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Annual Radiation

Annual Radiation Protection Medicinal Licencee Program Audit NUREG- 1556 Vol.9 Rev 2 APPENDIX L
	All referrence are to 10 CFR parts unless noted otherwise
	Facility:	San Antonio Military Medical Center (SAMMC)
	Location:	JBSA, Fort Sam Houston, TX 78234
	Radiation Safety Officer:	Mr. Kevin Martilla
	Last Audit Date:	8-Feb-16
	Surveyor:	1LT Ashley N. Burleigh
	Audit Period:	1-29 December 2017

Audit History

Audit History
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Were previous audits conducted annually?	(c) The licensee shall periodically (at least annually) review the radiation protection program content and implementation.	10 CFR 20.1101 (c)
Ask RSO & Check Files
B. Were records of previous audits maintained (3 years)?	(b) The licensee shall retain the records required by paragraph (a) (1) of this section until the Commission terminates each pertinent license requiring the record. The licensee shall retain the records required by paragraph (a) (2) of this section for 3 years after the record is made.	10 CFR 20.2102 (b)
Verify past audits & location
C. Were any deficiencies identified during previous audit and were corrective actions taken?	Any deficiencies identified at previous audit should be addressed and corrected prior to next audit/	OIP conducted on 08 February 16
Look for repeated deficiencies
List of previous deficiencies:
1
2
3
4

Organization & Scope of Work

Organization and Scope of Program
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Radiation Safety Officer:
1. If the RSO was changed, was the license amended (30 days)?	The NRC License must be updated within 30 days of the change of RSO.	10 CFR 35.13				License was amended on __________.
When was license amended?
2. Does the new RSO meet NRC training requirements	(b)(1) Has completed a structured educational program consisting of both:	10 CFR 35.50, 35.57, 35.59
	(i) 200 hours of classroom and laboratory training in the following areas—
	(A) Radiation physics and instrumentation;
	(B) Radiation protection;
	(C) Mathematics pertaining to the use and measurement of radioactivity;
	(D) Radiation biology; and
	(E) Radiation dosimetry; and
Check RSO’s (313a)
	(ii) One year of full-time radiation safety experience
3. If the scope of the program expands, does the RSO have training in radiation safety, regulatory issues, and emergency procedures for the new uses?	(e) Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval.	10 CFR 35.50(e)
What exactly is RSO trained on?
4. Is the RSO fulfilling all duties?	Authority and responsibilities for radiation for radiation protection program	10 CFR 35.24
What duties is RSO tasked with? Are there delegated duties? Ways to track?
5. Is the written agreement in place for a new RSO (appointment orders)?	(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.	10 CFR 35.24(b)
Location of appointment orders? Copy?
B. Radiation Safety Committee
1. Are AU’s being approved by the RSC?	The RSC has reviewed and approved the training and experience of individuals to be listed as authorized users or as Radiation Safety Officer.	10 CFR 35.22(b) (2)
Check permits.
2. Does RSC meeting occur quarterly?	The Radiation Safety Committee has met at least on a quarterly basis.	10 CFR 35.24(f), TB MED 525, 1-4.f (1)
Check Previous minutes.
3. Are copies of the minutes being provided to each RSC member?	Each RSC member was promptly provided with a copy of the minutes.
Check correspondence w/RSO.
4. The RSC has reviewed and approved minor changes in the radiation safety program with the consent of the RSO and Committee chairperson	Changes are allowed but must be documented and records must be maintained for 5 years	10 CFR 35.26 and 35.2026
5. Does the RSC evaluate the overall ALARA program annually?	The RSC will evaluate our institution's overall efforts for maintaining doses ALARA on an annual basis. This review will include the efforts of the RSO, authorized users, and workers as well as those of management.	Reg. Guide 10.8, Appendix G (2) (3)
Check previous meeting slides.
C. Radiation Safety Program
A. Were any minor changes to made to the program?	(a) A licensee may revise its radiation protection program without Commission approval if--	10 CFR 35.26
	(1) The revision does not require a license amendment under § 35.13;
	(2) The revision is in compliance with the regulations and the license;
	(3) The revision has been reviewed and approved by the Radiation Safety Officer and licensee management; 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 in accordance with § 35.2026
Check for revisions
B. Records of changes maintained for 5 years.	A licensee shall retain a record of each radiation protection program change made in accordance with § 35.26(a) for 5 years. The record must include a copy of the old and new procedures; the effective date of the change; and the signature of the licensee management that reviewed and approved the change.	10 CFR 35. 2026, 35.26
Check records
C. Is the content and implementation being reviewed annually by the licensee?	(c) The licensee shall periodically (at least annually) review the radiation protection program content and implementation.	10 CFR 20.1101(c)
When was the last time the radiation protection program reviewed?
D. NRC License
1. Multiple places of use? If yes, list locations.	Verify Conditions Item #10 listed on the NRC Form 374A	10 CFR 35.13
10.Licensed material may be used or stored at the licensee's facilities located at:
A. Brooke Army Medical Center, 3551 Roger Brooke Drive, Building 3600, Fort Sam Houston, JBSA, Texas
B. Brooke Army Medical Center, 3551 Roger Brooke Drive, Building 3600, Annex C, Trailer 16, Fort Sam Houston, JBSA, Texas
C. U.S. Army Public Health Command Veterinary Food Analysis and Diagnostic Laboratory, 2899 Schofield Road, Building 2630, Fort Sam Houston, JBSA, Texas
D. U.S. Army Medical Department Center and School 3151 Scott Road, Building 2785, Fort Sam Houston, JBSA, Texas.
E. Brooke Army Medical Center, 3551 Roger Brooke Drive Building 3608, Fort Sam Houston, JBSA, Texas.
Check License for locations
2. Are all locations listed on license?	All areas where radioactive material is used or stored should be listed on the license at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC	10 CFR 35.13
Check Item 10- Conditions on NRC Form 374A
3. Were annual audits performed at each location? If no, explain.
Check previous audit for each location
4. Isotope, chemical form, quantity, and use as authorized?	The materials and uses authorized on the NRC license must match the actual use.	10 CFR 31.11, 35.100, 200, 300, 400, 500, 600, 1000
Verify listed material use matches facilities license
5. Does the total amount of radioactive material possessed require financial assurance [30.35(a)]? If so, is the financial assurance adequate?	Facility must have a decommissioning funding plan for financial assurance and recordkeeping for decommissioning on file.	10 CFR 30.35(a)
Check files for required memo

E. Special license conditions or issues to be reviewed:
1. If authorized for 10 CFR 35.1000 medical uses, review the program for conformance with license application commitments, license conditions, and regulations.	A licensee may use byproduct material or a radiation source approved for medical use which is not specifically addressed in subparts D through H of this part if—	10CR 35.1000
	(a) The applicant or licensee has submitted the information required by § 35.12(b) through (d); and
	(b) The applicant or licensee has received written approval from the Commission in a license or license amendment and uses the material in accordance with the regulations and specific conditions the Commission considers necessary for the medical use of the material
F. Amendments since Last Audit
1. Any Amendments since last audit?	(a) Before it receives, prepares, or uses byproduct material for a type of use that is permitted under this part, but is not authorized on the licensee's current license issued under this part; except that—	10 CFR 35.13
	(b) Before it permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except—
	(c) Before it changes Radiation Safety Officers, except as provided in § 35.24(c);
	(d) Before it receives byproduct material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;
	(e) Before it adds to or changes the areas of use identified in the application or on the license, ;
	(f) Before it changes the address(es) of use identified in the application or on the license; and
Check amendments.
G. Notifications since Last Audit
1. Any Notifications since last audit?	(a) A licensee shall provide the Commission a copy of the board certification and the written attestation(s), signed by a preceptor, the Commission or Agreement State license, the permit issued by a Commission master material licensee, the permit issued by a Commission or Agreement State licensee of broad scope, the permit issued by a Commission master material license broad scope permittee, or documentation that only accelerator-produced radioactive materials, discrete sources of radium-226, or both, were used for medical use or in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, and for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist, under § 35.13(b). For individuals permitted to work under § 35.13(b)(4), within the same 30-day time frame, the licensee shall also provide, as appropriate, verification of completion of;	10 CFR 35.14
	(1) Any additional case experience required in § 35.390(b)(1)(ii)(G) for an authorized user under § 35.300;
	(2) Any additional training required in § 35.690(c) for an authorized user under § 35.600; and
	(3) Any additional training required in § 35.51(c) for an authorized medical physicist.
Check for current/any notifications.
2. Appropriate documentation provided to NRC, for ANP, AMP, or AU, no later than 30 days after the individual starts work?	(b) A licensee shall notify the Commission no later than 30 days after:	10 CFR 35.14 (b)
	(1) An authorized user, an authorized nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change;
	(2) The licensee permits an authorized user or an individual qualified to be a Radiation Safety Officer, under §§ 35.50 and 35.59, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer in accordance with § 35.24(c).
Has documentation been provided to the NRC NLT 30 days for ANP, AMP, & AU’s?	(3) The licensee's mailing address changes;
	(4) The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in § 30.34(b) of this chapter; or
	(5) The licensee has added to or changed the areas of use identified in the application or on the license where byproduct material is used in accordance with either § 35.100
	(c) The licensee shall send the documents required in this section to the appropriate address identified in § 30.6 of this chapter
3. NRC notified within 30 days after: AU, ANP, AMP, or RSO stops work or changes name; licensee’s mailing address changes; licensee’s name changes without a transfer of control of the license; or licensee has added to or changed an area of use for 10 CFR 35.100	(b) A licensee shall notify the Commission no later than 30 days after:	10 CFR 35.14(b)
	(1) An authorized user, an authorized nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change;
	(2) The licensee permits an authorized user or an individual qualified to be a Radiation Safety Officer, under §§ 35.50 and 35.59, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer in accordance with § 35.24(c).
	(3) The licensee's mailing address changes;
	(4) The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in § 30.34(b) of this chapter; or (5) The licensee has added to or changed the areas of use identified in the application or on the license where byproduct material is used in accordance with either § 35.100
Was the NRC notified within 30 days of changes?
H. RAM
1. Calibration, transmission, and reference sources?	Authorization for calibration, transmission, and reference sources. Any person authorized by § 35.11 for medical use of byproduct material may receive, possess, and use any of the following byproduct material for check, calibration, transmission, and reference use	10 CFR 35.65
a. Sealed sources manufactured and distributed by a person licensed pursuant to 10 CFR 32.74, equivalent Agreement State regulations, or redistributed by a licensee authorized to redistribute sealed sources, and sources do not exceed 30 millicuries each?	This is specific for item #1 above for sources used for calibration, transmission, and reference sources?	10 CFR 35.65(a) and (b)
Ensure limit of 30 mCi is not exceeded.
b. Any byproduct material (non-sealed sources) with a half-life not longer than 120 days in individual amounts not to exceed 15 millicuries?	This standard does not apply to Tc-99m	10 CFR 35.65(c)
Ensure limit of 15 mCi is not exceeded.
c. Any byproduct material (non- sealed sources) with a half-life longer than 120 days in individual amounts not to exceed the smaller of 200 microcuries or 1000 times the quantities in Appendix B of Part 30?	This is specific for item #7 above for sources used for calibration, transmission, and reference sources?	10 CFR 35.65(d)
d. Technetium-99m in individual amounts as needed.	(e) Technetium-99m in amounts as needed. Listed on license as 60 curies total	10 CFR 35.65(e)
Does current amount exceed 60 curies of Tc-99m?
2. Unsealed materials used.	§ 35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required. (see CFR Part 35—Medical Use of Byproduct Material)	10 CFR 35.100, 35.200, and 35.300:
	35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.
Should I list each Isotope here from license?	§ 35.300 Use of unsealed byproduct material for which a written directive is required.
a. Obtained from a manufacturer or preparer licensed?	An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing byproduct material for use by persons authorized	10 CFR 32.72
Is there a copy of the manufacturers license?
OR	(j) An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under part 35 of this chapter or equivalent Agreement State requirements (see § 30.32 Application for specific licenses)	10 CFR 30.32(j)
b. Obtained from a producer of PET radioactive drugs?
OR		10 CFR 30.32
c. Prepared by a physician AU, an ANP, or an individual under the supervision of an ANP or physician AU?
OR
d. Obtained and prepared for research in accordance with 10 CFR 35.100, 10 CFR 35.200, and 10 CFR 35.300, as applicable?
3. Are the sealed sources possessed and used as described in the Sealed Source and Device Registry (SSDR) certificate.	A licensee shall use only brachytherapy sources for therapeutic medical uses:	10 CFR 32.210, 35.400, 35.500, 35.600
	(a) As approved in the Sealed Source and Device Registry
	A licensee shall use only brachytherapy sources for therapeutic medical uses:
	35.500 (a) As approved in the Sealed Source and Device Registry
Are possessed seal sources used as described in the SSDR?	35.600 A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses:
	(a) As approved in the Sealed Source and Device Registry § 35.400; or
	(b) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of § 35.49(a) are met.
4. Are copies of (or access to) SSDR certificates possessed and are manufacturers’ manuals for operation and maintenance of medical devices possessed?	Copies of (or access to) SSDR Certificates must be possessed. Manufacturers’ manuals for operation and maintenance of medical devices must be possessed.	10 CFR 32.210, 35.400, 35.500, 35.600
Are the SSDR certificates copies accessible? Stored location?
5. Are there sealed sources containing accelerator-produced radioactive materials or discrete sources of radium-226 that do not have an SSDR certificate?	If the sealed source is not generally licensed or exempt from licensing, seek a license amendment providing information.	10 CFR 32(g) (2) or (3)
Check license amendments.
6. Are the actual uses of medical devices consistent with the authorized uses listed on the license?
Is the facility utilizing source the way they say they are?
7. If places of use changed, was the license amended?	(e) Before it adds to or changes the areas of use identified in the application or on the license, including areas used in accordance with either § 35.100 or § 35.200 if the change includes addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area. Other areas of use where byproduct material is used only in accordance with either § 35.100 or § 35.200 are exempt;	10 CFR 35.13(e)
Check license.
8. If control of the license was transferred or bankruptcy filed, was NRC’s prior consent obtained or notification made respectively?	(b)(1) No license issued or granted pursuant to the regulations in this part and parts 31 through 36, and 39 nor any right under a license shall be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the Commission shall, after securing full information, find that the transfer is in accordance with the provisions of the Act and shall give its consent in writing.	10 CFR 30.34(b) and 30.34(h)
	(2) An application for transfer of license must include:
	(i) The identity, technical and financial qualifications of the proposed transferee; and
	(ii) Financial assurance for decommissioning information required by § 30.35.
	(h)(1) Each general licensee that is required to register by § 31.5(c)(13) of this chapter and each specific licensee shall notify the appropriate NRC Regional Administrator, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (Bankruptcy) of the United States Code by or against:
	(i) The licensee;
	(ii) An entity (as that term is defined in 11 U.S.C. 101(15)) controlling the licensee or listing the license or licensee as property of the estate; or
	(iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.
	(2) This notification must indicate:
	(i) The bankruptcy court in which the petition for bankruptcy was filed; and
	(ii) The date of the filing of the petition.
	(i) Security requirements for portable gauges.
	Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.
I. Recordkeeping for Decommissioning
1. Are records of information maintained for decommissioning purposes?	Records of information important to the safe and effective decommissioning of the facility maintained in an independent and identifiable location until license termination?	10 CFR 30.35 (g)
Check location/file
2. Records include all information outlined in 10 CFR 30.35(g)?	Each person licensed under this part or parts 32 through 36 and 39 of this chapter shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with § 30.34(b), licensees shall transfer all records described in this paragraph to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated	10 CFR 30.35 (g)

Do records possess the information concerning these areas and locations provided the sources have not leaked or no contamination remains after any leak) or byproduct materials having only half-lives of less than 65 days etc.

https://www.google.com/url?q=https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/full-text.html&sa=U&ved=0ahUKEwj8zoTqmt7XAhXjYpoKHe9xBO4QFggGMAE&client=internal-uds-cse&cx=011004570523114117460:xvldhfywmga&usg=AOvVaw3OAnvEYwy3W77RvA0yljQP

Nuclear Medicine

Nuclear Medicine
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. REPORTING:
1. If there was a medical event to embryos, fetuses or nursing children- is it being documented?	Any medical events or doses to embryos/fetuses or nursing children properly reported and documented?	10 CFR 35.3045, 35.3047
Verify documentation or how many events occurred?
B. INSTRUMENTATION AND DOSE CALIBRATION:
1. Constancy:	At the beginning of each day of use, a constancy check on the dose calibrator was performed using a dedicated check source of appropriate activity. Documentation must be maintained for three years to include the model and serial number of the calibrator, the dedicated check source identity, the date, the measured activity, and the name of the individual who performed each daily check.	10 CFR 35.60 (b), 10 CFR 35.2060, and Reg. Guide 10.8 Appendix C
Verify daily constancy checks with ANP.
2. Accuracy:	At installation, after repair or calibration, and at least quarterly; the dose calibrator is tested for accuracy using at least two sealed source radionuclides of at least 50 μCi activity whose activity the manufacturer has determined within 5% of their stated activity and one of them with a gamma energy between 100 and 500 keV. Documentation must be maintained for three years to include the model and serial number of calibrator, model number, serial number, and identity of each source used, date of test, results of test, the name of the individual who performed the test, and the RSO signature	10 CFR 35.60 (b), 10 CFR 35.2060, and Reg. Guide 10.8 Appendix C
Verify accuracy checks with ANP. Maintained for 3 years?
3. Does the dose calibrator currently exceed 10% for constancy or accuracy?		Reg. Guide 10.8 Appendix C
When was the last time it was repaired, replaced?	The dose calibrator is required to be repaired or replaced if accuracy or constancy exceeds 10 %.
4. Linearity:	At installation, after repair or calibration, and quarterly; the dose calibrator is tested for linearity over the range of its use from 30 μCi to the highest activity normally assayed in a prepared radiopharmaceutical kit using 99mTc. Documentation must be maintained for three years to include the model and serial number of dose calibrator, calculated and measured activities, date of test, the name of the individual who performed the test, and the RSO signature	10 CFR 35.60 (b), 10 CFR 35.2060, and Reg. Guide 10.8 Appendix C
Is documentation maintained for 3 years for testing of linearity over range of use?
5. Geometry:	At installation, the dose calibrator is tested for geometry dependence over the range of volumes and volume configurations for which it is used. Documentation includes model and serial number of dose calibrator, the configuration of the source measured, the activity of the source measured, the activity for each volume measured, the date of test, the name of the individual who performed the test, and RSO signature.	10 CFR 35.60 (b), 10 CFR 35.2060, and Reg. Guide 10.8 Appendix C
Is dose calibrator tested for geometry dependence over the range of volumes and volume configurations for which it is used with necessary documentation?
6. Appropriate portable radiation survey instruments are available to conduct required surveys	a) In addition to the surveys required by Part 20 of this chapter, a licensee shall survey with a radiation detection survey instrument at the end of each day of use. A licensee shall survey all areas where unsealed byproduct material requiring a written directive was prepared	10 CFR 35.70(a)
Is correct survey instrumentation being used for end of day surveys?
C. POSTING:
1. A current copy of Form NRC-3, "Notice to Employees" and a notice which describes documents specified in 10 CFR 19.11 (a) (1, 2, 3) and states where they may be examined is posted. (10 CFR 19.11 (b-c)).
2. Rooms or areas were properly posted to indicate the presence of a RADIATION AREA	(a) Posting of radiation areas. The licensee shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."	10 CFR 20.1902(a)
3. Rooms or areas were properly posted to indicate the presence of a HIGH RADIATION AREA	(b) Posting of high radiation areas. The licensee shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."	10 CFR 20.1902(b)
4. Rooms or areas were properly posted to indicate the presence of an AIRBORNE RADIOACTIVITY AREA	(d) Posting of airborne radioactivity areas. The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA	10 CFR 20.1902(d)
5. Rooms or areas were properly posted to indicate the presence of RADIOACTIVE MATERIAL	(e) Posting of areas or rooms in which licensed material is used or stored. The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding 10 times the quantity of such material specified in appendix C to part 20 with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL	10 CFR 20.1902 (e)
6. Containers were properly labeled to indicate the presence of RADIOACTIVE MATERIAL	(a) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label must also provide sufficient information (such as the radionuclide(s) present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment) to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.	10 CFR 20.1904(a) and 10 CFR 20.1905
	§ 20.1905 Exemptions to labeling requirements.
Are containers properly labeled?	A licensee is not required to label—
Are exempted containers meeting requirements?	(a) Containers holding licensed material in quantities less than the quantities listed in appendix C to part 20; or
	(b) Containers holding licensed material in concentrations less than those specified in table 3 of appendix B to part 20; or
	(c) Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by this part; or
	(d) Containers when they are in transport and packaged and labeled in accordance with the regulations of the Department of Transportation,3 or
	(e) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record (examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells). The record must be retained as long as the containers are in use for the purpose indicated on the record; or
	(f) Installed manufacturing or process equipment, such as reactor components, piping, and tanks; or
	(g) Containers holding licensed material (other than sealed sources that are either specifically or generally licensed) at a facility licensed under Parts 50 or 52 of this chapter, not including non-power reactors, that are within an area posted under the requirements in § 20.1902 if the containers are:
	(1) Conspicuously marked (such as by providing a system of color coding of containers) commensurate with the radiological hazard;
	(2) Accessible only to individuals who have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of the containers; and
	(3) Subject to plant procedures to ensure they are appropriately labeled, as specified at § 20.1904 before being removed
7. Is an updated Health Physics Service telephone roster posted in common area?	The emergency phone number of the RSO and persons to contact in case of an emergency are posted in all radioactive material use areas	Local SOP
Where is it posted and last updated?
8. A copy of the Nuclear Medicine Radioactive Material Authorization is posted in a conspicuous place?	(a) Each licensee shall post current copies of the following documents: (2) The license, license conditions, or documents incorporated into a license by reference, and amendments thereto	10 CFR 19.11(a)(2)
Location?
D. SURVEYS, INVENTORIES AND TESTS:
1. All areas where radiopharmaceuticals are routinely prepared for use or administered are surveyed at the end of each day.	(a) In addition to the surveys required by Part 20 of this chapter, a licensee shall survey with a radiation detection survey instrument at the end of each day of use. A licensee shall survey all areas where unsealed byproduct material requiring a written directive was	10 CFR 35.70 (a) and 10 CFR 20.1501(a) (b) (c)
	10 CFR 20.1501
	(a) Each licensee shall make or cause to be made, surveys of areas, including the subsurface, that —
	(1) May be necessary for the licensee to comply with the regulations in this part; and
	(2) Are reasonable under the circumstances to evaluate--
Do survey results include date, plan of area, trigger/action levels, detected dose rate or DPM, instrument used, and individual's initials? Are instruments used calibrated?	(i) The magnitude and extent of radiation levels; and
	(ii) Concentrations or quantities of residual radioactivity; and
	(iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.
	(b) Notwithstanding § 20.2103(a) of this part, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with §§ 30.35(g), 40.36(f), 50.75(g), 70.25(g), or 72.30(d), as applicable.
	(c) The licensee shall ensure that instruments and equipment used for quantitative radiation measurements (e.g., dose rate and effluent monitoring) are calibrated periodically for the radiation measured.
2. Survey instruments used were able to detect dose rates as low as 0.1 mR/hr.		Local SOP/Area Survey Worksheet
3. A survey dose rate trigger level is established and the RSO is to be notified if a dose rate exceeds the trigger level.		Local SOP
What is the trigger/action level?
4. Monitoring of packages is done within ____ hours of receipt if received during normal working hours or not later than _____ hours from the beginning of the next working day if received after normal working hours.		10 CFR 20.1906
		Mr. Martilla update warehouse training
5. Radioactive material inventories are within the limits specified in the Nuclear Medicine Authorization.		Local SOP
Are these being inspected quarterly?
E. PERSONNEL DOSIMETRY:
1. A service dosimetry coordinator is designated on orders signed by the Chief?, Nuclear Medicine.		Local SOP
2. All radiation workers are issued dosimetric devices as required.	(a) Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by—	10 CFR 20.1502
	(1) Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in § 20.1201(a),
	(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);
	(3) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);2 and
	(4) Individuals entering a high or very high radiation area.
	(b) Each licensee shall monitor (see § 20.1204) the occupational intake of radioactive material by and assess the committed effective dose equivalent to—
	(1) Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALI(s) in table 1, Columns 1 and 2, of appendix B to §§ 20.1001-20.2402;
	(2) Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 rem (1 mSv); and
	(3) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent
Are all members of Nuclear Medicine issued a dosimeter?
Was use of dosimeters utilized during inspection?
F. AIRBORNE RADIOACTIVITY:
1. Appropriate process or engineering controls are used to control radioactivity that might routinely become airborne, namely gaseous and volatile radionuclides.	The licensee shall use, to the extent practical, process or other engineering controls (e.g., containment, decontamination, or ventilation) to control the concentration of radioactive material in air.	10 CFR 20.1701
What engineer controls are being used to control airborne radioactivity?
2. Appropriate gaseous radioactivity administration devices are available and maintained for use.	The licensee shall use, to the extent practical, process or other engineering controls (e.g., containment, decontamination, or ventilation) to control the concentration of radioactive material in air.	10 CFR 20.1701
What administration controls are being used to control gaseous radioactivity?
3. To preclude inadvertent release of gaseous radioactivity by a patient during administration, appropriate precautions and alternate ventilation is provided and administrative procedures are in place to use this system.	The licensee shall use, to the extent practical, process or other engineering controls (e.g., containment, decontamination, or ventilation) to control the concentration of radioactive material in air.	10 CFR 20.1701
What administration controls are being used to preclude inadvertent release of gaseous radioactivity?
G. MEDICAL QUALITY ASSURANCE:
1. Records maintained and include required information?	A licensee shall maintain a record of instrument calibrations required by § 35.60 for 3 years. The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.	10 CFR 35.2060
Are calibration records maintained for 3 years?
2. Every radiopharmaceutical dosage is determined and recorded prior to administration.	35.63 (a) A licensee shall determine and record the activity of each dosage before medical use.	10 CFR 35.63(a)
How is each dose being determined and recorded?
3. Determination of dosages of unsealed byproduct material?	§ 35.63	10 CFR 35.63
	(a) A licensee shall determine and record the activity of each dosage before medical use.
	(b) For a unit dosage, this determination must be made by—
	(1) Direct measurement of radioactivity; or
	(2) A decay correction, based on the activity or activity concentration determined by—
	(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
	(ii) An NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA;
	(c) For other than unit dosages, this determination must be made by—
	(1) Direct measurement of radioactivity;
	(2) Combination of measurement of radioactivity and mathematical calculations; or
	(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:
	(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements;
	(d) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.
	(e) A licensee shall retain a record of the dosage determination required by this section in accordance with § 35.2063.
What method is being used to determine doses of unsealed byproduct material? Does it differ more than 20%?
4. Measurement of unit dosages of photon- or beta-emitting radionuclides made either by direct measurement or by decay correction?	(b) For a unit dosage, this determination must be made by—	10 CFR 35.63(b)
	(1) Direct measurement of radioactivity; or
Which method used?	(2) A decay correction, based on the activity or activity concentration determined by—
	(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
	(ii) An NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA
5. Measurement of unit dosage of alpha-emitting radionuclide by decay correction of the activity provided by the producer licensed?	32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35	10 CFR 32.72
	(a) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing byproduct material for use by persons authorized pursuant to part 35 of this chapter will be approved if:
Verify Radium 223 radionuclide on license.	(1) The applicant satisfies the general requirements specified in 10 CFR 30.33; (see § 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35):
	(i) Registered with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a);
	(ii) Registered or licensed with a state agency as a drug manufacturer;
	(iii) Licensed as a pharmacy by a State Board of Pharmacy;
	(iv) Operating as a nuclear pharmacy within a Federal medical institution;
6. For other than unit dosages of photon- or beta-emitting radionuclides, measurement made by direct measurement of radioactivity or by combination of radioactivity or volumetric measurement and calculation.	(c) For other than unit dosages, this determination must be made by—	10 CFR 35.63(c)
	(1) Direct measurement of radioactivity;
How are other than unit dosages measured? Are they used at BAMC?	(2) Combination of measurement of radioactivity and mathematical calculations; or
	(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:
	(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements
7. For other than unit dosages of alpha-emitting radionuclide, measurement made by combination using	c) For other than unit dosages, this determination must be made by—	10 CFR 35.63(c)
the activity provided by the producer licensed in accordance with volumetric measurement, and calculation?	(1) Direct measurement of radioactivity;
	(2) Combination of measurement of radioactivity and mathematical calculations; or
How are other than unit dosages measured? Are they used at BAMC?	(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:
	(i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements;
8. Are the manufacturer's safety instructions for sealed sources are utilized?	(a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer	10 CFR 35.67 (a)
Are instructions being followed for sealed sources?
9. Do syringes or syringe shields have labels indicating the radioactive drug?	Each syringe and vial that contains unsealed byproduct material must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.	10 CFR 35.69
Are syringes with radioisotopes being labeled?
10. Syringe shields, vial shields, and appropriate dose reduction techniques are used when eluting generators, preparing kits, transporting doses, and when administering by injection) unless specifically contraindicated for a particular patient) in order for Nuclear Medicine personnel to maintain their radiation exposures ALARA.	b) The licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).	10 CFR 20.1101 (b)
Are engineering controls (i.e. syringe shields) being utilized by employees handling radioisotopes?)
11. Humans were only administered radiopharmaceuticals containing no more than 0.15 μCi of 99Mo-99 per mCi of 99mTc.	No radiopharmaceuticals administered with Mo-99 concentrations over 0.15 μCi per mCi of Tc-99m	10 CFR 35.204 (a)(1)
Have limits been exceeded? Documentation? How to verify?
12. The Mo-99 concentration was measured at least at the time of the first eluate after receipt of the generator.	First eluate after receipt tested for Mo-99 breakthrough	10 CFR 35.204(b)
How is Mo-99 concentration measured for 1st eluate?
13. For each measured elution of 99mTc, the record must include the ratio of the measured microCuries of 99Mo-99 to milliCuries of 99mTc (and must be less than 0.15 μCi 99Mo-99/mCi 99mTc), the date and time of the measurements and the name of the individual performing the measurement.	(a) For each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (or microcuries of molybdenum per millicurie of technetium), the time and date of the measurement, and the name of the individual who made the measurement; or	10 CFR 35.2204 (a)
Are all parameters being recorded when each elution of Tc-99m is being measured?
14. Fixed contamination monitoring equipment will have efficiency calculations performed with a source of known activity and to ensure it is operating within expected parameters prior to use.		Local SOP?
Are efficiency calculations being done prior to use of the gamma counter? Wizard(Gandalf)
15. Portable radiation and radioactivity surveying instruments will have constancy checks, battery checks, and background measurements made prior to use.		Local SOP?
Are survey meters being checked before area surveys are conducted?
16. Nuclear Medicine personnel will conduct necessary quality assurance and quality control checks on nuclear cameras and uptake probes based on accepted industry standards and manufacturer’s recommendations in order to provide the highest image quality commensurate with minimizing patient dose from nuclear medicine procedures.	b) The licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).	10 CFR 20.1101 (b)
Is nuclear medicine staff utilizing ALARA principles to minimize patient dose and occupational exposure from nuclear medical procedures?
17. Are records of radiopharmaceutical dose measurements are kept?	(a) A licensee shall maintain a record of dosage determinations required by § 35.63 for 3 years.	10 CFR 35.2063
	(b) The record must contain--
	(1) The radiopharmaceutical;
Do records have all required info? Where are they stored?	(2) The patient's or human research subject's name, or identification number if one has been assigned;
	(3) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 µCi);
	(4) The date and time of the dosage determination; and
	(5) The name of the individual who determined the dosage.
H.DOCUMENTATION/SOPs/RECORDS:
1. Procedures for picking up, receiving, and opening of a package containing radioactive material are available and are in routine use.	(a) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in § 71.4 and appendix A to part 71 of this chapter, shall make arrangements to receive—	10 CFR 20.1906
	(1) The package when the carrier offers it for delivery; or
	(2) Notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.
	(b) Each licensee shall—
	(1) Monitor the external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of a gas or in special form as defined in 10 CFR 71.4;
	(2) Monitor the external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in § 71.4 and appendix A to part 71 of this chapter; and
	(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.
	(c) The licensee shall perform the monitoring required by paragraph (b) of this section as soon as practical after receipt of the package, but not later than 3 hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours, or not later than 3 hours from the beginning of the next working day if it is received after working hours.
	(d) The licensee shall immediately notify the final delivery carrier and the NRC Operations Center (301-816-5100), by telephone, when—
	(1) Removable radioactive surface contamination exceeds the limits of § 71.87(i) of this chapter; or
	(2) External radiation levels exceed the limits of § 71.47 of this chapter.
	(e) Each licensee shall—
	(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and
Are procedures being followed and met for picking up, opening and receiving radioactive packages? Observe process!	(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.
	(f) Licensees transferring special form sources in licensee-owned or licensee-operated vehicles to and from a work site are exempt from the contamination monitoring requirements of paragraph (b) of this section, but are not exempt from the survey requirement in paragraph (b) of this section for measuring radiation levels that is required to ensure that the source is still properly lodged in shield.
2. Records of receipt of byproduct material pursuant to a license were properly maintained.		10 CFR 30.51
I. OTHER:
1. Calibration and reference sealed sources, except as specified in the license, do not exceed 15 mCi each for t½ ≤120 days, do not exceed 200 µCi for t½ >120 days, or as specified in the Nuclear Medicine Authorization.		10 CFR 35.65 (c)&(d)
2. Leaking sealed sources are reported to the RSO immediately upon discovery.		10 CFR 35.3067
3. All inpatient I-131 administration requests are documented in patient record. (AHLTA or Essentris upload)		Local SOP
		I-131 Guidance
4. All 131I administrations >30 µCi for the doses this quarter have been reviewed to ensure that an authorized user has signed and dated the order prior to administration of the dose.		10 CFR 35.40
J. Authorized Nuclear Pharmacist	(1) Have graduated from a pharmacy program accredited by the American Council on Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;	10 CFR 35.55, 35.57, 35.59
	(2) Hold a current, active license to practice pharmacy;
	(3) Provide evidence of having acquired at least 4000 hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience; and
	(4) Pass an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development; or
	(b)(1) Has completed 700 hours in a structured educational program consisting of both:
	(i) 200 hours of classroom and laboratory training in the following areas-
	(A) Radiation physics and instrumentation;
	(B) Radiation protection;
	(C) Mathematics pertaining to the use and measurement of radioactivity;
	(D) Chemistry of byproduct material for medical use; and
	(E) Radiation biology; and
	(ii) Supervised practical experience in a nuclear pharmacy involving--
	(A) Shipping, receiving, and performing related radiation surveys;
	(B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;
	(C) Calculating, assaying, and safely preparing dosages for patients or human research subjects;
	(D) Using administrative controls to avoid medical events in the administration of byproduct material; and
	(E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures
1. Certified by specialty board?	(a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (b)(2) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:
2. Identified and listed on NRC or Agreement State license?	(2) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraphs (a)(1), (a)(2), and (a)(3) or (b)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist
3. Identified on permit issued by broad-scope or master materials licensee and meets requirements?	(a)(1) An individual identified as a Radiation Safety Officer, a teletherapy or medical physicist, or a nuclear pharmacist on a Commission or Agreement State license or a permit issued by a Commission or Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope before October 24, 2002, need not comply with the training requirements of §§ 35.50, 35.51, or 35.55, respectively.	10 CFR 35.57(a) (3)
6. Designated as an ANP?	4) May designate a pharmacist (as defined in § 35.2 of this chapter) as an authorized nuclear pharmacist if:	10 CFR 32.72(b)(4)
	(i) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and
	(ii) The individual practiced at a pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC
K. Authorized User		10 CFR 35.57, 35.59, and 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.491, 35.590, 35.690
1. Certified by specialty board?	(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (c)(2) of this section. (The names of board certifications which have been recognized by the Commission or an Agreement State will be posted on the NRC's Web page.) To have its certification process recognized, a specialty board shall require all candidates for certification to:	10 CFR35.57, 35.59, 35.190, 35.290, 35.390
	(1) Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies as described in paragraphs (c)(1)(i) through (c)(1)(ii)(F) of this section; and
	(2) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or
	(b) Is an authorized user under §35.290, 35.390, or equivalent Agreement State requirements; or (c)(1)*
	(c)(1) Has completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies. The training and experience must include-
	(i) Classroom and laboratory training in the following areas—
	(A) Radiation physics and instrumentation;
	(B) Radiation protection;
	(C) Mathematics pertaining to the use and measurement of radioactivity;
	(D) Chemistry of byproduct material for medical use; and
	(E) Radiation biology; and
	(ii) Work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.190, 35.290, 35.390, or equivalent Agreement State requirements, involving—
	(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
	(B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
	(C) Calculating, measuring, and safely preparing patient or human research subject dosages;
	(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;
	(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
	(F) Administering dosages of radioactive drugs to patients or human research subjects; and
	(2) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in §§ 35.57, 35.190, 35.290, or 35.390, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under § 35.100.
2. Identified on NRC or Agreement State license?	(i) On a Commission or Agreement State license or other equivalent permit or license	10 CFR 35.13 (4)
	recognized by NRC that authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy;
3. Identified on permit issued by broad-scope or master materials licensee?		10 CFR 35.13 9 (4)
4. Identified on permit issued by master materials permittee of broad scope?	Commission or Agreement State broad scope licensee or master material license permit or by a master material	10 CFR 35.57
	license permittee
	of broad scope
	before October 24, 2002, need not comply with the training requirements of §§ 35.50, 35.51, or 35.55, respectively.
5. Meets requirements?	(b)(3) Physicians, dentists, or podiatrists who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses performed at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of subparts D through H of this part when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses at the locations and time period identified in this paragraph, qualifies as an authorized user for those materials and uses performed before these dates, for purposes of this chapter. § 35.57	10 CFR 35.57(b) (3)
6. Listed on facility license?
L. Training

https://www.nrc.gov/reading-rm/doc-collections/cfr/part020/part020-1905.html https://www.nrc.gov/reading-rm/doc-collections/cfr/part020/part020-1502.html

Radiation Oncology

Radiation Oncology
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Authorized Medical Physicist	2) An individual identified as a Radiation Safety Officer, an authorized medical physicist, or an authorized nuclear pharmacist on a Commission or Agreement State license or a permit issued by a Commission or Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope between October 24, 2002 and April 29, 2005 need not comply with the training requirements of §§ 35.50, 35.51, or 35.55, respectively. (see § 35.57 Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist).	10 CFR
		35.51,35.57& 35.59
1. Certified by specialty board?
2. Identified on NRC or Agreement State license?
3. Identified on permit issued by broad-scope or master materials licensee?	Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the Commission or Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or Agreement State broad scope licensee, or a permit issued by a Commission master material license broad scope permitted before October 24, 2002, who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of Subparts through H of this part as specified in § 35.57.	10 CFR 35.57 (b)
4. Identified on permit issued by master materials permittee of broad scope?	Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the Commission or Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or Agreement State broad scope licensee, or a permit issued by a Commission master material license broad scope permitted before October 24, 2002, who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of Subparts through H of this part as specified in § 35.57.	10 CFR 35.57 (b)
5. Meets requirements?	(a) (3) A Radiation Safety Officer, a medical physicist, or a nuclear pharmacist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of § 35.50, § 35.51 or § 35.55, respectively, when performing the same uses. A nuclear pharmacist, who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist, who used only accelerator-produced radioactive materials, at the locations and time period identified in this paragraph, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for purposes of this chapter, as specified in § 35.57.	10 CFR 35.57(a) (3)
6. Listed on facility license?
B. Nonmedical use authorized users	(a) An application for a specific license will be approved if:	10 CFR 30.33(a) (3)
	(3) The applicant is qualified by training and experience to use the material for the purpose requested in such manner as to protect health and minimize danger to life or property
Listed on facility license for same materials and uses?
C. Operating Procedures For Therapy Devices
A. Instructions on location of emergency procedures and emergency response telephone numbers posted at the device console [35.610(c)]?	(4) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include--	10 CFR 35.610 (c)
	(i) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;
	(ii) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and
	(iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.
	(b) A copy of the procedures required by paragraph (a)(4) of this section must be physically located at the unit console.
	(c) A licensee shall post instructions at the unit console to inform the operator of--
	(1) The location of the procedures required by paragraph (a)(4) of this section; and
	(2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.
	(d) A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual's assigned duties, in--
	(1) The procedures identified in paragraph (a)(4) of this section; and
	(2) The operating procedures for the unit.
	(e) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.
	(f) A licensee shall retain a record of individuals receiving instruction required by paragraph (d) of this section, in accordance with § 35.2310.
	(g) A licensee shall retain a copy of the procedures required by §§ 35.610(a)(4) and (d)(2) in accordance with § 35.2610.
B. Copy of the entire procedures physically located at the device console [35.610(b)]?	(4) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include--	10 CFR 35610 (b)
	(i) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;
	(ii) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and
	(iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.
	(b) A copy of the procedures required by paragraph (a)(4) of this section must be physically located at the unit console.
	(c) A licensee shall post instructions at the unit console to inform the operator of--
	(1) The location of the procedures required by paragraph (a)(4) of this section; and
	(2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.
	(d) A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual's assigned duties, in--
	(1) The procedures identified in paragraph (a)(4) of this section; and
	(2) The operating procedures for the unit.
	(e) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.
	(f) A licensee shall retain a record of individuals receiving instruction required by paragraph (d) of this section, in accordance with § 35.2310.
	(g) A licensee shall retain a copy of the procedures required by §§ 35.610(a)(4) and (d)(2) in accordance with § 35.2610.
C. Procedures include:	(i) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;
	(ii) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and
	(iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.
	(b) A copy of the procedures required by paragraph (a)(4) of this section must be physically located at the unit console.
	(c) A licensee shall post instructions at the unit console to inform the operator of--
	(1) The location of the procedures required by paragraph (a)(4) of this section; and
	(2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.
	(d) A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual's assigned duties, in--
	(1) The procedures identified in paragraph (a)(4) of this section; and
	(2) The operating procedures for the unit.
	(e) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.
	(f) A licensee shall retain a record of individuals receiving instruction required by paragraph (d) of this section, in accordance with § 35.2310.
	(g) A licensee shall retain a copy of the procedures required by §§ 35.610(a)(4) and (d)(2) in accordance with § 35.2610.
1. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions [35.610(a)(4)]?		10 CFR 35.610 (a)(4)
2. The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure [35.610(a)(4)]?		10 CFR 35.610 (a)(4)
3. The names and telephone numbers of the AUs, the AMP, and the RSO to be contacted if the unit or console operates abnormally [35.610(a)(4)]?		10 CRF 35.610 (a)(4)
D. Radiation survey of patient is performed to ensure source is returned to shielded position [35.604(a)]?	Before releasing a patient or a human research subject from licensee control, a licensee shall survey the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position	10 CFR 35.604 (a)
E. Records of radiation surveys maintained for 3 years [35.2404]?		10 CFR 35.2404
	A licensee shall maintain a record of the surveys required by §§ 35.404 and 35.604 for 3 years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey
F. AMP and AU:	In addition to the requirements specified in paragraphs (a) through (e) of this section, a shall--	10 CRF
	(1) For medium dose-rate and pulsed dose-rate remote afterloader units, require--
	(i) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and
	(ii) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.
	(2) For high dose-rate remote afterloader units, require--
	(i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and
	(ii) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.
	(3 throughout all patient treatments invo) For gamma stereotactic radiosurgery units, require anauthorized user and an authorized medical physicist to be physically present lving the unit.
1. Physically present during initiation of patient treatment with remote afterloaders? (Note: for MDR and PDR, an appropriately trained physician under the supervision of the AU may be physically present instead of the AU) [35.615(f)(1) and (2)].	(1) For medium dose-rate and pulsed dose-rate remote afterloader units, require--	10 CFR 35.625 (f) and 2
	(i) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and
	(ii) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.
	(2) For high dose-rate remote afterloader units, require--
	(i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and
	(ii) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.
2. Physically present throughout all patient treatments with a gamma stereotactic radiosurgery device [35.615(f)(3)]?	3 throughout all patient treatments invo) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present lving the unit	10 CFR 35.615 (3)
Training
1. Emergency drills and Safety procedures and instructions for remote after loader units, tele therapy units, and gamma stereotactic radiosurgery units	(e) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.	10 CFR 35.610

Unsealed Byproducts

Unsealed Byproduct Material for which a written Directive Is Required
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Safety precautions implemented to include patient facilities, posting, stay times, patient safety guidance, release, and contamination controls [35.315(a)]?	For each patient or human research subject who cannot be released under § 35.75, a licensee shall—	CRF 35.315 (a)
	(1) Quarter the patient or the human research subject either in—
	(i) A private room with a private sanitary facility; or
	(ii) A room, with a private sanitary facility, with another individual who also has received therapy with unsealed byproduct material and who also cannot be released under § 35.75;
B. RSO and AU promptly notified if patient had a medical emergency or died [35.315(b)]?	A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

Brachytherapy

Brachythertapy or Brachytherapy Source Use
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Safety precautions implemented to include patient facilities, posting, stay times, and emergency response equipment [35.415]?	(a) For each patient or human research subject who is receiving brachytherapy and cannot be released under § 35.75, a licensee shall--	10 CFR 35.45
	(1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving brachytherapy;
	(2) Visibly post the patient's or human research subject's room with a "Radioactive Materials" sign; and
	(3) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.
	(b) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source--
	(1) Dislodged from the patient; and
	(2) Lodged within the patient following removal of the source applicators.
	(c) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.
B. Survey immediately after implant [35.404(a)]?	(a) Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.	10 CFR 35.404(b)
	(b) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed
C. Patients surveyed immediately after removing the last temporary implant source [35.404(b)]?	(b) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed	10 CFR35.404 b)
D. RSO and AU promptly notified if patient had a medical emergency or died [35.415(c)]?	c) A licensee shall notify the Radiation Safety Officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.	10 CFR 35.415(c)
E. Records maintained [35.2404]?	A licensee shall maintain a record of the surveys required by §§ 35.404 and 35.604 for 3 years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.	10 CFR 35.2404

Radiation Protection

	Radiation Protection and Control of Radioactive Materials_ Department
TASK		STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Use of radiopharmaceuticals
1. Protective clothing worn?
2. Personnel routinely monitor their hands?
3. No eating/drinking in use/storage areas?
4. No food, drink, or personal effects kept in use/storage areas?
5. Proper dosimetry worn?
6. Radioactive waste disposed of in proper receptacles?
7. Syringe shields and vial shields used?
8. Proper use of remote handling tools and radiation shields?
B. Leak tests and inventories:
		A licensee in possession of a sealed source shall—	10 CFR 35.67 (b)
1. Leak test performed on sealed sources and brachytherapy sources [35.67(b) (1) or leak test license condition]?		(1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and
2. Inventory of sealed sources and brachytherapy sources performed semiannually [35.67(g)]?		A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. The licensee shall retain each inventory record in accordance with § 35.2067(b).	10CFR35.67 (g)
3. Records maintained [35.2067]?		A licensee shall retain records of leak tests required by § 35.67(b) for 3 years. The records must include the model number, and serial number if one has been assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of the test; the date of the test; and the name of the individual who performed the test.	10 CFR 35.2067
		(b) A licensee shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by § 35.67(g) for 3 years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source by radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.

Radiation Survey Instruments

Radiation Survey Instruments
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Survey instruments used to show compliance with 10 CFR Part 20 and 10 CFR 30.33(a)(2):	An application for a specific license will be approved if:	10CFR 30.33 (a)(2)
	(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property;
1. Appropriate operable survey instruments possessed or available [10 CFR Part 20]?	A licensee shall calibrate the survey instruments used to show compliance with this part and 10 CFR Part 20 before first use, annually, and following a repair that affects the calibration. A licensee shall--
	(1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source;
2. Calibrations [35.61(a) and (b)]:	A licensee shall calibrate the survey instruments used to show compliance with this part and 10 CFR Part 20 before first use, annually, and following a repair that affects the calibration. A licensee shall--	10 CFRB35.61 (a)and (b)
	(1) Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source;
	(2) Calibrate two separated readings on each scale or decade that will be used to show compliance; and
	(3) Conspicuously note on the instrument the date of calibration.
	(b) A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20 percent.
a. Before first use, annually, and after repairs?		(A)(B)
b. Within 20% on each scale or decade of interest?
	A licensee shall maintain a record of radiation survey instrument calibrations required by § 35.61 for 3 years. The record must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.	10 CFR 35.2061
3. Records maintained [35.2061]?
B. Radiation surveys performed in accordance with the licensee’s procedures and the regulatory requirements [20.1501, 35.70]? If producing PET radioactive drugs under 10 CFR 30.32(j) or 35.100(b), 35.200(b), or 35.300(b), the survey frequencies described below should be reviewed and adjusted as necessary.		CFR 20.1501, 35.70
1. Daily in all areas where radiopharmaceuticals requiring a written directive are prepared or administered (except patient rooms) [35.70]?		10 CFR 35.70
2. Weekly in all areas where radiopharmaceuticals or waste are stored?
3. Weekly for wipes in all areas where radiopharmaceuticals are routinely prepared, administered, or stored?
4. Trigger levels established?
5. Corrective action taken and documented if trigger level exceeded?
6. Techniques can detect 0.1 mR/hr, 2000dpm?
7. Surveys made to assure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the sources(s) in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry [35.652(a)] and records maintained [35.2652]?
a. After new source installation?
b. Following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical mechanism that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s)?

Mobile Medicine Service

Mobile Medical Service
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Operates services?	(c) A licensee providing mobile medical services shall retain the letter required in paragraph (a)(1) and the record of each survey required in paragraph (a)(4) of this section in accordance with § 35.2080(a) and (b), respectively.	10 CFR 35.80, 35.647
B. Compliance is being evaluated and met?	(a) Each licensee shall conduct operations so that -	10 CFR 20.1301
	(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contributions from background radiation, from any administration the individual has received, from exposure to individuals administered radioactive material and released under § 35.75, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with § 20.2003, and
	(2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with § 35.75, does not exceed 0.002 rem (0.02 millisievert) in any one hour.
	(b) If the licensee permits members of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.
	(c) Notwithstanding paragraph (a)(1) of this section, a licensee may permit visitors to an individual who cannot be released, under § 35.75, to receive a radiation dose greater than 0.1 rem (1 mSv) if-
	(1) The radiation dose received does not exceed 0.5 rem (5 mSv); and
	(2) The authorized user, as defined in 10 CFR Part 35, has determined before the visit that it is appropriate.
	(d) A licensee or license applicant may apply for prior NRC authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv). The licensee or license applicant shall include the following information in this application:
	(1) Demonstration of the need for and the expected duration of operations in excess of the limit in paragraph (a) of this section;
	(2) The licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and
	(3) The procedures to be followed to maintain the dose as low as is reasonably achievable.
	(e) In addition to the requirements of this part, a licensee subject to the provisions of EPA's generally applicable environmental radiation standards in 40 CFR part 190 shall comply with those standards.
	(f) The Commission may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.
C. Letter signed by management of each client	a) A licensee providing mobile medical service shall--	10 CFR 35.80(a)
	(1) Obtain a letter signed by the management of each client for which services are rendered that permits the use of byproduct material at the client's address and clearly delineates the authority and responsibility of the licensee and the client
D. Licensed material not delivered to client’s address (unless client was authorized)	b) A mobile medical service may not have byproduct material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the byproduct material. Byproduct material delivered to the client must be received and handled in conformance with the client's license	10 CFR 35.80(b)
E. Dosage measuring instruments checked for proper function before use at each address of use or on each day of use, if more frequent	(2) Check instruments used to measure the activity of unsealed byproduct 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 required by this paragraph must include a constancy check	10 CFR 35.80(a)
F. Survey instruments checked for proper operation before use at each address of use	(3) Check survey instruments for proper operation with a dedicated check source before use at each client's address	10 CFR 35.80(a)
G. Survey of all areas of use prior to leaving each client address	4) Before leaving a client's address, survey all areas of use to ensure compliance with the requirements in Part 20 of this chapter	10 CFR 35.80(a)
H. Additional technical requirements for mobile remote after loaders	(a) A licensee providing mobile remote afterloader service shall--	10 CFR 35.647
	(1) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and
	(2) Account for all sources before departure from a client's address of use.
	(b) In addition to the periodic spot-checks required by § 35.643, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of--
	(1) Electrical interlocks on treatment area access points;
	(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;
	(3) Viewing and intercom systems;
	(4) Applicators, source transfer tubes, and transfer tube-applicator interfaces;
	(5) Radiation monitors used to indicate room exposures;
	(6) Source positioning (accuracy); and
	(7) Radiation monitors used to indicate whether the source has returned to a safe shielded position.
	(c) In addition to the requirements for checks in paragraph (b) of this section, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.
	(d) If the results of the checks required in paragraph (b) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
	(e) A licensee shall retain a record of each check required by paragraph (b) of this section in accordance with § 35.2647

Training, Retraining

Training, Retraining and Instructions to Workers
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Have workers been provided with required instructions?	(a) All individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv) shall be--	10 CFR 19.12
	(1) Kept informed of the storage, transfer, or use of radiation and/or radioactive material;
	(2) Instructed in the health protection problems associated with exposure to radiation and/or radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;
	(3) Instructed in, and required to observe, to the extent within the workers control, the applicable provisions of Commission regulations and licenses for the protection of personnel from exposure to radiation and/or radioactive material;
	(4) Instructed of their responsibility to report promptly to the licensee any condition which may lead to or cause a violation of Commission regulations and licenses or unnecessary exposure to radiation and/or radioactive material;
	(5) Instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and/or radioactive material; and
	(6) Advised as to the radiation exposure reports which workers may request pursuant to § 19.13.
	(b) In determining those individuals subject to the requirements of paragraph (a) of this section, licensees must take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and/or radioactive material which can reasonably be expected to occur during the life of a licensed facility. The extent of these instructions must be commensurate with potential radiological health protection problems present in the work place.
C. Is the individual’s understanding of current procedures and regulations adequate?	Is the instructing individual’s understanding of current procedures and regulations adequate? Training material should be specific to the work area and should be updated periodically.	10 CFR 19.12
1. Operating procedures, emergency procedures and Periodic training required and implemented?	(a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user, as allowed by § 35.11(b)(1), shall--	10 CFR 35.27, 35.310, 35.410,
		35.61
	(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of this chapter, and license conditions with respect to the use of byproduct material; and
	(2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of byproduct material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this chapter, and license conditions with respect to the medical use of byproduct material.
	(b) A licensee that permits the preparation of byproduct 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 § 35.11(b)(2), shall--
	(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the preparation of byproduct material for medical use, as appropriate to that individual's involvement with byproduct material; and
	(2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of byproduct material for medical use, written radiation protection procedures established by the licensee, the regulations of this chapter, and license conditions.
	(c) A licensee that permits supervised activities under paragraphs (a) and (b) of this section is responsible for the acts and omissions of the supervised individual.
	Subpart E—Unsealed Byproduct Material—Written Directive Required
	§ 35.310 Safety instruction.
	In addition to the requirements of § 19.12 of this chapter,
	(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include—
	(1) Patient or human research subject control;
	(2) Visitor control, including—
	(i) Routine visitation to hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and
	(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter;
	(3) Contamination control;
	(4) Waste control; and
	(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.
	(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.
	Subpart F—Manual Brachytherapy
	§ 35.410 Safety instruction.
	In addition to the requirements of § 19.12 of this chapter,
	(a) The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include the--
	(1) Size and appearance of the brachytherapy sources;
	(2) Safe handling and shielding instructions;
	(3) Patient or human research subject control;
	(4) Visitor control, including both:
	(i) Routine visitation of hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and
	(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter; and
	(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.
	(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.
	Subpart H—Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
	§ 35.610 Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
	(a) A licensee shall--
	(1) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;
	(2) Permit only individuals approved by the authorized user, Radiation Safety Officer, or authorized medical physicist to be present in the treatment room during treatment with the source(s);
	(3) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and
	(4) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include--
	(i) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;
	(ii) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and
	(iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.
	(b) A copy of the procedures required by paragraph (a)(4) of this section must be physically located at the unit console.
	(c) A licensee shall post instructions at the unit console to inform the operator of--
	(1) The location of the procedures required by paragraph (a)(4) of this section; and
	(2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the Radiation Safety Officer to be contacted if the unit or console operates abnormally.
	(d) A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual's assigned duties, in--
	(1) The procedures identified in paragraph (a)(4) of this section; and
	(2) The operating procedures for the unit.
	(e) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.
	(f) A licensee shall retain a record of individuals receiving instruction required by paragraph (d) of this section, in accordance with § 35.2310.
	(g) A licensee shall retain a copy of the procedures required by §§ 35.610(a)(4) and (d)(2) in accordance with § 35.2610.
4. Were all workers who are likely to exceed 1 mSv (100 mrem) in a year instructed and was refresher training provided, as needed	§ 19.12 Instruction to workers.	10 CFR 19.12
	(a) All individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv) shall be--
	(1) Kept informed of the storage, transfer, or use of radiation and/or radioactive material;
	(2) Instructed in the health protection problems associated with exposure to radiation and/or radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;
	(3) Instructed in, and required to observe, to the extent within the workers control, the applicable provisions of Commission regulations and licenses for the protection of personnel from exposure to radiation and/or radioactive material;
	(4) Instructed of their responsibility to report promptly to the licensee any condition which may lead to or cause a violation of Commission regulations and licenses or unnecessary exposure to radiation and/or radioactive material;
	(5) Instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and/or radioactive material; and
	(6) Advised as to the radiation exposure reports which workers may request pursuant to § 19.13.
	(b) In determining those individuals subject to the requirements of paragraph (a) of this section, licensees must take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and/or radioactive material which can reasonably be expected to occur during the life of a licensed facility. The extent of these instructions must be commensurate with potential radiological health protection problems present in the work place.
5. Was each supervised user instructed in the licensee’s written radiation protection procedures and administration of written directives, as appropriate	(a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user, as allowed by § 35.11(b)(1), shall--	10 CFR 35.27
	(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of this chapter, and license conditions with respect to the use of byproduct material; and
	(2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of byproduct material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this chapter, and license conditions with respect to the medical use of byproduct material.
	(b) A licensee that permits the preparation of byproduct 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 § 35.11(b)(2), shall--
	(1) In addition to the requirements in § 19.12 of this chapter, instruct the supervised individual in the preparation of byproduct material for medical use, as appropriate to that individual's involvement with byproduct material; and
	(2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of byproduct material for medical use, written radiation protection procedures established by the licensee, the regulations of this chapter, and license conditions.
	(c) A licensee that permits supervised activities under paragraphs (a) and (b) of this section is responsible for the acts and omissions of the supervised individual.
6. Are initial and periodic training records maintained for each individual	In addition to the requirements of § 19.12 of this chapter,	10 CFR 35.2310
	(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include—
	(1) Patient or human research subject control;
	(2) Visitor control, including—
	(i) Routine visitation to hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and
	(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter;
	(3) Contamination control;
	(4) Waste control; and
	(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.
	(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.
E. Do additional therapy device instructions/training include?	The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees. (See § 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35); and	10 CFR 35.100 (4)
1. Unit operation, inspection, associated equipment, survey instruments?	Each applicant for a specific license authorizing the possession and use of unsealed byproduct material of half-life greater than 120 days and in quantities exceeding 105 times the applicable quantities set forth in appendix B to part 30 shall submit a decommissioning funding plan as described in paragraph (e) of this section. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 105 is greater than 1 (unity rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the	10 CFR 30.35 (a)
2. License conditions applicable to the use of the unit?
F. 10 CFR Part 20 – Are workers cognizant of requirements for:
1. Radiation Safety Program [35.24, 35.26, 20.1101]?	(a) Each licensee shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities and sufficient to ensure compliance with the provisions of Radiation protection programs	10 CFR 20.1101
2. Annual dose limits [20.1201, 20.1301, and 20.1302]?	a) The licensee shall control the occupational dose to individual adults
3. NRC Forms 4 and 5?
4. 10% monitoring threshold	§ 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.	10 CFR 20.1502
	Each licensee shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of this part. As a minimum—
	(a) Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by—
	(1) Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in § 20.1201(a),
	(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);
	(3) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);2 and
	(4) Individuals entering a high or very high radiation area.
	(b) Each licensee shall monitor (see § 20.1204) the occupational intake of radioactive material by and assess the committed effective dose equivalent to—
	(1) Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALI(s) in table 1, Columns 1 and 2, of appendix B to §§ 20.1001-20.2402;
	(2) Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 rem (1 mSv); and
	(3) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 mSv).
5. Dose limits to embryo/fetus and declared pregnant worker	(a) The licensee shall ensure that the dose equivalent to the embryo/fetus during the entire pregnancy, due to the occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). (For recordkeeping requirements, see § 20.2106.)	10 CFR 20.1208
	(b) The licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (a) of this section.
	(c) The dose equivalent to the embryo/fetus is the sum of--
	(1) The deep-dose equivalent to the declared pregnant woman; and
	(2) The dose equivalent to the embryo/fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.
	(d) If the dose equivalent to the embryo/fetus is found to have exceeded 0.5 rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee, the licensee shall be deemed to be in compliance with paragraph (a) of this section if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.
6. “Grave Danger” Posting	(a) Posting of radiation areas. The licensee shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."	10 CFR 20.1902(c)
	(b) Posting of high radiation areas. The licensee shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."
	(c) Posting of very high radiation areas. The licensee shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA."
	(d) Posting of airborne radioactivity areas. The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA."
	(e) Posting of areas or rooms in which licensed material is used or stored. The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding 10 times the quantity of such material specified in appendix C to part 20 with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."
7. Procedures for opening packages	(a) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in § 71.4 and appendix A to part 71 of this chapter, shall make arrangements to receive—	10 CFR 20.1906
	(1) The package when the carrier offers it for delivery; or
	(2) Notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.
	(b) Each licensee shall—
	(1) Monitor the external surfaces of a labeled3a package for radioactive contamination unless the package contains only radioactive material in the form of a gas or in special form as defined in 10 CFR 71.4;
	(2) Monitor the external surfaces of a labeled3a package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in § 71.4 and appendix A to part 71 of this chapter; and
	(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.
	(c) The licensee shall perform the monitoring required by paragraph (b) of this section as soon as practical after receipt of the package, but not later than 3 hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours, or not later than 3 hours from the beginning of the next working day if it is received after working hours.
	(d) The licensee shall immediately notify the final delivery carrier and the NRC Operations Center (301-816-5100), by telephone, when—
	(1) Removable radioactive surface contamination exceeds the limits of § 71.87(i) of this chapter; or
	(2) External radiation levels exceed the limits of § 71.47 of this chapter.
	(e) Each licensee shall—
	(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and
	(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.
	(f) Licensees transferring special form sources in licensee-owned or licensee-operated vehicles to and from a work site are exempt from the contamination monitoring requirements of paragraph (b) of this section, but are not exempt from the survey requirement in paragraph (b) of this section for measuring radiation levels that is required to ensure that the source is still properly lodged in its shield.

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Training For Manual

Training for Manual Brachytherapy and Use of Unsealed By Products Materials For which A written Directive Is Required
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Does safety instruction to personnel include control of patient and visitors?	Subpart E—Unsealed Byproduct Material—Written Directive Required	10 CFR 35.310, 35.410
	§ 35.310 Safety instruction.
	In addition to the requirements of § 19.12 of this chapter,
	(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include—
	(1) Patient or human research subject control;
	(2) Visitor control, including—
	(i) Routine visitation to hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and
	(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter;
	(3) Contamination control;
	(4) Waste control; and
	(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.
	(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.
	Subpart F—Manual Brachytherapy
	§ 35.410 Safety instruction.
	In addition to the requirements of § 19.12 of this chapter,
	(a) The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include the--
	(1) Size and appearance of the brachytherapy sources;
	(2) Safe handling and shielding instructions;
	(3) Patient or human research subject control;
	(4) Visitor control, including both:
	(i) Routine visitation of hospitalized individuals in accordance with § 20.1301(a)(1) of this chapter; and
	(ii) Visitation authorized in accordance with § 20.1301(c) of this chapter; and
	(5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.
	(b) A licensee shall retain a record of individuals receiving instruction in accordance with § 35.2310.
2. Routine visitation to patients in accordance with 10 CFR 20.1301?	§ 20.1301 Dose limits for individual members of the public
	(a) Each licensee shall conduct operations so that -
	(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contributions from background radiation, from any administration the individual has received, from exposure to individuals administered radioactive material and released under § 35.75, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with § 20.2003, and
	(2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with § 35.75, does not exceed 0.002 rem (0.02 millisievert) in any one hour.
	(b) If the licensee permits members of the public to have access to controlled areas, the limits for members of the public continue to apply to those individuals.
	(c) Notwithstanding paragraph (a)(1) of this section, a licensee may permit visitors to an individual who cannot be released, under § 35.75, to receive a radiation dose greater than 0.1 rem (1 mSv) if-
	(1) The radiation dose received does not exceed 0.5 rem (5 mSv); and
	(2) The authorized user, as defined in 10 CFR Part 35, has determined before the visit that it is appropriate.
	(d) A licensee or license applicant may apply for prior NRC authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv). The licensee or license applicant shall include the following information in this application:
	(1) Demonstration of the need for and the expected duration of operations in excess of the limit in paragraph (a) of this section;
	(2) The licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and
	(3) The procedures to be followed to maintain the dose as low as is reasonably achievable.
	(e) In addition to the requirements of this part, a licensee subject to the provisions of EPA's generally applicable environmental radiation standards in 40 CFR part 190 shall comply with those standards.
	(f) The Commission may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose
3. Contamination control and size/appearance of sources?	In addition to the requirements of § 19.12 of this chapter,	10 CFR 35.310
	(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include—
	3) Contamination control
4. Safe handling and shielding instructions?	(a) The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include the-- (2) Safe handling and shielding instructions;	10 CFR 35.410
5. Waste control?	In addition to the requirements of § 19.12 of this chapter,
	(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include—
	4) Waste control
6. RSO and AU notification if patient had a medical emergency or died?	( In addition to the requirements of § 19.12 of this chapter,	10 CFR 35.310
	(a) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under § 35.75. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include—
	5) Notification of the Radiation Safety Officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.
7. Records retained with names of individuals, list of topics, date etc?	A licensee shall maintain a record of safety instructions required by §§ 35.310, 35.410, and 35.610 for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.	10 CFR 35.2310

Facilities

Facilities
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Facilities as described in license application?
B. Therapy device facilities provided with electrical interlock system, viewing and intercom systems, radiation monitor, source retraction mechanism, and source indicator lights?
C. Emergency source recovery equipment available?	10 CFR 35.415: (b) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source--	10 CFR 35.415, 35.615
	(1) Dislodged from the patient; and
	(2) Lodged within the patient following removal of the source applicators.
	10 CFR 35.615:(g) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source--
	(1) Remaining in the unshielded position; or
	(2) Lodged within the patient following completion of the treatment.
D. Storage areas:
1. Materials secured from unauthorized removal or access?	The licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas	20 CFR 20.1801
2. Licensee controls and maintains constant surveillance of licensed material not in storage?	The licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.	10 CFR 20.1802
E. Therapy unit operation:
1. Unit, console, console keys, and treatment room controlled adequately?	20.1801	10 CFR 20.1801, 35.610(a) (1)
	The licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas
	The licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.
	35.610(a)(1)
	(a) A licensee shall--
	(1) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;
2. Restricted to certain source orientations and/or gantry angles?
3. Ceases to operate in restricted orientation(s)?
4. Only one radiation device can be placed in operation at a time within the treatment room?	(a) A licensee shall--	10 CFR 35.610(a) (3)
	(3) Prevent dual operation of more than one radiation producing device in a treatment room if applicable;

Public Dose

Public Dose
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Is licensed material used in a manner to keep doses below 1mSv (100 mrem) in a year [20.1301(a)(1)]?	Each licensee shall conduct operations so that -	10 CFR 20.1301 (a))(1)
	(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contributions from background radiation, from any administration the individual has received, from exposure to individuals administered radioactive material and released under § 35.75, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with § 20.2003, and
	Each licensee shall make or cause to be made, surveys of areas, including the subsurface, that —	10CFR 20.1501(a)
B. Has a survey or evaluation been performed per 20.1501(a)?
C. Have there been any additions or changes to the storage, security, or use of surrounding areas that would necessitate a new survey or evaluation?	a) Each licensee shall conduct operations so that -
	(2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with § 35.75, does not exceed 0.002 rem (0.02 millisievert) in any one hour.
D. Do unrestricted area radiation levels exceed 0.02 mSv (2 mrem) in any 1 hour [20.1301(a)(2)]?	Each licensee shall conduct operations so that -
	(2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with § 35.75, does not exceed 0.002 rem (0.02 millisievert) in any one hour.
E. Is licensed material used or stored in a manner that would prevent unauthorized access or removal [20.1801 and 20.1802]?	The licensee shall secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas.	10 CFR 20.1801, 20.1802
	The licensee shall control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.
F. Are records maintained [20.2103, 20.2107]?	Each licensee shall maintain records showing the results of surveys and calibrations required by §§ 20.1501 and 20.1906(b). The licensee shall retain these records for 3 years after the record is made.	10CFR 20.2103, 20.2107
	Each licensee shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public (see § 20.1301).
	(b) The licensee shall retain the records required by paragraph (a) of this section until the Commission terminates each pertinent license requiring the record.

Release of Patient

Release Of Patients or Human Research Subjects
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Individuals released when TEDE is less than 0.5 rem?	(a) A licensee may authorize the release from its control of any individual who has been administered unsealed byproduct material or implants containing byproduct material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem).1	10 CFR 35.75 (a)
	1The current revision of 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 5 mSv (0.5 rem).
B. Instructions to the released individual, including breast-feeding women, include required information [35.75(b)]?	A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). If the total effective dose equivalent to a nursing infant or child could exceed 1 mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions must also include—	10 CFR 35.75 (b)
	(1) Guidance on the interruption or discontinuation of breast-feeding; and
	(2) Information on the potential consequences, if any, of failure to follow the guidance.
C. Release records maintained [35.2075(a)]?	A licensee shall retain a record of the basis for authorizing the release of an individual in accordance with § 35.75, if the total effective dose equivalent is calculated by--	10 CFR 35.2075 (a)
	(1) Using the retained activity rather than the activity administered;
	(2) Using an occupancy factor less than 0.25 at 1 meter;
	(3) Using the biological or effective half-life; or
	(4) Considering the shielding by tissue.
D. Records of instructions given to breast-feeding women maintained, if required [35.2075(b)]?	) A licensee shall retain a record that the instructions required by § 35.75(b) were provided to a breast-feeding female if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem)	10 CFR 35.2075 (b)

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Radioactive Waste

Radioactive Waste
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Disposal:
1. Decay-in-storage [35.92]?	(a) A licensee may hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if it—	10 CFR 35.92 (a,b)
	(1) Monitors byproduct material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and
	(2) Removes or obliterates all radiation labels, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee.
2. Procedures followed?	(a) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label must also provide sufficient information (such as the radionuclide(s) present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment) to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures	10 CFR 35.92 (2)
	b) Each licensee shall, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials	10 CFR20.1904
3. Labels removed or defaced [20.1904, 35.92]?
B. Special procedures performed as required?
	A licensee shall dispose of licensed material only--
C. Authorized disposals [20.2001]?	(1) By transfer to an authorized recipient as provided in § 20.2006 or in the regulations in parts 30, 40, 60, 61, 63, 70, and 72 of this chapter;
	(2) By decay in storage; or
	(3) By release in effluents within the limits in § 20.1301; or
	(4) As authorized under §§ 20.2002, 20.2003, 20.2004, 20.2005, or 20.2008.
	(b) A person must be specifically licensed to receive waste containing licensed material from other persons for:
	(1) Treatment prior to disposal; or
	(2) Treatment or disposal by incineration; or
	(3) Decay in storage; or
	(4) Disposal at a land disposal facility licensed under part 61 of this chapter; or
	(5) Disposal at a geologic repository under part 60 or part 63 of this chapter.
	A licensee shall dispose of licensed material only--	20.2103
D. Records maintained [20.2103(a), 20.2108, 35.2092]?	(1) By transfer to an authorized recipient as provided in § 20.2006 or in the regulations in parts 30, 40, 60, 61, 63, 70, and 72 of this chapter;
	(2) By decay in storage; or
	(3) By release in effluents within the limits in § 20.1301; or
	(4) As authorized under §§ 20.2002, 20.2003, 20.2004, 20.2005, or 20.2008.
	(b) A person must be specifically licensed to receive waste containing licensed material from other persons for:
	(1) Treatment prior to disposal; or
	(2) Treatment or disposal by incineration; or
	(3) Decay in storage; or
	(4) Disposal at a land disposal facility licensed under part 61 of this chapter; or
	(5) Disposal at a geologic repository under part 60 or part 63 of this chapter.
E. Effluents:
1. Release to sanitary sewer [20.2003]?	(a) A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:	10 CFR 20.2003
	(1) The material is readily soluble (or is readily dispersible biological material) in water; and
	(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table 3 of appendix B to part 20; and
	(3) If more than one radionuclide is released, the following conditions must also be satisfied:
	(i) The licensee shall determine the fraction of the limit in table 3 of appendix B to part 20 represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table 3 of appendix B to part 20; and
	(ii) The sum of the fractions for each radionuclide required by paragraph (a)(3)(i) of this section does not exceed unity; and
	(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage system in a year does not exceed 5 curies (185 GBq) of hydrogen-3, 1 curie (37 GBq) of carbon-14, and 1 curie (37 GBq) of all other radioactive materials combined.
	(b) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in paragraph (a) of this section.
a. Material is readily soluble or readily dispersible?	The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage system in a year does not exceed 5 curies (185 GBq) of hydrogen-3, 1 curie (37 GBq) of carbon-14, and 1 curie (37 GBq) of all other radioactive materials combined.	10 CFR20.2003
	(b) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in paragraph (a) of this section.
b. Monthly average release concentrations do not exceed 10 CFR Part 20, Appendix B, Table 2 values?
c. No more than 5 Ci of H-3, 1 Ci of C-14, and 1 Ci of all other radionuclides combined, released in a year [20.2003]?	c. No more than 5 Ci of H-3, 1 Ci of C-14, and 1 Ci of all other radionuclides combined, released in a year [20.2003]? See above.
d. Procedures to ensure representative sampling and analysis implemented [20.1501]?		10 CFR20.1501
2. Release to septic tanks [20.2003]? Within unrestricted limits [10 CFR Part 20, Appendix B, Table 2]?		10 CFR part 20 appendix B table 2
3. Waste incinerated?	A licensee may treat or dispose of licensed material by incineration only:	10 CFR 20.2004
	(3) As specifically approved by the Commission pursuant to § 20.2002.
a. License authorizes [20.2004(a)(3)]?	A licensee may treat or dispose of licensed material by incineration only:	20.2004 (a) 3
	(3) As specifically approved by the Commission pursuant to § 20.2002.
b. Exhaust directly monitored?		10 CFR 20.1302
c. Airborne releases evaluated and controlled [20.1302, 20.1501]?		10 CFR 20.1302, 20.1501
4. Air effluents and ashes controlled [20.1101, 20.1201, 20.1301, 20.1501, 20.2001]? (See also IP 87102, RG 8.37.) If applicable, includes air effluent releases from production of PET radioactive drugs?
a. Air effluent less than 10 mrem constraint limit [20.1101]?
i. If no, reported appropriate information to NRC?
ii. If no, corrective actions implemented and on schedule?
b. Description of effluent program:
i. Monitoring system hardware adequate?
ii. Equipment calibrated, as appropriate?
iii. Air samples/sampling technique (e.g., charcoal, HEPA) analyzed with appropriate instrumentation?
F. Waste storage:	(a) A licensee shall dispose of licensed material only--	10 CFR 20.2001
	(1) By transfer to an authorized recipient as provided in § 20.2006 or in the regulations in parts 30, 40, 60, 61, 63, 70, and 72 of this chapter;
	(2) By decay in storage; or
	(3) By release in effluents within the limits in § 20.1301; or
	(4) As authorized under §§ 20.2002, 20.2003, 20.2004, 20.2005, or 20.2008.
	(b) A person must be specifically licensed to receive waste containing licensed material from other persons for:
	(1) Treatment prior to disposal; or
	(2) Treatment or disposal by incineration; or
	(3) Decay in storage; or
	(4) Disposal at a land disposal facility licensed under part 61 of this chapter
1. Protection from elements and fire?
2. Control of waste maintained [20.1801]?		10 CFR 20.1801
3. Containers properly labeled and area properly posted [20.1902, 20.1904]?
4. Package integrity adequately maintained?
G. Waste disposal:
1. Sources transferred to authorized individuals [20.2006, 20.2001, 30.41]?
2. Name of organization:
H. Records of surveys and material accountability maintained [20.2103, 20.2108, 35.2092]?
C. RADIOACTIVE WASTE
1. All radiation labels were either removed or obliterated prior to disposal		10 CFR 35.92 (a)(2)
2. All radioactive waste is appropriately controlled and, if able to be held for “decay-in-storage” is properly disposed at the completion of storage.		10 CFR 35.92
3. Liquid radioactive waste materials may be disposed only in designated sinks, must be soluble in water, the monthly activity must not exceed concentrations listed in table of appendix B to 10 CFR 20 based on average monthly value of water released into the sewer, and when more than one radionuclide is released, the ratio of the monthly concentrations released to allowed concentrations, when summed, must not exceed unity.		10 CFR 20.2003

Receipt and transfer of Radioac

Receipt and Transfer of Radioactive Materials
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Description of how packages are received and by whom?
B. Written package-opening procedures established and followed [20.1906(e)]?		10 CFR 20.1906 (e)
C. All incoming packages with a DOT label monitored for radioactive contamination, unless exempted (gases and special form) [20.1906(b)(1)]?		10 CFR 20.1906 (b) 1
D. Incoming packages surveyed [20.1906(b)(2)]? When authorized for return, includes “empty” transport radiation shields from other consortium members receiving PET radioactive drugs under 10 CFR 30.32(j) authorization?
E. Monitoring in (C) and (D) performed within time specified [20.1906(c)]?		10 CFR 20.1906 (c)
F. Transfer(s) performed per [30.41]?		10 CFR 20.1906 (e)

G. If authorized under 10 CFR 30.32(j) for production and noncommercial transfer of PET radioactive drugs, all transfers of these drugs for medical use are to medical use licensees within the consortium?
H. All sources surveyed before shipment and transfer [20.1501(a)]?
I. Records of surveys and receipt/transfer maintained [20.2103(a), 30.51]?
J. Package receipt/distribution activities evaluated for compliance with 20.1301?

Transportation

Transportation (10 CFR 71.5(a) and 49 CFR 171-189)
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Shipments, including shipments of accelerator-produced radioactive materials and discrete sources of radium-226, and PET radioactive drugs produced for noncommercial transfer to other medical use licensees in the consortium, are:		10 CFR 71.5
1. Delivered to common carriers?	facility, educational	49 CFR 171- 189
	(j) An application from a medical institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under part 35 of this chapter or equivalent Agreement State requirements shall include:
	(1) A request for authorization for the production of PET radionuclides or evidence of an existing license issued under part 30 of this chapter or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.
	(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in § 32.72(a)(2) of this chapter.
2. Transported in own private vehicle?
3. Both?
4. No shipments since last audit?
B. Return radiopharmacy doses to drug manufacture or commercial nuclear pharmacy or sealed sources to source or device manufacturer?
Note: Licensees authorized under 10 CFR 30.32(j) for production and noncommercial transfer of PET radioactive drugs are not authorized to receive unused dosages or empty syringes and vials back from consortium members.
1. Licensee assumes shipping responsibility?
2. If “NO,” describe arrangements made between licensee and radiopharmacy for shipping responsibilities.
C. Packages:		10 CFR 30.32
1. Authorized packages used?		10 CFR 10 CFR 30.32
2. Performance test records on file?		30.32
a. DOT-7A packages		30.32
b. Special form sources		30.32 (2) b
3. Two labels (White-I, Yellow-II, Yellow-III) with Transport Index (TI), Nuclide, Activity, and Hazard Class?
4. Properly marked (Shipping Name, UN Number, Package Type, Reportable Quantity, “This End Up” (liquids), Name and Address of consignee)?
5. Closed and sealed during transport?
D. Shipping Papers:
1. Prepared and used?
2. Contain proper entries (Shipping Name; Hazard Class; Identification Number (UN Number); Total Quantity; Package Type; Nuclide; Reportable Quantity; Physical and Chemical Form; Activity; Category of Label; TI; Shipper’s Name, Certification and Signature; Emergency Response Telephone Number; “Limited Quantity” (if applicable); “Cargo Aircraft Only” (if applicable))?
3. Readily accessible during transport?

Teletheraphy

Teletherapy and Gamma Stereotactic Radiosurgery Servicing
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Inspection and servicing performed following source replacement or at intervals not to exceed 5 years?	(a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first, to assure proper functioning of the source exposure mechanism.	10 CFR 35.655 (a)
B. Needed service arranged for as identified during the inspection?	b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State.	10 CFR 35.655 {b}
C. Service performed by persons specifically authorized to do so?		10 CFR 35.655 (b)

Full Calibration

Full Calibration-Therapeutic Medical Devices
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Proper protocol(s) used?		(e.g., TG-21, AAPM 54, TG-56, TG-40)?
B. Performed prior to first patient use?	A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit--	10 CFR 35.633(a) (10), 35.635(a)(1)
	(1) Before the first medical use of the unit; and
C. At intervals not to exceed 1 year for teletherapy, gamma stereotactic, and LDR remote afterloader; at intervals not exceeding 1 quarter for HDR, MDR, and PDR remote afterloaders		10CFR 35.632(a) (3), 35.633(a)(3) and 4 35.635(a)(3)]?
	(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit—
	(3) At intervals not exceeding 1 year.
	A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit--
	(3) At intervals not exceeding 1 quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and
	A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit—`
	(3) At intervals not exceeding 1 year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.
D. Whenever spot-checks indicate output differs from expected by ±5%?	A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit--	10 CFR 35.632(a)(i),(2)(35.635(a)(2)(i)
	(2) Before medical use under the following conditions:
	(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;
	) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit--
	(2) Before medical use under the following conditions--
	(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;
E. After source exchange, relocation, and major repair or modification [35.632(a)(2), 35.633(a)(2), 35.635(a)(2)]?	(a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit--	10 CFR 35.632 (a)(2), 35.633(a),35.635(a) (2)
	(2) Before medical use under the following conditions:
	(i) Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;
F. Performed with properly calibrated instrument [35.632(c), 35.633(c), 35.635(c)]?	A licensee shall use the dosimetry system described in § 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates relative dose rates.	10 CFR 35.632 (C),
		CFR 35.633 (c), 35.635 (c)
G. Includes:
1. For teletherapy:
a. Output measured within ±3% of expected for the range of field sizes, range of distances?	To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of--	10 CFR 35.632 (b)(1)
	(1) The output within +/-3 percent for the range of field sizes and for the distance or range of distances used for medical use;
b. Coincidence of radiation field and field light localizer?	2) The coincidence of the radiation field and the field indicated by the light beam localizing device;	10 CFR 35.632 (b)(2)
c. Uniformity of radiation field and beam angle dependence?	The uniformity of the radiation field and its dependence on the orientation of the useful beam;	10 CFR 35,632(b)(3)
d. Timer accuracy and linearity over the range of use?	The timer accuracy and linearity over the range of use	10CFR 35.632 (b) (4)
e. On-off error?	On-off error	10 CFR 35.632 (b) (5)
f. Accuracy of all measuring and localization devices?	The accuracy of all distance measuring and localization devices in medical us.	10 CFR 35.632 9(b)
2. For remote after loaders:
a. Output measured within ±5% of expected [35.633(b)(1)]?	The output within ± 5 percent	10 CFR 35.633 (b)(1)
b. Source positioning accuracy within ±1 millimeter [35.633(b)(2)]?	Source positioning accuracy to within ±1 millimeter	10 CFR 35.633 (b) (2)
c. Source retraction with backup battery upon power failure [35.633(b)(3)]?	Source retraction with backup battery upon power failure;	10 CFR 35.633 (b)(3)
d. Length of source transfer tubes [35.633(b)(4)]?	Length of the source transfer tubes	10 CFR 35.633 (b)(3)
e. Timer accuracy and linearity over the typical range of use [35.633(b)(5)]?	Timer accuracy and linearity over the typical range of us
f. Length of the applicators [35.633(b)(6)]?	Length of the applicators	10 CFR 35.633 (b) (6)
g. Function of source transfer tubes, applicators, and transfer tube-applicator interfaces [35.633(b)(7)]?	Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.	10 CFR 35.633 (b)(7)
h. Autoradiograph quarterly of the LDR source(s) to verify source(s) arrangement and inventory [35.633(e)]?	In addition to the requirements for full calibrations for low dose-rate remote afterloader units in paragraph (b) of this section, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding 1 quarter.	10CFR 35.633 (e)
3. For gamma stereotactic radiosurgery:
a. Output measured within ±3% of expected?	The output within ±3 percent;	10 CFR 35.635 (b)(1)
b. Helmet factors?	Relative helmet factors	10 CFR 35,635(b)(2)
c. Isocenter coincidence?	Isocenter coincidence	10 CFR 35.635 (b)(3)
d. Timer accuracy and linearity over the range of use [35.635(b)(4)]?		10 CFR 35.635 (b)(4)
	Timer accuracy and linearity over the range of use
e. On-off error [35.635(b)(5)]?	On-off error	10CFR 35.65 (b) (5)
f. Trunnion centricity [35.635(b)(6)]?	Trunnion centricity;	10 CFR 35.635 (b)(6)
g. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off [35.635(b) (7)]?	Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off	10 CFR 35,635 (b) (7)
h. Helmet microswitches?	Helmet microswitches	10 CFR 35.635 (b)(8)
i. Emergency timing circuit [35.635(b)(9)]?	Emergency timing circuits; and	10 CFR 35.635 (b)(9)
j. Stereotactic frames and localizing devices (trunnions) [35.635(b)(10)]?	Stereotactic frames and localizing devices (trunnions).	10 CFR 35.635 (b)(10)
H. Output corrected mathematically for decay [35.632(e), 35.633(g), 35.635(e)]?	A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding 1 month for cobalt-60, 6 months for cesium-137, or at	10 CFR 35.632 (e), 35.633(g), 35.635 (e)
	intervals consistent with 1 percent decay for all other nuclides. A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section for physical decay at intervals consistent with 1 percent physical decay.
	A licensee shall mathematically correct the outputs determined in paragraph (b)(1) of this section at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all other radionuclides.
I. Records maintained [35.2632]?	A licensee shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by §§ 35.632, 35.633, and 35.635 for 3 years.	10 CFR 35.26532

Periodic Spot Checks

Periodic and Spot Checks for Therapeutic Devices
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Performed at required frequency?	A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each cal	10 CFR 35.642(a), 35.643(a),35.645 (a)
	endar month that include determination of—
	A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit—
	A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit.
B. Procedures established by AMP [35.642(b), 35.643(b), 35.645(b)]?	A licensee shall perform measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.	10 CFR35.642 (b), 35.643(b)
	A licensee shall perform measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.
C. Procedures followed?
D. Medical physicist reviews results within 15 days [35.642(c), 35.643(c), 35.645(b)]?	) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.	10 CFR 35.642 (c), 35.643 (c) 35.645 (b)
	A licensee shall have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.
	A licensee shall--
	(1) Perform the measurements required by paragraph (a) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.
	(2) Have the authorized medical physicist review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.
E. Performed with properly calibrated instrument [35.642(a)(5), 35.645(c)(2)(i)]?	The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b); and	10 CFR 35.642 (a) (5), 35.645(c)(2)(i)
	The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b);
F. Output and safety spot checks include:
1. For teletherapy:
a. Timer accuracy and linearity over the range of use [35.642(a)(1)]?	Timer accuracy, and timer linearity over the range of use;	10 CFR 35.642 (a)(1)
b. On-off error [35.642(a)(2)]?	On-off error.	10 CFR 35.642 (a)(2)
c. Coincidence of radiation field and field light localizer [35.642(a)(3)]?	The coincidence of the radiation field and the field indicated by the light beam localizing device;	10CFR 35.642 (a)(3)
d. Accuracy of all measuring and localization devices [35.642(a)(4)]?	) The accuracy of all distance measuring and localization devices used for medical use.	10 CFR 35.642 (a)(4)
e. The output for one typical set of operating conditions [35.642(a)(5)]?	The accuracy of all distance measuring and localization devices used for medical use	10 CFR 35,642 (a)(5)
f. Difference between measured and expected output [35.642(a)(6)]?	The difference between the measurement made in paragraph (a)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).	10 CFR 35.642(a)(6)
g. Interlock systems [35.642(d)(1)]?	Electrical interlocks at each teletherapy room entrance	10 CFR 35.642 (d)(1)
h. Beam stops [35.642(d)(2)]?	Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism)	10 CFR35.642 (d)(2)
i. Source exposure indicator lights [35.642(d)(3)]?	Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility	10 CFR 35.642 (d)(3)
j. Viewing and intercom systems [35.642(d)(4)]?	Viewing and intercom systems;	10 CFR 35.642 (d)(4)
k. Treatment room doors, inside and out [35.642(d)(5)]?	Viewing and intercom systems;	10 CRF 35.642 (d)(5)
l. Electrical treatment doors with power shut off [35.642(d)(6)]?	Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.	10 CFR 35.642 (d)(6)
2. For remote afterloaders:
a. Interlock systems [35.643(d)(1)]?	Electrical interlocks at each remote afterloader unit room entrance;	10 CFR 35.643 (d)(1)
b. Source exposure indicator lights [35.643(d)(2)]?	Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;	10 cfr 35,643 (d)(2)
c. Viewing and intercom systems, except for low dose-rate (LDR) [35.643(d)(3)]?	Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility	10 CFR 35.643(d)(3)
d. Emergency response equipment [35.643(d)(4)]?	Emergency response equipment	10 CFR 35.643 (d)(4)
e. Radiation monitors used to indicate source position [35.643(d)(5)]?	Radiation monitors used to indicate the source position	10 CFR 35.643 (d)(5)
f. Timer accuracy [35.643(d)(6)]?	Timer accuracy;	10 CFR 35.643 (d)(6)
g. Clock (date and time) in the unit’s computer [35.643(d)(7)]?	Clock (date and time) in the unit's computer; and	10 CFR 35.643 (d)(7)
h. Decayed source(s) activity in the unit’s computer [35.643(d)(8)]?	Decayed source(s) activity in the unit's computer.	10 CFR 35,643
		(d)(8)
3. For gamma stereotactic radiosurgery:
a. Treatment table retraction mechanism [35.645(c) (1)(i)]?	Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;	10 CFR 35.645 (c)(1)(i)
b. Helmet microswitches [35.645(c) (1)(ii)]?	Helmet microswitches	10 CFR 35.645 (c)(ii)
c. Emergency timing circuits [35.645(c) (1) (iii)]?	Emergency timing circuits; and	10 CFR 35.645 (c)(1)(iii)
d. Stereotactic frames and localizing devices [35.645(c)(1)(iv)]?	) Stereotactic frames and localizing devices (trunnions).	10CFR 35.645 (1)(iv)
e. The output for one typical set of operating conditions [35.645(c)(2)(i)]?	The output for one typical set of operating conditions measured with the dosimetry system described in § 35.630(b)	10 CFR, 35.645 (c)(2)(i)
f. Difference between measured and expected output [35.645(c)(2)(ii)]?	The difference between the measurement made in paragraph (c)(2)(i) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);	10 CFR 35.645(c)(2)(ii)
g. Source output compared against computer calculation of output [35.645(c)(2)(iii)]?	Source output against computer calculation	10 CFR 35.645 (C)(2)(iii)
h. Timer accuracy and linearity over the range of use [35.645(c)(2)(iv)]?	Timer accuracy and linearity over the range of use;	10 CFR 35.645 (c)(2)(iv)
i. On-off error [35.645(c)(2)(v)]?	On-off error; and	10 CFR 35.645 (c)(2)(v)
j. Trunnion centricity [35.645(c)(2)(vi)]?	Trunnion centricity	10 CFR 35.645 (c)(2)(vi)
k. Interlock systems [35.645(d)(1)]?	Electrical interlocks at each gamma stereotactic radiosurgery room entrance	10 CFR 35.645 (d)(1)
l. Source exposure indicator lights [35.645(d)(2)]?	Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;	10 CFR 35.645 (d)(2)
m. Viewing and intercom systems [35.645(d)(3)]?	Viewing and intercom systems	10 CFR 35.645 (d)(3)
n. Timer termination [35.645(d)(4)]?	Timer termination	10 CFR 35.645 (d) (4)
o. Radiation monitors used to indicate room exposures [35.645(d)(5)]?	Radiation monitors used to indicate room exposures; and	10 CFR 35.645 (d)(5)
p. Emergency off buttons [35.645(d) (6)]?	) Emergency off buttons	10 CFR 35.645 (d)
G. Licensee promptly repaired items found to be not operating properly and did not use unit until repaired, if required [35.642(e), 35.643(e), 35.645(f)]?	) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.	10 CFR 35.642 (e). 35.643(e), 35.645(e)
	(f) A licensee shall retain a record of each spot-check required by paragraphs (a) and (d) of this section, and a copy of the procedures required by paragraph (b), in accordance with § 35.2642.
	) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
	) If the results of the checks required in paragraph (d) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.
H. Records maintained [35.2642, 35.2643, and 35.2645]?	A licensee shall retain a record of each spot-check for remote afterloader units required by § 35.643 for 3 years.	10 CFR 35.2642, 35.2463, 35.2465
	(b) The record must include, as applicable--
	(1) The date of the spot-check;
	(2) The manufacturer's name, model number, and serial number for the remote afterloader unit and source;
	(3) An assessment of timer accuracy;
	(4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and
	(5) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.
	(c) A licensee shall retain a copy of the procedures required by § 35.643(b) until the licensee no longer possesses the remote afterloader unit.
	) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by § 35.645 for 3 years.
	(b) The record must include--
	(1) The date of the spot-check;
	(2) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;
	(3) An assessment of timer linearity and accuracy;
	(4) The calculated on-off error;
	(5) A determination of trunnion centricity;
	(6) The difference between the anticipated output and the measured output;
	(7) An assessment of source output against computer calculations;
	(8) Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and
	(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.
	(c) A licensee shall retain a copy of the procedures required by § 35.645(b) until the licensee no longer possesses the gamma stereotactic radiosurgery unit.

Installation, ,Maintenance

Installation, Maintenance and Repair of Therapy Devices
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Only authorized individuals perform installation, maintenance, adjustment, repair, and inspection [35.605, 35.655]? Name of organization/individual.	Only a person specifically licensed by the Commission or an Agreement State shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).	10 CFR 35.605, 35.655
	(b) Except for low dose-rate remote afterloader units, only a person specifically licensed by the Commission or an Agreement State shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.
	(c) For a low dose-rate remote afterloader unit, only a person specifically licensed by the Commission or an Agreement State or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.
	(d) A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units in accordance with § 35.2605.
B. Records maintained [35.2605, 35.2655]?	A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by § 35.605 for 3 years. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.	10 CFR 2605, 35.2655

Personnel Radiation

Personnel Radiation Protection
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Exposure evaluation performed [20.1501]? Includes evaluation for uses of accelerator-produced radioactive materials and discrete sources of radium-226?	§ 20.1501 General.	10 CFR 20.1501
	(a) Each licensee shall make or cause to be made, surveys of areas, including the subsurface, that —
	(1) May be necessary for the licensee to comply with the regulations in this part; and
	(2) Are reasonable under the circumstances to evaluate--
	(i) The magnitude and extent of radiation levels; and
	(ii) Concentrations or quantities of residual radioactivity; and
	(iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.
	(b) Notwithstanding § 20.2103(a) of this part, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with §§ 30.35(g), 40.36(f), 50.75(g), 70.25(g), or 72.30(d), as applicable.
	(c) The licensee shall ensure that instruments and equipment used for quantitative radiation measurements (e.g., dose rate and effluent monitoring) are calibrated periodically for the radiation measured.
	(d) All personnel dosimeters (except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities) that require processing to
B. ALARA program implemented [20.1101(b)]?	(b) The licensee shall use	10 CFR 20.1101
	, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).
C. External Dosimetry:		10 CFR 201101
	1. Monitors workers per [20.1502(a)]? Includes workers using or working near accelerator-produced radioactive materials and discrete sources of radium-226?
	§ 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.
	Each licensee shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of this part. As a minimum—
	(a) Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by—
	(1) Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in § 20.1201(a),
	(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);
	(3) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);2 and
	(4) Individuals entering a high or very high radiation area.
	2. External exposures account for contributions from airborne activity [20.1203]?
	§ 20.1203 Determination of external dose from airborne radioactive material.
	Licensees shall, when determining the dose from airborne radioactive material, include the contribution to the deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent from external exposure to the radioactive cloud (see appendix B to part 20, footnotes 1 and 2).
	Note: Airborne radioactivity measurements and DAC values should not be used as the primary means to assess the deep-dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep-dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.
		10CFR 20.1502(A)
1. Monitors workers per [20.1502(a)]? Includes workers using or working near accelerator-produced radioactive materials and discrete sources of radium-226?
2. External exposures account for contributions from airborne activity [20.1203]?		10 CFR 20.1203
3. Supplier Frequency	3. Supplier Frequency	10 CFR 20.1501
	4. Supplier is NVLAP-approved [20.1501(c)]?
	§ 20.1501 General
	(c) The licensee shall ensure that instruments and equipment used for quantitative radiation measurements (e.g., dose rate and effluent monitoring) are calibrated periodically for the radiation measured.
4. Supplier is NVLAP-approved [20.1501(c)]?	20.1501 General	10 CFR 20.1501 (C)
	(c) The licensee shall ensure that instruments and equipment used for quantitative radiation measurements (e.g., dose rate and effluent monitoring) are calibrated periodically for the radiation measured.
5. Dosimeters exchanged at required frequency?		10 CRF 20.1501 (5)
D. Internal Dosimetry:		10CRF 20.1501 5 (D)
1. Monitors workers per 20.1502? Includes workers using or working near accelerator-produced radioactive materials and discrete sources of radium-226?	dose.	10CRF 20.1502
	Each licensee shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of this part. As a minimum—
	(a) Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by—
	(1) Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in § 20.1201(a),
	(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);
	(3) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);2 and
	(4) Individuals entering a high or very high radiation area.
	(b) Each licensee shall monitor (see § 20.1204) the occupational intake of radioactive material by and assess the committed effective dose equivalent to—
	(1) Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALI(s) in table 1, Columns 1 and 2, of appendix B to §§ 20.1001-20.2402;
	(2) Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 rem (1 mSv); and
	(3) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 mSv).
2. Program for monitoring and controlling internal exposures [20.1701, 20.1702] briefly described?	The licensee shall use, to the extent practical, process or other engineering controls (e.g., containment, decontamination, or ventilation) to control the concentration of radioactive material in air.	10 CFR 20.1701,20.1702
3. Monitoring/controlling program implemented (includes bioassays)?
4. Respiratory protection equipment [20.1703]?	If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material,	10CFR 20.1703
	(a) The licensee shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH) except as otherwise noted in this part.
	(b) If the licensee wishes to use equipment that has not been tested or certified by NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application to the NRC for authorized use of this equipment except as provided in this part. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by licensee testing or on the basis of reliable test information.
	(c) The licensee shall implement and maintain a respiratory protection program that includes:
	(1) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;
E. Review of Records and Reports:		10 CFR 20.2104
1. Reviewed by Frequency	(a) For each individual who is likely to receive an annual occupational dose requiring monitoring under § 20.1502, the licensee shall determine the occupational radiation dose received during the current year.	10 CFR 20.2104
	(b) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine—
	(1) The internal and external doses from all previous planned special exposures; and
	(2) All doses in excess of the limits (including doses received during accidents and emergencies) received during the lifetime of the individual.
	(c) In complying with the requirements of paragraphs (a) or (b) of this section, a licensee may—
	(1) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;
	(2) Accept, as the record of cumulative radiation dose, an up-to-date NRC Form 4, or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer (if the individual is not employed by the licensee); and
	(3) Obtain reports of the individual's dose equivalent(s) from the most recent employer for work involving radiation exposure, or the individual's current employer (if the individual is not employed by the licensee) by telephone, telegram, electronic media, or letter. The licensee shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.
2. Auditor reviewed personnel monitoring records for period to	(a) For each individual who is likely to receive an annual occupational dose requiring monitoring under § 20.1502, the licensee shall determine the occupational radiation dose received during the current year.
	(b) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine—
	(1) The internal and external doses from all previous planned special exposures; and
	(2) All doses in excess of the limits (including doses received during accidents and emergencies) received during the lifetime of the individual.
	(c) In complying with the requirements of paragraphs (a) or (b) of this section, a licensee may—
	(1) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;
	(2) Accept, as the record of cumulative radiation dose, an up-to-date NRC Form 4, or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer (if the individual is not employed by the licensee); and
	(3) Obtain reports of the individual's dose equivalent(s) from the most recent employer for work involving radiation exposure, or the individual's current employer (if the individual is not employed by the licensee) by telephone, telegram, electronic media, or letter. The licensee shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.
3. Prior dose determined for individuals likely to receive doses [20.2104]?		10 CFR 20.2104
4. Maximum exposures TEDE Other		10 CFR 20.2104
		-4
5. Maximum CDEs Organs		10CFR 20.2104
		-5
6. Maximum CEDE		10CFR 20.2104
		-6
7. Internal and external summed [20.1202]?	with th(a) If the licensee is required to monitor under both §§ 20.1502(a) and (b), the licensee shall demonstrate compliance e dose limits by summing external and internal doses. If the licensee is required to monitor only under § 20.1502(a) or only under § 20.1502(b), then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (b) of this section and the conditions in paragraphs (c) and (d) of this section.	10CFR 20.1202
	(Note: The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.)
	(b) Intake by inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep-dose equivalent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity:
	(1) The sum of the fractions of the inhalation ALI for each radionuclide, or
	(2) The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or
	(3) The sum of the calculated committed effective dose equivalents to all significantly irradiated1 organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit.
	(c) Intake by oral ingestion. If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than 10 percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits.
	(d) Intake through wounds or absorption through skin. The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption.
	Note: The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated.
8. Occupational limits met [20.1201]?	with th(a) If the licensee is required to monitor under both §§ 20.1502(a) and (b), the licensee shall demonstrate compliance e dose limits by summing external and internal doses. If the licensee is required to monitor only under § 20.1502(a) or only under § 20.1502(b), then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (b) of this section and the conditions in paragraphs (c) and (d) of this section.	10CFR 20.1201
	(Note: The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.)
	(b) Intake by inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep-dose equivalent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity:
	(1) The sum of the fractions of the inhalation ALI for each radionuclide, or
	(2) The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or
	(3) The sum of the calculated committed effective dose equivalents to all significantly irradiated1 organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit.
	(c) Intake by oral ingestion. If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than 10 percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits.
	(d) Intake through wounds or absorption through skin. The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption.
	Note: The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated.
9. NRC forms or equivalent [20.2104(d), 20.2106(c)]?	(d) The licensee shall record the exposure history of each individual, as required by paragraphs (a) or (b) of this section, on NRC Form 4, or other clear and legible record, including all of the information required by NRC Form 4.4 The form or record must show each period in which the individual received occupational exposure to radiation or radioactive material and must be signed by the individual who received the exposure. For each period for which the licensee obtains reports, the licensee shall use the dose shown in the report in preparing the NRC Form 4. For any period in which the licensee does not obtain a report, the licensee shall place a notation on the NRC Form 4 indicating the periods of time for which data are not available.	10 CFR 20.2104 (d), 20.2106 (c)
a. NRC-4 Complete:		10 CFR 20.2106 (a)
b. NRC-5 Complete:		10CFR20.2106 (b)
10. If a worker declared her pregnancy during the audit period, was the dose in compliance [20.1208] and were the records maintained [20.2106(e)]?	(a) The licensee shall ensure that the dose equivalent to the embryo/fetus during the entire pregnancy, due to the occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). (For recordkeeping requirements, see § 20.2106.)	10 CFR
	(b) The licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (a) of this section.	20.1208,20.2106 (e) (10)
	(c) The dose equivalent to the embryo/fetus is the sum of--
	(1) The deep-dose equivalent to the declared pregnant woman; and
	(2) The dose equivalent to the embryo/fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.
	(d) If the dose equivalent to the embryo/fetus is found to have exceeded 0.5 rem (5 mSv), or is within 0.05 rem (0.5 mSv) of this dose, by the time the woman declares the pregnancy to the licensee, the licensee shall be deemed to be in compliance with paragraph (a) of this section if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy
	.
F. Any planned special exposures (number of people involved and doses received) [20.1206, 20.2104, 20.2105, and 20.2204]?	(e) The licensee shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records.	10 CRF 20.1206, 20.2104,20.2105 and 2`0.2204
G. Records of exposures, surveys, monitoring, and evaluations maintained [20.2102, 20.2103, and 20.2106]?	A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in § 20.1201 provided that each of the following conditions is satisfied--	10 CFR 20.2102, 202103, 202106
	(a) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical.
	(b) The licensee (and employer if the employer is not the licensee) specifically authorizes the planned special exposure, in writing, before the exposure occurs.
	(c) Before a planned special exposure, the licensee ensures that the individuals involved are--
	(1) Informed of the purpose of the planned operation;
	(2) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and
	(3) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.
	(d) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by § 20.2104(b) during the lifetime of the individual for each individual involved.
	(e) Subject to § 20.1201(b), the licensee does not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed--
	(1) The numerical values of any of the dose limits in § 20.1201(a) in any year; and
	(2) Five times the annual dose limits in § 20.1201(a) during the individual's lifetime.
	(f) The licensee maintains records of the conduct of a planned special exposure in accordance with § 20.2105 and submits a written report in accordance with § 20.2204.
	(g) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures is not to be considered in controlling future occupational dose of the individual under § 20.1201(a) but is to be included in evaluations required by § 20.1206 (d) and (e).

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Personnel Radiation Protection

Personell Radiation Protection
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
1. Event date Information Source		1
2. Notifications: NRC Ops Center NRC Region Referring Physician Patient In writing/By telephone If notification did not occur, why not?		10 CFR 35.3045
3. Written Reports [35.3045]: Submitted to Region within 15 days?	A licensee shall report any event, except for an event that results from patient intervention, in which the administration of byproduct material or radiation from byproduct material results in—	10 CFR 35.3045
	(1) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and
	(i) The total dose delivered differs from the prescribed dose by 20 percent or more;
	(ii) The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or
	(iii) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more.
	(2) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following—
	(i) An administration of a wrong radioactive drug containing byproduct material;
	(ii) An administration of a radioactive drug containing byproduct material by the wrong route of administration;
	(iii) An administration of a dose or dosage to the wrong individual or human research subject;
	(iv) An administration of a dose or dosage delivered by the wrong mode of treatment; or
	(v) A leaking sealed source.
	(3) A dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue and 50 percent or more of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site).

Notification and Reports

Notification and Reports
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. In compliance with 10 CFR 19.13, and 10 CFR 30.50 (reports to individuals, public and occupational, monitored to show compliance with Part 20)?	(a) Radiation exposure data for an individual, and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual, shall be reported to the individual as specified in this section. The information reported shall include data and results obtained pursuant to Commission regulations, orders or license conditions, as shown in records maintained by the licensee pursuant to Commission regulations. Each notification and report shall: be in writing; include appropriate identifying data such as the name of the licensee, the name of the individual, the individual's social security number; include the individual's exposure information; and contain the following statement:	10 CFR 19.13, 10 CFR 30.50
	This report is furnished to you under the provisions of the Nuclear Regulatory Commission regulation 10 CFR part 19. You should preserve this report for further reference.
	(b) Each licensee shall make dose information available to workers as shown in records
B. In compliance with 10 CFR 20.2201, and 10 CFR 30.50 (theft or loss)?	(a) Telephone reports. (1) Each licensee shall report by telephone as follows:	10 CFR20.2201, 10 CFR 30.50
	(i) Immediately after its occurrence becomes known to the licensee, any lost, stolen, or missing licensed material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in appendix C to part 20 under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas; or
	(ii) Within 30 days after the occurrence of any lost, stolen, or missing licensed material becomes known to the licensee, all licensed material in a quantity greater than 10 times the quantity specified in appendix C to part 20 that is still missing at this time.
	(2) Reports must be made as follows:
	(i) Licensees having an installed Emergency Notification System shall make the reports to the NRC Operations Center in accordance with § 50.72 of this chapter, and
	(ii) All other licensees shall make reports by telephone to the NRC Operations Center (301)-816-5100.
	(b) Written reports. (1) Each licensee required to make a report under paragraph (a) of this section shall, within 30 days after making the telephone report, make a written report setting forth the following information:
	(i) A description of the licensed material involved, including kind, quantity, and chemical and physical form; and
	(ii) A description of the circumstances under which the loss or theft occurred; and
	(iii) A statement of disposition, or probable disposition, of the licensed material involved; and
	(iv) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas; and
	(v) Actions that have been taken, or will be taken, to recover the material; and
	(vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed material.
	(2) Reports must be made as follows:
	(i) For holders of an operating license for a nuclear power plant, the events included in paragraph (b) of this section must be reported in accordance with the procedures described in § 50.73(b), (c), (d), (e), and (g) of this chapter and must include the information required in paragraph (b)(1) of this section, and
	(ii) All other licensees shall make reports to the Administrator of the appropriate NRC Regional Office listed in appendix D to part 20.
	(c) A duplicate report is not required under paragraph (b) of this section if the licensee is also required to submit a report pursuant to §§ 30.55(c), 37.57, 37.81, 40.64(c), 50.72, 50.73, 70.52, 73.27(b), 73.67(e)(3)(vii), 73.67(g)(3)(iii), 73.71, or 150.19(c) of this chapter.
	(d) Subsequent to filing the written report, the licensee shall also report any additional substantive information on the loss or theft within 30 days after the licensee learns of such information.
	(e) The licensee shall prepare any report filed with the Commission pursuant to this section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable part of the report.
C. In compliance with 10 CFR 20.2202, and 10 CFR 30.50 (incidents)?	(a) Immediate notification. Notwithstanding any other requirements for notification, each licensee shall immediately report any event involving byproduct, source, or special nuclear material possessed by the licensee that may have caused or threatens to cause any of the following conditions--	10 CFR 20.2202, 10 CFR 30.50
	(1) An individual to receive--
	(i) A total effective dose equivalent of 25 rems (0.25 Sv) or more; or
	(ii) A lens dose equivalent of 75 rems (0.75 Sv) or more; or
	(iii) A shallow-dose equivalent to the skin or extremities of 250 rads (2.5 Gy) or more; or
	(2) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the annual limit on intake (the provisions of this paragraph do not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures).
	(b) Twenty-four hour notification. Each licensee shall, within 24 hours of discovery of the event, report any event involving loss of control of licensed material possessed by the licensee that may have caused, or threatens to cause, any of the following conditions:
	(1) An individual to receive, in a period of 24 hours--
	(i) A total effective dose equivalent exceeding 5 rems (0.05 Sv); or
	(ii) A lens dose equivalent exceeding 15 rems (0.15 Sv); or
	(iii) A shallow-dose equivalent to the skin or extremities exceeding 50 rems (0.5 Sv); or
	(2) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational annual limit on intake (the provisions of this paragraph do not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures).
	(c) The licensee shall prepare any report filed with the Commission pursuant to this section so that names of individuals who have received exposure to radiation or radioactive material are stated in a separate and detachable part of the report.
	(d) Reports made by licensees in response to the requirements of this section must be made as follows:
	(1) Licensees having an installed Emergency Notification System shall make the reports required by paragraphs (a) and (b) of this section to the NRC Operations Center in accordance with 10 CFR 50.72; and
	(2) All other licensees shall make the reports required by paragraphs (a) and (b) of this section by telephone to the NRC Operations Center (301) 816-5100.
	(e) The provisions of this section do not include doses that result from planned special exposures, that are within the limits for planned special exposures, and that are reported under § 20.2204.
D. In compliance with 10 CFR 20.2203, and 10 CFR 30.50 (overexposure and high radiation levels)?	(a) Reportable events. In addition to the notification required by § 20.2202, each licensee shall submit a written report within 30 days after learning of any of the following occurrences:	10 CFR20.2203, 10 CFR 30.50
	(1) Any incident for which notification is required by § 20.2202; or
	(2) Doses in excess of any of the following:
	(i) The occupational dose limits for adults in § 20.1201; or
	(ii) The occupational dose limits for a minor in § 20.1207; or
	(iii) The limits for an embryo/fetus of a declared pregnant woman in § 20.1208; or
	(iv) The limits for an individual member of the public in § 20.1301; or
	(v) Any applicable limit in the license; or
	(vi) The ALARA constraints for air emissions established under § 20.1101(d); or
	(3) Levels of radiation or concentrations of radioactive material in—
	(i) A restricted area in excess of any applicable limit in the license; or
	(ii) An unrestricted area in excess of 10 times any applicable limit set forth in this part or in the license (whether or not involving exposure of any individual in excess of the limits in § 20.1301); or
	(4) For licensees subject to the provisions of EPA's generally applicable environmental radiation standards in 40 CFR part 190, levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.
	(b) Contents of reports. (1) Each report required by paragraph (a) of this section must describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:
	(i) Estimates of each individual's dose; and
	(ii) The levels of radiation and concentrations of radioactive material involved; and
	(iii) The cause of the elevated exposures, dose rates, or concentrations; and
	(iv) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license conditions.
	(2) Each report filed pursuant to paragraph (a) of this section must include for each occupationally overexposed1 individual: the name, Social Security account number, and date of birth. The report must be prepared so that this information is stated in a separate and detachable part of the report and must be clearly labeled "Privacy Act Information: Not for Public Disclosure."
	(c) For holders of an operating license or a combined license for a nuclear power plant, the occurrences included in paragraph (a) of this section must be reported in accordance with the procedures described in §§ 50.73(b), (c), (d), (e), and (g) of this chapter, and must include the information required by paragraph (b) of this section. Occurrences reported in accordance with § 50.73 of this chapter need not be reported by a duplicate report under paragraph (a) of this section.
	(d) All licensees, other than those holding an operating license or a combined license for a nuclear power plant, who make reports under paragraph (a) of this section shall submit the report in writing either by mail addressed to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555–0001; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, where practicable, by electronic submission, for example, Electronic Information Exchange, or CD–ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC’s Web site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to [email protected]; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001. A copy should be sent to the appropriate NRC Regional Office listed in appendix D to this part.
E. Aware of NRC Operations Center telephone number?	(1) Licensees shall make reports required by paragraphs (a) and (b) of this section by telephone to the NRC Operations Center.1 To the extent that the information is available at the time of notification, the information provided in these reports must include:
	(i) The caller's name and call back telephone number;
	(ii) A description of the event, including date and time;
	(iii) The exact location of the event;
	(iv) The isotopes, quantities, and chemical and physical form of the licensed material involved; and
	(v) Any personnel radiation exposure data available.
	(2) Written report. Each licensee who makes a report required by paragraph (a) or (b) of this section shall submit a written follow-up report within 30 days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made. These written reports must be sent to the NRC using an appropriate method listed in § 30.6(a); and a copy must be sent to the appropriate NRC Regional office listed in appendix D to part 20 of this chapter. The reports must include the following:
	(i) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;
F. In compliance with 10 CFR 20.2203 (constraint on air emissions)?		10 CFR 20.2203

https://www.nrc.gov/reading-rm/doc-collections/cfr/part020/part020-2203.html https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0050.html

Bullletins

Bulletins and Information Notices
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Bulletins, Information Notices, NMSS Newsletters, etc., received?
B. Appropriate action in response to Bulletins, Generic Letters, etc.?	(j) An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under part 35 of this chapter or equivalent Agreement State requirements shall include:	10 CFR 30.32
	(1) A request for authorization for the production of PET radionuclides or evidence of an existing license issued under part 30 of this chapter or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.
	(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in § 32.72(a)(2) of this chapter.
	(3) Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in § 32.72(b)(2) of this chapter.
	(4) Information identified in § 32.72(a)(3) of this chapter on the PET drugs to be noncommercially transferred to members of its consortium.
	§ 30.34 Terms and conditions of licenses
	(j)(1) Authorization under § 30.32(j) to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs.
	(2) Each licensee authorized under § 30.32(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:
	(i) Satisfy the labeling requirements in § 32.72(a)(4) of this chapter for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.
	(ii) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in § 32.72(c) of this chapter.
	(3) A licensee that is a pharmacy authorized under § 30.32(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:
	(i) an authorized nuclear pharmacist that meets the requirements in § 32.72(b)(2) of this chapter, or
	(ii) an individual under the supervision of an authorized nuclear pharmacist as specified in § 35.27 of this chapter.
	(4) A pharmacy, authorized under § 30.32(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shallmeet the requirements of § 32.72(b)(5) of this chapter.

Laser Program

Laser Program
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
Is an inventory available for Class 3b or 4 laser systems?		TB MED 524,
		Ch. 11 and 12
Do Class 3b or 4 lasers require medical surveillance?		DA PAM 40-506, App E, ANSI Z136.3, paragraph 6.1 & 6.4
Has a Laser Safety Program been established?		DA PAM 385-24, paragraph 1-4k(1) and paragraph 1-4k(2), ANSI Z136.3
Has a Laser Safety Officer been designated in writing?		DA PAM 385-24, paragraph 1-4k(1) and paragraph 1-4k(2), ANSI Z136.3, paragraph 1.3
Is Laser Safety Training being done annually?		AR 385-10, paragraph 10-10, DA PAM 385-24 paragraph 7-1
When was the last laser safety audit performed?		DA PAM 385-24 paragraph 1-4k(2)(c)
Are SOPs available in the clinics with lasers that warn of the hazards posed by the laser and what safety precautions to observe?		ANSI Z136.3, paragraph 4.2.1
Is there a Medical Surveillance Program in place for laser workers?	The medical surveillance program includes identifying laser workers and incidental personnel. Laser workers should have ocular history review and Amsler Grid, initially.	DA PAM 40-506, App E, ANSI Z136.3, paragraph 6.1 & 6.4
Does the Occupational Health regulation or local SOPs include procedures for responding to suspected laser injury?	Does the Laser program ensure laser accidents are reported to the Tri-Service hotline and to USAPHC and follow accident reporting procedures?	MEDCOM Reg 40-42, Paragraph 4-9, DA PAM 385-24, paragraph 5-3e, and DA PAM 385-40, DA PAM 385-24 5-3e
Is laser eye protection of the correct wavelength and optical density available for each laser?		ANSI Z136.3, paragraph 4.6
Are appropriate signs available and posted when required?		ANSI 136.1-2007 Appendix A, para A1.2(7), ANSI Z136.3, paragraph 4.7

Audit Findings

Audit Findings
TASK	STANDARD	REFERENCES	YES	NO	N/A	COMMENTS
A. Summary of findings.
B. Corrective and preventive actions.

Excel Cleanup

Annual Radiation

Audit History

Organization & Scope of Work

Nuclear Medicine

Radiation Oncology

Unsealed Byproducts

Brachytherapy

Radiation Protection

Radiation Survey Instruments

Mobile Medicine Service

Training, Retraining

Training For Manual

Facilities

Public Dose

Release of Patient

Radioactive Waste

Receipt and transfer of Radioac

Transportation

Teletheraphy

Full Calibration

Periodic Spot Checks

Installation, ,Maintenance

Personnel Radiation

Personnel Radiation Protection

Notification and Reports

Bullletins

Laser Program

Audit Findings

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