216 R.I. Code R. 216-RICR-40-20-9.6

Current through December 26, 2024

Section 216-RICR-40-20-9.6 - General Technical Requirements

9.6.1Possession, Use, and Calibration of Instruments Used to Measure the Activity of Unsealed Radioactive Material

For the purpose of this Part, requirements for possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material are defined by 10 C.F.R. § 35.60.

9.6.2Calibration of Survey Instruments

A. For the purpose of this Part, requirements for calibration of survey instruments are defined by 10 C.F.R. § 35.61.

B. The licensee shall retain a record of each calibration required in §9.6.2(A) of this Part for three (3) years. The record shall include:

1. The model and serial number of the instrument;

2. The results of the calibration;

3. The name of the individual who performed the calibration; and

4. The date of calibration.

9.6.3Determination of Dosages of Unsealed Radioactive Materials for Medical Use

A. For the purpose of this Part, requirements for determination of dosages of unsealed radioactive materials for medical use are defined by 10 C.F.R. § 35.63.

B. The licensee shall retain a record of the dosage determinations required by §9.6.3(A) of this Part for three (3) years. To satisfy this requirement, the record shall contain:

1. The radiopharmaceutical;

2. Patient's or human research subject's name, and identification number if one has been assigned;

3. Prescribed dosage and determined dosage, or a notation that the total activity is less than one tenth (1.1) MBq (thirty (30) µCi);

4. Date and time of the dosage determination; and

5. Name of the individual who determined the dosage.

9.6.4Authorization for Calibration, Transmission and Reference Sources

For the purpose of this Part, authorization for calibration, transmission and reference sources is defined by 10 C.F.R. § 35.65.

9.6.5Requirements for Possession of Sealed Sources and Brachytherapy Sources

A. For the purpose of this Part, requirements for possession of sealed sources and brachytherapy sources are defined by 10 C.F.R. § 35.67.

B. A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a physical inventory of all such sources at intervals not to exceed six (6) months.

1. The licensee shall retain each inventory record for three (3) years.

2. The inventory records shall contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, date of the inventory, and the signature of the Radiation Safety Officer or the individual who performed the inventory.

9.6.6Vial Shields

A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield.

9.6.7Labeling of Vials and Syringes

For the purpose of this Part, requirements for labeling of vials and syringes are defined by 10 C.F.R. § 35.69.

9.6.8Surveys for Contamination and Ambient Radiation Dose Rate

A. A licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radioactive drugs containing radioactive material were prepared for use or administered.

B. A licensee shall survey with a radiation detection survey instrument at least once each week all areas where radioactive drugs containing radioactive material or radioactive wastes are stored.

C. A licensee shall conduct the surveys required by §§9.6.8(A) and (B) of this Part so as to able to measure dose rates as low as one (1) microsievert (one tenth (0.1) mrem) per hour.

D. A licensee shall establish dose rate action levels for the surveys required by §§9.6.8(A) and (B) of this Part and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if a dose rate exceeds an action level.

E. A licensee shall survey for removable contamination at least once each week all areas where generators and radioactive drugs containing radioactive material are prepared for use or administered or radioactive materials are stored.

F. A licensee shall conduct the surveys required by §9.6.8(E) of this Part so as to be able to detect contamination on each wipe sample of two thousand (2,000) dpm.

G. A licensee shall establish removable contamination action levels for the surveys required by §9.6.8(E) of this Part and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds action levels.

H. A licensee does not need to perform the surveys required by §9.6.8(A) of this Part in an area(s) where patients or human research subjects are confined when they cannot be released pursuant to §9.5.116 of this Part.

I. A licensee shall retain a record of each survey for three (3) years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

9.6.9Mobile Nuclear Medicine Service Requirements

A. The Agency shall license mobile nuclear medicine services or clients of such services. The mobile nuclear medicine service shall be licensed if the service receives, uses or possesses radioactive material. The client of the mobile nuclear medicine service shall be licensed if the client receives or possesses radioactive material to be used by a mobile nuclear medicine service.

B. A licensee providing mobile nuclear medicine service shall:

1. Obtain a letter signed by the management of each client for which services are rendered that permits the use of radioactive material at the client's address and clearly delineates the authority and responsibility of the mobile nuclear medicine service and the client. If the client is licensed, the letter shall document procedures for notification, receipt, storage and documentation of transfer of radioactive material delivered to the client's address for use by the mobile nuclear medicine service;

2. Inform the client's management who is on site at each client's address of use at the time that radioactive material is being administered.

3. Maintain all records required by this Part and Parts 1 and 2 of this Subchapter at a location within the Agency's jurisdiction that is:

a. A single address of use:

(1) Identified as the records retention location; and

(2) Staffed at all reasonable hours by individual(s) authorized to provide the Agency with access for purposes of inspection; or

b. When no address of use is identified on the license for records retention, the mobile unit:

(1) Identified in the license; and

(2) Whose current client's address schedule and location schedule are reported to the Agency.

4. Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, this check for proper function shall include a constancy check;

5. Transport to each client's address only syringes or vials containing prepared drugs or radioactive materials that are intended for reconstitution of radioactive drug kits;

6. Bring into each client's address all radioactive material to be used and, before leaving, remove all unused radioactive material and associated radioactive waste;

7. Secure or keep under constant surveillance and immediate control all radioactive material when in transit or at a client's address;

8. Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function shall include a constancy check;

9. Check survey instruments for consistent response with a dedicated check source before use at each client's address;

10. Prior to leaving a client's address, perform area surveys and survey for removable contamination in all areas of use, to ensure compliance with the requirements in Parts 1 and 2 of this Subchapter;

11. Use radioactive gases only in areas of use and under conditions which have been evaluated and approved by the Agency pursuant to §9.7.6 of this Part; and,

C. A mobile nuclear medical service shall not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client's license.

D. A licensee providing mobile nuclear medical services shall retain a copy of each letter required by §9.6.9(B)(1) of this Part. Each letter shall clearly delineate the authority and responsibility of the licensee and the client and shall be retained for three (3) years after the last provision of service.

E. A licensee providing mobile nuclear medical services shall retain the record of each survey required by §9.6.9(B)(10) of this Part for three (3) years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

F. A licensee providing mobile nuclear medical services shall, at a minimum, maintain the following documents on each mobile unit:

1. The current operating and emergency procedures;

2. A copy of the license;

3. Copies of the letter(s) required by §9.6.9(B)(1) of this Part;

4. Current calibration records for each survey instrument and diagnostic equipment or dose delivery device in use; and

5. Survey records covering uses associated with the mobile unit during, at a minimum, the preceding thirty (30) calendar days.

9.6.10Decay in Storage

A. For the purpose of this Part, requirements for decay in storage are defined by 10 C.F.R. § 35.92(a).

B. For radioactive material disposed in accordance with §9.6.10(A) of this Part, the licensee shall retain a record of each disposal for three (3) years. The record shall include the date of the disposal, the model and serial number of the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.

9.6.11Survey Instruments

A. Licensees authorized for radioactive material use under §§9.7.1, 9.7.3, 9.8.1, 9.9.1 and/or 9.11.1 of this Part shall possess an operable survey instrument that has been calibrated in accordance with §9.6.2 of this Part and meets the following criteria:

AUTHORIZED USE	SURVEY INSTRUMENT
9.7.1 - Uptake, dilution, and excretion studies	Portable radiation detection survey instrument capable of detecting dose rates over the range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrems) per hour
9.7.3 - Imaging & localization studies; or 9.8.1 - Unsealed radioactive material for diagnostic or therapeutic medical use for which a written directive is required; or 9.9.1 - Manual brachytherapy	Portable radiation detection survey instrument capable of detecting dose rates over the range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrems) per hour; and Portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrems) per hour.
9.11.1 - Remote afterloader unit, teletherapy unit and/or gamma stereotactic radiosurgery unit	Portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1000 mrems) per hour.

B. A licensee authorized to use radioactive material as a sealed source for diagnostic purposes pursuant to §9.10.1 of this Part shall have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range one (1.0) µSv (one tenth (0.1) mrem) per hour to five hundred (500) µSv (fifty (50) mrems) per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range ten (10) µSv (one (1) mrem) per hour to ten (10) mSv (one thousand (1,000) mrems) per hour. The instrument shall be operable and calibrated in accordance with §9.6.2 of this Part.

216 R.I. Code R. 216-RICR-40-20-9.6

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