven months prior to the expiration date of the facility accreditation certificate submit the facility application described in section 30315.33;
(2) For each radiation machine that will be used for mammography, either:
(A) Pass a clinical image review conducted by the Department pursuant to section 30315.35(c) prior to the expiration date of the current facility accreditation certificate; or
(B) Have the machine's accreditation renewed by an entity approved by FDA pursuant to 42 United States Code Section 263b(e)(1)(A); and
(3) Possess a current and valid certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(b).


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.


s 30315.24. Interim Facility Accreditation Certificate.
An interim facility accreditation certificate shall not be issued until a facility has complied with section 30315.22(a)(1) through (3) and has obtained a provisional certificate issued by FDA pursuant to title 21, Code of Federal Regulations, section 900.11(b)(2).


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.


s 30315.33. Complete Facility Application.
(a) An application submitted for compliance with sections 30315.22 or 30315.23 shall be considered complete if the application contains the following:
(1) The legal name of the applicant, the mailing address, and the telephone number;
(2) The name under which the applicant's facility does business and, if doing business under a fictitious name, a copy of the applicant's fictitious name permit;
(3) The name of the contact person for the facility;
(4) The facility location address and mailing address if different from location address.
(5) The registration number issued by the Department pursuant to section 30108 and the expiration date of registration;
(6) The applicant's federal employer identification number and California taxpayer identification number;
(7) If the facility is accredited by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A), the name of that entity.
(8) If the applicant requests approval to perform mammography in a mobile setting:
(A) The physical address of each location where mammography will be performed;
(B) For each location where mammography will be performed, the name and telephone number of the responsible person who is allowing the service to be provided at the location;
(C) Whether the mammograms will be processed with an on-board processor or at specific locations. If the facility will process mammograms at specific locations, the physical address of each location where mammograms will be processed;
(D) Whether the radiation machine is fixed or used, exclusively, in a mobile vehicle or is transported to the use location and moved to where mammographic examinations will be performed. If the radiation machine is moved to where mammographic examinations will be performed, the designated room number within the physical building at each location of use; and
(E) A description of the quality assurance tests that will be performed each time the radiation machine is relocated.
(9) Responses to the following questions:
(A) "Have you ever performed mammography authorized pursuant to a certificate issued by FDA?" If the answer is yes, provide in your response the names under which mammography was performed;
(B) "If you have been certified by FDA to perform mammography, has that certificate ever been revoked or suspended, or has FDA ever denied to renew that certificate?" If the answer is yes, provide in your response the following:
1. The identity of any specific radiation machine(s) that failed to pass clinical image review;
2. The dates of failure;
3. The actions taken to correct any clinical image review deficiencies including physician or technologist training, radiation machine or processor repair and acquisition of replacement equipment or image receptors;
4. Whether the radiation machine passed the clinical image review subsequent to actions taken as identified in subsection (a)(9)(B)3 and when;
5. If, within the three years prior to the date of application, any radiation machine used for mammography identified in subsection (a)(15) failed clinical image review during a time when accredited by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A), copies of the failure reports; and
6. If accreditation issued by an entity approved by the FDA pursuant to 42 United States Code Section 263b(e)(1)(A), was suspended or revoked, a description of the circumstances that led to suspension or revocation.
(C) "Is any interpreting physician you seek to allow to interpret mammograms currently under a Department-directed plan of corrective action for interpretation done at some other facility?" If the answer is yes, provide in your response the following:
1. The name and medical license number of the interpreting physician; and
2. The facility's name and registration number where the interpreting physician was required to complete a directed plan of corrective action.
(10) The name of the individual designated as the lead interpreting physician.
(11) The name, medical license number, certificate number and expiration date as shown on the individuals certificate issued pursuant sections 30466(d) or 30467 of each physician who will interpret mammograms produced by the facility;
(12) The name, certificate number and expiration date of certification shown on the certificate issued pursuant to section 30455.1 for each mammographic radiologic technologist who will perform mammographic examinations for the facility;
(13) The name of each medical physicist who will perform the tests specified in section 30316.20(e) for the facility;
(14) The name of the quality assurance technologist;
(15) For each radiation machine that will be used to perform mammographic examinations:
(A) The machine's manufacturer, model number, and serial number of the control;
(B) Whether the machine will be used in a mobile setting. If the machine will not be used in a mobile setting, the designated room number within the facility where the machine is installed or fixed;
(C) Whether the machine is a screen-film, xeromammography or digital system. If the machine is a screen-film system, the name of the manufacturer of the screen and film, and the type of screen and film used; and
(D) If the machine requires a screen-film image receptor, a phantom image of a phantom that meets the requirements of section 30316.22.
(16) A copy of the report indicating the results of a mammography system evaluation performed less than 6 months prior to the date of the application by a medical physicist or in lieu thereof for renewal applications, a copy of the report indicating the results of a survey performed less than 12 months prior to the date of the renewal application by a medical physicist and if the mammography system evaluation report or the survey report identifies deficiencies or recommendations for improvements in facility operations:
(A) A list and description of corrective actions taken and the date corrections were achieved;
(B) Copies of work invoices;
(C) Documentation that those corrective actions were taken and those actions corrected the deficiencies or that those recommendations were followed.
(17) For each film processor that is used to process mammograms:
(A) The make and model number; and
(B) Whether the processor uses extended processing or standard processing.
(18) If this is a renewal application, the number of the following procedures performed in the previous year:
(A) Screening procedures;
(B) Diagnostic procedures;
(C) The total number of screening and diagnostic procedures;
(D) Biopsy procedures;
(E) Needle localization procedures; and
(F) Therapeutic procedures.
(19) If this is a renewal application, the identification number and expiration date shown on the FDA certificate issued to the applicant's facility;
(20) Whether the applicant participates or intends to participate in either the Breast Cancer Early Detection Program or the Breast and Cervical Cancer Control Program of the Department or any of their successors;
(21) If the applicant is a Medi-Cal provider, the nine-digit Medi-Cal number used to bill for mammographic examinations performed at the facility's location;
(22) If the applicant is a Medicare provider, the nine-digit Medicare number used to bill for mammographic examinations performed at the facility's location;
(23) Name, title, signature and date of signature of the applicant and lead interpreting physician.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.


s 30315.34. Application Processing Times.
(a) Within 30 calendar days of receipt of an application for or renewal of a facility accreditation certificate, the Department shall:
(1) Notify the applicant that the application is complete; or
(2) Notify the applicant that the application is incomplete and identify what is required for the Department to consider it complete.
(b) Unless the applicant responds to the notification in subsection (a)(2) within 30 calendar days the application shall be deemed withdrawn and the applicant may reapply by submitting a new application.
(c) Within six months of receipt of a complete application, the Department shall issue or deny the facility accreditation certificate.
(d) The Department's time periods for processing an application for or renewal of a facility accreditation certificate from receipt of the initial application to the date the final decision is made, are as follows:
(1) The median time is five and one-half months;
(2) The minimum time is four months;
(3) The maximum time is 12 months.


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 15376, Government Code.


s 30315.35. Clinical Image Review.
(a) After receipt of an interim facility accreditation certificate issued pursuant to section 30315.24, applicants for a facility accreditation certificate shall:
(1) Select mammograms in accordance with the criteria specified in title 21, Code of Federal Regulations, section 900.4(c)(4); and
(2) Within 75 calendar days of the date of issuance as shown on the interim facility accreditation certificate, submit those mammograms for clinical image review.
(b) If the mammograms fail the review, additional mammograms may be submitted if the resubmission is made no less than 75 calendar days prior to the expiration date of the interim facility accreditation certificate.
(c) Applicants for renewal of a facility accreditation certificate shall:
(1) Select mammograms in accordance with the criteria specified in title 21, Code of Federal Regulations, section 900.4(c)(4); and
(2) Submit those mammograms for clinical image review no less than 75 calendar days prior to the expiration date of the facility accreditation certificate.
(d) Mammograms submitted pursuant to this section shall meet the FDA-accepted attributes as specified in title 21, Code of Federal Regulations, section 900.4(c)(2).


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30315.36. Mammography Review.
(a) Each facility possessing a facility accreditation certificate shall, upon request, make mammograms and reports specified in section 30317.40(a) available to the Department and allow those mammograms and reports to be removed from the facility for the purpose of evaluating mammogram image quality.
(b) For sample sizes of two mammographic examinations:
(1) If one mammographic examination fails the review, the facility shall submit a plan of corrective action, acceptable to the Department, addressing those areas that resulted in the failure and satisfactorily complete that plan; or
(2) If both mammographic examinations fail the review, the facility shall satisfactorily complete a plan of corrective action as directed by the Department addressing those areas of the review that resulted in the failure. The facility shall be subject to additional review using a larger sample.
(c) For sample sizes greater than two mammographic examinations:
(1) If 20 percent of the mammographic examinations fail the review, the facility shall submit a plan of corrective action, acceptable to the Department, addressing those areas that resulted in the failure and satisfactorily complete that plan;
(2) If 40 percent of the mammographic examinations fail the review, the facility shall satisfactorily complete a plan of corrective action as directed by the Department addressing those areas of the review that resulted in the failure; or
(3) If 80 percent or more of the mammographic examinations fail the review, the facility shall cease the performance of mammography and submit to additional review and:
(A) If 70 percent or more of the mammographic examinations pass this additional review, the facility may restart the performance of mammography after satisfactorily completing a plan of corrective action as directed by the Department and shall, within 75 calendar days of notification that the mammograms passed the review, submit mammograms in accordance with section 30315.35(a)(1); or
(B) If less than 70 percent of the mammographic examinations pass this additional review, the facility shall not restart the performance of mammography and shall notify every patient who had a mammogram at the facility during the two-year period preceding the date of failure. The notification shall be approved by the Department prior to mailing and include:
1. The name of the patient;
2. The date the patient's mammogram was performed;
3. The statement, "The Department of Health Services of the State of California has conducted a review of the mammograms produced by (the name of the facility) and has determined that the mammograms do not meet the standards set by the Department. Therefore, we strongly advise you to consult with your physician as soon as possible regarding a repeat mammographic examination."
(d) Mammograms reviewed pursuant to this section shall meet the FDA-accepted attributes as specified in title 21, Code of Federal Regulations, section 900.4(c)(2).


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30315.50. Interpreting Physician Requirements.
(a) An interpreting physician for a facility shall:
(1) Possess a current and valid radiology supervisor and operator certificate issued pursuant to sections 30467 or 30466(d); and
(2) Meet the requirements specified in title 21, Code of Federal Regulations, section 900.12(a)(1).


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Section 115060, Health and Safety Code.


s 30315.51. Personnel Requirements for Individuals Who Perform Mammography.
(a) Mammographic examinations shall not be performed unless the individual who performs the mammographic examination:
(1) Possesses a current and valid mammographic radiologic technology certificate issued pursuant to section 30455.1; and
(2) Meets the requirements specified in title 21, Code of Federal Regulations, section 900.12(a)(2).


Note: Authority cited: Sections 100275 and 115060, Health and Safety Code. Reference: Sections 115060 and 115115, Health and Safety Code.


s 30315.52. Medical Physicist Requirements.
(a) A medical physicist for a facility shall:
(1) Be authorized by the Department pursuant to section 30315.60;
(2) Have a masters degree or higher in a physical science from an accredited institution, with no less than 20 semester hours or 30 quarter hours of college undergraduate or graduate level physics;
(3) Complete 20 hours of documented specialized training in conducting surveys of mammography facilities; and
(4) Conduct a survey of at least one mammography facility and a total of at least ten mammography radiation machines under the direct supervision of a medical physicist who has already met the requirements of this section, but in no case may more than one survey of a specific radiation machine conducted within a period of 60 calendar days be counted towards the total number of radiation machines surveyed. The period of time spent in meeting the survey requirement may be counted toward meeting the 20-hour training requirement in subsection (a)(3). After April 28, 1999, experience conducting surveys shall be acquired under the direct supervision of a medical physicist who meets the requirements of subsections (a)(1) through (4) and (b); or
(5) In lieu of subsections (a)(2) through (4), qualify as a medical physicist under Title 21, Code of Federal Regulations, section 900.12(a)(3), as published in the December 21, 1993 Federal Register (58 Fed.Reg. 67571) and have retained that qualification by maintenance of the active status of any licensure, approval, or certification required under those regulations and prior to April 28, 1999:
(A) Received a bachelor's degree or higher in a physical science from an accredited institution with no less than 10 semester hours or equivalent of college undergraduate or graduate level physics;
(B) After meeting the requirements of subsection (a)(5)(A), completed forty hours of documented specialized training in conducting surveys of mammography facilities; and
(C) After meeting the requirements of subsection (a)(5)(A), conducted surveys of at least one mammography facility and a total of at least 20 mammography radiation machines but in no case may more than one survey of a specific radiation machine conducted within a period of 60 calendar days be counted towards the total radiation machine survey requirement. The period of time spent in meeting the survey requirement may be counted toward meeting the 40- hour training requirement in subsection (a)(5)(B).
(b) A medical physicist for a facility shall meet the requirements specified in title 21, Code of Federal Regulations, section 900.12(a)(3)(iii) and (iv).


Note: Authority cited: Sections 100275, 115060 and 115100, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code.


s 30315.60. Authorization and Renewal of Authorization to Conduct Mammography Surveys, Revocation and Suspension of Authorization and Application Processing Times.
(a) To be eligible for authorization to conduct mammography surveys an individual shall submit a complete application consisting of the following:
(1) Name, social security number (pursuant to the authority found in sections 100275 and 115100 of the Health and Safety Code and as required by section 17520 of the Family Code, providing the social security number is mandatory. The social security number will be used for purposes of identification), mailing address, daytime telephone number, and FAX number;
(2) Documentation that the applicant meets the requirements of:
(A) Sections 30315.52(a)(2) through (4); or
(B) Section 30315.52(a)(5).
(3) Documentation that the applicant meets the requirements of section 30315.52(b);
(4) Three sample survey reports, meeting the requirements of section 30316.60, indicating the name of the medical physicist providing direct supervision and that the applicant performed all tests. Each report shall include language and data that establishes that all tests were performed to determine if the facility meets the requirements of this article and that, if a test method is specified, the test method was followed; and
(5) The following information:
(A) Manufacturer, model and serial number of the phantom used to produce phantom images;
(B) Whether the type of system resolution tool used to evaluate system resolution is a bar pattern or, until October 28, 2002, a star pattern;
(C) Method used to evaluate kVp;
(D) Method used to evaluate compression;
(E) Type of instruments used to determine average glandular dose and a copy of the most recent calibration report for that instrument indicating that it complies with section 30316.61;
(F) Whether aluminum filters used to determine the radiation machine's half-value layer of the useful beam is type 1100 or type 1145;
(G) Manufacturer, model and serial number of the densitometer, sensitometer and photometer used during surveys; and
(H) A list of equipment used to evaluate the mammography system for artifacts and the radiation machine's AEC performance; or
(6) In lieu of subsections (a)(2) and (3), a copy of the letter issued to the applicant by FDA stating that the applicant met the requirements of title 21, Code of Federal Regulations, section 900.12(a)(3).
(b) Individuals approved by use of subsection (a)(2)(B) shall not provide direct supervision.
(c) Surveys of radiation machines used to perform interventional mammography or research mammography shall not be used to comply with this section.
(d) Authorization shall be valid for three years.
(e) To be eligible for renewal of authorization to conduct mammography surveys an individual shall submit a complete application consisting of the following:
(1) Name, social security number (pursuant to the authority found in sections 100275 and 115100 of the Health and Safety Code and as required by section 17520 of the Family Code, providing the social security number is mandatory. The social security number will be used for purposes of identification), mailing address, daytime telephone number, and FAX number;
(2) The following information:
(A) If changes to the information submitted pursuant to subsection (a)(5) have occurred, the updated information;
(B) A copy of the most recent calibration report for the instrument used to determine average glandular dose.
(3) Documentation indicating that at least 8 hours of training in surveying radiation machines were received for each new mammographic modality; and
(4) Documentation that the applicant meets the requirements of section 30315.52(b).
(f) Authorization to conduct mammography surveys may be revoked, suspended, amended or restricted for any of the following:
(1) Failure to comply with section 30315.52(b);
(2) Knowingly conduct or perform mammography system evaluations, quality assurance testing evaluations or surveys that cause or would have caused, if not detected, a facility to be in 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;
(3) Knowingly submits to the Department false, incorrect or fraudulent information;
(4) Failure to inform a facility that a violation of this article has occurred when the medical physicist knows of the violation; or
(5) Procuring authorization by fraud, or misrepresentation, or because of mistake.
(g) Within 10 calendar days of receipt of an application for or renewal of authorization, the Department shall:
(1) Notify the applicant that the application is complete; or
(2) Notify the applicant that the application is incomplete and identify what is required for the Department to consider it complete.
(h) Unless the applicant responds to the notification in subsection (g)(2) within 30 calendar days the application shall be deemed withdrawn.
(i) Within 30 calendar days of receipt of a complete application, the Department shall issue or deny the authorization.
(j) Any applicant deemed by the Department to have withdrawn an application pursuant to subsection (e) may reapply by submitting a new application.
(k) The Department's time periods for processing an application for authorization from receipt of the initial application to the date the final decision is made, are as follows:
(1) The median time is 30 calendar days;
(2) The minimum time is seven days;
(3) The maximum time is 90 calendar days.


Note: Authority cited: Sections 100275, 115060 and 115100, Health and Safety Code. Reference: Sections 115060, 115100 and 115115, Health and Safety Code; and Section 15376, Government Code.


s 30316. Mammography System Requirements.
(a) A radiation machine designed for general purpose radiography, or special nonmammography procedures or that has been modified or equipped with special attachments for mammography shall not be used for mammography.
(b) Radiation machines used for mammography shall:
(1) Be specifically designed and manufactured for mammography and meet the requirements of section 30305(a)(4). (continued)