216-40-20 R.I. Code R. § 9.5

Current through June 20, 2024

Section 216-RICR-40-20-9.5 - General Administrative Requirements

9.5.1Authority and Responsibilities for the Radiation Protection Program

A. In addition to the radiation protection program requirements of § 1.6 of this Subchapter, a licensee's management shall approve in writing:

1. Requests for a license application, renewal, or amendments before submittal to the Agency;

2. Any individual before allowing that individual to work as a Visiting Authorized User, Visiting Authorized Medical Physicist, Visiting Authorized Nuclear Pharmacist, or Visiting Ophthalmic Physicist; and

3. Radiation protection program changes that do not require a license amendment and are permitted under §9.5.15 of this Part;

B. A licensee's management shall appoint a Radiation Safety Officer, who agrees in writing, to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one (1) or more Associate Radiation Safety Officers to support the Radiation Safety Officer. The Radiation Safety Officer, with written agreement of the licensee's management, must assign the specific duties and tasks to each Associate Radiation Safety Officer. These duties and tasks are restricted to the types of use for which the Associate Radiation Safety Officer is listed on a license. The Radiation Safety Officer may delegate duties and tasks to the Associate Radiation Safety Officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.

C. For up to sixty (60) days each year, a licensee may permit an individual qualified to be a Radiation Safety Officer under §§9.5.10 and 9.5.14 of this Part, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in §9.5.1(E) of this Part, if the licensee takes the actions required in §§9.5.1(B), (D), (E) and (H) of this Part, and notifies the Agency in accordance with §9.4.6 of this Part.

D. A licensee may simultaneously appoint more than one (1) temporary Radiation Safety Officer, if needed to ensure that the licensee has a temporary Radiation Safety Officer that satisfies the requirements to be a Radiation Safety Officer for each of the different types of use of radioactive material permitted by the license.

E. A licensee shall establish in writing the authority, duties and responsibilities of the Radiation Safety Officer.

F. A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to:

1. Identify radiation safety problems;

2. Initiate, recommend, or provide corrective actions;

3. Stop unsafe operations; and,

4. Verify implementation of corrective actions.

G. Licensees that are authorized for two (2) or more different types of uses of radioactive material under §§9.8.1, 9.9.1 or 9.11.1 of this Part, or two (2) or more types of units under §9.11.1 of this Part, shall establish a Radiation Safety Committee to oversee all uses of radioactive material permitted by the license. The Committee shall include an Authorized User of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an Authorized User nor a Radiation Safety Officer, and may include other members as the licensee deems appropriate.

H. A licensee shall retain a record of actions taken by the licensee's management in accordance with §9.5.1(A) of this Part for five (5) years. The record shall include a summary of the actions taken and a signature of licensee management.

I. The licensee shall retain a copy of both authority, duties and responsibilities of the Radiation Safety Officer as required by §9.5.1(E) of this Part, and a signed copy of each Radiation Safety Officer's agreement to be responsible for implementing the radiation safety program, as required by §9.5.1(B) of this Part, for the duration of the license. The records shall include the signature of the Radiation Safety Officer and licensee management.

J. A licensee's Radiation Safety Committee shall meet as necessary, but at a minimum shall meet at intervals not to exceed six (6) months. The licensee shall maintain minutes of each Radiation Safety Committee meeting which shall include the date of the meeting, members present, members absent and a summary of deliberations and discussions.

K. For each Associate Radiation Safety Officer appointed under §9.5.1(B) of this Part, the licensee shall retain, for five (5) years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Officer signed by the licensee's management.

9.5.2Duties of Authorized User and Authorized Medical Physicist

A. A licensee shall ensure that only Authorized Users for the type of radioactive material used:

1. Prescribe the radiopharmaceutical dosage and/or dose to be administered through the issuance of a written directive or reference to the diagnostic clinical procedures manual; and

2. Direct, as specified in §§9.5.3 and 9.5.4 of this Part, or in license conditions, the administration of radioactive material for medical use to patients or human research subjects;

3. Prepare and administer, or supervise the preparation and administration of radioactive material for medical use, in accordance with §§9.4.3(A)(1), (2) and 9.5.3 of this Part.

B. A licensee shall ensure that only Authorized Medical Physicists perform, as applicable:

1. Full calibration measurements as described in §§9.11.7, 9.11.8 and 9.11.9 of this Part;

2. Periodic spot-checks as described in §§9.11.10, 9.11.11 and 9.11.12 of this Part; and

3. Radiation surveys as described in §9.11.14 of this Part.

9.5.3Supervision

A. A licensee that permits the receipt, possession, use or transfer of radioactive material by an individual under the supervision of an Authorized User, as allowed by §9.4.3(A) of this Part, shall:

1. In addition to the requirements in § 2.5 of this Subchapter, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, Regulations of this Part and license conditions with respect to the use of radioactive material;

2. Require the supervised individual to follow the instructions of the supervising Authorized User for medical uses of radioactive material, written radiation protection procedures established by the licensee, written directive procedures, this Subchapter, and license conditions with respect to the medical use of radioactive material; and;

3. If the individual is involved in administration of radiation/radioactive materials to humans, ensure that the individual possesses a current license in accordance with Subchapter 05 Part 34 of this Chapter, Licensure of Radiographers, Nuclear Medicine Technologists, Radiation Therapists and Radiologist Assistants, unless the individual is specifically exempted from licensure by said Regulations;

B. A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an Authorized Nuclear Pharmacist or physician who is an Authorized User, as allowed by §9.4.3(A)(2) of this Part, shall:

1. In addition to the requirements in § 2.5 of this Subchapter, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material; and

2. Require the supervised individual to follow the instructions of the supervising Authorized User or Authorized Nuclear Pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, this Subchapter, and license conditions.

C. A licensee that permits supervised activities under §§9.5.3(A) and (B) of this Part is responsible for the acts and omissions of the supervised individual.

9.5.4Written Directives

A. A written directive shall be dated and signed by an Authorized User prior to administration of I-131 sodium iodide greater than one and eleven one hundredths (1.11) MBq (thirty (30) µCi), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material.

1. If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive shall be documented as soon as possible in writing in the patient's record. A written directive shall be prepared within forty-eight (48) hours of the oral directive.

B. The written directive shall contain the patient or human research subject's name and the following information:

1. For an administration of a dosage of radioactive drug containing radioactive material: the radioactive drug containing radioactive material, dosage, and route of administration;

2. For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;

3. For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;

4. For high dose rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose;

5. For permanent implant brachytherapy:

a. Before implantation: the treatment site, the radionuclide, and the total source strength; and

b. After implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, the total source strength implanted, and the date; and

6. For all other brachytherapy including low, medium and pulsed dose rate remote afterloaders:

a. Prior to implantation: treatment site, the radionuclide and dose; and

b. After implantation but before completion of the procedure: the radioisotope, treatment site, number of sources, total source strength and exposure time (or, the total dose); and date.

C. A written revision to an existing written directive may be made provided that the revision is dated and signed by an Authorized User prior to the administration of the dosage of radioactive drug containing radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose or the next fractional dose.

1. If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision shall be documented as soon as possible in the patient's record. A revised written directive shall be signed by the Authorized User within forty-eight (48) hours of the oral revision.

D. The licensee shall retain a copy of each written directive for three (3) years.

9.5.5Procedures for Administrations Requiring a Written Directive

A. For the purpose of this Part, procedures for administrations requiring a written directive are defined by 10 C.F.R. § 35.41.

B. A licensee shall retain a copy of the procedures required under §9.5.5(A) of this Part for the duration of the license.

9.5.6Visiting Authorized User, Visiting Authorized Medical Physicist, Visiting Authorized Nuclear Pharmacist and Visiting Ophthalmic Physicist

A. A licensee may permit any Visiting Authorized User to use licensed material for medical use under the terms of the licensee's license for sixty (60) days each year if:

1. The Visiting Authorized User has the prior written permission of the licensee's management and Radiation Safety Committee if one is required;

2. The licensee has a copy of an Agency, Agreement State or U.S. Nuclear Regulatory Commission license that identifies the Visiting Authorized User by name as an Authorized User for medical use; and

3. Only those procedures for which the Visiting Authorized User is specifically authorized by an Agency, Agreement State or U.S. Nuclear Regulatory Commission license are performed by that individual.

B. A licensee may permit a medical physicist to act as a Visiting Authorized Medical Physicist, and perform the duties of a medical physicist under the terms of the licensee's license for sixty (60) days each calendar year if:

1. The medical physicist is registered with the Agency, under the provisions of § 3.6 of this Subchapter, as a provider of Radiation Physics Services in the area of calibration and compliance surveys of therapeutic medical units; and

2. The Visiting Authorized Medical Physicist has the prior written permission of the licensee's management and Radiation Safety Committee, if one is required; and

3. The licensee has a copy of:

a. An Agency, NRC or Agreement State license that identifies the individual as an Authorized Medical Physicist; or

b. A permit issued by an Agency, NRC or Agreement State specific license of broad scope that identifies the medical physicist by name as an Authorized Medical Physicist.

C. A licensee may permit a nuclear pharmacist to act as a Visiting Authorized Nuclear Pharmacist, and to perform the duties of a nuclear pharmacist under the terms of the licensee's license for sixty (60) days each calendar year if:

1. The nuclear pharmacist possesses a current license as a pharmacist in accordance with Subchapter 15 Part 1 of this Chapter, Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors; and

2. The visiting Authorized Nuclear Pharmacist has the prior written permission of the licensee's management and Radiation Safety Committee, if one is required; and

3. The licensee has a copy of:

a. An Agency, NRC or Agreement State license that identifies the individual as an Authorized Nuclear Pharmacist; or

b. A permit issued by an Agency, NRC or Agreement State specific license of broad scope that identifies the nuclear pharmacist by name as an Authorized Nuclear Pharmacist.

D. A licensee may permit an ophthalmic physicist to act as a Visiting Ophthalmic Physicist, and to perform the duties of an ophthalmic physicist under the terms of the licensee's license for sixty (60) days each calendar year if:

1. The visiting Ophthalmic Physicist has the prior written permission of the licensee's management and Radiation Safety Committee, if one is required; and

2. The licensee has a copy of:

a. An Agency, NRC or Agreement State license that identifies the individual as an Ophthalmic Physicist; or

b. A permit issued by an Agency, NRC or Agreement State specific license of broad scope that identifies the ophthalmic physicist by name as an Ophthalmic Physicist.

E. A licensee need not apply for a license amendment in order to permit:

1. A Visiting Authorized User to use licensed material as described in §9.5.6(A) of this Part;

2. A Visiting Authorized Medical Physicist to perform licensed duties as described in §9.5.6(B) of this Part;

3. A Visiting Authorized Nuclear Pharmacist to perform licensed duties as described in §9.5.6(C) of this Part.

4. A Visiting Ophthalmic Physicist to perform licensed duties as described in §9.5.6(D) of this Part.

F. A licensee shall retain copies of the records specified in §§9.5.6(A), (B), (C), and (D) of this Part for three (3) years from the date of the last visit.

9.5.7Requirements for Suppliers of Sealed Sources or Devices for Medical Use

For the purpose of this Part, requirements for suppliers of sealed sources or devices for medical use are defined by 10 C.F.R. § 35.49.

9.5.8Quality Control of Diagnostic Equipment

Each licensee shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies. The licensee shall conduct quality control procedures in accordance with written procedures.

9.5.9Report and Notification of a Medical Event

A. Other than events that result from intervention by a patient or human research subject, a licensee shall report any event in which:

1. The administration of radioactive material or radiation from radioactive material, except permanent implant brachytherapy, results in:

a. A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than five one hundredths (0.05) Sv (five (5) rem) effective dose equivalent, one half (0.5) Sv (fifty (50) rem) to an organ or tissue, or one half (0.5) Sv (fifty (50) rem) shallow dose equivalent to the skin; and

(1) The total dose delivered differs from the prescribed dose by twenty percent (20%) or more;

(2) The total dosage delivered differs from the prescribed dosage by twenty percent (20%) or more or falls outside the prescribed dosage range; or

(3) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by fifty percent (50%) or more.

b. A dose that exceeds five one hundredths (0.05) Sv (five (5) rem) effective dose equivalent, one half (0.5) Sv (fifty (50) rem) to an organ or tissue, or one half (0.5) Sv (fifty (50) rem) shallow dose equivalent to the skin from any of the following:

(1) An administration of a wrong radioactive drug containing radioactive material or the wrong radionuclide for a brachytherapy procedure;

(2) An administration of a radioactive drug containing radioactive material by the wrong route of administration;

(3) An administration of a dose or dosage to the wrong individual or human research subject;

(4) An administration of a dose or dosage delivered by the wrong mode of treatment; or

(5) A leaking sealed source.

c. A dose to the skin or an organ or tissue other than the treatment site that exceeds by:

(1) One half (0.5) Sv (fifty (50) rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration of the dose expected from the administration; and

(2) Fifty percent (50%) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.

2 For permanent implant brachytherapy, the administration of radioactive material or radiation from radioactive material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in:

a. The total source strength administered differing by twenty percent (20%) or more from the total source strength documented in the post-implantation portion of the written directive;

b. The total source strength administered outside of the treatment site exceeding twenty percent (20%) of the total source strength documented in the post-implantation portion of the written directive; or

c. An administration that includes any of the following:

(1) The wrong radionuclide;

(2) The wrong individual or human research subject;

(3) Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or

(4) A leaking sealed source resulting in a dose that exceeds one half (0.5) Sv (fifty (50) rem) to an organ or tissue.

B. A licensee shall report any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results, or will result in, unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

C. A licensee shall notify the Agency by telephone no later than the next calendar day after discovery of the medical event.

1. All required notifications shall use Agency contact information specified in § 1.4 of this Subchapter.

D. The licensee shall submit a written report to the Agency within fifteen (15) days after discovery of the medical event.

1. The written report shall include:

a. The licensee's name;

b. The prescribing physician's name;

c. A brief description of the event;

d. Why the event occurred;

e. The effect, if any, on the individual(s) who received the administration;

f. What actions, if any, have been taken, or are planned, to prevent recurrence;

g. Verification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.

2. The report shall not contain the individual's name or other information that could lead to identification of the individual.

E. The licensee shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than twenty-four (24) hours after its discovery, unless the referring physician personally informs the licensee either that he/she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or affected individual cannot be reached within twenty-four (24) hours, the licensee shall notify the individual as soon as possible thereafter. The licensee shall not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If an oral notification is made, the licensee shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.

F. Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, individuals affected by the medical event, or that individual's responsible relatives or guardians.

G. A licensee shall retain a record of medical events reported in accordance with this section for three (3) years. The record shall contain:

1. The licensee's name;

2. Names of the individuals involved;

3. Identification number or if no other identification number is available, the social security number of the individual who is the subject of the medical event;

4. A brief description of the event; why it occurred; the effect, if any, on the individual;

5. The actions, if any, taken, or planned, to prevent recurrence; and

6. Whether the licensee notified the individual (or the individual's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician.

H. The licensee shall provide a copy of the record required by §9.5.9(G) of this Part to the referring physician, if other than the licensee, no later than fifteen (15) days after the discovery of the medical event.

9.5.10Training for a Radiation Safety Officer

For the purpose of this Part, training requirements for a radiation safety officer and associate radiation safety officer are defined by 10 C.F.R. § 35.50.

9.5.11Training for an Authorized Medical Physicist

A. For the purpose of this Part, training requirements for an Authorized Medical Physicist are defined by 10 C.F.R. § 35.51.

B. In addition to the requirements in §9.5.11(A) of this Part, an Authorized Medical Physicist must be registered with the Agency, under the provisions of § 3.6 of this Subchapter, as a provider of Radiation Physics Services for the therapeutic modality(s) in which the individual is seeking approval as an Authorized Medical Physicist.

9.5.12Training for an Authorized Nuclear Pharmacist

A. For the purpose of this Part, training requirements for an Authorized Nuclear Pharmacist are defined by 10 C.F.R. § 35.55.

B. In addition to the requirements in §9.5.12(A) of this Part, an Authorized Nuclear Pharmacist must possess a current license as a pharmacist in accordance with Subchapter 15 Part 1 of this Chapter, Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors.

9.5.13Training for Experienced Radiation Safety Officer, Teletherapy or Medical Physicist, Authorized Medical Physicist, Authorized User, Nuclear Pharmacist, and Authorized Nuclear Pharmacist

A. For the purpose of this Part, training requirements for an experienced Radiation Safety Officer, teletherapy or medical physicist, Authorized Medical Physicist, Authorized User, nuclear pharmacist, and Authorized Nuclear Pharmacist are defined by 10 C.F.R. § 35.57.

B. An individual who does not qualify as an experienced medical physicist pursuant to §9.5.13(A) of this Part, but has, prior to October 24, 2004, registered with the Agency, under the provisions of § 3.6 of this Subchapter, as a provider of Radiation Physics Services for the therapeutic modality(s) in which the individual is seeking approval as an Authorized Medical Physicist need not comply with the training requirements of §9.5.11 of this Part. Individuals who need not comply with training requirements as described in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on Agency licenses for the same uses for which these individuals are authorized.

9.5.14Recentness of Training

For the purpose of this Part, training requirements regarding recentness of training are defined by 10 C.F.R. § 35.59.

9.5.15Radiation Protection Program Changes

A. A licensee may revise its radiation protection program without prior Agency approval if:

1. The revision does not require an amendment under §9.4.5 of this Part;

2. The revision is in compliance with this Subchapter and the license;

3. The revision has been reviewed and approved by the Radiation Safety Officer, licensee management and licensee's Radiation Safety Committee (as applicable); and

4. The affected individuals are instructed on the revised program before the changes are implemented.

B. A licensee shall retain a record of each change for five (5) years. The record shall include the effective date of the change, a copy of the old and new procedures, the reason for the change, a summary of radiation safety matters that were considered before making the change and the signature of the licensee management representative that reviewed and approved the change.

C. A copy of the record required by §9.5.15(B) of this Part shall be submitted to the Agency within thirty (30) days of adopting said change(s).

9.5.16Release of Individuals Containing Unsealed Radioactive Material or Implants Containing Radioactive Material

A. A licensee may authorize the release from its control of any individual who has been administered radioactive drugs or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed five (5) mSv (one half (0.5) rem).

1. NRC NUREG 1556-Vol. 9 "Consolidated Guidance About Materials Licenses: Program Specific Guidance About Medical Licenses" describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding five (5) mSv (one half (0.5) rem).

B. For patients administered radioactive material for which a written directive is required, a licensee shall provide the released individual, or the individual's parent or guardian, with oral and written instructions on actions recommended to maintain doses to other individuals as low as reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed one (1) mSv (one tenth (0.1) rem). If the total effective dose equivalent to a breast-feeding infant or child could exceed one (1) mSv (one tenth (0.1) rem) assuming there were no interruption of breast-feeding, the instructions shall also include:

1. Guidance on the interruption or discontinuation of breast-feeding; and

2. Information on the consequences, if any, of failure to follow the guidance.

C. For patients administered radioactive material for which a written directive is required, the licensee shall maintain a record, for three (3) years after the date of release, of the basis for authorizing the release of an individual.

D. The licensee shall maintain a record, for three (3) years after the date of release, that instructions required by §9.5.16(B) of this Part were provided to a breastfeeding woman if the radiation dose to the infant or child from continued breastfeeding could result in a total effective dose equivalent exceeding one (1) mSv (one tenth (0.1) rem).

E. The licensee shall immediately notify the Agency in accordance with §9.5.17 of this Part if a patient departs prior to an authorized release.

F. The licensee shall notify the Agency in accordance with §9.5.19 of this Part:

1. When they are aware that a patient containing radioactive material and who has been released in accordance with §9.5.16 of this Part dies; and

2. If it is possible that any individual could receive an effective dose equivalent in excess of five (5) mSv (one half (0.5) rem) as a result of the deceased's body.

9.5.17Reports of Patient Departure Prior to Authorized Release

A. The licensee shall notify the Agency by telephone immediately upon discovery that a patient or human research subject has departed from the licensee's facility without authorization under §9.5.16(A) of this Part.

B. The licensee shall submit a written report to the Agency within thirty (30) days after discovery of the unauthorized departure. The written report must include:

1. The licensee's name;

2. The date and time of the unauthorized departure;

3. The projected date and time when release would have occurred;

4. The address of the patient's or human research subject's home or anticipated destination following departure;

5. The radionuclide, chemical and physical form and calculated activity at time of release;

6. The apparent reason(s) for the departure prior to authorized release; and

7. A description of any changes in the licensee's patient release criteria or patient instructions that are designed to avoid a recurrence of such an event.

9.5.18Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child

For the purpose of this Part, training requirements for report and notification of a dose to an embryo/fetus or a nursing child are defined by 10 C.F.R. § 35.3047.

9.5.19Notification of Deceased Patients or Human Research Subjects Containing Radioactive Material

A. The licensee shall notify the Agency by telephone immediately upon discovery that a patient or human research subject containing radioactive material has died, and it is possible that any individual could receive an effective dose equivalent in excess of the dose limits set forth in §1.8.1 of this Subchapter as a result of the deceased's body.

B. The licensee shall submit a written report to the Agency within thirty (30) days after discovery that the patient or human research subject referenced in §9.5.19(A) of this Part has died. The written report shall include:

1. The licensee's name;

2. The date of death;

3. The radionuclide, chemical and physical form and calculated activity at time of death; and,

4. The names (or titles) and address(es) of known individuals who might have received a TEDE exceeding five (5) mSv (one half (0.5) rem).

216 R.I. Code R. § 216-RICR-40-20-9.5

Adopted effective 1/1/2019
Amended effective 5/25/2022