ML20149H103
| ML20149H103 | |
| Person / Time | |
|---|---|
| Issue date: | 11/07/1994 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Axelson W, Hehl C, Jacob Philip NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20149H107 | List: |
| References | |
| NUDOCS 9411160328 | |
| Download: ML20149H103 (4) | |
Text
.
a a'%
'3 E'
E UNITED STATES E'
NUCLEAR REGULATORY COMMISSION k
WASHINGTON O.C. 205S54001
~
November 7, 1994 MEMORANDUM 10:
Those on Attached List FROM:
Carl J. Paperiello, Director Division of Industrial and Medical Nuclear Safety, NMSS
SUBJECT:
GUIDANCE ON REQUIRED ELEMENTS OF A WRITTEN DIRECTIVE AS DEFINED IN 10 CFR 35.2 This memorandum provides guidance on a number of issues regarding the required elements of written directives defiaed in 10 CFR 35.2.
The following questions are addressed:
(1) Is there a specific format the authorized user must follow when preparing a written directive for brachytherapy other than HDR ("all other brachytherapy")?
(2) What are NRC's expectations for " total source strength," as it is used in the definition of written directive 10 CFR 35.2 "(6) for all other brachytherapy"?
(3) May the authorized user specify, in the written directive, a range of doses or dosages for a specific patient?
(4) May the authorized user specify a range of dates for the overall treatment period?
(5) When an authorized user initials a written directive, is the requirement to sign a written directive satisfied? and (6) Must the authorized user date the written directive at the time of signing, or may a predated written directive be signed?
1.
Format of a Brachytherapy Written Directiv_g:
A written directive for all brachytherapy other than HDR, as described in 10 CFR 35.2 and subparagraph (6) of that definition, " written directive," is "an order, in writing for a specific patient, dated and signed by an authorized user containing the following information:
(i)
Prior to implantation: the radioisotope, number of sources, and source strengths; and (ii) After implantation, but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose)."
Some authorized users do not prepare written directives for ma.1ual brachytherapy strictly as described in 10 CFR 35.2.
Such licensees prepare a
" treatment plan" (which contains the information described in 35.2(6)(i)) and serves as part (1), and, subsequently, prepare another document containing the information specified in part (ii) of the definition of written directive in 10 CFR 35.2.
In these cases, part (ii) is signed and dated by the authorized user either prior to implantation or after implantation, but prior to completion of the treatment.
Part (i) is usually not signed.
The two documents may, or may not, be on the same form.
^
q @42_ _
2 o :' ::
y i'
t 2
Licensees may use a " treatment plan" as part (i) provided it contains the required elements.
Such a written directive would be prepared in two steps, I
once prior to implantation and the second after implantation, therefore, parts (i) and (ii) must each be signed and dated by an authorized user. There is no requirement that parts (i) and (ii) be contained on the same or separate forms.
The staff believes that in such an example the failure to sign twice has minor safety significance, provided that the documents comprising the written directive are prepared and reviewed by an authorized user at the l
proper times.
2.
Total Source Strenath:
The definition of written directive, specified in 10 CFR 35.2(6)(11), "for all other brachytherapy" requires, in part, that, after implantation, but before completion of the procedure, "the total source strength and exposure time (or, equivalently, the total dose)" be specified.
It is common practice to use nominal source strength when describing the activity of the sources when planning a therapy procedure. However, since the actual source strength is required to accurately determine the total dose, licensees must use the actual source strength and exposure time if the total dose is not specified.
3.
Use of Rance of Doses:
Some licensees prescribe a range of doses or dosages when preparing written I
directives, especially for therapeutic use of 1-131 sodium iodide or for manual brachytherapy.
Historically, NRC inspectors have not cited licensees for the use of prescribed ranges because prescribing a range of doses or dosages was not a violation of any NRC requirement, and was the standard of practice.
However, the " Quality Management Program and Misadministrations" rule (QM rule), which became effective on January 27, 1992, requires that byproduct material be administered as directed by an authorized user.
If a range is used on a written directive, the responsibility for determining the exact dose or dosage for the administration falls on the individual administering the treatment, who is frequently not the authorized user.
Therefore, although a range of doses or dosages may be clinically acceptable for a given treatment, a single value must be specified on the written directive.
If the authorized user makes a decision to revise that dose or dosage, the written directive must be modified in accordance with 10 CFR 35.32(a), footnote 1.
4.
Overall Treatment Period:
A question has been raised as to whether a range is acceptable for the "overall treatment period" (e.g., eight to 10 weeks) on a written directive for teletherapy administrations.
In the Statements of Consideration for this provision, the Commission stated that:
"the phrase 'overall treatment period' was added to emphasize that the treatments will end after the specified number of weeks, unless the treatment period is revised by the authorized user prior to continuing."
4 1
b 3
The overall treatment period may have to be adjusted due to a patient's adverse reactions, a missed appointment by the patient, or other reasons.
However, it is necessary to include the overall treatment period on the written directive to ensure that treatmer.ts are not administered more or less often, discontinued, or extended over a longer period of time than intended, without the involvement of the authorized user.
Therefore, a range is not acceptable for the overall treatment period.
5.
Sianature:
Section 35.32 requires that a written directive, signed and dated by an authorized user, be prepared prior to administration of certain specific applications of byproduct material. The staff believes the common practice of physician authorized users to initial, rather than sign, the written directive meets this requirement.
6.
patina:
The authorized user must date the written directive at the time of signature.
This date attests to when the written directive was signed, and not to when the treatment is to be administered.
Contacts: Sally L. Merchant, HMSS 415-7874 or Patricia K. Holahan, NMSS 415-7847
b MEMORANDUM FOR: Those on Attached List DATED November 7,1994
SUBJECT:
GUIDANCE ON REQUIRED ELEMENTS OF A WRITTEN DIRECTIVE AS DEFINED IN 10 CFR 35.2 Charl as W. Hehl, Director Divi :on of Radiation Safety and Safeguards, RI J. Philip Stohr, Director Division of Radiation Safety and Safeguards, RII i
William L. Axelson, Director Division of Radiation Safety and Safeguards, RIII Samuel J. Collins, Director Division of Radiation Safety and Safeguards, RIV Frank Wenslawski Materials Branch, Walnut Creek Field Office /RIV b
l i
i i
I
\\
J