ML19290D067
| ML19290D067 | |
| Person / Time | |
|---|---|
| Issue date: | 01/16/1980 |
| From: | Minogue R NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| Shared Package | |
| ML19290D068 | List: |
| References | |
| TASK-OS, TASK-TP-102-3 SECY-80-026, SECY-80-26, NUDOCS 8002190212 | |
| Download: ML19290D067 (85) | |
Text
SRee.4 JM 16 IE0 O,: a
.f
/v}
..j-For:
The Corraissioners
~
From:
Robert 8. Minegue, Director, Office of Standards Development Thru:
Lee V. Gossick Executive Director for Operations Nd g-
Subject:
EFFECTIVE AMENDMENTS OF 10 CFR PART 35 TO REQUIRE REPORTING OF MISADMNISTRATIONS* OF BYPRODUCT MATERIAL
Purpose:
To obtain Commission approval of a notice of final rulemaking that will require medical licensees to (1) keep reccads of all misac.;aistrations; (2) prcmptly repcrt therapy misacainistrations to NRC, the referring physician, and the patient or a responsible relative (or guardian);
and (3) report diagnostic misadninistrations quar
- erly to NRC.
Catecory:
This paper covers a major policy question and resource estimates are final (Category 2).
Issues:
(1) Should medical licensees be required to report aisadministrations
'o NRC?
'. 2 ) Tc whom, besides NRC, si.ould the licensee be required to report cisaaministrations?
Cecision Cri terii:
Issue 1 - Consistency with NRC's medical policy statement to regulate the raciation safety of pat!ents where justified by tne risk to patients sno where voluntary stancards, or compliance with thesa standards, are inadequate.
Issues 1 & 2 - GAO's recommendation that NRC require reports of all misadministrations and decide the issue of patient notification at a later date.
Issue 2 - Consistenc/ with n'RC's medical policy statement to minimize intrusion into medical jndaments affecting patients and other areas traditionally considered te ce a part of the practice of medicine.
- Misacministration is defined in tne final rule as the administration of:
(1) a radio-pharm ceutical or radiation frcm a sealed source other than the one intended; (2) a radiopharmaceutical or radiaticn to the wrong patient; (3) a radicpharmaceutical or radiation by a rc' ate of Mainistration other than that intendad by the prescribing physician: (4) a diagnostic dose of a radiopharmaceutical differing from the crescribed dose by more than 50%; (5) a -berapeutic cose of a radicoharmaceutical differing feca the prescribud dose by c, ore than 10%; or (6) a Inerapeutic dose from a sealed scurce such tnat errors in tne source calibration, tiee of exposure, and treatment gecmetry result in a calculated total treatment dose differing frca the final prescribsd total 1.g/
trea'a::ent dose tw mora tnan 10T.
5 d'd Contac P.-
E. Fodolak 443-5850
/
go o219 0 #/N
The Ccemissicners 2
~
Issue}2-ConsistencyviththePresident'sexpressedconcernthat indivicuals have a rignt to see their cwn medical records and ensure that they are accurate, timely and relevant to their care.
Alternatives:
Issue 1:
(Report misadministrations to NRC?)
1.
Do not require misadministration reporting.
2.
Require reporting of all misadministrations.
3.
Require reporting of all thera?y misadministrations and those diag-nostic misacministraticns causing a clinically detectable acverse effect (rule as originally prcposed).
Issue 2:
(Licensee reports tc whou cesides NRC?)
1.
Do not require any reccrting other than to NRC.
2.
Require the licensee to inform the referring physician.
3a.
For all misadministraticns, require the licensee to inform the referring physician and tna patient or a responsible relative (or guarcian), unless the referring pnysicisn cbjects.
3b.
For theracy misadministrations only, require the licensee to inform the referring cnysician and the oatient Or a responsible relative (or guardian), unless the referring pnysician objects.
Discussica:
Co March 2, 1978 the staff briefed the Commissica on a replacement for a 1973 AEC prcposed rule thct would ha e required reports of.aaical misadministrations.
The staff orcoosal (SECY-73-70) would recuire recordkeeping of all misacministraticns and reporting to NRC and the referring physician:
(1) theracy misedministrations; and (2) those diagnostic misacministrations that cause a clinically detectable adverse effect in the patient.
The Commissicn requested that the paper be returned to the staff for elaboraticn of an ELD recommendaticn that the licensee report directly to the patient or a responsible relative, those misacministrations reportable to NRC.
The Cetmission approved the ELD version (SECY-78-244) which was published in the Federal Register (Enclosure 3, 44 FR 29297) for a 60-day comment period that expired Octcber 5, 1978.
The proposed rule was mailed to all medical licensees, about 30 profes-sional and public interest groups, 2,CCO state and county T.adical societies, and the Agreument States.
This aggressive solicitation of
'public cmments w23 the result of t"a Cermission's expressed concern cbcut tne possibility of uncue intrusion into the physician patient relatico: hip.
The Cormissionarc 3
O ^ 'TD
~
D
~
7 nhidLr.
ea u-2 The Commission received 150 ccmments on the proposed rule through November 1978.
These ccrcents are sur.marized and analyzed in Enclo-sure 4.
Ninety percent of the ccm.v.ents were opposed to the proposed rule.
Basically, the commenters were opposed to misadministration reporti.ig to NRC where the reports would be open to public scrutiny and misadministration reporting to patients which would cause " undue alarm" and " unwarranted malpractice suits".
A majority of the comments were detailed and specific.
Some of the comments were quite forcefully worded.
The vast majority of the comments came from physicians or physician groups.
The two most controversial features of the proposed rule were the defini-tion of a misadministration and the immediate reporting requirement:
s 1.
Definition of Misadministration.
In the proposed rule, misadmin-istration was datinea cs tne ac.ninistration of:
(1) A radiopharmaceutical cr radiction to the wrong patient; (2) A rcdicpharmcceutical cr rcdistion by a route of accinistra-tion ctner than th t interd:d by the prescribing physician; (3) A diagnostic dese of a radicphcrmccoutical differing frca the prescribed dose by mere than 20 percent; or (4) A therapeutic dose of a radiopharmaceutical or exposure from a radiation source such tnat the total treatment uuse or exposure differs from the prascribec dose or exposure by more than 10 percent.
2.
Ienediate Recortinc.
The proposed rule would require the licensee to repor; all therapy misadministrations and those diagnostic misccainistrations thc; could cause a clinically detectable adverse effect.
The licensee would have tc r.otify by phone within 24 hcurs after discovery that a misacministration is likely to have occurred:
(1) NRC, (2) the patient's referring physician and (3) the patient or the patient's reconnsible relative, unless the referring physician personally informs the licensee that in his medical judgsment telling the patient or the patient's responsible relative would be harmful to one or tne other, respectively.
The immediate reporting requirement generated the most comment.
Very few cocmenters realized that there was a threshold in the preposed rule for reporting diagncstic misadministrations, i.e. only tnose diagncstic misadministrations that could cause a clinically datectable
'dverse affect.
a
The Cemmissiur.ers 4
Comments
.As noted above, 90 percert of the commenters were opposed to the pro-Accepted:
posed rule. A majority of the negative comments opposed the misadmin-istration reporting requirement and not the recordkeeping requirement.
Most of these commenters were opposed to reporting diagnostic misadmio-istrations to patients and relatives, many citing that the definition of a diagnostic misadministration as a 20 percent error' was too low.
These commenters pointed out that the recommended dosage in the drug labeling covers a range of up to an order of magnitude.
They also stated that, comoaring nuclear medicine departments, there is often a 100% or greater difference in the standard dosages for the same proce-dures.
They were distressed that NRC considered a 20 percent error in a diagnostic administration as a misadministration.
' cst of these commenters believed (erroneously) that all diagnostic misaccinistratica would have to be reported to patients.
They feit that reporting 20 percent errors to patients would at best confuse the patients and at worst cause them unnecessary anguisn.
On the same subject, several ccmmenters cbjected to the ambiguity of the phrase "ccuM cause a clinically detectable acverse effect" as the threshold for raporting d' agnostic misadministrations.
They felt that the threshcld./as maning'ess baccuse any radiatico eynosure "cc.ula cause" a clinically catectable effect eventually.
A few commenters objected to the absence of a definition for a "clini-cally detectable adverse effect".
Some questioned who would make that determinrtion.
Others cbjected to the physicia.1 navine tco mucn leracy in making the cetermination.
Still others ccrcolained that, withcut guidelines, they woula have dif ficulty in making the dater :ination.
The staff believes that these comments on diagnostic misadrinistraticns have narit.
The staff chose the definition of a diagnostic misadminis-tration in the proposed rule as a 20 percent error because it is within tha state-of-the-art in racionharmaceutical measurenant.
A 20 cercent difference between the prescribed and delivered radiopharnaceutical dosage is not likely to affect the quality of a diagnostic image or the efficacy of the procedure.
The clinical significance of a diagnostic misadministration can be placed in perspective by looking at the dosage range for a typical radiopharmaceutical.
This dosage range is found in the drug labeling which is reviewed and approved oy the Food and Drug Administration (FDA).
The dosage range varies with eacn diagnostic procedure.
For sodium pertechnetate Tc-99m, the most common radiopharmaceutical, the suggested dosage range in the average adult (70Kg) is:
10-20 mci for brain imaging; 1-10 cCi for thyroid gland imaging; 1-5 mci for salivary gland imaging; 10-20 mci for bicod pool maging and 1-3 nCi for placenta localization.
Clearly, standard dosages cover a wide range.
Also in the drug labeling are the radiation doses for the maximum recon-mended radiopharmaceutical dose of 20 mci:
5.0 rad to the sto acn waii.
9
The m aissioners 5
ghJ) g g g
Kp f[.Ut n hunAll/ o 2.6 rad to the thyroid, and 0.28 rad whole-body.
These radiation doses and those from other diagnostic nuclear medicine procedures are roughly comparable to diagnostic x-ray procedures such as the chest x-ray.
In the final rule, Enclosure 1, the definition of a diagnostic misadmin-istration has been changed to read:
" A diagnostic dose of a radicpharmaceutical differing from the prescribed dose by more than 50 percent."
Raising the limit to a 50 percent error acccmplishes three things.
First, it is a level where a mistake obviously has occurred and few will argue successfully otherwise.
Second, it is a level tnat affects the quality of the diagnostic procedure, often causing re-takes.
- Third, it is a level that significantly reduces the number of reports by cullir out the more minor errors.
This will ease the burden on licensees of reporting all misacministrations (see GAO Reconc o tica colo.v).
The threshold for recorting dicgnostic misadministraticns wnich aroearec in the proposed rule, i.e. tnose having a clinically detectaF e adverse effect on tM patient, has c an acanconed in the final rule.
In the final rule the licensee will be required to recort all diagnostic misadministrations to NRC onh, The licensee will not be recaired to report to the patient because tha risk f rom a diagnostic misacministra-tion dces not warrant federel intervention in essentially a local decision.
The threshold was cuancened because it vias almo t evciu-sively ;udgemental and virt.ua!ly imccssit,le to define and enforce.
The diagnosis of an "2cverse effect" may in one case be basec cn a single drcmatic sp ptom-In another case it may be based cn a att er of indivicualiy minor acviations f am the normal for that pati _ut.
The most significant reason for recuiring reports of all diaqcostic misacainistrations is tnat GRC will be able to evaluate proclem trends both at individual medical inst.itutions and among all of our medical licensees.
The significance of diagncstic misacministrations goes beyond unnecessary radiation exposure if it results in a misdiagnosis.
Apparently isolated instances at individual medical institutions could reveal a generic pecblem., hen cercpared nationally.
Finally, even a diagnostic misadministration of minor consequence to the patient could be the harbinger of a more serious prcblem at that institution.
In the final rule, licensees will be required to report diagnostic misadministrations quarterly.
This frequency reduces the administra-tive burden on licensees and NRC.
The staff intends to develop a reporting form to further ease the turnen on licensees and to aid NRC recordkeeping.
The time-frame for develcping the NiiC form will depend on the lessons learned in inplementing'tne rule.
In the final rule, the definition of a th'erapy misacainistration has been changed to read:
The C3-Hssioners 6
"A therapeutic dose cf a radiopharmaceutical' differing from the prescribed dose by more than 10 percent; or A therapeutic radiation dose frca a sealed source, such that errors in the source calibration, time of exposure, and treatment geometry result in a calculated total treatment dose differing from the final, prescribed total treatment dose by more than 10 percent."
These changes result frca s?veral public comments.
The new definition distinguishes between radiopharmaceutical therapy and sealeo source therapy.
The new definition recogni es that the tnerapist adjusts the fractioned dosa during treatcent, based on the response of the temor and other factors.
The new definition also recognizes that the radia-tion dose in sealed sourca therapy is calculated as a functicn of d0se rate, time, and treatment gecretry and that it is not usually maasured directly.
Some other chances in the final rule also result frca public ccmments.
The final rule permits the referrina physician, rather than the licensee to inform tne patient of a tharacy misadministraticn.
The final rule provides
.o" reporting to a " guardian" as an alternative to a relative.
Corments Not Some suggestions from the commenters were not incorporated into the Accected:
final rule.
One cctmenter suggested that NRC sena a confirxctory report to the patient.
The 3tsff recommends against this rnicss there is significant non-compliance with the final rule.
One comm. enter insisted that IPC require licensees to keep reccrds of misadministrations for 50 years because of the long latency oeriod for radiation induced cancars.
The staff is proposing instead for NRC to maintain a central registry of all misadministrations and retain the requirement for the licensee to keep records for 5 years.
To that end the final rule will require licensees to submit the patient's n?ne.
social security number, and date of birth in a separate part of the misadministration report.
This is similar to the existing recuirement in $20.405 for licensee reports of overexoosures.
It will permit NRC to safeguard the patient's identity and it will permit follcwup in later years.
Patients' identities are exempted frca disclosure under the Freedom of Information Act (see 59.S(a)(6)).
I&E believes that it is absolutely necessary for teC to keep a central listing of all misadmin-istraticns in order to respond to congressional and public inquiries.
The vast majority of the cocmenters consider the proposed rule as an unprecedented, serious intrusion into the physician patient relation-ship.
They contend that tne proposed rule is an intrusion of a regu-latory agency into the care of a patient without assuming respersibil-ity for that care.
Many ccmmenters pointed out that the misadmin-istration reporting requirement was unique in medical practice and 9
The Comissioners
.' 7' noted that NRC regulations did not apply to x-rays, accelerator or radium therapy, and accelerator produced radiopharmaceuticals.
The rule would, of course, intrude into the physician patient relation-ship in the sense that the rule oces affect, to a limitad degree, the nature of the physician's obligation to his or her patient--it imposes in certain circumstances an obligation on the physician to report infor-mation to the patient and the NRC.
For many in the health professions this limited involvement may be understood, rightly or wrongly, as for-shadowing sonie greater degree of Governmental involvement, or as symbolizing some general movecent toward more regulation of the profes-sion.
This, along with the fear of malpractice suits discu sed below, may exclain the nuccar and intensity of adverse co=ents frca those in the health professions.
However, the staff believes that these cent ns break cown upon analysis.
Scme physicians do suoport the rule--the cedical cr:fas-sian is not unaniccus that the rule would constitute an unwarrantad intrusion into the pnysician patient relationship.
The " physician-patient" relaticnship is a concept that was developad to advance tne neecs of the natient.
The relatic -hip involves duties of reasc.mble care anc skill, confidentiality, crd good faith owed by the physicia to the patient.
fictning in the r21a would detract frN1 these duties.
Thus, in a strict sense. tne rule would nct interfere with the relationship.
It is true that no similar repm ting requirements are attached to use of x-rays, accelerator er radium th rspy, or accelerator produced isotopas.,
However, thi; is the direct reselt of limitations in NRC's regulatory authority.
At cresent, unless tengress should exaand NRC's authority, tne t2C must, as a catter of law, ocerate under the presug. tion that Congress intended that a greater cegree of Federal regulatory control be exercised over nuclear materials as cpposed to these other sources of radiation.
In many respects the adverse comments track those received by FDA in response t] a recuest for corments to help FDA formulate a policy on labeling of prescription drug products to prcmote patient uncerstand-ing of the nature and effects of the drugs prescribed for them.
In a notice of proposed rulemaking (44 FR 40016, July 9, 1979), the FDA rejected the assertion tnat maadatory labeling for patients would con-stitute an unwarranted interference in the physician patient relation-ship, pointing out among other things that a patient has a right to know about a drug's benefits, risks, and directions for use.
Many cce. enters were concerned that the proposed rule, in particular
.the patient reporting requirenent, would invite unwarranted malprac-tice suits ard ;hereby boost medical costs.
Some cormenters suggested that the rule would lead to covering up misadministrations to avoid liability.
Some commenters believed that the NRC's Public Document Roca uculd provide a aans for unscrupulous lawyers to find cilents.
<The Commissioners
_8 We do not believe that ph/sicians.will disregard the rule.
Also, there is nothing in the rule that would in any way modify the legal rules governing Malpractice suits arising cut of misadministrations.
A number of the commenters who were concerned aav.t " nuisance" malprac-tice suits might be content with raising the limit for a diagnostic misadministration to errors greater than 50 percent.
However, many others will be alarm.ed to find that reports of therapy misadministra-tions to NRC are likely candidates to be reported to Congress as Abnormal Occurrences (See Enclosure 7).
Advisory Committee: The Advisory Ccmmittee on the "edical Uses of Isotopes (ACMUI) reviewed the proposed rule.
Four members and the medical physicist consultant approved tha prooosed rule.
Two of these wanted the definition of a therapy misacministration clarified.
Clarification is providad in the final rule.
Two ACMUI members ccmmented without accroving or diseccroving the pro-posed rule.
One of taece stated that the recaire. ment to notify 1RC was objectionable ar.d tnat the patient and public are already prctected by tha prevaiii.g practice :stterns ccrmon to mecicina in ger. ai.
Tha other of these two memcers' ccmnents was docketed and is responded to He accepted the rule ir, principle but at curment #35 of Enclosure A believed that 1 would be unanforceacie.
One ACMUI ceccer disacoroved uf the proposed rule.
His three pages of detailed comments were doc <eted and responded to at comment #110 of Enclosurs 4.
Value/! acct: sets out the Va!ue/I.apact Analysis.
Caa purpore of the rule is to icentify the causcs of misadministraticns in crcar to correct them and prevent their recurrence.
The other purpose of the rule is to inform patients of therapy misadministraticns.
Therapy misadministrations have caustJ fatalities.
Misadninistration report-ing snould save li.es oy alerting NRC which can, as a minimum, alert other licensees to potential prcolems.
Both the value and the costs of the rule should be procerticnal to the number of reported misadministrations.
The misadministration rule was coordinated with the Agreement States.
As they have done in the past with similar important matters of public health and safety, we expect them to adcpt this requirement for their licensees.
For various reasons, including the different methods of enacting state regulatiens, State Programs will not make misadministra-tion reporting an item of comoatibility.
Therefore, indivicual Agree-ment States may raquire more er less informatica frca licensees than that required by NRC.
Voluntary participation in NRC's central registry will be offereG to the Agree 2nt States,
0 [dd N ibh h I
The Cc.missioners 3
Ib)
Jk. bdh b \\. lI J
Assuming one diagncstic misadministration per year at ear.h of the 2500 NRC medical licersees :nc i total or ')O therapy micadministrations per
' year: the cost fcr recercu apiag at 350 per record will be $130,000 for NRC licensees and about $155,000 for the 3,000 Agreement State licensees; the cost for reporting the diegnostic misadministrations would be $500,CC for NRC licensees and $600,000 for Agreement State licensees at $200 per report; the cost for reporting therapeutic misadministrations at $750 per combined report to NRC, the referring physician, and the patient will be $75,000 for NRC licensees; the coct to Agreement State licensees would be similar.
In summary, the total cost of recordkeecing and reporting for the final rule is esti ated to be $705,C00 for NRC licensees and $330,C00 for Agreement State licensees.
The reportir.g recuir: ment in this ruia may weil increase the cast of malpra:tica insurance.
The m u... cf this increa e is not.nct.a.
Ja response to staf f's request tha National Association of Insurara
';roker.; regi f eu:
a ev : e :e to cuantify tha ef fec ca "It is s in :1 b ay wei medicci Talorcctice insurer:ce catas cf your proposed rule.
...That the p ;pc;2d cbcags.eculd have an adverse effect cn these rates scams ir.di., s.;ie, sinca t..a d ctors would t.e required, in a sensc, to o cpare testi:acny against them-selves. We frankly da.bt :. hat anyone can gauge the liL.iy etfect of such a rule.."
The annual cost to !UTC of revi wing licen:ca reports of misadministra-t'cr.s s.O responding tc tns 1G t':2. c;;j asac:inistraticos is 15 = n-years:
10 :an years for IEE: 1 :n year for SD; 2 man years for N?'SS; and 2 man years throughout the rest of MilC.
This is the cost of investigccion, precaring Abnormal Cccurrence reports for Ccngress, Prelimincey Natifications, rule cnangas or guidance indicated by misadninistrations, misacministrations registry, etc.
The cost of maintaining a misadministration registry is estimated to be 520,000 per year exclusive of personrel costs.
SP believes that the above estimates of 2500 diagnostic misadministra-tions and 100 therapy misadministrations annually are too high.
They expect that the manpc..<er required of the Agreement States to implement this rule will be negligible.
GA0 Recermendations:
In its January 1979 report (ENG-79-16) the General Accounting Office (CAO) r+cccmenJed that the Ccemission im ediatcly rer,ui,e c:edical licensees to beg n r2ccr:f rq all misar.rainistrations to NRC ar.d to the i
patian;'s ;..js ician.
The., r u.m nade Qat the Cc.aaission dalete the requirenent for patient nc.ificction nd Mcide on it at a later date.
" di vl emun" aw si tion to C '"' ~ ~ ' t" " n t i r9.-
~!
iarv 4 o li;; p 3.
W.
E.'.1 T i C 3 ;i c r.
a..:c s ac i ',;a t. t this to daiay the ti..al rul0.
Tha Ce missicc.ers iC Basically, GA0 believes that requiring redical-licensees to report misadministraticas to T.C is not an intrusion into medical practice.
They stated:
"This is clearly consistent with NRC regulatory responsibilitics and a necessary part of an effective nuclear medicine regulatory program. Without this kind of feeoback on incidents affecting public health and safety, NRC cannot be sure it is adequately regulating the possession.and use of nuclear materials in medicci practice."
The staff agrees with GAO that NRC should require reports of all impor-tant misac7inistrations.
However, the staf f recommends that the Cc: nit-sion tackle the issue of patient notification at this time.
li'are haI been a full airing of the issues and the matter is ripe for a dacisica.
Relevant Legi c i a ticn:
There is a trend in Federal legislation toward recognizing the right of individLals to know inform:tica c.bcut themselves contained in the rccords cf 'nstitutions b;;h ins!. ana outside of the Fedcral sector.
Empias are:
the Privacy Act of 1574, which sets out rules for recor -
h22pi'; f :
c G r:1 agencies: th'
.:r Credit Reporting ~ct d?d relcts:
c acts, which give consLmers the rig".; to know information cbcut tnomsel>e; containea in the records of credit-reporting bureaus; and ti': Family Educatien :iights and Privacy Act, mich grsnts students the ri;ht t0 see personal records held by educaticnal institutions.
In April 1973, the President cent the proposed " Privacy of Medical Inforn tica Act" to Ccngress.
Tha Presideat said:
"The " Privacy cf "adical Infer ation Act" is being submittac to you toaay.
It establishes privacy protections for inferrtation maintained by almost all medieal institutions.
The Act will give individuals the right to see thair cwn medical records.
If direc:
access n.a) harm the patient, the Act pruvides that accc:s may be proviced through an intermediary.
This legislatica alicus the individual to ensure that the information maintained as part of his medical care relationship is accurate, timely, and relevant to that care.
Such accuracy is of increasing importance because medical information is used to affect employment and collection of insurance and other social benefits..."
Alternatives Pros and Cens:
Issue 1.
Mould medical licensees be required to report misadministre-tions to NRC?
Alternative 1.
Do not require misadministration reporting.
P_ro:
(1) Responds to the pre omir. ant ccmcents from the medical ccmmunity.
Tha Com.:issioners
,.11 (2) Avoids NRC involvement in the physician patient relationship.
Con:
(1) N.iG will not be able to identify the causes for misadmin-istrations and help correct them and prevent their recurrence.
(2) Is unresponsive to GA0's recommendation and those commenters who believe a misadministration reporting requirement is necessary.
Alternative 2.
Require reporting of all misadministrations.
Pro:
(1) Gives maximum protection cf the oublic because NRC can detect probico trends at indivicual institutions and among all licensees--regardless of the type of misadministratica.
(2) Rasponds tc GAO's recommendation.
(3) Coas not discourt the significance of diagnostic misadministrations.
Ccn:
(1) Requires substantial commitment of HRC resources.
(2) Is a substantial burdan on licensees.
Alternative 3.
Require reporting cf all theracy misadministrations ait cnose ciagnostic misadministratiors n ving a clinically de.ect-able Jverse effect (rule as criginally preposed).
ero:
(l' Eas;cnds to some comr:nts en both sides of the issua.
(2) Avoids a large number of reports of misadministrations.
Can:
(1) Is unresponsive to GAG's recommendation and those ccmmenters who believe tnat all misadministrations snould be reported.
(2) Is a burden on licensces.
(3) Term " clinically detectable" is virtually impossible to define and is essentially a judgment call of a physician.
Issue 2.
To whom, besides NRC, should the licensee be required to report misadministrations?
Alteractive 1.
Do not require any reporting other than to NRC.
Pro: Avcids NRC involverent in the physician patient relationship.
Con: No assurance that patientc or referring' physicians will be infor
The Ccmmissioners 12 Alternative 2.
Require tne licensee to inform the referring physician.
Pro:
(1) Accepts current medical practica and responds to many commenters.
(2) Minimizes NRC involvement in the physician patient relation-ship.
(3) Responds to GA0's recommendation not to let the final rule get bogged down o'er this issue.
Con:
(1) No absolute assurance that patients will be informed of misadministrations.
(2) Is less consistent than Alternatives 3a and 3b with the trend recognizing the catient's right to be inforr.ed.
Alternative 3a.
For all misadministrations, require the licensee to inform the referring pnysician and tne patient or a res?onsible relative (or guardian), unless the ceferring physician objects.
Pro:
(1) Helps ensure that patiar.ts will be informed of misadmin-istrations.
(2) Consistent with the trend recognizing the patient's right to be informed.
Con:
(1) Scme NRC involvement in the physician patient relationship.
(2) Unrasponsive to the largest numcar of public Ocmments.
Alternative 36.
For therapy aisadministrations only, require the licensee to inform the referring physician and the patient or a respon-sible relative (or guardian), unless the referring physician objects.
Same pro's and can's as 3a. exceot that this aoproach will mollify the many ccc: enters w.*o objected to a couire ent to notify patients of diagnostic misadministrations.
The preamoie to the final rule will encourage physicians and institutions to notify patients of diagnostic misadministration.
However, the staff believes that the risk of diag-nostic misadministrations does not warrant Federal intervention in this decision.
If in time we are proven wrong about the risk of diagnostic misadministrations, the central registry will be able to list those patients who have not been informed.
Racccmendation-The Commission:
1.
Accrove a notice of a final rule (Enclosure 1) that would require medical licensees recort all misacministrations to NRC and acci-tionally reac-t all ther;oy m.iradministraticns to the refarr cg
Tle Cu.uissiv.v3 0
d physicial and the.7atient or a responsible relative (or guardian),
unless the r272rrina t: iciar. cN atts (Alternative 2 of Issue 1 and Alternaci/e 3b of lisue 2).
2.
Note:
a.
The amendment would be published in the Federal Register to be effective in 75 days; b.
All affected licensees and the appropriate congrassional committees will be informed; c.
A public announce=2nt sucn a: Enclosure 2 will be issued,; hen the final rule :s filed with the Office of the Federal Regisce d.
Clearance of *te record u :]irg rcquirements by thi G+.eral Accounting 0.
ica >ill be obcained criar to the effcctive cate of the amerd-enr..
Cecrdina-?cn:
" e Office of "ucler Meteri'l Sir,ty and Safeguards, Iqspecticn :nc c o :: ent7 St:tn rcy :: :
_ nd Evalr;tien of Opm cticnal :'rt:
'a m
Poiicy Evalunion, and we Divisic.i cf Rules aria Records concur in tN raccrendtion cf this p?per,
'he Cf fice of the Executive Lagal Directo -
b:s w le;il chj?ction.
Tra 'lalu: " o'ct stateren: was revie. -d by tre O'fice cf %r.3gezent and Preg 3,
'n:. lysis which croposed a folicw-up stud, (Ecclesure S).
The draf t pt.b!!c anncuncament was era-ed by '.:n Of fice of Ptblic Af fairs.
Scheduline This paper should be scheduled at an ecer agenda session.
Di:M m- : b n "IE reluctantly cor.ditions their ccncurrence kI'2' (Encicsure 9) cn the a ?il.bility :f r:scurces.
Rcbert E. "icogue, Director (See Encicsure 10 for alternative resource Office of Standarcs Development str?tcaies.)
Enclosures:
1.
Federal Recister Notice of Distribution:
Ettective Rule Making Central Files 2.
Draft Public Announcement SD RDG/ ALPHA GErtter 3.
Proposed Misacministration RHSB RDG/SUBJ LSa pp Rule (43 FR 29297)
Minogue SECY (3) 4.
Summary and Analysis of Ccements Goll er 5.
Value/ Impact Analysis Purple 6.
Draft Congressional Latter Parsont 7.
Chai..:an's le tter en A/C's Podolak a.aMi cicn u L.l icw un.
..M.
. sea,Po Stue/
S..
W h
cncurrence IF '
T"?;F A2 27'!3.f!"53'.[3.M AEC] b.<,.
SP b^b-CPEi.u k A C #.*
LHigd]nbc M 4.
JSullivca PCanf CMelti m Jr!cGra th
. - - >t n/q ?.-
11/i?/7C 11/19/79 11/1/ 79 11/17
11/19/79 11/19/79 g/-
ED0
@,EL D. - ~SW F.: S'/r:MS/SD AD/ 3;:SS /SD D/SHSS/.5D D/::
L' iS/D EDd-!! W RA b rpIe "RGoli:9-RCNi1q u:
dircks
[ * ? -
11!-[/79
(
D""
MParsint b
11/21/79 12/k/79 Hf==7C79 11/g/79 11/.//79 1.1/3 /79 W
IOR.-3