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DEC 101985 j,J, L,
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- MEMORANDUN FOR: John G. Davis, Director Office of Nuclear Map)erial Safety f
a nd Safeguards
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Richrd E. Cunningham, Di h-tor 4
Divillon of Fueltycle anddaterii 'M(ety t
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SUBJECT:
QUALITY ASSURANCE AND PENALCIES F0, JEGLIGENCE t
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'In our discussions during. the week of December 1,31$8hyouaskedabout, 1
imposing immediately effective requirements for, medical licensees to l
prevent misadministration.
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The staff's preliminary review in(icatgqht ceFtrA1 quality assurance
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requirements few medical procedure; en y3 mposed A, nn immediately i
. effective finaT rule as discussed,-D the Enclosure The requirements' would
, lqqsan the chance'of therapy misirJministrations ano provide 'a basis for e9forcemart actions.
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u evelm a Federal Register not' ice centaining.an immediately l
effectivegrith, Nd shamit'c'i; to theformissioned with the. Advance Notice of Propoka' Pulemaking t8at has been Weveloped ingrespeise to the staff requirements memora The. immediately effective rule will be coordinat#)ys ti on this tppic.Ah appropriate staff offices and the Advisory on Nedical Uses 'of hotopes on g expeditedpsis.
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4 Richard E. Cunninghsrn f.
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Richard E. Cunningham, Director Division of Fuel Cycle and
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Enclosure:
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ENCLOSURE
.IMMEDIATELY EFFECTIVE REQUIREMENTS FOR QUALITY ASSURANCE Introduction Radiation therapy isL comprised of several functions where error may occur.
The staff has identified certain functions where additional regulations might help to assure. error-free performance. They are as follows: 1. referral and prescription; 2. treatment planning; 3. recordkeeping; 4. physical measurements of radiation sources; and 5. physical measurements of applied dose.
The staff believes that the following quality assurance regulations can be o
implemented without requiring licensees to acquire new capital equipment or provide new training for employees. Small licensees may have to make new business arrangements to comply with the provisions that require independent checks of calculations.
l Although drafted as cuality assurance requirements, these regulations would.
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. provide a basis for enforcement action in many therapy misadministration events.
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'Some regulations would be of general (G) applicability--they would apply)to l
brachytherapy (B), or radiopharmaceutical therapy (R)y to teletherapy (T,
all types of radiation therapy.
Some would apply onl l
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APPLICABILITY FUNCTIONS AND REQUIREMENTS REFERRAL 10 PRESCRIPTION l
G The authorized user shall assure that the patient to be treated has;been correctly identified and has been referred for radiation therapy.
G The authorized user shall write the prescription and changes on the patient's chart. The authorized user shall not make prescriptions or changes orally, or write them in a place other than the patient's chart.
G The prescription must clearly identify the body part to be treated.
- T The prescription must clearly identify the teletherapy unit to be used, the total tumor dose, the number of ports to be used, and the fraction to be delivered from each port.
B The prescription must clearly identify the sources to be used and the total tumor dose.
R The prescription must clearly identify the radiopharmaceutical to be used, the activity to be administered, and the route of administration.
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Radiation Therapy 2
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'f; l3 TREATMENT. PLANNING TB
.i The licensee shall check calculations for accuracy bifore; 20% -
of the prescribed dose has been adeiinistered..
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Manual' calculations must be independently checked by an individual who did not make the calculations.
Computerized calculations must be checied;.,anua,).1
, )y for accuracy of the. dose given to a single point in the treatment field by an individual who did not select the computer program to be used for the cese at harid, or efiter the patient data into the computer.
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RECORDKEEPING G
Entries must be legible.
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T Arithmetic entries that are made daily trust be checked ke.ekly.
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PHYSICAL MEASUREMENTS OF RADIAlION SOU3CES The teleherapy physicist shall measure t!ys. change in output caused by T
wedges, compensators, trays, and other accouterments during the annual calibration.
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The brachytherapy physicist shall measure the. source strength of sources before first use and annually thereafter. For sturces manufactured by lots, a sample way be selected rather than measuring each source.
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The tie.ensee shali Yprify that the correct radiopharmaceutical is R
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on hand and sht,71 tieasure the amount of radioactivity in the dosage 1
before a' ministeririg it.
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',s PHYSICAL MEASUREMENT OF APPLIED DOSE
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> l/If tiie field size, field contour, or source-to-skin' disdie.e j fall outside the range of those normally used by trA l$densee, X '.l #' A
.the licensee shall make a physical measurement of the' dose O
rate to be. applied to'the patient.
It must be made before
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more than TP4 of the treatment dose has been administered.
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