ML20137R745

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Forwards Matls Sent to Regions,For Comment,Re Human Use of Licensed Matl
ML20137R745
Person / Time
Issue date: 12/29/1983
From: Glenn J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To: Mcelroy N
NRC
Shared Package
ML20136D915 List: ... further results
References
FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230638
Download: ML20137R745 (16)
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NRC REGION 1 TECH PGMS BR. P.02

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- I. Human use of licensed material is distinct from other licensed 1l uses since 10 CFR 20.107 provides that nothing in Part 20 should y v

be interpreted as limiting the intentional exposure of patients $f 1

to radiation for the purposes of nedical diagnosis or medical .J

.11 therapy. 10 CPR 20.204(b) modifies the requirenants for posting and controlling high radiation areas because of patients con- @,..

.M taining byproduct material provided that personnel in attendance M will take the necessary precautions. 10 CFR 20.303(d) provides 3 i

that excreta from individuale undergoing medical treatment is f

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exempt from the disposal requirements of Part 20. It is there- ]

!I fore appropriate that Part 35 provide standards for protection ';

q of visitors, patients receiving materials, other patients, and kj y ancillary personnel who cono in contact with patients containing is

.p' byproduct $saterials.

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.3 A. Protection of the patient receiving radioactive material through quality assurance procedures. {

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1. Confirmation that the delivered dose 10 the name as the 9 prescribed dose is obtained by using a dose calibrator.

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~U' The accuracy of this instrument should be determined for f4 the energy and activities most often used. (Technetium-99m W h

g in the millicuria range). Thus 35.50(6)(2) should be modi- *]

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-NRC REGICN i TECH PGMS BR. P.03 r,

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(2)- Test each dose calibrator for accuracy upon instal- k

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1stion and at least annually thereafter by assaying 9,il il at least two sealed sources containing different

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radionuclides whose activity the manufacturer has de-w

~ termined within'5' percent ~of'ite-stated activity, and Yt +

whose activity is at least 10 microcuries for radium-226 gd 1

.or 50 microcuries for any other photon-emitting radio- j f}

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nuclide; and at least 1 millicurie of a low-anargy, $g,

-[( to .5 h photon-emitting radionuclide.

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6-if /inuu} ad cam /amo( are ok, su nadf ln'I' l

.2. YThe preecribed dosage should be recorded as well as the . .$,

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measured does. Thus 35.53(c) should be modified to add _and renumber as follows:

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< 9, (c) " Retain a record.of the measurements required by this 'I' l p -:

section for two years. To satisfy this requirement,. y 3'

W the record must contain the:

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(1) Generic name, trade name, or abbreviation of tha )!

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radiopharascautical, its lot number, and expiration 4' date 1e (2) Patient's name, and identification number if one has y been assigned; j l3 g4.

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NRC REGION 1 TECH PG1S BR. P . 0,4 3

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(3) Activity of the dosage prescribed by the authorized user; N s

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(4) Total activity of the dosags at the time of measure- ly ad ment, or a notation that the activity is less than 10 4,..

microcuries; fji

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.d (5) Date and time of the measurement; and jj s.g Il l (6) Initials of the individuals who made the measurement.  %

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3. Protection of visitors, other patients, and ancillary y b .

nospital start enrough radiation protection procedures.

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1. Radiation measuring instruments should be tested to d assure function and accuracy. Survey instruments must 91 he tested against known radiation sources in the range [

lt4 of exposures expected to be encountered. 10 CFR 35.51(b) 3:

"fj should be modified to assure an adequate radiation source 'S d

for testing: I+ *

(3) Conspicuously note on the instrument the apparent ex- [4;3  !

posure rate from a dedicated check source as determined i+

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at the time of calibration, and the date of calibration; +y

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NRC REGION 1 TECH PGMS DR. P.05 C'

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'(4) Perform calibration tests with radionuclide sources which y:j

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(1) Have activities or exposure rates at given distances .d M

traceable by documented measurements to a standard D-hI P'

source certified to a National Bureau of standards calibration; and E "U A ' "7 '""

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n G h.x h e> w. /h & a u vdA hs (ii) Have an exposure rate at, 20 centimeters sufficient 3st m

to cause a full scale deflection on the highest M t

scale calibrated. .

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2. Contaminat[onmeasurementsare)u .

not meaningful unless ,

expressable in units of activity and the minimum de- j; tactable activity is below the level at which contamina- }!

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f tion becomes significant. Medical licensees have been 5

observed in the past to count contamination wipes in a P

dose calibrator with a minimum detectable activity of 3 1 microcurie. Part 20 has almost no guidance on /

M seceptable standards for contamination. 35.70 should :r a !s be modified to add a new 35.70(s): 4

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(3) The iteensee shall have and maintain radiation , ,

y detection equipment with sufficient sensitivity to j detect 0.001 microcuries of removable contamination. .h

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y iPC REGION 1 TECH PG1S BR. P.06

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11 (h) The licenses shall retain a record of each survey _

{ -I for one year. The record must include the'date ~ of if

.the survey, a plan of each area that was surveyed, y b

< the action level established for each area, the '/

measured exposure rate at several points in each -

staa expressed in milliram per hour or disintegra- '

tiene per minute, the model number of the instrument ';i

[ < used to make the survey or analyse the samples, and fl.I g

-'p' the initials of the individual who performed the h',

cyo survey.

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3. Control of aerosols, volatile compounds, and gases i s,
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aseessary to control exposure of other patients and hospital emplopens to concentrations of radioactive i materials. Because of 10 CFR 20.107, some confusion t

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any result about the applicability of 10 CyR 20.103 ,

and 20.106 to byproduct material administered to 1 patients. 35.205 should be modified to explicitly

. y require compliance with these regulations: S

,t 35.205 Control of aerosols and gases.

The licenses who administers radioactive aerosole,

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I bvs1[iile~ compoun{ds, or asses shall do so with a system if o- r~m n _u ; -aw i .

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.a that will liait dispersal of the byproduct material to (

maintain concentrations of airborne activity within

,d concentrations prescribed pursuant to the regulations ,

a in Part 20 of this chapter.) phin :J Ni a J.LM4f V'

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(b) The system must either be directly vented to the atmosphers j

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through an air exhaust or provide for collection and decay ';)

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or disposal of the aerosol or gas in a shielded container.

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(c) The licensee shall maintain rooms or areas in which radio-

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active aerosols. (vola tile compounds 3 or gases are adminis-

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tered to patients at a lower relative pressure than ('1 surrounding areas. s _; , a c

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P (d) The licenses shall test the operation of the collection or exhaust systes at least semi-annually. ,4 , ; P h F

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4. Nurses, visitors and other patients in the vicinity of q patients receiving charapoucic doses of radiopharma- fj i.

cauticals witi likely be exposed to radiation icvels and ,[

h concentrations in excess of Part 20 limits. It has been 4 0

past practice to allow entry into the patients room by .j M

visitors and staff provided certain precautions were taken. .

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reasonable in this case. Therefore, Part 35 should be sore ,

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NRC REGION 1 TECH'PGMS BR. P.08

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explicit than currently proposed. 35.310 should be modi-

?b fied as follows to provide adequate standarde while f; permitting necessary access to the patient: q?

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35.310 safety instruction. N}

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(a) The licensee shall provide oral and written radiation safety instructions for all personnel caring for the n 9

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patient undergoing radiopharmaceutical therapy. To @ f v

( satisfy this requirenant, the instructions must describe t i v procedures fort i j

(1) Fatient control, including
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, (i) All patients treated with 1-131 or Au-198 will e

f be placed in a private room that has a toilet;  ;

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Patients will remain in bed while visitors are O (ii) in the rooms and y a

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(iii) Fatients will be confined to theirroomsexcept[) ,y I for special medical or nursing purposes approved i

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by the Radiation Safety Officer.

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I (2) Visitor control, includingt

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NRC REGION 1 TECH PGPiS IR. P.09 1 Ja, b f,4 (1) An entry by the Radiation Safety Officer or his  ;

j designee in the patient's chart and-ofp} p sting ~o n' i __ ~., f~" M[

If the patient's doop indicating at what distance and 9 tt -

[ how long the visitor may remain in the room; and (

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(. (ii) Visitors will be limited to those 18 years of age or [1..

over until the patient no longer presents a radiation hl hazard. j 4 h

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(3) Contamination control, including: 3 F .4 j ;5 p

/ gj (1) All linens will be surveyed for contamination

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before being removed from the patient's room and,

, [ a)u if necessary, will be held for decay. t k' I d I, f '

Disposable plates, cups, eating utennile, tissue, 5

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(ii)

[hg d W surgical dressings, and other similar vaste itens h

' will be placed in a specially designated container.

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] The material will be collected daily by the Radiation

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Safety Officer or his designee, checked for contauina-

"i w tion, and disposed of as normal or radioactive vaste, an ."

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( appropriate. i ol i M

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, 1 (iii) Nondisposable items used for these patients will be bald b C y

( in plasti'c base in the patient's room and will be chechef

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tRC REGION 1 TECH PGMS BR. P.10 9 t f

for contamination by the Radiation Safety Officer or his } <

1 designee.' Items may be returned for normal use, held for 4 e di ,

g decay, or decontaminated, as apprcyriate.

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g (iv) If urine and' vomitus from I-131 therapy patients are col-lacted, they will be stored for decay in the radioactive q h

/ waste storage area. Such stored wastes will be re'tained Pis' until they have reached background levels, as ' measured vi a low-level survey meter. They will than be released to -

the sanitary sewer system. 4.

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!(v)' Before a therapywypatient w Qig's room.vw is reassigned to another 1, m

patient, the room will be surveyed for contamination and b

4 decontaminated if necessary. 4 ,

(4) Waste control, including:

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p p_( )7Before a therapy patient's room is reassigned to another ..

patient, all radioactive waste and waste containers will b.1 0

removed: and

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, Fg Stored wastes will be shielded to maintain exposure to pe h(ii) sonnal as low as reasonably achievable. I b>hy/!b) th 5Y *YO (5) NatificAtton of the radiation safety officer in case of the f latt'c6Ab' h m

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patient's death or medical emergency. j d.: .d,.

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5. Similar potential for exposure to radiation levels exists for patients, y 4

, nurses and visitors in the vicinityofpatientsundergoingbrachytheray'J{

t ,i Thus, 35 410 should be modified to include explicit precautions not i t Ji i necessarily covered by Part 20: p

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35.410 Safety instruction. gl N

., (a) The licenses shall provide written radiation safety instructions .

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-i to all individuals carius for the patient undergoing brachytherapy .]

7 To satisfy this requirement, the instructions must describes v &

n< q (1) Sise and appearance of the brachytherapy sources, including: h R

, (1) Instructions to never touch needles, capsules, or con- / l tainers holding brachytherapy sourcest Mo

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J (ii) Instruction that it' a source becomes dislodged, use long )3 forceps and put it in the corner of the room or in the ,3

.w 1r shielded container provided; contact Radiation Therapy, f A 4

Py the Radiation Safety Officer, or the Muclear Medicine g g ,

Department at once; y 1

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,Tr 11 (2) Procedures for patient control, including

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(i) All patients treated with brachytherapy sources will ~}i 2

has a toilet; e

  • 'b' be placed in a private ro /ca that 0 L /u

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nn nul./7./bca/k%).,;N.

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l t (ii) Yhese patiente must etay in bed unless orders to N1g de fe7 /n d&AlaMd In k-

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the cont'rary are written. any event, patients will  %

remain in their assigned rooms.during the treatment . f*

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period;-+ 61V&tt $fVY*.</ld]lMububJafl'ru l'ungsff syrmdWCAAh,, "

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- a L (3) Procedures for visitor control, including  ?

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.% y (i) Exposure rate measurements will be taken at 3 feet [) h 1

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(or 1 m) from the patient with sources implanted, at i the patient's bedside, at 3 feet (or 1 m) frca the j'J k rw / O

( bed, and at the entrance to the room. (The Radiation qP; h

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-k Officer or his designee will then determina p

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) howlongaperson'mayrema,in}at these positionsandwilig kr-J O

., post these times ind the exposure rate at 3 feet (or i !g :

N m) from.the pation the patient's chart; [

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i (ii) Visitors will be limited to those 18 years of ese or /*'(

over unless other instructions are noted on the pre-Ife a '

L' caution sheet on the patient's chart; gg{y &at (4) Procedures for notification of the Radiation Safety F [

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tRC REGION 1 TECH PGMS FR. P.13 ,

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'; y Officer in case of the patient's death or medical d if emergency. {'?

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II.-The proposed ALARA program does not explicitly require that recommendatione 'I

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to reduce exposure be made known to management. 35.30(c)(2) should be modi ~ )

fled to reads f.

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(2) A requirement that~the Radiation Safety Officer brief management once each W"

year on the byproduct material program and present to management any recouy[i u

,y q mandations generated as the result of the annual review which might reduceb; individual sud collective doses. M4 #A

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1. A m'ajor purpose of the revision to Part 35 is to eliminate amendments chich can be covered by regulations. Although the Commission has directed

)43 physician qualifications be reviewed, current practice is to approve physi- hj

~44 cians for procedures for which they have been previously approved on an f k

NRC or Agreement State license. $

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ly It is recommended that the visiting authorised user authorisation be expandedg Z

to cover any physician previously authorized on another license. The authorist 3

eser list would only be updated when an amandment is otherwise required by U k

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NRC REGION 1 TECH PGMS BR. p,14

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5 (b) Before the licensee permits anyone, except a provisional authorized user A -

'descrf. bed in paragraph 35.34, to work as an authorized user under the I licensal a

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35.34 Provisional authorised user. lj h

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(c) A licensee may, permit any vig$ ting or newly hired authorized user to

  • use licensed material for human use under the terms of the licensee's .Id license if: tll (1) The provisional authorised user has the prior written permission p v

of the licensee's management and, if such use occurs on behalf of iN d

an institution, the institution's Radiation Safety Committee; o f' (2) The licenses has a copy of a commission or Agreement State 3i 7

license that lists the provisional authorised user an an if O

authorised user for human uses and b6 4 g

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(3) The provisional authorised user performs only those proca-  %

dures for which the provisional authorised user is specifically Ifl authorised by a Commission or Agreement State license. ] ,

N (b) .The licensee need not apply for a license amendment 4, authorising provisional use described in paragraph (a) of f[i; this section.

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tHC REGION 1LTECH PGMS BR. P.15

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i (c) The licensee shall retain for.two years after provisional

, use is terminated copies of the records hpecified in para- p f.

. graph (a)(1) of this section and of the licenso specified }{

in paragraph (a)(2) of this section.

(d)' The licenses shall submit the names of provisional authorised b M

users added' to the medical staff along with tha license number Ik of the Commission or Agreement State license that lists the y, ~

provisional authorised user as an authorised user for human umE with any amendment request otherwise required by 35.17 of this h

.N Part. 4

'.M V. Tho proposed. requirement to use syringe shields covere onlyadministrationof/f o radiopharmaceutical to a patient. Studies indicate that the radiation desa(p4 to the hande from drawing up the radiopharmaceutical dose is at least asgreath' 9

cc the radiation dose for administration. Therefore, 35.60(b) shouldbemodih 4

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-(b) The licensen shall require each individual who draws or administers a ti radiopharmaceutical by injection'to use a syringe radiationshieldunlesaffj the use of the shield is contraindicated for that injaction.

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NRC REGION 1 TECH PGMS ER. P.16

ih A. 35 16(d)(1) should be modified to indicate " Material Licensing .(M "4j .

.section" rather than " Material Program Section No. 2". Although I:n iQ no such section exists, it is descriptive enough to assure correct Y1

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distribution of applications and will not require a @ change to the If

$5 regulations everytime a reorganization takes place. y, '

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$N B. 35.16(d)(2) should be modified to place a "," after " Material Licensing '

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C. 35.17(f) is too broad to be meaningful. Needs to be rewritten. il a

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