ML20126E977
| ML20126E977 | |
| Person / Time | |
|---|---|
| Issue date: | 02/05/1981 |
| From: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Garrett Hansen HOUSE OF REP. |
| Shared Package | |
| ML20126E978 | List: |
| References | |
| FRN-45FR31701, RULE-PR-35, TASK-OS, TASK-TP-102-3 45FR31701-7, NUDOCS 8103050077 | |
| Download: ML20126E977 (12) | |
Text
,. .2 .
f ' *,, UNITED STATES I :
2 ,, a NUCLEAR REGULATORY COMMISSION wash WGTO N, D. C. 20555 !q I/ f
{ ,I
's **,,* ,o}f /h;/ 4 pgDPUED AULL N ~~r
</f At 31701 [$
FE3 0 51c: W M FIIi15961>;4 l -
+ s P W;i . , y es :sesst , i The Honorable George Hansen C mies e United States liouse of Representa P'}
Washington, D. C. 20515 g (,L{ bll) e Y Q ., ,,g g o,' ;
Dear Congressman Hansen:
I FEB 171991*g emmu"*b t3 v.s. This responds to your January 12, $'1 rs%tf4Wfor[ ormation for your constituent Charles E. Smith, M.D., t rding c tly-concluded NRC rulemaking on reporting requirements sadministration of radioactive materials. Dr. Smith expre cern that this regulation ; will be detrimental to the health care profession and to physician / patient ! relationships. Throughout this rulemaking, the Comission was very aware of the potential intrusion into the physician / patient relationship. At the proposed rule stage, in July 1978, the Comission expressed concern about the possibility of undue intrusion into the physician / patient relationship and asked commenters to focus on the manner in which referring physicians and their patients , were informed of misadministratiens. In that regard, the Comission directed the staff to solicit extensive comentary thereon by distributing the prcposed misadministration rule widely to physicians both within and outside of the nuclear medicine comunity. Accordingly, the proposed ru'e was mailed to all of NRC's medical licensees, about 30 pmfessional and public interest groups, and f' about 2,000 local American-Medical Association chapters. Letters from 150 comenters were received and 90 percent of them were - opposed to misadministration reporting, with most citing it as a serious intrusion into the physician / patient relationship. The Comission took several steps during the final rulemaking process to mitigate this intrusien. For example, in the final rule the Comission does not require diagnostic , misadministrations to be reported to the patient. Also, in the final rule there are provisions for the referring physicians, if they wish, to infom patients of therapy misadministrations, as opposed to a strict requirement for' the licensee to infom the patient. The possibility of an undue intrusion into the physician / patient relationship by the NRC, was unquestionably the issue of greatest concern when the Comission censidered the final rulemaking. In reaching its decision, the Comission' concluded that the benefit of identifying the causes of misadministrations and thereby enabling reeasures td be taken to prevent recurrence, coupled with specific steps to minimi:e the intrusion into the physician / patient relationship, outweighed the possible detriment to that y relationship resulting from the reporting of misadministrations. ji-ifI : 81880500 77
E- ,$ 4 & . f M . Q .W Q q- j.4.# el.. 4,,s ... %Z. .' ... (( The Honorable George Hansen 2 s.
. Y In his correspondence with you, Dr. Smith erroneously stated that NRC had not prepared a value/ impact analysis for the subject medical missdministration reporting requirements. A value/inpact analysis supporting the rulemaking~
was prepared and was used by the Comission when it decided to promulgate the final rule. The notice of final rulemaking which was published in the Federal Reoister on May 14, 1980 (45 FR 31701), copy enclosed, also gave notice of the availability of that value/ impact analysis for public scrutiny. A copy of the value/imoact analysis is enclosed. Additionally, copies of two Comission papers, which provide an analysis of the public coments on the rulemaking are enclosed. At this time the NRC does not intend to reopen the rulemaking.on misadministra-tion reporting unless there is substantial pertinent information that was not available to the Comissicn when they approved the final rule. However, when they approved the final rule, the Comission instructed the staff to reexamine the rule after it had been in place for three years. I trust that this infonation is sufficient for your office to prepare a reply to Dr. Smith. If there are any further qt:estions, please contact me
- or Edward Podolak in our Office of Standards Development (Telephone: 301-443-5860).
l Sincerely,
%ned1T. A,nahm
- hs . :
#11111am J. Dircks Executive Director
~ - for Operations
Enclosures:
(3) \j , 1. Federal Recister Notice
- 2. Value/ Impact Analysis
- 3. Comission Papers (SECY80-26) and SECY 80-25A 7-45K # '
@ H 035*- Y DISTRIBUTION:
Central File SD RDG/ ALPHA - RHSB RDG/ Subject Smith Goller Guibert ~ Parsont ; Podolak : WJDircks G. Ertter (G.K 10043) SECY and LUnderwood, MPA
^-----
- mh& - -- - ~ \
MParijn) F *JCGuibert"'W's
...1/#/ge.81..
-KRGoller" - "
ed *RGSmith "WJDircks" - -~~--~~-~~
~~~~---i - e
...............l
.a.'shd.m..
/ 1/3c/as .s1. . .1/. k/ 81. . . . . . . . . .1/. . . ./.S.1. . . . . . .
d Federal Register / Vcl. 45. Nr. 95 / Wid tesday. May 14, 1980 / Rules and Reguhti:ns 31701 ; NRC. the toferring physician, and the
, patient or a respon:ible relative (unless
. the referring physician stated that the information would harm them); and .
, (3) Follow the prort.pt report with a !
). written report to h1C and the patient or
' responsibie relative within 15 days.
In the proposed rule, a misadministration wse defined as the
- administration of:
. (1) A radiopharmaceutical or
, radiation from a sour.:s other than the one intended:
(2) A radiophaimaceutical or I radiation to the wrong patient: l
.' (3) Aradlepharmaceuticalor radiation by a route of administration ;
other than that intended by tha i prescribing physician: * '
. (4) A diagnostic dose of a radiopharmaceutical differing from the NUCt. EAR REGU1.ATCRY prescribed dose by more than 20 j COMMISSION, percent:or I (5) A therapeutic dose of a. , j 10 CFR (' art 3E ~
radiopharmaceutical or exposure from a i radiation source such that the total dose ! Misadministration Reporting . or exposure differs from the prescribed Requirements dose or exposure by more than 10
'. percent.
Acancy:U.S. Nuclear Regulatory The public was invited to submit . Commission (NRC). written ecmments and suggesticna on
, Action: Final rule. the proposed rule.The proposed rule
***** * "" ** **"8
SUMMARY
- The NRC is amendinIits about 30 professional and public.'ntere i
ragulations to require its !!c
. keep records of all misar'-",ensees*strations to:(1) groups, and a.000 state and cou:t of radioactive esterial: (2) pro =ptly scedical ocieties.
report therapy =isad=inistrations to de Comments enPropcsedRule NRC, the referring physician, and de lse Comtnissica received 150 letters padent or the patient's respansible commenting on the proposed rule. I relative (or guardian): and (3) repcrt Copies of these letters, a summary and diagnostic misadministrations c;uarterlY analysis of the comments. and the to NRC, valus/ impact analysis suppo.-ting the ' arrucTty DATs: November 10.1960. Snal rule are availab!e for public Sta-NRC has submitted if s rule to de inspection at the Com=ission's Public Coesptrouer General for review under the Document Room st 1717 H Street. NW., Federal Repens Act. as amended. 44 U.S.C. Washington.D.C. Single copies of the 3511The dsts on wiuch the ru!s bececes summary and analysis of the comments efective reflects inclusica of de 45. day or value/ impact analysis may be period that the statute allows for dis review obtained frem Edward Podolak at th's (44 U.S.C. 35u(c!(21). dove address. I POR FURTHER INFORMaTION CCNTaCT: Ninety percent of the comments were Edward Podolak. Office of Standards opposed to the rule, most citing it as an Development. U.S. Nuclear Regulatory unprecedented intrusien into medical Commission. Washington, D.C. 0335 practice. Basically, the commenters
, (Telephone:301-443-5860). were opposed to misarfministration !
I
. SUPM.EMENTARY INFORMATION: On July reporting to NRC where reports would 7.1978. NRC published in the Federal be open to public scrutiny, and !
- Register (43 FR :s:s7) a proposed rule misadministration reporting to pntients j
- on the misadministration of radioactive which they felt would cause " undue
. material to patients.The proposed alarm
- and " unwarranted malp tetics i 35.33 would have required =edical suits." Many commenters offered aelpful t . Licensees to do dree 6mgs: suggestions which were incorpersted (1) Keep records of nil into the final rule as explained below misadministrations for 5 years; under % mmary of. Major Changes in
(:) Promptly report all derapy the Einct Rule." misadministratiens and those diagnostic Many com= enters questioned the misadministrations that could cause a need for a =isadmimstration reperting climcally detectable adverse effect to: rule.They cated de low number of
. _ . - -e ~ n e -. , . . .
2 . - ._ . .
. . . . . 4, ..: ,
~
,, }
3C02 Fed:ral Register / Vol. 45. No. 95 / Wednssday. May 14, 1980 / Rules and Regulations should expand NRC'e authortty, the. reported misedminstrations.They stated' Commission beifever that the NRCmust operate underde thzt misadministrations of radioactive misadminisestion racordkeeping and matrrial wereIess fregrmt thare reporting mquirement is necessary to. presuegdor.that Coneress intended that , i mistdministrations of other cfra:;s ur protect patients. a dispropowianare degree of Federal - ! Many commentere wee c . J regulatory control be exercised ovee ' I
- typeeof therspy. And daynoted ther about the privacy of patients' tocards, nuclearmatscals as opposed to these taire are tro simihrreporting requirerrierrte in medfcal practice, when misadministruticas are reportad to other sources of radiacon. -
a thud party such as NRC. In many respects the adverse Thf Commisalon's purposela cornmente tracis those recaived by the requiring misadmirristration reports to .The finsk rule staas that the patients name shamidnot be reperred to NRC. Food and Drug Admunstration(FDA)is NRC le to identify their esases in order I The reports of =w=*=centions would respense to arequest for enamentsto to correct them and prevent their
- help FDAformulass a policy onlaheiing recurrenes De Commissiore emo do this be :.vailable for public review but . of prescriptian drug products to promote
~ by ratifying other licensees IJthereis a without infermaties that weald !and to identification of the patient. patientunderstandingof the nature and possibility thertheycould make the effecte of the drugs presenbed for them.
same errors.Deconurriesimecan eiso The vast majority of the commenters ' in a notice of proposedrufemmMag(48 , chinge its reguistions to pregerrt specific consider the proposed rule es a sensue intrusion into the physician. patient
- FR 400186 Inly 6.19:91. the FDA retected 4 errore. The sigmffcat.ce of e diesnostic relationship.Thay contend that the the assertion thatmanziatory patient i misadministratime goes beyond the i unnecessary radiation exposure if it proposed rule is an intrusion of a labeling would constitute an results in misdiagacele. Apparently regulatory at: ncy into the care of a unwarrantadinterference inthe , )
patient wtthr~t assumtag responsibility physician-patient relationship, pointing i is:Isted incidents atindividual medical for that care:Many anznenters pointed out among other things that a patient institutione could reveel e generic problem when :ompared nationally. out that the misauministration reporting has a right to know anout a dr:3's Examples of rule changes resulting requirement was un41 e in medical benefits. risks. and directions for use. ! practice and noted ths t NRCregulations Also.in t January isnreport(DtD . frca misadministrations are: a rule 79-16). the General Accountmq Cf!!ce
- requiring annust calibration of did not apply to X-es) s. accelerator or teletherapyunite(44 FR 17:::). and a rule radium therapy and a=alerators . (GAOJ stated:
produced radiopharmaceut:cals. I requiring radiation surveye of patients In our view requiring medicallleensees tu following removal olimplants (43 FR The Commissionrecogni ss the report misedministraticas eo .NRC is not as ' Intrusion Inta the prysicsan-patienf intrusion into mescal precuca.Thisla clearly 55MS). consistent with NRC rerdatory Th7 Commissierr does not know the relationship in the sense thatthe rule does affect. to a !!=ited cfegree, the raponubihtles and a necessary paa of as entire extent of mitadmir:fstretions of effectfve nuclear medic:ce regulatory radioactive material. In is:SNRC nature of the physician's ocIfgation to his ce her pa tientr-il imposes in certain program. Without ttus kind at fandback as investigated arrincidentwhere 400 incidents acecting es puoi!c genIm ami therapy patiente hed reesh ed radiation ciremnstances an ob!!gation on the safeW cuandm a ingequemly doses excceding the prescr:hed doses by physicfan tn report infor: nation to the **' " as much as n percent.!n1977 NRC pathmtand the NRC.yor many in the M N '[adical a. -
' received seve reports of healtitprofessions this IImited Many commenters wers concerned ,
misadministratiene rar.gfng hem minor lavolvement may be u=derstood. rightfy that the proposed ru!a. particularly the
'misadministrations to a. serious or wrongly, as fereshadowing some put;ent reporting requirement, would teletherapy overexposure. !n 1978 NRC greater degree of Covernmental invite unwarranted malpree: fee suits - i received eleven reports of involvement or :s symbollzing some. '
and thereby boost credical costs. Some raisadminisestfoes.2ne of them e general movement toward mor, of these commenters suggested that the ! sIrious misadministration of four It-192 regulation of te pr:fession. rule would lead to ecvenng up i sacds that wereleftin a patient. In 1979 The Comnussien does not believe, however, that this!!mited fntnision misadministrations to avoid liabdtry. j NRChas received a singlereport of a The C3mmission be!! eves car the-misedministratics: colleida! P-32 was warrants abandening the rule. Some I physicians do soppert 2e rule-the requirement in the fmal rule to report administered (nstead cf soluble P-32. therapymisadministratfons to patf ents . The Commission doernat knowwhat medicalprofessieu !s not unanimous that the rule would constitute an or a respcasible relative is important. fraction of the actuelincidence of Patients have a right te know when they misidministrations these reports unwarranted intrusion into the have been involved in a serious represent. However, wheneverthere has physician-pa tient relationship. na misadministration. enfass this be:n a serious misadminfettation. the "phrefcian-patient'*relariansMp fe p information would be haemfal to them, Commissiert has been able te act to help concept thatwas devehped te advance NRC haeparalfel requirements for prevent recurrence byissuing notices or the needs of the patient.The licenses reports to workers on ceders to licensees or 2 rough relationship involves duties of reasonable care and skd!. occupadonak overexposurer. A!so, there ruleinskfng. . is a trend in Federallegislation that The Cornmission recognizes that its confidentiality, and good faith owed by misadministration reportfug requirement the physicfan to the patient. Nothing in recognizes the right of individuale to may be unique to medical practice. The the rule would detract from these duties. know information about themselves Commission riso recognizesthat ths Thus,in a stuct unsa, the rule would which is contained in the records of not interfere w'.th the relationship. Institutions both inside and outside of misadmirdstration of the Federal sector. Examples are: tha redlopharmaceutic Ir and radiatfan it is true that no simdarreporung from seeled sour:ee may beless requirements are attached to use of X- Privacy Act of 1974. which set rulee for rays, et.celarator arradium therapy. o* Federal Agencies' recordkeeping: the frequent Was the mirseministration of Fair Credit Reporting Act and related oder drugs or forms of therapy.because _ acesferator produced Isotopes. Howevar, this is the direct result of acts, which gave consumers the right to the radiopharmaceutical doser and limitations in NRCs regulatory know fnformatiott about themselver
. radia:fon dosee can be measured before administration to patients. However, the authority. At present utdess Congress contained in the records oferecit.
-) 1
- 1
. --,_A
s, .
# Federal Reg! ster / Vol. 45. N$ 95 /-Wet!nesday. May 14. 1980 / Rules ard Regulations M703
^
reportang baresus:and the Family give a smaHer radanos dose to the Seve al commenters questiened Education Rights and Prtvacy Act, patient. whether extravasation is considered *a which gave students the risht to see The proposedru!o had a 6tesheld for misadmmistrados. , personal records held by educatienal reporung diaenostic masadmnustrations. heavasation is the infiltration of , insututions. Also,in Apnlis:7. the injected !!uid into the tissus suzround.ng ne thresheld was not cient.The a vein or artery.htravasation ; President sent the proposed *Pnvacy of proposed Me reswed reporunof 41 Medical Information Acr* to Congress, therepy misadadaisara uona anst dose frequent!; occurs in oderwise normal intraveacus ce inirnenerialinjections. It and Pasident said: diagnostic missdmmrstraticas thes could cause a *ctin:cmEy detectable' adverse is vimally impossible to avoid, De "pr:vacy ad MacsalInformatana Ass
- Therefore. the Commission does not ,
.le being sahawtad to you today. 2 antah!Ishes efect on the pagant, prWacy pmenes facham cr. e asana to b a T misadmannstration. -
maintenwd by almess au sindicat inentetsans. a g.he .-.u. staff. *hattar as e 208"es that 6e d.*flaition of Some coatsweters questioned whether - The Act wiD pew edwideem tie nght to see percent erm fs too Icwmatleni was they would have to measure the act vity ther own moeinnheuards. !! abens as-se choses or girmi?y because it was within may hamm ihm pnessa the Aar souvide mas in a synnge before and after tha , access may be ass =umsdiks-go as the state-of-the. art for - iniacsim order to denernme if a - ' intermamary.This't - aGementhe radiopharmaceutical measurement and misadsmaseadon has occurred. ladividual to emawn unas taa >*h- the Canunission was concamed dat the MIsadauanstratians of a : maintained as pars ofina mad!sai sase limit fat a diagr:osthe re!sadmnistration radiopW.nsceuMs defined as a . minuonship is scaurste. tfsanff and relennt would be co serwf as good pracdce. percenrage error from de f.rescnbed ? The Conumssiera rer ;:i:ss that are dose, itis necessary to measure the tance ans e is are facters. suchts pa tient sched=Eng, acuvity ).rior to injecton and then inject r
. used to afect em-foyment and codecno.n.of wnich are not errors but could cause de de contents'of the syr.nge. !t is not i inwance and seer sound hemmass. . i patient to recalve a he di5ar6g hem necnesary to meneure the t== dual Regarding da enmment das de rule se prescribeddone bymore thas 3 activity n 2s synnge. i' would Invita mal;rsc:Ica suits ard percent without afect5g the One cotarmentar suggested ist thereby bcost =a.!Ical costs. this =ay eHecuveness of me test.De Saal rule ticansees be aq ired to keep records of I well be tnis. The ame.:st of this increase defbes a diagnost'c=isad um<esdon. misadministraticos for 50 years.!astead !
is not known. In nspensa to NRCquary, in part. as dat difenng frem the of de prrposed 5 years. because of the ]' the National Assoefation of!asurance prescrtbed dose by rncre than 5A long latency pertori for radiation. i Brchars apM , percent. At this limit of 50 percant:(1) an induced cancass. Foe the same reason. : It is simply beyami ses competancs to error has obvicusly occurred and ( ) 50 anc5er commenter suggested that the ; quantdy the ecfess as me&sm1=4acasa percent over or undar the presc=hed records be maintainedfor 30 years. ; ' rates of your proposedrule. * *
- taasthe dose can clearly com; tem:s* tha . Da Comcassma a6taas that dare are i
' pmoosed changs M have aa admse sfeedveness of de dia6=ostic compelhes reasons !ar insanng that de ' e5ect ce mise seems !cansyntaMa since de arecedure, records of misadrmnia:rnefens should be r - . i doctors would be teamred. he e soare. to ; prepare testimony agemst themserves.We Some commenters cb{ected to 6e {amiaissecs. foe a period of time anger absence of a definifen for a *c!!nically "an de Gn years an angsnady l frankly doubt ther anyces aan gauge the pmposed. A: da some nineitis not yet tikely ecastaf sockatu3e * *
- detec+able adverse effect"in Se ,
Regarding the ruggestfon that the rule threshold for reportinif diagnostic misadmmistratorrr. Othen quertioned j{foghaspecc would !eed to covenng up , misadminintestfans to avoid !!abinty, the who won}d = ale dat deter = met:en., g, ,, ,3,,,, ,y, g, ,,,y g,g,, Othen objected to the physican having a s d m stadon .
- Cornmission does not beifsve dat He physicians would wCfuDr d!s
- rgsrd is too much Inway in makMg the determmation. Std! ethers complained records for any specEc!ength of time. I rule Moreover, there is ncthingin de ,
, hat, without guideDnes. they would bheMr W 'MScemees rule thatwould is any way mcci.8y de .
shad puserve C ~eados . ' l legal rules governing malpractice st=ts have diEculty in making de records nd) da Commission audornes ! arising out of reported . determination. ' dispostacn.n s apprA-c.Ms consstant l
- misadminf-trations. At the prepcsed rule stage. de wtth part
- c.W1 of NRCs .equlations
- A maienty of the comm w.u i.o Commission believed dat .linicaDy which requins that NRC licensees I i
opposed the nie were opposed to the detectable" was a term weD understood mamtain and preserve radiadon in medicine. According to some exposars recerda foe mentored I requirement for reporting diag =ostic misadsWdstruticas to patfeats.They commenters,this !a not de casa.ne personneluntd the r -.= ion I stated that mest misadmtmstratisms of -Ccmmuasion t P-*a that the authertzee disposition. diagnostic radiopharmaceuticals would d!agno is of an "adversa efecs* may in Under the provunens ofSection :ca of i act harm the patient.ney also stated one case be based on a negla dramatic the T.nergy Reorgamzatico Act of 1974 that the de!!nition of a diagnostfc syciptom. while in another esse it may the Comminaion reports each quartae to r
- misedmimsostion as an arrorgreater be based on a number ofindMduaDy the Congress on any abnormal than :D percens wonid unduly alam the minor deviations from de normal for occurrences invoirmg facdities and patient because it was toolow.They that patient. Because of this and activities regulated by the NRC. An
- stated that the recommences dosage because adverse effects may be delayed abncemal occurrenca is danced in i
- ranges in the drugiMg spenced in time, de term "c=acally detectab!s sectica aca as an unscheduled incident factors cf two end grsater.ney further adverse effect" is a monna target, or event whsch the Corn =ussion stated that the stancard dosages vary Therefore. Se Commission is determines is symEcant frem de between insatunons by as maca as 100 abancen.teg t!us term and the threshc!d. stand;cet af ;uc2c hesah cr safety.
percent.They also stated Si trus na Gnal ru:e wtil nqmn repornng of ne C:=nusatc= pub;isced a policy definition discrimmated against short au diagnesuc =isademtstrauens to state =ent en a'e nerman cc urrence half life radiopharmaceuncais wiuch NRC. reportng in de Federal Register (4* TR , ow-4w.e- -www a*= .-i.4,%. = w.,w..r.,. ,,w<.v.,,..-w- nw..~,- ,.-,w-,,q q,...w.-3 .. ,,- ., m gw a ..-w, -o % .a .w,, y s- e n e- - 3 ,v-,,--,--wa-
- ..- - _-- - -. - -. - - _. .-~
3ro4 Tederal Register / Vol. 43. No. 95 / Wednesday May 14. teso / Rules and Resulations . In The final rule,is definition of a caledated total treatment dose d!fer=g 10950).Those misadmimstrations which the Commission deter =ines meet the thersey misadministration in i 23.41 (e) hm de Ena! pres =ded total treat =ent enterie ter abncrmal oc:urrence and (f) distbpishes between dose by =cre $an 10 percent. , wporting will be published in de radiopharmaceutical therapy and saaled 1 35.42 Meoons omeney - quarterly " Report to C:ncess on source therapy. For sealed source "***""""*' - ' Abnorma! Occurrences.' In de past. Gerapy, the new deanition recopizes . tehtherapy overexposuns have been that the therapist often adjusts me dose (a) Latm6me tele # sng npon. When a misedaumseaks !avones any reported to Congress in ils manner. dunna esatment. Also, the new g 1 dersey procedun, the licensee shall -
*6 Summary of Wjor Changes in the Final g(y,'Q8d notfy, by trie: hone only, the
& k apprepnate NRC Regional Of".cs usted
- I"I* cabulated as a lunction of dose rate,
- The finaliule was organized into e.c. and treatment geometry, and is not in Appeda D, of Pan 20 of tis chapter, The bcensee anul also notify the -
separate secdons, spechily 11 35.41 usually measured directly. nase mlerring physklan of de afected . through 35.45, to make te requirements . changes nsulted from several comments padent and be padent w a neponsNe easier to undentand. from radiation therapists. ', Several commenter's soggesdans were- relative (or guarcif an), un/c s the incorporated into the Saal rule. As FinalRule - nferring physician personaUy informs , noted above. the term "could cause a Under the" Atomic F.nergy Act olis54.- the Ucensee ei6er that he milinfom c!!nically detectable adverse effect"in as amended, the Energy Reorganizacon the patent or tat.in his medical , the thmshold for nportng diapostic Act of 1974. as amended and Secticus judg=ent, telung the patient or $a 9-'8-Mistrations haGuen acanconed 532 and 353 of Title 5 of de Unf ted ;atient's responsib!a relative (or in the final rde. Instead. all d=posuc States Code. de fcCowmg acend=ents guarti!an) would be har=!d to one or misedmin'strahns wiH be re;crted to;It! 10. Chapter! Ccde of Federal ce eder.nspecevery.nese - qu'arterly to NRC enly.nesa n; orts of Regulatens. Part 25. an pubushed as a r.atifications sha3 be =ade within :s . dispostic misadamstrations are to be . hours after the licensee d.scovers the document sub>ect to codEcation. bs 1stter format and ;os marked not misad-Matration. If Se refemns pART 35-HUMAN USES CF 8'"'" 8"' "' e """$ late 6an *0 days followmg de
- calendar quarters ancing in Wrch. June. BYPRCDUCT MATERIAL U"*U$"
'EU"S N U."N"IN*d"*U.
Septe.2 {" j' ""l*J'"",["'JiUZ'; "y" dc b New !! 35.41 drough 25.45 are added "j "; $ , The C m.ssic ce ges !!censeies
~ L3 report diagnostic misad=nniseatcas to 10 CTR Part 35 to read as foCows: gyt; g yjg;,guna y,8,unsun ,
. la patents but does not beUave that $9 - =
Ucenses shall not delay medical care for
. risk of a dispostic misad-Wsertlon En Oef.=idos of a misadminiseston. de patient because =f this.
warrants Federal interven:ica !n this 35.42 Reports of cersyy (b) Written mpert. Wldin 15 days i det:ision.Therefers, de Cc==f ssion missc:nuiseseena, alter de initial cerapy
, will not require !!censees tn report
- 25.a3 Reports of diagnostic misad-Mstration re;crt to NRC. is
, diagnostic misadm.matraticas to the misacznnistrations. Ucenses shall re;crt. in wnthg. to de pttient er relative (or pardan). 2s.44 Records of ai! =isad==iseascus. NRC Regicnal CI5ce imida!!y In the final rule. only $ cts;y ,
35.4s R!shts and duties of Ucansees. te!aphened and to the refering
,.misadministrations.are requited to be Authonty:Seesons St. tot h. and o Pub.L physician. and krnish a copy of is
. repcrted to the nierrin:; physician and 83.ros, sa Stat. s7.3. Ha E and a.42 U.S.C ;,po;. to de ;adent or 2e patient's ~
the patient er reeponsihie re!anve.There :tu.=01 A and og Seccen :ct.Puh.L 23 responsth!e relauve (or partiian) if . are two changes regarding ncti$caton 4:s. as Stat.1*42. 42 U.S.C 3441. eiber was previously netEad by de of the pacent or aspensible relative in yw,s w.tration Reports and Records licensee under paragraph (al:f tis i
! 33.4:(a). t:rst, a phrensc*.ical "{or secten. Le wntten repcrt shall incbde guard!=c)" was added to "tws;onsible i 3s.41, Defirunon of a mieederurustration. .he Scansds name 2e nfamng i relatin' to cover p:rsons wna do not For this part, missWstration ;hysician's na=c a brief desc=; tics of have relatives. See:nd.now is means te administreeon of: ceevent e eHect on Se patent de ru smng physicians. if they wish. =sy (a) A radephar=aceuccal or acten takes to prevent ac.tranem .
Inform te pat!!=t of de redation frJm a sealed source other whoder the licensee informed de . misadm%tratien. than We one intendes patient or de pacent's respensible " In de Saal rule, de !!mit !ct a (b) Aradic;har=acented orradiadon relative (or guardian), and if not, way disposce misad=iniscation in l 25.41 to te wrces patient not.The report sha!! not incbde 6e has been raised to errors greater dan 50 (c) A radicpharmaceutical or padent's name, or cder infor ation percent. Many commenters pointed out . redacon by a route of ad==stration wnich could lead to idanuScation of is that be recommended dnsages !n other das $at intent.ed by the E gg,,g, radiopharmaceuticallabeHng cover - prescibing physiciam ranges of up to a factor of10 and that. (d) A dispostic dose of a j ss.a3 Aeoerts of casgnesee , comperms nuclear med! cine radiopharmscouncal diffanng'fitm de m6asemmistratfora dipartments. dere is often a 1005 or ' presenhed dose by more dan 50 When a misadmisfstration involves a greater difference in de standard percent dispostic procedure. the licenses shall - d3 sages for the same precedure.no (e) A therapeutic dese of a actify,in wnting, the nierring physican Commission did not raise the limit of radiopharmaceuccal Sf.fering from te and ce a;;rc;nate NRC Reg:enal . errer for a dispestic misad=in:stratica presenbed dose by mere man 13 CfEce listed in A;;endix D of Part *0 ci above the 5c*5 !evel because dis level per: enc =r bis chapter. IJeansee teperts of begms to affe:t de quality cf tne !f} A derapeutic radiatien dezefr:m a dispese: misad=mistratiens are due dispcstic preced=es. A ;ccr quality sealed sour:: su:n dat e r:n in ce wicin 10 days after de end of de dapestic;rceed=e ceuid requ:re a re - - :e :a!ibration. t=e :f ex;csun, and ca:endar quarters (delbed by March. take er c uid resdt 2 a =:sdiapests. 'rea:=ert ;ec=etry result in a kne. Septr=ber, and ':ece=:er) a w..ich cey oc:ur. Dese wntten re;cr*s a.
. . . . - - . . , ,.%.-- ..-w,.-w.-...,,....-- m , , a-.2, - - ~ -mv.---~,em---m. ee-.... -w e erm,-.-e.+-,,eus-wr-e.w-,..,e,-y,- w e-e m -.w . - r tv v a v r* irt t#
i 1
- ~
. . . i
- Federal Redster / Vol. 45. No. 95 / Wednesday. May 14. 1980 / Rules and Regulations 31705 i
shall include the licensee's name: the referring physician's name. a description of the event the effect on the patient and the action taken to prevent recurrence.The report should not p. Include the patient's name or other information which could lead to identification of the patient. . l3L44 Records of an misedmin6strations.
- EachIIcensee shallmaintain for Commission inspection, records of all
- misadministrations of radiopharmaceuticals or radiation from -
teletherapy or brachytherapy sources. - These records sha11 contain the names of allindividuals involvedin the event (including the physician. allied health personnel, the patient, and the patient's refering physician), the patient's social security number, a brief desesption of the event. the effect on the patient. and the action taken to prevent recurrence. These records shall be preserved until the Commission authon=es their ' dispositico. - j 35.45 Rignis and duties of !!censeen. Aside from the notificadon requirement. ncthing in this stetion shall affect any rights or duties of!!censees and physicians in relation to each other, patient or responsible relatives (or . guardians). Dated at Washington.Dr this 7th day of May 1979. For the Nuclear Regulatory Commi:sion. Samuel J. Chi:k. Secretary of the Commission. (rm one. an.ian ru.u-ts.aa us amt causeo caos tsse-st.as 9 9 G e F
~ - ,. , .- . a _ww -.- > . - . - - .-
e
I REPORT JUSTIFICATION ANALYSIS FOR GAO b AND VALUE-IMPACT ANALYSIS I. Tyce of Recordkeeoinc and Reoort ~ . Under the misadministretion rule, licensees will be required to: (1) keep records of all misadministrations, (2) promptly report to NRC, the referring i
- physician, and the patient or responsible relative (or guardian) all therapy ;
misadministrations and (3) report diagnostic misadministrations quarterly to NRC. The prompt report is a telephone report within 24 hours of the event. - The telephone report will be followed by a written report to those previously ! notified within 15 days. The record will include the names of individuals and a brief description of the event, the effect on the patient, and the action . ' ~ taken to prevent recurrence. The follow-on written report of the therapy misadministration and the quartarly report of the diagnostic misadministration will contain the same information. II. Need for the Recort ; In 1972, the General Accounting Office recommended that NRC require licensees to report misadministrations of byproduct matarial. The GA0 stated l that the information would help NRC to alert other licensees to generic mis-administration problems. The records or reports will permit Inspection and -
. Enforcement to investigate the incidents where warranted. Nuclear Materials Safety and Safeguards and State Programs will use the information to alert other medical licensees. Standards Development will use the information for i 9
1
, ~ - , - - - - - , , . , , . - - . _ . -,%.------.,-,,%y. ,y - - . - = =, -e v , - - . - - , - e - + - . . , , .-+,mn-=* w y ,-
rulemaking actions, if indicated. GAO reaffirmed it 1972 recommendation in a January 1979 report (EMD-79-16).
- p. .
The misadministration recordkeeping and reporting requirement should save lives.
~
III. GAO Report Justification Analysis Misadministration data are very sparse, and what data do exist, are suspect. The frequency of misadministrations of radioactive material is not known.. Food and Drug Administration (FDA) receives voluntary reports of adverse drug reac-tions (not misadministrations). Approximately 2500'NRC licensees and most of the 3000 Agreement State licensees will be affected by the proposed recordkeeping and reporting reqJirement. The estimates in this report can be multiplied by a factor of two to account for the potential burden on the Agreement Statas and their licensees. Assuming that, on the average, each NRC licensee has diagnostic misadministration (as defined in the final rule) per year there will be 2,500-records and reports to NRC. GAO is concerned about the cost, in man-hours, of actually producing the
- record or report and the cost of reviewing them. The analysis of the incident and other associated costs are considered costs of complying with the regulation and not costs of recordkeeping or reporting. Both the recordkeeping and report-ing requirements can be fulfilled by extracting pertinent facts from the patient's medical records.
The estimated cost to the licensees of preparing a record is one man-hour per misadm.nistration. The estimated cost to 'the licensee of telephone reporting is one-half man-hour each for the NRC report,. the referring physician report, and the patient report. The estimated cost to the licensee for a written report P 2 -- , - + , - ~w:
- is'2.5 man-hours. The total cost to the licensee for the reporting to NRC, the referring physician and the patient is therefore 4 man-hours per therapy incident.
Where they exist, misadministration reports are currently reviewed by NRC <
- r. .
inspectors during scheduled inspections. The estimated cost of reviewing a
. licensee-record is one man-hour per misadministration. Each telephone recort of a therapy mi's administration is estimated to require one man-heur to rseeive I
and write up. Each written report is estimated to require one man-hour to review and enter into the central registry. The total cost to the NRC is estimated to be 2 man-hours per diagnostic misadministration and 3 man-hours per therapy misadministration. With these assumptions the following calculations apply: (1) 1 man-hour per record x 2,600 records = 2,600 man-hours annually for licensee recordkeeping; and 2,600 man-hours annually for NRC review.
! (2) 4 man-hours per therapy report x 100 therapy misadministrations =
400 man-hours annually for ifcensee reporting; and half that or 200 r . man-hours annually to NRC (for therapy misadministrations). (3) 2.5 man-hours per diagnostic report x 2,500 diagnostic misadministra-tions = 6250 man-hours annually for licensee reporting; and 2,500 man-hours annually to NRC (for diagsostic misadministrations). (4) (2,600 + 400 + 6250) man-hours = 9250 man-hours annually to licensees for recordkeeping and reporting. -
-(5) (2,600 + 200 + 2500) man-hours = 5,300 man-hours annually to NRC for reviewing records and receiving and reviewing reports.
- - - _ J- ;
IV. Evaluation of Alternatives There are no alternative data sources. Voluntary reporting was not satisf actory to GAO in 1972, and is probably an unworkable alternative. Adverse drug reactions voluntarily reported to FDA usually do not includw reports of misadministrations, j Several commenters suggested alternatives to'the rule. All of these alter-natives were remedial measures to prevent misadministraticns which are by now l familiar, such as, requiring a written prescription. NRC has taken steps to 3 prevent future misadministrations of the type that are presently known such as the one in the example. However, the purpose of misadiinistration reporting i is to uncover novel types of misadministrations and to evaluate the effectiveness , of steps taken to prevent the recurrence of misadministrations. V. Value/Imoact Assessment It is difficult to place a dollar value on a human life. In the case of 1 a fatality through malpractice, the courts have awarded judgments on the order of magnitude of 1 million dollars per death. The cost of illness and loss of productivity associated with misadministrations is more difficult to assess. . An additional difficulty is that many of the patients, particularly therapy patia.nts, may have a tarminal cancer. i The actual, annual cost in dollars to licensees for preparing and main-r taining (for 5 years) reewds of all misacministrations misadministrations is estimated to $50 for each of the 2,500 misadministrations cr 5130,000. The actual cost in dollars to licensees for reporting misadninistrations is estimated I to be $750 for each of 100 reportable misadministrations or 575,000. The annual i cost for reporting the diagnostic misadministrations to NRC would be-5500,000 I at $200 per report. This 5705,000 total annual cost to licensees does not include the cost of investigating the incidents, followup mecical care, or malpractica. l 4 vn----n,e my p- n. s v----,e n-n,n- n e. -w,--,r , - - - , - ,, .,n-,a- -w a , - + - - - - - - , . - -
The reporting requirement in this rule may well increase the cost of malpractice insurance. The amount of this increase is not known. All of the increases in mecical costs due ts t.nis rule will certainly be, passed on to Y .
~
patients. .
. t The Office of Inspection and Enfercament estimatas the cost of investigating 100 reports of therapy misadministrations to be 7.5 additional persons (3 man-weeks per investigation x 100 investigations. + 40 man-weeks / person). They estimata that an additional 2.5 persons are required for reviewing the 2,600 licensee
- records of misadministrations, preparing preliminary notifications, preparing ,
Abnormal Occurrence reports, etc. The Office of Standards Development esci-mates that one additional person will be needed to prepara regula1! ions anc stand-ards to prevent future misadministrations. The Office of Nuclear Materials . Safety and Safeguards estimates that two additional persons will be needed to plan corrective actions, prepare orders to licensees review new regulations, and maintain the central registry. The remainder of the NRC offices will need a total of 2 additional persons to handle the work lead generated by the misadminis-tratier.s reports. The estimated, total annual cost to NRC is 15 persons at , 530,000 per person er $.180,000. The estimated, total annual cost of the misadministratien rule is $1,185,000 ($480,000 + $705,000). If the misadministration rule can prevent the death of a single individual annually, its value is established. The value of the rule should be proportional to the number of misadministrations and, hence, the cost, since the purpose of the rule is to identify the causes of misadministrations i in order to prevent their recurrence.
- i s
S E
~ '
5 e,v.~~.. . , - - - - vo+-,,.--n,,...--an.--,a. --.m-,>,m-+-,,---m,ee-w,----~-,m...-w.,.,-, ,,-c, ----,---,,,,,,,,--w,,, -mw---, - - - , . . ,,,,e-, -, , .v-+-g}}