[34 Pa.B. 3823]
[Continued from previous Web Page]
Subchapter C. GENERAL LICENSES FOR RADIOACTIVE MATERIAL § 217.141. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 31 (relating to general domestic licenses for byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 31.4 and 31.14 (relating to information collection requirements: OMB approval; and criminal penalties) are not incorporated by reference.
§ 217.143. Certain measuring, gauging or controlling devices.
In addition to the parts of 10 CFR 31.5 (relating to certain detecting measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere) incorporated by reference, general licensees subject to registration under 10 CFR 31.5(c)(13)(i) or possessing general licensed devices containing 37 MBq (1 mCi) or more of accelerator-produced material, as determined on the date of manufacture, or 3.7 MBq (0.1 mCi) or more of radium-226 shall also comply with the following:
(1) Conduct a physical inventory every 6 months to account for all sources or devices, or both, received and possessed under this section and do the following:
(i) Maintain the physical inventory records for 3 years from the date of each inventory.
(ii) Furnish a report to the Department annually showing to the extent practicable, the make, model, serial number, isotope, source activity and location of each device. The report shall list an individual to contact regarding questions about this report.
(2) For portable devices, also comply with the following:
(i) A person who initiates acquisition, transfer or disposal of a portable device shall notify the Department within 15 days of the action. Sending a portable device for calibration, maintenance or source replacement does not constitute transfer.
(ii) Portable devices may only be used by or under the direct supervision of individuals who have been instructed in the operating and emergency procedures necessary to ensure safe use.
(iii) For each individual that the licensee permits to use a portable device, the licensee shall maintain a record showing the type of device use permitted and the basis, such as training certificates, for that authorization. An individual's record shall be kept for at least 3 years after the individual terminates association with the licensee.
(iv) Portable devices shall be secured from access by unauthorized personnel whenever the device is not under the direct surveillance of an individual authorized to use the device.
(v) The licensee shall maintain a current sign out log at the permanent storage location of the portable device. Log entries shall be available for inspection by the Department for 3 years from the date of entry. The following information shall be recorded for each portable device:
(A) The model and serial number of the device.
(B) The name of the assigned user.
(C) The locations and dates of use.
(vi) Emergency instructions shall accompany each portable device taken off the premises of the licensee.
Subchapter G. LICENSING OF SOURCE MATERIAL § 217.171. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 40 (relating to domestic licensing of source material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 40.6, 40.8, 40.12(b), 40.23, 40.27, 40.28, 40.31(k) and (i), 40.32(d), (e) and (g), 40.33, 40.38, 40.41(d), (e)(1) and (3) and (g), 40.51(b)(6), 40.64, 40.66, 40.67, 40.81 and 40.82 are not incorporated by reference.
Subchapter J. RECIPROCITY § 217.201. Incorporation by reference.
Except as provided in this subchapter, the requirements of 10 CFR 150.1, 150.2, 150.3, 150.11 and 150.20 are incorporated by reference.
§ 217.202. Effect of incorporation of 10 CFR Part 150.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 150 (relating to exemptions and continued regulatory authority in agreement states and in offshore waters under section 274), the following words and phrases shall be substituted for the language in 10 CFR Part 150:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) A reference to ''byproduct material'' includes NARM.
(5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
§ 217.203. Reciprocity of licenses for byproduct, source, naturally occurring and accelerator-produced radioactive material and special nuclear material in quantities not sufficient to form a critical mass.
(a) Subject to this article, a person who holds a specific license from the NRC or a state where the licensee maintains an office, issued by the agency having jurisdiction to direct the licensed activity and to maintain radiation safety records, is granted a general license to conduct the activities authorized in the licensing document within this Commonwealth, except for areas of exclusive Federal jurisdiction, for a period not in excess of 180 days in a calendar year if:
(1) The licensing document does not limit the activity authorized by the document to specified installation or locations.
(2) The out-of-State licensee notifies the Department in writing at least 3 days prior to engaging in the activity. The notification shall indicate the location, period and type of proposed possession and use within this Commonwealth, and shall be accompanied by a copy of the pertinent licensing document. If for a specific case the 3-day period would impose an undue hardship on the out-of-State licensee, the licensee may, upon application to the Department, obtain permission to proceed sooner. The Department may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in this subsection.
(3) The out-of-State licensee complies with this title and with the terms and conditions of the licensee's document, except terms and conditions which may be inconsistent with this title.
(4) The out-of-State licensee supplies other information as the Department may request.
(5) The out-of-State licensee does not transfer or dispose of radioactive material possessed or used under the general license provided in this subsection except by transfer to a person who is one of the following:
(i) Specifically licensed by the Department, the NRC or by another state to receive the material.
(ii) Exempt from the requirements for a license for the material under Subchapter B (relating to general provisions for radioactive material).
(b) Notwithstanding the provisions of subsection (a), a person who holds a specific license issued by the NRC or a state authorizing the holder to manufacture, transfer, install or service a device described in Subchapter C (relating to general licenses for radioactive material) within areas subject to the jurisdiction of the licensing body is granted a general license to install, transfer, demonstrate or service the device in this Commonwealth subject to the following conditions:
(1) The person files a report with the Department within 30 days after the end of a calendar quarter in which a device is transferred to or installed in this Commonwealth. The report shall identify the general licensee to whom the device is transferred by name and address, the type of device transferred and the quantity and type of radioactive material contained in the device.
(2) The device has been manufactured, labeled, installed and serviced in accordance with the specific license issued to the person by the NRC or a state.
(3) The person assures that labels required to be affixed to the device, under regulations of the authority which licensed manufacture of the device, bear a statement that ''Removal of this label is prohibited.''
(4) The holder of the specific license or his intermediary shall provide a copy of the conditions of general license contained in Subchapter C to the general licensee upon transfer of the radioactive material or installation of a device containing the radioactive material.
(c) The Department may withdraw, limit or qualify its acceptance of a specific license or equivalent licensing document issued by another agency, or product distributed under the licensing document, upon determining that the action is necessary to prevent undue hazard to public health and safety or property.
(d) When a person is granted a general license under subsection (a) and subsequently exceeds the prescribed 180-day period, the person shall file a license application with the Department under Subchapter B within 30 days after the end of the 180-day period.
(e) Implementation of the requirements of this section regarding byproduct, source and special nuclear material is subject to § 217.133 (relating to persons possessing a license for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass on the date the Commonwealth becomes an agreement state as published in the Federal Register).
CHAPTER 218. FEES
GENERAL § 218.1. Purpose and scope.
(a) This chapter establishes fees for registration and licensing and provides for their payment. For the purpose of this chapter, radiation-producing machines under the same administrative control in a single building are registered or licensed as a single facility. Radiation-producing machines under the same administrative control at the same address or in a contiguous group of buildings may be registered or licensed as a single facility if the Department determines that it is appropriate.
(b) Except as otherwise specifically provided, this chapter applies to a person who:
(1) Is required to register or renew registration for radiation-producing machines or radiation-producing machine service providers under Chapter 216 (relating to registration of radiation-producing machines and radiation-producing machine service providers).
(2) Is an applicant for or holder of a radioactive material license issued under Chapter 217 (relating to licensing of radioactive material).
(3) Is an applicant for or holder of an accelerator license issued under Chapter 228 (relating to radiation safety requirements for particle accelerators).
PAYMENT OF FEES § 218.11. Registration, renewal of registration and license fees.
(a) Annual registration fees for radiation-producing machines, other than accelerators, are the sum of an annual administrative fee and an annual fee for each X-ray tube or radiation generating device as follows:
Type Facility Annual
Administrative FeeAnnual Fee per
X-ray Tube or
Radiation
Generating DeviceDentists, podiatrists, veterinarians $ 70 $35 Hospitals $520 $35 Other Facilities $250 $35 (b) A registrant filing an initial registration under § 216.2 (relating to registration of radiation-producing machines) or an application for renewal of a certificate of registration under § 216.4 (relating to renewal of certificate of registration) shall remit the appropriate fee calculated by using the information on the registration or application form and the fee schedule in subsection (a). Fees for any initial registration under § 216.2 are payable upon the filing of the registration. Fees for the renewal of a certificate of registration are payable upon the submission of an application for a renewal of a certificate of registration. If the number of tubes increases after an initial registration or after an application for renewal has been filed with the Department, no additional fee is required until the time of the next registration. Likewise, if the number of tubes decreases during the year, no refund will be made for that year.
(c) Annual license fees for radioactive material are set forth in Appendix A (relating to fees for radioactive material licenses).
(1) No refund will be made for termination of a license.
(2) If, by amendment or otherwise, a license changes to another fee category, the fee for the new category will take effect on the anniversary date of the license.
(d) Particle accelerators are licensed under Chapter 228 (relating to radiation safety requirements for particle accelerators). Annual fees are as follows:
(i) Accelerators, below 50 MeV, other than for ion implantation--$1,500 for the first accelerator at the facility plus $500 for each additional unit at that facility.
(ii) Accelerators used for ion implantation--$500 plus $50 for each additional unit at the same facility.
(iii) Accelerators above 50 MeV--full cost of staff time to review license applications and conduct inspections as needed. (Hourly rate is $50 per hour). For the purpose of anticipating costs and compliance with subsections (e) and (f), a minimum annual fee of $1,500 for the first accelerator at the facility plus $500 for each additional unit is established. Additional invoices will be issued by the Department at regular intervals at least quarterly when net costs are incurred above the minimum annual fee.
(e) An initial application for a license or reciprocity shall be accompanied by a check payable to the Department in accordance with the fee schedules in subsections (c) and (d). Thereafter, the Department will issue an annual fee invoice in accordance with the appropriate fee schedule at least 2 months prior to the license expiration. Fees are payable by the last day of the license expiration month as shown on the license fee invoice. This provision is not applicable to full cost recovery licenses specified in Appendix A.
(f) The Department will not accept an initial application for a license prior to payment of the fees required by subsections (c) and (d).
(g) If the registration involves more than one of the facilities in subsection (a), or if a license involves more than one of the categories in subsection (c), the highest applicable fee applies.
(h) A radiation-producing machine service provider shall pay an annual registration fee of $100.
APPENDIX A
Fees for Radioactive Material Licenses
Fee Category5,6 Description Annual Fee
($)1,2,3,4,71C Special Nuclear Material Sealed Source Gauges (X-Ray Fluorescence) 875 1D Special Nuclear Material--Other 2,475 2B Source Material as Shielding 450 2C Source Material--Other (not 11e2) 8,650 3A1 Manufacturing & Distribution Commercial Broad Scope--10 CFR 30, 33 19,875 3A2 Manufacturing & Distribution Commercial Broad Scope--NARM Only 4,000 3B1 Manufacturing & Distribution Commercial Specific License--10 CFR 30 4,650 3B2 Manufacturing & Distribution Commercial Specific License--NARM Only 2,000 3C1 Manufacturing & Distribution Pharmaceuticals--10 CFR 32.72--32.74 11,650 3C2 Manufacturing & Distribution Pharmaceuticals--NARM Only 4,000 3D1 Pharmaceuticals--Distribution Only--10 CFR 32.7x 2,825 3D2 Pharmaceuticals--Distribution Only--NARM Only 2,000 3E Irradiator--Shielded Source 2,575 3F Irradiator--Unshielded < 10kCi 4,300 3G Irradiator--Unshielded >= 10kCi 10,750 3I Distribution As Exempt--No Review of Device 3,525 3J Distribution--SSD Devices to Part 31 GLs 1,550 3K Distribution--No Review-Exempt Sealed Source 1,300 3L1 Research & Development Broad Scope 8,300 3L2 Research & Development Broad Scope--NARM Only 2,000 3M1 Research & Development 3,650 3M2 Research & Development--NARM Only 750 3N Services other than Leak Testing, Waste Disposal or Calibration 3,875 3O Radiography 10,850 3P1 Other Byproduct Material 1,900 3P2 NARM Licenses not covered elsewhere 750 3Q Generally licensed devices under § 217.143 (relating to certain measuring, gauging or controlling devices) 315 4A Waste Storage, Processing or Disposal Full Cost * 4B Waste Packaging or Repackaging 8,175 4C Waste Receipt of Prepackaged for Disposal 6,125 5A Well Logging & Non Field Flood Tracers 7,500 5B Well Logging Field Flood Tracer Studies Full Cost * 6A Nuclear Laundry 14,250 7A Human Use--Teletherapy 11,275 7B1 Human Use--Broad Scope (except Teletherapy) 19,975 7B2 Human Use--Broad Scope (except Teletherapy)--NARM Only 2,000 7C1 Human Use--Specific License (except Teletherapy) 4,300 7C2 Human Use--Specific License (except Teletherapy)--NARM Only 750 8A1 Specifically licensed sources used in static eliminators, nonexempt smoke detectors, fixed gauges, dew pointers, calibration sources, civil defense uses or in temporary (2 years or less) storage 875 8A2 Specifically licensed NARM sources used in static eliminators, nonexempt smoke detectors, fixed gauges, dew pointers, calibration sources, civil defense uses or in temporary (2 years or less) storage 200 14 Decontamination, Decommissioning, Reclamation or Site Restoration Full Cost * 16A Reciprocity (180 days/year) 900 16B Reciprocity--NARM (180 days/year) 300 SB15 Small Business--Category 1 2,100 SB26 Small Business--Category 2 400 1 A license may include as many as four noncontiguous sites at the base fee. Sites that are within 5 miles of the main Radiation Safety Office where the license records are kept will be considered contiguous. An additional fee of 25% of the base fee will be added for each noncontiguous site above four.
2 All fees for NARM licenses will be effective upon publication of the final rules in the Pennsylvania Bulletin. The fees for NRC licenses that are transferred to the Commonwealth will be effective on the next license anniversary date. NARM licenses will be changed to the corresponding category of byproduct material license on the next license anniversary date after achievement of Agreement State status and fees adjusted at that time. The NARM license categories will cease to exist one year after Agreement State status is achieved.
3 Annual fees for categories of NRC licenses that are not included in this table will be calculated as follows: PA Fee = 0.7 (NRC Annual Fee + 0.10 NRC Application or Renewal fee).
4 Annual fees charged to holders of transferred NRC licenses with multiple sites will not exceed the fees charged by the NRC for the same licenses in the year of transfer, provided the number of noncontiguous sites remains constant.
5 Small Businesses Not Engaged in Manufacturing, and Small Not-For-Profit Organizations with Gross Annual Receipts of more than $350,000 and less than $5 million; Manufacturing Entities that have an average of 35--500 employees with Gross Annual Receipts of more than $350,000 and less than $5 million; Small Government Jurisdictions (including publicly supported, nonmedical educational institutions) with a population between 20,000 and 50,000; and nonmedical Educational Institutions that are not state or publicly supported and have 35--500 employees.
6 Small Businesses Not Engaged in Manufacturing, and Small Not-For-Profit Organizations with Gross Annual Receipts of less than $350,000; Manufacturing Entities that have an average of less than 35 employees and less than $350,000 in Gross Annual Receipts; Small Government Jurisdictions (including publicly supported nonmedical educational institutions) with a population less than 20,000; and nonmedical Educational Institutions that are not state or publicly supported and have less than 35 employees.
7 Full cost recovery licensees and licensees required to provide financial assurance for decommissioning are not eligible for reduced fees under category SB1 or SB2.
* Full cost recovery consists of a professional fee, to cover the activities and support of Department personnel, and any other additional incidental charges incurred, such as related contracted services or laboratory costs. The professional fee component (Hourly Rate) is $50 per hour. Other costs are recovered at 100% of actual cost. Invoices shall be issued by the Department at regular intervals but at least quarterly when net costs are incurred.
CHAPTER 219. STANDARDS FOR PROTECTION AGAINST RADIATION
Subchapter A. GENERAL PROVISIONS
GENERAL PROVISIONS § 219.3. Definitions.
The following term, when used in this subchapter, has the following meaning, unless the context clearly indicates otherwise:
Medical reportable event for radiation-producing machine therapy--The administration to a human being, except for an administration resulting from a direct intervention of a patient that could not have been reasonably prevented by the licensee or registrant, that results in one of the following:
(i) An administration of a therapeutic radiation dose to the wrong individual.
(ii) An administration of a dose for therapy when the result is an increase in the total expected doses inside or outside of the intended treatment volume for organs, tissue or skin that exceeds 20% of the total prescribed dose for the intended target volume.
(iii) A total dose delivered to the treatment site identified in a written directive for therapy that is outside the prescribed dose range or differs from the total prescribed dose by more than 20%, or for a fractionated dose, when the weekly administered dose differs from the weekly prescribed dose by more than 30%.
§ 219.6. Effect of incorporation of 10 CFR Part 20.
To reconcile differences between this chapter and the incorporated sections of 10 CFR Part 20 (relating to standards for protection against radiation), the following words and phrases shall be substituted for the language in 10 CFR Part 20 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) A reference to ''licensee'' includes registrant.
(4) A reference to ''license'' includes registration.
(5) A reference to ''licensed'' includes registered.
(6) A reference to ''Department'' in 10 CFR means the United States Department of Energy.
(7) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
(8) 10 CFR Part 20, notwithstanding, exposures involving the use of X-rays may be weighted, in a manner specified by the Department, so that, with Department approval, the effective dose equivalent may be substituted for the deep dose equivalent in determining compliance with occupational exposure limits for specified groups of individuals.
§ 219.8. Requirement for a Radiation Safety Committee.
The requirements of 10 CFR 35.24 (relating to authority and responsibilities for the radiation protection program) apply to registrants as well as licensees. For the purpose of this requirement, facilities that utilize two or more modalities in which patients are likely to receive, or will receive a dose to an organ in excess of 200 rads (2.0 gray), shall have a radiation safety committee.
Subchapter E. TESTING FOR LEAKAGE OR CONTAMINATION OF SEALED SOURCES § 219.61. Testing for leakage or contamination of sealed sources.
(a) In addition to incorporation by reference of 10 CFR Part 20 (relating to standards for protection against radiation), a licensee possessing a sealed source shall assure that:
(1) Except as specified in subsection (b), each sealed source is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee has a certificate from the transferor indicating that the sealed source was tested within 6 months before transfer to the licensee.
(2) Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed 6 months or at alternative intervals specified in the Sealed Source and Device Registry approved by the Department, a state or the NRC.
(3) Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed 3 months or at alternative intervals specified in the Sealed Source and Device Registry approved by the Department, a state or the NRC.
(4) For each sealed source that is required to be tested for leakage or contamination, the sealed source is tested for leakage or contamination before further use at any time there is reason to suspect that the sealed source might have been damaged or might be leaking.
(5) Except for brachytherapy sources manufactured to contain radium, tests for leakage for sealed sources shall be capable of detecting the presence of 185 Bq (0.005 µCi) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For a sealed source contained in a device, test samples are obtained when the source is in the ''off'' position.
(6) The test for leakage for brachytherapy sources manufactured to contain radium shall be capable of detecting an absolute leakage rate of 37 Bq (0.001 µCi) of radon-222 in a 24-hour period when the collection efficiency for radon-222 and its progeny has been determined with respect to collection method, volume and time.
(7) Tests for contamination from radium progeny shall be taken on the interior surface of brachytherapy source storage containers and shall be capable of detecting the presence of 185 Bq (0.005 µCi) of any radium progeny which has a half-life greater than 4 days.
(b) A licensee need not perform tests for leakage or contamination on the following sealed sources:
(1) Sealed sources containing only radioactive material with a half-life of less than 30 days.
(2) Sealed sources containing only radioactive material as a gas.
(3) Sealed sources containing 3.7 MBq (100 µCi) or less of beta or photon-emitting material or 370 kBq (10 µCi) or less of alpha-emitting material.
(4) Sealed sources containing only hydrogen-3.
(5) Seeds of iridium-192 encased in nylon ribbon.
(6) Sealed sources, which are stored, are not being used, and are identified as in storage. The licensee shall test each of these sealed sources for leakage or contamination and receive the test results before any use or transfer unless it has been tested for leakage or contamination within 6 months before the date of use or transfer.
(c) Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the Department, an agreement state, a licensing state or the NRC to perform these services.
(d) Test results shall be kept in units of becquerel or microcurie and maintained for inspection by the Department.
(e) The following shall be considered evidence that a sealed source is leaking:
(1) The presence of 185 Bq (0.005 µCi) or more of removable contamination on any test sample.
(2) Leakage of 37 Bq (0.001 µCi) of radon-222 per 24 hours for brachytherapy sources manufactured to contain radium.
(3) The presence of removable contamination resulting from the decay of 185 Bq (0.005 µCi) or more of radium.
(f) The licensee shall immediately withdraw a leaking sealed source from use and take action to prevent the spread of contamination. The leaking sealed source shall be repaired or disposed of in accordance with this article.
(g) Reports of test results for leaking or contaminated sealed sources shall be made under § 219.227 (relating to reports of leaking or contaminated sealed sources).
Subchapter M. REPORTS § 219.228. Reports of medical reportable events for radiation-producing machine therapy.
(a) For a medical reportable event for radiation-producing machine therapy, the licensee or registrant shall do the following:
(1) Notify the Department by telephone within 24 hours after discovery of the event.
(2) Submit a written report to the Department within 15 days after discovery of the event. The written report shall include the licensee's or registrant's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee or registrant notified the patient, or the patient's responsible relative or guardian (for notification purposes under this section, this person will be included in subsequent references to ''the patient''), and if not, why not; and if the patient was notified, what information was provided to the patient. The report may not include the patient's name or other information that could lead to identification of the patient.
(3) Notify the referring physician and also notify the patient of the event within 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the patient or that, based on medical judgment, telling the patient would be harmful. The licensee or registrant is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within 24 hours, the licensee or registrant shall notify the patient as soon as possible thereafter. The licensee or registrant may not delay appropriate medical care for the patient, including necessary remedial care, because of delay in notification.
(4) If the patient was notified, the licensee or registrant shall also furnish, within 15 days after discovery of the event, a written report to the patient by sending one of the following:
(i) A copy of the report that was submitted to the Department.
(ii) A brief description of both the event and the consequences, as they may affect the patient, if a statement is included that the report submitted to the Department can be obtained from the licensee or registrant.
(b) The licensee or registrant shall retain a record of each medical reportable event for radiation-producing machine therapy for 5 years. The record shall contain the names of the individuals involved (including the prescribing 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, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence and the actions taken to prevent recurrence.
(c) Aside from the notification requirement, this section does not affect rights or duties of licensees or registrants and physicians in relation to each other, patients or the patient's responsible relatives or guardians.
§ 219.229. Other medical reports.
Within 30 days of the determination by a physician of either actual or suspected acute or long-term functional damage to an organ or a physiological system of a patient exposed to therapeutic or diagnostic radiation from a radiation-producing machine, the registrant or licensee shall document the finding and provide a report to the Department and provide a clinical summary to the prescribing physician and the patient. The report shall be retained for at least 5 years. Exempt from this reporting requirement are any events already reported under § 219.228 (relating to reports of medical reportable events for radiation-producing machine therapy) and any functional damage to a patient organ or a physiological system that was an expected outcome when the causative procedures were prescribed.
CHAPTER 220. NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS AND INVESTIGATIONS § 220.2. Posting of notices to workers.
(a) A licensee or registrant shall post current copies of the following documents:
(1) This chapter and Chapter 219 (relating to standards for protection against radiation).
(2) The license, certificate of registration, conditions or documents incorporated into the license by reference and amendments thereto.
(3) The operating procedures applicable to activities under the license or registration.
(4) A notice of violation involving radiological working conditions, proposed imposition of civil penalty or order issued under Chapter 215 (relating to general provisions) and response from the licensee or registrant.
(b) If posting of a document specified in subsection (a)(1), (2) or (3) is not practicable, the licensee or registrant may post a notice which describes the document and states where it may be examined.
(c) Department Form 2900-FM-RP0003, ''Notice to Employees,'' shall be posted by a licensee or registrant as required by this article.
(d) Department documents posted under subsection (a)(4) shall be posted within 2 working days after receipt of the documents from the Department; the licensee's or registrant's response shall be posted within 2 working days after dispatch from the licensee or registrant. The documents shall remain posted for a minimum of 5 working days or until action correcting the violation has been completed, whichever is later.
(e) Documents, notices or forms posted under this section shall appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from the particular work location to which the document applies. The documents, notices or forms shall be conspicuous and shall be replaced if defaced or altered.
CHAPTER 221. X-RAYS IN THE HEALING ARTS
GENERAL PROVISIONS § 221.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Filter--Material placed in the useful beam to modify the spectral energy distribution and flux of the transmitted radiation and preferentially absorb selected radiation.
Filtration--The amount of material placed in the useful beam to modify the radiation's characteristics, typically expressed in terms of millimeters of aluminum or copper equivalent.
* * * * * Half-value layer (HVL)--
(i) The thickness of specified material which attenuates the exposure rate by 1/2 when introduced into the path of a given beam of radiation. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.
(ii) The term is used to describe the penetrating ability of the radiation.
Healing arts screening--The testing of human beings using X-ray machines for the detection or evaluation of health indications when the tests are not specifically and individually ordered for the purpose of diagnosis or treatment by a licensed practitioner of the healing arts legally authorized to prescribe the X-ray tests.
* * * * * Protective glove--A glove incorporating radiation absorbing materials.
Radiation detector--A device which provides a signal or other indication suitable for measuring one or more quantities of incident radiation.
* * * * *
ADMINISTRATIVE CONTROLS § 221.11. Registrant responsibilities.
(a) The registrant is responsible for directing the operation of X-ray systems under his administrative control and shall assure that the requirements of this article are met in the operation of the X-ray systems.
(b) An individual who operates an X-ray system shall be instructed adequately in the safe operating procedures and be competent in the safe use of the equipment. The instructions shall include items included in Appendix A (relating to determination of competence) and there shall be continuing education in radiation safety, biological effects of radiation, quality assurance and quality control.
(c) A chart, which specifies the techniques for examinations performed with the system, shall be provided in the vicinity of each diagnostic X-ray system's control panel. This chart shall include information pertinent to the particular examination, such as:
(1) The patient's body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized.
(2) The type and size of the film or film-screen combination.
(3) The type of grid, if any.
(4) The type and location of placement of patient shielding-for example, gonad, and the like.
(5) For mammography, indication of kVp/target/filter combination.
(6) Source to image receptor distance to be used, except for dental intraoral radiography.
(d) Written safety procedures and rules shall be available at a facility including restrictions of the operating technique required for the safe operation of the particular X-ray system. The operator shall be able to demonstrate familiarity with the rules.
(e) Except for patients who cannot be moved out of the room, only the staff and ancillary personnel or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. The following apply for individuals other than the patient being examined:
(1) Individuals shall be positioned so that no part of the body will be struck by the useful beam unless protected by at least 0.5 millimeter lead equivalent material. The lead equivalent of the material is to be determined at 60 kV.
(2) All persons required for the medical procedure shall be protected from the stray radiation by protective aprons or whole protective barriers of at least 0.25 millimeter lead equivalent or shall be so positioned that the persons are not in the direct line of the useful beam and the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.
(3) A patient who cannot be removed from the room shall be protected from the stray radiation by protective barriers of at least 0.25 millimeter lead equivalent material unless the shield would compromise the health of the individual or shall be so positioned that the patient is not in the direct line of the useful beam and the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.
(4) No individual, other than the patient being examined, may be in the useful beam, unless required to conduct the procedure.
(f) During diagnostic procedures in which the gonads are in the useful beam, gonad shielding of at least 0.5 millimeter lead equivalent shall be used for patients except for cases in which this would interfere with the diagnostic procedure.
(g) An individual may not be exposed to the useful beam except for healing arts purposes or under § 221.15 (relating to use of X-rays in research on humans). An exposure shall be authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:
(1) Exposure of an individual for training, demonstration or other nonhealing arts purposes.
(2) Exposure of an individual for the purpose of healing arts screening except as authorized by the Department. When requesting authorization, the registrant shall submit the information outlined in § 221.13 (relating to information to be submitted by persons requesting approval to conduct healing arts screening).
(h) If a patient or image receptor requires auxiliary support during a radiation exposure the following apply:
(1) Mechanical holding devices shall be used when the technique permits.
(2) The human holder shall be protected as required by subsection (e).
(3) An individual may not be used routinely to hold image receptors or patients.
(i) Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.
(j) The screen and film system used shall be spectrally compatible. Defective screens may not be used for diagnostic radiological imaging.
(k) With the exception of intraoral dental radiography, film may not be used without intensifying screens for routine diagnostic radiological imaging.
(l) The registrant shall have a quality assurance program. This quality assurance program shall be documented and be in accordance with guidelines established by the Department or by another appropriate organization recognized by the Department. At a minimum, the quality assurance program shall address repeat rate; image recording, processing and viewing; and maintenance and modifications to the quality assurance program. Records shall be maintained by the registrant for inspection by the Department for 3 years. The Department's guidelines and a list of recognized organizations will be maintained and made available on the Department's website and on request.
(m) Neither the X-ray tube housing nor the collimating device may be hand-held during the exposure.
§ 221.13. Information to be submitted by persons requesting approval to conduct healing arts screening.
(a) The Department will consider efficacy as a factor in evaluating healing arts screening procedures. In its review, the Department will consider National medical organization consensus statements as well as peer reviewed scientific and medical literature that addresses the efficacy of the proposed screening procedures. The review may also consider relevant information from appropriate Federal agencies. For procedures that result in an individual organ dose or deep dose equivalent greater than 1 mSv (100 mrem) to a screened individual the Department will consult with the Department of Health (DOH) for assistance in reviewing the efficacy of the proposed procedures but the final decision will remain that of the Department. The DOH will have access to all relevant materials when rendering its review.
(b) A person requesting that the Department approve a healing arts screening program shall submit in writing the following information for evaluation by the Department. If information submitted to the Department becomes invalid or outdated, the registrant shall immediately notify the Department.
(1) The name and address of the applicant and, if applicable, the names and addresses of agents within this Commonwealth.
(2) The diseases or conditions for which the X-ray examinations are to be used.
(3) The description in detail of the X-ray examinations proposed in the screening program.
(4) A description of the population to be examined in the screening program--age, sex, physical condition and other appropriate information.
(5) An evaluation of all known alternate methods that could achieve the goals of the screening program and why these methods are not used in preference to the proposed X-ray examinations.
(6) An evaluation by a qualified expert of the X-ray systems to be used in the screening program. The evaluation shall show that the systems satisfy the requirements of this article. The evaluation shall include a measurement of patient entrance exposures and calculation of the maximum shallow dose, deep dose equivalent and organ dose from the X-ray examinations to be performed.
(7) A description of the diagnostic X-ray quality control program.
(8) A copy of the technique chart for the X-ray examination procedures to be used if exposure parameters are set manually or a description of how exposure parameters are determined.
(9) The qualifications of all individuals who will be operating the X-ray systems.
(10) The qualifications of the physician who will be supervising the operators of the X-ray systems. The extent of supervision and the method of work performance evaluation shall be specified.
(11) The name, address and qualifications of the individual who will interpret the screening procedure results.
(12) A description of the information and procedure for advising the individuals screened of the potential for false positive or negative results and the implications for the patient; the procedure for recording informed consent for the procedure following disclosure of this information; and the procedure for advising the individuals screened and their private practitioners of the healing arts of the results of the screening procedure and further medical needs indicated.
(13) A description of the procedures for the retention or disposition of the diagnostic images, data and other records pertaining to the X-ray examination.
(14) Mammography facilities shall comply with 21 CFR Part 900 (relating to mammography).
(15) An approximation of the frequency of screening activities and duration of the entire screening program.
§ 221.15. Use of X-rays in research on humans.
(a) Registrants conducting research using X-rays involving human subjects are exempted from the requirements of this section if the research is conducted, funded, regulated or supported by a Federal agency which has implemented the Federal policy for the protection of human subjects or if the research is carried out in an institution which conducts other Federally funded or supported human research and follows all Federal requirements for protocol review and research subject protection.
(b) If not exempted under subsection (a), a person shall submit, in writing, the following information and evaluation to the Department and receive approval by the Department before conducting the research. If the information submitted to the Department becomes invalid or outdated, the person shall immediately, in writing, notify the Department.
(1) The name and address of the applicant and, if applicable, the names and addresses of agents within this Commonwealth.
(2) A description of the population to be examined in the research program, age, sex, physical condition and other appropriate information.
(3) An evaluation of all known alternate methods that could achieve the goals of the research program and why these methods are not used in preference to the X-ray examinations.
(4) An evaluation by a qualified expert of the X-ray system to be used in the research program. This evaluation shall show that the system satisfies the requirements of this article. The evaluation shall include a projected measurement of individual and cumulative patient exposures from the X-ray examinations to be performed.
(5) A description of the diagnostic X-ray quality control program.
(6) A copy of the technique chart which specifies the information for the X-ray examination procedures to be used if exposure parameters are set manually or a description of how exposure parameters are determined.
(7) The qualifications of all individuals who will be operating the X-ray system.
(8) The qualifications of the physician who will be supervising the operators of the X-ray systems. The extent of supervision and the method of work performance evaluation shall be specified.
(9) The name, address and qualifications of the individual who will interpret the data.
(10) A copy of the research protocol authorized by a committee consisting of at least three qualified persons. At least one of the committee members shall be knowledgeable in radiation effects on humans.
(11) The provisions for independent institutional review.
(c) Proposed subjects or their legal representative shall sign a statement acknowledging that they have been informed of their anticipated radiation exposure and possible consequences arising from this exposure.
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