ML20003C472
| ML20003C472 | |
| Person / Time | |
|---|---|
| Issue date: | 02/13/1981 |
| From: | Nussbaumer D NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Tefft D NEW HAMPSHIRE, STATE OF |
| References | |
| NUDOCS 8103060190 | |
| Download: ML20003C472 (8) | |
Text
- e t>0 GV fo, UNITED STATES
['
i NUCLEAR REGULATORY COMMISSION 4;
WASHING TON, D. C. 20555 j
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FEB 131961 Ref: SA/ LAB Ms. Diane E. Tefft, Manager q[k@/ /
Radiological Health Program
'p /((
Division of Public Health Services
/)g QU,Q Department of Health and Welfare A
State Laboratory Building s g Hazen Drive, P.O. Box 148 y *'4 CBgO p
/S g 7 A b 3 Concord, New Hampshire 03301 m
Dear Ms. Tefft:
4
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52N This is to confirm the com.ents made to you y ~., r tt at the conclusion of the rt:ent radiation control prog s.
Based on the results of the review, the staff believes that the New Hampshire program for control of agreement materials is adequate to protect the public health and safety and is compatible with the NRC's program.
While no significant problems were found in any program area during the review, we believe that improvements can be made in the program.
Specific comments and recomendations are enclosed.
I would appreciate your review of our recomendations and receiving your comments on them.
I appreciate the courtesy and cooperation extended to Mr. Bolling during the meeting.
Sincerely, a a/ h.
k n os-.
Donald A. Nussbaumer Assistant Director 1
for State Agreements Program Office of State Programs
Enclosure:
As stated cc:
Dr. M. Mires J. Stanton 8,108060 80
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-t COMMENTS AND RECOMMENDATIONS ON THE f
I NEW~ HAMPSHIRE RADIATION CONTROL PROGRAM t
I.
Licensing.
Licensing Procedures is a Category _jI Indicator.
I The following minor deficiency was noted.
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A.-
Comment
}
A review of program licensing procedures and discussions with I
i program staff indicate the need for developing supplementary i
licensing guidance for license reviecers.
Recommendation We recommend the development of internal licensing guides. These guides will help to assure that uniform and up-to-date licens-ing practices are followed. New licensing guides will also aid in the training of new staff.
Licensina.
Licensino Actions is a Category I I dicator. The 4
following minor deficiency was noted.
.i B.
Comment
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A review of selected license files indicates that greater emphasis is needed on the use and performance,testina of dose calibrators.
Recommendation We strongly recommend that each medical applicant whether for initial license or renewal be required to have a dose calibrator.
The applicant should have step-by-step procedures for its use and calibration.
Each applicant should have a set of appropriate -
i check sources.
(See attachment) l Licensing.
Licensing Actions is a Category I In'dicator. The following minor deficiency was noted.
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A
_2 1
C.
Comment A review of selected license files. indicates that the training and experience of radiation safety committee members is not always adequately documented.
Recommendation We recommend that applicants be required to submi', training and experience data for each radiation safety committee member.
This information should be documented in the licensee's folder and updated as new committee members are added by amendment and during license renewals.
II. Compliance.
Independent Measurements is a Category II Indicator.
~
The following minor deficiency was noted.
i A.
Comment j
A review'of selected compliance files indicated that independent measurements were not performed during all compliance inspections.
1 Recomrenda tion We recommend that confirmatory measurements be performed during each inspection and that the results of such measurements be documented in the inspection report.
l Compli ance_.
Enforcement Procedures is a Category I Indicator.
The following minor deficiency was noted.
1 l
B.
Comment 1.
- l A review of selected compliance files showed the need for a more l-timely review of inspection reports and dispatch of enforcement 1
letters.
Recommendation 4
1 J
We recommend that inspection reports be reviewed and enforcement letters be dispatched within 30 days of the licensee inspection.
Compliance.
Inspection Frequency is a Category II Indicator. The following minor deficiency was noted, t-I
C.
Comment Th'e insoection priority schedule indication is that in-plant radiography is assigned to priority B-II.
This calls for inspections at 24-month intervals after an initial inspection at 8 months.
Recommendation We strongly recommend that in-olant radiography be upgraded to inspection priority I.
This would require yearly inspections with extensions to 18 months for licensees with favorable compliance histories.
This recommendation is based on the fact that in-clant radiography is as potentially hazardous as field radiograchy and that under NRC practice, industrial radiography would be subject to insoectior at a frequency of one Der year.
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APPENDIX D (Continued)
Section 2 METilODS FOR CALIBR ATION OF DOSE CALIBR ATOR*
AU radiopharmaceutieak must be assayed for activity to 3.
Calculate net activity of each source subcacting an xcuracy of 10 percent. The most common instrument for out background lesel.
accomphshm; this is an tenuatmn-t> pe dose calibrator. The morument must be checked tar accurate e;rration at the ne of inc Hation and ;'er:cd:cany the eatter a
For each source, plot net activity versus the day of the year on semdog graph paper.
Test for the feucmrg.
1 5.
Log the backgrou.d leve!x 1.
Incru men' constancy i J.n!> i 1
Istrument accuracy tat instaliation and annua??>
o.
Indicate the predicted activity of each source the reaf ter i based on decay calculations and the 25 percent limits on the graph.
3 frwir nent linearity tat mstaMation and quarterly therea f'e r )
7.
Repeat the procedure used for the Cs-137 source 4
Geo netncal sar:arion (at mstallatien) for all the commonly used radionuchde settmgs.
B.
Yter repair nr ad;utment of the Jose cabbrator, repeat 8.
Variations greater than !5 percent from the pre-au the appropr ate tests hsteJ above idependent upon dicted activity indicate the need fr. Instrument the nature of the repairst repair or adjustment.
C.
Test for instrument Ccnstancy 9
Investigate higher than normal background levels to determine their origin and to ehminate them
/csmmnt constancy mea is that there is reproduci-if possible by decontaminatton, relocation, etc.
[
bihty, within a stated acceptable degree of precision, in measurmg a constant activity over time. Assay at
! cast one relatively long-lived re4rence source such as D.
Inspect the instrument on a quarterly basis to ascertain Cs-13', Co-F," or Ra-226' us:ng a reproducible that the measurernent chamber liner is in place and geometry before each day's use of the instrument.
that instrument rero is properly set (see manufacturer's Preferably, at Ican two reference sources (for example, instructions).
-5 mci of Co-5 7 and 100-200 pCs of Cs-137 or 1-2 mg Ra 226 (w:th appropriate decay corrections) will be ahernated eash day of ase to test the instrument's E.
Test of Instrument Linearity performance oser a range of photon energies and source actnities.
The linearity of a dose calibrator should be ascertained over the entire range of activities employed. This test 1.
Assay each reference source using the appropriate will use a vial of Tc-99m whose activity is equivalent to instrument settin g (i.e., Cs-137 se tting for Cs-137).
the maximum anticipated activity to be assayed (e.g.,
the first elution from a new generator).
2.
Measure background les el at same instrument set-ting, or check that Jutomatic background sub-1.
Assay the Tc-99m vist in the dose calibrator, and traction is operating properly when blanks are subtract background level to obtain net tetivity inscrted in the cabbrator.
in millicuries.
see est N4:.u ses." Cat +ratian and Usase of Dose Cahnrator 2.
Repeat step i at time intervals of 6,24,30, and t*vati.m chamNrs for the Assa, or Madi.ineclides" (American Nai%f StandarJs Institu re. Inc.,14.10 Broadway. New York. N.Y.
48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> af ter the initial assay.
too n.
3.
Using the 30 hour3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> activity measurement as a start-Co.s7 and Ra-2:6 are not suiiect to NRC licenung: the respective ing point, calculate in: predicted activities at 0, s Ng"'rkis afen).
e, 24, and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> using the following table:
101 27 w
O D
9 dJu o
Ju n
Assay Time' /hr)
Correction Factor as in st.p 1. (Follow good radiation safety prac-tices to avoid contaminatton and to mimmize 0
31.633 radiation exposure )
6 15.853 24 1.995 3.
Select one volume as a standard (such as the 30 I
volume of reference standard useJ in performing
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48 0.126 the tot for m(trument accuracy), and calculate the ratio of memred aetnit.cs for each solume
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Example : If the net activity measured at 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> to the reference volume activity. 'Ihis represents was 15.625 mci, the calculated activities for 6 and the volume correction factor (CF).
48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> would be 15.625 mci x 15 853 = 247.7 mci and 15.625 mci x 0.126 = 1.97 mci, respec-Eumvic. It setnities of 2.04. 2.02, and 2.00 mci tively.
are measured for 4. 8. and 10 mi volarnes and 10 mlis the reference solum # selected.
4 On log 4cg coordinate caper, plot the measured net activity (for each time mterval) versus the 2.00 i
calculated activity (for the same time intervaD.
lume CF = g = 0.95 4 mi 5.
The activities plotted should be withm 15 percent of the calculated activity if the instrument is 4
plot the correction fastors against the solt....e on hnear and functionin*, proper!y. Errors greater hnear graph paWr. Use this paph to se!est the than + 5 percent tndic ate the need for repatt or proper volume correct:on factors for rouune
)
adjustment of the inst.ument assay of that radionuch "
6.
If instrument hneanty cannot be cor ected. it will 5.
The true activity of a sarnp;e is calculated as l
be necessary in routmc assays to use either(a)an follow s '
aliquot of the e!uate that - be accurately mea-sured or (b) the graph constructed in step 4 to True Act.vity = Measured Actatt> s relate measured activities to calculated activities.
Correction Factor I
F.
Test for Geometrical Variation where the correction factor used is for the same volume and geometncal configuration as the There may be significant geometrical vanation in activi-sample rneasured.
l ty measured as a function of sample volume or configu-ration, depending on tce volume and size of the ioniza-6.
Simdarly. the same acta tty of Co 5 7 m a synr x I
tion chamber used m the dose cabtrator. The cittent may be compared with that of 10 mlin a 30-ce geometrical vanation should be ascertuned for vial, and a correction tactor may be calcule!
l comr..only used radionuclides and appropnate correc-tio n factors computed if variations are sigmficant, i.e.,
7 It should be noted that d fferences of 200 percent j
g eater than 12 percent. (Even though correction fac-in dose cahbrator readmgs between glass and tors may be provided by the manufacturer, the accu-plastic synr.ges have been observed for lower-racy of these should be checked.)When available from energy radionucbdes such as ! 125 which shouh!
i the manufacturer. certified data on geometncal vana-be assayed m a dose cabbrator only if the reha-l tiens may be used in beu of these t'easurements.
bility of such an assay can be estabbsted. Glass tubes and synnges may also vary enou;h m thd.
i To measure vanation with volume of liquid, a 30 cc ness to cause sigmficant crrors m assaying 1125.
vial conaing 2 mci of Co-57 or other appropnate Hence adequate correcton factors must 1e radionuclide in a volume of 1 ml will be used.
established.
I 1.
Assay vial at the appropnate instrument setting.
An alternative to proviJmg synnge cahbratton and subtract background level to obtam net factors n to simply assay the stock vial l'etore activity.
and at'ter fillm; the s>Tmge The activity in the syrmge is then the difierence in the two readmgs to 2,4,8,10,20. and 25 mi by adding the arpro-
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Increase the volume of hquid in the vial m steps (with a vvlame correction if sigmficant) priate amount of water or saline. After each addi-G.
Test for instrument Accuracy 6
tion, gently shake vial to mix contents and assay Check the accuracy of the Jose calibrator for several l
radionuclides, incluJ ng Cs 137. Co-57, and Ba-133, i
Asnav times should be messared in whole hours and correction using appropriate reference standards whose activities rectors should he used to the third decimal place as endnaicJ. lhe hava beer calibrated by compansons with standard
'i more recent hair-bre or T
- 6.02 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> has been used in calculating these correction ractors. 3 /;
sourecs that hav e been assayed by N BS anJ documented.
10.8-28
'e-=
~-
= = ~ ~
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The actinty lesels of the reference sources used shou!d 4.
Repeat the above steps for other commonly used approumate those lesela normally cnsountered in chn-radionuchJes for which JJequate reference stand-teal use te g.. Co 57, 3-5 mdhcunes) giung adequate ards are sia:!able.
l attention to sourse configuration. IJentify in your apphcation the three sourses that you wdl use. State 5.
Keep a log of these cabbration checks.
nuchde, settury. and cahbration accuracy. The lower-energy refnence standards t Tc-99m, Xe-133, I l:5) 6.
Cahbration checks that do not agree within e
i must be in vials with the same thickness of glass as the
+ 5 percent indicate that the instrument should l
actualsamples to be r easured far best accuracy, be reptred or adjusteJ. If this is not possiMe, a l
cabbration factor should be calculated for use during routine assays of radionuchJes i
Astw the reference standard in the dose cahbra-tot at the arnrer : ate setting, and subtrJc! The 7
At the same time theinstrumentis beinginitially SackcrNnd h el to chtan the net activity.
calibrated at the bcensee's facthty with the refer-ence standards place a long hned source in the cabbrator, set the instrument, in turn, at the vard 2.
Repeat sier I for a totalof 3 determinations, and ous radionuclide settings used 4Cs-13 7,1131, neace redn.
Tc 99m,1125, etc.), and record the readings These values may later be used to check instru-ment cabbration at each setting faf ter correcttng 3-The ner :e uta tt) determined in ster shou!J for deca) of the long-hsed source) withcut re-agree w:th the cert:fied actiuty of the reference quiring more reference standards. Keep a log of source witi;n 2 5 rercent af ter decay corrections.
these initial and subsequent readings I
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CALIBRATION OF DOSE Call 8RATOR A
Sources Lsed for Lineanty Test i
(Check as app,ropnate)
First elution from new \\to 99/Tc 99m generator i
or Other' (specify).
I B.
Sources Used for Instrument Accaracy and Constaney Tests I
1 1
Sug;est ed i
Radionuclide h t n tt, ( mCil Ltivay i mci)
L t. ra, >
Co-5 7 35
{
l Ba l33 0 1 0.5 Cs-l 3 7 0.1 0.2 i
Ra 226 1-2 i
C.
The proced ares desenbed in Section 2 of \\ppenda D will be u,1 tor calibrat:en of the Jose cahtrat or or Equnalent procedures are attached.
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l e rne licensees ho are not authorised for w-90/Tc em generainrw acieviiy musi 8, equ,..i nr io rne n,;nes u rivii usea.
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