ML20247K307

Discusses 971224 Ltr to Hl Thompson Requesting Info About Safety Benefits of Adopting Quality Mgt Program & Misadministration, 10CFR35 Amend Effective on 920127. Statement of Consideration That Supports Program Encl

ML20247K307
Person / Time
Issue date:	05/01/1998
From:	Bangart R NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Bailey E CALIFORNIA, STATE OF
References
NUDOCS 9805220059
Download: ML20247K307 (22)

Text

_ .

MAY 1 - 1998 Mr. Edgar D. Bailey, C.H.P., Chief Radiologic Health Branch Food, Drugs & Radiation Safety Division State Department of Health Services P.O. Box 942732 Sacramento, CA 94234-7320

Dear Mr. Bailey:

At the Califomia annual meeting held on March 4,1998, the State identified that it has not received the information requested in its December 24,1997, letter to Hugh L. Thompson, Jr.

Specifically, the State requested information about the safety benefits of adopting the " Quality Management Prograrn and Misadministration," 10 CFR Part 35 amendment (56 FR 34104),

that became effective on January 27,1992.

As you know, NRC staff has been directed by the Commission to revise 10 CM Part 35 in its entirety. The quality management program and misadministration requirements in the new Part 35 are likely to be significantly different from the current requirements. Given the schedule to have the new Part 35 published in 1999, we now believe that conserving your rulemaking resources to address the new Part 35 is appropriate. Nevertheless, the Statement of Consideration that supports the Quality Management Program Misadministration rulemaking is enclosed.

If you have any questions about this issue, please contact me or Lance Rakovan at (301) 415-2589, internet: LJR2@NRC. GOV.

Sincerely, MM9d BY RICHARD L BANGART Richard L. Bangart, Director Office of State Programs

Enclosure:

As stated

\ \

Distribution:

DIR RF (8S119) DCD (SP08)

SDroggitis PDR (YES f._ NO )

JHomor RBlanton, ASPO i ' ? ~~~

KSchneider ~~' '"'" T f I' "

California File ~ '~~~ ~

E DOCUMENT NAME: G:\LJR\CAQM.LTR

• SEE PREVIOUS CONCURRENCE.

To recohrt a cop!r of this document. Indicate in the box: "C" = Copy without attachment / enclosure "E" = cop r with attachment / enclosure "N" = No copy OFFICE OSP l OSP:DD l OSP:D/fn l

NAME LRakovan:nb:kk:nb PHLohaus RLBangartM0 DATE 04/23/98

• 04/23/98

• 05/O I/98 9805220059 980501 OSP FILE CODE: SP-AG-4 PDR STPRG ESOCA PDR

, s Mr. Edgar D. Baliey, C.H.P., Chief Radiological Health Branch Department of Health Services P.O. Box 942732 Sacramento, CA 94234-7320

Dear Mr. Baliey:

At the California annual meeting held on March 4,1998, the State identified that they have not received the information requested in their December 24,1998 letter to Hug'h L. Thompson, JR.

Specifically, the State requested information about the safety benefits of' adopting the " Quality Management Program and Misadministration," 10 CFR Part 35 amerfdment (56 FR 34104) that became effective on January 17,1993. /

Subsequent to receiving this request, NRC staff was directed t$ revise 10 CFR Part 35 in its entirety. Thus, we believe that to provide any information at this time would be inappropriate, and we consider this matter closed. -

If you have any questions about this issue, please colhact me or Lance Rakovan at (301) 415-2589, internet: LJR2@NRC. GOV.

p Sincerely, Richard L. Bangart, Director Office of State Programs

/

/

/

l Distribution:

DIR RF (8S119) DCD (SP08)

SDroggitis PDR (YES.f__ NO )

l JHornor RBlanton KSchneider California File DOCUMENT NAME: G:\LJR\CAQM.LTR i Tm receive a cop t of this document, Indicate in the bor: "C" = Copy without attachrnent/endosure "E" = Cop f with attachment / enclosure "N" = No copy OFFICE OSP [g O S P; g Q d OSP:D l NAME LRakovan:nb } PHLohS("7 RLBangart l DATE 04/d/98 _

04/M98 04/ /98 OSP FILE CODE: SP-AG-4

, a p3KE*g g4 +, UNITED STATES l

i g ,jt NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20086 4001 l

k....,/ May 1, 1998 i Mr. Edgar D. Bailey, C.H.P., Chief Radiologic Health Branch Food, Drugs & Radiation Safety Division l State Department of Health Services P.O. Box 942732 Sacramento, CA 94234-7320 l

Dear Mr. Bailey:

At the Califomia annual meeting held on March 4,1998, the State identified that it has not received the information requested in its December 24,1997, letter to Hugh L. Thompson, Jr.

Specifically, the State requested information about the safety benefits of adopting the " Quality Management Program and Misadministration," 10 CFR Part 35 amendment (56 FR 34104),

that became effective on January 27,1992.

l

As you know, NRC staff has been directed by the Commission to revise 10 CFR Part 35 in its

! entirety. The quality management program and misadministration requirements in the new Part 35 are likely to be significantly different from the current requirements. Given the i schedule to have the new Part 35 published in 1999, we now believe that conserving your rulemaking resources to address the new Part 35 is appropriate. Nevertheless, the Statement of Consideration that supports the Quality Management Program Misadministration rulemaking is enclosed.

l If you have any questions about this issue, please contact me or Lance Rakovan at l (301) 415-2589, internet: LJR2@NRC. GOV.

Singrely, ic 14t M Richard L. Bangart, Directo[V Office of State Programs

Enclosure:

As stated I

I

PART35 e STATEMENTSOFCONSIDERATION cmsfa.4.ca clamge, either lacrease or they do not invoh c any provisions that amendment also modifies the derreuse. in rad 4ution exposure to t!n" svould impose backfits as defined in10 notification, reporting and pubbc or to the smvirunmeni beyond the g Cllt 50.109f a)(1). recordkeeping requirements related to e nia.mures currently resulting from the quality management program and stehrer the thee to the patient. g3 ,, I"M misadministration.

( - %e Environmental Assessment and M CFR Port 30 erpecttys safs: January 27.1992.

l Mmhng of No Significant Impecs is avxilutete for inspection at the NRC g. product matarid.ChindWy, PCs Puerman peronssation oostracr:

g.arament contracta. Dr. Anthony N. Toe. OfBee of Nuclear Pabhc Document Roosn si 2120 L Stroct NW. (14wer tivell. Wnahingtua. DC Intergovernrnentd relations laotopea. Regulatory Researr.h. U.S. Nucleat Single copics of the Assc.asment are Nuciour materials. Radiation protection. Regulatory Commission. Washington, Reporting and recordkeeping DC 30555, telephone (301) 402-3797

[ fuan Ds.Too (ace Aconsseas  ;,, , ,,,,,,,,,,,,,,,.

It:prtwori flerf u tism Act Stutconent O'#

1his finalrule amends information cutlectirm requirements that are subject Dyproduct material. Crimmalpanalty.

s ID ,g d"*-

State and Federal Regulations.

to the Paperwork Reduction Act of1980 Drafas. HeaWaches.Heahh pro sions. Incorporation by seference. D. NRC s Regulatory Program.

(44 U.S.C. 3501 et seg ). These Medical devices. Nuclear snatarials. NRC s Pohey. {

regiilrements were approved b the Occupaumal safety and henhh, NEs Rupesibihuu.

Office of Management and Budget Radiation protection. Reporting and Mindministration Reports nepmval stumoers $150-(1010 smd 3150- recordkeepirig requirements. a i s.

W7. l'or the renous set out in the public repmting bursien for this  !!!. Pubbcation of the Proposed Rule and preamble and under the authority of the Discuulon of Related NRC Activitin.

n.t'imti.n. of infornwtion in estimated to Atonne F.ncray Act of1954 as amerided. The Proposed Rule.

• wwwe 25 hour2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> per response, including the Energy Reorganization Act of1974. The Pilot Program.

the time fur sevacwing instrue:mns. as anmuded. and 5 U.S.C. 552 and 553. Public workshops.

n..ircking existing data sources. the NRC is adopting the following Public Comunents and NRC Responus.

g.ithering and mairrtaining the data amendmentt, to 10 Cm parts 30and 35. IV. Discunion of Final Rule Text.

mfuted. send completrng and nrvie whig V. Implementation Plan and Agreement State 88 FM 23360 Compatibihty.

the toIlection of soformatiort. Srnd comments regard.ng this burden >utmahed 5/21/91 VI. Administrative Statements.

estirnate or any cther aspect of this Effeethe 4/20/93 Findmg of No Sasnificant Enytroamental impact Avsilabihty.

cu!!ection of informatina, including Saandards forProtection Against Paperwork Reduction Act Stateswnt.

augpostions for seducing this busden. to Aed.abon Regulatory Analysis.

the Ir.Intmation and Records Regulatory Flexibthty Certification.

Management Branch (MNBD-7714). U.S. See Part 20 Statements of Consideration BacW Analysis. l Nuclear Regulatory Commission.  ! Jet of Sub}ects in to C71t Parts 3 and 35.

Washington, DC 20',5h; and to the Desk ** '"' *

as FM S4104 Offaccr.Othee ofinformation and Published 7/25/91 IBYProduct Materialin Medicine Regulatury Affaits.NCOD-3019 Enocthe 1/21/92 0017 and 3150 4010). Ollice of l3150- y,, g,fByproduct Material Waagement and Budget. Washington, to CFR Ports 2 and 35 Since 1946 growth in the medical DC 0503, applications of radioisotopes has been Nei3136 AC65 Regulotorf.im,1ys'.' very rapid as their usefulness has

• " become more apparent in diagnosis.

1he Conunionion bus prvpared a regulutury analysis for these gQ" therapy, and medical renarch. Current medical procedures employ a number of m u stdmenta.1he amnlysis caumina the aessocy: Nuclear Regulatory radioisotopes in a wide variety of henrf.ts and empa. cts considervd 1.y the Conn.nission. chemical and physical forms. Nuclear MC 1hc regulatory analysis is acrtost Final rule. medicine procedures for diagnostic and assilable for inspection at the NRC therapeutic applications involve the Pulalic Ducunwnt Room at r1201. Street aussesamv:The Nuclear Regulatory intemal administestion of radiolabeled NW.{!am er level). Washington. PC. Commission (NRC)is amending tracers. Administration of the Singic copics are availah!c from Dr. T c regulations governing therapeutic radiolabeled tracers, known as Isee apoststas hending). administrations of byproduct material rediopharmaceuticals. may be 1he Commission requeste public and certain uses of radioactive sodium performed by intravenous injection.

comrnenis on the regulatory analysin. iodide to require implementation of a inhals tion, or oral ingestion. Diagnostic Comments are welcome at any time quality management program to provide nuclear medicine in most cases involves during the three. year period that the high confidence that the byproduct imaging agents used for the delineation interim final rule is in effect. Comments material or radiation from byproduct and localization of organ tinues by ett the analysis may be submitted to the material will be administered as acint! graphy (e.g tectmetium-99m NRC as indicated under the apomasses dir*cted by an authorized user hydroxymethylene diphosphonate used hend*B- Physician.The Commission believes this as a bone. seeking radiopharmaceutical).

g,4,jg*.4. ### . performance based amendment will Orsan function may be determined by result in enhanced patient safety in a quantifying the secumulation of The NRC has dctermmed that the cost-effective manner while allowing the, radiopharmaceuticals in organs of

!=ckfit rule.10 CTR D0.109,does'not flexibility necessary to minimize intert st (e.g iodine.131 uptake studies

.mply to thes'comendtnents because intrusion into medical judgments. This used to assass thyroid function).

f September 29,1995 35 8C 10

mmn . swmmrs wcommric.

herapeutic nuclear medicine may use byproduct materialin 22 States, the occurrences, and diagnostic j, various radiopharmaceuticals for the District of Columbia, the misedministrations in the therapy range treatment of disease by selective Commonwealth of Puerto Rico, and over the period of November tee 0 .

absorption or concentration (e.g., lodine- various territories of the United States through December 1980 for the NRC 131 used to treet thyroid cancer). Other and has licensed 2.000 civilian and licensees.ne results of the analysis for therapeutic applications may involve the military hospitals and clinics. events that occurmd from November use of radiopharmaceuticals in colloidal 1980 through December 1988 were suspenelons for the treatment of summarised in the preamble to the malignant tumore (e.g., phosphate-32 proposed rule published January 16,1000 l infusion for treatment of peritoneal or R.NRC's Regulatory W (55 FR 1430). %e events that occurred in pleural effusions associated with NAC's hlicy 1980 and 1000 were similar to the events

~ from the earlier years except that the ce 1900s, radiation in a policy statement published on number of there y evente in 1900 was therapy has become one of the major February 9,1ers (44 FR a242), entitled

" Regulation of the MedicalUses of approximately ouble the average modalities of treatment in the number of therapy events for the management of neoplastic disease. Radioisotope: Statement of General I

Policy " the NRC stated: pmvlous years. Table 1 provides a brief l nerally referred to as cancer. description of the therapy distion therapy may also be used as a (1)N NRC will continue to regulate misadministradons, abnormal palliative agent in the medical treatment the medical uses of radioisotopes as occurrences, and diagnostic process.The objective of conventional necessary to provide for the radiation safety of workers and the general public. misadministration involving iodine that radiation therapy using a teletherop[y (2) N NRC will mgulate the occur ed in lese and 1990. Although sealed source is to deliver a precise some of the events listed in the table measured dose of radiation to a defined radiation safety of patients where justified by the risk to patiente and may have cawed direct harm to the tumor volume.This is usually patients, the overall significance of accomplished by delivering a does in where voluntary standards, or compliance with these standards, are these events is that theyindicate a daily increments over several weeks. breakdown in the licensee's program for External beam radiation therapy has inadequate.

ensuring that byproduct material or l evolved using innovative technology (3)h NRC will minimise intrusion radiation is administered as directed by that has led to the development of the into medical judgments affecting the authorised user. it has been apumed gamma stereotactic radiosurgery device patients and into other areas used for treatment of precisely defined traditionally considered to be a part of that a proportional number of such the practice of medicine. occurrences has also taken place in the intracranial targets (e.g., brain tumore De NRC has the authority to regulate Agreement States although the data and arteriovenous malformations). base is not yet complete.

Brachytherapy uses a variety of the medical use of byproduct material or smaller sealed sources for localised radiation from byproduct material to ne canes of thwe treatment of cancer. Typically the protect the health and safety of patierits, misadministration and/or abnormal but also recognises that physicians have occurrences may be characterized by oesled sources are either inserted in a cavity (e.g., coelum.137 sources used for the primary responsibility for the insufficient supervision, deficient intracavitary treatment of cervical protection of their patients. NRC Procedures or failure to follow cancer) or implanted in tinue (e.g regulations are predicated on the procedures. inattention to detail, and iodine.125 seeds med for interstitial assumption that properly trained and inadequate training.

treatment of prostate cancer). Various adequately informed physicians will nose factors are often significant in remote afterloading devices have ben make decisions that are in the best causing or contributing to developed for low, medium, and high interest of their patients. misadministration or abnormal dose rate brachytherapy treatments. .

occurrences.The purpose of this NAC's Responsibilities rulemaking is to address these factors State andFedem/ Regulations & NRC distinguishes between the by requiring each applicable part 35 Byproduct material or radiation from unavoidable risks attendant in licensee to establish and implement a byproduct materialis regulated by purposefully prescribed and properly quality management program.Thus, either State or Federal laws. Twenty- performed clinical proceduru and the each licensee will be required to have eight states, known as Agreement unacceptable risks ofimproper or and implement procedures to ensure l

l States, have entered into an agreement carelena use. The NRC is responsible, as that the byproduct material or radiation with the NRC to regulate the use of part ofits public health and safety from byproduct material is administered byproduct material (as authorised by charge, to establish and enfcree as directed by the authorized user section 274 of the Atomic Energy Act). regulations that protect the public from physician. Improved training of nose States inue licenses and risks of improper procedures or careless personnel who handle and administer currently regulate about 4.000 use. byproduct material can also reduce institutions, e.g., hospitals, clinics, or mistakes. However, this rulemaking M8admini88milon RepoM8 does not address training: the need for physicians in private practice.

The NRC regulates the administration & NRC has analyzed therapy training initiatives will be considered by of byproduct material or radiation from misedministrations, abnormal NRC in the future.

\

1 l

l l

35-8C-11 September 29,1995

f PART35 e STATEMENTSOFCONSIDERATION TAeLa 1.-.MIsAonmeastRAtlones, AamoRMAL occurrences. AND OTHem Evsofra osee l unenese lstl Descripton

.RC -,

Ti -

01/33 Aseen Norseeassem Mespeel 8 MN . Wrone Tresonant One. Adm 200 sees to wron0 push due to aproper manurg 08/se Mennetec Wessy tend Op 8 ME . Wrong Petere Adm 100 rede to treet 08/27 bisone Umr Sehess et Messene 8 IN _. Wrong Treennent See Aen 9 tractens of 300 rods each to the wrong he due to enerhog 07/94 Weresster Oly Heepnel 8 MA ... . Wrong Patent. Aen 300 rods to apme 01/33 Yses New Menen Meepaal CT Wron0 Dese Aan 1000 sees. As 800 reds, ese to wrong doesy sector 01/31 St Luke's Mespeel- MO.. Wrorg Does. 90% esiderdese due to wrong sowoe opength.

08/10 Med Or af Desseere DE . . Wrong Does. Aen 1731 sees. k 3001 reds-10/35 Chapon's Mempaal. MA Wrong Dame Aan 3e62 reds. k 4634 rede 11/30 vele teen Haven Mespeal. CT . .. Wrong hm-ave Aan 900 reds. As 2000 reds.

seusener ^ _ , C, - _ Range OS/14 - New Ergiend Med Car 8 MA . Wrong meespheminoeutoed Aen 6 m0 6-131.Rs 1 m0 4-123.

05/23 Ahhee leerthmestem Mespeel 8 _ MN Wrong Reespaismiscouteel Adm 3 enO l-131, b 300 p01-123 10/10 Mayo Foundamena WN .. Wrong Desage Adm 1 mo 6-131. Rs 100 p0 4-131.

11/30 Kuesure testeel Center 8 Hl .. .. Wrong Petern. Aen 9 m01-131.

Iduelser - _ L i mange er Invohnn0 leene 08/09 itemenseer Conwel Messnel PA Wrong Petere Aan 175 p0 6-131 hepuren.

08/30 Mesaukee CounIy Med Center W1. . Wrong Patent. Adm 90 pQ 6-131 hepuren.

02/30 Weehmgeon Hompnal Center DC . Wrone Potent. Adm 155 *O l-131 hepuren.

03/30 Chneten Mani MO Wrong Petert Adm 17 pG bist toeum esede 04/03 VA Matosi Conner FL Wrong Recophemisoeumont Aen 0.33 mo L131 tuppuren. As 5.20 mG Tc-SDm MAA.

06/16 Marshey Meenal Center PA . Wrong Retopharmeasument Adm 0.8 MCI l-131 MISG. As 0.5 m0 6-131 NP-68 07/00 Menesesse Desepeal PA .. . Wrong Desage Aen 24 p0 6-131. Rs 12 p0 6-131.

9WIC use8sestS-ISSO Teessherapy 08/08 Qoueland Clouc 8 OM . . Wrong Does Adm 3 fractons of 278 rede each. As 2 Wectone 02/16 Weerungeon Mespeel Or 8 DC.,. . Wrong Petort Adm 46 reds to lung 08/19 Geesiger Motoel Center PA .. Wrong Does. Aen 4300 reds. Ms 3000 reds ese to e edetonal fractons f 03/12 Mushagee Reg Med Ctre OK .. Wrong Treatment See Adm 2100 reds 03/is R=srede Reg Med Ce 8 VA . Wrone Petern Adm fe6 rede to brem.

03/18 St Mary's Med Cara MI . Wrons Treatment Sas. Aen 200 rods 04/30 St Luke's Mempnel OH . Wrong Does Aan este reds. Rs 6304 reds.

06/07 Intens Urev School of Moesne IN . Wrong Does Aen 1000 reds. As 1360 reds shse to moeiterproung the preecnphort 06/22 St Luke's Meegesel f . OH.. Wrong Treatment See. Adm 170 rods 08/14 Presbyterian Hespeel PA . .. Wrone Does Aan S226 reds. k 4000 reds due to 4 edetonal fractonc

-d ,1_ ,

01/17 Menengehees vesey Mempnel 8 PA Failure to Detect Detodged Source Orie estodged samum.117 ocurse treested the potent's log 02/02 Ses Memonal Mespeel 8 IN .. Wron0 Treatment See Aen 1900 reds, sealed source in wrorg looston.

02/07 Unseremy of Weoorum 8 WI Wron0 Does Adm 4120 reda. As 3940 rede chas to wron0 enpus to the semputer 03/15 Ureversey of Woosnama Wi_ , W,ong Tresemeen Sne' Adm 400 rods akse to wrong piput to the computer 03/16 John F. Mennedy Meepest 8 NJ Feewe to Detect Delodged Source- Seures eslodged and War potent's fece Wreested 1032 reds 03/21 Portviour Mom Meepeal IN Feeure to Detect Desodged dource. Asphaeler puted out by the potent, the potent's legs Wreested 823 reds.

03/00-06/90 St Mary Med Cir. Gary eral Mahert 8 IN _ Penern of wrong Desse Entre brachytherapy operatene were Wivesteeted and suspended.

OS/39 Unw of Cmonnoti 8 OH .. Wrong Treatment See Most oseds were eigeansed oJesses the pmeesto 08/17 Ceepr Meeced Center E. Wrong Dose- Adm 1404 reds. Ru 3000 reds due to urong postment pian ekseener - u- - m Degneste menee 94/17 St France Med Car PA Wrong Deeses Adm OS mCll-131. Rs 50 p0 6-131.

06/14 Overtook Meepnel 8 NJ Adm 1.4 m0 k131. Rs 300 p01-123 Os/04 Veney Messnes NJ Wrorg Reeopharmaceutool'o Wron0 Dosage Aen 4.61 en Sr-se. Rs 3 54 mo sr-se.

05/08 Wassy keespnel 80 . Wrong Deeses Adm 4.02 mQ St-80. k 2 07 rn0 Gr-40 08/05 toercy Womenet Med Car 8 Mt Wrong Donego Adm 4J mC6 h131. As 60 p0 6131. ,

OS/10 Tnpier Army Meenal Center 8 -. Ml - Usurnended Does to Nuresq Intern Ac enennt recomed does from mother's ensk due to 4.80 enO l-131 esm to enrlher. Mient thyred seHeted 07/10 teorth Ceumy Heepnet VT , Unentended Does to Fetus. A pregnant potor,t adm 16 p0 4-131; teced to sek a pregnert 07/10 St Vmoont Med Cr PA .. Wrong Dosage Adm 110.1 rn0 4-131. k trJD mci 6-131.

07/10 Sngham and Women's Moepnel MA . Wrong Dessee Adm 100 m0 Dy 186. N 170 m0 Dy-165.

07/27 horth Depoit General Mosonsi e Ml_ . Freudueent Stuese. Oed smagmg Mms outrrohed for current potente resultrne in esones doses for repeated stuees 08/01 Frankford Mospect PA .., , Wrong Dose 0s Adm 20 mQ 8-131. N 94 rnQ 4-131.

09/22 West Shore Moepnel 8 Mr . .. Wrong Dosage Adm 176 rrC ~ -DDm. Rs e mo Tc-90m. i 10/16. .. . Wdhem Beaumont Moeptal B Ml .. Wrong Dosage Adm 316 rnQ 6-131. N 175 enQ 1-131- 1 11/2s VA Moses Comer 8 CA ..... Wrong Reeopharmaceuteet Adm ses mo Te eem. Rs s ma in-111.

September 29,1995 36-SC-12

PARTSh e STATEMENTSOFCONSIDERATION TAsts 1.-Mm==TRAT Does. AsseoReaAL OccuRRasects, AND OTMsR Evswis--Continued Dois l umanese lsTl Dessoenn eeuelser ^ ^ L_ Range er bevelagig toene 08/o1 VA Eduard tense Jr. essesef Center IL wron0 Reesp8iermaanieset Aan 0.714 MCI k131 Megneen. As 3.s niCi Tb j 801.

Oe/Os VA essenet censer ca . wrone Reespeissmassuamnt Aan 1 mcl i 131 enemanuse. mm 1 enci k131 eeGG.

I 03/30 ci innd cans oH wrene Desase: Aan 130 pCI k191. 8h' too yo s.131.

i 03/30 Dommnver many and seusemer Dimenomens nel . Wrong Damage. Aan 100 p0 6-131. An it p01-131.

03/00 Deus adem Heapnel wv . wrong Desege: puserne seemves so% ames assage of 6-1311 hen pre-I sersted l 04/30 Johnson Wee Hespeal VA Wrong potent Aen 9 p0 k191 eseum leeds.

Os/04 Central piams Caruc - 80 . wreeg Recepfemisseuseet Aan 0.01 mQ klas Amunun As as mQ Tc.

Sem.

es/or caser Homensi

• VT . wrene Deeses. Aen tia no k191, As 10 po k131.

ce/os aannenses rsen Hansasi oH weerg Reespharmassument Aan kiss. As 6-131.

08/13 weet part6 Hespeel WY wrong Donego Aen 0 00as m01 131. Am 1 seO l-131.

10/30 Dept et vet Asines edeessi censer p FL . weerg seent Adm o.3nt mo 6-131 Mesuren.

13/Os Jersey Shore Hespeel PA . wrong Resopharmaasussel. Aen 6-13e MSA. Ru To-80m USA 13/13 Jeresy Shore Hespeel PA Wrong Recaphernissaienst. Aan 6-18s tGA As Te 40m UGA e namesmmmessene emmensied as ennemos -

VoluntaryInitiatives rule.%e ACMUI also suggested that a prior notice was given through Federal The NRC is aware of voluntary pilot program would be useful to Register announcements. Brief initiatives to improve quality assurance determine the licensees

• abihty to meet discussions of these activities are (QA). Examples include " Patterns of a proposed rule, to assess its impact, presented below.

Care," a study managed by the and to determine how to minimise its n, pilot Pmgram American College of Radiology (ACR). impact without decreasing its

" Quality Assurance Program in effectiveness. Furthermore, the ACMUI De P il ot program was coeducted to Radiation Oncology." prepared by ACR. stated that. under existing NRC provide a real-world test of the end " Physical Aspects of Quality regulations. the definition of the term ProPwed rule in licensee hospitals and Assurance in Radiation Therapy." " misadministration" is unclear and that clinics and to gain insights beyond those prepared by the American Association the related reporting requirements are generally obtained from the public cf Physicists in Medicine (AAPM). confusing. comment process. Three basic questions The NRC encourages voluntary Subsequently, the NRC decided to wm of intmot initiatives by the industry to develop develop a performance based rule and a (1) Can licensees develop QA consensus standards and will consider regulatory guide and, as a part of the Programs to meet the ob}ectives of the endorsing these standards in its same rulemaking, to review the term Proposed rule following a performance-regulatory guidance at an appropriate taased approach using the regulatory

" misadministration."its scope and time. However, because these voluntary guide or any other guidance of their related reporting requirements. In addition, the NRC also decided to O

standards may not be adopted by all g2) i NRC reviewed a licensee's licensees, voluntary programs alone are conduct a pilot program, written QA program, would the NRC not sufficient to ensure that the IB. Publicaties of the Proeosed Rule and ee that the program meets the byproduct material will be administered rhada= of Related NRC Activities ectives of the proposed rule?

as directed by the authorized user. (3)If NRC visited a licensee's hospital Consequently, the NRC has determined De Picposed Aul, that there is a need for this fin 41 rule. The NRC published proposed *im er ed p a mee the amendments to 10 CFR part 35 in the objectives of the proposed rule?

EorlierNACEfforts Federal Register on January 16,1990 (55 Also, after the licensees had tested On October 2.1987 (52 FR 38942), the FR 1430) and provided a 90 day public the proposed rule, the NRC wanted to NRC published a proposed rule that comment period.The proposed rule learn from licensees if they had would have required its part 35 contained amendments that would problems with the proposed rule and licensees to implement some specific require part 35 licensees to establish their recommendations on how the rule basic QA practices to reduce the and implement a basic QA program. It should be revised in order to minimize number of mistakes in the therapeutic also contained proposed modifications its cost and clarify its objectives without administration of radiopharmaceuticals to the definition of " misadministration" decreasing its effectiveness.

cr radiation from byproduct material and the associated reporting and Based on the principles of acceptance and the administration of radioactive recordkeeping requirements. sampling, the plan was to invite a group iodine. Public comments received on the To collect additionalinformation of 72 volunteer licensees that represent proposed rule indicated that, although about the proposed rule from NRC and the U.S. population of part 35 type these proposed QA practices might Agreement State licensees, the NRC licensees. The total was divided into 24 reduce the number of mistakes, the conducted a pilot program. Also, the NRC and 48 Agreement State volunteers imposition of prescriptive requirements NRC conducted public workshops with because there are approximately twice might not afford sufficient flexibility for professional associations. the joint as many Agreement State licensees as all licensees. Public comments, including Commission on Accreditation of there are NRC licensees. Cruups were l

Healthcare Organizations ()CAHO). the defined using the five NRC regions and recommendations from the NRC's Advisory Committee on the Medical Afeement States. and met with the the 28 Agreement States.The number of -

rmC's ACMUI to obtain additional volunteers invited from each group was I Uses of lootopes (ACMUI). suggested cornments on the proposed rule. These in proportion to the number of licensees that a performance-based rule should be workshops wers open to the public, and in that group. Also it was desirable to promulgated, rather than a prescriptive 35-SC 13 September 29,1995 l

_ _ _ _ _ _ _ _ _ _ . _ _ _ _ i

PART35 o STATEMENTSOFCONSIDERATION have the volunteers represent specific (1) Licensees can develop acceptable - institution without reporting to NRC:

QA programs under a performance. events exceeding a higher threshold )

licenne characteristics within each '

group, as well as possible, considering based approach. should be reported to NRC(or the the number of volunteers randomly (2) ne licensees' programs, as applicable Agreement State).

selected from that group. The specific written, did meet most of the proposed A NUREG/CR report summarizing the licensee characteristics were class of I 35.35 objectives, even without benefit pilot program is under preparation and licensee (i.e., teletherapy. of an iterative process (e.g., questions will be published in the near future.

brachytherapy radiopharmaceutical and revisions) as occurs during public workshops therapy, and diagnostic nuclear licensing.

swdicine), type of facility (i.e., private or (s)The licensees

• programs as ACN and SNM nonprivate), eine of facility (i.e., small- actually implemented were found during De NRC conducted a public up to 250 beds, or large-over ago bede). the 14 site visits to be more complete workshop with representatives of the and facility location (14 arben within a than the written programs in meeting the American College of Nuclear Physicians U.S. Bureau of Census Standard proposed i 35.35 objectiver Some (ACNP) and the Society of Nuclear -

Metropolitan Statistical Area. or rural- programs completely met the objectives. Medicine (SNM) in Rockville. Maryland.

otherwin). (4)Most licensees already had an on July 23.1980. De proposed QA rule latters inviting participation in the was compared with the current JCAHO ilot program were sent to a total of 185 am because of JCAHO existing or a profonioQA Qnociety; thus, neither Standards and with a JCAHO type QA scensees. Seventy-six institutions program for one hospital to determine if volunteered (27 NRC and de Agreement the in 21 work nor te cost involv o meet the proposed 5 35.35 equivalence exleted. It was concluded saw hcenem). objectives were substantial. that the proposed QA rule is comparable Five one-day workshope were held, to the ICAHO Standards.The ACNP one in each NRC region.to explain the overall process of the pilot program and 1 to[ ensure that the medical use is(5and Proposed 135.35 SNM provided objective various number questions.

to discuss the proposed rule and draft indicated for the patient s medical d dh condition" and objective number 4 to rdWesppM & MM regulatory guide. Following these fundamentally. ACNP and SNM workshope, the volunteers developed " ensure that the responsible individuals understand the directions provided by representatives questioned the need for QA programs that conformed to 135.35 the rule and whether additional NRC or amended their existing QA programs the authorised user should be deleted.

to meet the objectives of proposed but the other six objectives should be I 35.35. The volunteers also conducted retained.

Quirements ucing the numberwould of contribute to any necessary training in preparation misedministrations.no malor ACNP-(e) ne word "errore.'in 135.35(a) SNM recommendations are:

for their trial use of the i 35.35 type QA should be replaced with a term to (1Wi& drew me proped QA rule.

programs. During a 80-day period from specifically describe what is to be mid.Msy to mid July 1990. the (2) Endorse the JCAHO accreditation prevented. process and allow NRC licensees to volunteers used their i 35.35-type QA (7)To avoid confusion in the comply with JCAHO requirements in f

programs for their administrations of thousands of hospitals that are already lieu of the proposed QA rule for byproduct material or radiation from accredited by JCAHO the NRC should byproduct material. diagnostic nuclear medicine use a term other than " quality administrations.

To address the first two questions su urance.

stated above. the NRC evaluated each AAPM ACMP. ACR. AES, and AST1tO volunteer s written i 35.35-type QA (8) The term " written directive-should be used instead of " prescription" On November 19 and December 15.

program to determine whether it met the to avoid confusion with existing medical 1990, the NRC conducted public proposed objectives.To address the practices. workshops with representatives of the third question stated above, the NRC American Association of Physicists in visited the hospitals or clinics of 18 (12 (9)The sentence structure should be simplified by stating multiple Medicine (AAPM). American College of NRC and 6 Agreement State) volunteers requirements or criteria in lists,i.e (a). Medical Physics (ACMP). American to determine whether their i 35.35-type (b). and (c). College of Radiology (ACR). American QA programs, as implemented, met the (10) A required " written referral" for Endoeurietherapy Society (AES). and proposed objectives.nese site visite diagnostic procedures would be American Society for Therapeutic were conducted during the to-day trial unneensarily costly. RadioloSy and Oncology (ASTRO)in un period. (11) ne patient should be Reston, Virginia he proposed QA rule.

At the end of the pilot program five redundantly identified. definitions, reporting requirements, and two-day workshops were held one in (12) The " annual comprehensive regulatory guide were discussed on a each NRC region except Region V, to audit" should be replaced with an line by line basis. Numerous suggestions learn about the volunteed experiences annual program review based on a \ were provided by the representatives of in using their i 35.35-type QA programs random sample of patient each profeestonal association. Their and to discuss the volunteers' problems administrations. major recommendations are:

with and recommendations on how to (13)The reporting requirements of (1)Do not use the title " Quality revise the proposed rule and draft proposed il 35.33 and 35.34 should be Assurance Program" to avoid confusion regulatory guide. Prior to these simplified. with the existing ICAHO programs.

workshops, each volunteer was asked to (14) The reporting threshold criteria of (2) Do not use the term complete a written questionnaire as an an organ does of 2 reme and a whole "mindministration."

evaluation of the proposed rule and body dose of 0.5 rem should be modified (3) Use " calculated" administered draft regulatory guide. There were 64 because these criteria are exceeded dose for teletherapy and brachytherapy.

volunteers (23 NRC licensees and 41 during most routine diagnostic (4) Increase the range of tolerance Agreement State licensees) who actually procedures. between calculated administered dose participated in all aspects of the pilot (15) The procedure should be retained and prescribed dose in teletherapy and program. De following is a summary of that allows the licensee to handle brachytherapy.

the lessons learned from the pilot " events."i.e., mistakes that exceed a l (5) Use " written directive"instead of program. relatively low threshold, within its " prescription."

mm m - ~ ~ ~ ,

PART35 e STATEMENTSOFCONSIDERATION

, (6) Remove the word ensure from the %e major mcommendatior.s provided time to calculate the actual dose beginning of each proposed objective. by the mpresentatives are: delivered in complex situations.

(7) Do not use the word prevent (1) All administrations of byproduct (0) Retain the requirements for l because it sounds too absolute. material or radiation from byproduct therapy events to be evaluated and (8) Allow events (i.e mistakes that material should be approved by the responded to within the licensee's exceed a relatively low threshold) to be authorised user prior to administration. Institution.

handled within the institution. (2) Do not use the title " Basic Quality (10) Delete the mquirement to notify Assurance Program" to avoid confusion the referring physician in the case of a The JCAHO reportable event.

with the ICAHO program.

'!be staff conducted a public (3) Revise the proposed dose (11) Allow the report to the patient to workshop with the JCAHO in Chicago, be a summary description of the event in Illinois, on December 17,1900. The threshold levels for " events" and "misedminktradons.- that the patient can l common elements of the proposed QA tend rather than a copy of the (4) The rule, definitions, and reporting rule and JCAHO requirements were technical report sent to the NRC.

requirements should be revised based discussed.The staff atten ted to on recommendations from the ACMUI D2) AHow es licenm to make determine if the NRC mgu anon. modincations to maximise the program's on January 14 and 15,1991, and abould licensing. and inspection processes are be republished for public coaunent. efficiency and require a copy of the equivalent to the JCAHO standards, modifications to be provided to the NRC accreditation, and survey procems. (6) ne proposed regulations should not be a matter of CanPatibility for Regional Office within 30 days.

Based on this workshop. the NRC staff At its meeting on May 10.1991, the 8

concluded the follo  :

^8""e"e'pmp'"os'ed (1)he JCAHO st rds are nearly (6)If adons am ACMUI management recommended that ru or quality assurance no quelltfe required to be adopted y the equivalent to the diagnostic components on mdical we of g khd h mded w of the proposed QA rule with only minor f ions required to achieve

, , " * " *d','y @;'I appropriate.

no higher than Division 3. hblic Comments andNRCResponses (2)The JCAhO does not perform a & ACMUI About 3,000 les of the notice of the licensing review prior to a facility proposed rul as published in the The NRC staff presented a draft final

'""Ye wi h Ci ne h e'es'** rule, reporting requirements. and associated definitions to the ACMUI Federal Regleter (January 16,1990: 55 FR 1439) were mailed in january 1990 to all However, the ]CAHO awards accreditation only after a facility survey, during a public meeting on January 14 applicable licensees under to CFR part (3) The JCAHO survey process is and 15.1991, in Alexandria. Virginia. 38. Agreement State and Non-partially equivalent to the NRC The ACMUIis an advisory body, Agreement State agencies, professional inspection process with the significant currently composed of physicians, associations, and other interested difference being the amount of time medical physicists, a radiopharmacist, groups spent in the specific departments; that and a technologist, established for ne NRC received 79 comment letters is.in most cases the NRC spends advising the NRC staff on matters from many different sources in response involving the administration of to the proposed rule. In terms of the considerably Overall, althomoreh the ]time' CAHO byproduct material and radiation from types of organizations, there were 52 byproduct material.The ACMUI comment letters from hospitals and accreditation app ies to the entire professional hospital and the NRC license would devoted one and a half days to a line.

by line discussion of the draft final rule, clinics.12 associations,6 fromfrom Agreement State or only apply to the radiation therapy and reporting requirements, and associated nuclear medicine de artments, the two local government agencies (11etter definitions.The NRC staff also met with contained comments from 5 Agreement processes have simi er objectives.

a Subcommittee of the ACMUIin a States). 3 from pharmacies, and e from The Agreement States public workshop on March 26,1991,in individuals. In terms of professions, the St.14uis Missouri. to discuss the same tally is 32 from physicists or he NRC conducted public workshops topica.no major ACMUI technologists as from physicians,8 from with representatives of the Agreement recommendations on the draft final rule Pharmacists, and la others. Forty seven States on March 14.1900. December 18 as of March 1991 are: setters (e0 percent) opposed the and 19, teso, and February 7 and 8,1991.

De workshops were held in Rockville, (1) Do not include diagnostic proposed rule. Twenty eight letters (35 components and associated definitions percent) did not specificaJy indicate Maryland:Irving. Texas: and San in the final rule. support or opposition for the rule, but Mateo, California, respectively. The did suggest modifications. Four letters (5 (2) Retain the therapy components following Agreement States were and the use of a " written directive." percent) supported the rule.

represented at one or more of the (3) Do not use the word " prevention" General categories of public workshops: Alabama, Arkansas, because it sounds too absolute, cornments and NRC's responses are California, Illinois, louisiana, Maryland, (4) Do not include any assessment of presented below. in Section IV entitled New York, Rhode Island. Texas, Utah, the patient's ptsgnancy and nursing " Discussion of Final Rule Text."

and Washington. A representative from status in the objectives of the final rule, modifications of the proposed rule that the City of New York also attended two (8) Use the term " reportable event" are due,in part, to specific public workshops.The Agreement States that instead of" misadministration."

comments are indicated. Some comment provided written comments that were (8) Add a dose threshold criterion for letters also addressed items in the draft incorporated into the record during the reporting diagnostic events, such as the regulatory guide. The comments on the San Mateo, California, workshop were dose to the patient exceeds 5 reme regulatory guide will not be discussed Alabama, Kentucky, Nebraska, North effective dose equivalent. here, but they were considered during Dakota Oregon, and Utah.ne (7) Do not include " unintended dosage the preparation of the final regulatory proposed QA rule (and subsequent draft to en embryo or fetus or to a nursing guice, revisions). definitions, reporting infant" as criteria for a reportable event. (1) Many commenters stated that the requirements, and regulatory guide were (s) Change the time period for patient quality assurance rule represents an discussed.De Agreement States notification of a reportable event from unwarranted intrusion into the prac ice provided line-by-une recommendations. 34 hours3.935185e-4 days <br />0.00944 hours <br />5.621693e-5 weeks <br />1.2937e-5 months <br /> to 15 days to allow adequate of medicine.They stated that the NRC 36-SC 15 September 29,1995

PART35 e STATEMENTSOFCONSIDERATION should canoontrate its eNorts on proposed rule would have little effect on cost effective fee., deleting the g radiation protection. reducing the reported mistakes. Almost diagnostic components of the proposed Response. He NitC that any all commenters supported the pal of rule). Considering that several proposed intrusioninto medical to reducing mistakes and stated that most provisions or actions have been effecting patients sh be =lan=i=ad. facilities already have good quality eliminated,i.e written diagnostic ne purpose of the rule, however. is not assurance programs.In fact, some referrals, diagnostic events, specific to limit the authorised user, but to a====iters pointed out that the investigations by the Radiation Safety ensure' that the licensee esiahhaham frequency of reported mistakes is Officer, and reports to licensee

, . - - - a lo control the ad='a'as stian already small and that the proposed rule management on diagnostic events, as of byproduct material or radiation from could not substantially reduce that well as the adoption of other byproduct material.De rule frequency. suggestions and the performance-based concentrates on the question of whether a roach, the NRC believes that the cost Assponse. N NRC has analysed the gectiwnem of the final rule has been each administration of byproduct reported mistakes involving byproduct material by the healthcare workers. material since 1980.N results of the OPtimised. Also, refer to the response to upon whom the authorised us" analyses suggest that the major causes commnt 2. abm.

depends. ls. in fact. administered as are insufficient supervision, deficient (4) Many commenters stated that the directed by the authorised user.h procedures or failure to follow dem to pauenu fra mistekn in NRC recognises that radiation therapy is proceduru,inadequk training. w diagnostic nuclear medicine a dynamic prooses and that the inattention to details. Although the rate administrations, empHhm autnorised user has the right and the has been very low, the number of procedures involving either sodium moponsibility to modify a previously reported mistakes in therapeutic iodide I-125 or I-131, would not result in

"'*'" 8"*II" administrations in 1900 was almost any measurable effect to the patient.

tmatunt, depen [a.'I*' ""U""I'4 suggested that the requirements on of the patient.N Qupon &ethat C believes progmes double the average number for previous the ow-risk diagnostic procedures be requiring a heensee to ensure that the F**", *g stated in b NRC's poucy shminated.

process of administering byproduct Statement on Medical Uses of Aesponse. %e NRC agrees with this meterialis conducted as directed by the Radioisotopes, the risk to the patient comunent and believes that the authorised user is directly related to the can be significant for mistakes involving diagnostic use of radiopharmaceuticals radiation protection of the patient and all therapeutic and certain diagnostic is,in most cases, an area of relatively does not constitute an unwarranted procedures.hmfwe, the licusws low radiation risk to patients.De intrusion into medical judgments

• should make every effort to prevent ACMUI also advised the NRC that the The Commission notes that similar mistakes in therapeutic administrations. diagnostic components should be comments were raised by members of De NRC believes that after a licensee ehminated from the final rule on the the medical community on the implements the quality management basis of cost wmus befit Commission's original proposed (QM) program, most mistakes will be omidwatim.Thus, the QM petion of t misadministration reporting rule Jetected and corrected, thus minimising the final rule does not contain any I published for comment on July 7.1979 the occurrence of misadministration. &agmuc canpents fu low risk (43 FR 20297). For the reasons stated in (See comment 6 regarding the use of the radiopharmaceuticals. However, the the notice that accompanied the final term " quality management program." Anal rule stains mpeting mquiments misadministration rule on May 14.1980 instead of " quality assurance program.") for deviations that exceed specific dose (45 FR 31701). the Commission believed Derefore, to ensure adequate patient thresholds and requirements for higher that these requirements were justified to safety it is necessary for the NRC to risk radiopharmaceutical identify the causes of require licensees to implement a QM administrations, such as either sodium misadministration in order to correct m sufficient to ensure that the iodide I-125 or 1-1811n quantities them and prevent thett recurrence. This roduct material or radiation from smate than 30 micmeurin.

view was consistent with the byproduct materialis administered as (6) Many commenters stated that the conclusions of a review performed by directed by the authorised user. JCAHO and other professional the General Accounting Office (EMD- h NRC realises that it is impossible associations, such as the ACR and the 79-te; January 1979) which stated: to prevent all mistakes, but beheves that AAPM, are committed to quality "In our v=w. requiring medical beeneses to bcensees should do their best to avoid answam in awdicine.They further report misadministration to NRC is not an them.The rule will emphasise the stated that because these organizations intrusion into medical practice. This le clearly importance of a QM program and the have developed quality assurance consistent with NRC regulatory need for each worker to participate in programs to be used as voluntary responsibilities and a necessary part of an the propram. standards and that many medical effective nuclear medicine regolatory (3) seany commenters stated that h facilities are already using these program. Withut this kind of feedback on programs, this rule is unnecessary. Also, cost ofimplementing the proposed rule incidente affecting the pubhc health and commenters suggested that the NRC safety. NRC cannot be sure it is adequately would be high with little potential for a

- ' reduction in mistaka should consult with these organizations D"8'Ibe commenters stated that the in the development of the rule and n in med p c . abould permit the use of the voluntary Isaplementation of the proposed rule De Comunission reaffirms these cannot be justified, standards in place of the rule to avoid conclusions in promulgating the Jtesponse. In light of the public duplicate efforts.

requirements in today's notice and notes conunents, lessons learned from the Response. Since the standards that, contrary to the views expressed a of program, and recommendations developed by profusional apociations decade ago on the potentialimpacts of the professional associations and are voluntary and since not all the misadministration requirements, the ACMUI. the proposed rule has been healthcare facilities are accredited by experience with thne mquirements to modified significantly to reduce cost date has not shown the reporting and

[CAHO. there is no guerrntee that all without significantly reducing the level consee facilities will have a QM notification requirements to be a of protection. De proposed program. Bis rule is designed to ensure problem or an unreasonable burden on requirements that would have had that each applicable licensee will ) ;

the regulated community. minimalimpact on risk have been implement a QM program. It is possible (2) Some commenters stated that the ehminated to make the final rule more that the NRC may endorse one or more September 29,1995 35-SC 16

i PART35 e STATEMENTSOFCONSIDERATION of the voluntary standards in regulatory such as overexposure resulting in death program, and the recommendations from t_ guides in the future. or serious injury.De comumenters public conunents and the ACMUI.the

\ In response to the second suggestion, further stated that " misadministration" organ threshcid of 50 rems dose es discussed in Section III of this has a negative connotation that implies oguivalent and a whole body threshold Supplementary Information, the NRC willful or gross negligence on the part of of 8 reme effective dose equivalent were did meet with JCAHO and seven the physician and other hospital adopted as thresholds for identifying professional associations in 1990 and workers. Terms such as events. snisedministrations.These levels discussed ways to improve the proposed unscheduled events. Incidents, or _.j to a threshold well below rule.Moreover many of their deviations were suggested as preferred the onset of acute, clinically detectable suggestions were incorporated into the replacements. adverse effects that may be caused by finet rule. Response, ne NRC disagrees with a ure to ionising radiation (refer tu in response to the third suggestion. this comment.De term Commentary No. 7.

since this is a performance-based rule a " misadministration" correctly conveys " Misadministration of Radioactive By-licensee using a voluntary program may that a mistake in the administration of product Material-Scientific not need to replace its existing program. byproduct material or radiation has Background." National Council on rather only supplement it, thereby occurred. It is neither pejorative, nor Radiation Protection and Measurements, ensuring that the ob}ectives of the rule does it connote wrongdoing or Bethesda, Maryland, July.1991). Also, cre being met.Thus, the use of a malpractice, merely that byproduct these levels correspond to the annual performance-based rule is intended to material or radiation from byproduct dose limits in the new to CFR part 20 for eliminate duplicate efforts. During the material has, for whatever reason. not occupational workers which are pilot program, the volunteers were been administered as directed by the thresholds for reporting overexposure esked about their existing QA programs authorized user. Therefore, the term to the NRC.Derefore, the Commission cad the amount ofincremental work or " misadministration" and its definition, believes that applying these same l cost required by the proposed rule.The modified as indicated in raponse to thresholds to reporting of exposures to volunteers responded that they were comments (8) and (9) below, have been patients in excess of what was intended ciready meeting most of the objectives retained. In diagnostic administrations is in the proposed rule as part of their (8) Some commenters stated that the reasonable.

cxisting QA programs. Thus, the proposed definitions of diagnostic (10) Many commenters stated that the incremental burden on most volunteers misedministrations, therapy occurrence of a misadministration may appears to be small. and that is misadministration, diagnostic events, not necessarily be an indication of an expected to be the case in general for and therapy events and the associated inadequate QM program.The the typicallicensee. sePorting requirements are overly commenters stated that,in fact, the (8) Many commenters stated that the complex and thus confusing ne identification of misedministrations i term " quality assurance" should not be commenters recommended that these could be viewed as evidence of a good used in this rule. Quality assurance, as definitions be simplified. QM program. Based on the " Patterns of used in all departments of a hospital,is Response. The NRC agrees with this Care Study." those hospitals with a program to ensure that high quality comment. Based on the lessons learned superior personnel and facilities had the medical care is provided to the patients. from the pilot program, suggestions highest cure rates. Why would one In a nuclear medicine or a radiation made by the professional associations, conclude that the hospitals with the oncology department, quality assurance the ACMUI. and the Agreement States, lowest cure rates have adequate means responsiveness to perceived care the termiulogy was simplified by (a) monitoring programs to detect needs. degree of symptom relief, degree using only two terms. " recordable misadministration or have adequate to which the care is the technical state events" and " misadministration." and QM programs? In particular, facilities cf the art, efficient we of funds (b) moving the definition of all terms to that never report misadministration available, appropriate we of health care 6 35.2. (The terms recordable event and sney not have adequate QM programs misadministration, as defined therein, for the detection of those resources, etc., as well as administering will be used in subsequent discussions misedministrations.Thus, it is not the byproduct material as directed by m this final amendment.) necessarily correct to associate good the authorized user.The commenters (9)Many commenters stated that the l . QM programs with no recommended that a different term be PNPmd laul current) dose thresholds, l

wed in this rule to indicate that this rule misedministrations or to suociate 1 1.e en organ due greater than 2 rems or inadequie QM programs with the l cddresses only the delivery process og a whole body dow greater than 0.5 som. occurrence of a misadministration.

l administering byproduct material. are too restrictive for determining Furthermore, the commenters stated that l Aesponse. The NR whether to subm't a report to the NRC. the rule may discourage licensees from comment.The term ,C agrees with quality assurance this.,

ne commentere, stated that at these reporting misedministrations.

has the wrong connotation became dose levels, ti'ere are no biological Aesponse. The NRC agrees that the l under JCAHO it applies to the entire effects to the patient. They further occurrence of a misadministration may hospital. Since this rule addrenes only stated that many commonly used not necessarily be evidence of the process of administering byproduct nuclear medicine diagnostic procedures inadequate QM. However, for example, material, the term " quality management routinely produce doses to nontarget either a case of gross negligence or a program"is used in the final rule to organs in the range of two to eight rems. case of multiple misedministrations l preserve the quality concept and avoid Clearly, these routine procedures should could be considered a lack of sufficient I confusion with the existing " quality not constitute misedministrations. licanoes management attention in casurance" concept. The term quality Aesponse. De NRC agrees that implementing ite QM program. With management (QM) program will be used routine doses from diagnostic regard to reporting misedministrations.

in subsequent discussions. procedures represent a small amount of the Commission encourages licensees to (7) Some commenters responded to risk to the patient. Similar comments proraptly identify and report safety the NRC's question, stated in the were made by professional societies and problems as reflected in the current Federal Register notice, concerning the the ACMUI. Further, the ACMUI enforcement policy. Furthermore.

l proper use of the term recommended a whole body threshold because the NRC wants to encoursge

" misadministration." that it should be of 5 reme effective dose equivalent. and support licensee initiative for self-reserved for the most serious incidents Based on lemons loomed from the pilot identification and correction of 35-SC 17 September 29,1995 l

1

1 PART85 e STATEMENTSOFCONSIDERATION Policy and Procedure for NRC Port M-MedicalUse ofByproduct problems, the NRC may exercise enforcement discretion if certain Enforcement Actions Material )

cedities am a aM As stated in the proposed rule notice, Section 35.2 Definitions

) Some commenters questioned the Commission views tim occumace d To consolidate the definitions, all whether the NRC has enough quellAed misadministratius as a subject of definitions were moved to i 35.2. Based l concem in the medical use of byproduct on the public comments, lessons learned

.I to inspect QM programs in the material and, in certain circumstances, boepitals, chnics, or private from the pilot program, and precuceofhow may subject the licenne to enforcement recommendations from ACMUI.the I

action. Supplement VI of appendix C following proposed definitions have Aasponse. In scent years, the NRC was modified by amending current been deleted from the final rule: Basic has incmased its mcmitant d examples dealing with Quality Assurance. Diagnostic Event.

- n " who have experience and misadministretions and adding specific. and Diagnostic Referral.The other hwiedge either in nuclear medicine or examples of violations of the QM definitions were adopted with some in radiation therapy. inspectors will be program.no examples added to part 2 modifications and are discuned in trained in all aspects of the rule and the of the Anal amendment are essentially alphabetical order, regulatory guide and will be previded the same as in Section V. Diagnostic ClinicolProcedures with specific inspection guidance. " Enforcement." of the proposed Manual.This definition has been l

! Accordingly, the NRC believes that it amendment with the following modified as follows:

has enough qualified inspectors to modifications: 0) ne word " diagnostic" was added conduct deq t pections (1) At severity Inveilli, the term to clarify that this term only applies to assoc .

" misadministration"is used to replace diagnostic procedures.

two proposed terms. " diagnostic (2)The proposed phrase "in a single IV, rum saa of Final Rule Text mindministradons",,and " therapy binder" was deleted to permit the use of misadministration. multiple binders.

This section discusses the final rule (2) At Severity 14 vel!!!. the example Misodministmtion. The term c:xt and tlw modincations made to the " failure to conduct adequate audits of a " misadministration" as used in pmposed rule. nroughout the following QM program or take prompt corrective proposed i 35.2 and described in discuulon. mferring to the text of t" actions for deficiencies identified proposed il 35.33(b) and 35.34(b) has Anal regulations may aid in through each audit"is moved to Severity been retained. Table 2 provides a understeading the specific points of this g,velIV. Also, the phrase " annual summary of the mistakes captured by discussion. review"is used instead of the proposed the terms " misadministration" and word audit to conform to the rule " recordable event." although the aort 2-Aules ofPmeticeforDomestic language in the final amendment. requirements themselves should be Ucensing Pmceedings l (3) At Severity LevelIV " failure to consulted for the precise definitions of Appendix C. General Statement of keep records"is added as an example, these terms.

l l TAsLE 2.-MISTAKES CAPTunED sy THE TEnus "REoDnDAsLE EVENT" AND *MisADuNsTRATION" l me.orese,s .wr. u.somresee n er.cee,e j

as Deonese,asees ne me.e.e .r - . wrong p.non- e.es. .r sonese .n, og <30 po Nat. Stas or k131). e Ones >s rom E#eceve Does Eenveiern or to som to ereen-eseum iness menosmermeasuecame tenere o Adme eneses eners W >10% arenar eseess e wrone poesnt

> 30 p0 Nel bits or k131). mne >1s pCL e Wrone remopherm I e Aoun eneses eners try >20% presor sneese ane >30 e w/o 0 w,o omne.n easy o erecen se - ,c<

l Theressume meananormoomenene e Aemn sosses eners my >10% prescr aussee.- . o wrono pesant a w/o onesa erecew e wrono reensherm e w/o easy monese record a wrone roes of somn o Aemm sosses eners by >30% premer esesos l Tessmerapy e Colodeted wasmy some 1s% >presor does e wrono potent

( e w/o unnen ereceve e wrone made of ensemars i e w/o seer esse record e wrons mesenent one e r *= moeu meser 30% >preser moes e Cainuisied total enes eners by >20% total pract enes e N <3 esceans, esic tosel does eners try >10% total presor sees trashymerapy e Caic enes enere by >10% preest some. e Wrorg potent a w/o wnnen erecen a wrone r===~ ara o w/o easy eene eeoord a wrone meetment ene e tes=no sources e Femure to remove sourose for a tensorary emplant e Cascuested neun eene enere my >30% presor ease Gamme Storestacec Redesurgery 3 w/o uniten erecewe e Wrorg pseont e W/c desy does record e Wrene essenent see e.r-.es.tem apren eene e,. ore ., >1.s em - )

september 29,1995 35-sc 1e

RMIT85 e STATEMENTSOFCONSIDERATION Six categories of misadministration among the organs or tissues. including three fractional doses of 400 rede each

, cre defined in the final amendment. the target organ. For example, a fraction. One undesirable complication g Parapaphs (2) (3). (4). (5) and a part of frequently used therapeutic of a substantial overdose (e.g., so

\ paragraph (1) replace therapy radiopharmaceutical and route are percent greater than the prescribed misadministration as propond in sodium phosphate p-a2 given . dose) for this treatment might be B 35.34(b). Paragraph (e) and a part of intravenously, which is preferentially radiation pneumonitis or even death.

paragraph (1) replace diagnostic taken up by the target organ, the Derefore, such events need to be misadministration as proposed in skeleton.De only way the wrong organ promptly reported to the NRC and i 35.33(b). could be targeted is if the wrong addressed by the licensee.

Each category of misadministration rednopharmaceutical or route of Paragraph (4)(111) replaces proposed under this definition is discussed here in administration were used. Both of these 6 35.M(b)(3)(ii), with the exceptions of the same sequence as it appears in the errors are already included in the (a) the phrase " weekly dose"is used definition of misadministration in i 35.2 definition of a misselministration.Dus, instead of " fractional dose" and (b) the of the final rule. the wrong target organ is redundant. phrase "30 percent greater than the .

(1)nie paragraph appiles to any Paragraph (2)(11)is the same as weekly prescribed done" is used instead p d i MM4 d b of greater than twice or less than one.

30 mi of el er ium i exception that the thrnhold is now 30 half of the prescribed fractional dose."

1125 orI131 Para pacent fw the same reasmsa m =aad Dese changes allow a weekly h (1)(1)is above. in category (1) of essentially th'e sam a the comparison with the prescribed dose misedminletration, because many excellent therapy corresponding items in proposed phrases (3) This par sph applies to samma departments currently utilise a weekly Gwrong 35.34(b)(1).

target organHowever, and stereotactic the,' wrong route refoeurgwy and replaces a chart check and the ACR recommends a part of proposed I $ 35.34(b)(1) and weekly check. Recall that if the weekly cf administration

• were deleted because the thyroid is the only target organ for 35.34(b)(3). Paragraph (3)(1) is essentially administered does exceeds the weekly the same as in proposed 3 35.34(b)(1) prescribed dose by more than 15 sodium lodide end it concentrates in the with the exception that the phrase thyroid regardim of the route of percent a recordable event has

" wrong sealed source" was deleted occurred,which the licensee will administration. Paragraph (1)(ii) is the because the device used for this type of respond to internally to the institution.

same as proposed i 35.M(b)(2) with two procedure contains only cobalt so modifications. First, the threshold is Since the licensee should be detecting sources. the smaller weekly deviations and now 30 percent. instead of to percent. Paragraph (3)(11)is the same as taking appropriate actions. calculated Recall that if the administered dosage proposed i 35.34(b)(3)(i). The threshold weekly administered doses that are 30 differs from the prescribed dosage by of to percent for the total dose was percent greater than the weekly more than to percent. a recordable retained because a large radiation dose prescribed doses will be reported svent has occurred that the licensee is is administered during the procedure, because they could possibly indicate a required to respond to internally within and therefore, deviations greater than 10 deficiency in the QM program, which the institution. Since the licensee is percent may have greater safety could be of prester safety significance, detecting these smaller deviations and significance and need to be reported to rather than because they necessarily t: king the appropriate actions, these NRC and promptly addressed by the indicate a risk to the patient. However, svents do not need to be reported to licensee. calculated weekly administered doses NRC. However larger deviations that (4)This paragraph applies to that are less than the weekly prescribed exceed 30 percent are required to be teletherapy and it replaces proposed doses will not be reported because the reported because they could possibly 6 35.34(b)(3) and a part of 6 35.M(b)(1). criteria for the total doses capture indicate a deficiency in the QM Paragraph (4)(1) is essentially the same significant deviations.

program. not because they necessarily as in proposed i 35.34(b)(1). but uses the Parapaph (4)(iv)is the same as indicate a significant risk to the patient. phrase " wrong mode of treatment." proposed i 35.34(b)(3)(i), with the For these reasons, the threshold was rather than " wrong sealed source." nie exception that the threshold is now 30 increased to 20 percent, change is intended to clarify that percent. Since the licensee is monitoring Secondly, an addit onal threshold of klethwapy misadministration capture weekly dose deviations and taking 30 microcuries is added. If the difference the use of the wrong sealed source, as appropriate actions, a deviation from a between the administered dosage and well as such events as a patient total prescribed dose that exceeds 30 the prescribed dosage is 30 microcuries receiving cobalt 40 teletherapy when percent will be reported because it could or less. it is not reported even if the linear accelwater therapy was possibly indicate a deficiency in the QM difference exceeds 30 percent.This prucribed. propam, which could be of greater cdditional threshold was added to avoid ParagraPhs (4)(11) through (4)(lv) esfety significance, rather than because the unnecessary work associated with replace proposed i 35.34(b)(3). The it necessarily indicates a significant risk the generation of reports on events with phrou **calculakd adminiskred h" tient small differences and that pne replaces the proposed phrase to(5)theNe par.apaph applies to relatively minor risks to the patients. " administered dose" to clarify that a brachytherapy and it replaces proposed measured dose is not expected. 8 35.34 (b)(4) (b)(5), and part of (2) This paragraph applies to any paragraph (4)(li) applies to teletherapy I 35.34(b)(1). Paragraph (5)(1) is the same therapeutic radiopharmaceutical treatments with three or fewer fractions, as in proposed i 35.M(b)(1) with the administration except those involving it is the same as proposed following two modifications:(a) De sodium iodide I-125 or 1-131. Paragraph I 35.34(b)(3)(i).%e threshold of to phrase " wrong radioisotope" replaces (2)(1)is the same as the corresponding percent for the total dose was retained the phrase " wrong sealed source" and items in proposed i 35.34(b)(1). De because these procedures involve larger (b) a parenthetical note for permanent phrase " wrong target organ" was radiation doses per fraction than implants was added to clarify the intent.

deleted because the ures with more than three radiopharmaceutical(i.e the correct " Radioisotope"is a more specific tum etions, and thus deviations greater than " sealed source." For permanent chemical compound) and the route of than 10 percent may have greater safety implants, the intent is to exclude from administration determine the significance. For example, a hemi body the determination of the wrong distribution of byproduct matwiel teletherapy treatment might involve treatment site seeds that were 35-SC 9 Septemtser 29, #95 1

PIMIT35 e STATEMENTS OFCONSIDERATION implanted in the correct site but the NRC. Recordoble event. The tenn migrated outside that site. (c)ne phrase "ifit involved the un " recordable event" mplaces " therapy paragraphs (5)(11) and (5)(111) are of byproduct material not authorised for event" as defined in proposed i 35.34(a). l essentially the same as proposed medical use in the license" in proposed The term " recordable event"is used to 135.34(b)(4).De phrase "one or more $ 35.38(d) was deleted because it is indicate that a record and not a report is sealed sources that are not removed na--y. Under current regulations required. A recordable event is upoo completion of the procedem"was at to CPR 35.13. licensees are required evaluated by the licensee pursuant to used in (5)(111) instead of the proposed to amend their licenses prior to using i 35.32(c) of the final amendment. The phrene "is lost or is unrecoverable byproduct material not authorised phrase "any therapeutic medical use not during the brachytherapy treatment." to decir knanama and at 5 30.41(c). the authorised by the license"in proposed se **is lost or transferring the byproduct i 35.34(a)(4) was deleted, because under clarify the intent.De uced confusion material must verify that me transferee current regulations at 10 CFR 35.13. the is unrecoverable" among the pilot program volunteers, la authorised by license to receive the licensee is required to amend its !! cense whereas, the phrase "is not removed type, form, and quantity of byproduct prior to using any byproduct material upon completion"is clear and was materialto be transferred. not authorised by its license; and at to recommended by the professional (d) De phrase " administration of a CFR 30.41(c), the licensee transferring dosage differing by at least fivefold from the byproduct material must verify that associations. the transferee is authorized by license paragraph (5)(iv)is the same as the prescribed dosage"in proposed 135.38(d) was replaced by dose for the receipt of the type, form, and proposed 6 35.34(b)(5) except that the thresholds for the same reasons as quantity of byproduct material to be phrase " calculated administered dose" discussed in item (b) above. transferred.

was used instead of" administered Each type of recordable event under dose" to clarify that a measured does is Aescrihet/dosqpe his definition has been modified as follows: this definition is discussed in the same not expected.

Note that, as specified in the (1)ne proposed phrase "before sequence as it appears in the definition definition of prescribed does for administration of the of recordable event in i 35.2 of the final radiopharmaceutical" was deleted rule:

brachytherapy.providing the total (1) The phrase " written directive" was source strength and exposure time may because it is part of the definition of

" written directive;" thus, it is redundant. und to replace " prescription." Also, the be en alternative to providing the total dose. However, this alternative does not (3) De proposed word " prescription" phrase "a prior review of the patient's was replaced by " written directive." The case by an authorised user or a cpply to high-dose-rate remote physician under the supervision of an afterloading devices because the total reasons for the change are provided authorised user."in proposed dose must be specified prior to under the discussion of written I 35.34(a)(1), was deleted because if an beginning the treatment. directive.

(3)The proposed p'.rese "if the authorized user signed the written (6)This paragraph applies to any directive, the phrase is not necessary, diagnostic administration of a procedum is perforraed pursuant to a (2)This type of recordable event, radiopharmaceutical other than sodium diagnostic referral" was deleted. A new without daily recording, is enentially )

iodide I-125 or 1-131. in quantitles phrase. "or in any e.ppropriate record in the same as published in the proposed gruter than 30 microcuries. This type of accordance with the directions of rule with only minor editorial changn.

misadministration is similar to the authorized user for diagnostic (3) We type of recordable event. in diagnostic misedministrations in procedures." was added to clarify that which dosage differs by more than 10 proposed il 35.33(b) and 35J3(d). an authorised user may direct any Percent, applies to any administration of However, there are several differences: diagnostic procedure that was not quantities greater than 30 microcuries of (a) The phrase " wrong organ"in included in or departs from the either sodium iodide I-125 or 1-131. This proposed i 35.33(b)(1) was deleted diagnostic clinical procedures manual as recordable event is the same as in because the radiopharmaceutical(i.e long as the prescribed dosage is proposed i 35.34(b)(2) but with an the correct chemical compound) and the documented in an appropriate record, additional threshold of 15 microcuries:

route of administration determine the bescribeddose. This definition has 1.e.. if the difference between the distribution of byproduct material been modified as follows: administered dosage and the prescribed among the organs or tissues, including (1) Gamma stereotactic radiosurgery dosage is 15 microcuries or less. It is not the target organ as described previously was added to this definition. Although a recordable event even if the difference for " recordable event." be exceeds to percent. This threshold was this type oftoprocedure considered be a single mefraction (b) The thresholds for reporting in added to avoid unnecessary work proposed i 35.33(d), "a whole body dose teletherapy procedure,it is listed because of the generation of recordable greater than 0.5 rem or an organ dose separately from teletherapy to allow for events cound by small differences (e.g greater than 2 rems." were changed to the differences between the two. if the prucribed dosage is 35 "an effective don equivalent of 5 reme (3)N phrase "as documented in the m acuries, and the administered or a dose equivalent of 80 rems to any written directive" was used to clarify dosage is 40 microcuries, the difference individual organ"in the final where the actual prescribed don is exceeds to percent but does not exceed amendment. Both the public comments recorded. 15 mincudes; thus. Ms not a and the ACMUI recommendations (3) For brachytherapy, the phrase "the total source strensth and exposure time rec rdable event).

suggested that the dose thresholds used (4) This type of recordable event in for reporting should correspond to some was used to spectly an altamative way which dosage differs by more than to kind of biological e ificance. hee of defining the total dose. This phrase also calls attention to the importance of percent, applies to radiopha,rmaceutical thresholds are well low the don therapy. other than sodium sodide 1-125 levels that would cause some harmful or the exposure time.For temporary or 1-131. and it is the same as in detrimental deterministic effect as implanta. efter the sealed sources have proposed i 35.34(b)(2).Ms. if the opposed to a stochastic effect. hoe been implanted and the appropriate calculations performed, administering administered dosase differs from the thresholds correspond to the annual prescribed dosage by more than to don limits .a the new to CFR part so for the correct prescribed dose becomes a percent. it is a recordable event. If the occupational workers, which are matter of removing the neled sources difference exceeds 20 percent. It is }

thresholds for reporting overexposure to on time (e.g., after og houre).

September 29,1995 36-SC 20

PART35 o STATEMENTSOFCONSIDERATION handled se a misadministration. to b adminletration of a dennition d prescription.His (5) Dis type of recordable event, a radiopharmaceutical or radiation. paragraph mquires the authorised user jj wrong radiation does, applies to teletherapy and is similar to the paragraph (1) applies to any to specify, befom implantation, the lg administration of quantities greater than radioisotope, the source strengths, and proposed i 35.34(a)(3) with the following 30 microcuries of either sodium lodide the number of sources, but does not

! modifications: ' l-125 or 1-131. Die paragraph is require the total does because detailed (e)The phrase " calculated weekly essentially the same as paragraph (b) calculations am required to determine dose" was used to replace " fractional under the proposed definition of the total dose after the sources are dose" to allow a weekly comparison prescription, with the exception that the implanted. However. following with the prescribed dose because many phrases "the radioisotope" and implantation but before completion of therapy departments currently utilise a " physical form. chemical form. and route the procedure, the authorised user must weekly chart check and the ACR of administration" were deleted.%ese specify, among other parameters, the recommends a weekly check: phrases are unnecessary because after total source strength and exposure time.

, (b)De word " calculated" was added specifying either sodium iodide M25 or If the authorised user prefere. the total i

13 the weekly dose to clarify that a 1-131. specifying the radioisotope and does may be used instead of the total measured dose is not expected; and the chemical form would be redundant. source stres gth and exposure time.his l (c) The dose threshold was decreased The route of administration is not change, using total source strength and i

ts 15 percent of the weekly prescribed necessary because sodium iodide will exposure time, provides an easy way of dose instead of the proposed 20 percent always concentrate in the thyroid, specifying the total does and simplifies of fractional dose to be less than the regardless of the route. the determination of a l

misadministration threshold for the total raragraph (2) applies to any misadministration. Since the total administered dose. therapeutic administration of a source strength is Axed when the (e) nis type of recordable event, also radiopharmaceutical, other than sodium sources are implanted. delivering the

, a wrong radiation dose, applies to iodide M25 or I-131.His paragraph is prescribed dou is a matter of using the brachytherapy and parallels item (5) essentially the same as paragraph (b) cornet (i.e prescribed) exposure time.

i above. If the calculated administered under the proposed definition of in other words, after implanting the d:se differs from the prescribed dose by pmscription. with the exception that it cornet sources, the exposure time (and m:re than to percent,it is a recordable uses the phrase "the total dose) will be correct if the sources svent. If the difference exceeds 20 radiopharmaceutical"instead of the are removed at the right time.

percent,it is handled as a phrase "the radioisotope, physical form, misadministration. As previously and chemical form," because the word Section 35.8 information Collection discuued under the definition of radiopharmaceutical includes the Requirements:OMB Appr.M l priscribed dose for brachytherapy, the d ois e icalform The y pe a,nd

, Paragraph (b) of this sect on was tstal source strength and exposure tim modified by adding i 35.32 to the list of m2y be used as an alternative to the the route of administraHon must h 8pe ifi d sections that contain information total dose, except for the high-dose-rate collection mquiments.

Paragraph (3) applies to gamma mp r i ple o 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />. ven stereotactic radiosurgery. This definition Section 35.25 Supervision that the total source strength has been W88 Separated from teletherapy in order his section was not in the proposed implanted and is therefore a fixed value, 'yorm M ho th mle. It is not necessary to Publish this i d be cluded in a recordable event has occurmd if the revision for public comment because the

, a written directive for this procedure.

sealed sources are not removed within mvisions em confirmatory tri natum. In Paragraph (4) applies to teletherapy

! plus or minus 4.8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> from 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />. the revised i 35.25(a)(1), the phrase "and procedures. This paragraph is the same Written directive. This term replaces as paragraph (c)in the proposed in b licensu's wnuen qualHy the word " prescription" as defined in definition of prescription with the management program" was added to  ;

proposed i 35.2. Based on the lessons following modifications: (a) The phrase require each licensee to instruct the l lertned from the pilot program and " dose per fraction" replaces the phrase . supervised individual in the procedures suggestions made by the professional of h qualny manageurn pmgrain.

" number of fractions" to emphasise the associations, the Agreement States, the Also in the revised $ 35.25(a)(2), the dose to be delivered in a single fraction ,

ACMUI, and the pubhc comments, the and (b) the phrase "overall treatment phrase " follow the written radiation  ;

term " written directive" should be used period" was added to emphasise that safety and quality management  ;

to avoid any potential confusion with the treatments will end after the procedums established by the licensee, i existing medical practices or the specified number of weeks, unless the mplaces the phrase " follow the commonly used definition of treatment period is revised by the Procedures established by the Radiation j prescription. authorized user prior to continuing. Safety Officer" to clarify that the j in the introductory paragraph, the Paragraph (5) applies to procedures in both the radiation safety proposed phrase "or a physician under brachytherapy using high dose-rate Programs and in the quality the supervision of an authorized user" mmote afterloading devices.This management program will be .

was deleted because such supervision is definition was separated from other established by the licensee and must be i already allowed under the current brachytherapy procedures because of followed by the supervised individual.

I 35.25 entitled " Supervision." Thus, this the need for the written directive to Replacing the phrase "the Radiation

phrase was redundant and unnecessary- specify the total dose, along with other Safety Officer" with the phrase "the l

Also in the same paragraph, the phrase parameters, before administration of the licensee" is essentially no change since

" administration of byproduct material" radiation because the time period for the Radiation Safety Officer is employed replaces the phrase " medical use," and exposure is very short when compared by the licensee and the licensee can the phrase " prior to the administration with other types of brachytherapy, delegate responsibihties.

cf byproduct material or radiation from Paragraph (e) apphes to byproduct material except as specified Section 35.32 Quality Management brachytherapy procedures other than in paragraph (e) of this definition" was those specified in paragraph (5) above. "8'*"'

added to clarify the intent that the His paragraph is essentially the same his section was renamed.NRC use of written directive must be prepared prior as paragraph (d)in the proposed the term " quality assurance" led to some 35-SC 21 September 29,1995

PMT35 e STATEMENTSOFCON81DERATION recomunendations suggested that each to clarify the intent (e.g ask the misunderstanding because under patient's name and also ask the patient JCAHO's accreditation programsit objective should not start with the word

" ensure" because trying to ensure that for any one of the following: birth date.

applies to the entire hospital. Since this each objective is achieved has the same address, social security number and j rule addresses only the delivery process confirm this by comparing it with cf administering byproduct material or connotation as preventing all errors. In this manner, the word " ensure" corresponding information in the radiation from byproduct material, a patient's record; or check the name on new title," Quality Ma ment produced unnecessary fruttation.nus, the word " ensure" was deleted from the patient's ID bracelet; or ask for the program."is used in the I rule to patient's signature). (b) the proposed each objective it. the final rule. Also, as pruerve the quality concept and avoid phrase "or the diagnostic referral" was discussed previously, the phrase any confusion or interference with the deleted to conform with the removal of thousands of existing ]CAHO quality " written directive" replaces the

r. j word " prescription." the diagnostic components.

coeurance programa. Also. this section (3) Objective 3 is essentially the same Bach objective retained in the Anal was designated as 3 35.32 instead of the as the proposed objective 3 with the proposed designation 5 35.35.%is rule is Aa-ad below. exception of using the phrase " final (1) Objective 11e essentially the same predesignation locates this section in plans of treatment and related front of I 35.33 and establishes a logical as the proposed objective 2 except that:

(a)De phrase " prior to each calculations"instead of the proposed esquence.nis section is very similar to administration" replaces the proposed phrase " treatment planning." he phrase the proposed i 35.35 with the following phrase " prior to any medical use" to " treatment planning" is not static and is moamcations. clarify the intent to narrowly focus on often thought of as a continuing activity la 6 35.32(a), the phrene "to provide the delivery to h patient of the of the authorized user as the patient high confidence that the byproduct material or radiation. (b) b progruses. Also, the professional material or radiation from byproduct di event types of therapy procedures, associations (e.g ACR) stated that, material will be administered as including samma stereotactic imtlally, there may be several directed by the authorised user" radiosurgery, were listed separately for alternative plans of treatment, and replaces the proposed phrases "to ease of understanding. and (c) the following a discussion between the prevent, detect, and correct the cause of phrase " sodium iodide" was added to physicist or dostmetrist and h errors in medical use" and'" errors in exclude all other lodine compounds such authorised user, a final plan of medical use will be prevented." Die as iodohippurate. which delivers a much treatment would be selected and used.

modification states the oblective of the smaller radiation dose to the thyroid as Hus, the change was necessary to QM program in a positive manner rather compared to an equal avoid confusion as to which plan than a negative manner. Also, this radioPharmaceutical dosage of sodium needed to be in accordance with the modification was made in response to written directive. Also, samma lodide.

many public comments and workshop Although many commenters stereotactic radiosurgery was added to recommendations that the word " error. guestioned the need for requiring a conform with similar changes, as is too broad, and that the proposed written directive for diagnostic discussed previously, language imp 1les that a11 errors must be procedures involving quantities greater (4) Ob ctive 4 is the same as the prevented. Also in the same paragraph, than 30 microcuries of either sodium propose objective S with the exception d I' lodih I-125 or I-131, the final rule that the proposed phrase "or a

' b s,pP capn' appl "that retains this provision.no purpose of diagnostic referral a enly to those part as licensees who this provision is to put the authorized procedures manual',nd clinical was deleted to perform procedures for which a written user in direct control of ordering and conform with the removal of the directive is required. delivering a dosage greate: than 30 diagnostic components, he following proposed objectives microcuries of either sodium iodide I- (5) Objective 5 is euentially the same were deleted in re to public 128 or 1-131.nis dosage would deliver as the proposed objective 7 with the comments and wor op about 50 rems dose equivalent to the following modifications: (a) The phrase recommendations: thyroid.However. In the reported "and appropriate action is taken" was (a)The proposed objective 1" ensure mistakes of administration there have added to clarify the intent to have that any medical use is indicated for the bun several cases of a technologist appropriate action taken after the patient's medical condition" was misinterpreting the referring physician's unintended deviations are identified deleted becane it is not necessary. request. not checking with the based on a recommendation from the When directing the administration of authorised user, and administering pilot program participants and (b) the byproduct material. It is already part of millicurie amounts of sodium lodido proposed phrase "or a diagnostic the authorised per's responsibility as a 3-131 instead of h requated microcurie referral and clinical procedures manual" physician to ensure that the amounts. Inadvertent administration of was deleted to conform to the removal administration is indicated for the millicurie quantities of I-131 can cause of the diagnostic components.

patient's medical condition. Further, the significant adverse effects to the patient. Section 35.32(b)is essentially the objectives of the QM program can such as ablating the thyroid gland or same as proposed i 36.36(b) with the nevertheless be achieved became the impatring its proper function. If the following modifications:

southorized user is required to sign a requirement for a written directive had Section 35.82(b)(1)is the same as the written directive prior to the been in effect at that time, a technologist first sentence of the proposed administration. could not administer a dosage greater i 38.35(b)(1) except for the following (b)The proposed objective 3 became &an 30:nicrocurin of either sodium changes: (a) ne word " review" replaces unnecewery after the diagnostic lodide I-tas or 1-131 without a written h proposed phrase

• comprehensive components of the QM program for most directive dated and signed by the audit" to use a term more radiopharmaceuticals were deleted (as authorized user, and thus thwe events understandable to licensees based on discussed previously). would probably have been prevented. lessons learned from the pilot (c)The proposed objective 4 was (2) Objective 2 is essentially the same programand (b) the phrase " including.

deleted becaun logically it would be since the last review, an evaluation of (i) unnecessary if the required condition of Posed ob octive 6 with the a8 foi fowing modi cations:(a)De phrase a representative sample of patient i proposed objective 6 was met. by more than one method , was added administrations, (ii) all recordable public comments and workshop

]

September 29,1995 36-9C 22

M$5 o STATEMENTSOFCONSIDERATION events, and (iii) all misadministration" consolidated and simphfied. no record the effective date of b rule.Having a {

was added to clarify the content of the retention period was shortened to three copy of the program will facilitate any review based onlessons learned from years; the proposed ten years is not inspections conducted prior to a license I the pilot program. necessary based on the current renewal date.%e proposed i 35.35(c)(3)

\ Section 35.32(b)(2)is the same as the inspection frequency. was unnecessary and was deleted second sentence of the proposed Many commenters asked about the because of the requirement to submit a 135.35(b)(1) except for the following meangof the phrase "in an auditable copy of the QM program to the NRC.

changes:(a) The word " licensee" form." ne phrees means that the i replaces the proposed phrase "heensee's beensee must be able toproduce a Section 35.33 Notifications. Reports, j management" to simplify the final rule legible record, or copy of the record, and Records of Misadministration language, and (b) the phrase "if within a reasonable period of time upon %1s section replaces the proposed required, make modihcstions to meet mquest by an NRCinspector.De i 35.33 (d) through (f) and I 35.34 (d) the objectives of paragraph (a) of this records may be maintained in any through (3). he final rule language was section" replaces the proposed phrase location or by any means. including greatly simphfied as compared to the "promptly implement modifications electronic or microfiche. proposed rule.%e definitions of within 30 days that will prevent the Section 35.32(d)is the same as misadministration and recordable event recurrence of errors in medical use" to 135.34(f)(1) with the exception that two were moved to i 35.2 and the two .

give the responsibility to the licensee for paragraphs are seperated for clarity, proposed sections il 35.33 and 35.34 l d:termining whether or when Section 35.32(e)is a simplified version were consolidated into a single section:

modifications are needed.This is in of the proposed 5 35.35(b)(2),in thus, duplicative language was evolded.

kIeping with a performance. based response to lessons learned from the Section 35.33(a) specifies the actions approach. (lot program and recommendations that a licensee must take when a the professional associations, the Section 35.32[b)(3)is the same as the misadministration is discovered and is het sentence of proposed 135.35(b)(1) Agreement Stalos. and the ACMUL the essentially the same as the combination with the exception of using the phrase Anal rule allows the licensee to modify of the proposed n 35.33(d) and i 35.34(d)

" review, including the evaluations and He QM Program 2 inemm the with certain modifications.The findings of the review"instead of the efficiency of the program, i.e., the requirement to notify the referri proposed phrase " audit and Heenm may change he QM program physician was retained because e management evaluation" to conform to provided the effectiveness of the QM NRC expects that the authorized user j the changes made in 4 35.32 (b)(1) and program is not decreased. For example, and the referring physician would jointly (b)(2) and to use terms more MPPm es hcene wm cmduchas a decide whether and how to inform the understandable tolicensees.

• • nely Miew d 6e QM pmgram patient.

pursuant to 8 35.32(b), but nbsequently Section 35.32(c) replaces the For clarity,9 35.33(a) was divided into 6 35.34(c) and a part of 6 35.34(h) posed decided to review the QM program four parts. Each part is discussed below.

pertaining to therapy events. Many twice a ym. O&w changes an (a) se Section 35.33(a)(1) requires that the commenters and participants in the puot program stated that the proposed 3h g" p, "g8d 30 days from the proposed 15 da

• to licensee notify the NRC by telephone.

Two modifications were made to the recordkeeping and reporting proposed requirement. The phrase "the requirements were too complicated and NRC Operations Center no later than allow

• 8 more d time to 7re d the c:nfusing. In the final rule, proposed requirements related to diagnostic .

, Qd C Pria the next calendar day" replaces the posed phrase "the appropriate NRC events were eliminated following apkmaldprogram fesional Office listed in Appendix D of recommendations of the ACMUI,and ted because thism&Scations requirements wasno to CPR part 30 nolater than the next the term " recordable event" replaces the longer necessary.Following the subrnhtal M se pmgram mdincadons. da proposed term "thwepy event."If a Federal During weekends Government or on holi worki7ays.y."

the recordable event occurs. the final rule se NRC has se opuon dskppI 8

• NRC Regional Offices are closed, but allows the licenne to respond to that licenses fmm conunuing 2 m d e modified program if the NRC determines the NRC Operational Center remains event within the institution, much like open.Thus. by reporting to the NRC proposed i 35.34(s), but without that the modifications would decrease the effecHvenna d &e p or se Operations Center, a licensee may make requiring that a report be written to telephone notifications any calender licensee management.The proposed oPuon of obtaining mm don,if "4"I" g- day and facilitate a timely and requirements in il 38.34(c) and appropriate response from NRC.

35.34(f)(2) for therapy events were Section 35.32(f)(1)is tha same as Secondly, for misadministration greauy simplified and consolidated in proped i 35.35(cX1) with the involving certain diagnostic dosages and this paragraph to reduce the level of e*CePtion that the brase "as radiopharmaceuticals, a notification detail and evold unnecessarily applicable was a ded to clarify that some part as licensees will not be uirement was added.The NRC burdensome costs based on lessons subject to this provision. i.e., thm Qieves that then occurnnees warrant learned from the puot program, a telephone notification to the NRC The modifications are (a) the word beensees administering byproduct of material for which a written directive is

" licensee" replaces the proposed phrases " Radiation Safety Officer" and not required.

because alsadministration therequires definition the of this tNose thresholds be exceeded, i.e., thresholds "the licensee management" to provide Section 38.32(f)(2)is essentially the of 5 rems effective dose equivalent or 50 flexibihty for the beensee to determine same as the proposed 8 35.35(c)(2) with reme dose equivalent to any individual the appropriate personnel to investi the following modifications: (a) The organ, as a result of one of four specific the cause or take corrective action. b) (gate proposed phrase " designed in types of mistakes.The telephone the phrase " assembling the relevant accordance with this section"was notification will allow NRC to promptly facts including the reuse" replaced the deleted because it is unnecessary, and take any necessary actions based on the proposed, phrase 'promptly investigate (b) a new phrase,"along with a copy of circumstances, e g., dispatch an the cause

• to reduce the emphasis on the program," was added to require inspector or consultant or notify other the speed of the investigation. and (c) existing licensees to submit a copy of licemes of potential generic problems.

the recordkeeping requirement was their program to the NRC on or before W33 September 29,1995

PART35 o STATEMENTSOFCONSIDERATION Section 35.33(a)(2) requires that the inconsis'ency because the written report regulate machine-produced radiation, licensee submit a written report to the submitted to the NRC, as required by naturally occurring and accelerator-NRC. This requirement is the same as i 35.33(a)(2). could be released to the produced radioactive material, as well public if requested under the Freedom af as byproduct materish thus, the QM )

propr-d with the exception that the Information Act.Thus,in order to programs of their licensees need to be phrase "and if the patient was informed.

what information was provided to the protect the privacy of the patient,it multi-purpose, of broader scope, and not would not be appropriate for this report limited to byproduct material patient" was added to complement the changes in i 35.33(a)(4) about furnishing to include the patient's name. On the consideration in order to cover the other hand, the record required under diagnostic and therapeutic modalities a report in writing to the patient.

Section 35.33(a)[3] requires that the not regulated by the NRC (e.g., x-ray, 135.33(b) is maintained at the licensee's and LINAC). Thus, the Agreement States licensee notify the patient.His facility, ttius, the patient's name saust be requirement is the same as the proposed included since the relevant records are will be allowed to establish QM maintained according to the patient's requirements that are more stringent requirement. Patients need to be than NRC's requirements, but not less promptlyinformed when a name or identification nuesber, e.g.,

social security number, stringent. In accordance with existing misadministration occurs so that thr:c, a Section 35.33(c)is the some as NRC policy the Commission expects the consultation with their personal proposed 136.34(g) except for a minor Agreement States to implement these physician are allowed to make timely new requirements by January 25,1935.

decisions regarding remcdial and editorial change, However, under the existing NRC roepective health care. However, the y'. ~

Ham Plan and A 8'**""t Agreements, each Agreemtet State has consee still has the responsibility to 8880e - empegty the authority to implement the QM provide appropriate medical care to the program by heense conditions prior to petient. including any necessary he effective date of this amendment will be January 27,1902. On or before establishing a regulation within the remedialcare as a result of the the effective date, each applicable part required 3 year period.

misadministration. To serve as a 35 licensee must implement the QM Although the Agreement States mminder for licemees. the phrasu

" lor:luding any necessary remedial care Program and submit to the NRC a copy recommended that the revised final rule of the program and a written should be republished for public as a result of the misadministration" comment. this action is not necessary was added after the phrase "any certification that the program has been implemented. After the effective date, because the final'ule is generally appropriate medical care" to the last sach application for a new license or consistent with the scope of the sentence of 8 35.33(a)(3). renewal under part 35, as applicable, propoud rule and does not pose any Next-day notification of NRC was will have to include a QM program as incremental burdens, and because the also retained because NRC needs to be informed promptly to take necessary prt of the application.Ti.e finalguide, changes made to the rule are responsive actions. Examples of these actions segulatory Guide s.33, ** Quality to the extensive public comments and include alerting other licenees or Management Program." provides workshops that are part of the public equipment manufacturers of a generic guidance on how to develop an record for this rulemaking. The proposed problem to prevent similar events, acceptable QM program.On the rule contained provisions for both emuring that the licensee takes effective date, part 35 licensees will be diagnostic and therapeutic )

corrective actions to prevent recurrence, subject to the revised recordkeeping and administrations of byproduct material or and dispatching NRC inspectors or reporting requirements of this radiation from byproduct material. The consultants,if warranted, to nuess the amendment. scope of the final rule has been reduced facts surrounding the rnisadministration. Because this amendacnt has safety by eliminating the provisions for most Section 35.33(a)(4) requires that the significance for the Agmement State diagnostic administrations while licensee furnish a written report to the ucensees as well as the NRC licensees, retaining the other proposed provisions pat 4nt if the patient was previously this final amendment is an item of for therapeutic administratia ud q notlied. This requirement is the same as compatibility for the Agreement States. admbi i t proposed with the exception of allowing. All definitions contained in this than 30 es f i er e as an alternative, a brief description of rulemaking are Division 11tems of iodide b125 or M31.%mfm sbce k both the event and the consequences, se compatibihty.The definitions contained the proposed rule the public was given they may affect the patient. to be in this rulemaking must be the same for notice and an opportunity for comment furnished to the patient. all NRC and Agreement State licensees on all the prtwisions that remain in the Section 35.33(b) requires that the so that comistency will be maintained II"*I F#I'* there is no need to republish licensee keep records of each for the evento reported quarterly to the tho8e provisions.

misadministration. His requirement is Congmas. Also,in order to have any meaningful analysis of the data from the same as i 35.34(f)(2) with the misedministrations, the criteria for what VI. Admialstrative Statenants exception that the record retention period was reduced to 5 years from the is to be reported needs to be consistent finding of No Significant Environmental proposed to years to reduce licensees' across all NRC and Agreement State Impact:Arollobility costs because a 5-year retention period licennes. Agreement States may require additional events to be recorded or The Commission has determined is adequate for inspection purposes under the National Environmental Policy given that the current impection reported (e.g., misadministration involving accelerator- uced Act of tone, as amended, and the frequency is less than 5 years.

Some commenters stated that there radioactive material t is not licensed Commission's regulations in subpart A appeared to be an inconsistency by the NRC). of10 CFR part 51, that this final Additionally, the Commission amendment is not a major Federal between i 35.33(b) and i 35.33(a)(2).

Section 35.33(a)(2) states that the report believes that il 35.32 and 35.33 should action significantly affecting the quality must not include the patient's name or be Division 2 items of compatibility of the human environment and other information that couM lead to because the QM programs required by therefore an environmentalimpact identification of the patient, but this the rule are necessary to ensure statement is not required. The paragraph states that the record must adequate protection of the public health amendment requires each applicable contain the patient's name. There is no and safety.ne Agreement States NRC licensee to implement a quality

}

September 29,1995 35-SC 34 i

PART35 o STATEMENTSOFCONSIDERATION management p om to provide high AsgulatoryAnofysie regulations are currently subject to the confidence that byproduct material or radiation from byproduct material De CoWee rd a 8x18 ting mporting and recordkeeping i will be administemd as directed by the mgulatory analysis for 1 requirements

,g,,gg3,,,3,,,, ,,,which.,except

,, ,3,,gg,,,ggyfor certain N amendment. The analysis examines the authorised different from the mporting and performanceuser base ph[sician.%is amendmentwill benefits and impacts considered by the result in enhrnced patient safety in a NRC.The regulatory analysis is newdkup%uimmets in h AM amendment. Therefore, there abould not cost-effective manner while allowing the available norinspection at the NRC be a signincut ecommicimpact on flexibility necessary to rainimise public Document Room at 2130 L Street these small entities. (See the Regulatory intrusion into medical udgments.This NW. (lawer level). Washi DC.

Analysis for the anticipated economic ame dment also modi es the

,,P e co a Dr. T" impact of this regulation on licensees.)

mc r eping q tre nts related to coerfact huding). Aockf# Analysis the QM program and Aagulatory Mexibility Certification ne NRC has determined that the misedministrations. backfit analysis is not required for this As required by the Regulatory The implementation of a QM program Anal amadant, bocem es backnt Flexibility Act of 1000. 5 U.S.C. 806(b),

will help ensure that the byproduct rule, to Cm 50100, applies only to new the Commission certifies that this material will be administered as amendment will not have a significant mq*emnts fw pown reactm M directed by the authorised user economic impact on a substantial asce7, September 30.1985). However, as physician and, thus, will likely reduce number of small entitles.ne notd abm, he NRC he pmpared a unnecessary radiation exposures. it is "8"I*'"Y ""*I Y'I' ***"I'l*8 **

expected that there will be no incrase amendment affects about 1.100 NRC licensed institutions under to CFR part benefits and impacts of the final in radiation exposure to the public or to 35. Of these, about 180 are issued to amadannt.

the environment beyond the exposures physicians in private practice. Under tl's currently resulting from delivering the Met of Subjects size standards adopted by the NRC (80 byproduct material or radiation from I FR 80241: December 9,1985), some of byproduct maternal to the patient. no these licensus could be considmd Administrative practice and environmental assessment and finding "small entities" for purposes of the of no significant impact on which this procedum. Antitrust. Byproduct Regulatory Flexibility Act (average sr.aterial. Classified information, determination is based is avallable for grou annual receipts do not exceed 83.5 inspection at the NRC public Document Environmental protection. Nuclear Room. 2120 L Street NW, (Lower Level), million for an institution and do not materials. Nuclear power plants and Washington. DC. Single copies of the uceed 31 dilon for a private practice reactors, penalty, Sex discrimination.

physician).Tne number ofIloonsees that Source material, Specialisuclear environmental asusement and the findmg of no significant impact are would fall into the small entity category material, Weste treatment and disposal.

available from Dr.Tse (ou Poa mrmen is estimated to be a very small 20 C m N t35 percentage of the total number of moporosations coerract heading).

licensen and does not constitute a Byproduct material. Criminal penalty.

Paperwork Reduction Act Statement substantial number for purposes of the Druss Health facilities. Health This final rule amends information Regulatory Flexibility Act. professions, incorporation by reference, collection requirements that are subject The amendment requires each Medical deview. Nuclear materials, to the Paperwork Reduction Act of1980 applicable NRC licensee to implement a Occupational safety and health, (44 U.S.C. 3501 et seq.). These QM program to provide high confidence Radiation protection Reporting and re utrements were approved b the that the byproduct material or radiation recordkeeping requirements.

u 1 0 i e do ee th Tat omaal Regulations aNvlic reporting burden for this authorised user physician.nis Under the authority of the Atomic collection of information is estimated to Performance-based amendment will Energy Act of 1954, as amended, the be 8.920 hours0.0106 days <br />0.256 hours <br />0.00152 weeks <br />3.5006e-4 months <br /> per year (for 3,300 result in enhanced patient safety in a Energy Reorganization Act of 1954, as applicable NRC and Agreement State cost effective manner while allowing the amended, and 5 U.S.C. 552 and 553. the licensees), or an everage of about 2 flexibility necessary to minimise NRCis adopting the following hours per year per licensee, including intrusion into medical judgments. His amendments to 10 CFR parts 2 and 35.

the time for reviewing instructions, amendment also modifies the searching existing data sources, notification, reporting, and gathering and maintaining the data recordkeeping requirements related to needed, and completing and reviewing the QM program and 58 PR 81382 the collection ofinformation. Send misadministration. puts 6ehod 13/3/e1 comments regarding this burden The Commission believes that most Esective S/20/91 estimate or any other aspect of this licensees currently have a QA progrom ce!!ection of information, including based on voluntary standards Stenderes br Prosecten Against suggestions for reducing this burden, to established by ]CAHO and professional Andeten; Correcron the Information and Reports associations. Since this amendment is a Management Branch (MNBB-7714), U.S. performance based rule, a licensee using See Port 30 Basements of Nuclear Regulatory Commission, a voluntary program may not need to Consideestin Washington. DC 20555; and to the Desk replece its existing program, rether only Officer. Office ofInformation and supplement it, thereby ensuring that the Regulatory Affairs.NEOB-3019 (3150 objectives of the rule are being met.

0010). Office of Management and Furthermore, alllicensees under 10 CFR Budget Washington, DC 20503, part 35 or similar Agrwment State 35 SC 25 September 29,1995 1

I

_ - - - - - _ - - - - _ _ _ _ - - - __ J

PART 35 a STATEMENTS OF CONSIDERATION Society of Nuclear Medicine petitioned contained specific basic quality the U.S. Court of Apper.ls for the District 87 Pn 4137s assurance practices. In response to l public comments and recommendations . of Columbia Circuit for review of the Putmahed t/10/92 E#ectko 9/10/92 final rule.On May 22.1992, the Court from the Advisory Committee on the found no basis to overturn the Quality Medical Uses of Isotopes (ACMUI), the Commission reexamined its approach Management and Misadministration 10 CFR Part as Rule. Accordingly, the Court denied the and published the second proposed rule, containing performance based petition for review. The Court found that RW 3 % AC65 requirements, on January 18,1990 (55 FR the NRC had acted within its broad

~ " Program and 1439).Following publication of the statutory mandate to establish "such Guauty Misedminla Ma dlNE;"NRC Override of atandards * *

• as the Commission may January 1990 proposed rule a pilot OMS Disapproval of MRC information cleem necessary or desirable to * *

• program was conducted to provide a Conection Repet real-world test of the proposed rule in protect health or to minimize danger to licensee hospitals and clinics and to life."It also concluded that the messocv: Nuclear Regulatory substantive requirements of the QM rule Commission, gain inalghts beyond those generally obtained from the public comment were not arbitrary, capricious, or an Acticec l'inal rule. process. Sixty-four volunteers (23 NRC abuse of discretion.

suasesAsm The Commission has voted to licensees and 41 Agreement State Subsequently,in a letter dated June override the Office of Management and licensees) participated in the pilot 26.1992. OMB stated that it disapproved program.The staff also conducted the information collection request (ICR)

Budget (OMB)disapprovalof the information collection requirements public workshops to discuss the results associated with the July 1991 finst rule.

of the pilot program and to obtain OMB concluded that "this information 1,mposed in the final rule entitled collection request is not necessary for Quality Managemant Program and recommendations on how to modify the Misadministration (July 25.1991: 56 FR proposed rule with professional the proper performance of the functions 34104). As part of this final rule, the organizations and Agreement States, of the agency and that the information

"' collection will not have practical utility and sought guidance f om ACMUI.

to r et mil asi r e t of a ne for the agency. However, the During more than 20 public meetings, Paperwork Reduction Act (PRA) control number to these information the impact of the recordkeeping and co!!ection requirements. The providea that an independent regulatory reporting requirements on medical use agency such as NRC may override the Commission reevelosted the need for licensees received substantial attention OMB disapproval by a majority vote of this finalrule and the information fr m the NRC and the regulated collection requirements it contains. The its Commissioners (44 U.S.C. 3507).

community. As a result, the Commission The Commission fully supports the Commission continues to believe that its believes that recordkeeping and requirements for written quality objectives of the PRA and strives to reporting requirements contained in the ensure that the private sector is management programs and final rule were reduced by more than misadministration reports. If complied half from those presented in the January requested to maintain or provide only )

such information as is needed to carry with. have a reasonable likelihood of 1990 proposed rule. These reductions decreasing misadministration (e g., out regulatory responsibilities. For included the removal of the reasons specified below, pursuant to 44 wrong dose or wrong patient) with a recordkeeping and misadministration U.S.C. 35C7(c), the Commission has small incremental cost to licensees. repo ong requirements for nearly all overridden the OMB determination. In a Without the reporting and recordkeeping diagnostic procedures. Considering the letter dated August 14.1992, the requirements, it would not be possible to modifications to the proposed rule and implement and enforce these regulations Commission certified that it had the performance-oriented approach, the overridden OMB s disapproval and effectively. Commission concluded that the cost. requested that OMB promptly assign a EFFECTIVE DATE: September 10.1992. effectiveness of the final rule had been new control number to the ICR F0ft FURTHER 800FORsRATIOe8 C00tTACT: optimized without significantly reducing associated with the Quality Anthony N.Tse Office of Nuclear the level of protection. Manegement and Misadministration Regulatory Rasearch U.S. Nuclear In December 1991, the NRC was Rule for a period of 3 years.

Regulatory Commission, Washington, notified by OMB that notwithstanding In its implementing regulations OMB DC 20555, telephone (301) 492-3797. Its earlier approval of the proposed rule. specifies (5 CFR 1320.11,1320.4(b) and SUPPLeistNTAny steeonasATeoec which received the appropriate OMB (c)) that in approving an ICR it evaluates control number,it had concerns with the whether (1) the esency has chosen the On July 25.1991 (56 FR 34104), the information collection requirements of least burdensome means to obtain the Commission published in the Faderal Register a final rule amending to CFR the final rule. In order to resolve OMB's ini rmation. (2) the information sought concerns, the NRC both corresponded is available to the agency through some parts 2 and 35, entitled " Quality and met with OMB. However, NRC and Management Program and other means, and (3) the information Misadministration." The final rule OMB staff interactions failed to resolve a usht has practical utility. Practical became effective on January 27.1992. OMB concerns. In light of OMB approval '

The final rule requires that opphcable of theinformationcollection ",, ,Yef to 8'"CY, is 8i o requirements contained in the proposed scennt the informatiori e accuracy, part 35 licensees implement Quality Management (QM) programs, continue rule and because the final rule did not a equacy, and reliability, and the to report misedministrations but at substantially change those requirements '

higher reporting thresholds, and keep that were retained in the final rule from "g,8'"

gorm ti a Ny on.

the proposed rule, the information OMB disapproval of the ICR does not certain records. collection requirements contained in the The Commission published two proposed rules related to this subject.

final rule became effective on lanuary ind

,,q gt*[mfnts re n ecessarily g gg, The first proposed rule was published 27,1992. g g on October 2,1987 (52 FR 36942).This in February 1992, the American about misadministration and medical I proposed rule was prescriptive in that it College of Nuclear Physicians and the

PART 35 e STATEMENTS OF CONSIDERATION quality management programs, or that environmentalimpact statement nor an spesesAny:The Nuclear Regu'atory l the information is available through environmental assessment has been Commission (NRC)is amending its some other means. OMB disapproval prepared for this final rule. regulations to eliminate certain relied on the third evaluation criterion recordkeeping requirements related to Paperwork Reduction Act described above and made a finding of the preparation and use of no practical utility. But, contrary to 5 In a letter dated June 26,1992. OMB radiopharmaceuticals. Specifically, this CFR 1320.7(o). OMB does not discount stated that it disapproved the NRC's rule eliminates recordkeeping the accuracy, reliability, or adequacy of information collection request requirements related to the justification the information sought, or challenge the associated with the rule entitled for and a precise description of the Commission's ability to process the "Quahty Management Program and departure, and the number of departures information in a timely fashion. OMB Misadministration. from the Food and Drug Administration disapprovalindicates that OMB has As required by the Paperwork (FDA) approved manufacturer's concluded that there is no need for the Reduction Act, the Commission has instructions. Both the NRC and the FDA Commission's final rule and regulatory certified to OMB, in a letter dated staffs agree that the major trends in program to reduce injuries from August 14,1992, that by unanimous vote departures that may be identified by this i misadministration and that, therefore, the Commission had overridden the recordkeeping are already discernible any paperwork burden that the rule OMB's disapprovalof theinformation and collecting additional data is would impose is unreasonable, collection request associated with this unnecessary, The Commission-whir.h is the rule. arrsCTtys DATs: October 2,1992.

agency charged with substantive On August 21,1992. OMB assigned the responsibility for making such following new control number: 3150- ron ruspan sueOnuanON COMAC1','

judgments-continues to believe that its Samuel Z. }ones, Office of Nuclear 0171, effective until August 31,1995.

requirements for written quality Regulatory Research, U.S. Nuclear This new control number is only Regulatory Commission, Washington, managernent programs and applicable to the sections in to CFR part DC 20555, telephone (301) 492-3738.

misadmmistration reports,if complied 35 amended by this rule. Information with, have a reasonable likelihood of " " " " ' " * " " " "

collection authority for all other sections decreasing misadministration (e.g. of to CFR part 35 remains under the wrong dose or wrong patient) with a BackI d existing general control number: 3150-small incremental cost to licensees. 0o30. On September 15,1969 (54 FR 38239),

Without the reporting and recordkeeping the NRC published in the Federal requirements,it would not be possible to 1 Jet of Subjects in 19 CFR Part 35 Register a notice of receipt of a petition implement and enforce these regulations for rulemaking (PRM-35-9) from the effectively, Byproduct material Criminal penalty, Drugs. Health facilities. Health American College of Nuclear Physicians On August 21,1992. OMB assigned a professions, Incorporation by reference, (ACNP) and the Society of Nuclear new control number Therefore, the Medical devices. Nuclear materials, Medicine (SNM). The ACNp and SNM effective period for these information Occupational safety and health, requested, among other things, that the collection requirements is from January Radiation protection, Reporting and NRC amend its regulations in to CFR 27,1992 through August 31.1995. recordkeeping requirements, part 35," Medical Use of Byproduct The Commission will continue to Material l to recognize their appropriate monitor implementation and inspection Text of Final Regulations practice of medicine and to allow: (1) under the rule to ensure that it provides For the reasons set out in the Departures from the manufacturer) the Commission with necessary preamble and under the authority of the instructions for preparing diagnostic information without imposing undue Atomic Energy Act of1954, as amended. radiopharmaceuticals and (2) the use of burden on the private sector. If the the Energy Reorganization Act of1974, radiopharmaceuticals for therapeutic Commission finds the rule,in whole or as amended, and 5 U.S.C. 552 and 553, indications and methods of in part, to be overly burdensome or the NRC is adopting the following administration not included in the FDA ineffective, it will consider modifying or amendments to 10 CFR part 35. approved package insert.

deleting portions of the rule. Further, the On August 23,1990 (55 FR 34513), the NRC will hold a public workshop with NRC published in the Federal Register the medical community and other an Interim Final Rule granting the interested parties, to ensure that there is petition. In part, to specifically allow mutual understanding as to the intent of departures from the manufacturer's the rule, especially its information 37 FR 45566 instructions for preparing diagnostic collection requirements, and to discuss Pubhohed 10/2/92 radiopharmaceuticals using generators effective implementation. In particular. Epoctive 10/2/s2 and reagent kits for which the FDA has NRC will discuss the extent to which the approved a New Dnig Application industry's self-auditing guidelines can (NDA). The Interim Final Rule also be used.Following the workshop, the included recordkeeping requirements for Commission will develop additional 10 CFR Parts 30 and 35 the specific nature of the departure, a guidance on compliance with the rule, brief statement of the reasons for the written in clear language appropriate to Ress 3150-aE23 departure, and the number of the medical community. Departures From Manufacturer's departures. The Interim Final Rule is, EnvironmentalImpact: Categorical Instructions; Eliminat6on of effective through August 23,1993.This Exclusion Recordkeeping Requirements action was taken after consulting with the FDA and with the intention that the The NRC has determined that this is aosmcy: Nuclear Regulatory provision might become permanent after the type of action described in Commission.

categorical exclusion to CFR acnOw: Final rule, 51.22(c)(3)(ii). Therefore, neither an 35-SC 27 Septernber 29,1995

PMT 35 e STATEMENTS OF CONSIDERATION

1. Comment. A commenter suggested knowing the patient's pregnancy or further experience had been seined under the new provision, inciuding an the termination of the mmainder of the breast-feeding status.

Aesponse. With respect to the first I casessment of licensee documentation Interim FinalRule in favor of the of departures. ne NRC's original intent provisions detailed in the ACNp-SNM point, the elimination of the petition (pRM-354). recordkeeping requirements addressed w:s to examine this documentation and in this rule will not compromlae public make it available to the FDA and to Assponse!The NRC is currently health and safety because this rule consult with the FDA prior to anY considering allissues raised in the continues the requirement that decision regardmg either mvision or ACNp-SNM petition. NRC consideration includu the continuation of departures departures may only be made by continuation of the Interim Final Rule or following the directions of an authorized making it permanent.De NRC staff has as set out in the Interim Fmal Rule. u er physician.Therefore, since there is recently consuhed with the FDA staff on However, at this time the NRC is no reduction in the protection of the the documentation collected to date. public health andand safety, the NRC Based on this documentation, the NRC limithi this rulemaking to seping cutinum 2 mwt he legislatin

,,co requirements has and FDA staffs concluded that the major determined not to expand this mandate.With respect to the second trends in departures are already clear rulemaking to include the termination of cad that collecting additional data the remainder of the Interim Final Rule, point. licensees must continue to comply wruld not be expected to reveal any not subject.the termination of the with all applicable regulatory requirements and wili continue to be significant new information. On June St. remainder of laterim Final Rule, will be 1992 (57 FR 24763), the NRC published a subject to the same inspection and covered when the NRC has completed enforcement efforts. Therefore, the NRC proposed rule in the Federal Register its consideration of the ACNp/SNM that suggested amendments to to CFR believes that licensees' attitudes will not petition be negatively affected by this rule, and parts 30 and 35 to eliminate 3. Comment. A e===nter noted a recordkeeping requirements involving typographical error in the temt of

""' "IU "'I P"""'

• 0*

health and safety of the pfu lic.

" O' the justification for and a precise i 35.300 of the pmposed rule which Concerning the statement made in the description of the departure and the indicated paragraph (1)instead of number of departures from the FDA public workshop notice as related to the paragraph (c). rationale for this rule, the NRC views epproved manufseturer's instructions. Response. His typographical error The FDA staff had no objection to these two regulatory issues as separate s.liminating these recordkeeping has bun cormeted. mat.ers.The rationale for this rule is to requirements.The issue of whether 4. Comment. A commenter suggested eliminate a regulatory burden that is no departures, as set out in the Interim that if there are no public health and longer needed.The NRC has collected safety issues identified, the data specific to licensees' departures Final Rule should be allowed on a permanent basis is currently under authorization to deviate should not from manufacturer's instructions. The consideration by the NRC as part of its expire on August 23.1903. NRC and FDA staffe have concluded eff rt to resolve pRM-35-9. Response.The purpose of this rule is that the major trends in departures are to p ovide relief to licensus concerning already clear and that collecting )

Public Comments and NRC's 8==paa==s the recordkeeping burden related to the additional date would not be expected requirements in the Interim Final Rule. to reveal any significantly new The NRC received nine comment 1:tters in response to the proposed rule. Therefore, the effective period of this information. This rule le not connected rule was intotionally used to be to the issue concerning inadvertent in terms of the types of organizations, consistent with the effective period of radiation exposures to an embryo. fetus, there were three comment letters from or breast feeding infant. In particular, the Interim Final Rule, hospitals and clinics. two from the NRC has not stated that departures professional associations, and one each The NRC anticipates that the ACNp-from an Agreement State, a pharmacy, a SNM petition (pRM-85.-0), including the from manufacturer's instructions have issues associated with the Interim final led to an unintended radiation exposure Federal agency, and an individual Rule, will be resolved prior to August 23 to an embryo fetus, or breast. feeding member of the public. Eight of the letters supported the proposed amendments 1993. infant. Also. the NRC staffis not aware

5. Comment. A commenter opposed of any cases involving an urintended end one letter opposed the rule. radiation exposure to an embryo fetus, this rule. The commenter provided the Brief descriptions of the issues raised foll wingrationale; or breast-fwding infant that has bun in public comment letters and NRC's (a) While reduction of regulatory caused by a licensee departins from a responses to these issues are presented burden may be a worthy goal,the manufacturer's instructions. %erefore.

in the following paragraphs- legislative mandate to protect public the NRC sees no contradiction between

1. Comment. A commenter suggested health and safety must take precedence the rationale for this rule and the that the NRC allow the disposition of over en administrative goal: statement made in the public workshop records of departures generated under (b) ne modification in this rule would notice.

the Interim Final Rule after 3 years invite and promote an attitude or The issue regarding unintended (instead of 5 years as specified in the climate which resulted in the Three Mile radiation exposu os to an embryo. fetus.

Interim Final Rule) because the records Island accident, and thus would present or breast-feeding infant from medical '

have apparently served their purpose. a danger to the health and safety of the use of byproduct materialis currently Aesponse.The NRC agrees that the public: and under study by the NRC to determine

! records have served their purpose and (c)The NRC's rationale for this rule whether any regulatory action is cdditional retention of these records is contradicts a statement made by the necemary.

n:t necessary.This rule eliminates the NRC,in a Federal Register notice retention period for thue records.Thus, announcing a public workshop (57 FR Na==Aa= ef the Final Rule Text as of the effective date of this rule. 27711: ]une 22.1992). that some medical Based on public comments and NRC's licensees are no longer required to keep use licensees have administered responses discussed above no records of departures carried out under byproduct material to patients who are substantive changes to the final rule are the Interim Final Rule, pregnant or breast feeding without necessary.Thus, the text of the final rule h

, , n. .c.n

w w w ww y w W W W WWW y yy y yW y EXECUTIVE TASK MANAGEMENT SYSTEM

- ~~~~~ ---- ~~_____ . . .---

<<< PRINT SCREEN UPDATE FORM >>>

TASK # - 8S119 DATE- 04/14/98 , , 5- - .i MAIL CTRL. - 1998 TASK STARTED - 04/14/98

--. -~~ -~~~~

TASK DUE - 04/30/98

. -~~~_.

TASK COMPLETED -

--___ -~~~~ .

/ /

TASK DESCRIPTION - RESPONSE TO CA RE: QM RULE - BROUGHT UP AT ANNUAL MTG.

-- --~~ . .

REQUESTING -~~ -__. -

OFF.-~ CA REQUESTER - BAILEY WITS

~~~

- 0 FYP - N PROG.- LJR PERSON -

STAFF

~~~~~~~~~

LEAD'- LJR PROG. AREA -

PROJECT STATUS -

. -~~ .

OSP DUE DATE: 4/30/98 PLANNED ACC. -N LEVEL CODE - 1 l

l l

I l

l L________-____ _ - . _ - _ _ _ _

Ps .

STATE OF Calif 0RNIA--HEALTH AND WELFARE AG(NCY PETE WILSON, Governor

. . DEPARTMENT OF HEALTH SERVICES .,

714/744 P STREET M ,

P.O. SOK 942732 Y SACRAMENTO, CA 94234-7320 December 24,1997 1

Hugh L. Thompson, Jr.

Deputy Executive Director for Regulatory Programs U. S. Nuclear Regulatory Commission Washington, D. C. 20555-0001

Dear Mr. Thompson:

1 On June 18,1997, you sent S. Kimberly Belshd, Director, California Department

, of Health Services, a copy of the final Integrated Materials Performance Evaluation l

Program (IMPEP) report on the review of the California Agreement State Program which was conducted October 21-25,1996. In the letter of transmittal, you requested that we respond to recommendations of the IMPEP team which were included in that report:

1 Attached are the responses of the Radiologic Health Branch to these recommendations. For your convenience in reviewing the California responses, we have included Section 5 of the report with our responses to the recommendations immediately following the recommendation. We hope that you will find these acceptable.

I I want to again express my appreciation to you and the other members of the i Management Review Board and the members of the IMPEP team involved in the review  :

of the California program. All of the Califomia staffinvolved in the review and I felt that the IMPEP process was a great improvement over the fonner review and evaluation '

system. We look forward to future reviews.

If you should need additional information regarding this mater, please contact me i at (916) 322-3482.

1 Sincerely,

\

l l

gar D. ailey, C.Hhef l Radiological Health Branch l l

Attachments I

1 EDO -- G970891

I l

l' California Final Report 5.0

SUMMARY

As noted in Section 3 and 4 above, the review team found the State's performance with respect to each of the common and two non-common performance indicators to be satisfactory and the non-common indicator, Scaled source and Device Evaluation Program, to be satisfactory with recommendations for improvements. Accordingly, after consideration of the satisfactory finding for the non-common indicator, " Legislation and Regulations," the team recommended, and the MRB concurred, in finding the Califomia program to be adequate to protect public health and safety and compatible with NRC's program.

Below is a summary list of recommendations and suggestions, as mentioned in earlier sections of the report, for action by the State.

1. The review team recommends that the State consider keeping a collective staff training record to help formalize technical training as an ongoing requirement for the position and to better allow management to assess the training level of the staff. Waivers granted to individual staff members from attendance at specific training courses based on past education and experience, should be documented. (Section 3.2) i Resoonse:

i The California Radiologic Health Branch (RHB) maintains a computer record and l update ofstaftraining (See Attachment 1). Because the number ofhealth physicists employed by theprogram, we mustprioritize their training by employing the criteria of need andseniority. The criterion of"need" is based on the area ofwork assigned, previous experience, education, andobservations ofthe supervisor. Understanding our criteriafor selection ofstaffor training is important to understanding our system of l record keeping. Our record oftraining does not intend to duplicate otherpersonnel records which list each individual's education and experience.

2. The review team recommends that the State.take necessary action (renew the calibration  ;

contract) in order to maintain the instrument calibration schedule (Section 3.4).

l Resoonse:

RHB has entered into a contract with a private company to calibrate all radiation monitoring equipment at the requiredfrequency. The company uses sources that are traceable to NISTand correctionfactors are supplied with the calibration certificatefor each meter. The contract is a multi-year contract which will expire in June 2000.

l

3. The review team recommends that the State make a concened effort to adopt regulations l which are required for compatibility and are overdue for adoption. A special effort should be made to adopt the amendments on Notification ofIncidents, the Irradiator rule, and the Definition of Land Disposal and Waste Site QA program amendment. Due to the safety benefits attendant to the QM rule, the State is encouraged to adopt a compatible QM rule. (Section 4.1)

Response

l RHB has repeatedly attempted to get legislative approvalfor staffng andfundingfor development ofregulations and supporting documentation required to legallypromulgate regulation in Cahfornia. To date these requests have been denied. Nonetheless, RHB will continue to divert staffrom other assignments and strive to ensure that required regulations are adopted in a more timely manner.

4 Notipcation ofIncidents is contained in Regulation Proposal RS3-94. This Regulation Proposal waspied with the Secretary ofState on September 9,1997 and is now efective.

l The irradiator rule is slatedfor adoption. Expected efective date: September,1998.

The Low Level Radioactive Waste (LLRW) Program will respondseparately to the l recommendation concerning the adoption ofregulations related to low level radioactive waste.

No action is contemplated with regard to the QM rule since the NRC has provided no data or information that indicates its adoption ofthe QM rule has resulted in " safety 1 benepts. " Pleaseprovide this data!information.

4. The review team recommends that the State exert greater management oversight over the SS&D evaluation progmm. The team believes that such oversight is needed to assure full implementation of the recommendations in this area, given that some recommendations from the 1994 follow-up program review have not been fully addressed. (Section 4.2) l l Resoonse:

The SS&D evaluation program has gained a lot ofattentionfrom the Cahfornia Radiation Control Program since the NRC changed itspositionfrom a mutual benepcial review to an "oficial compatibility" review in 1994. It was recognized in NRC 's IMPEP l report ofthe 1997 Cahfornia Review that the IMPEP review teamfound that Cahfornia haddevelopedandimplementedprocedures to improve the SS&Dprogram. The ,

supervisor ofthe SS&Dprogram self-identified some weakness in implementing these l procedures and appeared committed to rebuilding the program as a modelfor other regulatoryprograms to emulate. Cahfornia is committedto the achievement of 2

i L________.__________._____________._ _ . _ _ _ _ _ . _ _ _ _ _ . . _ _ _ _ _ _ _ _ . _ _ . _ _ _ _ _ _ . _ _ _ _ _ . . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ . _ _ . _ _

excellence. We have implemented better quality assurancefor SS&D reviews by imposing mandatorypeer review.

5. The review team recommends that the State consider adopting regulations compatible l with 10 CFR 30.32(g) and 10 CFR 32.210. (Section 4.2) l l Response' l Applicationsfor use ofSS&D must disclose information required by 10 CFR 30.32(g) as l a matter ofCalifornia licensingpractice. The guidanceprovided in 10 CFR 32 Subpart D is utilized by California licensees as a basisfor submission ofSS&Dproduct registration information. Submission ofSubpart D information by California l manufacturers is a long-standingfeature ofour licensingpractice.

l

6. The review team recommends that the State detennine and document in evaluation I certificates whether sealed sources approved for use in well logging applications meet the l requirement for insoluble as practicable. (Section 4.2) i i

Resoonse: l A new checklist has been developed andput into use which outlines the requirements imposed on product design ofwelllogging equipment, including the requirement that the active material be as insoluble aspracticable. (See Attachment 2)

7. The review team recommends that the State review and possibly modify Section 1.8 of ADAC Laboratories' users manual which appears to condone direct hand contact with the j sealed source. (Section 4.2)

Resoonse: ,

The section was reviewed and a deficiency letter sent April 21,1997. Responses were received on June 10,1997 andJuly 15,1997. Theseprovidedadequate technical response. The ADAC SS&D certificate was amended to reflect the change on September 17,1997. (See Attachment 3).

8. The review team recommends that the State obtain SS&D training for those staff members that have not yet had or have limited SS&D training, either by using training offered by NRC or another Agreement State program. (Section 4.2)

Resnonse:

The Supervisor, David Wesley, has received training at NRC workshops held September 12-15,1995, at Gaithersburg, MD, and April 7-11,1997, at Rockville, MD.

In addition, two reviewers have received training at NRC workshops. Pete Patel 3

attended the workshop held September 12-15,1995, and Tom Schell attended the workshop heldApril 7-11,1997. Anyfuture stafmembers will attend the same or similar training when available.

9. The review team recommends that the State develop a policy position which includes information on the useful life of a product and uses operational history data to augment l prototype testing when evaluating SS&D. (Section 4.2) l Response-The policy has been stated to the staf(see Attachment 4) and will be ,ncluded in the next update (currently in progress) to Radioactive Materials Licensing Policy Memo 89-1.

l

" Sealed Source and Device Registry Certifcase Review Procedures ".

10. The review team recommends that the State determine the actual use conditions for those gauging sources that do not meet the ANSI standard classification for vibration and evaluate the need to modify SS&D sheets if the condition of use is typical for industrial gamma gauging devices as indicated in ANSI N-542. (Section 4.2)

Resoonse:

The ANSI classifcationfor gamma gauges is divided into three categories, asfollows:

l Medium and High Enery - Unprotected Source ANSI 77C43333 Medium and High Enery - Source in Device ANSI 7743232 Low Energ ANSI 77C33222 The sources in question are limited in nuclides with gamma energies below 200 kev which are considered to be low enery and, therefore, would require a classification of ANS177C33222. The sources were determinedto have a classification ofANSI 77C65424 which meets or exceeds the requirementsfor low energ gamma gauge use.

11. The review team recommends that the State re-evaluate the Nova R&D Inc., model CINDI, neutron device with special attention to the potential exposure received by the general licensed user. Ifit is determined that the exposure rate exceeds that which is al' owed for persons covered under the general license, the device should be reclassified for distribution to persons covered under a special license, and the SS&D evaluation certificate should be amended to reflect any required changes. (Section 4.2)

Resoonse:

A defciency letter was sent to the manufacturer ofthe CINDI neutron device, requesting information which will help in the evaluation ofthe generallicense criteria. The licensee acknowledged receipt ofthe letter and requested extra time to gather all ofthe information necessary. Inappropriate, the registration certificate will be updated with 4

these results. In the meantime, the licensee let their distribution license expire without submitting a renewal request; therefore, they are no longer authorized to distribute the device to generallicensees. We notified the licensee ofthe expiredlicense, and they have acknowledged that they will not distribute any more ofthe devices until they hm'e satisped our requestfor information and the license is reinstated. We have received a letter (see attachment 5)from NOVA R&D datedNovember 24,1997, in response to our depciency letter. The response will be reviewed within the next 90 days.

12. The review team recommends that the State fully implement a program of peer review of SS&D evaluations as a technical quality assurance measure. (Section 4.2)

Resoonse:

The peer reviewprogram now includes independent technical reviews by two license reviewers. The lead reviewer will generate any deficiency letters based upon the evaluation and the registry certficate. Responses to deficiency letters will also be evaluated by both reviewers. Thisprocess will be included in the next update to Radioactive Materials Licensing Policy Memo, 89-1. " Sealed Source and Device Registry Certificate Review Procedures. "

13. The review team recommends that the State amend the appropriate Industrial Nuclear Inc. l SS&D certificates. (Section 4.2) l Resoonse: 1 The registration certificatefor the Industrial Nuclear Inc., ModelIR-100 has been amended to include the corrective actions taken to meet the hori:ontal shock test.

i

14. The review team recommends that the State develop a checklist or internal procedures to follow when approving products for distribution to persons covered under a general license. (Section 4.2) i Resnonse:

l A new checklist has been developed andput into use which outlines the requirements imposed onproducts to be approvedfor distribution topersons covered under a general license (See Attachment 6). We recommend that the NRC adopt the same or similar l checklistsfor it's staf's use.

1

15. The review team recommends that the LLRW program consider keeping official records I of each staff member's technical training and participation in workshops, conferences, etc., in the individual's training files. (Section 4.3) l 5

i Resoonse:

1 The LLRW Program will respond separately to this recommendation.

L Good Practice: Along with the recommendations for California, the review team identified the following good practices in California:

l

1. The use of the License Review Alert Form (RH 2033) used by the inspection staff to communicate information to the licensing staff. (Section 3.3) i

2. The use of the User's Declaration Form to establish a legally binding agreement l between California and a licensee that can be executed by an inspector in the field to put l an instant end to a serious noncompliant activity. (Section 3.4)

Resoonse:

The twoforms referenced under "GoodPractice " were mai! sIto the attention of Cathy Schneider on August 4,1997. These werepublished by the NRC as Attachments C and D in Enclosure 1 to see Agreement States letter SP-97-081 dated November 21,1997, i

6

o +

l9 4

. Attachment I f f y r d .ir l

[1 rr ,  ; rj ,g, r rgggg rrj s

rri jg 4

$ $ $ $ s  ! $ $ $$ $

$ls e$

e l s as'Eillne$ en s eu ee e te e t i te te Es! ! I S I

s !E siEs  ! !

E

! I ts! ! $ M $  !

. fu e eie!!l!$ ttet tR eet ee in! stu t e t . . $, e 1,

$ 5 $$ $ $ $ $ $ 5 $ $ h 5 $

I 8 B  !!  !  !  ! RB B  ! 9 2 8 r  ! RB e

c e I h e e & h "

h eh 55 E I!Il$ E:I'35 I 33 IE E 5 E lI EE I

s s e e c ell E $ r $  ! ! s s  !

8% & B R.3:2 2 8 8 9 9 2 2 s s s ss s s a

!  ! 6 33 f B

!$ E s i  ! _s s "  ! s s a 9 3 9 R B B i R E  !  !:S!! t t _,

g

. $ r 5 a n 2 2 8 5 h

u t 2 i 7-

?  ?

5 5 0

5 s $ b

$ 9!R ti!IB 88.t BI R S et t i S 9 e E e E E t e We 6 5 e 5 5 5 5 5 ~5_ 5.~ 5 5_ .t 5 l

. . . t . t ee e e e e_i .

h

\ ~

l e 5 i  ;

[

l l e 5 e e 4 $

= 0

% B I .

t -

5

$ I E

E

$ $ e t t l

____ , , _ _ _ _ . - - - _ - - - - - - - - - - - - - - ~""-'"'--- '

' CHECKLIST FOR ADDITIONAL REQUIREMENTS IN THE EVALUATION OF SEALED SOURCES FOR WELL LOGGING MANUFACTURER / DISTRIBUTOR:

MODEL #: REGISTRATION #:

REVIEWER: DATE:

Description OK/Def Comments Labeling Does the smallest component of the source, source housing, or logging tool (which contains radioactive material inside) that is transported as a separate piece of equipment, bear a durable, legible, and clearly visible marking or label containing the following7:

The radiation symbol (no color requirements)

The wording " DANGER (or CAUTION) RADIOACTIVE MATERIAL" Leak Testing is the maximum leak test interval set at 6 months?

Design is the source doubly encapsulated when containing non-gaseous radioactive material?

(A doubly encapsulated source may not, in fact , be doubly encapsulated if, in the process of constructing the secondary encapsulation it is subjected to stresses that destroy its integrity.

Review the submitted drawings and description of fabrication. A written description of the source fabrication process should always accompany drawings of the source since a fabrication process may not be correctly inferred from drawings alone.)

is the radioactive materialin a form which is as nondispersible as practical and as insoluble as practical when containing non-gaseous radioactive material?

Prototype Testing Ten.,>erature For sources containing non-gaseous radioactive material, was the test source held at -40'C for 20 minutes, 600*C for 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />, and then subjected to a thermal shock test with a temperature drop from 600*C to 20*C within 15 seconds?

/mpact: For sources containing non-gaseous radioactive material, was a 5 kg steel hammer,2.5 cm in diameter, dropped from a height of 1 m onto the test source?

Vibration For sources containing non-gaseous radioactive material, was the test source subjected to a vibration from 25 Hz to 500 Hz at 5 g amplitude for 30 minutes?

Puncturet For sources containing non-gaseous radioactive material, was a 1 gram hammer and pin,0.3 cm pin diameter, dropped from a height of 1 m onto the test source?

Pressuret For sources containing non-gaseous radioactive j

material, was the test source subjected to an external pressure l of 24,600 pounds per square inch absolute (1.695 x 10' pascals)?

Rev 0 - 4/24/97

,~

.")

Attachment 3

,1 -

l l

l. REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES .

SAFETY EVALUATION OF DEVICE I (AMENDED IN ITS ENTIRETY) l BEL: CA102D10lS DATE: September 17,1997 PAGE: 1 of 6 I

DEVICE: Line source housing for SPECT cameras l t

MODEL: Vantage MANUFACTURER / DISTRIBUTOR: ADAC Laboratories 540 Alder Drive Milipitas,CA 95035 SEALFD SOURCE MODEL DESIGNATION: North American Scientific,Inc.

Model MED 3601 or DuPont Merck Model NES-8412 l

l ISOTOPE: Gadolinium 153 MAXIMUM ACTIVITY: 300 millicuries per  ;

housing (600 mci i total per system)

LEAK TEST FREOUENCY: Six (6) Months l

PRINCIPAL USE: General Medical Use (V)

CUSTOM SOURCE: YES X NO A %t @ 4 w h M n .

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i (AMENDED IN ITS ENTIRETY)

HQ; CA102D10lS DATE: September 17,1997 PAGE: 2 of 6 DESCRIPTION:

! ADAC Laboratories Model Vantage source housing assemblies are devices designed to contain, for use and storage, a Gadolinium 153 line source. The source housing assembly is then capable of being permanently attached to nuclear medicine equipment. Identical housing assemblies have been assigned different model numbers so as to aid in the identification of pairings among specific housing assemblies and their respective detectors [line source one transmits to detector one and line source two transmits to detector two). Both a line source and a detector are required for the operation of the system.

These devices are designed and manufactured by ADAC Laboratories [and/or contractors] and contain Model MED 3601 or Model NES-8412 sealed sources manufactured by North American  :

Scientific, Inc. and DuPont Merck respectively, as components of nuclear medicine gamma cameras. The system produces transmission data which is used to correct for attenuation artifacts in cardiac SPECT imaging. The transmission part of the acquisition enhances the diagnostic

! accuracy of SPECT. The device assemblies contain 5 mm of lead which provides sufficient shielding for the Gd-153 sources to near background radiation levels [less than 0.2 mR/hr at the surface of the assembly]. The lead shielding is reinforcedwith cold rolled steel Type 1018 and for rigidity, aluminum Type 061-T6.

l Both line source housing utilize a spring loaded shutter which opens when the solenoid is l activated by motor pulses. The housing shutter will automatically close upon loss of power.

When the shutter is open, a 1 nun aperture allows transmission imaging to proceed. Open and l

l closed modes can also be accomplished by means of a manual lever switch. This switch rotates l the cylindrical shutter to the unshielded [open] position and the shielded [ closed] position. The l position of the manual switch lever serves as a visual indicator of the shutter's status. In addition, sensors have been built into the assembly's software system which will indicate, to the operator, any shutter failure in either the open or closed positions.

LABELING: Each device will be labeled with the following information:

o Caution Radioactive Material o Universal Radioactive Symbol Label o Isotope ID (Gd-153) o Model # MED 3601 or Model NES-8412 o Activity in mci's (example: 200 mci) o Serial # (xxxx-xxxx)

{

. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___O

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) i ND.: CA102D10lS DATE: September 17,1997 PAGE: 3 of 6

( o Date of mfg. (month /date/ year) l l o Company ID l

4 DIAGRAM: See attachments 1,2,3 and 4 CONDITIONS OF NORMAL. USE:

This device is intended for use with SPECT cameras in the clinical environment of a nuclear medicine imaging facility. The Models VANTAGE (line source housings) act as a permanent storage fixture and as a component of a SPECT imaging system. The devices should not be subjected to conditions exceeding those specified by the ANSI 77C64444 rating.

PROTOTYPE TESTING:

l The North American Scientific, Inc. line source Model # MED 3601 or DuPont Merck Model NES-812 exceed all ANSI requirements for a closely related use environment. According to ANSI N.542-1977, the requirements for sealed sources used for " Medical Radiography" is a rating of 77C32312, and the MED 3601 has been rated to ANSI Class 77C64444. In addition, l testing by ADAC has shown that the source housings, containing the line source, can withstand a  !

4 ft, drop test with no damage (hazard analysis supplied by ADAC).

EXTERNAL RADIATION LEVELS:

I Radiation levels were measured with both a Technical Associates Model # TBM-3S survey meter (serial #40512) and TLD's issued by Landauer, Inc. At the surface of the line source housing with the shutter closed, radiation levels were less than 0.2 mR/hr with the TBM-3S survey meter. All radiation measurements were made using a 300 mci Gd-153 source.

l l

OUALITY ASSURANCE AND CONTROL:

ADAC utilizes a TQM total quality management process, which is consistent with ISO 9000 standards. Specific QA/QC procedures are summarized as follows:

I i

i

n l-

- 1

)

I I

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l (AMENDED IN ITS ENTIRETY) l l 11(1: CA102D10lS DATE: September 17,1997 PAGE: 4 of 6

1. An initial inspection ofincoming materials for obvious deviation of manufacturer's specifications, is followed by the measurement / verification of the housing's lead shielding (dial calipers),

i

2. Upon installation of the line sources, radiation level measurements are made to verify they are within specification limits.

l

3. The software, mechanical, and electrical functionality is then verified by conducting motion and shutter checks.

4. The self calibration operation is then verified and completes the testing sequence. Upon delivery to the users' facility, additional functional tests are completed upon installation.

5. All incoming materials used in ADAC's manufacturing of the VANTAGE line source housing assembly , undergo a series of tests and checks to verify specification compliance, proper functionality and safety.

6. During the North American Model MED 3601 or Dupont Merck Model NES-8412 line source manufacturing phase, the line sources are inspected, checked and verified using a series of prescribed tests. At each site, in the course of the line sources' installation, these tests are performed again, further reinforcing quality, proper functionality and safety.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

1. License requirements: These devices shall be distributed to specific licensees of the NRC or Agreement States. .

I l-

2. Leak Testing: The sources contained in these devices shall be tested for leakage at time intervals not to exceed six (6) months. Leak testing shall be in accordance with the individual license requirements issued by the NRC or Agreement States.

3. Environmental Limitations: These devices are designed for use in controlled clinical laboratory conditions and should not be subjected to conditions exceeding those specified 1 by ANSI 77C64444 ratings.

1 l

l l

t

)

l .

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

HQ: CA102D101S DATE: September 17,1997 PAGE: 5 of 6

4. Handling: standard operating procedures for these devices should be followed and must include radiation safety considerations for the intended use.

5. Users: These devices should be handled only by qualified and licensed individuals authorized by a specific license.

6. Installation: The installation of these devices shall be performed by ADAC or other persons specifically authorized by a radioactive materials license issued by the NRC or Agreement States.

7. Storage: These devices are designed to be permanently installed as a component of a SPECT system and will contain the sources at all times. However, when not in use, the shutter will remain closed and the radiation levels will be at near background levels.

8. Transfer and Discosal: These devices shall be transferred or disposed of only to specific licensees of the NRC or Agreement States.

9. This registration cenificate and the information contained within the references shall not be changed without the written consent of the California Department of Health Services.

SAFETY ANALYSIS

SUMMARY

Based on our review of the information and hazard analysis cited below, we conclude that the Model VANTAGE line source housing designs are acceptable for licensing purposes. The l Radiologic Health Branch did not evaluate the computer software programs for image quality l

enhancement for associated occupational or public radiation safety considerations, other than to

! repon the manufacturer's claims and test results.

The exposure reading at the surface is less than 0.2 mR/hr at all times the units are not operating and the safety and hazards analysis performed by ADAC Laboratories evaluates all likely failure modes and associated consequences.

[

l In addition, the North American Scientific Model MED 3601 or DuPont Merck NES-8412 line sources exceed all ANSI standard requirements for a closely related use (Medical Radiography).

o-----__------_--.--_---_ ------ . - - . - - _ - - - - - - - . -- -- d

, mI i

e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

,1 NO.: CA102D10lS DATE: September 17,1997 PAGE: 6 of 6 l

l

REFERENCES:

The following supporting documents for the Model VANTAGE line source housings are hereby incorporated and made a part of this registry document:

1. ADAC Laboratories letter dated December 22,1994 and attached draft registry certificate and hazard analysis.

2. ADAC Laboratories letters with attachments (including QA procedures) dated March 28,1995 and May 3,1995.

3. North American Scientific, Inc. registry certificate number CA510S121S, dated February 20,1995.

4. ADAC Laboratories letter with attached QA procedures dated May 3,1995 including FDA 510 (k) notification letter date stamped April 26,1995.

5. North American Scientific,Inc. jetter dated July 7,1995 [QA commitment).

6. ADAC Laboratory's letter dated July 15,1997, with attachments revising Vantage Operators Manual specific to line source manipulation and procedures.

7. ADAC Laboratory's letter dated August 18,1997, with attachments thereto, regarding the addition of DuPont Merck Model NES-8412 to the registration.

I DATE: Sentember 17.1997 AMENDED BY: '

/ '

/7 Thomas Schell DATE: Sentember 17.1997 CONCURRED BY: / O David Wesley ISSUING AGENCY: California Department of Health Services

Attachment 4 I

~

Wesley, David From: Wesley, David Sent: Thursday, April 24,199712:44 PM To: Patel, Pete; Reyes, Robert; Schell, Tom; Toyama, Fred Cc: Wong, Gerard

Subject:

Policy for including Useful Life and Operational History in SS&D review When evaluating sealed sources or devices in the past we have ignored manufacturers statements regarding usefullife or operational history as being nothing more than product endorsements. However, that information i may be of great benefit to perform a complete safety analysis. I i

For instance, if the integrity of a source is known to deteriorate after 10 years, then that limitation should be made available to a license reviewer working on a request to add the source to a license. Likewise, operational history of a source or device which has been used in various environments can sometimes p testing would provide, and may also highlight conditions of use which are ate not and appropn,rovide should be noted onbetter data the registry certificate.

Therefore, it will be our policy to ask the manufacturer for the useful life of the product, unrelated to the decay of the radioactive material. If the manufacturer can't or won't provide that information we will state as such on the

! registry certificate. Otherwise, we will state the useful life and the basis for that time-frame on the certificate. In all l cases, the applicant will provide the information which we will then pass on. We will not perform an independent analysis of the usefullife.

It will also be our policy to ask the manufacturer for information on the operational history for any devices or sources which require an amendment to their registry, or for new devices or sources which use their similarity to other models as the basis for acceptance. The information we are seeking should include the number of units distributed, to whom they were distributed (Agency or Industry), extremes in conditions of use (temperature, l moisture, etc.), any accident conditions involving the source or device, the amount of time a worker is expected to l handle the device or source during a year, and any information regarding the dose received to workers handling i the device or source.

These changes will be outlined in the next update (currently in process) to RML policy memo 89-1, " Sealed Source and Device Registry Certificate Review Procedures". Please follow the new policy based on this memo until the official policy memo has been issued.

l l

i l

l I

1 l

l i

Page1

l -

1 .

f. Attechment 5 4i b g NOVA R&D,Inc.

1525 Third St., Suite C l5 #q.

f. Riverside, CA92507 USA j

l Telephone: (909) 781-7332

! FAX: (909) 781-0178 November 24,1997 i Mr. David Wesley, Chief - M Industsi Licensing / SS&D Radiologic Balth Branch Department of halth Services gh a+.

714/744 P Street P.O. Box 9422732

'Ngg6 M l Sacramento, CA 94234-7320

Dear Mr. Wesley:

In response to your letter dated April 24,1997. Please find the following answers to your questions.

1) The drawings of the CINDI can be found in section 4, page 9 and 10 of 21 within the enclosed binder.

2) The number of units distributed and who they were distributed and incident history are as follows:

Oncrational / Distribution Historv for CINDI

! Year Otv Name and Location 1994 5 U.S. Coast Guard, Puerto Rico, Key West, Miami Beach, Miami and Petersburg Stations 1 US Customs, JFK Airport, NY l Baton Rouge Police Department, Baton Rouge, LA 1995 10 U.S. Coast Guard, Groton, CT 1996 14 US Coast Guard, Groton, CT I TOTAL 31 units distributed.

l Incident History of CINDI There has been no reported accidents with the CINDI Units. We have had three incidents of repair on two units. CINDI serial # 94 1004 was returned to NOVA on 4/15/95 for repair of the audio sound. A newer version of the PCB was installed to repair the problem. De same unit was sent to NOVA on 9/13/95 for an audio problem and an electronic component replacement. CINDI ,

I serial # 94-1005 was returned to NOVA for replacing the membrane switch. There were no other j l reported incidents of malfunctioning of the units. i l

l l

Use of the unit is approximately 240 hour0.00278 days <br />0.0667 hours <br />3.968254e-4 weeks <br />9.132e-5 months <br /> as shown in section 4, page 18 of 21. In section 7, j page 1, a memo from Dr. Daniel A. Gollnick includes a table which determines dose limits for  !

General Licensees. The table indicates that when a CINDI unit has 55 microcuries the user can use the unit for up to 410 hours0.00475 days <br />0.114 hours <br />6.779101e-4 weeks <br />1.56005e-4 months <br /> without exceeding the general licensees dose limit of 100 mrem /

year.

(

3) The typical accident condition would occur while the unit is dropped from the operators hand onto the floor approximately 4 feet (this assumes unit being dropped from chest height of an average man).

This test has not been performed as of this date, but we are making arrangements to perform such a test.

4) The -10'C temperature was based on the weakest link within the unit for the low temperature range:

Low temperature ( 10'C): Detector limitation As for the shielding integrity at -10*C; the majority of shielding is provided by the Moderator which consists of polyethylene. Polyethylene's brit'leness temperature is -76*C which is well below the stated limit of-10 C.

An analysis was performed by Amersham Holdings, Inc. Their analysis indicates that the containment and shielding would be maintained in a range of-40'C to 70'C,(refer to section 6, attachment 2, page 3 under DOT Regulation 173.412 (d) under additional remarks), in their analysis the actual unit was tested as the actual primary package. The rest of the packaging consisted of the cushion and the outer j carrying case.

5) Information on our current QC program can be found in section 4, page 6 of 21. But to assure a continuation of a high degree of quality of the CINDI unit, we will develop a comprehensive QA program. The QA program will consist of the following 19 elements which could be completed within the next three to five months.

I. Quality assurance requirements

2. Quality assurance organization

3. Quality assurance program 4 Package design control

5. Procurement control

6. Instructions, procedures, and drawings

7. Document Control

]

8. Control of purchased material, equipment and services

9. Identification and control of materials, parts and components j

10. Controlofspecialprocesses

11. Internalinspection l

12. Test control l

13. Control of measuring and test equipment

14. Handling, storage and shipping control

15. Inspection, test and operating status

16. Nonconforming materials, parts or components

17. Corr:ctive action

18. Quality assurance records

19. Audits

., e',-

We are seeking manufacturing and technical advice of Alpha -Omega Services. Inc's RSO and personnel for completion of our 19 element QA program.

6) he reconunended method for storage of the CINDI by the general licensee is specified in the CINDI operation manual which you can find in section 5, page 6,1st paragraph. De maximum dose rate on the j surface of the container is Neutrons =7.3 mrem /hr and Gamma Rays = 1.4 mrem /hr. De maximum dose at j 1 meteris Neutrons-4).5 mrem /hr and Gamma Rays = 0.016 mrem /hr. De Neutron measurements where

[

made with an Eberline NRD/Ludlum 2200 rem ball and the Gamma ray measurements where made with a j Bicron MicroRem. Both measurements where performed by Dr. Daniel A. Gollnick.

We hope this information answers any questions or concerns you may have. If not please advise us of any additional questions you may have.

Sincerely, y N . __

Shi Yin I Radiation Safety Officer Nova R&D, Inc.

Enclosure (1) cc: Cary Hedger, Alpha-Omega Services,Inc.

i i

l i

l l

._-_-______-__a

Attachment 6 CHECKLIST FOR ADDITIONAL REQUIREMENTS IN THE EVALUATION l OF DEVICES USED'UNDER A GENERAL LICENSE f*

i DISTRIBUTOR:

I MODEL #: REGISTRATION #:

REVIEWER: DATE: j i

l Description OK/Def Comments l Design I la the device designed for the purpose of detecting, measuring, l l gauging or controlling thickness, density, level, interf ace '

l location, radiation, leakage, or qualitative or quantitative l chemical composition, or for producing light or an ionized l l atmosphere? '

Operation

( Can the clevice be safely operated by persons not having training in radiological protection?

Can the rindioactive material contained in the device be released l l or inadvertently removed from the device under ordinary '

l conditions of handling, storage, and use?

If periodic tests (leak, shutter, etc.) are allowed for periods greater thim 6 months, use and attach the Periodic Test Checklist.

Maximum Dose Commitments

( is it unlikely that any person will receive in one year a dose in excess of 10 percent of the annual limits specified in 10 CFR 20.1201(#17 (Provide an estirnate of the dose to a worker for each activity to be performed)

Under accident conditions (such as fire and explosion) associated I with the handling, storage and use of the device, is it unlikely l that any person would receive an external radiation dose or dose commitnwnt in excess of the dose to the appropriate organ as follows:

Part of Br_d.y Dose frem)

Whole body; head and trunk; active blood forming organs; gonads; cr lens of eye 15 i

Hands and forearms; feet and ankles; localized creas of skin averaged over areas no larger than 1 square centimeter 200 l

l other organs 50 Labeling Does each device bear a durable, legible, clearly visible label or labels?

I Does the label (s) contain in a clearly identified and separate statement, instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and ussd to provide this information)?

l 1

Rev 0: 4/23/97 Page 1of 3 l

1 l

CHECKLIST FOR ADDITIONAL REQUIREMENTS IN THE EVALUATION s i

OF DEVICES USED UNDER A GENERAL LICENSE I

!1 Description OK/Def Comments Does the label (s) contain in a clearly identified and separate statement, the requirements, or lack of requirement, for leak

{

testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of j radioactivity, and date of determination of the quantity?

Does the label (s) contain la a clearly identified and separate statement the information called for in the following statement in j the same or substantially similar form?:

The receipt, possession, use, and transfer of this device Model

', Serial No. 2, are subject to a general license or the 4 l

equivalent and the regulations of the U.S. NRC or of a State with I which the NRC has entered into an agrt.sment for the exorcise of regulatory authority. This label shall be maintained on the device i in a legible condition. Removal of this label is prohibited.

CAUTION-RADIOACTIVE MATERIAL (Name of manuf acturer, or initial transferor)*

' Devices designed for generallicensure prior to January 19, 1975 rnay bear labels authorized by the regulations in effect on January 1,1975.

8 The model, serial number, and the name of the manufacturer, or initial transferor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

Periodic Testing )

If the device is to be tested at intervals longer than 6 months for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material, or for both; has the applicant provided sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices, and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism orindicator?

The following information was use:I to justify an increased interval:

Primary containment (source capsule)

Protection of primary containment Method of sealing containment l Containment construction materials  !

Form of contained radioactive material l Maximum temperature withstood during prototype tests Maximum pressure withstood during prototype tests i Maximum quantity of contained radioactive material Radiotoxicity of contained radioactive material Operating experience with identical devices or similarly designed and constructed devices.

Other (specify)

I l

l\

Rev 0:4/23/97 Page 2of 3 {

[ ]

' CHECKLIST FOR ADDITIONAL REQUIREMENTS IN THE EVALUATION

, OF DEVICES USED UNDER A GENERAL LICENSE Description OK/Def Comments Accompanying Documentation Verify NRC Regions and Agreement State listing is up-to-date and copies of all pertinent regulations Servicing if the generallicensee will be authorized to perform any of the following activities, did the applicant provide written instructions to be followed by the general licensee, estimated calendar doses associated with such activity or activities, and the bases for these estimates? (Maximum allowed doses apply to these

! activities in combination with any other doses received from l handling, storage or use) install the device Collect the sample to be analyzed by a specific licensee for leakage of radioactive material Service the device Test the on-off mechanism and indicator Remove the device from installation l

l i

i l l l

l l

l l

i Rev 0: 4/23/97 Page 3of 3

l , age ." my un m sw 9tr nun NUtb bHUiU P M W. m@ E3 R@@ < P. 92 f

g or ecurc.auvt- rir.a.ngyu as emev , _

mn wn.s.w o-.,

, DEPARTMENT OF HEAL.TH SERVICES w4amm

. 1.CA9@4UN

..,m m.m. January 12,1998 Hugh L. Thompson, Jr.

l Deputy Executive Director for Regulatory Programs l U.S. Nucient Regulatory Commission l Washington, D.C. 20555-0001

Dear M r. ~nomspon:

a NPEP REVlF.W OF CALIFORNI A LOW LEVEL RADIO ACTIVE WASTE PROGRAM l

The December 24,1997 response from the California Department of Health Services Radiologic Health Branch to the recommendations of the Integrated Materials Performance Eva!ustion Program report did not address those recommendations specific to the Low. Level Radioactive Waste Program, but indicated that these issues would be dealt with separately by th LLRW Program. The purpose of this lener is to respond to these recommendations, thereby supplementing the December 24,1997 letter.

Rece udio.n. No. 3 The review team recommends that the State make a concerted e ort to adopi regulations that are required for compatibility and sie overdue for adoption. A special effort should be made to adopt the amendments on , the Definition of Land Disposal and the Waste Site QA P ogiam amendment.

Rerown The LLRW Prograns has drafted the subject reg,datiorns, and has subnutted them to the Department 's Offisc ofAdmmntranve LawforRevicw The promsdgation prricsss isexpected to conchi h by September 1998 Becems.n.dation No 15 The review team recommends that the LLRW program considej keepmg official records of each staff rnember's technical training and participation in workshops, conferences. etc in the individual's training files 1

[Mpm.c 1hc LLRW Program has started maintorning such records, effective January 1,1997.

Ihank you for your consideration of these responses. If you have any questions, please contact me at (916) 323 3693.

Sincerely, I

T.

d /.ph..<

. i..

./. / .vr".uv A Carl Lischeske, P E, Manager, Low-Level Radioactive Waste Program cc. Edgar D Bailey, C.H.P . Chief itadiologic Health Branch I

i bdb2b bb~,

- as ,

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ . _ _ _ _ _ _ _ . - - . _ _ _ -