reglab/statecodes huggingface dataset:
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 218 - FEES › PAYMENT OF FEES › Section 218.12 - Failure by registrant or licensee to pay required fee

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A registrant or licensee who fails to pay
						an annual fee required under this chapter shall be subject to the civil and
						criminal penalties provided under the act.
(b) Nonpayment of fees required by this
						chapter shall be cause for revocation of licenses or registrations issued by
						the Department under the act.
The provisions of this §
														218.12 amended under sections 301
							 and 302 of the Radiation Protection Act (35 P. S.
							 §§
															7110.301 and
							 7110.302).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter A - GENERAL PROVISIONS › Section 219.1 - Purpose

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This chapter
						establishes standards for protection against ionizing radiation resulting from
						activities conducted under licenses or registrations issued by the Department.
						Licensees and registrants shall comply with this chapter.
(b) The requirements of this chapter are
						designed to control the receipt, possession, use, transfer and disposal of
						sources of radiation by a licensee or registrant so the total dose to an
						individual, including doses resulting from all sources of radiation other than
						background radiation, does not exceed the standards for protection against
						radiation prescribed in this chapter. This chapter does not limit actions that
						may be necessary to protect health and safety.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter A - GENERAL PROVISIONS › Section 219.2 - Scope

Current through Register Vol. 54, No. 28, July 13, 2024
Except as specifically provided in other chapters of
						  this article, this chapter applies to persons licensed or registered by the
						  Department to receive, possess, use, transfer or dispose of sources of
						  radiation. The limits in this chapter do not apply to doses due to background
						  radiation, to exposure of patients to radiation for the purpose of medical
						  diagnosis or therapy or to voluntary participation in medical research
						  programs.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter A - GENERAL PROVISIONS › Section 219.3 - Definitions

Current through Register Vol. 54, No. 28, July 13, 2024
The following terms, when used in this subchapter, have
						  the following meanings, unless the context clearly indicates otherwise:
Medical reportable event for
						  radiation-producing diagnostic or interventional X-ray procedures
-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 unintended peak skin dose to the same
						area in a single procedure greater than 1500 rad (15 Gy).
(ii) An unintended dose, other than skin
						dose, in a single procedure exceeding five times the facility's established
						protocol and 50 rad (0.5 Gy) to any organ.
(iii) A dose to the wrong patient, or wrong
						site for the entire procedure, and exceeding 50 rad (0.5 Gy) to any
						organ.
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, wrong treatment site or using a
						treatment delivery intended for another individual.
(ii) An administration of a dose for therapy
						identified in a written directive that differs from the prescribed dose for the
						treatment site or any other organ from the intended prescribed dose, by one of
						the following:
(A) More than 20% of the total
						prescribed dose.
(B) Exceeds 30% of
						the weekly prescribed dose.
(C)
						Exceeds 50% of a single fraction dose of a multifraction plan.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter A - GENERAL PROVISIONS › Section 219.5 - Incorporation by reference

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Except
						as provided in this chapter, the requirements of 10 CFR Part 20 (relating to
						standards for protection against radiation) are incorporated by
						reference.
(b) Notwithstanding the
						requirements incorporated by reference, 20.1006, 20.1009, 20.2206(a)(1), (3),
						(4) and (5), 20.2401 and 20.2402 are not incorporated by reference.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter A - GENERAL PROVISIONS › Section 219.6 - Effect of incorporation of 10 CFR Part 20

Current through Register Vol. 54, No. 28, July 13, 2024
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 (relating to energy) shall be
						directed to the Department, except as required under
						10 CFR
						20.2206 (relating to reports of individual
						monitoring).
(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.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter A - GENERAL PROVISIONS › Section 219.7 - Effect of incorporation of 10 CFR 20.1403 "Criteria for license termi nation under restricted conditions

Current through Register Vol. 54, No. 28, July 13, 2024
The Department will not terminate a license under the
						  conditions of restricted release as provided for in
						  10 CFR
						  20.1403 (relating to criteria for license
						  termination under restricted conditions) until a license termination plan
						  (LTP), approved by the Department, has been in effect for a period of time
						  sufficient to demonstrate to the Department that continued implementation of
						  the plan will be effective in maintaining compliance with the required
						  conditions of the plan. The Department may choose to implement the license
						  termination process in one or more of the following steps:
(1) The license is amended to authorize
						activities necessary to begin decommissioning under the LTP.
(2) After decommissioning activities are
						complete and the provisions of
						10 CFR
						20.1403 are in effect under the LTP, the
						license may be amended to end authorization of licensed activities. The license
						shall remain in effect for up to 5 years being limited to ownership/possession
						of the decommissioned material.
(3)
						At the end of the period prescribed in paragraph (2), the Department will make
						a determination of the effectiveness of the LTP as enacted. If the LTP has
						demonstrated the ability to maintain compliance with
						10 CFR
						20.1403, the license will be terminated
						subject to the revisitation provision of
						10 CFR
						20.1401(c) (relating to
						general provision and scope) regarding new evidence of a significant threat to
						health and safety. Otherwise, the licensee will be directed by the Department
						to take corrective actions as necessary to conform to
						10 CFR
						20.1403 and the process shall revert back to
						paragraph (2).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter A - GENERAL PROVISIONS › Section 219.8 - Requirement for a Radiation Safety Committee

Current through Register Vol. 54, No. 28, July 13, 2024
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.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter D - RADIATION DOSE LIMITS FOR INDIVIDUAL MEMBERSOF THE PUBLIC › Section 219.51 - Dose limits for individual members of the public

Current through Register Vol. 54, No. 28, July 13, 2024
In addition to incorporation by reference of 10 CFR
						  Part 20 Subpart D (relating to dose limits for individual members of the
						  public), registrants who met the previous limit (5 mSv or 0.5 REM in 1 year)
						  for locations having existing radiation-producing machines or equipment or
						  other registered radiation sources will not be required to retrofit
						  installations existing before November 18, 1995. The Department does not
						  require the retrofitting of shielding for the replacement of equipment in the
						  facility as long as the equipment is being replaced with similar
						  equipment.
This section cited in 25 Pa. Code §
														223.7 (relating to structural
							 shielding).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter D - RADIATION DOSE LIMITS FOR INDIVIDUAL MEMBERSOF THE PUBLIC › Section 219.52 - Reserved

Current through Register Vol. 54, No. 28, July 13, 2024
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter E - TESTING FOR LEAKAGE OR CONTAMINATION OF SEALED SOURCES › Section 219.61 - Testing for leakage or contamination of sealed sources

Current through Register Vol. 54, No. 28, July 13, 2024
(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.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter E - TESTING FOR LEAKAGE OR CONTAMINATION OF SEALED SOURCES › Section 219.62-219.66 - Reserved

Current through Register Vol. 54, No. 28, July 13, 2024
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter I - STORAGE AND CONTROL OF LICENSED OR REGISTERED SOURCES OF RADIATION › Section 219.131 - Security of stored sources of radiation

Current through Register Vol. 54, No. 28, July 13, 2024
In addition to incorporation by reference of 10 CFR
						  Part 20 (relating to standards for protection against radiation), the licensee
						  or registrant shall secure from unauthorized removal or access radiation
						  sources that are in storage.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter I - STORAGE AND CONTROL OF LICENSED OR REGISTERED SOURCES OF RADIATION › Section 219.132 - Control of sources of radiation not in storage

Current through Register Vol. 54, No. 28, July 13, 2024
In addition to incorporation by reference of 10 CFR
						  Part 20 (relating to standards for protection against radiation), the licensee
						  or registrant shall maintain control of radiation producing machines that are
						  not in storage.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter J - PRECAUTIONARY PROCEDURES › Section 219.159 - Posting of radiation-producing machines

Current through Register Vol. 54, No. 28, July 13, 2024
The registrant or licensee shall ensure that each
						  radiation producing machine is labeled in a conspicuous manner which cautions
						  individuals that radiation is produced when it is energized. For
						  example:
"CAUTION-RADIATION
THIS EQUIPMENT PRODUCES RADIATION
WHEN ENERGIZED."
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter J - PRECAUTIONARY PROCEDURES › Section 219.160 - Exceptions to posting requirements

Current through Register Vol. 54, No. 28, July 13, 2024
In addition to incorporation by reference of 10 CFR
						  Part 20 (relating to standards for protection against radiation), a room or
						  area is not required to be posted with a caution sign because of the presence
						  of radiation machines used solely for diagnosis in the healing
						  arts.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter M - REPORTS › Section 219.221 - Reports of stolen, lost or missing licensed or registered sources of radiation

Current through Register Vol. 54, No. 28, July 13, 2024
In addition to incorporation by reference of the
						  requirements in 10 CFR Part 20 (relating to standards for protection against
						  radiation) covering the reporting requirements associated with reports of theft
						  or loss of licensed material, the following reporting requirements apply to
						  radiation-producing machines:
(1)
Telephone reports.
Each licensee or registrant shall report to
						the Department by telephone immediately, after its occurrence becomes known, a
						stolen, lost or missing radiation producing machine.
(2)
Written reports.
Each
						licensee or registrant required to make a report under paragraph (1) shall,
						within 30 days after making the telephone report, make a written report to the
						Department setting forth the following information:
(i) A description of the licensed or
						registered source of radiation involved, including, for radiation producing
						machines, the manufacturer, model and serial number, type and maximum energy of
						radiation emitted.
(ii) A
						description of the circumstances under which the loss or theft
						occurred.
(iii) A statement of
						disposition, or probable disposition, of the licensed or registered source of
						radiation involved.
(iv) Exposures
						of individuals to radiation, circumstances under which the exposures occurred
						and the possible total effective dose equivalent to persons in unrestricted
						areas.
(v) Actions that have been
						taken, or will be taken, to recover the source of radiation.
(vi) Procedures or measures that have been,
						or will be, adopted to ensure against a recurrence of the loss or theft of
						licensed or registered sources of radiation.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter M - REPORTS › Section 219.222 - Notification of incidents and reportable events

Current through Register Vol. 54, No. 28, July 13, 2024
In addition to incorporation by reference of the
						  requirements in 10 CFR
						  20.2202 and
						  20.2203 (relating to notification
						  of incidents; and reports of exposures, radiation levels and concentrations of
						  radioactive material exceeding the constraints or limits), those notification
						  requirements, as well as written 30-day reports under
						  10 CFR
						  20.2203(a), also apply to
						  radiation-producing machines and NARM.
This section cited in 25 Pa. Code §
														225.76 (relating to reporting
							 requirements).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter M - REPORTS › Section 219.227 - Reports of leaking or contaminated sealed sources

Current through Register Vol. 54, No. 28, July 13, 2024
If the test for leakage or contamination, required
						  under §
												219.61 (relating to testing for
						  leakage or contamination of sealed sources), indicates a sealed source is
						  leaking or contaminated, a report of the test shall be filed within 5 days with
						  the Department describing the equipment involved, the test results and the
						  corrective action taken.
This section cited in 25 Pa. Code §
														219.61 (relating to testing for
							 leakage or contamination of sealed
							 sources).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter M - REPORTS › Section 219.228 - Reports of medical reportable events for radiation-producing machine therapy

Current through Register Vol. 54, No. 28, July 13, 2024
(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.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 219 - STANDARDS FOR PROTECTION AGAINST RADIATION › Subchapter M - REPORTS › Section 219.229 - Diagnostic or interventional procedure medical reports

Current through Register Vol. 54, No. 28, July 13, 2024
(a) 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 radiation from a
						diagnostic or interventional procedure 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.
(b) Upon discovery of a medical reportable
						event, the registrant or licensee shall:
(1)
						Notify the Department regarding the medical reportable event within 1 business
						day.
(2) Provide a written report,
						including the analysis of the medical reportable event, by the qualified
						medical physicist, as defined in §
													221.2 (relating to definitions),
						to the Department within 15 business days.
(3) Provide a clinical summary to the
						prescribing physician and patient within 15 business days.
(4) Maintain a record of the medical
						reportable event as part of the patient's permanent medical
						record.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 220 - NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS AND INVESTIGATIONS › Section 220.1 - Purpose and scope

Current through Register Vol. 54, No. 28, July 13, 2024
This chapter establishes requirements for notices,
						instructions and reports by licensees or registrants to individuals engaged in
						activities under a license or registration. This chapter also establishes
						options available to the individuals in connection with Department inspections
						of licensees or registrants to ascertain compliance with the provisions of the
						act and regulations, orders and licenses issued thereunder regarding
						radiological working conditions. This chapter applies to persons who receive,
						possess, use, own or transfer radiation sources licensed by or registered with
						the Department under Chapters 216 and 217 (relating to registration of
						radiation-producing machines and radiation-producing machine service providers;
						and licensing of radioactive material).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 220 - NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS AND INVESTIGATIONS › Section 220.2 - Posting of notices to workers

Current through Register Vol. 54, No. 28, July 13, 2024
(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.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 220 - NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS AND INVESTIGATIONS › Section 220.9 - Incorporation by reference

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Except
					 as provided in this chapter, the requirements of 10 CFR Part 19 (relating to
					 notices, instructions and reports to workers; inspections and investigations)
					 are incorporated by reference.
(b)
					 Notwithstanding the requirements incorporated by reference,
					 10 CFR
					 19.4,
					 19.5,
					 19.8,
					 19.30 and
					 19.40 are not incorporated by
					 reference.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 220 - NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS AND INVESTIGATIONS › Section 220.10 - Effect of incorporation of 10 CFR Part 19

Current through Register Vol. 54, No. 28, July 13, 2024
To reconcile differences between this chapter and the
						incorporated sections of 10 CFR Part 19 (relating to notices, instructions and
						reports to workers; inspection and investigations), the following words and
						phrases shall be substituted for the language in 10 CFR Part 19 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
					 "license," "licenses," "licensed" and "licensed radioactive material" also
					 include "registration," "registrant" "registered," and "registered source of
					 radiation," respectively.
(4)
					 Notifications, reports and correspondence referenced in the incorporated parts
					 of 10 CFR (relating to energy) shall be directed to the Department.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › GENERAL PROVISIONS › Section 221.1 - Purpose and scope

Current through Register Vol. 54, No. 28, July 13, 2024
This chapter establishes requirements for the use of
						  X-ray equipment by or under the supervision of a licensed practitioner of the
						  healing arts. A registrant or licensee who uses X-rays in the healing arts
						  shall comply with this chapter. This chapter is in addition to, and not in
						  substitution for, other applicable provisions of this
						  article.
The provisions of this §
														221.1 amended under sections 301
							 and 302 of the Radiation Protection Act (35 P.S.
							 §§
															7110.301 and
							 7110.302); and section 1920-A
							 of The Administrative Code of 1929 (71 P.S. §
															510-20).
This section cited in 25 Pa. Code §
														221.35a (relating to fluoroscopic
							 X-ray systems).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › GENERAL PROVISIONS › Section 221.3 - Reserved

Current through Register Vol. 54, No. 28, July 13, 2024
This section cited in 25 Pa. Code §
														221.35a (relating to fluoroscopic
							 X-ray systems).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › ADMINISTRATIVE CONTROLS › Section 221.11 - Registrant responsibilities

Current through Register Vol. 54, No. 28, July 13, 2024
(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.
(1) The operator or the individual who
						supervises the operation of a high-risk procedure shall have additional
						instruction, which may include certification or registration in the applicable
						specialty by a professional organization recognized by the Department.
						Continuing education for high-risk procedures shall occur, at a minimum, every
						2 years.
(2) Continuing education
						for all other (low-risk) procedures shall occur, at a minimum, every 4
						years.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › ADMINISTRATIVE CONTROLS › Section 221.12 - Records, maintenance and associated information

Current through Register Vol. 54, No. 28, July 13, 2024
The registrant shall maintain records of surveys,
						  calibrations, maintenance and modifications performed on the X-ray systems
						  including the names of persons who performed the services. The registrant shall
						  keep these records for inspection by the Department for 5
						  years.
The provisions of this §
														221.12 amended under sections 301
							 and 302 of the Radiation Protection Act (35 P. S.
							 §§
															7110.301 and
							 7110.302); and section 1920-A
							 of The Administrative Code of 1929 (71 P. S. §
															510-20).
This section cited in 25 Pa. Code §
														221.35a (relating to fluoroscopic
							 X-ray systems).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › ADMINISTRATIVE CONTROLS › Section 221.15 - Use of X-rays in research on humans

Current through Register Vol. 54, No. 28, July 13, 2024
(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.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › ADMINISTRATIVE CONTROLS › Section 221.16 - Training, competency and continuing education

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Training and competency.
The registrant shall ensure that:
(1) An
						individual who operates X-ray equipment during diagnostic or interventional
						procedures or supervises the operation of X-ray equipment during a procedure is
						trained and competent in all of the following subject areas, as applicable to
						the procedures performed and the specific equipment utilized:
(i) Basic properties of radiation.
(ii) Units of measurement.
(iii) Sources of radiation
						exposure.
(iv) Methods of radiation
						protection for patients and others.
(v) Biological effects of radiation
						exposure.
(vi) Facility-specific
						and modality-specific X-ray equipment.
(vii) Facility-specific and modality-specific
						image recording and processing.
(viii) Patient exposure and
						positioning.
(ix) Facility-specific
						and modality-specific procedures.
(x) Facility-specific and modality-specific
						quality assurance.
(xi)
						Facility-specific and modality-specific dose reduction, monitoring and
						recording procedures.
(xii) Units
						of measurement and dose, such as dose-area product values, CT dose index and
						air kerma.
(xiii) Factors affecting
						fluoroscopic outputs.
(xiv)
						High-level control options.
(xv)
						Dose management including dose reduction techniques, monitoring and
						recording.
(xvi) Principles and
						operation of the specific fluoroscopic X-ray system to be used.
(xvii) Fluoroscopic and fluorographic outputs
						of each mode of operation on the system to be used clinically.
(xviii) Applicable State and Federal
						regulations.
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS › Section 221.21 - Diagnostic equipment requirements

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Diagnostic systems incorporating one or
						more certified components shall comply with
						21 CFR
						1020.30-1020.33.
(b) Equipment registered after January 24,
						2019, must comply with 21
						CFR 1010.2 (relating to
						certification).
The provisions of this §
														221.21 amended under sections 301
							 and 302 of the Radiation Protection Act (35 P.S.
							 §§
															7110.301 and
							 7110.302); and section 1920-A
							 of The Administrative Code of 1929 (71 P.S. §
															510-20).
This section cited in 25 Pa. Code §
														221.35a (relating to fluoroscopic
							 X-ray systems).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS › Section 221.22 - Battery charge indicator

Current through Register Vol. 54, No. 28, July 13, 2024
On battery-powered X-ray generators, the control panel
						  shall have means to indicate visually whether the battery is adequately charged
						  for proper operation.
The provisions of this §
														221.22 amended under section 302
							 of the Radiation Protection Act (35 P. S. §
															7110.302); and section 1920-A of The
							 Administrative Code of 1929 (71 P. S. §
															510-20).
This section cited in 25 Pa. Code §
														221.35a (relating to fluoroscopic
							 X-ray systems).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS › Section 221.23 - Leakage radiation from the diagnostic source assembly

Current through Register Vol. 54, No. 28, July 13, 2024
The leakage radiation from the diagnostic source
						  assembly measured at a distance of 1 meter in any direction from the source may
						  not exceed 100 milliroentgens (25.8 µC/kg) in 1 hour when the X-ray tube
						  is operated at its leakage technique factors. Compliance shall be determined by
						  measurements averaged over an area of 100 square centimeters with no linear
						  dimension greater than 20 centimeters.
The provisions of this §
														221.23 amended under section 302
							 of the Radiation Protection Act (35 P. S. §
															7110.302); and section 1920-A of The
							 Administrative Code of 1929 (71 P. S. §
															510-20).
This section cited in 25 Pa. Code §
														221.35a (relating to fluoroscopic
							 X-ray systems).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS › Section 221.24 - Radiation from components other than the diagnostic source assembly

Current through Register Vol. 54, No. 28, July 13, 2024
The radiation emitted by a component other than the
						  diagnostic source assembly may not exceed 2 milliroentgens (.516 µC/kg)
						  in 1 hour at 5 centimeters from an accessible surface of the component when it
						  is operated in an assembled X-ray system under conditions for which it was
						  designed. Compliance shall be determined by measurements averaged over an area
						  of 100 square centimeters with no linear dimension greater than 20
						  centimeters.
The provisions of this §
														221.24 amended under section 302
							 of the Radiation Protection Act (35 P. S. §
															7110.302); and section 1920-A of The
							 Administrative Code of 1929 (71 P. S. §
															510-20).
This section cited in 25 Pa. Code §
														221.35a (relating to fluoroscopic
							 X-ray systems).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS › Section 221.26 - Multiple tubes

Current through Register Vol. 54, No. 28, July 13, 2024
If two or more radiographic tubes are controlled by one
						  exposure switch, the tube or tubes which have been selected shall be clearly
						  indicated prior to initiation of the exposure. This indication shall be both on
						  the X-ray control panel and at or near the tube housing assembly which has been
						  selected.
The provisions of this §
														221.26 issued under section 302 of
							 the Radiation Protection Act (35 P. S. §
															7110.302); and section 1920-A of The
							 Administrative Code of 1929 (71 P. S. §
															510-20).
This section cited in 25 Pa. Code §
														221.35a (relating to fluoroscopic
							 X-ray systems).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS › Section 221.27 - Mechanical support of tube head

Current through Register Vol. 54, No. 28, July 13, 2024
The tube housing assembly supports shall be adjusted so
						  that the tube housing assembly will remain stable during an exposure unless
						  tube housing movement is a designed function of the X-ray
						  system.
The provisions of this §
														221.27 issued under section 302 of
							 the Radiation Protection Act (35 P. S. §
															7110.302); and section 1920-A of The
							 Administrative Code of 1929 (71 P. S. §
															510-20).
This section cited in 25 Pa. Code §
														221.35a (relating to fluoroscopic
							 X-ray systems).
Pennsylvania Code › Title 25 - ENVIRONMENTAL PROTECTION › Part I - Department of Environmental Protection › Subpart D - Environmental Health and Safety › Article V - Radiological Health › Chapter 221 - X-RAYS IN THE HEALING ARTS › DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS › Section 221.28 - Technique indicators

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
						technique factors for radiographic systems shall be indicated before exposure
						except for units utilizing automatic exposure controls, in which case the
						maximum mAs shall be indicated.
(b)
						The requirement of subsection (a) may be met by permanent markings on equipment
						having fixed technique factors. Indication of technique factors shall be
						visible from the operator's position except in the case of spot films made by a
						fluoroscopist.
The provisions of this §
														221.28 issued under sections 301
							 and 302 of the Radiation Protection Act (35 P. S.
							 §§
															7110.301 and
							 7110.302); and section 1920-A
							 of The Administrative Code of 1929 (71 P. S. §
															510-20).
This section cited in 25 Pa. Code §
														221.35a (relating to fluoroscopic
							 X-ray systems).