West Virginia Code of State Rules › Agency 64 - Health › Title 64 - LEGISLATIVE RULE WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 64-23 - Radiological Health Rule › Section 64-23-12 - Use of Radionuclides in the Healing Arts

Current through Register Vol. XLI, No. 28, July 12, 2024
12.1. Scope. - The provisions of this Section
				apply to all registrants who use sealed sources in the healing arts and are in
				addition to, and not in substitution for, other applicable provisions of this
				rule.
12.2. Definitions. - As used
				in Section 12. the following definitions apply:
12.2.a. Address of Use - the building or
				buildings that are identified on the registration and where radioactive
				material may be produced, prepared, received, used, or stored.
12.2.b. Area of Use - a portion of a physical
				structure that has been set aside for the purpose of producing, preparing,
				receiving, using, or storing radioactive material.
12.2.c. Authorized User - a practitioner of
				the healing arts who is identified as an authorized user on an agency [or the
				Nuclear Regulatory Commission] registration or registration that authorizes the
				medical use of radioactive material.
12.2.d. Brachytherapy - a method of radiation
				therapy in which sealed sources are utilized to deliver a radiation dose at a
				distance of up to a few centimeters, by surface, intracavitary, or interstitial
				application.
12.2.e. Dedicated
				Check Source - a radioactive source that is used to assure the constant
				operation of a radiation detection or measurement device over several months or
				years. This source may also be used for other purposes.
12.2.f. Diagnostic Clinical Procedures Manual
				- a collection of written procedures that describes each method (and other
				instructions and precautions) by which the registrant performs diagnostic
				clinical procedures; where each diagnostic clinical procedure has been approved
				by the authorized user and includes the radiopharmaceutical, dosage, and route
				of administration.
12.2.g. Medical
				Institution - an organization in which several medical disciplines are
				practiced.
12.2.h. Medical Use -
				the intentional internal or external administration of radioactive material, or
				the radiation therefrom, to humans in the practice of the healing
				arts.
12.2.i. Misadministration -
				the administration of:
12.2.i.1. A
				radiopharmaceutical dosage greater than one and eleven one-hundredths (1.11)
				megabecquerels (thirty [30] :Ci) of either sodium iodide, I-125 or I-131:
12.2.i.1.A. Involving the wrong patient or
				wrong radiopharmaceutical; or
12.2.i.1.B. When both the administered dosage
				differs from the prescribed dosage by more than twenty (20) percent of the
				prescribed dosage and the difference between the administered dosage and
				prescribed dosage exceeds one and eleven one-hundredths (1.11) megabecquerels
				(thirty [30] :Ci);
12.2.i.2. A therapeutic radiopharmaceutical
				dosage, other than sodium iodide, I-125 or I-131:
12.2.i.2.A. Involving the wrong patient,
				wrong radiopharmaceutical, or wrong route of administration; or
12.2.i.2.B. When the administered dosage
				differs from the prescribed dosage by more than twenty (20) percent of the
				prescribed dosage;
12.2.i.3. A gamma stereotactic radiosurgery
				radiation dose:
12.2.i.3.A. Involving the
				wrong patient or wrong treatment site; or
12.2.i.1.B. When the calculated total
				administered dose differs from the total prescribed dose by more than ten (10)
				percent of the total prescribed dose;
12.2.i.4. A teletherapy radiation dose:
12.2.i.4.A. Involving the wrong patient,
				wrong mode of treatment, or wrong treatment site; or
12.2.i.4.B. When the treatment consists of
				three (3) or fewer fractions and the calculated total administered dose differs
				from the total prescribed dose by more than ten (10) percent of the total
				prescribed dose; or
12.2.i.4.C.
				When the calculated weekly administered dose exceeds the weekly prescribed dose
				by thirty (30) percent or more of the weekly prescribed dose; or
12.2.i.4.D. When the calculated total
				administered dose differs from the total prescribed dose by more than twenty
				(20) percent of the total prescribed dose;
12.2.i.5. A brachytherapy radiation dose:
12.2.i.5.A. Involving the wrong patient,
				wrong radionuclide, or wrong treatment site (excluding, for permanent implants,
				seeds that were implanted in the correct site but migrated outside the
				treatment site); or
12.2.i.5.B.
				Involving a sealed source that is leaking; or
12.2.i.5.C. When, for a temporary implant,
				one or more sealed sources are not removed upon completion of the procedure;
				or
12.2.i.5.D. When the calculated
				administered dose differs from the prescribed dose by more than twenty (20)
				percent of the prescribed dose;
12.2.i.6. A diagnostic radiopharmaceutical
				dosage, other than quantities greater than one and eleven one-hundredths (1.11)
				megabecquerels (thirty [30] :Ci) of either sodium iodide I-125 or I-131, both:
12.2.i.6.A. Involving the wrong patient,
				wrong radiopharmaceutical, wrong route of administration, or when the
				administered dosage differs from the prescribed dosage; and
12.2.i.6.B. When the dose to the patient
				exceeds fifty (50) millisieverts (five [5] rem) effective dose equivalent or
				five hundred (500) millisieverts (fifty [50] Rem) dose equivalent to any
				individual organ.
12.2.j. Mobile Nuclear Medicine Service - the
				transportation and medical use of radioactive material.
12.2.k. Output - the exposure rate, dose
				rate, or a quantity related in a known manner to these rates from a teletherapy
				unit for a specified set of exposure conditions.
12.2.l. Prescribed Dosage - the quantity of
				radiopharmaceutical activity as documented:
12.2.l.1. In a written directive;
				or
12.1.l.2. Either in the
				diagnostic clinical procedures manual or in any appropriate record in
				accordance with the directions of the authorized user for diagnostic
				procedures.
12.2.m.
				Prescribed Dose:
12.2.m.1. For gamma
				stereotactic radiosurgery, the total dose as documented in the written
				directive; or
12.2.m.2. For
				teletherapy, the total dose and dose per fraction as documented in the written
				directive; or
12.2.m.3. For
				brachytherapy, either the total source strength and exposure time, or the total
				dose, as documented in the written directive.
12.2.n. Recordable event - the administration
				of:
12.2.n.1. A radiopharmaceutical or
				radiation without a written directive where a written directive is
				required;
12.2.n.2. A
				radiopharmaceutical or radiation where a written directive is required without
				daily recording of each administered radiopharmaceutical dosage or radiation
				dose in the appropriate record;
12.2.n.3. A radiopharmaceutical dosage
				greater than one and eleven one-hundredths (1.11) megabecquerels (thirty [30]
				:Ci) of sodium iodide I-125 or I-131 when both the administered dosage differs
				from the prescribed dosage by more than ten (10) percent of the prescribed
				dosage, and the difference between the administered dosage and the prescribed
				dosage exceeds five hundred fifty five (555) kilobecquerels (fifteen [15]
				:Ci);
12.2.n.4. A therapeutic
				radiopharmaceutical dosage, other than sodium iodide I-125 or I-131, when the
				administered dosage differs from the prescribed dosage by more than ten (10)
				percent of the prescribed dosage;
12.2.n.5. A teletherapy radiation dose when
				the calculated weekly administered dose exceeds the weekly prescribed dose by
				fifteen (15) percent or more of the weekly prescribed dose; or
12.2.n.6. A brachytherapy radiation dose when
				the calculated administered dose differs from the prescribed dose by more than
				ten (10) percent of the prescribed dose.
12.2.o. Teletherapy - therapeutic irradiation
				in which the source of radiation is at a distance from the body.
12.2.p. Visiting Authorized User - an
				authorized user who is not identified on the registration of the registrant
				being visited.
12.2.q. Written
				Directive - an order in writing for a specific patient, dated and signed by an
				authorized user prior to the administration of a radiopharmaceutical or
				radiation, except as specified in 12.2.q.iv., containing the following
				information:
12.2.q.1. For any administration
				of quantities greater than one and eleven one-hundredths (1.11) megabecquerels
				(thirty [30] :Ci) of sodium iodide I-125 or I-131: the radionuclide, and
				dosage; or
12.2.q.2. For a
				therapeutic administration of a radiopharmaceutical other than sodium iodide
				I-125 or I-131: the radiopharmaceutical, dosage, and route of administration;
				or
12.2.q.3. For gamma stereotactic
				radiosurgery: target coordinates, collimator size, plug pattern, and total
				dose; or
12.2.q.4. For teletherapy:
				the total dose, dose per fraction, treatment site, and overall treatment
				period; or
12.2.q.5. For
				high-dose-rate remote afterloading brachytherapy: the radionuclide, treatment
				site, and total dose; or
12.2.q.6.
				For all other brachytherapy,
12.2.q.6.A.
				Prior to implantation: the radionuclide, number of sources, and source
				strengths; and
12.2.q.6.B. After
				implantation but prior to completion of the procedure: the radionuclide,
				treatment site, and total source strength and exposure time (or, equivalently,
				the total dose).