ML20082C665
| ML20082C665 | |
| Person / Time | |
|---|---|
| Issue date: | 06/30/1991 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| NUREG-BR-0117, NUREG-BR-0117-N91-2, NUREG-BR-117, NUREG-BR-117-N91-2, NUDOCS 9107220210 | |
| Download: ML20082C665 (11) | |
Text
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U.S. Nuclear Office of Nuclear NUREGlBR-0117 Q
Regulatory Material Safety No.91-2 Commission and Safeguards June 1991 E
i i
REVISED 10 CFR PART 20: NiiW DOSE 1.lMITS (i) The total effectise dose equivalent being egnal to 5 rems (0.05 Sv); or (ii) 'lhe sum of the deep-dose equivalent and the This article is the second in a senes that will discuss the committed dose equivalent to any mdwidual important changes in radiation protection standards organ or tissue other than the lens of the eye made by the sweeping revisions in the new 10 CFR being equal to 50 rems (0.5 Sv).
Part 20. The revised Part 20 was published in the Tcdcral Register on May 31,1991.
(2) 'lhe annual hauts to the lens of the eye, to the sum, and to the extremities, which are:
The revised Part 20 eliminates the use of the quarterly dose limits and the use of the cumulative hfettme dose (i) An eye dose equivalent of 15 rems (0.15 Sv), and limit of 5(N-18), w here N is the worker's age in years. No lifetime dose limit is specified. Under the old 5(N-IS)
(ii) A shallow-dose equivalent of 50 rems (0.50 Sv) t the skin or to each of the extremities, limit, the unused portion of the dose limit (the difference between 5 rems and the actual dose receivea) became Special Considerations part of a " dose bank" that could be drawn on in later years (at a rate of up to 3 rems per quarter or 12 rems per y ear).
,tdjustments to Dose Paramerces. The revised Part 20 pro-This " dose bank " which is inherent in an age-prorated vides additional flexibihty for estabhshing more accurate formula, does not exist with the straight annual limit. If dose controls. It allows the use of actual particle-size the worker's exposure is under the 5-rem annual dose distributions and physiochemical characteri.stics of air-limit, there is no way to recapture the difference for use in borne particulates to defmc site-specific derived air-future years. Consequently, the average annual dose (for concentration limits. With N RC approval, these modified the more highly exposed woikers) associated with the re-concentration limits can be used in lieu of the general val-vised Part 20 is expected to be less than under the former ues in Appendix 11. Although these adjustments might rule.
permit higher airborne radionuclide-concentration limits I
When annual occupational limits in the revised Part 20
("
are compared to existing limits, note that the conceptual the same.
differences are probably more important than the nu-merical differences. T he major conceptual dtfferences in-Embryo / Fetus. The limit for the embryo / fetus of a de-clude:
clared pregnant woman is 0.5 rem oser the entire gesta-
" E#
"" F (1) summation of internal and external doses when re-tion, the woman must declare her pregnancy in writmg to 4" #
her employer and request it. The revised Part 20 also ad-minishes licensees to avoid substantial variation above (2) use of the committed effective dose equivalent for internal exposures, rather than the " critical organ" the average monthly exposure rate that would comply approach; and with the 0.5 rem limit. These conditions are consistent with the Federal guidance on occupational radiation ex.
(3) wider sele +. tion of methods for estimating radio, posure and with the recommendations of the National nuclide intakes and internal doses.
Council on Radiation Protection and Measurements (NCRP), in NCRP Report No. 91.
The dose tiinits in the revised Part 20 for the occupational dose La individu6s (excluding planned special expmures)
Occuparmnal Dase Limits for Minors. The annual occupa-are:
tional dose limits for minors are 10 percent of the annual dw limits specified for adult workers. Minors are indi-(i) An annual limit, whichever is the more lim.tmg of viduals under age 18.
9107220210 9' G
PDR Nur EG BR-0117 1 M
Plmmed 5 wial Droswes. 'the planned special eyvsure JUNE 19A NhtSS LICENSEli
/
NEWSLETI'ER CONTl!NTS (PSl!) permits workers to receive doses, acwunted for se;urately f rorn the annual dose limits, in special circum-1%c stances 'the dose allowed in any year from a planned spe-cial exposure is $ rems. A hfetime total limit from 1.
Revised 10 CFR Part 20: New Dose planned special ex;osures of 25 rems is also included in Limits (Contact: Cynthia Jones, the new Part 20. Under this new provision for PSEs, a 301-492-0613)..
I worker could possibly receise a 10-rem dose in 1 year:
5 rems from a planned special ex;usur e and 5 rems from 2.
The Radiography Cross-Reference routine operations. 'this is roughly equivalent to the System (Contact: Steve flaggett, 12 rems (3 rems! quarter) that could be received under 301-492-0542) 2 the pruent Part 20 limits. Once a licensee decides to con.
duct a planned special exposure, unique hmitations, re-3.
Regulatory Guides issued February 1, porting, and recordkeeping requirements apply, even if 1991-hiay 31,1991 (Contact: Paul the doses actually recen cd fall within the dose limits for Goldberg,301-492-0631) 3 routme operations.
Dose Limits to Mem!cs of the Pubhc 'the dose limit for ual mem en o the puMc was redud to M rem n
199 hi
,1 n 1:
ul Goldberg,301-4924)631) 3 P7'"
- u ""'
intended to be applied as a long term average goal;it is an annual limit. It applies onis to the dose produced by the
~
5.
Public Availabihty of Documents licensed facdity, rather than a sum of all doses to a mem-Submitted to the Nuclear Regulatory ber of the public.
Commission (Cantact: Kevin Ramsey, 301-492-0534) 3 A licensee can apply to the Nuclear Regulatory Commis-sion for permission to operate at a limit of 0.5 rem for a 6.
Information Notices Pubbshed February 1, limited penod. One group that this tem;urary higher 1991-June 7,1991 (Contact: Paul Goldberg, limit applies to is licensees with dealed source irradiation 361-492-0631) 3 facihties (e.g., teletherapy) that were designed to meet the older hmit; the temporary higher limit would allow 7.
Selected Signihcant Event 3 Reported to th m to keep operating while they were conductmg stuJ.
the U.S. Nuclear Regulatory Commission ies of uw, mupancy, and actual dose rates in unre-(Contact: Kathleen Black, 301-492-4495) 5 stncted areas, to determme whether they could meet the lower revised hmit, or w hether additional modifications should be made.
8.
Significant Enforcement Actions Agamst h1aterials Licensees (Contact: Joe The limit of 2 milbrem m any I hou, in an unrestricted Delmedico, 301-492-0739) 8 area has been reinstated in the revised Part 20, to provide a short-term Incasurable limit.
9.
Update on National hiixed-Waste Profile (Contact: Chad Glenn,301-192-0567).
10
- 10. NRC and EPA Distribute Information to Licensees That Generate hiixed Waste Due to the nature of radiography and its associated (Contact: Nick OrlanJo, 301-492-0566),
10 health and safety risks, it i3 crucial w hen heensing indus-Inal radiography sources and desices that these units be approved and be compatible with presious inodels. Im-proper matching between 'imts can lead to various me.
Comments, and suggestions you may have for infor.
chanical problems, allowmg the possibility of severe ra-mation that is not currently being included, that diation overexposure to indiviJuals.
might be helpful to licensees, should be sent to:
The Nuclear Regulatory Commission has developed a E. Kraus pC-based program to manage and manipulate radiogra.
Nh1SS Licensee Newsletter Editor phy source and device data. Version 1.01 of the program Office of Nuclear h1aterial Safety and Safeguards provides a cross-reference system of known compatible One White Flint North, hiail Stop 6-E-6 stems. The program provides a search displayed on the U.S. Nuclear Regulatory Comrmssion monitor only, as well as assorted pnntout options. The Washington, D.C. 20555 program requires any IliN1 compatible system having DOS 2.0 or higher, one floppy dnve and a hard dove with 2
l 1.7 hibyte of free disk space, a monitor, and a minimum of PUllLIC AVAll ABILITY OF DOCUhtEN'IS 200K free memory, A laser or dot matnx pnnter is re-SUllhtflTED TO Tile NUCLl!AR Rl!GUI ATORY quired to use the program's printout options.
COhthilSSION (NRC)
For additional information on the program, or to obtain 1 icensees should remember that all documents submit.
the program, please contact the following:
ted to NRC will be made available to the public, with cer.
tain exceptions. These exceptions include classified data, Scaled Source Safety Section trade secrets, and personnel and medical files, the disclo-hiedical, Academic, and Commercial Use sure of w hich would clearly constit ute an unwarranted in-Safety 13 ranch vasion of privacy.
Division of Industrial and hiedical Nuclear Safety, NhtSS Please be aware that any documents you send to N RC will U.S. Nuclear Regulatory Commission normally be made available for public inspection. We rec-Washington, DC 205$5 ommend that you not include in any submittal trade se-(301) 492-0540 crets or personal information about your employees, vn-less the information is directly related to radiation safety or specifically required by NRC For example: (1)lnfor.
REGULATORY GUIDES ISSUED FEllRUARY 1.
mation submitted on training and experience of employ-1991-ht AY 31,1991 ces should be limited to that related to radiation safety;
( ) H nw a um and home tdephone numbers DR AIT GUIDF" should be submitted only if they are part of emergency
- "htaterial Control and Accounting for Ur:nium En-proecdures; and (3) Dates of birth, social security num-bers, and radiation dose information should be submitted richment Facilities Authorized to Produce Special Nuclear hiatenal of low Strategic Signtficance" only if specifically required by NRC.
1.
Issued 2/91 If you do submit trade secrets, proprietary information, or personal information that you want withheld from 2.
Contact:
Don Joy, 301-492-0352 public disclosure,you must request withholding in accor-dance with the procedure specified in 10 CFR 2.790. Fail-un to Mow h pnicedun may n wit in diwlomre of RULEh1AKINGS PUllLISif ED FEllRU ARY 1, the information to the public and/or substantial delays in 1991-hiAY 31,1991 processing your submittals. Using labels such as "confi-FINAL RULES dential or "restocted" will not guarantee that your docu-ments will be withheld.
e " Access Authorization Fee Schedule for Licensee Personnela Please note that any request for withholding is subject to D
1' Published 2/14/91 actually be withheld in accordance with applicable laws and regulations. Questions may be directed to your h-2.
Contact:
James Dunleavy,301-492-7343 censing office.
"ASNT Certification of Industrial Radiographers" e
1.
Published 3/19/91; correction published 5/1/91 INFORNIATION NODCES PUlllJS1IED 2.
Contact:
Bruce Carrico,301-492-0634 Note that these are only summaries of information to
" Change in Commercial Telephone Number for tices. Information notices are automatically sent tolicen.
e Region V see catepones to which they pertain. If a notice appears 1.
Pubhshed 4/26/91 relevant to your licensed operation and it has not been received, we recommend that you obtain the notice or 2.
Contact:
David L Meyer,301-492-7086 speak with a Nuclear Reputatory Commission (NRC) contact about its provisions.
PROPOSED RULE A. Recent Safety-Related incidents at large Irradia-tors-IN No. 91-14, dated h1 arch 5,1991 e " Revision of Fee Schedules,100% Fee Recovery" Technical
Contact:
Sus;m 1 Greene,301-492-0686 (Superseded by final rule approved by Commission and (to be) published in mid July )
Tius notice rennnds irradiator licensees of the potential 1.
Published 4/12/91 for large irradiators to dehver life-threatening radiation doses when safety and secunty systems are bypassed or 2.
Contact:
James llolloway, 301-492-4301 preventive mamtenance programs are ignored. Licensees 3
should review this information with all facility workers services at nuclear facilities, proper engineering and and radiation staff,The notice describes an incident in Is-maintenance of the design basis become significant.
rael and an incident in El Salvador in w hich workers died i
as a result of bypassing safety and security systems and not D. Accidental Radiation Overexposures to Personnel following safety and operating procedures when equip, Due to industrial Radiography Accessory Equip.
ment malfunctioned.
ment Malfunctions-IN No. 91-23, dated March 26, 1991 Technical
Contact:
Cynthia G. Jones,301-492-0629 B. Unmonitored Release Pathways from Slightly Contaminated Recycle and Recirculation Water This notice informs licensees of recent radiography inci.
Systems at a Fuel Facility-IN No. 91-16, dated dents involving both extremity and whole4)ody overexpo-March 6,1991 sures of radiographers. 'Ihese occurred as a result of:
Technical Contacts: Susan S. Adamovitz, 404-331-4774 (1) not surveying a radiographic exposure device and Edwin D. Flack,301-492-0403 source guide tube after each exposurc; or (2) using cither a magnetic or non magnetic stand for applications that This notice alerts addressees to potential prob! cms re-applied stresses exceeding the limits of the stand. These sulting from using runoff water and process effluents, events, which are described in this notice, illustrate: the both contaminated with radioactive materials, in non.
failure to carry out radiation surveys after the retraction nuclear processes. A fuel facility used recycle water, ob.
of a scaled source; failure to personally supervise an assis-tained in part by collecting rain water from roof and storm tant radiographer while radiographic-exposure devices sewer drains contaminated by particulate fallout from ef.
are in use; the use of a magnetic or non magnetic stand fluent discharges, for non contact cooling of plant sys-not built to bear the weight of the intended equipment tems, the fire protection system, sanitary facilities a gnt (e.g., a 12 pound collimator); the necessity of consistently blaster, and gaseous effluent scrubbers. The licensee following standard operating and, w hen necessary. cmcr-failed to evaluate either the processes that used recycle gency procedates; and the need to understand the signifi.
water or the release pathways from the recycle water sys-cance of radiation doses that result from the misuse of tem, that released excess water dunng heavy rain storms.
large radiographic sources.
This resulted in unmonitored releases of radiaactivity by several pathways.
E. Potential Nonconservative Errors in the Working.
Fonnat llansen Roach Cross-Section Set Provided with the KENO and SCALE Codes-IN No. 41-26, This notice reminds licensees that they must make sur.
veys to ensure compliance with 10 CFR 20.301, which de.
dated Apnl 2,1991 Technical
Contact:
Robert E. Wilson,301-492-0126 scribes authorized means of disposal of licensed material in waste, and must make surveys to ensure compliance
.this n tice alerts beensees to potential problems result-with 10 CFR 10.106, which limits the yearly av erage con-ing fmm ems in a common calculational method used in centration of radioactive material in air or water dis-the support of criticahty safety. These errors coulo r esult charged to unrestricted areas.
in nonconservative calculations forming the bases for enticality safety hmits and practices. Because the C. Fire Safety of Temporary Installation or Services-
"workmg format" or " stand-alone" Hansen Roach neu-IN No. 91-17, dated March 11,1991 tron cross-section data set distributed with the KENO Technical
Contact:
D. J. Nelson,919-457-9531 and SCALE codes was not intended for safety calcula-tions, known errors had not been cotrected.The set has, 11u.s notice alerts licensees to the fire hazards that may however, been widely used to support enticahty safety, A arise because of madequate engineering design and su' corrected version of the data is now available, and users pervisory control of electrical and mechanical systems have been notified, through newsletters, of the errors.
temporarily installed to support operational or mainte-The use of the " working-format" data set may have led to nance activities. A fire in the personnel access airhick be' a large number of enticahty safety evaluations that are tween the Unit i reactor building and the drywell at the sif,nificantly nonconservative. User reviews of these Brunswick Steam Electric Plant was caused by the over-evaluations for continuing operations would ensure that heating of electrical cables from the combined effects of adequate safety margins are retained.
excessive current and insufficient heat dissipation. The fire spread along the cables to just inside the drywell. Nu-F.
Inadequate Calibration of Thermoluminescent merous cables, hoses, and other lines passing through the Dosimeters Utilized to Monitor Extremity Dose at restricted space to permit maintenance and repair work Uranium Processing and Fabrication F'acilities-during a refueling outage reduced the ability of the elec-IN No. 91-30, dated April 23,1991 trical cables to dissipate heat and also seriously hampered Technical Contacts: George Kuio,404-331-2560 efforts to extinguish the fire. He licensee and the NRC John Potter,404-331-5571 staff concluded that the temporary services passing througn the ai.rlock were not properly engmeered. In NRC discussions with uramum processmg and fabnca-view of the magnitude and complexity of some temporary tion licensees revealed that the licensees were monitor-ing extremity dose through the use of single chip 4
thermoluminescent dosimeters (TLDs) mounted in plas-dimensions spectfically designed to prevent criticality of tie finger rings.Thc TLDs w e:e supplied and processcJ by its fissile matenal contents. An unfavorable geometry vendor laboratories. In resps nse to NRC inquiries, one tank can be used, however,if the amount of fissile mate-heensee made independent calculations of the dose rate rial is kept below that needed to achiese enticahty.)
from unshielded uranium, which revealed that the dose rates calculated on the basis of information supphed by liighly concentrated uranium solutions m an adjoinmg the vendor were low by a factor of approximately 2.The part of the proecss were available m quantities that were vendor informed the licensee that TLDs were cabbrated more than sufficient to have caused a enticahty acadent with a cesium-137 source. The necessary correction fac-m the unfavorable geometry tank. 'the hydrostatic head tor for converting from cesium based dose to uramu+
assocuted with those highly concentrated solutions based dose had not been applied, accounting for the low er would have forced those solutions mto the unfavorable dose values. A beta-correction factor of approximately 2 peometry tank if normally closed valves were faulty or was required, and higher dose values were r,ubsequently were not fully closed.
assigned to personnel handhng unciad uramum materi-als, in using TI.Ds for extremity momtonng, hcensees I illmg of storage tanks with liquid waste fiom the sohent should venfy that the appropnate correction factor for estraction system m the high ennched uranium recovery the different TLD response between uranium and the process began on November 27,1990. When the tanks calibration source is used.
were full and the contents mixed, the contents w ere sam-pled. An analysis on Nosember 28,1990, showed the ura-nium concentration to be below the authonzed discard hmit.
O labchng Requirements for Transportmg Multi.
Ilazard RaJioactive Materials-IN No. 91-35, dated June 7,1991 On November 30,1990, another sample showed the ura.
Technical Contacts: J. R. Cook, 301-492-0458 nium concentration to be abose the authorized discard K. M. Ramsey, 301-492-0534 hmit. 'the beensee reported the incident to the Nuclear Office of flazardous Materials Regulatory Commission (NRC) NRC inspectors pet.
Transport, Depacmem of formed a special team mspection.
Transportation, 202-3604488 The licensee identified the probable causes of the Nc This notice mforms licensees of the U.S. Department of vember 28 esent as:(1)less than adequate pipmg laywt Transportation (DOT) requirements for labeling pack-that allowed uranium solutions to flow into the unfas ages containing hazardous matenals that meet the defini-able geometry tank, and (2) operators who had no knowl-tion of more than one hazard (e.g., radioactive and poi-edge of the potentul for crossoser of highly ce emrated son). A licensee was found to have labeled its uramum solutions mto unfavorable tanks as e result of multi hazard packages only for the radioactn e hazard and open vahes or other anomahes in the piping systems.
not for the additional hazard. DOT regulations require that packages be labeled accordmg to their pctmary hab NRC concluded that there appea, to be other root ard and, unless they meet the defmitions for small quanti-causes m addition to those given by the hcense melud-ties, they must also be labeled for secondary hazards, ing:
(1) A less than adequate safety basis for the plant be-SliLECTliD SIGNIFICANT EVENTS REPORTl!D cause a documented safety analysis was not available, TO Tile U.S. NUCLEAR REGULATORY COMMISSION (2) Equipment important to safety was not properly identified, protected, emphasized m plant-control documents and trainmg sessions, tested and main-Event 1: Sigmficant Degradation of Plant Safety tamed appropnate to its safety function, and did not at Nuclear Fuel Services, Inc., in Erwm.
Mw positive closure mdication.
I e-assee Date Report;d: November 28, lWO (3) The system drawmgs lacked adequate detail.
Licensee: Nuclear Fuel Services, Inc.
Correctne actions included modificatian of the pipmg Erwin, TN s) stem to present highly concentrated utamum solutions from flodng into the unfavorable geometry tanks. A re-Nuclear Fuel Services, Inc., personnel discovered that view of the fuel recosery facthty was imtiated to identify 395 grams of uranium-235, contained in hquid waste, had the nuclear safety features and controls for each unfavor-been pnicessed through the waste water treatment sys-able geometry vessel. A Nuclear Criticahty Safety Per-tem for collection and disposal of the uranium. This quan-formance improvement Program, which had been insti-tity was above the admmistrative enticahty safety hnut of tuted before the meidat, was accelerated and expanded 350 grams for the unfavorable geometry tanks used to to address the niot causes. Traming was also given to fuel hold the waste. (A favorable geometry tank is one havmg recovery personnel, to make them aware of the problem.
l 5
A full-time resident inspector reportcJ for duty at the fa-patient for bypothyroidism and for breast and thyroid cility on April 22,1991.
- cancer, This misadministration, caused by modifying (mcreasmg i
hiedical IAgnosGe hiisadmmistration the dosage of) the intended diagnostic procedure because Event 2:
of discussion between the physician's assistant and the Date Reported: January 24,1991 nuclear medicine technologist, was not reviewed by or ap-proved by the patient's actual physicianJihe physician,in Licensee: Ilutrel llospital f act, desired the thyroid seem procedure, using the lower Detroit, hiichigan dosage.
The licensee notified NRC Region til that a medical diag-An NRC inspection determined that the hospital had not nostic misadministration had occurred at its facility en provided trammg m the proper ordering and administra-January 17,1991, when a patient was administered a dos-tion of radiopharmaceuticals to mdividuals working un-age of iodine-131 that was 100 times greater than pre-der the supervision of a physician designated on the NRC scribed.
license.
On January 16.1991, a 37-year-old female patient (who the hospital adopted nc* precedures, requiring specific had given birth to a baby 2 days cather) was scheduled to "PP"*^I by an authorized physician, before the oral ad-have a thyroid scan to determine if she had a goiter be-mmistration of more than 50 microcuries ofiodine-131.
neath the breastbone. The licensee's normal procedure This authoruation is to be obtained immediately before for such a thyroid scan usually involves a6ninistration of a the planned admmistration. lhe hospital also reaffirmed 50-microcurie dosage of iodine-131, with a resultmg thy-that the technologist and physician's assistants are not roid dose in the range of 50-70 raJs. The prescription for permitted to change an order given by an attending physi-the procedure was prepared by a physician's assistant, at C33"'
the direction of the referring physician. 'lhe nuclear medicine technologist subsequently discussed the proce-dure with the physician's assistant and questioned whether the thyroid scan was the appropriate pmecdure.
1hent 3: hiedical Therapy hitsadmmistration The technologist indicated that a whole tody scan, to
- 1) ate notified: February 1,1991 identify thyroid tissue throughout the tuly, would be the appropriate test. The physician's assistant agreed and lxensee: Washington llospital Center submitted a new order for the whole body scan.
Washington, D.C.
'lhe iodine-131 was administered to the patient on Janu-On February 1,1991, NRC Region I was notified by the aty 17,1991, with the whole-body scan performed on licensee that a therapy misadministration involving a January 18,1991.'Ihe whole-body scan used 5 millicuries teletherapy unit had occurred at its facility earlier that of iodine-131,instead of the 50 microcuries used for the day.
diagnostic procedure actually prescribed by the referring physician.
A 74-) ear-old patient was to has e received 250 rads to the brain, for cancer treatment. 'the technologist identified Before administering the iodme-131, the technologist the patient; however, using the wrong chart, the tech-determined that the patient was not breast feedmg her nologist proceeded to set up to 5.0 centimeters by 6.5 cen-baby and did not intend to breast-feed. Some direct radia-timeters field size and initiated treatment of the patient's tion exposure was received by the baby because of the larynx. The thyroid of the patient was not blocked from presence of the iodine-131 in the mother's body. This ex-exposure to the teletherapy beam. While the patient was posure was estimated to be only approximately 0.5 milli-undergoing treatment to the larynx, the technologist real-rads, because the baby was with the mother for just a ized that the wrong organ was being treated and termi-30 minute period, because of the mother's medicci prob-nated the patient treatment. It was estimated that 57 rads lems. After the misadministration was discovered, con-were delisered to the larynx, and about the same to the tact between the mother and baby was restricted for 2 thyroid. After termination of the larynx treatment, the days, to avoid further radiation exposure to the infant.
patient was given the proper treatment of 250 rads to the brain.
NRC retained a medical consultant to evaluate the cir-cumstances of this case. The consultant estimated that the technologist exammed the wrong chart without veri-the patient received a dose of approximately 6500 rads to fying the name on the chart or the picture of the patient her thyroid.This exposure would carry a shghtly increased on the chart. No patient treatment area markers, such as risk of the patient developing hypothyroidism or thyroid tattoos, were used.
ccmccr. Because the patient was lactating, there would also be an increase in the patient's nsk of breast cancer.
An NRC medical consultant noted that there were no The consultant recommended periodic monitoring of the acute symptoms and that there should be no long term 6
medicalimplications during the expected lifetime of the A radiotherapy physician prescribed a therapeutie dosage l
- patient, of 10 millicuries of iodine-131 to a patient with hyperthy-toidtsm. 'lhe physician who was familiar with the patient was not able to administer the therapeutie dosage and livent 4: Medical Therapy MisaJmmistration asked another physician to administer it, in the mean-time, a transporter, while reviewing the patient transport Date notified: February 22,1991 requests, noted that the patient was listed as being in a 1icensee; Ilahnemann Unhersity Ilospital bed that she believed was occupied by a different patient.
Philadelphia, PennsTivania
'lhe transporter notified the nuclear medicine secretary to check into the discrepancyJihe sectetary referred to a On l'ebruar3 22,1991, NRC llegion I was notified by the patient hst for the patient's name, noted the area of the licensee thai a therapy misadministration had occurt ed at hospital where the patienti room was, and changed the its facility during the period from February 14 to 18,1991, request form.The secretary did not know that there were w hile a patient was undergoing radiation therapy for a tu.
two patients in the hospital with the exact same names.
l mor in the ese.
(lhe second patient was m the hospital for a lang condi.
tion.) Also, the secretary diJ not know the computer pro-A radiotherapy physician presenbed a therapeutie dose of gram that generated the patient list did not print entries 30,000 rads to the base of the tumor and 14,300 rads to the fordupheate names.~lhe name of the patient who was to apex of the t umor from a custom designed iothne-125 eye undergo treatment for hyperthyroiJ8m was not printed plaque. 'the staff physicist who designed the eye plaque on the hst, informed the radiotherapy physician that a dose of 30.000 rads would be delivered to the base of the tumor and
'lhe physician who aJministered the dose picked up the 9,925 rads to the ;.pex over 127A hours. This treatment request form and the iodine-131 dosage from the No.
plan was acceptable and agreed upon. While the physicist clear Medieme Department and went to the nursing sta-was designing the eye plaque and calculating the antici-tion on the fhior of the patient with the lung problem.
pated dose, he changed to an eye plaque with a ddferent
'lhe physician did not mform the nursing staff that he was radius of curvature. ~lhe physicist changed the coorJi about to admmnter a therapeutie dosage to one of their nates for placement of cach ioshne-125 seed used in the patients and went to the lurg panent's room. There, he plaque, but failed to change the points for calculation of asked the patient his name and senf ed the name on the dase to various depths within the c)e.
wnst band, but Jid not cross-check the patient numberon the wnst band with the panent number on the request On I ebruary 18,1991, the physicist suspected that an cr-form. The physician completed the request form and re-ror had occurred whde planning a treatment for another turned the patient folder to the nurses' station. Within 5 patient with a siraJat tumor. At that pomt, he retrieved minutes of the admmistration of the radiopharmaceuti-patient data lrom the computer for the treatment started cal, the nurses dneovered the error anJ mformed the on February 14,1991, reviewed the data, and confirmed physician anJ the RaJianon Safety Officer. The licensee that an trror had been made. The panent's eye plaque admimstered a thyroid bhick 7g agent immediately, with was then remos ed..At that time, a total of 99.25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> had three subsequent dmes, each. given at 4-hour mtervals.
elapsed since the begmning of the treatment, resultmg m a total treatment dose of about 59,000 raJs to the base of the licensee determmed that the thyroiJ of the patient the tumor and 19,500 rads to the apex of the tumor. ihe receised an uptake of between 80 and 100 micnieuries of beensee stated that the dose received by th, yorwas iothne-131, givmg a possible dose of between 112 and 140 within acceptable medical treatment protocols f or that rads. An NI(C methcal consultant, who resiewed the type of tumor, and that no acute effects were obsened in es ent, concurred with these figures The licensee aJvised the patient.
NRr that no aJserse elfects were anucipated dunng the hfetime of the panent, as a result of the imidministra-An NRC consultr't stated that there was an mcreased uom nsk of long term aJserse ef fects (e p, cataract, tissue damage).
The event was attnbuted to fadure to follow the hospital protocol of checking the patient idenuhcation number, thent 5: M edical 'I h e ra py M isad mirnst rat ion and fadure to mform the fhior head nurse about the Date nottfied: March 28,1991 1.icensee: Clara Maass Medical Center The licensee's planned conectne action meludes estab-Hellevdle, New Jersey hshmg a check ist that must be completed by individuals admtrustenng therapeutic dosages Other acuons melude
'the beensee mformed NRC Region I that a therapy mis-chanping the computer program so that all the mforma-admmistration, insoh mg admirnstranon of iodme-131 to tion is prmted out on the patient lot, and s emstruction to the wrong patient, had occurrcJ on Match 21 personnel on patient senficanon pn(edures.
1 7
Event 6: hiedical Therapy hiisadministration dures for use of this computer to generate patient-Date notified: July 26,1989 SIGNIFICANT ENFORCEh1ENT ACrlONS
_ Agreement State AGAINST N1NIERIALS LICENSEES Licensee:
Good Samaritan hiedical Center Phoenix, Arizona One way to avoid regulatory problems is to be aware of enforcement probf ms others have faced.hus, we have On July 26,1989, the licensee reported to the Arizona neluded here a discussion of some representative ~ en.
Radiation Regulatory Agency (State Agency)a series of forcement actions against materials licensees.These en-three misadmmistrations invohing the use of a cobalt-60 forcement actions include civil penalties, orders of vari-teletherapy unit in the licensee's Radiation Oncology De*
ous types, and notices of violations.
partment.
4 The three patients received exposures of approximately 14,11, and 12 percent greater than the prescribed doses 1.
C & R I aboratories, Pearl City, llawaii of 6200 rads,6480 rads, and 5000 rads, respectively, from Supplements V and VII, EA 89-101 an AECL Theratton-SG unit containing 5,529 curies of cobalt 40 assayed on September 16,1988. A beam._
A Notice of Violation and Proposed Imposition of Civil correcting wedge had been used, along with a treatment.
Penalty was hsued to emphasize the importance of mak-planning computer, Although the computer already con-ing proper surveys, creatmg accurate records, and prop-tained a wedge-correction factor, the technologist and erly supen-ising part time and temporary employees. A dosimetrist added a second wedge-correction factor, after former part time employee failed to conduct required ra-checking with the consulting physicist and being told that diation surveys of an exposure device, willfully created a wedge factor would be required.
false records to make it appear that the surveys had been performed, and failed to properly post the van used for While preparing to treat a fifth patient assigned the same storage. An Order blodifying 1.icense was issued formal-treatment protocol, a point hand calculation indicated a ipmg the licensee's commitment not to use the radiogra.
wide discrepancy when compared to the computer-P.her without nottfying the Nuclear Regulatory Commis-generated treatment time. This discrepancy led to a com-ston (NRC).
prehensive search of past cases, which revealed the three 2.
McCallum Testing laboratories, Inc., Chesapeake, overexposures out of four possible cases.
Virginia All three patients showed signs of skin crythema (redden-Supplement VI. EA 90-183 ing) and the first two patients (who had received radiation A Notice of Violation and Proposed Imposition of Civil to the larynx region) reported hoarseness and pain on Penalty was issued to emphasize the importance of com-swallowmg. The licensee stated that these symptoms are ply ng with regulatory requirements associated with h-not unusual for patients undergoing radiotherapy, and, in cense conditions.nere was failure to control a moisture fact, these same symptoms were mentioned to the pa.
density gauge that was unsecured and in a truck lent to a tients as possible side effects of the treatment.
non employee who left it unattended and running. De
"" E 4" * #'" "" "'
A consulting physicist was retained to review patient rec-ords and the hospital's handling of this case. Among the 3.
hiuskogee Regional Medical Center, hiuskogee, findings were:
Oklahoma Supplement VI, EA 90-212 (a) De hospital staffing level was inadequate for the pa.
A Notice of Violation and Proposed imposition of Civil tient k>ad.
Penalty was issued to emphasize the importance of strict (b) There was a loss of continuity in physics services, with adherence to procedures related to radiation safety, the the departure of one physicist and the hinng of an.
importance of effective oversight, and the importance of
-other physicist.
lasting corrective actions for these weaknesses. Thera-peutic misadministration resulted in radiation therapy
-(c) There was poor cominunication (documentation) on treatments being administered to the wrong side of a pa-the use of the computer-generated treatment plans.
tient's neck. The licensee's corrective actions were The licensee has hired a full time quahfied therapy physi-cist and a technical administrator. These individuals will 4.
Newman hiemorial 1lospital, Shattuck, Oklahoma not have responsibilities outside the therapy department.
Supplements IV and VI EA 94106 All computer-generated treatment plans will have point A Notice of Violation and Proposed Imposition of Civil hand calculations to verify the computer readings. Proce-Penalty was issued to emphasize the importance of 8
radiation safety program management and compliance any NRC-licensed activities on behalf of the licensee, with radiation safety requirements. 'lhere were 10 viola-pending further authorization by NRC. 'lhe assistant ra-tions demonstrating a lack of attention to NRC require-diographer apparently received a serious overexposure to ments by the radiation safety officer and a lack of manage-his right hand and was hospitalized. It seemed that he ment oversight by the Radiation Safety Committee.'the failed to perform a radiation suncy to confirm that the base civil penalty was escalated 100 percent because of source had returned to the shielded position before he NRC identification of the violations and a lack of prompt approached the source, and the radiographer had failed and comprehensive corrective actions after the initial to supcivise him.
NRC inspection.
9.
University of Wisconsin-Madistm, Madison, Wisconsin 5.
Process Technology North Jersey, Rockaw ay, New Jersey Supplements IV and VI, !!A 90-098 Supplements IV, VI and Vil, li A 89-80 A Notice of Violation and Proposed imposition of Civil A Notice of Violation and Proposed Imposition of Ccvil Penalties was issued to emphasize the need for compli.
Penalties was issued to emphasize the importance of u.
ance with NRC regulatory requirements and the licen, suring that: (1) heensed activities are conducted safely see's radiological safety procedures.~lhete were failures and in accordance with the conditions of the license; to have tramed operators present on two occasions while (2) deficiencies, when they exist, are promptly identified treating patients with the high dose-rate afterloader, to and corrected; and (3) all information communicated to verify treatment time calculations on 35 occasions (one NRC it both complete and accurate.1here was a viola.
of w hich led to a therapy misadministration), and to have tion involving inaccurate and incomp!cte statements by a second person Cfy 35 treatment plans (one of which the licensee's staff and violations that represented a sig-led to a therapy misacannistration). One of the civil pen-nificant lack of attention to and carelew "ss toward li-allies was escalated WO percent because NRC identified censed responsibilities by supenisors ad managers the associated violations and because there were multiple (most of whom were subsequently removed by the licen-examples.
see).
- 10. Veterans /\\dnunistration Medical Center, Allxmy.
NC* YO'k 6.
Radiology-Ultrasound-Nuclear Consultants. PA, Supplements IV and VI. EA 40-209 Freehold. New Jersey Supplement VI, liA 9041 A Notice of Violation and Proposed impos; tion of Civil A Notice of Violation and Proposed Imposition of Civil Penalty was issued to emphasite the importance of ade-Penalty was issued to emphasi/c the need for increased quate management attention to and oversight of the and improved attention to the licensee's radiation safety radiation safety program, including pmper oversight of program, to ensure that activities were conducted safely the Radiation Safety Officer.
and in accordance with the terms of the license. The base civil penalty was escalated 100 percent based on NRC H. Severity lxvel til Violation, No Civd Penalty identtfication of the violations and because the licensee's corrective actions were neither prompt nor comprehen-1.
Stuart Circle llospital, Richmond. Virginia sive.
Supplements IV and VI, EA 91-010 7.
Sequoyah Fuels Corporation, Gore, Oklahoma A Notice of Violation was issued because of violations in.
E A 90-162 solving the improper transfer of NRC licensed material to an ut, authorized individual. The incident, identified s
An Order Modifying 1icense was issued, requiring that and reported by the licensee, involved the alleged theft of the licensee characterize the site, take actions to prevent a lixiscope device from the facility. A civd penalty was not further releases of contaminated water, and conduct ap-issued because the licenser identified and reported the propriate monitoring of ground water. The Order was incident and because of good past performance.
t based on concerns that uranium-contaminated water sceping from underneath the main pmcess building might 2.
Union Carbide Chemicids and Plastics Company, have been contaminating ground water and the environ.
Inc., Sisterville, West Virginia ment, in the plant's unrestricted area.
Supplements IV end IV, E A 91-013 A Notice of Violatioit was issued because of a violation 8.
Tumbleweed LRay Company, Greenwood, insolving the misdignment of a 37-millicune cesium-137 Arkmsas E A 1 L 210 scaled-source holder with an open shutter. A civil penalty was not proposed because the hcensee identified and re-An order Modifying l xensc was issued to prohibit a rade portcJ the mcident and because of good past perform-ographer and an assistant radiographer from engaging in ance.
9
UPDATE ON NATIONAL MIXIiD-WASTli waste is waste that satisfies the Radioactn e Waste Pohey PROFILE Amendments Act of 1985 and contains hazardous waste that is either: (1) hsted as a hazardous waste in 40 Cl R The U.S. Nuclear Regulato.y Commis>ica (NKC) and Part 261, Subpart D; or (2)causes the waste to exhibit any the U.S. Environmental Protection Agency (l!PA) are of the characteristics identified in 40 Cl R Part 261, Sub-sponsoring a joint study to compile a national profile on part C.
the volumes, characteristics, and treatability of commer-cially generated mixed waste. hiixed waste is low-level The first document, a pimphlet entitled " low l evel waste that contains a radioactive component subject to hiixed Waste, an RCR A Perspectise for NRC 1.icen-the Atomic Energy Act (AEA) and a hvardous compw sees," has been developed by EPA, with the assistance of nent subject to the Resource Conservation and Recosery NRr a instruction for N RC licensees that may not be Act (RCRA). The mixe+ waste profile will help States, familtar with the !!PA regulations that apply to mixed compact officials, pnvate developers, and Federal agen-waste. The pamphlet summarized the applicabdity of cies plan and develc.p treatment and disposal facdities for RCR A to cornmerculty generated mixed waste,includmg mixed waste. This study began with an evaluation of past information on the types of facihties that may generate State, compact, and industry surveys, to determine if ex-mixed waste, the RCR A regulatory framews ek, and re-isting infonwtion is adequate for compiling a national quirements and opportunities for pollution prevention.
mixed waste profile.De results indicate that existing in-formation is inadequate, and that additional information The second document outlines guidance developed by will be needed to develop a national profile. Therc~ ne.
EPA on the effects of the land Disposal Restnctions selected NRC and Agreement State beensees will be (l DRs) on the storage and disposal of mixed waste. T he asked to participate in a mixed-waste survey. The sui. ey guidance provides a generaloverview of the LDR regula-design and survey instrument are being prepared, and a tions and presents mformation on those regulations that mixed waste questionnaire is expected to be sent to se-specifically affect beensees that handle mixed waste.
lected licensees m October 1991.The results of this stuJy will be published in NUREG form.
1.icensees are reminded of their responsibihties to dis-pwe of radioactne matenalin a manner that satisfiu the requirements of all regulatory agencies havmg ju isdic-NRC AND EPA DISTRIBlJTli INFORN1 ATION TO tion over the matenal. Presently, a commercial mixed-LICENSEES Til AT GENER ATE hilNED W ASil!
waste dispwal facdity has not been permitted and h-censed for operation. Therefore, generators of mixed The Nuclear Regulatory Commission (NRC) and the waste may hase to store their waste onsite untd a dnposal Environmental Protection Ageng (EPA) have recently facihty is available.
developed, and distributed to NRC licensees that may generate mixed low-level radioactive and hazardous If you are a licensee that generates or must manage mixed waste, two documents relating to the Resource Conserva.
waste and diJ not recene a copy of these documents, you tion and Recovery Act (RCRA) and the regulation of may obtam smgle copies by contacting Nick Orlando at mixed waste h1ixed low-level radioacuse and hazardous 301-492-0566.
3 6
4 10
muism
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