High Dose Rate (hdr) Remote Afterloader Brachytherapy




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High Dose Rate (HDR)

Remote Afterloader Brachytherapy



Audit Guide



Note: This HDR Audit Guide is not all inclusive. Additional requirements are found in the Medical Permit Audit Guide and the High Confidence Program (HCP) Audit Guide.



References
Title 10, Code of Federal Regulations (CFR), Subpart H, Part 35.600

Photon Emitting Remote Afterloader Units,



Teletherapy Units, and Gamma Stereotactic Radiosurgery Units”

[19 Sep 2007]
Nuclear Regulatory Commission (NRC) Inspection Manual, Inspection Procedure 87132 “Brachytherapy Programs

[24 Oct 2002]
NUREG-1556, Vol. 9, Rev. 1

Program Specific Guidance About Medical Use Licenses”



[May 2005]
NEHC - Medical Permit Audit Guide and High Confidence Program Audit Guide

[Dec 2003]
Naval Radiation Safety Committee (NRSC) Bulletins 2004-01 and 2006-01

Receipt, Storage and Security of Radioactive Materials”



[13 Feb 2004 and 28 Dec 2006]


Permittee (Name and Address): NRMP Permit No.: ____________________

_____________________________________ Most Recent Amendment No.: ___________


_____________________________________ Date of Last Amendment: _______________
_____________________________________

_____________________________________ Date of This Audit: ____________________


Radiation Safety Officer (RSO) Date of Last Audit: ____________________

_____________________________________ Date of Next Audit: ____________________


Authorized Medical Physicist (AMP)
_____________________________________
Type of Inspection: ( ) Announced ( ) Unannounced

( ) Routine ( ) Special

( ) Initial ( ) Reinspection
Summary of Findings and Actions: ( ) No Deficiencies

( ) Deficiency or Deficiencies

( ) Follow-up on Previous Deficiencies
Comments: ______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

Auditor: Management Review:
_____________________________________ ____________________________________

(Name) (Name)
_____________________________________ ____________________________________

(Signature) (Date) (Signature) (Date)


Topics

Page

Permit Authorization

1 - 2

Audit History

2

Use by Authorized Individuals

3

Facilities

3 - 4

Training and Instructions to Workers

4 - 5

Dose Measuring Equipment

6

Leak Tests and Inventories

6

Radiation Instruments and Surveys

6 - 7

Therapy-Related Computer Systems

7

Full Calibration of HDR Unit(s)

8

Periodic Spot-Checks of HDR Unit(s)

9

Installation, Maintenance, and Repair of HDR Unit(s)

10

Operating and Emergency Procedures

10

Public Dose

11

Procedures for Ensuring “High Confidence” of WDs

11


Permit Authorization

A. Regarding the use of a High Dose Rate (HDR) remote afterloader unit, a permittee may use byproduct material in the form of a radiation sealed source approved for medical use under 10 CFR, Subpart H, Part 600 [10 CFR 35.600], if:


1. The applicant or permittee has submitted the information required by 10 CFR Part 35.12(b) through (d) to the Navy Environmental Health Center (NAVENVIRHLTHCEN); and

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
2. The applicant or licensee has received written approval by the Naval Radiation Safety Committee (OPNAV-N455) in a permit or permit amendment and uses the material in accordance with the regulations and specific conditions the Nuclear Regulatory Commission (NRC) considers necessary for the medical use of the material?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
B. Permit authorization wording in accordance with guidelines in NUREG-1556, Vol. 9 and in the Sealed Source Device Registry (SSDR) Certificate?
1. ___ Item 5 – Radioactive material: Iridium-192, including sealed source or device manufacturer’s name and model number, as well as the maximum activity per source, number of sources, and total activity allowed. Note that if greater than or equal to 22 Ci total, the command must also have met the NRC’s Increased Controls (ICs) for radioactive material quantities of concern (RAM QC).

2. ___ Item 6 – Purpose(s) for which licensed material will be used: Medical use of a sealed source(s) in a device for therapy in a remote afterloader unit, including the model name and number of the unit.

3. ___ Permit Condition to restrict the use of the HDR unit to a specific room location.

4. ___ Permit Condition to restrict the loading of the source into the HDR unit based on the decayed activity of the source, and any other condition as specified in the SSDR Certificate.

5. ___ Permit Condition to name and authorize an Authorized Medical Physicist (AMP) and an Authorized User (AU) physician(s) for medical use under 35.600.

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________

C. Are the sealed sources possessed and used as described in the SSDR certificate? Are copies of (or access to) SSDR Certificates possessed? Are manufacturer’s manuals for operation and maintenance of the HDR unit possessed?

( ) Y ( ) N

______________________________________________________________________________


______________________________________________________________________________
D. Are the actual uses of the HDR unit consistent with the authorized uses listed on the permit?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________

Audit History

A. Were previous HDR audits conducted annually or conducted as a component of previous audits of the permittee’s medical permit [10 CFR 20.1101]?

( ) Y ( ) N

______________________________________________________________________________


______________________________________________________________________________
B. Were records of previous HDR audits maintained for 3 years [10 CFR 20.2102]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
C. Were any deficiencies identified during previous HDR audit(s), and if so, were corrective actions taken and were they effective? (Look for repeated deficiencies).

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
D. Any amendments or notifications since the last audit that affected HDR, including the addition or removal of AUs or AMPs [35.13, 35.14]? Were formal notifications within 30 days [35.14]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
Use by Authorized Individuals
A. Authorized User (AU) [35.57, 35.59, 35.690]:

1. ___ Certified by specialty board recognized by the NRC;

2. ___ Identified on NRC or Agreement State license;

3. ___ Identified on permit issued by broad scope or master materials license;

4. ___ Listed on facility’s permit?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
B. Authorized Medical Physicist (AMP) [35.57, 35.59, 35.51]:

1. ___ Certified by specialty board recognized by the NRC;

2. ___ Identified on NRC or Agreement State license;

3. ___ Identified on permit issued by broad scope or master materials license;

4. ___ Listed on facility’s permit?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
Facilities
A. Facilities as described in the permit and permit application?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
B. Facility provided with electrical interlock system, viewing and intercom systems, radiation monitor, source retraction mechanism, and source indicator lights [35.615]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
C. Emergency source recovery equipment readily available [35.615]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________

D. Storage, Receipt and Security:


1. Materials secured from unauthorized removal or access when in storage, and permittee controls and maintains constant surveillance of licensed material when not in storage [20.1801, 20.1802]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
2. Additional measures for the receipt, storage and security of the HDR sealed source(s), such as a system for ensuring proper delivery and receipt of new sources, and a secondary independent locking mechanism to ensure security. [NRSC Bulletins 2004-01 and 2006-01]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
E. Therapy Unit Operation:

1. ___ HDR unit, console, console keys, and treatment room controlled adequately [35.610(a)(1)], and;

2. ___ Only one radiation device can be placed in operation at a time within the treatment room [35.610(a)(3)]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
Training and Instructions to Workers
A. Authorized user (AU) physicians meet the training and experience requirements [35.690]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
B. The AUs and authorized medical physicist (AMP) have receive the required vendor training for use of the HDR unit, including appropriate classroom training/instruction, and the required number of actual patient cases performed under the direct supervision of the vendor representative, as applicable?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________

C. Have workers been provided with required instructions as applicable, to include initial and periodic training in:

1. ___ Operating procedures, including unit operation, inspection, and associated equipment;

2. ___ Emergency procedures, including emergency drills;

3. ___ Surveys and survey equipment, and;

4. ___ Permit conditions applicable to the use of the HDR unit [35.610]?

( ) Y ( ) N

______________________________________________________________________________


______________________________________________________________________________
D. Are records of required instruction to individuals appropriately documented and maintained for each individual for 3 years [35.2310]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
E. Supervision of individuals by AU physicians [35.27]? (Describe methods)

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
F. Appropriate documentation of experience and training requirements? (List when the AU or AMP initially met the training and experience requirements)

( ) Y ( ) N




Authorized Individual

(Specify AU or AMP)



Date Completed

Training Requirement



Date Completed Experience Requirement

( )







( )







( )







( )







( )









Dose Measuring Equipment
A. The authorized medical physicist (AMP) performed independent measurement of source output for initial full calibration and periodic spot-checks using a dosimetry system calibrated within the previous 2 years and after servicing, by:

1. ___ NIST;

2. ___ AAPM-accredited dosimetry calibration lab (ADCL), or;

3. ___ Calibrated by intercomparison within the previous 4 years [35.630(a)]?

( ) Y ( ) N

______________________________________________________________________________


______________________________________________________________________________
B. Record of each calibration, intercomparison, and comparisons of dosimetry equipment properly documented and maintained for the duration of the license [35.2630]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
Leak Tests and Inventories
The permittee is in compliance with inventory and leak test requirements for HDR source(s) [35.67]? Records are properly documented and maintained [35.2067]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
Radiation Instruments and Surveys
A. Appropriate operable survey instruments possessed and used to show compliance with 10 CFR Part 20 and 30.33(a)(2)?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
B. Instruments are calibrated before first use, annually and after repairs, within 20% on each scale or decade of interest, and records properly documented and maintained for 3 years [35.61, 35.2061]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________

C. Radiation surveys performed in accordance with the permittee’s procedures and the regulatory requirements [20.1501, 35.70].


1. Radiation surveys made to assure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position does not exceed the levels stated in the SSDR Certificate, and records properly documented and maintained for the duration of use of the unit [35.652, 35.2652]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
2. Required surveys are conducted:

(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(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s), and;

(c) ___ Quarterly in all areas where radioactive sealed sources are stored [35.652, NUREG-1556, Vol. 9., App. R.]?

( ) Y ( ) N

______________________________________________________________________________


______________________________________________________________________________
Therapy-Related Computer Systems
Permittee performed acceptance testing on the treatment planning system of HDR-related computer systems in accordance with published protocols accepted by nationally recognized bodies, including as a minimum, verification of:

1. ___ Source-specific input parameters required by dose calculation algorithm, ensuring accurate and correct units of source activity;

2. ___ Accuracy of dose, dwell time, and treatment time calculations at representative points;

3. ___ Accuracy of isodose plots and graphic displays;

4. ___ Accuracy of the software used to determine sealed source positions from radiographic images, and;

5. ___ Accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system [35.657]?

( ) Y ( ) N

______________________________________________________________________________


______________________________________________________________________________

Full Calibration of HDR Unit(s)
A. Proper nationally-recognized protocol used (e.g., AAPM TG-43, etc.)? (State the protocol)

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________

B. Performed by the authorized medical physicist (AMP) with properly calibrated instrument:

1. ___ Prior to first patient clinical use;

2. ___ At intervals not exceeding one quarter, and;

3. ___ After source exchange, relocation, and major repair or modification [35.633]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________

C. For HDR units, full calibration includes:

1. ___ Output measured within ± 5% of expected;

2.___ Source positioning accuracy within ± 1mm;

3. ___ Source retraction with backup battery upon power failure;

4. ___ Length of source transfer tubes;

5. ___ Timer accuracy and linearity over the typical range of use;

6. ___ Length of applicators, and;

7. ___ Function of source transfer tubes, applicators, and transfer tube-applicator interfaces [35.633]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________

D. Output corrected mathematically for decay at intervals consistent with 1% physical decay [35.633(g)]?

( ) Y ( ) N

______________________________________________________________________________


______________________________________________________________________________

E. Records of full calibrations properly documented and maintained for 3 years [35.2632]?

( ) Y ( ) N

______________________________________________________________________________


______________________________________________________________________________

Periodic Spot-Checks of HDR Unit(s)
A. Performed by a qualified individual using procedures established by the AMP:

1. ___ Prior to first use on a given day, and;

2. ___ After each source installation [35.643(a), 35.643(b)]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
B. If not performed by the AMP, were the results of the spot-check reviewed by the AMP within 15 days [35.643(c)]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
C. For HDR units, periodic spot-checks include:

1. ___ Electrical door interlocks;

2. ___ Source exposure indicator lights;

3. ___ Viewing and intercom systems;

4. ___ Emergency response equipment;

5. ___ Radiation monitors used to indicate source position;

6. ___ Timer accuracy;

7. ___ Clock (date and time) in the unit’s computer, and;

8. ___ Decayed source(s) activity in the unit’s computer [35.643]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
D. Permittee promptly investigated and repaired items found to be not operating properly and did not use the unit until repaired, if required [35.643(e)]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
E. Records of periodic spot-checks properly documented and maintained for 3 years [35.2643]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
Installation, Maintenance, and Repair of HDR Unit(s)
Only authorized individuals perform installation, maintenance, adjustments, repairs, and inspections of HDR unit(s) and related software and equipment, and records are properly documented and maintained for 3 years [35.605, 35.2605]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
Operating and Emergency Procedures
A. Instructions on location of emergency procedures and emergency response telephone numbers are posted at the HDR unit console [35.610(c)]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
B. Copy of the entire procedures physically located at the HDR unit console [35.610(b)], which include at a minimum:

1. ___ Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

2. ___ Process for restricting access to an posting of the treatment area to minimize the risk of inadvertent exposure, and;

3. ___ Names and telephone numbers of the AU(s), AMP and the RSO to be contacted if the unit or console operates abnormally [35.610(a)(4)]?

( ) Y ( ) N

______________________________________________________________________________


______________________________________________________________________________
C. Radiation survey of patients and the head of the HDR unit are performed to ensure source is returned to the shielded safe, and survey records are properly documented and maintained for 3 years [35.604(a), 35.2404]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
D. Authorized medical physicist (AMP) and authorized user (AU):

1. ___ AMP and AU are physically present during initiation of all patient treatments, and;

2. ___ AMP and either an AU or a physician, under the supervision of an AU, who has been trained in the operation and emergency response for the HDR unit, to be physically present during continuation of all patient treatments [35.615(f)(2)]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________

Public Dose
A. Is permitted material used in such a manner to keep doses below 1 mSv (100 mrem) in a year, and for unrestricted areas, radiation levels that do not exceed 0.02 mSv (2 mrem) in any one hour [20.1301]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
B. Has a survey or evaluation been performed to ensure compliance with regulatory limits, and are records properly documented and maintained [20.1501(a), 20.2103, 20.2107]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
Procedures for Ensuring “High Confidence” of Written Directives
A. A written directive (WD) is signed and dated by an AU physician before the administration of a therapeutic dose from an HDR unit, containing the following information:

1. ___ Patient’s name;

2. ___ Radionuclide;

3. ___ Treatment site;

4. ___ Dose per fraction;

5. ___ Number of fractions, and;

6. ___ Total dose [35.40]?

( ) Y ( ) N

______________________________________________________________________________
______________________________________________________________________________
B. Permittee has developed, implemented, and maintained written procedures to provide high confidence that:

1. ___ Patient's identity is verified by two separate means before each administration, and:

2. ___ Each administration is in accordance with the WD [35.40, 35.41]?

( ) Y ( ) N



___________________________________________________________________________
___________________________________________________________________________

Notes:

  1. Additional requirements for ensuring procedures provide “high confidence” for administrations of radioisotopes requiring written directives, including criteria for medical events (i.e., misadministrations) are found in the High Confidence Program (HCP) Audit Guide.

  2. Additional requirements for the radiation safety program, including organization and scope of the program, personnel radiation protection, posting and labeling, recordkeeping for decommissioning, notifications and reports, receipt and transfer of radioactive material, etc., are found in the Medical Permit Audit Guide.








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