Ohio Admin. Code 3701:1-58-01

Current through all regulations passed and filed through October 28, 2024

Section 3701:1-58-01 - Definitions

The terms used in this chapter have the same meaning as found in rule 3701:1-38-01 of the Administrative Code, unless an alternative definition is provided in this rule or in another rules of this chapter:

(A) "Associate radiation safety officer" means an individual who:

(1) Meets the requirements in rules 3701:1-58-18 and 3701:1-58-22 of the Administrative Code; and

(2) Is currently identified as an associate radiation safety officer for the types of use of radioactive material for which the individual has been assigned duties and tasks by the radiation safety officer on:

(a) A specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state; or

(b) A medical use permit issued by a United States nuclear regulatory commission master material licensee.

(B) "Authorized medical physicist" means an individual who:

(1) Meets the requirements in paragraph (A) of rule 3701:1-58-19 and in rule 3701:1-58-22 of the Administrative Code; or

(2) Is identified as an authorized medical physicist or teletherapy physicist on:

(a) A specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state;

(b) A medical use permit issued by a United States nuclear regulatory commission master material licensee;

(c) A permit issued by a United States nuclear regulatory commission or agreement state broad scope medical use licensee; or

(d) A permit issued by a United States nuclear regulatory commission master material license broad scope medical use permittee.

(C) "Authorized nuclear pharmacist" means a pharmacist who:

(1) Meets the requirements in paragraph (A) of rule 3701:1-58-20 and in rule 3701:1-58-22 of the Administrative Code; or

(2) Is identified as an authorized nuclear pharmacist on:

(a) A specific license issued by the director, the United States nuclear regulatory commission, or an agreement state that authorizes medical use or the practice of nuclear pharmacy;

(b) A permit issued by a United States nuclear regulatory commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;

(c) A permit issued by a United States nuclear regulatory commission or agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

(d) A permit issued by a United States nuclear regulatory commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

(3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

(4) Is designated as an authorized nuclear pharmacist in accordance with rule 3701:1-46-43 of the Administrative Code.

(D) "Authorized user" means a physician, dentist, or podiatrist who:

(1) Meets the requirements in rule 3701:1-58-22 of the Administrative Code and paragraph (A) of rule 3701:1-58-33, paragraph (A) of rule 3701:1-58-36, paragraph (A) of rule 3701:1-58-40, paragraph (A) of rule 3701:1-58-41, paragraph (A) of rule 3701:1-58-42, paragraph (A) of rule 3701:1-58-51, paragraph (A) of rule 3701:1-58-54, or paragraph (A) of rule 3701:1-58-71 of the Administrative Code; or

(2) Is identified as an authorized user on:

(a) A license issued by the director, the United States nuclear regulatory commission, or an agreement state that authorizes the medical use of radioactive material;

(b) A permit issued by a United States nuclear regulatory commission master material licensee that is authorized to permit the medical use of radioactive material;

(c) A permit issued by a United States nuclear regulatory commission or agreement state specific licensee of broad scope that is authorized to permit the medical use of radioactive material; or

(d) A permit issued by a United States nuclear regulatory commission master material license broad scope permittee that is authorized to permit the medical use of radioactive material.

(E) "Brachytherapy" means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

(F) "Brachytherapy source" means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

(G) "Client's address" means the area of use or a temporary job site, as defined in this rule, for the purpose of providing mobile medical service in accordance with rule 3701:1-58-31 of the Administrative Code.

(H) "High dose-rate remote afterloader," as used in this chapter, means a brachytherapy device that remotely delivers a dose rate in excess of twelve gray (one thousand two hundred rads) per hour at the point or surface where the dose is prescribed.

(I) "Low dose-rate remote afterloader," as used in this chapter, means a brachytherapy device that remotely delivers a dose rate of less than or equal to two gray (two hundred rads) per hour at the point or surface where the dose is prescribed.

(J) "Manual brachytherapy," as used in this chapter, means a type of brachytherapy in which the brachytherapy sources, such as seeds or ribbons are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume.

(K) "Medical event" means an event that meets the criteria in paragraph (A) or (B) of rule 3701:1-58-101 of the Administrative Code.

(L) "Medium dose-rate remote afterloader," as used in this chapter, means a brachytherapy device that remotely delivers a dose rate of greater than two gray (two hundred rads) per hour, but less than or equal to twelve gray (one thousand two hundred rads) per hour at the point or surface where the dose is prescribed.

(M) "Mobile medical service" means the transportation of radioactive material to and its medical use at the client's address.

(N) "Ophthalmic physicist" means an individual who:

(1) Meets the requirements in paragraph (A)(2) of rule 3701:1-58-49 and in rule 3701:1-58-22 of the Administrative Code; and

(2) Is identified as an ophthalmic physicist on a:

(a) Specific medical use license issued by the director,the United States nuclear regulatory commission, or an agreement state;

(b) Permit issued by a United States nuclear regulatory commission or agreement state broad scope medical use licensee;

(c) Medical use permit issued by a United States nuclear regulatory commission master material licensee; or

(d) Permit issued by a United States nuclear regulatory commission master material licensee broad scope medical use permittee.

(O) "Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.

(P) "Patient intervention" means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.

(Q) "Personal Representative" means:

(1) A person who has authority to act on behalf of an individual who is an adult or an emancipated minor in making decisions related to health care, or

(2) A parent, guardian, or other person acting in loco parentis who has authority to act on behalf of an individual who is an unemancipated minor in making decisions related to health care.

(R) "Preceptor" means an individual who provides, directs, or verifies the training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a radiation safety officer, or an associate radiation safety officer.

(S) "Prescribed dosage" means the specified activity or range of activity of unsealed radioactive material as documented:

(1) In a written directive; or

(2) In accordance with the directions of the authorized user for procedures performed pursuant to rules 3701:1-58-32 and 3701:1-58-34 of the Administrative Code.

(T) "Prescribed dose" means:

(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(2) For teletherapy, the total dose and dose per fraction as documented in the written directive;

(3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or

(4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

(U) "Pulsed dose-rate remote afterloader," as used in this chapter, means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the "high dose-rate'' range, but:

(1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and

(2) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.

(V) "Radiation safety officer," as used in this chapter, means an individual who:

(1) Meets the requirements in paragraph (A) or (C)(1) of rule 3701:1-58-18 and in rule 3701:1-58-22 of the Administrative Code, or

(2) Is identified as a radiation safety officer on:

(a) A specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state that authorizes the medical use of radioactive material; or

(b) A medical use permit issued by a United States nuclear regulatory commission master material licensee.

(W) "Stereotactic radiosurgery" means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.

(X) "Structured educational program" means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

(Y) "Teletherapy," as used in this chapter, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

(Z) "Teletherapy Physicist" means the individual identified as the teletherapy physicist on a radioactive material license issued by the state of Ohio.

(AA) "Temporary job site," as used in this chapter, means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.

(BB) "Therapeutic dosage" means a dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

(CC) "Therapeutic dose" means a radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.

(DD) "Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

(EE) "Type of use" means use of radioactive material under rule 3701:1-58-32, 3701:1-58-34, 3701:1-58-37, 3701:1-58-43, 3701:1-58-53, 3701:1-58-55 or 3701:1-58-72 of the Administrative Code.

(FF) "Unit dosage" means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.

(GG) "Written directive," as specified in rule 3701:1-58-15 of the Administrative Code, means an authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject.

Ohio Admin. Code 3701:1-58-01

Effective: 8/15/2021
Five Year Review (FYR) Dates: 11/13/2020 and 08/15/2026
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 08/15/2005, 12/22/2008