RIS 2013-10, Interim Enforcement Policy on Permanent Implant Brachytherapy (Enclosure 3): Difference between revisions

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{{Adams
{{Adams
| number = ML12228A606
| number = ML13171A213
| issue date = 07/30/2013
| issue date = 07/30/2013
| title = Permanent Implant Brachytherapy Medical Event Reporting Under 10 CFR Part 35
| title = Interim Enforcement Policy on Permanent Implant Brachytherapy (Enclosure 3)
| author name = McDermott B J
| author name = Zelac R E
| author affiliation = NRC/FSME/DMSSA
| author affiliation = NRC/FSME/DMSSA/LISD/RMSB
| addressee name =  
| addressee name =  
| addressee affiliation =  
| addressee affiliation =  
Line 12: Line 12:
| case reference number = EDATS-SECY-2012-0415, SECY-2012-0415, WITS 201200139
| case reference number = EDATS-SECY-2012-0415, SECY-2012-0415, WITS 201200139
| document report number = RIS-13-010
| document report number = RIS-13-010
| package number = ML13156A195
| document type = NRC Regulatory Issue Summary
| document type = NRC Regulatory Issue Summary
| page count = 8
| page count = 5
}}
}}
See also: [[followed by::RIS 2013-10]]
{{#Wiki_filter:RIS 2013-10    Enclosure 3 Interim Enforcement Policy on Permanent Implant Brachytherapy  9.3 Enforcement Discretion for Permanent Implant Brachytherapy Medical Event Reporting  (10 CFR 35.3045)  This section sets forth the interim policy that the U.S. Nuclear Regulatory Commission (NRC) will use for medical event reporting violations under the current 10 CFR Part 35.  Enforcement discretion will typically be exercised for reporting violations in the following scenarios when the authorized treatment mode is permanent implant brachytherapy:  (1) the licensee uses total source strength and exposure time for evaluating the existence of a treatment site medical event; or (2) the total absorbed dose to the treatment site equals or exceeds 120 percent of the prescribed dose.  This policy does not provide regulatory relief from complying with any other aspect of §§ 35.41 or 35.3045, including the requirements related to the evaluation of dose to normal tissue.  The interim policy applies to violations that result from an otherwise appropriate use of total source strength and exposure time when determining the existence of a medical event and when the use of these values does not result in the misapplication of byproduct material by the licensee.  Specifically, under this interim Enforcement Policy, the NRC will normally not take enforcement action for using total source strength and exposure time to compare the dose delivered to the treatment site with the prescribed dose when evaluating whether a medical administration is a medical event under § 35.3045(a)(1) if the authorized treatment mode is permanent implant brachytherapy and all of the following criteria are met:   a. The licensee's documented procedures required under § 35.41 specify    total source strength and exposure time as the regulatory evaluation    values for treatment site dose comparisons;  b. The licensee entered both the prescribed dose and the delivered dose    into the written directive as total source strength and exposure time; and  c. Per § 35.3045, the licensee timely reported the event based on that    treatment site dose comparison, if applicable.
 
RIS 2013-10   Enclosure 3 In addition, the NRC will normally not take enforcement action against a licensee for not submitting a medical event report if the permanent implant brachytherapy treatment site total dose equals or exceeds 120 percent of the prescribed dose.  This enforcement discretion would only apply if: (1) licensees are using absorbed dose to compare the dose delivered to the treatment site with the prescribed dose; (2) doses to normal tissues and structures do not  exceed the regulatory dose limits for reporting medical events specified in current §
35.3045(a)(3); and (3) the total dose for the treatment site was expressed in the written directive as absorbed dose.
 
This discretion will not be exercised for licensees using source strength and exposure time to compare the dose delivered to the treatment site with the prescribed dose, since it is expected that the licensee has more control over delivery of the prescribed dose when using source strength and exposure time.  However, this is not intended to limit the physician's current ability to make intraoperative adjustments in the quantity of source strength to be implanted based on the conditions encountered during the surgical procedure.  Licensees shall comply with all other requirements, as applicable, unless explicitly replaced or amended in this interim policy.    This interim policy will remain in place until the implementation date of a final rule associated with the medical event reporting requirements.


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{{#Wiki_filter:  UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF FEDERAL AND STATE MATERIALS AND  ENVIRONMENTAL MANAGEMENT PROGRAMS WASHINGTON, DC  20555  July 30, 2013  NRC REGULATORY ISSUE SUMMARY 2013-10 PERMANENT IMPLANT BRACHYTHERAPY MEDICAL EVENT REPORTING UNDER 10 CFR PART 35  ADDRESSEES 
All U.S. Nuclear Regulatory Commission (NRC) medical-use licensees, NRC master material licensees (MMLs), Agreement State Radiation Control Program Directors, and State Liaison
Officers.
INTENT  The NRC is issuing this regulatory issue summary (RIS) to:  (1) supply information to assist
licensees in complying with the current NRC requirements related to permanent implant brachytherapy; and (2) announce that an Interim Enforcement Policy1(IEP), has been developed and published and explain the enforcement discretion NRC will use to provide regulatory relief to licensees until the implementation date of a revised final rule (10 CFR Part 35, Medical Use of Byproduct Material) associated with the Medical Event (ME) reporting requirements.   
No specific action or written response is required.  The NRC is providing this RIS to Agreement States for their information and for distribution to their medical licensees, as appropriate.
 
BACKGROUND  In SRM-SECY-12-00532, dated August 13, 2012, the Commission approved the staff's recommendations for modifying the regulatory requirements that appear in 10 CFR 35.3045 for
permanent implant brachytherapy ME reporting and conforming changes to the current written directive (WD) requirements in 10 CFR 35.40(b)(6), to convert from dose-based to            source-strength-based ME criteria for the treatment site.  The Commission also directed the staff to clarify ME reporting for permanent implant brachytherapy under the existing rule and provide insights about compliance with the current NRC requirements.  Finally, the Commission directed the staff to develop an IEP that would allow the staff to exercise enforcement discretion for both existing and future violations of current Part 35 that do not result in the misapplication of byproduct material by those licensees that use total source strength and treatment (exposure) time for determining the existence of a treatment site ME. 
ML13156A195  _____________________ 1  Docket ID NRC-2013-0114.  Available on the Federal Rulemaking Web site at:      http://www.regulations.gov.      2  Available on the NRC public Web site in the Agencywide Documents Access Management    System at: http://www.nrc.gov/reading-rm/adams.html. Use search number ML12228A606.       
            RIS 2013-10 Page 2 of 7 
SUMMARY OF ISSUE  Compliance With Current Regulations  In 10 CFR 35.2, Definitions, "prescribed dose" for manual brachytherapy is defined as "either the total source strength and exposure time or the total dose, as documented in the written directive," and "treatment site" is defined as "the anatomical description of the tissue intended to
receive a radiation dose, as described in a written directive."  In 10 CFR 35.40, Written  Directives (WD), the information required for the WD when the treatment mode is manual brachytherapy includes the patient's or human research subject's name and the following:  Before implantation, the treatment site, the radionuclide, and the dose (i.e., the prescribed dose); and after implantation but before completion of the procedure, the treatment site, the radionuclide, the number of sources (implanted), and "the total source strength and exposure
time (or the total dose)." 
The regulations reference many different terms all linked to the WD:  total source strength; total dose; treatment site; and dose.  These terms may have variable meanings and uses for licensees.  For instance, in manual prostate brachytherapy, treatment site may mean the
prostate only for one licensee and may mean the prostate plus a volume of tissue surrounding
the prostate for another licensee.  Therefore, licensees are reminded to be consistent in their
use of terms when documenting in the pre-implantation and post-implantation portions of the WD all components of the implant that will ultimately be used when evaluating the adequacy of the implant.   
10 CFR 35.41, Procedures for administrations requiring a written directive, states that a medical use licensee authorized for permanent implant brachytherapy must develop, implement and maintain written procedures to provide high confidence that, among other things, each administration is in accordance with the treatment plan, if applicable, and with the WD.  Therefore, licensees should have checks in place to ensure that each component of the WD is
met.  The NRC notes that some licensees' procedures were developed when the predecessor to
10 CFR 35.41, called Quality Management Program, was initiated (1990's) and licensees have
not updated these procedures even though their implant style and assessments may have
changed.  For instance, prior to 1990, many licensees implanted sources for prostate treatments without pre-planning or post-planning dosimetry.  Today, many licensees perform extensive imaging and dosimetry to prescribe and evaluate doses to not only intended tissue (e.g., prostate), but also to nearby tissue (e.g., rectum, bladder, or urethra).  Therefore, licensees are
reminded that procedures should correctly document the program currently in place, and for purposes of determining whether medical event reporting is required, provide definitive criteria for evaluating the adequacy of the dose delivered to the intended treatment site, compared to the prescribed dose, and the acceptability of the dose delivered to any other organ or tissue,
compared to the dose expected from the administration defined in the written directive. 
10 CFR 35.3045, Report and notification of a medical event, provides the criteria for ME  reporting and uses terms like dose, prescribed dose, organ or tissue other than the treatment site, and migrated seeds.  These terms again may have variable meanings and uses for
licensees.  In addition, differences in prescribing doses among licensees makes it difficult for
some licensees to assess if an ME has occurred. 
 
 
            RIS 2013-10 Page 3 of 7  For instance, in manual prostate brachytherapy, some licensees develop a treatment plan that includes expected doses to organs or tissues near the prostate and perform post-treatment planning after the implant with this same data.  However, some licensees do not perform
treatment planning at all, but instead rely on a nomogram approach for performing implants and review of post-implant images for assessing the adequacy of the placement of the sources.  Therefore, the first category of licensees may have data to assess whether an "organ or tissue other than the treatment site" received a dose (in terms of gray (Gy) or rads) in excess of the ME reporting criteria, but the second category of licensees would not readily have the data
available to make this assessment.  NRC has noted that both categories of licensees frequently do not document their post-treatment assessments in detail.  In addition, the second category of
licensees should develop mechanisms for collecting definitive data to perform an assessment of the adequacy of the implant.  For instance, a conventional x-ray taken immediately after the implant and reviewed may not be sufficient for determining where the sources are implanted. 
Therefore, all licensees are reminded that their procedures, developed in accordance with 10
CFR 35.41,  should be robust enough to allow the licensee to definitively evaluate the dose to
the defined treatment site and the doses to other organs or tissues in performing an assessment of whether an ME may have occurred.   
Total Dose Variance Determination 
For the treatment site, the ME reporting criteria in 10 CFR 35.3045(a)(1) includes a threshold for
delivered total dose variance from prescribed dose, in sieverts (Sv) or in rem, and a threshold for percent variance of delivered dose from prescribed dose.  Both of these dose thresholds (delivered total dose variance and percent dose variance) must be exceeded for a medical use
procedure to be deemed an ME based on treatment site dose variance. 
As stated above, "prescribed dose" is defined as "either the total source strength and exposure time, or the total dose, as documented in the written directive."  Section 35.3045 does not explicitly state whether the comparison of delivered total dose to prescribed dose for the treatment site, for determination of the percent dose variance, can be done with these doses expressed as total source strength and exposure time, consistent with one of the options in the
definition of prescribed dose, or whether the prescribed dose (and the delivered total dose) must
be expressed as total dose, the other option in the definition of prescribed dose.  However, because 10 CFR 35.3045(a)(1) specifies that the threshold for delivered total dose variance from prescribed dose is expressed in sieverts (Sv) or in rem in 10 CFR 35.3045(a)(1), section
35.3045 requires that this comparison of delivered dose to prescribed dose must be performed
in terms of total dose to determine whether a ME has occurred.  Thus, Section 35.3045 does
not provide licensees with the option to use total source strength and exposure time in lieu of total dose for the total dose variance determination. 
Medical use licensees authorized for permanent implant brachytherapy are advised that for completing the WD after implantation, the delivered dose (for the treatment site) may be
expressed as total source strength and exposure time as long as the prescribed dose was also expressed in terms of total source strength and exposure time for the pre-implantation entries of the WD.  However, as noted above, the determination under section 35.3045(a)(1) that a
particular procedure is or is not an ME based on treatment site dose variance must be done with
both the delivered dose and the intended (prescribed) dose expressed in Sv or rem for
determination of total dose variance. 
 
 
            RIS 2013-10 Page 4 of 7  Therefore, in order for the licensee to be in compliance with the requirements in section 35.3045(a)(1), if specifying treatment site doses in the WD in terms of total source strength and exposure time, the licensee should also provide sufficient information to allow for the calculation
of the total doses (prescribed and delivered) in Sv or rem.  Of course, for the WD, medical use
licensees authorized for permanent implant brachytherapy can also continue to express both the prescribed dose and the delivered dose as total doses, and make the determination under section 35.3045 as to whether a treatment site ME has occurred based on the total dose values (prescribed and delivered) in the WD.  Note that an implant that is considered ME reportable
based on the percent dose variance for a comparison of delivered total dose to prescribed total
dose might not be considered ME reportable if the comparison of delivered dose to intended
dose was performed based on total source strength and exposure time.  As interim guidance to NRC inspectors when reviewing permanent implant brachytherapy programs, in 2012 the NRC developed Appendix B, Reviewing Licensees' Implementation of Procedures for Permanent Implant Brachytherapy Administrations, and Appendix C, Questions & Answers for Inspecting Manual Brachytherapy Prostate Implants, to its Inspection Procedure (IP) 87132, Brachytherapy Programs.  Licensees may find these guidelines and examples, along with the IEP described below, useful in reviewing their permanent implant programs and procedures.  These Appendices are enclosed, as well as being available on the NRC public web
site.  Note that the IEP may supersede some of the information in IP 87132, including some of
the responses to the questions and answers in Appendix C, until IP 87132 is revised to reflect it.
However, note that, because the prescribed dose is large and is intended to be therapeutic, if the percent variance of delivered total dose from prescribed dose for the treatment site exceeds the threshold for reporting an ME, which is 20 percent, in every case the threshold for total dose
variance (delivered from prescribed) for the treatment site, at 0.5 Sv (50 rem), will also be exceeded, so the two linked criteria for a treatment site ME will both have been met.  This fact is the basis for part of the enforcement discretion in the IEP described below.   
Interim Enforcement Policy 
Based on the information in the paragraph above, NRC recognized the need to provide regulatory relief to licensees from the current requirement that a comparison of delivered dose to prescribed dose for determination of total dose variance for the treatment site be done with both doses expressed in Sv or rem.  Specifically, provision of regulatory relief would be justifiable in the case in which a licensee's procedure identifies use of total source-strength and
exposure time for the entire process, including determining percent variation of delivered total dose from prescribed dose as a criterion to identify a treatment site ME.  The NRC staff is currently revising the regulations in 10 CFR Part 35 for permanent implant
brachytherapy programs which may eliminate dose-based medical event reporting requirements for treatment sites.  In the interim, the NRC developed an IEP.
 
 
 
            RIS 2013-10 Page 5 of 7  On July 9, 2013, the IEP was published in the Federal Register (78 FR 41125).  The effective date of the IEP is July 9, 2013.  The NRC Enforcement Policy can be found at:
http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html.  Via the Federal Register Notice, the NRC provided notice of its revised Enforcement Policy.  To review the IEP, please
refer to Enclosure 3.  The IEP applies to violations that result from an otherwise appropriate use of total source strength and treatment time for determining the existence of a treatment site ME, and if use of these values does not result in the misapplication of byproduct material by the licensee. Under the IEP, enforcement discretion for existing and future violations of the ME reporting
requirement will be considered if the authorized treatment mode is permanent implant brachytherapy and licensees uses total source strength and exposure time for determining the percent variation between delivered total dose and intended (prescribed) dose (for the treatment
site), for determining under current 10 CFR 35.3045 whether a treatment site ME has occurred.      Enforcement discretion will only be considered if the licensee entered both the prescribed dose and the delivered total dose into the WD in terms of total source strength and exposure time; the licensee's documented procedures required under section 35.41 specify total source strength
and exposure time as the regulatory evaluation values for treatment site dose comparisons;  and the licensee timely reported the event based on that treatment site dose comparison, if applicable.
The IEP also provides enforcement discretion for existing and future violations of the current section 35.3045(a)(1)(i) ME reporting requirement when a treatment site total dose exceeds 120
percent of the prescribed dose.  This enforcement discretion will apply if the licensee used
absorbed dose to compare the dose delivered to the treatment site with the prescribed dose;
doses to normal tissues and structures do not exceed the regulatory dose thresholds for reporting MEs in current section 35.3045(a)(3); and the total dose for the treatment site was expressed in the WD as absorbed dose.  This additional regulatory relief is being offered
because variables in post-implant dosimetry studies cause calculated absorbed dose to be an
unreliable metric for regulatory purposes. 
This regulatory relief does not pose a safety concern because the permanent implant therapies planned by many practitioners have as their objective delivering as much radiation dose as possible to the treatment site without exceeding medically-recognized dose limits for nearby normal tissues and structures, i.e., organs at risk. 
Also, the NRC recognizes that the current ME reporting of delivered total dose to the treatment site exceeding 120 percent, compared to the prescribed dose, inappropriately limits the medical practitioner's ability to provide optimum medical care and treatment to his/her patients by maximizing the delivered total dose to the treatment site.  Note that the revisions to 10 CFR
35.3045 that are now under development for permanent implant brachytherapy would eliminate all treatment site dose variance threshold criteria present in the current 10 CFR 35.3045 ME reporting requirements. 
This enforcement discretion for treatment site total dose exceeding 120 percent of the
prescribed dose will not apply if the total dose for the treatment site was expressed in the written
directive as total source strength and exposure time. 
 
 
              RIS 2013-10                  Page 6 of 7  This is because licensees have more control over delivery of the prescribed dose when using
source strength and exposure time. This policy does not change the physician's current ability to
make intraoperative adjustments in the quantity of source strength implanted based on the
conditions encountered during the surgical procedure and to document such adjustments in the portion of the written directive required after implantation but before completion of the procedure.
This policy does not provide enforcement discretion for a delivered dose to the treatment site that is less than 80 percent of the intended dose, the lower limit for treatment site dose variance
in the current section 35.3045(a)(1)(i).  The intent of permanent implant brachytherapy is to  deliver at least a minimum dose in accordance with the physician's direction; therefore, exercising enforcement discretion for an underdose would not further this intent. 
BACKFIT DISCUSSION  This RIS requires no action or written response.  Any action on the part of addressees in accordance with the guidance contained in this RIS is strictly voluntary and, therefore, is not a
backfit under any regulatory requirement.  Consequently, the staff did not perform a backfit analysis.
FEDERAL REGISTER NOTIFICATION  A notice of opportunity for public comment on this RIS was not published in the Federal Register because this RIS is informational and does not represent a departure from current regulatory
requirements.
CONGRESSIONAL REVIEW ACT  This RIS is not a rule as defined in the Congressional Review Act (5 U.S.C. §§ 801-808).
PAPERWORK REDUCTION ACT STATEMENT 
This RIS references information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).  These information collection requirements
were approved by the Office of Management and Budget, approval number 3150-0010.  PUBLIC PROTECTION NOTIFICATION The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.   
 
 
            RIS 2013-10                  Page 7 of 7  CONTACT  This RIS requires no specific action or written response.  Please direct any questions to the
technical contact listed below or the appropriate regional office.
      /RA PHenderson for/      Brian J. McDermott, Director
    Division of Materials Safety and State Agreements
    Office of Federal and State Materials                  and Environmental Management Programs   
Technical Contact:  Ronald Zelac, Ph.D., FSME                          (301) 415-7635
                Email:    Ronald.Zelac@nrc.gov 
Enclosures:
1.  Appendix B - Inspection Procedure 87132 2.  Appendix C - Inspection Procedure 87132 3.  Interim Enforcement Policy  4.  FSME Generic Communications 
 
 
 
 
 
 
            RIS 2013-10                  Page 7 of 7  CONTACT
This RIS requires no specific action or written response.  Please direct any questions to the
technical contact listed below or the appropriate regional office.
      /RA PHenderson for/      Brian J. McDermott, Director
    Division of Materials Safety and State Agreements
    Office of Federal and State Materials                  and Environmental Management Programs 
Technical Contact:  Ronald Zelac, Ph.D., FSME                                (301) 415-7635                  Email:    Ronald.Zelac@nrc.gov 
Enclosures:
1.  Appendix B - Inspection Procedure 87132
2.  Appendix C - Inspection Procedure 87132 3.  Interim Enforcement Policy  4.  FSME Generic Communications
DISTRIBUTION:  WITS 201200139 EDATS-SECY-2012-0415 MSSA r/f 
   
                      ML13156A195 OFFICE MSSA/RMSB MSSA/RMSBMSSA/RMSBMSSA/RMSB OENAME RZelac SGabrielAMcIntoshSGabriel for CEinberg NHilton DATE 6/4/13 6/19/136/13/136/19/137/2/13OFFICE OIS OGC-NLOOGC-CRAMSSAMSSANAME TDonnellBJonesJAdler for BAmmonPHenderson  PHenderson for BMcDermottDATE 7/10/13 7/23/137/23/137/30/137/30/13OFFICIAL RECORD COPY 


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Revision as of 12:29, 30 March 2018

Interim Enforcement Policy on Permanent Implant Brachytherapy (Enclosure 3)
ML13171A213
Person / Time
Issue date: 07/30/2013
From: Zelac R E
NRC/FSME/DMSSA/LISD/RMSB
To:
Zelac R
References
EDATS-SECY-2012-0415, SECY-2012-0415, WITS 201200139 RIS-13-010
Preceding documents:
Download: ML13171A213 (5)
v • d • e


RIS 2013-10 Enclosure 3 Interim Enforcement Policy on Permanent Implant Brachytherapy 9.3 Enforcement Discretion for Permanent Implant Brachytherapy Medical Event Reporting (10 CFR 35.3045) This section sets forth the interim policy that the U.S. Nuclear Regulatory Commission (NRC) will use for medical event reporting violations under the current 10 CFR Part 35. Enforcement discretion will typically be exercised for reporting violations in the following scenarios when the authorized treatment mode is permanent implant brachytherapy: (1) the licensee uses total source strength and exposure time for evaluating the existence of a treatment site medical event; or (2) the total absorbed dose to the treatment site equals or exceeds 120 percent of the prescribed dose. This policy does not provide regulatory relief from complying with any other aspect of §§ 35.41 or 35.3045, including the requirements related to the evaluation of dose to normal tissue. The interim policy applies to violations that result from an otherwise appropriate use of total source strength and exposure time when determining the existence of a medical event and when the use of these values does not result in the misapplication of byproduct material by the licensee. Specifically, under this interim Enforcement Policy, the NRC will normally not take enforcement action for using total source strength and exposure time to compare the dose delivered to the treatment site with the prescribed dose when evaluating whether a medical administration is a medical event under § 35.3045(a)(1) if the authorized treatment mode is permanent implant brachytherapy and all of the following criteria are met: a. The licensee's documented procedures required under § 35.41 specify total source strength and exposure time as the regulatory evaluation values for treatment site dose comparisons; b. The licensee entered both the prescribed dose and the delivered dose into the written directive as total source strength and exposure time; and c. Per § 35.3045, the licensee timely reported the event based on that treatment site dose comparison, if applicable.

RIS 2013-10 Enclosure 3 In addition, the NRC will normally not take enforcement action against a licensee for not submitting a medical event report if the permanent implant brachytherapy treatment site total dose equals or exceeds 120 percent of the prescribed dose. This enforcement discretion would only apply if: (1) licensees are using absorbed dose to compare the dose delivered to the treatment site with the prescribed dose; (2) doses to normal tissues and structures do not exceed the regulatory dose limits for reporting medical events specified in current §

35.3045(a)(3); and (3) the total dose for the treatment site was expressed in the written directive as absorbed dose.

This discretion will not be exercised for licensees using source strength and exposure time to compare the dose delivered to the treatment site with the prescribed dose, since it is expected that the licensee has more control over delivery of the prescribed dose when using source strength and exposure time. However, this is not intended to limit the physician's current ability to make intraoperative adjustments in the quantity of source strength to be implanted based on the conditions encountered during the surgical procedure. Licensees shall comply with all other requirements, as applicable, unless explicitly replaced or amended in this interim policy. This interim policy will remain in place until the implementation date of a final rule associated with the medical event reporting requirements.


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