ML20202D394
| ML20202D394 | |
| Person / Time | |
|---|---|
| Issue date: | 02/01/1978 |
| From: | Minogue R NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| References | |
| SECY-78-070, SECY-78-070-R, SECY-78-70, SECY-78-70-R, NUDOCS 9902010384 | |
| Download: ML20202D394 (35) | |
Text
{{#Wiki_filter:.. NFehu;ary. 1, 197@
\i o'" c
~
~
SECY-78-70 uunto smus NUCLEAR REGilLATORY cOMMisslON
~
POLICY SESSIDN ITEM For: The Commissioners From: Robert B. Minogue, Director, Office of Standards Development Thru: Executive Director for Operations b r
Subject:
PROPOSED AMENDMENTS OF 10 CFR PART 35 TO REQUIRE REPORTING OF MISADMINISTRATIONS* OF BYPRODUCT MATERIAL
Purpose:
To obtain Commission approval of a notice of proposed rulemaking - that would: (1) Withdraw a 1973 AEC proposal that would have required reporting to the AEC and the patient of all misadministra-tions of radioactive material (and would have required paramedical training); and - (2) In essence, require licensees to maintain records of all misadministrations and report to NRC and the patient's referring physician only potentially dangerous misadminis g i trations. J,
&y Category: This paper covers a major policy question. V7e Issue: (1) Should the NRC require licensee reports of misadministra-tions?
(2) Should the NRC require the licensee to inform the patient? The referring physician? Both the referring physician and the patient? e Misadministration means the administration of: (1) a radiopharmaceutical or radiation from a source other than the one intended, (2) a radiopharmaceutical or radiation to the wrong patient, (3) a radiopharmaceutical or radiation by a route of administration other than the one intended, (4) a diagnostic dose of a radiophamaceutical differing from the prescribed dose by more than 20%, or (5) a therapeutic dose of a radiopharmaceutical or exposure from a radia-tion' source such that .the total treatment dose or exposure differs from the prescribed dose or exposure by more than 10L
Contact:
E. Podolak 443-6910 ,/ I Ih l[ .O h20 4 780201 , 78-070 R pyg R _.3
P l .'.. 4.T' . j
..s The Commissioners 2 D cision
-Criteria: Issue 1 - Consistency with NRC's proposed policy statemer' s regulate the radiation safety of patients where justif % by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
-Issue 2 - Consistency with NRC's proposed policy statement to j minimize intrusion into medical judgments affecting patients and '
- l. other areas traditionally considered to be a part cf the practice- 1 of medicine (physician patient relationships). -
~
. Alternatives: Issue 1. (report misadministrations)
- 1. Require reports to NRC of all misadministrations (publish ,
the 1973 AEC proposed rule in effective form). l
- 2. Do not require misadministration repcrts (withdraw the 1973 AEC proposed rule).
- 3. Require reports to NRC of only potentially dangerous misad-ministrations (withdraw AEC proposal and publish a new NRC proposed ;
rule). Issue 2. (inform the patient, the referring physician or both)
- 1. Require the licensee to inform the patient.
- 2. Require the licensee to inform the referring physician.
- 3. Require the licensee to inform the referring physician and the patient, unless the referring physician objects. ,
- 4. Not require the licensee to inform the patient or the l
referring physician. Discussion: On March 9, 1973 (38 FR 6399, SECY-R 621) the AEC published proposed amendments to its regulations (Enclosure 2) based on a 1972 GAO recommendation that in turn was based on GAO's review of the AEC's ' investigations of misadministrations of radioactive material involving 20 patients between 1961 and 1972. The 1973 proposed amendments would (1) require a physician to report to the AEC (NRC) sisadministrations of byproduct material, (2) g allow the delegation of certain duties to paramedical personnel, and (3) require the appropriate training of allied health person- 4 nel. An additional requirement, that a physician notify patients or their families of misadministrations, was a staff originated recommendation. v-
4 '
,s-
% M I
The Commissioners-3 , Ninety-eight (98) comment letterr ..e received, most objecting ! to the proposal for reporting ' t.he patient (Enclosure 3 is a quantitative summary _of all comments including those on tech-nician training). Reasons given for objections to the require-ment for reporting misadministrations to NRC and to patients were: (1) such reports would constitute self-incrimination, (2) . such reports would invite or increase malpractice suits, (3) ! this would introduce the government as a third party in the physician patient relationships, (4) this is a matter of medical ethics, (5) there are no comparable requirements for any other - drug.or physicians.in any other field of practice. . (The Office of the Executive Legal Director advises that, strictly speaking, there is no self-incrimination and that we have the legal author-ity.to enforce the regulation; however, the physicians' concern about inviting malpractice suits, either real or those having nuisance ~value, may not be unfounded.) The principal recommen-dation of the commenters was that reports of misadministrations
- be limited to therapeutic or significant amounts of radiopharma-ceuticals and that misadministrations of diagnostic quantities do not justify reporting.
It has always been the practice of the regulatory staff that a physician cannot delegate to a non physician the approval of nuclear medicine procedures, the prescription of radiopharma-ceuticals, the determination of the route of administration and , the interpretation of the results of diagnostic tests. (See the 1972 AEC " Guide for the Preparation of Applications for the Medical Use of Radioisotopes.") The duties that a physician may or may not delegate and those that paramedical personnel may perform are governed by State regulations and State medical licensing boards. (All States have laws defining what actions constitute " medical practice.") The general topic of technician training is discussed at length in the medical policy statement (SECY 78-68 ). Several programs currently provide minimum standards, guidelines or certification for technician training in nuclear medicine. These programs are administered by State, Federal, and private agencies including: the Health Services Administration (Medicare and Medicaid DHEW), the Bureau of Radiological Health (FDA/DHEW), the Joint Commis-sion on Accreditation of Hospitals (JCAH), the American Registry of Radiological' Technologists (ARRT), and the Registry of Medical Technologists (RMT). These programs are more comprehensive than the AEC proposed rule and many require both formal training and passing a written test.
l
.* l
.e
.. i E l s
1 The-Commissioners , l [ 1 Thidect of technician and hospital certification, as well as
' k combined actions of State and Federal agencies, on reducing misadministrations of radioactive material is not known. The benefit of.the 1973 AEC proposed technician training requirement .
in reducing further the number of misadministrations is also unknown. The majority of technologists are not certified. FDA's Bureau of Radiological Health has cautioned that the introduction of-a relatively less comprehensive NRC program may l undermine the efforts of voluntary organizations or those Federal ' agencies proposing more comprehensive guidelines. ) l Issue 1. (report misadministrations) The purpose of misadministration reporting is to allow NRC to i investigate the incident; determine if there was a violation of 1 NRC regulations; evaluate the corrective action taken by the i licensee to prevent recurrence; and, if there are generic implica- ! tions, allow NRC to begin generic corrective action. The staff recommends that the Commission withdraw the 1973 AEC 1 I proposed rule and replace it with a new NRC proposed requirement for both recordkeeping and reporting of misadministrations. The l essentials of the NRC proposed rule are (1) that' licensees would ; maintain records of all misadministrations and have them avail- ; able for NRC inspection.and (2) that licensees would be required i to report to NRC, and the patient's referring physician, all therapy misadministrations and only those diagnostic misadminis-trations that could cause a clinically. detectable
- adverse l effect on the patient. (Regarding the 1973 proposed training requirement, the staff is studying the various allied health certification programs currently in effect or that are being <
drafted by other Federal, State and professional agencies. If , the coverage provided by these programs is not considered adequate to protect the patient from unnecessary radiation exposure, the Commission will work with these groups to develop a new NRC proposed rule for the training of allied health personnel.) M
" Clinically detectable" is a term recommended by physicians and, the staff believes, well understood by them. It refers to diagnosis involving direct
. observation of the patient, and includes such non-invasive testing as blood .
tssts, in vivo and in vitro nuclear medicine, electrocardiograms, etc. The staff recommends against defining " clinically detectable adverse effect" in the Eregulation. Definitions, such as a percentage depression in the white blood-cell count, are, as a minimum, procedure-specific and patient-specific. The diagnosis , of an " adverse effect" may in one case be based on a single dramatic symptom, while in another case it may be based on a number of individually minor deviations > from the normal (for.that patient). !
t '
;. l
- a. 7 ,.
The Commi" ' aars 5 L 1 ! 1 The primary objection by physicians to reporting of all mis-administrations was the fear that reports to a Federal agency and to the patient would invite " nuisance" malpractice suits in cases where there was no harm to the patient. Several com-L menters at the May 6, 1977, public meetings on medical policy ! and NRC's Advisory Committee on the Medical Uses.of Isotopes ! also recommended that only serious misadministrations be reported. L If NRC.were to require.that all misadministrations be reported, l most of the reports of minor incidents would not be useful but l would be characteristic of the common types of misadministra-tions which the internal controls of medical institutions can . minimize but not eliminate. Patterns of minor incidents of L misadministration at individual institutions can be detected by ad hoc evaluations of the licensee's records during routine NRC l Inspections. The staff recommendation to require reports of all misadminis-trations that. involve a therapy procedure, and only those diag-nostic procedures that could cause a clinically detectable adverse effect, is based on the greater risk to the patient from therapy misadministrations. The risk of tissue or organ damage (or even death) is inherent in the use of therapeutic levels of
- - radioactive drugs. The diagnostic use of radioactive drugs is, in most cases, clearly an area of low risk to the patient. Radio-active drugs are relatively simple chemical compounds with little or no toxicological / pharmaceutical activity. Misadminis-trations of diagnostic radioactive drugs rarely result in an adverse effect on the patient.
Alternative 1. Require reports to NRC of all misadministrations 1 (publish the 1973 AEC proposed rule in effective form). Pro: Maximum patient protection, because NRC will be in a posi-tion to investigate all instances of misadministration regardless of severity. Con: (1) Creates a large number of reports of misadministra-tions that involve low patient risk. e (2) Preempts the proposed policy statement by committing l NRC to a position before public comments are received. Alternative 2. Do not require misadministration reports (with-l draw the 1973 AEC proposed rule). t
)
l I
l F Tha Commissioners 6 l
,l Pro: (1) Avoids'a large number of reports of misadministrations that involve low patient risk. ,
)
(2)- Eliminates NRC intrusion into physician patient relation-ships.
- Con: '(1) Unresponsive to the.GA0 recommendation and those commenters, primarily the NRC Agreement States, that l believe a misadministration reporting requirement is necessary.
l (2) Inconsistent with NRC's proposed policy of regulating the radiation safety of the patient. l (3) Preempts the proposed policy statement by committing l NRC to a position before public comments are received. ! Alternative 3. Require reports to NRC of only potentially l dangerous misadministrations (withdraw the 1973 AEC proposal and ! publish a new NRC proposed rule). ' Pro: (1) Responsive to many comments on both sides of issue. l: (2) Avoids a large number of reports of misadministrations - l that involve low patient risk. (3) Consistent with NRC's proposed policy statement. (4) Does not preempt the proposed policy statement by l committing NRC to a position before public comments are received.- ' Con: Extends an already long delayed proposed action. Issue 2. (inform the patient, the referring physician or both) l-The reporting requirement in Enclosure 1 differs from the 1973 l AEC proposal in that the AEC proposal would have required the i licensee to report all misadministrations to the patient or a responsible relative, while Enclosure 1 would require the licen-see to report to the referring physician only those misadminis-trations reported to the NRC (i.e., all therapy misadministra-tions and those diagnostic misadministrations that could cause a -! clinically detectable adverse effect). The vast majority of medical procedures using radioactive mate-rial are performed on a referral basis. The NRC proposal, to notify the patient's referring physician, is consistent with contemporary medical practice. Usually, N referring physician decides whether to inform the patient of ifsadministrations or
~
l The Comissioners 7 , other events that may adversely affect the ~ ent's health. A reasonable expectation is that the refer # 3 physician will inform the patient, unless he believer nat the patient will be harmed by the information. Many comenters to the 1973 AEC proposal believe that haviny'fhe licensee inform the patient directly is an intrusion into the' physician patient relationship. Requiring the licensee to report to the referring physician and to the patient, unless the referring physician objects, might answer that coment but many physicians will nevertheless consider it an NRC intrusion. The question of whether anyone (other than NRC) should be informed by requirement strikes closer to the heart of the matter. Clearly, the NRC does not need to require that the patient be informed in order to investigate the incident or take corrective action. The patient's "right" to be informed may be covered by local ethics comittees, hospital policies or " patients rights" provisions of Medicare and Medicaid (which have a spotty history). The majority of the regulatory staff believe that the patient does have a right to be informed about his condition and that NRC should encourage this exchange of information by requiring the licensee to report to the referring physician, but not directly to the patient. Alternative 1. Require the licensee to inform the patient. Pro: Absolute assurance that patients will be informed of misad-ministrations. Con: Introduces NRC as a third party in the physician patient relationships. Alternative 2. Require the licensee to inform the referring physician. Pro: (1) Accepts current medical practice. (2) Minimizes NRC intrusion into the physician patient relationship. l Con: No absolute assurance that patients will be informed of misadministrations. Alternative 3. Require the licensee to inform the referring physician and the patient, unless the referring physician objects. l l l l l l
I
- Tha Commissioners 8 l
Pro: Helps ensu- ..at patients will be informed of misadminis-tration-Con: Introduces NRC as a third party in the physician patient I relationship. Alternative 4. No additional reporting requirement. Pro: Eliminates NRC intrusion into the physician patient relation- 1 ship. l l Con: No absolute assurance that patients will be informed of I misadministrations. Recommendation: The Commission:
- 1. Approve a notice of proposed rulemaking (Enclosure 1) that l would withdraw the 1973 AEC proposal and introduce an NRC proposed rule requiring reporting to NRC and the referring physician, those misadministrations that could cause an adverse effect on the patient (Alternative 3 of Issue 1 and Alternative 2 of Issue 2).
1
- 2. Note:
- a. The proposed rule would be published in the Federal Register for a 60-day public comment (the proposed medical policy statement and the proposed rule regard-ing deletion of the clinical procedures from the group medical licenses will be published in the same edition of the Federal Register for a similar 60-day public L comment. A single Congressional letter and Public Announcement will cover all three proposed actions.)
- b. If, after expiration of the comment period, no signif-icant adverse comments or significant questions have
! been received and no substantial changes in the text of the rule are indicated, the Executive Director for Operations will arrange for publication of the amend-ment in final form. If significant questions have been received or substantial changes in the text of the rule are indicated, the revised amendment will be submitted to the Commission for approval;
- c. General Accounting Office review of the reporting and recordkeeping requirements will be obtained after Commission approval of the amendment but prior to 4 making the amendment effective. A Report Justifica-tion Analysis is attached (Enclosure 4).
l l , l Tha Commissioners 9 9
-Coordinat' ,. The Offices of Nuclear Materials Safety and Safeguards, Inspec-tion and Enforcement and the Division of Rules and Records concur in.the recommendation of this paper. The Office of State Programs concurs, but favors requiring the licensee to inform the patient (or a responsible relative) (Alternative 1 of Issue 2).
The Office of Executive Legal Director has no legal objection, but favors requiring the licensee to inform the referring physi- , cian and the patient, unless the referring physician objects (Alternative 3 of Issue 2). Office of Policy Evaluation comments are responded to at Enclosure 5. The Office of General Counsel has no comments at this time. d Schedulina: Consideration at an open meeting during the Week of February 27, 197E v$ Yk Robert B. Minogue, Director
.g Office of Standards Development
Enclosures:
- W -
- 1. , Federal Register Notice of Proposed Rulemaking 2.. 1973 AEC Proposed
-Misadministration Rule
- 3. Summary of Comments on 1973 Rule
- 4. Report Justification Analysis
- 5. OPE Comments
- 6. OSP Memorandum of Concurrence DISTRIBUTION Comissioners Comission Staff Offices Exec Dir for Operations Secretariat w- 9 + .-- - .
9 9
,e .-- ..... /
.d, -.e. mk /. . Yj .[p* [ ^y t i E # 3
,N' $5 5 ' / ' '3
..-].
3%4 *[ , . I g- a',
* , (to> W4;.., at . ,
..o. ~ .'b .. .
.a # , Y 's [ ) I ~Y - .$* $ I f3 -'- , s . 'N-mj? .2 ,; r- b4
{#}' wl, .,cki:y cW ._ , p ~.N v?, L t : , *4 r, t ,,
.l, , .
' }
., S 't, t (a y., -
4 ki, I
.,g
; 's,' g n r ,
e 9 #d *
- p . .i,.,#-;
s e. J f >'y *
- 5
.y, - , .
d,
*: .. , ) , ' esr 1' "
, #,,i.;\_ ,, 9 N# '\,
,. ' , * / ,
r,,
+,
j, p7* ^*g<,; - ., , i i t
.g',
\ W i
=.t q i*
.A
- 6. , . . ..y, .- ,<. f. < 3,e
.7...,- . J.
. ,\ .s%
' ;Y' r , , . t, u I" . )/. il * "'i
, ei S
< A. a *
-e yj ,,- ,
q' > 4 N e
'Mt P' -
.g 'j < i ,.I
.f ;, y I' .
s . ., I g .)
~~ - .
r
#* y e
f 9 ENCLOSURE 1 FEDERAL REGISTER NOTICE OF PRO?0 SED RULEMAKING.. t r - 4 , d ~s,k i *O g
*4@W,0;, . n,, i* y g;g ;, . .; ., 'p. ,.c -J<e:: a.' yy;p;.; . g 'i . , ,.,,
y ~. d< ,, * <'
.%+
e .,
+. . F -f ,, ,K
.< (p , *: nu'..f s
_s '}..d .f4, s -
.t
') . ,
e i s ) jj~.p .p ,,'.yk 44 ,;;>* 1.'.
.. .t
*I ~" ( .
, .o 4,,s..
g
-, . syg 4.
- . . . r .t f x z '."_ . .,:,,';f t , ' ,., }i. N' ,' C t ' . .
. .,i, I
a '4,'[ - #l ' f
.Y; * , .,g -
Y l' f $ > s ,, -. l# 1 e s 4 7
,"e b-c', f 4,',[j ,
,' ,7 vi ?, 3, #f'.'u 7 ~f, ',' , r i: .
,73 - e- /. ; 5 s ,
g g. 9 4 k, t
' > , + j ,
d'
- f. g', ,yh 'd
,J, p, -.. , - + . - * -< . ' 1+,
s i s. 5
, 4-r e -y.I
,b, 6
5 4 4
~
.* 1 a
, , 'O NUCLEAR REGULATORY COMMISSION [10 CFR Part 35] ; HUMAN USES OF BYPRODUCT MATERIAL Misadministration Reporting Requirements AGENCY: U.S. Nuclear Regulatory Commission. 1 ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission is considering amending its regulations to require licensees to (1) keep records of all misadministrations of radioactive material or radiation from radfr.-
active material, and (2) immediately report to the NRC and the patient's referring physician potentially dangerous misadministra- j tions. DATES: Comment period expires . ADDRESSES: Written comments or suggestions for consideration in connection with the proposed amendment should be submitted to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, A Insert cate 60 days from publication in Federal Register. 1 Enclosure 1
k* -
"I's l
1
..', . (.
Washington, D.C. 20555, Attention: Docketing - .vice Branch. Copies of comments received may'be exaC .. at the Commission's l Public Document Room at 1717 H " .ac, N.W., Washington, D.C. I FOR FURTHER INFORMATION CONTACT: Edward Podolak, Office of Standards Development, U.S. Nuclear Regulatory Commission, Wash-ington, D.C. 20555 (Phone: 301-443-6910). l SUPPLEMENTARY INFORMATION: Following its organization under the Energy Reorganization Act of 1974 (Public Law 93-438), NRC, with a view to possible changes, began reviewing its regulations and procedures pertaining to licensing and regulation of nuclear facili- j i ties and materials originally promulgated by the Atomic Energy Commission (AEC). On March 9, 1973, the AEC published a proposed rule in the FEDERAL REGISTER (38 FR 6399) that would have required licensees to report to the AEC and to the patient all misadministrations of byproduct material and also would have required licensees to deter-mine that paramedical (allied health) personnel were adequately trained in the safe use of radioactive materials. Because 5 years have elapsed since the AEC requirement was proposed, it is being withdrawn and a new NRC proposed misadministration recordkeeping I and reporting requirement, 10 CFR 6 35.33, is being offered for public comment. The NRC proposed rule reflects the public comments on the AEC proposal. l l 2 Enclosure 1 l- .
l
,,W Af . ~ ' .
s, The Commissior Wying the various allied health certifica-tion progrr arrently in effect and being drafted by oth a Federal,. l 1 Stat- ..d professional agencies. If the coverage provided by these programs is not adequate to protect patients from unnecessary radiation exposure, the Commission will work with these groups to develop a new NRC proposed rule for the training of allied health personnel. The purpose of the misadministration reporting requirement is to allow NRC to investigate the incident; determine if there was a violation of NRC regulations; evaluate the corrective action taken l l by the licensee to minimize the chance for recurrence; and, if j i there is a possibility of other licensees making the same error, to allow NRC to begin generic corrective action which, as a minimum, would inform other licensees of the potential problem. Specifically, NRC proposed S 35.33 would require licensees to maintain for inspection by the Commission, records of all mis-administrations of radiopharmaceuticals or radiation from tele- l I therapy and brachytherapy sources. Licensees would also be required to immediately report to the NRC and to the patient's referring physician, all misadministrations that involve a therapy procedure l and those diagnostic misadministrations that could cause a clinically detectable adverse effect on the patient. The record or report would contain a brief description of the event, the effect on the patient, and the action taken to prevent recurrence. The names of individuals would be maintained in the licensee's record but not reported to the NRC. 3 Enclosure 1
.. - - . ~ - - - - - . .- -. .
,j -
.) ,
,+
-\ , . 1 H,
l An example of the follow-up action NRC might take upon receipt l of a misadministration report was the NRC investigation of an incident where 400 patients treated for cancer with a cobalt-60 teletherapy unit received radiation doses that exceeded the pre-scribed doses by as much as 41 percent. This incident occurred ! because the radiation dose rate from the teletherapy unit had not l been properly determined. Soon after its investigation, NRC acted to ensure that all teletherapy units licensed by it were properly calibrated. NRC also published in the FEDERAL REGISTER (42 FR 25743) a proposed amendment to S 35.13 requiring teletherapy licensees to routinely calibrate and check their teletherapy devices. The teletherapy calibration proposal also included a specific misadmin-istration reporting requirement that would be replaced by 5 35.33 (a more general proposal). Comments received in response to the earlier teletherapy misadministration reporting requirement will be considered in conjunction with the proposed rulemaking. In this newly proposed rule, 6 35.33(a) (4) and (5) define misadministration in part as administrations differing from the total prescribed dose or exposure by more than 10% for therapeutic ) l procedures or 20% for diagnostic procedures. These limits should not be viewed as the normal calibration limits for these procedures but rather the points where obviously an error has occurred. The narrower tolerance for the therapeutic procedures recognizes the greater risk to the patient from therapeutic misadministrations. Pursuant to the Atomic Energy Act of 1954, as amended, the 1 Energy Reorganization Act of 1974, as amended, and Sections 552 and 4 Enclosure 1 S
-A'.,,*
.a . '
l j . .- i i 553 of. Title 5 of the United States Code, notice is hereby given> !. . ~ that the 1973 AEC' proposed rule (38 FR 6399) is withdrawn and adoption of the following amendments to 10 CFR Part 35 is contem-plated. A new 9.35.33 is added to 10 CFR Part 35 to read as follows: 5 35.33 Records and reports of misadministrations. (a) Each licensee shall maintain for 5 years for Commission inspection records of all misadministrations of radiopharmaceuticals 1 or radiation from teletherapy or biachyth'erapy sources. These ! i records shall contain the names of all individuals involved in the ! event (including the physician, allied health personnel, the patient ] and the patient's referring physician), a brief description of the event, the effect on the patient, and the action taken to prevent I recurrence. (b) When a misadministration involves a diagnostic procedure that could cause a clinically detectable adverse effect on the patient or any therapy procedure, the licensee shall notify by telephone only the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter. The licensee shall also These i notify the referring physician of the affected patient. notifications shall be made within 24 hours after the licensee's discovery that the misadministration is likely to have occurred. The initial report shall be followed within a period of fifteen The (15) days by a written report to the same NRC Regional Office. written report shall include a brief description of the event, the effect on the patient, and the action taken to prevent recurrence. 5 Enclosure 1
-,-~w
m- _ _. t m ...
.'j Any report filed with the Commission under this section sh.
not include the names of individuals involved in th- isadministration l (patients, physicians, or allied health per- .el). l (c) For the purpose of the req"f . ..nents of this section, misadministration means the administration of: (1) A radiopharmaceutical or radiation from a source other than the one intended, i l-(2) A radiopharmaceutical or radiation to the wrong patient, 1 (3) A radiopharmaceutical or radiation by a route of admin-Istration other than that intended by the prescribing physician, (4) A diagnostic dose of a radiopharmaceutical differing from the prescribed dose by more than 20%, or (5) A therapeutic dose of a radiopharmaceutical or exposure from a radiation source such that the total treatment dose or expo-sure differs from the prescribed dose or exposure by more than 10%. (Secs. 81, 161, Pub. Law 83-703, 68 Stat. 935, 948 (42 U.S.C. 2111, 2201); Sec. 201, Pub. Law 93-438, 88 Stat. 1242 (42 U.S.C. 5841)) Dated at this day of 1977. For the Nuclear Regulatory Commission. Samuel J. Chilk Sacretary of the Commission 6 Enclosure 1
(.. .
+. {.': ,,, ,* , f .' g.*m: L.I L N.ig y m ,
- l. :. _ : ,
.$+ g'. 4 I
\ N ,
b ,
, 'c;_ .
.y* U
- Q[-;*f.'a,
. 'J'> e ENCLOSURE 2 1973 AEC PROPOSED MISADMINISTRATION RULE 4
, i 1
8 ] if
. . p ;.
.s e
m__.
a _ 4 .
,,e .
s i UNITED STATES NUCl EAR REOULATORY COMMISSlHN
..dLiiS and REGULATIONS .a
. d. CHAP'TER 1 CODE OF FEDERAL, REGULATIONS-ENERGY l
r-HUMAN USES OF BYPRODUCT MATERIAL 35 PROPOSED RULE MAKING
- 3. "Dyproduct material shall be used properly trained to perform the activi- (
38 FR 6399 ties which are delegated to them, e'er- j Published 3/9/73 by, or under the supervision of sone or tiacation in nuclear medical technoiogy Comment Penod expires 4/23/73 more named physicians) ."This condition
~ ~ ~
by either the American Registry of 1 is used in licenseitssued to medical in- Radiologic Technologists or the Rettstry MEDICAL USES OF RADIOL 50 TOPES stitutions which have medical isotopes committees to review all proposals for me sa y the require nt for (BYPRODUCT MATERIAL) stit" "*
- I80to w hin the such proper training; however, the Com-User and Reporting Requirements ,d d -
mission d es not consider it necessaty to The Atomic Energy Commission has nated on the application for license as nou e parame&al personM @ onb under consideration amendments to its having appropriate nuclear medicine assist physicians with simple manipulu regulations in 10 CFR Part 35. " Human training and expertence with isotopes. tions or in programs of limited scope to Uses of Byproduct Material." to: s!) The phrase ~or under the supervision of" be fully tratned and certined , Change the title of the part to " Medical provides a means thereby nonapproved technologt;ts, Uses of Radioisotopes aByproduct Ma- physicians under the supervision of a terial)," (2) specify certam responsibili- physician named on the license may ob. Section 20.403 of 10 CFR Part 20 of the tain basic and clinical radiotsotope train. Commission's regulations recunes h-ties of physicians authonzed to use radio- censees to notify the Commission of in-hotopes for medical uses, (3) specify ing and expenence to enable them to cadents involving the exposure of ind Wid-certain activities that may be delegated qualify as authorized users. by physicians to technietans and other 3. "A. Byproduct material shall be used uals to more than certain stated pcramedical personnel. (4s require phy- by, or under the supervision of, indi- amounts of radiation. section 20.405 8 c s viduals designated by the (name of requires that any exposure of an indi. sicians to determine that technicians and m.'- vidual to radiation which is required to Other paramedical personnel are properly stitution's isotopes committee >.
- - be reported to the Commission shall also trained to perform such activities. (5) '~"BfThe use of byproduct niaterial in be reported to the individual. However, require reporting to the Commission of or on humans shall be by a physician." since i 20.107 of 10 CPR Part 20 provides misadministrauons of radiotsotopes or This condition is used in licen es issued that nothing in the regulations in tnat radiation therefrom. and #6) require no* to medical institutions-usually medical part shall be interpreted as limiting the tification to the ps.tient or a responsible schools-whose isotopes committees have intenticnal exposure of patients to radi-relative of the patient of the misadmints- set up appropriate administrative pro- atton for the purpose of medical disg-tration of radioisotopes or radiation cedures, and training and expenence cri- nosis or medical therapy, notthcations therefrom which could adversely affect teria, for the committee to approve in- have not been required of incidents in.
the patient. dividual users. This condluon also allows other physicians to obtain training and volving the exposure of patients to radia-The title of 10 CFR Part 35 would be tion if the patient were receiving any changed by the proposed rule to " Medical experience under the supervision of a Uses of Radioisotopes tByproduct Ma- physician designated by the committee intentional medical exposure. Although teriall" to make the title more meaning- as an authorized user. incidents involving medical exposures It is recognized by the Commission have not been required to be reported,13 ful to users of radioactive matenal. If this rule is finally adopted, amendments that physicians utilize technicians and instances of misadministrations of radlo-to conform to this new title will be made other paramedical personnel to perform active materials involving 00 patients some of the activities and manipulations have been brought to the Commission's to this and other parts of the Commis. sion's regulations pertaining to byprod- involved in the medical uses of radioiso- attention. Since these inc: dents have act material, topes. In such instances. the physician is generally involved accidentar or erro-still considered to be the user of the neous exposures of patients to radiation In its licensing of the medical uses of radioisotopes pursuant to 10 CFR Part 35. radioisotopes. 'nte Commission has de. in amounts or forms other than intended. veloped with the assistance of its Adyts- it does not appear appropriate to con. the Commhston requires that the respon. ttnue the past practice of not requinng sible user be a physician licensed by a ory Comnuttee on the Medical Uses of reports of such misadmimstrat;ons of State or territory of the United States, Isotopes a list of responsibtilties which shall not be delegated by authortzed phy. radioactive matertals to medical pattents, the District of Columbia or the Common- The proposed new paragraphs is) and wealth of Puerto Rico to dispense drugs sician users of radioisotopes--execpt to in the practice of medictne. Physicians other physictans who are under the (c) of I 35.33 would require licensees are authorized to use radioisotopes by a supervision of authorized physicians- to report misadmimstrauom of raalo-condition of spectfle or general licenses and a list of activities that may be dele- pharmaceuticals or radiation Itom by-l issued by the Commission. One of the fol- gated by physicians to techntetans and product material sources to the Com-l other paramedical personnel. The pro- mission. Paragraph the cf 1 05.33 lowing three standard conditions is in-posed new i 35 32 would codify these non. would also regture a notification to the cluded in each specific license issued for medical use of radiotsotopes: delegable responsibthues and permtsrtble patient or to a responsible relative of the
- 1. " Byproduct material snall be used by delegations in the Comnussion's regula- patient of a misadministration wrach (a named physician)." This condition is tiens. Section 35.33 would also require could cause a demonstrablt arherre ef-physicians to determine that techrucians fect on the patient unless in the pnyt-used in licenses to phystetans in private clan's professional ludgment such nouth practice. and other paramedical personnel are 1 ' Enclosure 2 April 30,1975 35 7 l
- i l a - '
PART 35 o PROPOSED RULE MAKING
'I- ece41on tnuld be contrary to the best in-
>l mit tetivitts to be perfsrmed by techni- within 1 year Cf (effecthe date of rulO.
- terests d the patient or a survivmg rel- clans and ethir paramedical personn11 J
. o me patient. iln accordance with whichever occurs first. 1 pursuant to paragraph act of this section 8g) Whenever a technician or other
..e Freedom of Information Act and 10 shall; paramedical person admmisters a radio.
CFR Part 9 of the Comnussion's rules and eIl Prior to such permission deter- pharmaceutical to a patient by smertson. Neule.tions. copies of reports filed under these proposed rules, except for any de- mine that such techmelans and other a physician snot necessarily a physician paramedical personnel have been prop- authonzed by the Commission to be a taus which would identify the patient, erly tramed to perform their duties. This user of radioisotopes) shall be immedi-trill be available for pubhc inspection.) traming shall include traming in the ately accessible. Pursuant to the Atomic Energy Act of following subjects, as apphcable to the 1954. as amended, and section $53 of title . duties assicned: 3. A new I 35.33 is added to 10 CI'R 5 of the United States Code. notice is its General characteristics of radia- Part 35 to read as follows: hereby given that adoption ci the follow- tion and radioactive matenals. ing amendments to 16 CFR Part 35 is I 33 33adnm.Yifirseien. neul report. of nu..- till Physical. chemical, and pharma- . merneuina. eentemplated. All interested persons who ceutical characteristics of each radio-desire to submit written comments or pharmaceutical to be used. (a) Each Ilcensee shall notify the Di-suggesUons for consideration in connec- rector of the appropriate Atomic Energy tion with the proposed amendments basic f11is Mathematics and calculations Commission Regulatory Operations Re-should send them to the Secretary of the to the use and measurement of gional Omce listed in Appendix D of 10 radioactivity, meludmg units of quantity CFR Part 20 of the Commission's regula-Commission. U.S. Atomic Energy Com- of radioactivity a curses, mi!!icuries, mission. Washington. D.C. 20545. Atten- tions by telephone and telegraph of any microcuness and units of radiation dose misadministration of radiopharmaceutt-tion: Chief. Public Proceedings Staff by and radiation exposure. April 23.1973. Copies of comments on eiv) Use of radiation instrumentation cals or any misadministration of radia-the proposed amendments may be exam- for measurements and monitoring in- tion from teletherapy and brachytherapy ined at the Commission's Pub!!c Docu- cluding operating proce+1res, calibration sources. This notification shall be made ment Room at 1717 H Street N W., of instruments and limatations of instru- within 24 hours after such masadmmis-Washington. DC. . ments, tration is known. For the purpose of the
- 1. The title of 10 CFR Part 35 is 80 Principles and practices of radia- requirements of this section. misadmin-amended to read as follows: " Medical tion protection. istration is defined to include the admm-uses of radiotsotopes (byproduct i s1) Addat. tonal training in the above 1stration of:
materiaD ." subjects, as appropriate, when new duttes (1) A radiopharmaceutical, or radia- '
- 2. A new I 35.33 is added to 10 CPR are added. tion from a source other than the one Part 35 to read as follows; intended.
s2) Assure that such technicians and 12) A radiopharmaceutical or radia. 9 33.32 Camlision. nf licen.cs for med. other paramedical personnel recerse ap-iemi u*es of radioiwoopc propriate retraining in the subjects listed tion to the wrong patient, or (a) The user of radioisotopes in or in paragraph (d> <!) of this section to a3) A dose of a radiopharmaceutical, applied to humans for diagnostic. thera- maintain proneiency and to keep abreast or exp sure from a radiation source, out-peutic, or investigational purposes shall of developments in the field of nuclear side of the intended dose range pre =cribed be a physician authortzed by a condition medical technology by the physician or by a route of admin-
<3) Keep records showing the bases u11ng a s f r such determinations of proper train- the sic an.
c 1 ce e of br 88' 8" tb (1) Whenever a misadministration scope, issued by the Commission (au- i thorized physician). e4) Retain re-ponsibility as licensee or of a radiopharmaceutical or radiation ' (b) No authorized physician may dele- authorized user for the satisfactory per- from a teletherapy or brachytherapy gate to persons who are not physicians fomance of such activities. source could cause a demonstrably ad-tmder the supervision of the authorized se) Certification in nuclear medicine verse effect on the patient to whom it physician, the following: technology by the American Reststry of was administered, the licensee or the (1) 'Ihe approval of proceduits in. Radiolcgic Technologists or in nuclear notify authortzed physician shall promptly the patient or a responsible rela-tojving the administration to patients of medical technology by the Registry of tive of the patient of the misadmmistra-radiopharmaceuticals or the application Ittedical Technologists of the Ameriaan tion unless in the physician's profess:onal to patients of radiation from radiol.so- Society of Chnical Pathologuts will be judgment such notification would be tepe smarces, deemed to sausly the training require- contrary to the best interests of the pa. (2) 'Ihe prescription of the radiophar* ments of paragraph (d) (1) and (2) of tient or a surviving relatit e of the ttus section. maeeutical or source of radiation and the patient. dose or exposure to be administered. t!) An applicant for a license or for
- 2s ff death occurs after a judgment is (3) The determination of the route of amendment or renewal of a license shall made by the physician that notificauen administration, state whether he desires to permit tech- to the patient or a responsible rebtne of (4) The interpretation of the resulta nicians or other paramedical personnel the patient of the misadministrat;on gf diagnostic procedures in which radio- to perform activities pursuant to para- would be contrary to the best interests pharmaceuticals are admmistered- Eraph (c) of this section and. tf 50. shall of the patient and the misadministr.ition te) Subject to the provisions of para- include in his appucation for license, graphs (b), ed) sei, si), and tg) of this hcense amendment, or license renewal a may have been a contributory cau.se of sect 6cn. an authorir.ed physician msY statement of the activities to be so per- the death, the licensee or the authorned pemit technicians and other paramedia formed and a description of an adequate physician tive of theshall notify patient a respotutble of the rela-mtsadmmistra-esl personnel to perform the following program for training sulcluding retrain- tion unless the physician makes an ad-activitaes: ing as required to keep abreast of devel- dttional determmation that such nottn-(1) Preparation and quality control opments in technologys such personnel ration would be contrary to the best testing of radiopharmaceutacals and or for otherwise determimr'g that such interests of a surviving reLtuve of the sources of radiation, personnel are properly tramed to per- patient.
t2) 34easurement of radiopharma- form their duties. With respect to li-ceutical doses prior to administration. ccuses in effect on f edective date of ect In addition to the nottncation re-(3l Use of appropriate instrumenta- thlen, a licensee who ts permittmg or quired by paragraph sat of this section, who desires to permit techntetans or each heensee shall make a reort in s rit-t6on for the collection of data to be used by the physician, other paramedical personnel to perform ing within 30 days to the Director of (4) Administration of radiophar- activities pursuant to paragraph (e) of Reculatory Operationa. U.S Atomic this section shall file the mformation Enercy Commission. Washington, D C. maceuticals and radiation from radio. required by this paracraph with the 30545. with a copy to the Director of the isotope sources to patients, within limits Director of Licensmg. U S. Atomic En* appropriate Regulatory Operations Re-gtherwise permitted under apphcable ergy Commtaston. Wa.shington, D C. cional Omce specif' icd in Appendn D of Federal. State or local laws. 20545, with his next app! cation for 10 CFR Part 20. of each misadmmistra-(d) Authorized physicians who per- amendment or renewal of the license or tion. The repart required under this para-graph nwd not melude the name of the April 30,1975 S.g Enclostire 2
JI ' 1 .
, PART 35 o PROPOSED RULE MAKING patient but shall describe the nature, ex-lent, and cause of the misadministration (' S and the corrective steps taken or planned to assure against a recurrence. If the
- misadministration could cause a demon-strably adverse effect on the patient or if -
death occurs and the misadministration may have been a contributory cause of the death, the report shah either confirm that the patient or a responsible relative
- of the patient has been notined of the h g
misadministration as required by pars-graph (c) (1) and s21 of this section or sha!! state that notification was not given because in the physician's judement such notikation would be contrary to the best interest.1 of the patient or a surviving Mlative of the patient. If the patient or relative is not notified. the physician shall confirm that this decision was re-viewed by a local Ethics Committee or an esguinlent group of peers and shall state whether or not the committee or smup concurred with the decision. (d) Any notification or report filed with the Commission pursuant to para-sraphs (a) and (c) of this section shat! be prepared so that any details which would identify the patient will be stated e in a separate part of the notification or report. 40 FR 8832 Published 3/3/75 Comment Period expires 5/2/75
% (extetuted to 5/19/75)
Reports to the Commimon Conceming Defects and Noncomphance See Part 21 Proposed Rule Making. p 40 FR 20110 Published 5/8/75 Comment Period extended to 5/19/75
- Reports to the Commission Conceming Dr.
facts and Noncompliance; Proposed Re-qadrements: Estension of Comment Period See Part 21 Proposed Rule Making. Enclosure 2
**- me- a
- e -a
b=', q , e
+
. y-l-
.s :-
1
.').,
w .,_ e e .. A
<<4 .*
g: .- , j? ca 'g. t
,g .' 4
.. ENCLOSURE 3
,i: 4u. 3 /
SUMMARY
OF COMMENTS ON 1973 RULE 4 2..( 1 ,e,e.:.9-
- - J E
.'d m Y' Ni v.
, : /;b. jf p e d
..g,_
, . p .a
( 6 0 a
.4 'j ' ) .L , ,
a g 7 9 4 i. 5 w 3 i l i n d w em..
1,,,,
.. L.
A ..i 0F COMMENT LETTERS . Tn ~ 27.3 PROPOSED. AMENDMENTS TO 10 CFR PART 35 1 Ninety-eight comment letters were received and 244 comment items were tabulated.
- 2. Regarding 6 35.12, conditions of licenses for medical uses of isotopes (responsibilities of physicians, delegations of activities to technicians and training of technicians),
- a. Principal comment (16 letters) based on misunderstanding of proposal to deem certification in nuclear medicine by the American Registry of Radiologic Technologists as satisfying the training requirements for technicians. These commenters thought that all technicians would be required to be so certi-fied. Under the proposed rule such certification would be one alternative of adequate training but other training programs and other training and experience qualifications would be con-sidered on their merits.
- b. Nine commented that radiopharmacists should be recognized or required for preparation and quality control of radiopharma-cauticals.
1 Enclosure 3 L l- -
[ . .) L* .4 l
- c. Seven comented that certified radiation therapy technologists i
I are properly trained and should be recognized for teletherapy and brachytherapy activities. 1 l l d. Six objections and seven qualified objections were expressed to the requirement for retraining of technicians. Reasons given were that retraining is not necessary for persons actively I engaged in the field and that retraining is not required for other types of users of radiopharmaceuticals or for technicians in other fields. I
- e. Four comments favored and five comments opposed the entire 6 35.32, without making specific suggestions. j I
- f. Four comments favored and five comments opposed the requirement for training technicians, without making specific comments.
- g. Several objected to the workload and expense of " unnecessary" I
records and paper work.
- h. Several objected to these detailed training requirements because the physician is responsible for technicians under his supervision.
l l l i 2 Enclosure 3 l
-{ ..
- 3. Regarding 6 35.33, notifications and reports of misadministrations. . , , ,
- a. Six comments favored and 13 comments opposed the proposed rule without making specific suggestions.
I
- b. Twenty-seven objected to reporting misadministrations, as self-incrimination; some cited constitutional protection against l
self-incrimination.
- c. Fourteen objected to reports of misadministrations being public records. These commentators did not appear to object to reports i
I to the Commission for information and investigation if they could be reported privately. The commentators who objected on the basis of self-incrimination and public records usually stated that such reports would invite or increase malpractice suits and increase the cost of medical care.
- d. Eleven objected to requiring reports to patients on the basis that such requirement would place the government as a third I
party in the physician patient relationship. Several of these l physicians stated that patients are informed of misadministra-tions which adversely affect them as a matter of medical ethics but that such reports should not be regulated. 3 Enclosure 3 i
l ,2 , l ' a . l
-) ...
- e. Ten comented that there are no comparable requirem- . . a'ny
( other drug or for physicians in any other fb ar practice. l
- f. Fourteen commented that report- . misadministrations should be.
l limited to therapeutic or significant amounts of radiopharma-l l ceuticals and that misadministrations of diagnostic quantities (which are safe in normal use and which would not injure a person if administrated under conditions defined as misadminis-l tration) do not justify reporting. The Society of Nuclear , 1 Medicine commented that reports of such minor misadministrations ) I would make it impossible for the Commission to sort out and act on the important misadministrations. l
- g. Ten commented that " demonstrably adverse effect" should be clari-fied in view of such concerns about low doses as the no-threshold concept and genetic effects.
l
- h. Four commented that these misadministration reporting require-
! ments are not warranted by the number of misadministrations that have occurred. l 4 Enclosure 3
,s. Mu g a - - - +- A J a x 4 D--a-as_,-
k
* $ ( '
)- , ,
?. .c- I fig.; )
p l 1
#j- -p, , b ., yy s
l l l
+
4 6 l
, l l
l ENCLOSURE 4 REPORT JUSTIFICATION ANALYSIS
*
- I
, i e a '1
,\ . Y
<s h
1 g 9 e 4
. s-I l REPORT JUSTIFICATION ANALYSIS FOR GAO 1
l I. Type of Recordkeeping and Report l Unde. the proposed misadministration rule, licensees will be required to l keep records of all misadministrations and report to NRC and the referring physician, all therapy misadministrations and those diagnostic misadmin- j istratons that cause a clinically detectable adverse effect. The initial telephone report to NRC will be followed by a written report within 15 days. l 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 reoccurrence. The report to NRC will contain the same information with i the exception that the names of individuals will not be reported. II. Need for the Report In 1972, the General Accounting Office recommended that NRC require licen-sees to report misadministrations of byproduct material. The GAO stated that the information would help NRC to alert other licensees to potential generic misadministration 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 assess the potential for generic problems and take appro-priate action. The information will also be used by Standards Development as a basis for rulemaking actions, if indicated. 1 Enclosure 4
-t . , e.
.. 4 III. Cost:or Burden to Respondents and NRC Misadministration data is very sparse, and that which does exist is suspect due 'to the sensitivity of the information. The frequency of misadministra-tion of radioactive material is not known. Food and Drug Administration receives voluntary reports of adverse drug reactions (not misadministrations). Approximately 2500 NRC licensees and most of the 3000 Agreement State licensees will-be affected by the proposed recordkeeping and reporting requirement. Assuming that, on the average, each licensee has one mis-administration (as defined in the proposed rule) per year and 2 percent of these are reportable to NRC, there will be 5500 records and approximately 100 reportable indicents (requiring two reports to NRC or the Agreement State, and one to the referring physician). Only the cost of producing the record or making the notification is con-sidered in the following analysis. The analysis of the event and other associated costs are considered a cost of complying with the regulation and not costs of recordkeeping or reporting. Both the recordkeeping and reporting requirements can be fulfilled by extracting pertinent facts from the patient's medical records.* The cost to the licensees of the NRC recordkeeping requirement is estimated to be one-half man-hour per recorded
- misadministration. The cost to the licensee of the telephone reporting A
Because the names of individuals will not be reported, the reporting requirement need not infringe on physician patient privileges. 2 Enclosure 4
l . ;.L .
- j. s. ;.
?.. a - ,*)
l requirement is estimated to be one-half man-hour each for the NRC repd ' and the referring physician report. The cost to the licensee fe .. .e ! ,, written report to NRC is estimated to be one man-hour.
~
wotal cost to the licensee for the reporting requirement is the .are 2 man-hours per reportable' incident. 1
.Where they exist, misadministration reports are currently reviewed by NRC inspectors during otherwise scheduled inspections. The incremental cost
.of reviewing the new recordkeeping requirement will be very small and can be considered negligible. Each telephone misadministration report is estimated to require one-half man-hour by Regional Office personnel. Eac'h written report is also estimated to require one-half man-hour. The total cost to the NRC.is estimated to be one man-hour per reportable incident.
With these assumptions the following calculations apply: 1 (1) 0.5 man-hours per record x 5,500 records = 2,750 man-hours annually , for licensee recordkeeping (2) 2 man-hours per reportable incident x 100 reportable incidents = 200 man-hours annually for licensee reporting. (3) 1 man-hour per reportable incident x 100 reportable incidents = 100 man-hours annually to NRC. 3 Enclosure 4
' ~
.: o, l ... *d IV. Evaluation of Alternatives l ;
I There are no alternative dr' surces. Voluntary reporting was not satis- [ factory to GAO in 197F and is probably an unworkable alternative. Adverse drug reactions voluntarily reported to FDA do not normally i'nclude reports of misadministrations. V. Value/ Impact Assessment It is difficult to place a dollar value on a human life. In the case of a fatality through malpractice, the courts have awarded judgments on the order of magnitude of 1 million dollars per death. The total annual cost of the isadministration rule was estimated to be 3,050 man-hours for on the order of 5,500 recordable and 100 reportable misadministrations per year. At an estimated $30 per man-hour, including salary and overhead, the total cost of the recording and reporting requirement to ifcensees and NRC would be close to $100,000 annually. If the true number of misadminis-trations were known, as well as the individual costs of recordkeeping and reporting, the true total annual cost could be determined and may differ from the estimated cost by an order of magnitude in either direction. However, even at a true cost of $1 million annually ($100,000 x 10), if the misadministration rule can prevent the death of a single individual yearly, its value can be established. , 4 Enclosure 4 l
- A .-sa,4L.4- _4 a,,_ssa . .1. 4 4;p. _4 g ,g
% g M f tJ g e
- * . Se . rg b*-
a, l
- Ok i
4 ; 9 d-4 s 4
-,1' I t t
1 O
.4 i +
.; 7: 4
%' 1.
4- I I i ENCLOSURE 5 4
- ~
l i OPE COMMENTS l 4-i
,i {; -
+
e 4 l [ 1 r l ) l t-
-a , , w
= , , .
a c 0FFICE OF POLICY EVALUATION COMMENTS - !
, 1. Comment: OPE suggested that " misadministration" be defined in the Discussion section of the paper and that " clinically detectable adverse effect" be defined in both Discussion section and the proposed Federal Register notice.
Response: The term " misadministration" is now defined in the Commission Paper and the term " clinically detectable adverse effect" is explained along with a discussion of why it is not defined in the Federal Register notice.
- 2. Comment: OPE suggested that the Statement of Considerations note why the 1973 AEC proposed rule is being withdrawn and how comments on that proposed rule are reflected in NRC's proposed rule.
easponse: The Statement of Considerations now notes why the 1973 AEC proposed rule is being withdrawn and notes that comments on that earlier rule are reflected in the NRC proposal. An analysis of the comments and how they were incorporated is not included in the Statement of Considerations. If these were included, commenters on the NRC proposal may feel compelled to comment on the earlier public comments, on NRC's analysis of the earlier comments, or on the way they were incorporated in the new proposal. This may draw attention away from the new NRC proposal. 1 Enclosure 5
r a
' ~
<. +
l.
*g l ' '
i l 3. Comment: OPE noted that the Coordination section of both papers - l indicates (in anticipation) the concurrence of the various offices
. reviewing the draft and that other recent papers had similarly 3 cated concurrence in coordination drafts. OPE suggests tb . during the coordination rounds, this section indicate the offices reviewing l the paper and make no anticipatory statements about concurrences. l Response: The draft Commission Paper is prepared exactly as it is expected to go to the Commission. This includes the Coordination section filled out and up-to-date. The transmittal memorandum that requests review and concurrence from the designated NRC offices reflects the' status of the review (i.e., Technical review, Division l l
review, Office review) and other pertinent information. Offices are l then expected to comment if the Coordination section should be l changed to indicate "non-concurrence" or "no legal objection," etc. l Subsequent drafts (and the final paper) are updated accordingly. Since the OPE and OGC do not review the Commission Paper until the final round, it may be appropriate to handle their " concurrence" in 4 the Coordination section in a different manner.
- 4. OPE had several comments that indicated it did not receive the cover
' memorandum transmitting the proposed misadministration rule. The cover memorandum explained SD's intention to present to the Commis-sion simultaneously the medical policy statement, the misadministra-tion rule and the clinical procedures rule; and that the three 2 Enclosure 5 l
~
-.a _
~
24..
"J , o - $ r notices are intended to be published in the same e .. of the Federal Register for identical comment pe ' ..
3 Enclosure 5
_ . ~ . - _ . . _ _ . . . l.::1;Q f I. ';' E f -. e9'.. l F 1:*4. ,, 0 l . , g ;. > notices are intended to be published in~the same e'" .. of the Federal Register for identical comment pea'- .. l l. l 2 1 l l' j .. [ . L { j '. o y 3 Enclosure 5 R _ . . . . _ . _ _ . _ - . - _ _ -. . . . . . _ _ _ _ _ , _ . _ , _ _ _ . , 1
- . . . . - - . . . - . . . . - . . . . . . _ - - . . . - . ~ . - . . . - - . . ~ . - .
--* & 5 UNITED STATES 4j)'i f*h"O 1/
NUCLEAR REGULATORY COMMISSION wAswiwoTow - 2..s . 5 i t! *
/ .
OCT 13 W7 ' Ref: SA/ECA w , MEMORANDUM FOR: . RobertB'. Minogue, Director Office of Standards Development j FROM: Robert G. Ryan, Director Office of' State Programs
SUBJECT:
0FFICE REVIEW OF C0fEISSION PAPERS t' MISADMINISTRATION REPORTING AND CHANGES IN THE GROUP MEDICAL 1.ICENSES
'I This is in response to your memorandum of September 15, 1977, requesting review and comments on the subject Connission papers.
u-The Office of State Programs generally concurs'in the papers. We favor, however, retention in the new NRC proposal of the requirement in the 1973 AEC proposal that physicians be required to notify patients to whom they have misadministered by-product material in those instances which would require a report to the NRC. The comments from the medical fraternity to the. contrary are not in our judgment persuasive. Please note that the period for advance review by the Agreement States runs to October 21. The papers should not be forwarded to the Connission until after that date. ( Robert G. Ry n, Dir ctor. Office of l Stdte Programs V f a Enclosure 6 J g o l 4.'- s - - + . ~ - , -
.w.- m ,m.}}