ML19254C404
| ML19254C404 | |
| Person / Time | |
|---|---|
| Issue date: | 06/15/1979 |
| From: | Gossick L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| Shared Package | |
| ML19254C403 | List: |
| References | |
| FRN-42FR10950, RULE-PR-35 NUDOCS 7910160002 | |
| Download: ML19254C404 (11) | |
Text
,
For:
The Commissioners From:
Robert B. Minogue, Director, Office of Standards Development Thru:
Lee V. Gossick Executive Director for Operations
Subject:
EFFECTIVE AMENCMENTS OF 10 CFR PART 35 TO REQUIRE REPORTING OF MISADMINISTRATIONS OF BYPRODUCT MATERIAL Purcose:
To obtain Commission approval of a notice of final rulemaking that will require medical licensees to (1) maintain records of all misadministra-tions and (2) prcmptly report serious" misadministrations to NRC, the referring physician and the patient er a responsible relative (or guardian).
Category:
This paper covers a major policy question and rescurce estimatis are final (Category 2).
Issues:
(1) Should medical licensees be required to report misadministra;'ons to NRC?
(2) To whcm, besides NRC, should the licensee be required to report misadministrations?
Decision Criterlq:
Issue 1 - Consistency with NRC's medical policy statement to regulate the radiation safety of patients where justified by the risk te patients anc where voluntary standards, or compliance with these standards, are inadequate.
Issues 1 & 2 - GAC's recommendation that NRC require reports of all misacministrations and cecide the issue of patient notification at a later date.
Issue 2 - Consistency with NRC's mecical policy str+.ement to m nimi:e i
intrusi0n into medical judgments affecting patients anc otner a"eas traditionally considered to be a part of the ;:ractice of medicine.
Issue 2 - Ccnsistency with the President's expressed concern that incividuals have a right to see their own medical rec 0rds and ensure that they are accurate, timely ard relevant to their care.
Alternatives:
Issue I:
(Report misadministraticas to NRC) 1.
Do not recuire misadministration reporting.
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2.
Require reporting of all misadministrstions.
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" Serious" refers to all therapy misadministrations and those diagnostic misacministra-tions that cause a clinically detectable adverse effect in the patient.
Contact:
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3.
Require reporting of only serious misadministrations.
Issue 2:
(licensee reports to whom besides NRC?)
1.
Do not require any reporting other than to NRC.
2.
Require the licensee to inform the referring physician.
3.
Require the licensee to inform the referring pnysic'an and the patient or a responsible relati.
( or guardian), unless the referring physician objects.
Discussion:
On March 2,1978 the staff briefed the Commissicn on a replacement for a 1973, AEC proposed rule requiring reports of medical misadministra-tions.
The NRC proposal (SECY-78-70) would recuire recordkeeping of all misadministrations and reporting serious misadministrations to NRC aid the referring physician.
The Commission requested that the paper be returned to the staff for an elaboration of an ELD reccmmendation chat the licensee report directly to the patient or a responsible relative, those misadministrations reportable to NRC.
The Commission approved the ELD version (SECY-78-244) which was pJblished in the Federal Register (Enclosure 3, 44 FR 29297) for a 60 day comment period that expired October 3, 1978.
The proposed rule was mailed to all medical licensees, about 30 professional and public interest groups, 2,000 stata and county medical societies, and the Agreement States.
This aggressive solicita-tion of public comments was the result of the Ccemission's excressac concern about the possibility of undue intrusion into the pnysician-patient relationship.
The Commission received 150 ccmeents en tne propcsed rule througn Novemcer 1973.
These ccmments are summariced anc ana'yced in Enclo-sure 4.
Ninety percent of tne cccments were copcsed to tne prcccsec rule.
Sasically. the ccmmenters were opposed c misaccinistratica reporting to NRC where the reports wculc be open to cuolic scrutiny; and misadministration reporting to patients wnicn would cause "uncue alarm" and " unwarranted malpractice suits" A majority of tne comments were cetailed and specific.
A few ccements were vitriolic and acusive.
The vast majority of the ccmments came fron, pnysicians c pnysician groups.
Four features of the prccesed rule are incertant to urcerstancing the c0mments:
1.
Cefinition of visacministration.
In the precosed rule, misacrin-istration was cefined 33 the acministration of-(1) A radiopharmaceutical or radiation tc the wrong oatient; o**E*EM@'
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(2) A radiopharmaceutical or radiation by a route of acministra-tion other than that intended by the prescribing physician; (3) A diagnostic dose of a radiopharmaceutical differing from the prescribed dose by more than 20 percent; or (4) A therapeutic dose of a radiopharmaceutical or exposure from a radiation source such that the t0tal treatment dose or exposure differs frca the prescribed dose or exposure by more than 10 percent.
2.
Recordkeecino.
The proposed rule would recuire each licensee to keep records of all misadministraticns for 5 years for Ccmmission inspection.
The records would contain the names of everycne involved in the event, including the licensee, the authorized user (s), allied health persennel, the patient's referring physi-cian, the patient, and where a:cropriate the patient's respen-sible relative; a brief description of the event; the effect on the patient; and the action taken to prevent recurrence.
3.
Immediate Reoorting.
The proposed rule would require the licensee to report all therapy misadministrations and those diagnostic misadministrttions that could :ause a c!'nically detectable adverse effect.
The licensee would have to notify by pne' tthin 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery that a misadministration is likaly to have occurred:
(1) NRC, (2) the patient's referring physician and (3) the patient or the patient's respcnsible relative, unless the referring physician personally informs the licensee that in his medical jucgement telling tre patient er the patient's responsi le relative woulc be harmful ta one or tne other, respectively.
This part of tne peccesec rule generated the : cst comment.
Very few commenters realized inat trere was a taresnoic f:r re;crting Giagnostic misaininistrations, i. e.
tncse ciagncstic misacministra-tions that could cause a clinicaliy cetecta le acserse affect.
4 Written Recert.
The crcpesec rule required the licensee to make a written rep 0rt t NRC within 15 days of ciscovery tnat a mis-administration is likely to nave cccurred and furnisn a copy to the patient or patient's responsible relative if either was noti-fied uncer the immediate reporting requirement.
Many concenters assumed tnat the pr0?csed rule recuicec a written follow-up report for all misseministrations.
As noted above, 90 percent of the c0mmerters were Opposed to the Oro-pcsed rule.
A majority of the negative : mments ceposed the misa: min-istration reporting requirement and r.ot the recorckeeping recui*ement.
Most of these cocmenters ~ere ep0csed to recorting diagrostic misacain-istrations to.. atients rd elatives, many citing that the definition
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of a diagnostic misadministration as a 20 percent error was too 1cw.
The staff believes that, had the threshcid for reporting diagncstic misadministrations been clear in the proposed rule, there would have been fewer negative comments.
Several commenters cbjected specifi-cally to the lack of a threshold.
However, the staff cannot deter-m;ne how many commenters would be satisfied by having a threshold for reporting diagnostic misadministrations in the final rule.
A sub-stantial number of commenters who fccussed on the issue of reporting all diagrostic misadministrations, could have been opposed to misadmin-istration reporting in general.
.Cor example, one commenter who recognized the threshold for reporting diagnostic misadministrations, said that labeling errors as low as 20 percent as misadministrations had a perforative tone.
In any event, the final rule will have a clear threshold fer reporting diagnostic misadministrations.
On the same subject, several commenters objected to the ambiguity of the phrase "could cause a clinically detectable adverse effect" in the threshold fc-reporting diagnostic misadministrations.
They felt that the future tense rendered the threshold meaningless because any radia-t'on exposure "could cause" a clinically detectable effect eventually.
Tne staff agrees that the future tense is inappropriate and has change the verb to the present tense "causes".
A few commenters objected to the absence of a definiticn for a "clini-cally detectable adverse effect" Some questioned who would make thr.t determination.
Others cbjected to the pnysician having too much lesway in making the determinatica.
Still others ccmolained that, w'*her.
quidelines, they would have difficulty in making the determination.
The staff believes tnat " clinically detectacle" is a term tnat is well understcod in medicine.
It refers to diagnosis involving direct caservation of the catient, and includes such non-invasive testing as:
biccd pressure, temcerature, blcod tests, e33 The staff recommencs against defining " clinically :etectable acve-se effect" in tne regula-tien.
Definiticas, sucn as, a cercentage depression in the write biccc-cell ccunt, are prcceccre-speci#ic anc pat ent-speci'ic.
The i
diagnosis of an " adverse ef fect may in One case be basec on a single cramatic symptom; wnile in anctner case ic may be cased on a numcer of individually minor deviations frca tre n;rmal, for tnat catient.
- Thus, the licensee, basec cn the diagnosis of a physician, will cetermine wnen a diagnostic misadministration cat.ses a clinically cetectacle acverse effect On the catient.
The preamble to tne final rule discusses this questien.
The cefinition of a diagnostic misadministraticn in tne final rule has been changed to read:
A diagnostic ccsa of a sdicpnarmaceutical differing frca tne prescriced dcse by acre tnan:
20 percent for radicisctcpes wicn a half-life greater than or equal to 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />, and 50 percent for radioisotcpes with a half-life less than three hcurs.
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it change, orompted by the public comments, recognizes the difficulty
, scheduling the administration of very short half-life radionuclides.
These radionuclides have the acvantage of delivering a Icwer radiation dose to patients.
The definit'on of a theracy misadministration in the final rule has been changea to read:
A therapeutic dose of a radiopharmaceutical differing from the prescribed dose by more than 10 percent; or A therapeutic radiation dose frca a sealed source, sucn that errors in the source calibration, time of exposure, and treatment gecmetry result in a calculated total treatment dose differing from the final, prescribed total treatment dose by more than 10 percent.
These changes result from several public comments.
The new definition distinguishes between radicpharmaceutical therapy and Eaaled source therapy.
The new definition recognizes that the therapist adjusts the functioned dose during treatment, based on the response of the tumor and other factors.
Also, the new definition recognizes that the radiation dose in sealed source therapy is calculated as a function of dose rate, time, and treatment gecmetry; and that it is not usually measured directly.
Some otner changes in the final rule also result frca public comments.
The final rule permits the referring physician to inform the patient of a misadministration.
The final rule provides for reporting to a
" guardian" as an alternative to a relative.
The final rule has a recordkeeping repuirement of 50 years for misacainistrations because of the icng latency period for raciation induced cancers.
Some suggesti:ns frca tne :cmcent'ers were not incert. rated into tne final rule.
Cre c:rmenter suggestec that NRC senc a confir7.atcry report to the patient.
The staff reccamends aga;nst this unless there is significant non-compliance with the final rule.
Several c:: centers suggestec extending the limits in tne definitiens of ciagncstic and tnerapeutic misadministrations.
The staff recommends against taii because the limits i- :ne finai ule are within :ne state-of-the-trt and the limit for a therapy a.sacticistration is basec on severai literature re'erences addressing harm to the patient.
The vast majority of the commenters censider the propcsed rule as an unprecedented, sericus intrusion into the physician ?atie.it relation-ship.
They contend that the proposed rule is an intrusion af a regu-latory agency into the care of a patient withcut assuming res;cnsibii-ity for that care.
Many ccmmenters pointed cut thac tne misa:mir.-
istration reporting requirement was unique in recical practice and noted that NRC regulations did not apply to x-rays, accelerator Or radium theracy, and accelerator produced radicpnarmaceuticals.
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Many commenters were concerned that the preposed rule, in particular the patient reporting requirement, would invite unwarranted malprac-tice suits and thereby boost medical costs.
Soma ccmmenters suggested that the rule would lead to covering up misadministrations to avoid liability.
Some commenters believed that the NRC's Public Document Room would provide a means for unscrupulcus lawyers to find clients.
A number of the commenters who were concerned about " nuisance" malpractice suits might be content with the threshold for reporting diagnos*,ic misadministrations.
However, many others will be alarmed to find that reports cf misacministraticns to NRC are likely candidates to be reported to Con ress as Abncroal Occurrences (See Enclosure 7).
There is an important humane consiceration for safeguarding the identity of patients who are the subject of misadministration reports.
A study at the University of Southern California has found that many blue-collar workers stricken with cancer return to tneir jobs facing hostility frcm employers and cowcrkers.
This hostility was usually expressed by shunning, sarcastic comments, assignment changes and mimicry (in cases in which the voice is impaired).
Many ( 71oyers and employees wrongfully feared that cancer was contagious and would avoid the worker.
Both the proposed rule and the final rule instruct the licensee not to report the names of others involved in the misadmin.
ation, such as tne patient, physicians, and aliicd health personnel.
If licensees do recort the names of patients to NRC, the names will not be released to the public.
Value/Imcact:
The Value/Imcact Analysis is Enclosure 5.
One purocse of the rule is to icentify the causes of misadministrations in o-der to correct tnen and prevent tneir recurrence.
The ciner purpose of the rule is to inform patients of sericus misadministrations.
Misacministrations nave caused fatalities, Misacministratien reporting snould save lives by alerting NRC wnica can, as a minir.am, alert other licensees to pctential pecblems.
3cth the value and tne costs of the rule sncul:
te proporticnal to the umcer of reportable misacministraticns.
The misacainistration rule was ccordinated with the Agreement States.
As they have done in the past with similar imp 0rtant matters of puclic health and safety, we expect them to adept this requirement for tneir licensees.
Assuming cne minor misacministration per year at each Of tne 25C0 NRC medical licensees, the cost for recorckeecing, at 350 per record will be 3125,000 for NRC lic,nsees and about 3150,000 for tne 3,000 Agree-ment State licensees.
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Assuming 100 sericus misadministrations for NRC licensees per year at a cost of $750 per combined report to NRC, the re,' erring physician, and the patient, the cost to NRC licensees will be 575,000 for reporting serious misadministrations.
The cost to Agreement State licensees would be similar.
The reporting requirement in this rule may well increase the cost of malpractice insurance.
Tne amount of this increase is not known.
All of the increases in medical costs due to this rule will certainly be passed-on to patients.
The annual cost to NRC of reviewing licensee records of minor mi= admin-istrations and responding to the 100 serious, reportable misadministra-tions is 15 man years:
10 man years for I&E; 2 man years for 50; 1 man year ft? NMSS; and 2 man years throughout the rest of NRC.
This is the cost of investigaticn, preparing Abnormal Occurrence reports for Congress, ?reliminary Notifications, rule changes etc.
The cost to the Agreement States would be 1-2 man years per State.
GAO Recommendations:
In its January 1979 report (EMD-79-16) the General Accounting Office (GAO) reccamended that the Commission immediately require medical licensees to begin reporting all misadministrations to NRC and to the patient's physician.
They recommended that the Commission delete the requirement for patient notification and decide on it at a later date.
GAO noted the continuing and intensive medical ccmmunity cpposition to the patient notification and does not war.t this to delay the final rule.
Basically, GAO believes that requiring cedical licensees to report misacministrations to NRC is not an intrusion into medical practice.
They stated:
This is clearly consistent wita NRC regulatory responsibilities and a necessary part of an effective nuclear mecicine regulatory program.
'ditnout this kind of feecback en incicents affecting public health and safety, NRC cannet te sure it is aceauately regulating the possession and use of nuclear materiais in mecical practice.
The staff does not agree witt. GAC that NRC shoulc require rep:rts of all misacministrations.
Requiring licensees te keep records of all misacministrations and report these diagnostic misadministrations causing clinically detectacle adverse effects on patients, is acre rea-sonable and enforceable.
Also, the staff rec:Inends tnat the 00:mi3-sicn tackle the issue of patient notification of this time.
There is a trend in Federai legislation tcwar d recognizing the rignt of inci-vicuals to kncs infccmation about themselves contaiced in tne recorcs of institutions botn inside and cutsice of the Federal sector.
Exarples are:
The Privacy Act of 197~ ahich set rules for Federal agencies recordkeeping; the Fair Credit Reporting Act and related Acts wnicn 868 008 D
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gave consumers the right to know information accut themselves contained in the records of credit-reporting bureaus; and the Family Education Rights and Privacy Act which gave students the right to see personal records held by educational institutions.
In April 1979, the President sent the proposed " Privacy of Medical Information Act" to Congress.
The President said:
The " Privacy of Medical Information Act" is being submitted to you today.
It establishes privacy protections for information maintained by almcst all medical institutions.
The Act will give individuals the rignt to see their own medical records.
If direct access may harm the patient, the Act provides that access may be proviced through an intermediary.
This legislation allows 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.
There is a fine line between having records of misacministrations avail-able to patients and actually informing the patients of the misacmin-istrations.
A recurring theme throughout the public comments is the physicians' stated reluctance to inform patients of misadninistrations.
Issue 1.
Should medical licensees be required to report misadministra-tions to NRC?
Alternative 1.
Do not require misai'inistration repor'ing.
P"c:
(1) Responds to the vast majority of the public comments.
(2) Eliminatas NRC ir.tru;ien into the physician pacient relationsnip.
Con-(1) NRC will not be ttle ta identify the causes for misacmin-istrations sua nela correct them and prever.: their recurrence.
(2) Unresponsive to GAC's rec:mmencation and those ccmmenters that believe a misaccinistration reccrting requirement is necessary.
Alternative 2.
Require reporting of all misadministrations.
Pro:
('_) Maximum patier+ protection because NRC can investisate al' misadministrations regardless of severity.
(2) Responds to GAO's recommencation.
868 009 (3) Gives patients all the facts.
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Con:
(1) Requires substantial commitment of NRC resources if all minor misadministrations are investigated.
(2) Is a substantial burden on licensees.
(3) Will distress some patients e t of proportion to the risk.
Alternative 3.
Require reporting of e.y serious misadminist,ation:.
Pro:
(1) Responsive to many c0mments on both sides of the issue.
(2) Avoi s a large numcer of reports of minor misacministrations.
(3) Consistent with NRC's medical policy statement.
Con:
(1) Unresponsive to GAO's recommendation and those commenters who believe that all misacministrations should be reported.
(2) Is an added burden on licensees.
Issue 2.
To whom, besides NRC, should the licensee be equired to report misadministrations?
Alternative 1.
Do not require any reporting other than to NRC.
Pro: Eliminates NRC intrusion into the physician patier relationship.
Con: No assurance that patients or referring physicians will Oe informed.
Alternative 2.
Require the licensee to inform the referring pnysician.
Pro:
(1) Acce:ts current medical practice anc respencs t; :any commenters.
(2) Mininizes intrusier int: tne :nysici atian; relati:rsni::.
(3) Respcnds to GAC's rec:mc:endation not to let tre #iral rule get bogged dcwn over this issue.
Con:
(1) No absolute assurance that patients will be 'nformed Of misadministrations.
(2) Is less c0nsistent than Alternative 3 itn the trend rec 0gnizing the patient's rignt t0 be informed.
Alternative 3.
Recuire the licensee to inform t9e re'tr-ing 2.tysician anc :ne patient or a respcnsible relative (or guardian), miess tre referrirg physician objects.
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(1) Helps ensure that patients will be informed of misadmin-istrations.
(2) Consistent with the trend recognizing the patient's right to be informed.
Con:
(1) Introduces NRC as a third party in the physician patient relationship (maximum intrusion).
(2) Unresponsive to the vast majority of public ccaments.
Recommendation:
The Ccemission:
1.
Accrove a notice of a final rule (Enclosure) that would require medical licensees to keep records of all misadministrations and promptly report serious misadministrations to NRC, the referring physician and the patient or a responsible relative (or guardian),
unless the referring physician Objects (Alternative 1 of Issue 1 and Alternative 3 of Issue 3).
2.
Note:
a.
The amendment would be published in the Federal Register to be effective in 75 days; b.
All effected licensees and the appropriate congressional committees will be informed; c.
A public announcement such as Enciosure 2 will be issued when tne final rule is filed with the Office of ne Federal Register; d.
Clearance of the reco-ckeeping recuireme.its by ne General Acccunting Office will be obtainec prior to tne effective date of tne amencment.
Coordination:
The Offices of Nuclear Materials safety and Safeguarcs, Inscectica and Enforcement, State Programs anc the Division df Rules anc Recorcs concur in the recemcendation of this paper.
The Cffice cf tne Execu-tive Legal Director has no legal objection.
The Value/ Impact state-ment was reviewed by the Of' ice of Menagement and ?r gram Analysis.
The draft puolic announcement was prepared cy the Office cf Public Affairs.
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This paper should be scheduled at an ocen agenda session.
Robert B. Minogue, Director Office of Standards Development
Enclosures:
1.
F,
' Recister Notice of Effective Rule Making 2.
Drarc Public Announcemunt 3.
Proposed Misadministration Rule (43 FR 29297) 4.
Summary and Aralysis of Comments 5.
Value/ Impact Analysis 6.
Draft Congressional Letter 7.
Chairman's letter on A/O's 868 012