ML20137R745
| 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:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230638 | |
| Download: ML20137R745 (16) | |
Text
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NRC REGION 1 TECH PGMS BR.
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9 WC 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
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to radiation for the purposes of nedical diagnosis or medical
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.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-
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!I fore appropriate that Part 35 provide standards for protection q
kj of visitors, patients receiving materials, other patients, and ancillary personnel who cono in contact with patients containing is y
.p' byproduct $saterials.
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Protection of the patient receiving radioactive material through quality assurance procedures.
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Confirmation that the delivered dose 10 the name as the 9
prescribed dose is obtained by using a dose calibrator.
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(Technetium-99m W
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(2)- Test each dose calibrator for accuracy upon instal-k
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1stion and at least annually thereafter by assaying 9,il il['
at least two sealed sources containing different radionuclides whose activity the manufacturer has de-w
~ termined within'5' percent ~of'ite-stated activity, and Yt gd
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whose activity is at least 10 microcuries for radium-226 1
.or 50 microcuries for any other photon-emitting radio-f}
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$g, nuclide; and at least 1 millicurie of a low-anargy,
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to.5 h photon-emitting radionuclide.
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.2. Y he preecribed dosage should be recorded as well as the T
measured does.
Thus 35.53(c) should be modified to add _and Y
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$t renumber as follows:
i; b-9, (c) " Retain a record.of the measurements required by this
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section for two years.
To satisfy this requirement,.
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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
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(3)
Activity of the dosage prescribed by the authorized N
user; s
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(4)
Total activity of the dosags at the time of measure-ly ad 4,.
ment, or a notation that the activity is less than 10 fj microcuries; i
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Date and time of the measurement; and s.g Il l%
(6)
Initials of the individuals who made the measurement.
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Protection of visitors, other patients, and ancillary y
b start enrough radiation protection procedures.
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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
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lt4 of exposures expected to be encountered.
"fj should be modified to assure an adequate radiation source
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for testing:
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[4;3 (3)
Conspicuously note on the instrument the apparent ex-posure rate from a dedicated check source as determined i+
at the time of calibration, and the date of calibration;
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Perform calibration tests with radionuclide sources which
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Have activities or exposure rates at given distances
.dM traceable by documented measurements to a standard D-hI source certified to a National Bureau of standards P '
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calibration; and
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Have an exposure rate at, 20 centimeters sufficient 3st m
to cause a full scale deflection on the highest Mt scale calibrated.
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Contaminat[onmeasurementsare)u
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not meaningful unless expressable in units of activity and the minimum de-j;
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tactable activity is below the level at which contamina-t 5!
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
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M seceptable standards for contamination.
35.70 should
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be modified to add a new 35.70(s):
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(3)
The iteensee shall have and maintain radiation yj detection equipment with sufficient sensitivity to detect 0.001 microcuries of removable contamination.
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y iPC REGION 1 TECH PG1S BR.
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The licenses shall retain a record of each survey _
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The record must include the'date ~ of
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_y the action level established for each area, the
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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
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used to make the survey or analyse the samples, and 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, k.
aseessary to control exposure of other patients and L.
hospital emplopens to concentrations of radioactive t
i materials.
Because of 10 CFR 20.107, some confusion 4
~ 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:
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,t 35.205 Control of aerosols and gases.
'o st (a)
The licenses who administers radioactive aerosole, bvs1[iile~ compoun{ds, or asses shall do so with a system if I
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that will liait dispersal of the byproduct material to maintain concentrations of airborne activity within
,d concentrations prescribed pursuant to the regulations a
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in Part 20 of
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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.
aP (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
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surrounding areas.
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The licenses shall test the operation of the collection or exhaust systes at least semi-annually.
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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
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h concentrations in excess of Part 20 limits.
It has been 4
0 past practice to allow entry into the patients room by
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visitors and staff provided certain precautions were taken.
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@d Straight forward applications of Part 20 stight be un-
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reasonable in this case.
Therefore, Part 35 should be sore L
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b explicit than currently proposed.
35.310 should be modi-
?bf; fied as follows to provide adequate standarde while q?
permitting necessary access to the patient:
itM 35.310 safety instruction.
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(a)
The licensee shall provide oral and written radiation safety instructions for all personnel caring for the 9
n patient undergoing radiopharmaceutical therapy.
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satisfy this requirenant, the instructions must describe t
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procedures fort i
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Fatient control, including:
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All patients treated with 1-131 or Au-198 will e
i be placed in a private room that has a toilet; 4
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Patients will remain in bed while visitors are O in the rooms and ya 9\\
(iii)
Fatients will be confined to theirroomsexcept[)
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for special medical or nursing purposes approved i
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by the Radiation Safety Officer.
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Visitor control, includingt
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P.09 NRC REGION 1 TECH PGPiS IR.
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An entry by the Radiation Safety Officer or his and-ofp} sting ~o n' j
designee in the patient's chart p
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If the patient's doop indicating at what distance and tt 9
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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 hl over until the patient no longer presents a radiation hazard.
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(3)
Contamination control, including:
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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.
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Disposable plates, cups, eating utennile, tissue,
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surgical dressings, and other similar vaste itens
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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-
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tion, and disposed of as normal or radioactive vaste, an."
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appropriate.
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(iii)
Nondisposable items used for these patients will be bald b C
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in plasti'c base in the patient's room and will be chechef
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tRC REGION 1 TECH PGMS BR.
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for contamination by the Radiation Safety Officer or his }
1 designee.' Items may be returned for normal use, held for 4 e
di 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 -
f the sanitary sewer system.
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patient is reassigned to another 1,
Before a therapy m
patient, the room will be surveyed for contamination and 4
b decontaminated if necessary. 4 CGt7th "f
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Waste control, including:
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patient, all radioactive waste and waste containers will b.10 removed: and
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Stored wastes will be shielded to maintain exposure to pe sonnal as low as reasonably achievable.
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NatificAtton of the radiation safety officer in case of the f
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i patient's death or medical emergency.
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Similar potential for exposure to radiation levels exists for patients, y 4
vicinityofpatientsundergoingbrachytheray'J{
nurses and visitors in the t,i Thus, 35 410 should be modified to include explicit precautions not i
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necessarily covered by Part 20:
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gl 35.410 Safety instruction.
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The licenses shall provide written radiation safety instructions
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- i to all individuals carius for the patient undergoing brachytherapy.]v To satisfy this requirement, the instructions must describes
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Sise and appearance of the brachytherapy sources, including:
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(1)
Instructions to never touch needles, capsules, or con- / l M
tainers holding brachytherapy sourcest o
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(ii)
Instruction that it' a source becomes dislodged, forceps and put it in the corner of the room or in the
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shielded container provided; contact Radiation Therapy, 4
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the Radiation Safety Officer, or the Muclear Medicine g
g Department at once; y
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Procedures for patient control, including 11&,
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All patients treated with brachytherapy sources will
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has a toilet; e
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(ii)
Yhese patiente must etay in bed unless orders to l
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In any event, patients will
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remain in their assigned rooms.during the treatment M.
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L (3)
Procedures for visitor control, including
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(i)
Exposure rate measurements will be taken at 3 feet [)
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t (or 1 m) from the patient with sources implanted, at i
f the patient's bedside, at 3 feet (or 1 m) frca the j'J k
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bed, and at the entrance to the room. (The Radiation qP; i
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howlongaperson'mayrema,in}at these r-J O
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., post these times ind the exposure rate at 3 feet (or i
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(ii)
Visitors will be limited to those 18 If over unless other instructions are noted on the pre-e a
L' caution sheet on the patient's chart; gg{y &
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Procedures for notification of the Radiation Safety F
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Officer in case of the patient's death or medical if emergency.
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inT II.-The proposed ALARA program does not explicitly require that recommendatione
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35.30(c)(2) should be modi ~ )
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fled to reads
?fs (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; 4NMCM [ M' CMW77 individual sud collective doses. M4
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- 1. A m'ajor purpose of the revision to Part 35 is to eliminate amendments 3
chich can be covered by regulations.
Although the Commission has directed physician qualifications be reviewed, current practice is to approve physi-hj
~44 cians for procedures for which they have been previously approved on an fk 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 Uk i.
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3 h5 (b)
Before the licensee permits anyone, except a provisional authorized user A
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'descrf. bed in paragraph 35.34, to work as an authorized user under the licensal a*r 35.34 Provisional authorised user.
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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
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license if:
(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 iNd an institution, the institution's Radiation Safety Committee; f'
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The licenses has a copy of a commission or Agreement State 3i 7
license that lists the provisional authorised user an an ifO b6 authorised user for human uses and 4
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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,
f[i; authorising provisional use described in paragraph (a) of this section.
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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
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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 h
with any amendment request otherwise required by 35.17 of this
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4
'.M onlyadministrationof/f V. Tho proposed. requirement to use syringe shields covere radiation desa 4 o radiopharmaceutical to a patient.
Studies indicate that the (p
asgreath' to the hande from drawing up the radiopharmaceutical dose is at least 9
cc the radiation dose for administration.
Therefore, 35.60(b) shouldbemodih 4g' ficd to raadt 8
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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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P.16
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35 16(d)(1) should be modified to indicate " Material Licensing "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.
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35.16(d)(2) should be modified to place a "," after " Material Licensing if Section".
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35.17(f) is too broad to be meaningful.
Needs to be rewritten.
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