From:	Pomije, Brian D. (LCDR)
Sent:	Wednesday, August 10, 2005 2:28 PM
To:	Burke, Gerald; Casey, Richard W. LCDR; Clark, Dorothy M. (CIV); Ely, Karen D. (CIV); Fairchild Gregory R LT; Fong, Raynard K   CAPT; Giel, Daniel T. (CIV); Hecht, Sheila C , LCDR; Herrera, Mark E; Hope, Lawanda P. HM1; Johnson, Gabrielle M.; Kennemur, Lisa K LCDR; LaFontaine, Richard L CT; Loscocco, Michele F (CDR); Maher, John M CDR; Ozeroglu, Muhammed A  LT; Pomije, Brian D. (LCDR); Ruiz, Steven LCDR; Saylor, Tillman K (NNMC Contractor); Scott, John H., CIV.; Simays, Andrew E., CDR; Solanki, Haresh P; Swilley, Eugene A. (LT); Tu, Victor LT; Van Way, Rick L (LCDR); Younes, Georges  E LCDR
Cc:	Ely, Karen D. (CIV); Clark, Dorothy M. (CIV); Pomije, Brian D. (LCDR); Earles, Marvin R LCDR ; Glennon, Brendan K. CDR BUMED; Lino CDR Fragoso (E-mail) (Lino.Fragoso@navy.mil)
Subject:	NRMP - Clarification of 10 CFR 35.3045(a)(3): "Wrong Treatment Site - Reportable Medical Event" 

Clarification of 10 CFR 35.3045(a)(3)
"Wrong Treatment Site - Reportable Medical Event" 

To all Medical RSOs and NRMP Permittees:

The Nuclear Regulatory Commission (NRC) has recently provided clarification of 10 CFR 35.3045(a)(3) in the July 2005 issue of their NNMS Quarterly Newsletter.  The information is copied and pasted below for informational purposes only.  This information is applicable to radiopharmaceutical administrations as well as for brachytherapy.  

Also, keep in mind that all precursor events shall be reported to the Navy Environmental Health Center per the requirements of NRSC Bulletin 2004-03.  The Naval Radiation Safety Committee (NRSC) will make the determination as to whether or not the event is reportable, and only they will make required notifications and reports to the NRC.  

Each permittee's Radiation Safety Committee (RSC) should review and understand the contents of this message.

No response to NEHC regarding this message is required.

V/R,

LCDR Pomije

Brian D. Pomije, MS, DABR
Lieutenant Commander, Medical Service Corps, USN
Radiation Health Team Leader
Navy Environmental Health Center
620 John Paul Jones Circle (Suite 1100)
Portsmouth, VA 23708-2103

W: (757) 953-0766; DSN: 377-0766
Cell: (757) 651-2814
Fax: (757) 953-0685
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UNDERSTANDING 10 CFR 35.3045(a)(3)
WRONG TREATMENT-SITE
REPORTABLE MEDICAL EVENT

A few medical use licensees have incorrectly interpreted the criteria in 10 CFR 35.3045(a)(3) for determining when a medical event involving the "wrong site" must be reported to the NRC.  10 CFR 35.3045(a)(3) requires a licensee to report any events, except for an event that results from patient intervention, if there is 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 % 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).

Some licensees erroneously believed that if the "wrong site" received 0.5 Sv (50 rem) then it needed to receive at least 50 % of the dose intended for the correct treatment site before the event met the criteria in 10 CFR 35.3045(a)(3).  The correct interpretation is that once the "wrong site" receives 0.5 Sv (50 rem), the event is reportable if this site also receives a dose that is 50 % more than anticipated at the "wrong site" if the administration had been delivered correctly (i.e., the right dose was delivered in accordance with the written directive to the correct treatment site).

When the written directive specifies the dose to the treatment site, it is understood that, even when the administration is delivered correctly, doses may be delivered to areas beyond the treatment site.  For radiopharmaceuticals, tables may be used to identify the expected doses to other organs or tissues.  When using sealed sources or the radiation from sealed sources, treatment planning systems are used to estimate and map expected dose curves at or near the correctly placed sources or correctly delivered radiation beam.  When the dose or dosage is not given in accordance with the written directive, the licensee needs to determine the total dose delivered to the "wrong site" and compare it to the dose that would have been delivered to this "wrong site" if the administration had been given correctly.

If the "wrong site" were not expected to receive any dose during the correct administration, and it received 0.5 Sv (50 rem), the medical event needs to be reported.  

Examples: If the "wrong site" was supposed to receive 0.1 Sv (10 rem) during the correct administration but received 0.6 Sv (60 rem), the medical event would be reportable.  In this case, the dose received by the "wrong site" exceeded by 0.5 Sv (50 rem) the dose it should have received, as well as more than 50 % of what it should have received.  If the "wrong site" was supposed to receive 0.1 Sv (10 rem) and it received 0.4 Sv (40 rem), the medical event would not be reportable because the dose to the "wrong site" was under 0.5 Sv (50 rem) even though the "wrong site" received more than 50 % of what it should have.  For permanent implants, NRC recognizes that the sources may migrate after being implanted in the correct site.  This migration would not result in a reportable event under 35.3045(a)(3).

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