ML20236H854

Requests Commission Direction on Retaining Current Requirement for Medical Use Licensees to Notify Individuals & Referring Physicians of Medical Event,Per 10CFR35.33(a)(3) & (a)(4) & Capturing Precursor Events

ML20236H854
Person / Time
Issue date:	03/20/1998
From:	Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-98-054, SECY-98-054-01, SECY-98-054-R, SECY-98-54, SECY-98-54-1, SECY-98-54-R, NUDOCS 9807070390
Download: ML20236H854 (34)

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\,**..*/e RULEMAKING ISSUE (Notation Vote)

March 20.1998 se.uY-98-054 EOB: The Commissioners EEDJA L Joseph Callan Executive Director for Operations M JECT, COMMISSION RESOLUTION OF SIGNIFICANT ISSUES ASSOCIATED WITH THE REVISION OF 10 CFR PART 35, " MEDICAL. UGES OF BYPRODUCT MATERIAL" PURPOSE:

To obtain Commission direction on: (1) retaining the current requirement for medical use licensees to notify individuals and referring physicians of a medical event,' pursuant to 10 CFR 35.33(a)(3) and (a)(4); and (2) capturing precursor events.

CATEGORY:

This paper addresses significant rulemaking issues requiring Commission consideration and approval.

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' The Part 35 Working Group has replaced the term " misadministration" with " medical event," based on SRM - COMSECY-96-057, " Materia!s/ Medical Oversight (DSI-7) " March 20, 1997 (Attachment 1), in which the Commission said the staff should consider ". . . changing the nomenclature from 'misadmin!stration' to ' medical event' or comparable terminology." However, in historical discussions, the term " misadministration" is still used.

CONTACTS: Catherine Haney, NMSS/lMNS NOTE: TO BE MADE PUBLICLY AVAIALBLE WHEN (301) 415-6825 THE FINAL SRM IS MADE AVAILABLE Marjorie Rothschild, OGC l

(301)415-1633 l

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The Commissioners 2 BACKGROUND.

j The Commission, in its Staff Requirements Memorandum (SRM) of June 30,1997, SECY-97-115, " Program for Revision of 10 CFR Part 35, ' Medical Uses of Byproduct Material'

.and Associated Federal Register Notice," approved the staffs oroposed plan for the revision -

of 10 CFR Part 35 (Attachment 2). The staff implemented that plan by estabbshing a U.S. Nuclear Regulatory Commission Working Group and Steering Group, and by actively soliciung input from the public, the medical professional societies, States, and the Advisory Committee on the Medical Uses of Isotopes (ACMUI). The staff has benefitted from these l . interactions with the regulated community and the public and has received many useful L comments.

!. The Working Group considered the input from the public and the medical community in .

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, developing the "strawman" revision of the Part 35 rule that was placed on the INTERNET and in l - the Public Document Room on January 30,1998. That "strawman" ievision included: (1) the l' current requirements for notifying NRC, referring physicians, and individuals of medical events,

( because of the controversy associated with indFridual (patient) notification; and (2) a proposed i definition of a "significant precursor" (and related recordkeeping and reporting requirements).

DISCUSSION l

Notification Followina a Medical Event L The current regulations in 10 CFR 35.33(a) and (b) require, in part, that NRC medical use

- licensees inform NRC, the referring physician, and the individual receiving the misadministration (medical event) within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of its discovery, unless the referring physician personally -

h . Informs the licensee either that he or she will irrform the individual, or that, based on medical j judgment, telling the individual would be harmful Background information on 10 CFR 35.33(a) m, u and (b) is presented in Attachment 3.'

Staff is not requesting guidance on whether licensees should notify NRC of a medical event.

, Staff and licensees recognize that this notification is needed, at a minimum, for NRC to comply -

l- with Section 208 of the Energy Reorganization Act for reporting " Abnormal Occurrences" to f Congress. However, because of medical community and public comments, staff has been H evaluating whether the current regulations should be revised to require notification of NRC only,

- or of NRC and the referring physician.

The majority of the comments received on notification following a medical event (including those of two " patient rights advocates"*), indicated that there should Det be an NRC requirement for patient and/or referring physician notification in the case of a medical event. Individuals who

do not favor patient notification assert that there are no other areas of medicine in which there

~.8 However, a patient's right advocate at the ACMUI meeting on March 2,1998, expressed concern about the risk to the patient, if the patient or referring physician is not notified.'

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The Commissioners - 3 7

. is a Federal requirement for pat'iest notification and that an NRC requirement for patient notification is contrary to the 1979 Medical Policy Statement. According to some cf the ACMUI

' members and the NRC medical consuunt advising the Working Group, patient notification of medical events should occur as part of the patient-physician " fiduciary" relationship, in which it is the " standard of care" for a physician to provide the patient with complete and accurate

. .information.8 Members of the medical community have pointed out that they view the L

_ " fiduciary" relationship between the patient and physician as different from that between a licensee and an individusi receiving a dose in excess of the 10 CFR Part 20 limits. In addition, some members of the medical community particularly object to the requirement, in 10 CFR

~ 35.33(a)(l)-(ii), for licensees to provide the informed individual with a copy of the licensee's a report to the Commission (or a similar report), believing that the report greatly magnifies the l

. significance of the event when, in fact,- a medical event could be of minimal safety signif:cance.

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-Although patient (and referring physician) notification of medical mistakes or events is the

" standard of care," that practice may not be uniformly followed. Based on recent articles in a professional medical journal .and the national news media (Attachment 5), the issue of whether

physicians should notify patients of medical "evente" is the subject of considerable debate and

- is not at all well-settled. Thus, reliance on physicians to follow either the " standard of care" or the AMA ethical standards,' may result in patients not receiving information necessary for their

- medical care.'

Those opposing and those favoring retention of the requirement to notify the individual, referring

. physician and NRC agree that the issue is not whether patients should ha notified of medical events. Rather, the issue'is whether, in light of existing medical ethical and practice standards ,

.. obligating physicians to make such notifications, NRC should retain the provisions in Part 35 -}

requiring licensees to do so.*

j Staff has identified three possible attematives for notification of NRC, referring physician, and individuals, in the case of a medical event. Attachment 6 provides a detailed discussion of 1

- these attematives.

. Altemative 1: Retain the current reporting requirements in Part 35, with minor changes intended to clarify the term " responsible relative."

Altemative 2: Revise the' current reporting requirement to require a licensee to inform NRC and the referring physician (but not the patient) of the medical event. 1 i

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' 8 A patient's right to receive information from physicians is an element of the patient-physician relationship and is also part of " informed consent," based on American Medical l

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- Association (AMA) " Principles of Medical Ethics " (See Attachment 4)

I d if there is such a requirement, the Working Group / Steering Group agree that the rule

- should retain the provision permitting the referring physician to inform the patient and for the licensee not to notify the patient, if, based on medical judgment, telling the patient would be

- harmful.10 CFR 35.33(a)(3).

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i The Commissioners - 4 l

L Altemative 3: ' Revise the current reporting requirement to require a licensee to inform only NRC of a medical event.

On March 2,1998, the ACMUl voted 8-0, with one abstention, in favor of notifying only NRC l

(Altemative 3).

' Precursor Events Tne Ccmmission, in COMSECY- 96-057, directed staff to determine the best way to capture

!' T precursor events. Staff's objectives in capturing precursor events are to identify and analyze incidents that could lead to medical events, significant errors, or systematic problems that could

. have health and safety implications at the licensee's facility or at similar facilities.

Altemative pathways for capturing' precursor events were discussed with the ACMUI at the

~ September and March semi-annual meetings, and with the public during two facilitated public workshops (October and November 1997). In September 1997, the ACMUI recommended that i- NRC make reporting of precursor events voluntary. Participants in the facilitated public L

workshops, as well as members of the public, believe that: (1) there are already adequate

' mechanisms in place for identifying precursor events; (2) additional NRC requirements for

. notification of precursor events could result in a significant financial burden for both NRC and

. licensees, without an associated incremental increase in safety; (3) because of the nature of j precursor events, it will be hard to precisely define a precursor event in rule language; and I

(4) inclusion of a requirement for reporting of precursor events could lead to aa additional basis -

s for enforcement action.

!' Staff belicves that identification and reporting of precursor events at some level is warranted, given that a "significant precursor" may have future implications for that facility or for similar

. facilities (generic incidents), and thus such reporting could lead to improved radiation safety programs at licensed facilities.' Therefore, staff identified three possible attematives for capturing precursor events. Attachment 7 provides a detailed discussion'of these attematives.

Altemative 1: Revise Part 35 to require reporting of "significant precursors."

Altemative 2: Revise Part 35 to require reporting of deficiencies in equipment (hardware and/or software), byproduct material, or procedures supplied by a manufacturer or vendor that, in the opinion of the radiation safety officer, could lead to a medical L event at that facility or could have detrimental health and safety implications (L beyond the licensee's facility.

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' Altemative 3: Rely on current NRC reporting requirements in 10 CFR Parts 20,21, and 30, and the Memorandum of Understanding with the Food and Drug Administration and monitor / establish 's system with U. S. Pharmacopeia to review its database.

. On March 2,1998, the ACMUI voted 8-0, with one abstention, in favor of Altemative 2.

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l The Commissioners - 5

[ RECOMMENDATIONS:

L The staff is seeking Commission guidance on the preferred alternative for notification of -

p individuals and referring physicians of a medical event. This guidance is necessary because of -

the sensitivity associated with medical event reporting, the differences of opinion that exist among the staff, patient right's advocates, and the regulated community, and the fact that this is a major policy issue.

, Staff recommends that Alternative 2 be chosen as the preferred attemative for identification of L.

precursor events because it: -(1) clearly states the types of incidents and conditions that NRC needs to identify and analyze events and incidents that could lead to medical events, significant errors, or systematic problems that could have health and safety implications at the licensee's

. facility or at similar facilities; (2) requires licensees to submit reposts of precursor events; and (3) shouid not significantly increase the regulatory burden on licensees and the NRC.

j COORDINATION-i OGC reviewed this paper and has no legal objection.' The Office of the Chief Information Officer has no objection to this paper. The Office of the Chief Financial Officer has reviewed

- this Commission Paper for resource implications and has no objections; resources to implement ,

the rule will be considered in developing the FY 2000 budget.

i L. .J eph Callan Ex ive Director for Operations Attachments: DISTRIBUT70N:

1. SRM-COMSECY-96-057, dtd 3/20/97 - Commissioners Regions

2. SRM-SECY-97-115, dtd 6/30/97 OGC SECY 3.._ Background info on 10 CFR 35.33(a) and (b) OIG

! 4. AMA, " Code of Medical Ethics, Current Opinions OPA with Annotations"

' 5. ' Journal and Media Articles CFO

, 6. Notification Following a Medical Event goo E

17. Precursor Events ?

I' l . Commissioners' completed vote' sheets / comments should'be provided directly to~the Office oflthe Secretary by~ COB Tuesday, April 7, 1998.

Commission Staff Office comments, if any, should be submitted to the. Commissioners NLT. Tuesday, March 31,-1998, with an information copy to the Office of the Secretary.

'If the paper is_of such a nature that it requires additional review and comment, the Commissioners and the Secretariat.should be apprised of when comments may be expected.

' DISTRIBUTION:

Commissioners OGC:

OIG l-l4 L_______ 1 ________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Action: Paperiello/NMSS .!

Morrison, RES i

. p uo.% Cys: Callan  !

UNITED STATES p .. Thompson  !

, NUCLEAR REGULATORY COMMISSION Jordan

j. y wasamoToN. D.C. 205$5 0001  !

Norry Blaha

(% ***,#8 March 20, 1997 Bangart, SP l

SECRETARY Ross, AE00 l

l MEMORANDUM TO: L. Joseph Callan Execut've D* rector for Operations  !

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l FROM: Jo C. oy e, Secretary ,

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SUBJECT:

S AFF REQUIREMENTS - COMSECY-96-057 l MATERIALS / MEDICAL OVERSIGHT (DSI 7) l l

I With respect to the overall materials program, the Commission continues to support its preliminary views on this issue which were a combination of two options -- Continue the Ongoing Program with Improvements (Option 2) and Decrease Oversight of Low-Risk Activities with Continued Emphasis in High-Risk Activities ,

(Option 3). For the longer term, the Commission also believes I that consideration should be given to broadening NRC's regulatory oversight to include one or more of the higher-risk activities identified in Option 1.

With respect to the medical program, the Commission was not persuaded by the National Academy of Sciences, Institute of Medicine (IOM) report that recommends that NRC should not be the Federal agency involved in the regulation of ionizing radiation in medicine. The Commission continues to believe that the conclusions in the report were not substantiated and that the recommendations should not be pursued.

The~ Commission continues to support the use of ACMUI and professional. medical organizations and societies in developing regulatory guides and standards as was proposed in the Commission's preliminary views. In the longer term, the Commission would be willing to consider taking on broader regulatory responsibilities for higher risk activities involving other sources of ionizing radiation but such efforts should not divert resources from the 10 CFR Part 35 rulemaking discussed below.

i In lieu of a rulemaking plan in the context of Management Directive 6.3 the staff should submit a program for Commission approval for revising 10 CFR Part 35, and associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary. The program should describe how 10 CFR Part 35 can be restructured into a risk-informed, more performance-based regulation by a suspense date of 6/30/99. In developing the program the staff should consider the following:

Attachment 1

1 (1) Focusing Part 35 on those procedures that pose the highest risk.

(2) For diagnostic procedures, staff should consider regulatory oversight alternatives consistent with the lower overall risk of these procedures.

(3) The staff should address how best to capture not only relevant safety-significant events, but also precursor events.

Changing the nomenclature from " misadministration" to (4)

" medical event" or comparable terminology.

(5) Part 35 should be redesigned so that it can incorporate necessary regulatory requirements for new treatment modalities in a timely manner.

(6) The Quality Management Program provisions (10 CFR Part 35.32) should be re-evaluated and revised to focus on those requirements that are essential for patient safety, e.g., confirming patient identity, requiring written prescriptions and verifying dose. To the maximum extent possible, the requirements should be revised to be risk-informed. Given this objective, a mixed approach of performance-based rules and otherwise prescriptive regulations should be pursued.

-(7) The staff should consider the viability of using or referencing available industry guidance and standards within Part 35 and related guidance to the extent that they meet NRC needs.

(8) The staff should consider a rulemaking process that provides more opportunity for input from potentially affected parties than is provided by the normal notice and comment rulemaking process but would be less

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consumptive of resources and time than the process recently used in the development of NRC's rule on radiological criteria for license termination.

The staff's program to implement the above should be submitted to

'the Commission for its consideration no later than June 6, 1997.

The program should target June 30, 1999 as the date for completing the rulemaking process. This rulemaking and associated guidance development is a very high priority for the Commission. The Commission is prepared to provide additional resources to the extent necessary to complete the rulemaking process on this schedule.

(NMSS/RES) (EDO - Program) (SECY Suspense: 6/6/97) 9700065 (NMSS/RES) (ENx) - Complete Rulemaking) (SECY Suspense: 6/30/99) 9700065

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cc: Chairman Jackson Commissioner Rogers l- Commissioner Dicus.

l- Commissioner McGaffigan l :.

. Commissioner-Diaz K..Cyr l D. Rathbun l .

H; Bell l1 ~A. Galante-R. Scroggins l- W. Beecher

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- Action: Paperiello, NMSS

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- k UNITED STATES NUCLEAR REGULATORY COMMISSION Cys: Ca an g WASmNGTON.OC 20555-0001 g

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• • • • • Thadani, RES OFFICE Of THE gangart, gp 8'C"*"' She1 ton, CIO Meyer, ADM CHaney, NMSS SWoods, NMSS MEMORANDUM TO: L. Joseph Callan Exec 'v 2D' e tor for Operations C

FROM: John . Hoy e, Secretary

SUBJECT:

I ITAFF REQUIREMENTS - SECY-97-115 - PROGRAM ".

FOR REVISION OF 10 CFR PART 35, " MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE The Commission has approved the staff proposal to revise 10 CFR Part 35 consistent with the alternati"e program proposed in SECY-97-131 and subject t.o the following comments.

1. The staff should not only consider what regulations will be affected by the change to Part 35, but should also take a close look at existing guidance and draft guidance to determine what changes would be needed. To ensure that all regulatory rulemaking and guidance development potentially affecting medical uses will be consistent with the Commission's direction in DSI 7, the staf t sho 11d identify in the public meetings and Federal Recister notices all regulatory actions and proposed actions relating to or affecting Part 35 licensed activities. When appropriate, public comment should be 2.ivited.

2. The staf f shoul d continue to solicit input from members of the p-alic to ensure, to the degree possible, that all interests are represented. The staff should include groups representing radiopharmacists and medical technologists, and other experts, as appropriate.

3. The staff should prepare alternatives with specific rule text to help focus the discussion during the first-round of facilitated meetings and assist the staff in developing draft rule language for publication and comment.

SECY NOTE: SECY-97-115 WAS RELEASED TO THE PUBLIC ON JUNE 17, 1967. THIS SRM, SECY-97-131, AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL '

COMMISSIONERS HILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.

Attachment 2

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4. The staff should look for potential resource savingscan be achieved th consultants, and funds) that In making documents the.internet, teleconferencing, etc.

some caution should be available over the internet,the. number of and versions of exercised to ensure that are not so large and varied available' documents for comment that they'will overwhelm commenters and lead-to confusion responsible for the on

' the part of,the staff and management rulemaking.

" A Federal'Reaister notice and press release shouldattachments be. issued 1 reflectingcthe approach outlined in SECY-97-131,the. facilitated public ,

and 2, and published in ,,t-ime to suppiort 4

. meetings. .

(SECY Suspense: -9./5 /S.~L) 9700065

-(4904- (NMSS) 8/29/97 cc: Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Dia2.-

Commissioner..McGaffigan OGC CIO~

CFO OCA OIG.

= Office-Directors, Regions, ACRS,.ACNW, ASLBP (via E-Mail)

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l BACKGROUND INFORMATION ON 10 CFR 35.33(a) and (b)

The provision for notifying patients or the patient's " responsible relative" of a misadministration has been a feature of the misadministration rule since it was first proposed in 1973. " Medical Uses of Radioisotopes (Byproduct Material)," 38 Fed. Reg. 6399,6400 (March 9,1973). . That proposed rule would have required medical use licensees to report to a patient (or responsible relative) a misadministration that could cause ". . . a demonstrate; adverse effect, unless in the l physician's professionaljudgment, such notification would be contrary to the best interests of

, the patient or a surviving relative of the patient." 38 Fed. Reg. S400,6401. No explicit l- explanation was provided in the Statements of Consideration (SOC) of the purpose of such a requirement. However, the Commission's discussion of an exception in 10 CFR Part 20 for intentional exposure of patients to radiation for medical purposes and Part 20 requirements for reporting radiation exposures to other individuals, implied as a goal, achieving consistency between reporting requirements in Parts 35 and 20.8 Specifically, the Commission cited former  !

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10 CFR 20.107 (1973), which provided that nothing in the regulations in Part 20 ". . . shall be interpreted as limiting the intentional exposure of patients to radiation for the purpose of medical diagnosis or therapy." Based on former 10 CFR 20.107, notifications had not been required l ". . . of incidents involving the exposure of patients to radiation if the patient were receiving any intentional medica; exposurs." 38 Fed. Reg. 6399-6400. According to the Commission, since the incidents involving medical exposure that had been brought to its attention ". . generally involved accidental or erroneous exposures of patients to radiation in amounts or forms other than intended, it does not seem appropriate to continue . . . not requiring reports of such

, - misadministration to patients." 38 Fed. Reg. 6400.

The Commission withdrew the 1973 proposed rule in 1978 (citing as a reason the passage of a r

five-year period) and proposed new misadministration record keeping and reporting requirements. It changed, without explanation, the threshold for reporting a diagnostic misadministration to NRC, to the patient's referring physician, and ue patient's responsible relative. " Human Uses of Byproduct Material, Misadministration Reporting Requirements," 43 Fed. Reg. 29297 (May 7,1978). The threshold of "a demonstrably adverse effect" became a

" clinically detectable adverse effect." 43 Fed. Reg. at 29297-98. Noting that a purpose of the

'10 CFR 20.405(c) (1973) required that "Any exposure of an individual to radiation which is required to be reported to the Commission shall also be reported to the individual." This provision has been carried over in current 10 CFR 20.2205, " Reports to Individuals of exceeding dose limits," under which, when a licensee is required, pursuant to 10 CFR 20.2203, I

~ 2204, or 20.2206, to report the Commission any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material,

. the licensee shall also provide a copy of the report submitted to the Commission to the individual.

210 CFR 20.1002 states the scope of present Part 20 as not applying ". . . to doses due

' to background radiation, exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with (10 CFR] $ 35.75, or to exposure from voluntary participation in medical research programs."

Attachment 3

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3 misadministration rule ". . . is to inform the patient or a patient's responsible relative so that corrective action can be taken," the Commission expressed ". . . concem about the possibility of

undue intrusion into the patient-physician relationship." 43 Fed. Reg. 29297. Consequently, ,

the Commission specifically sought comment about 'those pcrtions of the proposed 1 amendments which deal with the manner in which referring physicians and their patients are informed of misadministration." M.

Ninety percent of the comments were opposed to the proposed rule, with most citing it as (j "... . an unprecedented intrusion into medical practice." Misadministration Reporting i Requirements," 45 Fed. Reg. 31701 (May 14,1980). A majority of the commenters who opposed the rule were opposed to the requirement for reporting diagnostic misadministration to patients. 45 Fed. Reg. at 31703. The Commission determined that the threshold of a

" clinically detectable adverse effect" in the proposed rule for reporting a diagnostic misadministration was a " moving target" and ". . . not well understood in the medical community.".43 Fed. Reg. at 31703. Therefore, in the final rule, although the Commission required licensees to report to NRC all diagnostic and therapeutic misadministration, it required that only therapy misadministration be reported to the referring physit.,lan and the patient or a responsible relative.' M.

. Many of the objections to the patient notification provisions specifically addressed by the . ,

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' Commission (as described above) have been raised again over the years, and those objections', as well as the Commission's response, warrant discussion here. Although the Commission recognized, in promulgating the rule in 1980, that the misadministration reporting requirement may be unique to medical practice, ". . . it is necessary to protect patients." 45 L Fed. Reg. at 31702. The Commission also recognized the rule's intrusion into the physician-patient relationship ". . . in the sense that the rule does affect, to a limited degree, the nature of the physician's obligation to his or her patient." M. Noting that some physicians supported the

. rule, the Commission did not, however, believe that objections warranted hbandoning the rule.

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'The Commission explained that:

[Ilt is expected that the licensee would report to the patient's responsible relative rather than the patient when, for example, the referring physician tells the licensees that in his medical judgment informing the patient would be harmful to the patient; the pehm r, . minor; or the patient is unconscious end incapable of comprehending the intertbn.  !

L 43 Fed. Reg. at 5237;

• The Commission also made two changes to tha rule regarding patient notification of the patient or " responsible relative": First, it added a p:renthetical "(or guardian)" to " responsible

. relative" to cover persons who do not have relatives. 45 End. Eng. at 31704. Secondly, as amended, the rule would permit referring phys lcians, if they wish, to inform the patient of the misadministration. .ld.

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As explained by the Commission:

The " physician-patient" relationship is a concept that was developed to advance the needs of the patient. The relationship involves duties of reasonable care and skill, confidentiality, and good faith owed by the physician to the patient. Nothing in the rule would detract from these duties. Thus, in a strict

!. sense, the rule would not interfere with the relationship.

M.

As to the comment noting the lack of a similar requirement in aspects of radiation medicine not L regulated by the Commission (e.g., x-rays, accelerator-produced isotopes), the Commission l stated that it ". . . must operate under the assumption that Congress intended a j

-disproportionate degree of Federal regulatory control be exercised over nuclear materials as i opposed to . . . other sources of radiation." 45 Fed. Reg. at 31702. As the Commission pointed l l out, the U.S. Nuclear Regulatory Commission was not the only Federal agency with requirements or policies to which the medical community objected on the ground of l l unwarranted interference in the physician-patient relationship. M. According to the  ;

l Commission, the Food and Drug Administration (FDA) had recently rejected an objection on that basis to its request for assistance in developing a policy on labeling of prescription drugs to promote patient understanding of drugs prescribed for them. M. The FDA determined that patients have a right to know about a drug's benefits, risks, and directions for use. M.

Although the Cortmission acknowledged possible truth to the comment that the patient notification provisions would invite unwarranted malpractice suits and thereby boost medical costs, the Commission stated that ". . . there is nothing in the rule that would in any way modify

- the legal rules goveming malpractice suits arising out of misadministration." 45 Fed. Reg.

at 31703. "The requirement . . . to report therapy misadministration to patients or a

responsible relative itimportant." 45 Fed. Reg. at 31702. " Patients have a right to know when they have been involved in a serious misadministration, unless this information would be -

l harmful to them." M. The Commission's response also cited ". . . parallel requirements for l ' licensee reports to workers on occupational overexposure" and the trend at the time in Federal legislation recognizing the right of individuals to know information about themse;ves that is contained in the records of institutions both inside and outside of the Federal sector." Fed.

. Reg. at 31702-03.

In a major revision of 10 CFR Part 35 (effective in 1987), the Commission changed the 4 misadministration rule to require a report to NRC and the referring physician for a mbadministration resulting ". . . In a dose to a patient greater than the dose to a member of the public permitted under (former) 10 CFR $ 20.105(a)." " Medical Use of Byoroduct Material,"

51 Fed. Reg. 36932, 36942 (October 16,1986). The Commission responded to renewed objections to misadministration reporting by agreement with assertions that the misadministration rate for radiopharmaceuticala is much lower than that for other drugs, that there is no reporting requirement for non-Atomic Er.ergy Act radiopharmaceuticals and other

. drugs, and that the risk to patients, workers, and te.c public is small. 51 Fed. Reg. at 36942.

! Nevertheless, the Commission concluded that ". . . the fact that there are other greater potential hazards found in the medical arena docs not relieve NRC of its responsibility to assure public

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health and safety as it may be affected by material under its ju.isdiction." 11 The Quality Management rulemaking retained provisions for patient notification of misadministration, but added events of arguably lesser significance (" recordable events") for which reporting to NRC or others was not required. " Quality Management Program and

- Misadministration," 56 Fed. Rcg. 34104 (July 25,1991). In proposing to retain the patient notification provisions, the Commission reaffirmed the two primary purposes of those provisions, discussed above: (1) to effectuate the rights of patients to know about misadministration unless that information would be harmful to them, and (2) to achieve consistency with parallel requirements that NRC licensees report to en individual certain .

radiation exposure data pertaining to that indivkfual. " Basic Quality Assurance Program, Records and Reports of Misadministration or Events Relating to the Medical Use of Byproduct Material," 55 Fed Reg. 1439,1444 (January 16,1990).

. Most recently, as part of the " wrong patient" rulemaking,' the Commission amended the definition of " misadministration" in 10 CFR 35.2, and the reporting requirements in 10 CFR 35.33 to substitute the wo d " individual" for the phrase " patient or human research subject." 60 Fed. Reg. at 48624. .(The latter term had been added in another rulemaking' to reflect inclusion of research subjects in the definition of " medical use" in 10 CFR 35.2). The Commission noted that if a misadministration occurs because the material was administered to the wrong individual, there may be no referring physician, in which case the licensee is relieved of complying with that portion of 10 CFR 35.33. Id. However, the licensee must comply with all other requirements in.10 CFR 35.33. _ld, i

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8 " Medical Administration of Radiation and Radioactive Materials," 60 Fed. Reg. 48623, (September 20,1995).

' " Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use," 59 Fed. Reg. 61767 at 61772, 61781, 61783, (December 2,1994).

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American Medical Association Physiciata dedicatedto thehealth of America $ l j

r Council on Ethical and Judicial Affairs 1996-1997 Editwn _

Code of l Medica Ethics

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Current Opinions with i Annotations L i

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Attachment 4

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1 Fundamerital Elements of the '

Patient-Physician Relationship From ancient times, physicians have recognized that the health r,nd well-being of patients depends upon a collaborative effort between physician and patient.

Patients share with physicians the responsibility for their own health care. The patient-physician relationship is of greatest benefit to patients when they bring medical problems to the attention of their physicians in a timely fashion, provide information about their medical condition to the best of their ability, and work with their physicians in a mutually respectful alliance. Physleians can best '

contribute to this alliance by serving as their patients' advocates and by fostering s these rights:

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1. The patient has the right to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment altemadves. Patients should receive guidance from their physicians as to the optimal course of action. Patients are also entided to obtain copies or summaries of their medical records, to have their questions answered, to be advised of potential conflicts ofinterest that their physicians might have, rad to receive independent professional opinions.

2. The patient has the right to make decisions regarding the health care that is recommended by his or her physician. Accordingly, patients may accept or refuse any recommended medical treatment.

3. The patient has the right to ecuttesy, respect, dignity, responsiveness, and timely attention to his or her needs.

4. The patient has the right to confidentiality. The physician should not reveal confidential communications or information without the consent of the patient, unless provided for by law or by the need to protect the welfare of the individual or the public interest.

5. The patient has the right to continuity of health care.The physician has an obligation to cooperate in the coordination of medically indicated care with other health care providers treating the patient. The physician may not discontinue treatment of a patient as long as further treatment is medically indicatad, without giving the patient reasonable assistance and sufficient opportunity to make alternative arrangements for care.

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_E8.27.199c 18 31Pr* ETHICS ST'ANDEDE NO.967 G.4/'

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i t fi. The patic t has a basic right to have avalfable adequa:e health care. Physicians.

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along wi the rest of socie:y, should continue to wctk toward this goal. Fulfill-ment of dls right is dependent on society'providing resources so that no patient is deprived af nr.cessary care becauss of an nabili:y to pay for the care. Physicians

, should cc ntinue their traditional assumptilon of a part of the resp

medical care of those who cannot 2%rd essential health care. Physicians should 3- advocate crpatients in dealing with third panies when appropriate. ,

l Report o the Conocilon Ethical andJudi'eiel Affairs of the American Medical Association. I I l i

4 OriginaD;' adopted June 1990. Updated Jt ne 1994. .  !

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TEB.27.199 is32Pr- ETHICS STSADCADE NO.98' 3.5/ l l

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-Il , l l l This opinion does not address contractual assignments ofliability between  ;

eitployers or in research arrangements, nor does it address government indemnifi-g citioa plans. (II) l

} Issued June 1992.

M }fpdated Iune 1994. ]

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E 8.08 Isfonned Consent The patient's right of self-decision can L T 2tively exercised ' 1 A only if the patient possesses enough information to enable an intelligent choice.

W 'I;he patient should make his or her own determination on treatment. 'Ihe l 7 physician's obligation is to present the medical facts accurately to the patient or to j

,the individual responsible for the patient's care and to make recommendations for l

=m management in accordance with good medical practice. 'Ihe physician has an .

e'thical obligation to help the patient make choices from among the therspoutic Y alternatives consistent with good medical practice. Inforened consent is a basic social policy for which exceptions are permitted: (1) where the patient is uncon-

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scious or otherwise incapable of consenting and harm from failure to treat is imminent; or (2) when risk-disclosure poses such a serious psychological threat of q j "f  ;

-- - I detriment to the patient as to be medically contraindicated. Social policy does not 1

--_! a'ecept the paternalistic view that the physician may remain silent because divul-M g'euce might prompt the patient to forgo needed therapy. Rational, informed jj j 7 isatients should not be expected to act uniformly, even under similar circum-stances, in agreeing to or refusing treatment. (1, II, III, IV, V) j w [ i

- Issued March 1931, l

W. Va,1993 W st Virginia Bosrd of Medicine received a consplaint from patient that physicisa i 6

a was using depossenion treatment. The hearing examlaer in part found that there had been a lack i j

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ofinformed consent for such treatment.The Board changed the examiner's report and added + j

-- snacdons. In doieg so,it quoted Opinion 8.08. On appeal, the circuit court revened, finding the j Bosrd's order arpitrary and an abuse of d!scretion.The appeutte court agreed that the Bond w obused its discretica, but ternanded the case for consideration of the issue of Informed consent

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fct dispossession tr:stment Modi v. West Mrginia Board ofMedWint, 463 $.E.2d 230,236. .  ;

joannal IMS Observes that physicians are unable to obtain informed consent because they can '

not guess which trearmant alternadves will best serve an indivMual patient's interests. Suggests 1 that this situuion would be improved if padents were paired with physicians who share their

- . personal values. Quotes Optalon 8.08. Voatch, Abandoning lefor=wd Consent, 2J Nastinkt ,

Center Rep. 3,6 iMarcWApril1995).

) 6 Journal 1M4 Discusses how physicians historically have taken too much licenso with patients' , i podies and placed g+ eater value on longevity than on quality ofilfe. Argues that pntients should }

be the ultimate decisionmakers in matters thrt effect ttair lives. Suggests thas greer emphuis , ,. i should be glien to physician dintosure abu gadons in order to improve the quality of patient 't j eensent. Quotes Opinion 8M (1981) (now Opinion 8.08). Katz, Infamed Contant - #ior It 3 i Atmain a Fairy Talt!101 Constmp. Health L & Pol'y 69,' 30 (1994). i Iournal1994 Reviews the evolution of the physidan.patientreisdens dp.Describalesn1 'i I

' onses to inersasing awareness of the importance of ensuring patient wtenorny. Examinet changing health care delivery environment. Concludes with n. discuulon of the linpact of 2

}hese changes on ps: font panhipation in medical decision making Quotes Preamble, Principles 7l l I, !!,III,IV, V, and VI, Fundamental Elements (1) and (2), and Oplafons 1.02 sad 8.01 (1981) .

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perdeipatingin capitalpunishment In plaec of any pracuce of a: rive voluntary euthsensia, recommends increased use of hospices, greater emphasis on training physicians to care for the dying patient, and further research aimed at producing symptee:stic relief in dying patients.

Cites Opmiens 2.06,8.10 (I916)(cow Opinion 8.11), and 9.06. Shewmon, Active Wlantary Euthanasta:A Nesdkn Pandora's Box. !!ssues in f.aw and Med. 219, 220, 222, 249 (1987).  ;

Journa11986 Addresses the problem cf " patient dumping" and explorus the various reasons underlying this practice. Examines spplicabla ecmmon law and s:atutory law, emphasir.ing the '

antidumping provisions of COBRA. Weaknesses in this federal 1:gislauve scheme are high-lightad and recommendations for strengthen!ng the statute and maximir.ing access to emergency medical care are offered. Quotes Principle VI and Opinion 8.10 (1986) (now Opinion 8.11).

Note, Preventing Patient Durnptng: Sharpening the COBRA's Fann 61 N. y. (J. L Rev ))86, 1189-90 (1986).

3.115 Termination of the Physician. Patient Relationship. Physicians have an obligation to support continuity of care for their patients. While physicians have the option of withdrawing from a case, they cannot do so without giving notice to the patient, the relatives, or responsible friends sufficiently long in advance of withdrawal to permit another medical attendant to be secured. (I, VI)

Issued June 1996 (formerly included in Opinion 8.11).

Mass. Super.1993 Plaintiff sought to enjcin d:fendant-physician from contacting padeau whom defendant treated while employed wl'h plaintiff. The court denied the injunction, noting that under Opinion 8.11 (now Opinion 8.115] defendant has a duty to noofy his patients befom withdrawing from a case and an injuneden would force defendant to choose between violating professional ethics or violating a court order. Plastic Swgical. ervs. cf New England. P.C. v.

Hall,1993 W1.818697.

8.12 Patient Information It is a fundamental ethical rec;uirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical stams and to be free of any mistaken beliefs concertung their conditions. Situations occasionally occur in which a padent suffers significant medical complications that may have resulted from the physician's mistake orjudgment. In these situations, the physician is ethically required to info:m the patient of all the facts necessary to ensure tmderstanding of what has occurred. Only through full dist.losure is a patient able to make informed decisions regarding future medical care.

Ethical responsibility includes informing patients of changes in their diag-noses resulting from retrospective review of test results or any other information.

This obligation holds even though the patient's medical treatment or therapeutic options may not be ahered by the new information.

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Concern regarding legal liability which might result follov/ing truthful disclosure sheuld not affect the physician's honesty with a patient. (I,II,III,IV) f Issued March 1981.

T Updated June 1994.

I Mina.1970 Defendant-physician appealed order to answer intstrogatorics, claim!ng that n l medical malprecuee plaintiR is prohibited from compelling expert tutimony from a defendaar to pteve a charge of ms3prsetice wisout calling other medical witnesses. In holding that a 1

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MAR-05-1998 10857 P.02 ]

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American Medical Association Principles of MedicalEthics '

j Preamble:

The medical profession has long subscribed to a body ofeddcal statements developed primaruy for the benefit of the patient.,As a member of this profession.

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a physicla'n must recognize responsibility not ordy to patievs, but also to . so to othe': health professionals, and to self. The following Principles adopted by the l Am% Medical Associadon are not laws, but standards of conduct which j j

l define the essentials of honorable behavior for the physician. 1 l

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A physician shall be dedicated to providing competent snedical service with  !

compassion and respect for human dignity. j!

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' A physician shall deal honestly with patients and colleagues, and strive to expose those physicians def5clent la character or competence, or who engage in fraud or l deception. "

i IIL A physician shali respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best laterests of the patient. )

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IV.

A physician shall respect the rights of patients, of colleagues, and of other health l l professionals, and shall safeguard patient confidences within the constraints of the

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L V.  ;

A physician sus!! continue to smdy, apply and advance scientific knowledge, make relevant information available to patients, colleagues, and the public, obtala e

consultation, and use the talents of other heahh professionals when ladicated.

l VL Aphysician shall, in the provision of appropriate patient care, except in emergen.

cies, be 6ee to choose whom to serve, with whom to associate, and the environ.

. . ment in which to provide medical servicosi l'

.VIL L

A physician shall recognize a responsibility to participate in activides contributing to_ animproved commun'ity.

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. C(C-10-87 14:11 Fros M 2 LEVIN CC 2024347490 T-953 P 02/02 hb-M ras new vann rmes HEAU H weson, cu g Doctors Urged to Ac mit Yistaxes '

B) DENi$E GR aDY g@#J ttl3tamhtpa with paltritA. i

' .i,m, ..outon1 cama et sumg b4-e Of blame th @lswhere cuuntry fueled by N

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the titegat nn prucess. we have people whri fer! It tir trasi wh vio-i HEN dc<taf % mee a m.s lated fee! tantrayed, and 4 tawian to L44-ntily %4meone at fault whD wdl then pay esart.isantly. makse si difft-takewhpuld they that herms tell tne a patient, pattunt rney get the sevni truth " bile tM tely the way to cwt to wa'ut out and finge yourself,"

what happened, apolegue and do Dr Dickey said "If you oo. you're whatever it t&5 to repair the darn- c4 schoolin Dr Wu.whograduttedfmm 1984, said be has neer mede playtria roulene The panent may age, resurefwrs tare urgmg, in a been wed say, *Cee, doc, thanks, tant took si,ance that is drewmg mixed re. One of bre co sumers. D* Sver' gruas courage and I won't take yni to v>ews from tne medical community, McPitu, da mtermst and protmor emon> aus even is one partent feels ensurance con:panies and lawyers of medietne at rhv University of Cah. that way there will be others,f amily The advice to come clean, in an forrwa n saa s'aue.eoe, eescritne a members and lawyers, who may on. i j

arttde an the current issue of The es e ut wNch nas f alk,re to orcer amucs" t.outsp panents to charge their i

y. Journal of General Interul Medi. sertata bbod test led to a lengthy Jack Pope. commualeations diroc.

eme. u offered by a team led by Dr.

Albert Wu. an mtermet and asadan te deley

• d'*ewns premochromato. ter for tier Pvtysselan insurars Asso. l j

professor at the Johns Hopkuss clation d America, taad that urgtag Schoolof Pubhc Health an Balumore clectors to confM t. heir restakes  !

Dr. Wu and has colleagues have c was "asking them to commit prtLfes. i i'

been advocatmg greater honesty stonal slutXIe " Without tort reform pabout medie t errers since test, to daeressa the nwnber of malprac.

whett they published a study shrang uc'e suits and large settlements, he that doctors in tranning ai thrse latge said. few dcernra could risk owmag reachina hospitats often kept serious 9 se errero. I i

mistaats 60 themselves: only half Wape $sndaar. teneral counsel I discussed mistakes wuh senior dec. for MMI Compemes lac., an msur-tota. end just a quartar told patients or their f amilies what had occurred. doctor out there saying. 'On,1 did At/ance provider, said De errors, which led to dlness and ' " its a latna hard for these of us who even death, includad massed or do. write the insurance."

layed diagrioses, mcorrect drug pre. Mark flathe. a lawyer unt! execu-scriptions and surgical rnistehet 4 *,*** t#we director of theysteenet Pminat There is still great reluctance in ks'ery Foundauun, aTETfTsunded g the medical pcotessten to admit mis- ,

f Di'vuriWe7F/%e A.M A said "If teet Dr tr.: said even thouah e:A you tell the twP. apologias and ses manuals have long called for dis. (_

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• p reach out to a family in grief, you can i closure. "Most medical whools do defuse samt of the a0ger Md polar- l not have shis sert of sharig in tricir

>g. inatten that ce,aransetze a typical curriculum," he said, acknowledgitig j '.awnft. But every word you citer is l that doctors, not unreasonably, mdy ,

% ao admisoon that can tse used fear that tahmg @e blame WI leave ~. age!stst you in a tourt of law "

Ibem open 10 lawsuits and hurt their Mr. Hathe sand that most mal o , ,'

reputations and careers. practice trwrance policles matruck Even so. Dr. Wu ssJd, there are g -

coctors rw to admit fault to patientA ,

g compelling reasvts fer telkrig p.> W e* * '" * "" M 1**" without first consulting the msur- 1 ante company tir their hospears tients to tne 00," he sadtruth "It is the The doctor panentright thing Dr Albert Wu seys adsmt13r.g lawyer. Dften hu said, lawyers then relahonship ts based on trust, he medical ettors is right and smart order doctors to say norhlag untd t!!

said, and morally and ettucally, a ele facts have been determaaed '

onctor's hrst responsibility in to act sis, a disorder in which prornpt trest. ht an the meantime, the patient m the patients best mterest Peop:e ment is very iciportant The patient may feel left in the dark, wor'dering who have bevn harmed have a rtght happened to tse a lam'yer. wut is goeg or "They want to know to know what went wrong, so they do m can smata how much I

, .g g g,, bM not worry that a sotback means their sweated tefore talkmg to him. Dr. denly not t.alking to them, and why health is f aihas, erhen the cause wes M8 Ph** *** ' l *d*'" # 1 * *8 g,rt,seces the hespnallawyer or festly a medical error wrong but was very sorry,'and there mm ' a ma g in addition. Dr. Wu said, such pa. wm consynces to ham that we d .m.h'sep e N ee @

asents may need estra treatmefW to be able to deai e-remedy the mistaae, as well as pay. To Dr. McPhee's immense rettet.

. ment of medical espannes and, pot,ss.

i thethat padent sa)d, "That's that the0doc-K." add- ggs n bly, tempensation for their injury mg he understocd g#pp{gggjgggj Only m the rarest lastatices, as tor could not thmk of everythths.

when a depressed partent could be.

cume incapacitated by bad neocc, ficultDr McPhee conver86 tion tesaid.

havt, no"It's que&a very dnh gy1g {Or dng ,

might it be Jusedtable to withhold tion. But medicarw is a human enter. g mformation about a mistata, Dr. Wu prise, and errors are part er amaing On eSS).

and nts colleagvo said human "

Leveling with the panent can be Dr. Wu said that other doctors' good for the doctor, too, Dr Wu sad reactions ta hee advise have varare. to put between a patet aruf m alA notmg that onctors who have harmed *1 get everything from total agree- care provider, but sometimes (* Ne pathmts 8tterally feci great guttt ment to laughter wluch is often a ara reasona to do it."

4Ad distress. "In some cases. d. sew utile sortem, se more cynscal cofh* Dr. h rd M ee& W cime ure is the only way the physician mettes wtuch basically imply that the article and an mternist and medical

{ can be absolved." he said Telling the woria needs to change first," he s ad echtetst at me mwewy of Cah-( truth snay also utengthen patients' Some, Dr. Wu sad tamk ins "in the nta at h hetico, said: "Thue f aith m the doctor's antegrity and real world,if you wert to adopt thts kre other consitjeretions than enal.

k thu seitegood mspite wdt. etten

- as they whde de- a cover may uprippec posture, you'd have your throat practice concerns that cusm te be out by ravenous hergators" armer patients and just make them part of this dectsdirt !f you take Dr f4ancy Oschey proudentelect seriously the Elca that physicians more also mcimedluries omagonise to sue. Cover ups may of the American Medical Assocta. have a very strong obhgation to act "There's a bit of folk wisdom, that . tion, said that in his call for the truth, in the best interest of patients, tre i "I betteve Dr. Wu 13 probably at lea st really should be fxusmg on the Dest some doctors never get sued." Dr substantially right.

Wu 6aad "Those thas nave realty interem at petsema, rhot our uwrt and "The problem is that the chmate not those of frw instdution" Attachment 5

Journal of General Internal Medicine, Volume 12. December 1997 JGIM -

PERSPECTIVES '

l To Tell the Truth '

Ethical and Practicalissues in Disclosing Medico! Mistal:es to Patients l Albert W. Wu. MD. MPH. Thomas A Cavanaugh PhD. Stephen J. McPhee. MD.

! Bernard lo. MD, Guy P. Micco, MD I

L whac moonughting in on emergency room. a resident ttsk management committee, rather than to the padent.

, physscion evaluatert a 3S speor old woman who was 6 More recently, the Americar} College of Phystetons Ethics moruns pregnant and municining of a heodoche. D' pnuwon diagnomt n mi.ml senuownus heocache ' Manual states. ' physicians should disclose to patients in-

• rhe panens resumed so stw Ett 3 days fater with an in- formation about procedural and judgment errors tnade in I

tracerebral hiced. presumouy refored so cefampsio. and the cearse of care. If such Information significantly affects

, ,.<g the care of the pallent. e The AMNs Cou cil on Ethical and Judicial Affairs states. ' Situations oc sionally occur in whleh a patient suffers significant me lent complica.

tions t. hat may have resulted from the phy ician's mNtak iTare humanum est: *to err is hurnan.' In medical orjudgment. In these situations. the phys tan is ethicall practice. mistakes are common, expected. and under required to inf3rm the patient of all facts necessary in e sta ndable. ' 8 Virtually all practicing physicians have surc understar. ding of what has occurred."

marle mistakes, but physicians often do not tell patients In this article, we analyze the various ethical arg or famihes abaut them? Even when a definite mistake ments for and against disclosing serious mistakes to results in a serious injury the patient often is not told, in tients. We also provide practical sugger.tlons for how to l.

onc study, house officers reported telling their attending discuss the sensitive topic of mistakes with patients.

phystesans about serious medical mistakes only half the time. and telung the patients or famlues in less than a l_ qunrter of cases.3 Highly publicized cases of fatal mts. WHAT IS A MISTAKE?

takes have heightened public and professional concems We define a medical mislake as a cornmission or n about how physicians and hospitals respond to serious omission with potentially negative consequences for the mistakes. When misiskes are not acknowledged in n patient that would have been judged wrong by skilled and Hmely manner, there may be n pcreepuon of a cover up-luiowledgeable peers at the time it occu Ted, independent and pubhe confidence in phystrians may be undermined.

of whether there were any negatire consequeneca. This The Amedcan Medical Associatioris (AMNs) Prince definition excludes the naturns history of diseas,! that plus o/ Medical Ethies 09571 states that a physician musi does not respond to treatnvnt ara the foreseeable com.

report an arcident. Injury or bad result stemming from pbcanons of a correctly perforroed procedure, as welt as his or her treatment.* However, many physictans inter.

enses in which there is reasonable disagreement over pret these requirements to meart that they should repo'1 whether a mistake occurred

' to thett auperiors or to the hospital qualRy assurance or We categorize errots according to their genesis. Sys.

tern errors, alsa referred to as latent c Tors.2 ditive prtmp Ily from flaws inherent in the sysicm of medical practice.

l Received from she Department of Neoith Pohey and Mancqc.

i In such errors, the system *rets up' Individuals to make ment Schnoi of Hygiene and Pubhe Henfth. and the Diveston of mistakes. I e., through the urtavailability of medical records.

Jmema! Medicine. Deporfir6eni q/Medirute. Johns Hopkins Uni- ,

by confusing labeling of medications, and the like. When

versity. Soltimore. Md. (AWW)

the Department qlPftilosophy, j Unwertry of Son Francisco. Cohf (TACJ: and mo Deuiston of a system error occurs, the physician shares responsibhity General Intema! Medietne. Department of Medicine. Unfuersity with other e!cments of the health enre delivery system.

l 9,f Catl(o' mia. Snn Fmnetsco (SJM. BL,. GPM). Consersely. Individual erreas are those dertving prt-l Presented in port at "Dromining Errors in Health Core: De. rna.ily from deficiencies in the physician's own autowledge.

ueioping a Prewntion. Education and Research A.genda.' Octo sktil. or attentiveness. For instance, o phys 6ctan mistak-l ber13-15.1996. Rancho Hirope. Colt f. . enly prescribed a nonsteroidal nnti-inflammatory age {t to i

' Address correspondence neto reprint requests to Dr. W i: a patient with renat insutiletency. resulting in perma.

.Heoith Scruices Resetvch and Development Center. 624 Norte

.11rondug Bolittnore. MD 21201 nently worsened renal failure.8 In such a case of individ.

I H0 ual error, the phys 6cian has primary responsibthey.

Attachment 5 t

JCIM Volume 12. December 1997 U3 The considerations in the disclosure of latent errors fered a gastrointestinal bleed. Telling patients at out such dilTer from those in the disclosure ofindividual crTors. For mistakes may resolve their uncertainty about the cause of example, in a latent error, the physician is often one link their condition. possibly allowing them to feel better oy in a chain of causes generstmg the error. Accordingly, the explahmg that recurrence would be unlikely.

disclosure of such an error may not be the sole responsb Olselosure of a mistake also provides patients with I

bihty nf the physician. In what follows, we considct only information needed to make infomied decisions. Pattents the. arguments for a physician to disclose his or her indt. may develop more realistic expectations about their doc-vidual error to a patient. We also restrtet ourselves to rnis. tors' interventions.' Acknowledgment of fallibility brings takes (ht.t causc significant harm, without regard to their uncertainties into the open, reduces the possibility of detectabiluy. misunderstandmgs, and encourages the patient to take Er ors causing harm can be subdivided into cases greater responsibility for his or her own care.

thm are rmt medically rernedtable and those that are med. In the case of an In surv. knowing about a mistake lerily remerttable. We argue that the physician has an ob. may aHow the padent to obtain compertsalto for lost liganon to disclose mistakes that cause significant harm, earnings or to pay for care necess! Lated by the njury." or which in the judgment of a risk ruanager or malpractice to at least get a bill wTtuen off. Such compensa .lon might insurer is hkcly to be rernediable. mitigable, or compen. be obtained through settlement rather than lawsult: un-salJle. Only in rare cases would a physician be permitted der the current system, obtaining such compensation not to disclose a mistake causing harm to the patient. would be difficuh or impossible without disclosure of the Specincally, physicians might be permiued not to tell if mistake.

they have good reasnn to believe that disclosure would FinaHy. disclosure of a mistake can promote trust in undennine the pullent's autonomy in some way (e.g.. in. physicians. Patients have a presumption of truth tellmg.'"

capacitate the ahendy severely depressed patient). Or the Thus, u patient who is not informed of a mistake ruay feel pM.cnt might have told the doctor explicitly.

• Doctor, if a: gry and betrayedH: the patient may think that a pnet.

.mything goes wrong. I don't want to know about it.' leged relationship has been violated."

T\vo ethical theortes assist In thinktag about the dis.

closint! of a mistake: consequendahsm and deontology. A consequenhallst ethical theory holds that one ought to do Potential Harms of Disclosure to the Patient that art which will real!xe the best overnll consequences. Patients may be harmed by learning that a mistake A deontological theory maintains that one ought to do was made in their care. De knowledge may cause alarm, that act by which one fulfills one's dunes or obligations. anxiety, and discouragement. h may destroy patients' tioth consequenttalist and deontological theories ground faith und ennfidence irt the physician's nbility to help argmocuts for disclosure. In what follows. we first con- them. Pahents may become disillusioned with the medical sider arguments based on consequences: then. we attend profession in general. This may cause thern to dcrline in arguments based on a physician's duties. beneficial treatments, or det;rease their adherbnce to ben-eficial treatment regimens or habits."

Not all pauents want to know everything about their POTENTIAL BENEFITS AND HARMS medical care. Some would rather nol be burdened with OF DISCLOSURE the compkxities of their t!! ness. The well meaning thwlo.

sum f potenuany semus. but incogsatucnual notakn Polential Benefits of Olsclosufe to the Potient may cause unwelcome confusion. In'such cases patients T1 e p.ulent could benellt in many ways from knowing muy feel they would be better oft'not knowing that a mis-that a mistake had occurred. Such knowledge would al. iake had been made in their care. As the Amertenn Colicge low the paUent to obtain timely and appropriate treat. of Ph5/slefons Ethics Monuol states.

• society recognizes the ment to correct problems resulting from the mistake. Dis. 'therapeuhe privilege / which is an exemptiorr from de.

cloSmv thereforc can prevent further harm to the pauent. tailed disrlosure when such disclosure has a high likeli-In some tatuations. close monitoring or a medical procc- hood of causing serious and irreversible harm to the pa.

dust tnay he necessary to mitigate the consequences of a tient.* However. the Amencan College of Physicians offers mistake. Pate.nts rnay be unwilling to permit or cooperate the followmg caution: "On balance. this privilege should with necessary measures if they are unaware of the rea. be interpreted narrowly: Invoking it too broadly can un.

son for dning so.' When further treatment is indicated. dennine the entire concept ofinformed consent.**

disclosure is esserittal for informed consent. Othetwise, the uninformed pauent is placed at risk of subsequent misdiagnosis and improper or inadequate treatment. Mdd Bends W Gschfe to N NysMon Disclosure of a mistake may also prevent the patient The physician might also beneftl from disclosing a from worrying needlessly about the etiology of a medical mistake to the patient or family. The kn'owledge of making problem. For example a pstlent who was prescribed too a mistake that harmed a patient can cause the physician muth wertafin resulting in excessive anticoagulation suf-to expertence great emodonal disyrs.Je 8m The physb

772 Wu cf aL Duelosing Medical hitstekes $!M etan may be relieved to admit the mistake. In the case of a without the expectation of overt punishm t it is dtificult serious mistake, the patient or family reember may be the to admti wrongdoing.

only person able to forgive the physician for making the A consequentialist argument for the disclosure of mistake. This may be the only way for the phystetan to mistakes to patients would be framed in terms of the gain absolutiori for the mistake # Many patients apprec6- above.noted benefits and harms to individual patients ate the phystelan's honesty. and disclosure of a mistake and phystefans. In the doctor. patient relationship. a phy.

metually rnay strengthen the doctor patient relationship, sician is to act for the sake of the patienu ttherefore, in l For example, when one of the authors failed to obtain a weighing the benefits and harvns of disclosure, the bene. I scrum ferrliin test during the evaluallon of a patient re. fils and harms to the patient should have greater weight ferred for un cr'larged liver, the diagnosis of hemochromas. than those to the physician. There are also duty based tosis was delayed significantly. When the patient was lold g:ounds for holding that. In certain cases, a physician about the omission. he responded. 'That's 0.K. After alt. should disclose medical error to n patient. We now turn to doctor, you can't think of everything." such arguments, l Candid disclosure of a mistake may decrease the !!ke.

' lihood of legal liability.4 Some have suggested that a strong doctnr.potient relationship makes patients less THE PHYSICIAN'S DUTIES 1(kely to bring suit.ie Furthermore, if the pallent leams in what follows, we argue that a physician's responsi-about a mistake and brings a lawsuit. fatture to disclose bittty to disclose a mistake to a pahent can be denved may place the physician in greaterjeopartly." from the fiduciary character of the doctor patient rela-Disc 6 sing mistakes rnay help physicians to learn and (

lionship (that is, the fact that this relationship is based improve their practice."'In a survey by Quilt and Wilham- on trust)M The fiduciary character of this relabonship  :

son. responding physicians reporteo that shorfng errors can be further articulated in accordance with the prmei-with colleagues. students, friends and sometimes pa. ples of nonmaleficence, beneficence, respeel for patient {

tients prevented isolation, and marked the beginning of autonomy, and justice.83 1 grieving about and learning from the mistake H' Admlittng Primum non nocere.

• fir.st, do no hah.' states the a mistake may also help the physician accept responsibit. principle of nonmaleficence: a caregiver has a grave re.

ity for it. and may help the phystetan make construcuve sponsibility to avoid harming the patient 8W The pnnet. j changes in practiec.3 Phystetans may also learn vtenri- ple of beneficence enjoins physicians to act for the best ously fror i mistakes rnade by others. und be able to avoid intr. rests of their patients' health even if the physici.an's j makmg sarnitar mistakes themselves.

own finanetal or professional well being is not benellied  !

by so acting.88 in cases in which Imrm resytting from u Potential Horms of Disclosure to the Physiclori mistake can be reversed or ameliorated, the physician is obligated to do so. For exampic. If a sponge has been ge rt Reveahng a medient mistake tu a pathent is often diffi.

in a pahent after surgery, the sponge can be removed arif't cult and paintul for the physician. The patieni may be. Infection can be prevented. In auch rases, remedymg dr come angry and upset, and such reactions can be ht:bly mitigaung the harms caused by a mistake orien recluires stressful lo doctors?

the physician to disclose the mistake to the patient.

Many physicians fear that disclusing a serious mcol.

flespect for pottent aufenomy enjoins physicians to cal mistake will expose them to the risk of a malprarthy disclose a mistake that seriously hanhed a palfent? This sult. If a lawsuit ensues the physician rnay be subjected ts the case when full disclosure frees patients o(mistaken t

' to increased malpractice premmms as well as psychologi. beliefs concerning their past, present. or future medical cal stress "

conditions. thus enabling them to raakc informed dect. -

' . Disclosure of a mistake may harm the phystetun sions about future medical care."It may also be the case through loss of referrals. hosplial admitting privileges, even if the patient does not need to know of16e error in J

. preferred provider a tatus. credentials. and even Hcensure, order io make future decisicpts about medical care. This is Selective contracting and physician proftling by managed berause pMients have a cla m to know their own history care .organtxations create more tangible threats to the and to be free of'mtstaken zeliefs conceming their past.

physleian's livehhood. The development of the Nauonal present, or future medical condluonf H in short, a physi.

Practitioner Data 13anko artds the possibility that an ince clan's obligation to respect' patient autonomy indicates  !

dent wdl leave a permanent mark on the physician's that a doctor has an ethleal obilgation to disclose mis.

record Disclosure of mistakes may also damege the phy- takes to patients.'

alcian s rcputauen through the loss of respect or status , t j among colleagues. In small commumlies, the physician's When a nontemediable mislake ha{ been made. the Pubtse repuusuon may also suffer. doctor may have an ethical duty to diatlose it to the pa tient so that the patient can be compensated. Jusuee re.

Following disclosure of a serious error, the career of a -

quires that people be given what la due to them. It woutri phystetan in training may be ha 7ned by poor evaluadons of be unfair not to cornpensate a pallent who was seriously letters of recommendadon. or even dismissal. Even harmed by mistake, c.g., for further medical care neceni.

e

, > gtM Volunw IT December 1997 713

\

mtcd by the mistake, for income lost due to the mistake. disclosure of a surgtent error should be delayed. If possi-for pain and suffering. or for loss of function. The more ble until the patient has recovered sufficiently to be able serious the hmm and the greater the need of the patient to understand' and deal with the infonnation, for compenwunn. the greater the phystelan's responsibd-(ty to make wnends. Who $hould Dixicselbe Mistake? When a mastakt is made Physlet.ms may be less obligated or not obligated at by a phystetan in trainmg. responsibihty is shared wuh p,i to disclow a mistake that had little marginal impact, the atter.dtng phyMetan of record it may be most appro-such as a senaus medication errgr involvmg a moribund prtate for the attending physician and house olTicer to dis-patient orihr fmlure to recognize a pneumothorax ct.used close the mistake to the patient together." Sometimes it during a fadeel uttempt at cardiopulmonary resuscitation. may be appropriate to invohe an instnutaonal representa-Although n rim he argued that disclost.ce is discreuonary live, such as a hospital administrator. risk m.anager. or in these can the counter-argument csn be advanced quality assurance representative, in the disclesure.

that even these mistakes should generally be disdosed.

The physicwn has littic to lose by so doing. These cases The locompeten^ r'otieni. Many patjents with impaired gg,g g acy provide o good opportunity for open and honest dis.

n#."lon and may strengthen the relationship with the pa-ifowever some pailents lack the mental capacity to un-tier.t ne famsly. derstand and appreclott what the physician tells them in surumary, the fiduelary character of the doctor. about meetcal errors, even if the discussion is simplified, g gg g patient relauenship indicates that a physteutn has the ever. If there is a family member or other effective decision ettacal duty to disclose error to a patient when disclosure furthers the pauent's heshh, respects the patient's auton. rnaker, lhts surrogatc should be informed. The physician g

omy. m enables thc pattent to be compensated for senous.

strepasahic harm. setting should also be informed.

What to Scy? Disclosure is often difGrutt. Inr several rea-  !

sons. Tne facts of the case muy be leo epmpucated so be Procheollssues in Disc losure of Mistakes explained easily. and may not be known precisch The physician rusy be tempted to frame lh'c disclosme in n Arecpung the physwlan's obligaHon to disclo$c mia-way that obscurcs that a misf ate was made.

take.s there are prochent issues concernhtg whether.

whrn, wlw. und how to tell about the nusinke. For unrcr- Disclosure of a mistake is an instance of *breakmg bad news

• to pahetus W' Theic is need for n$ediial edu- i lain e ascs. who should decide whether or not lo tell? Is there un ideal time to tell the patient? What should be conon obout conducting these d.sruntons. The upacumt:

rione in the case of the incompetent patient? When more news that a nestoke has occurred and infommuon re garding the consequences should be presented to the pa.

than one phys 8 clan was involved, who shouki tell the pa.

tient? What should be the rnic nf hasnital nonlify nwur. Lient in a way that runimixes distreu. The Anwicon Col.

unre and rbk management personnc!? g. y crw.n. m a,w,uut untra me ionnwmu guidance, which coukt he applied to the tiselnaure of a Deciding Whe/ hor to Drrdose a Mistake.tn cases in which misuke 1nlonunHon should he $en in tenns the pa diortoMac a mistake seems coc.troversial. who shnold de, uent ran undersumi W phstchm shouM w senadne ode whether or not to tell? The individual physician is bi- (n the r,aornra m]mne in Mung me pare of hito-ned against diselnsure and can easily rationalize the de. sure. . Olselosure shunto never be n mechanical ne per nsino not to tell. The t urden of proof should be on the lunctory process.'" The physician should mengnue that physiclun tajustify not disclosing a mistake. However the Palletus or lamilies may betume upset or angry. and ar-decision nhnntd not be left to the todividual physician's cept this us a natural response. taklug care not to react judenent. It would be important to obtu6n a second opin- defensively. -

len to represent what a reasonable physician would do in telhng the paHent about an error, the phystrian und be willing to defend in public. Th!s second opinion should begm by stating simply that he or she has made a would be partteularly important in casca in which there mistake. ll may be helpful to describe Ole decasions that was an adverse outcome, and the physician is meltned not were made. Including those m which the padent partict-to lell. A formal body such as an insutution's ethics com- pated. The course of events shouin then be described in trattee or goality revtew board seems preferable to informal detail. usartg nontechnical language. The nature of the consultation with peers, who might be similarly reticent. mistake. consequences, and correcuve acouri taken or to i

' be undertaken should be St.ated The physictan should Timing o/ Disclosure.The uming of disclosure should be then express personal ragret and apologu.e for the mis.

considered. Although the pauent might benent from take. Fmally the physician should clicit quemuons or con.

tearntne, about a mistake as sotm asp'ossible ufter it oc.

cerns from the patient and address thery, cuned. disclosure should be made at a time when the pa- The hr.im of dlwlosing a mtstakerqay be nurumuco if Orm in physically and emotionally stable. For ennmple. disclosure is made promptly and openly, if apolopes suc l

l l

Wu et af.. Disclosing Medical Mtstokes JGis .

i 774 offered, and if charges for associated care are forgone. mistakes may reduce the risk of htigation. If patients up When the rnistake had a msjor adverse impact on the pa. preciate physicians

• honesty dnd fal!ibility.'8 Second. sen.

tient, an offer should be made to esacel charges for sub. ous mistakes may come to light, even yf phystclans do not sequent care needed to remedy the mistake and to pro- disclose them. Patients may wondet about the cause of vide the necessary supportive services, their changed condition. ask other caregivers, or ever. ask rin.incial anands should include all extra expenses their physictana direcdy. Any percepti6n that the pnya Incurrril, such as physician scevices, error generated lab- cian tried to cover up a mistake might make a patient oratory fees. hospital expenses and drug costs. Hospital more angry and more htigious." Third, in disclosing mis.

rwk management teams sometimes adopt and malprac- takes physicians can take steps to mitigate any harms Lice Ins.urers Somtllmes encourage such an approach. that may occur to them. Physicians can Icarn how to dis.

which may reduce Ahe number and stat of malpractice close mistakes in a msnner that diffuses pattent anger, suits, we physictan rarely if ever pays for any of these Furthermore. when mistakes have caused sertous hami services out of pocket. Under caphated payment. the hos- to patients, physicians can take the initiative in recem.

petal or group absorbs the costs fit individual physictans mending to insthuuonal risk management personnel or are capitated for pharmacy services they may also share malpractice insurers that a prompt and fair settlement ir, the costal. If health insurance is available to pay for med. made out of court, leaf t'Me. a decision should be made whether nr not to bill For an injured patient to obtain compensation ihmue,h the msurer for the services. It can be argued that the in- the tort system requires proof of negligence, defined as s1 surance company bears some co.cqual responsibnhy be- olation of professional standards. This creates an untena, cause H insures the pe.tient for all owomes. However, bic conntet for physicians, fcr whom compensation to the companies may want recourse to reclaim aame of the patient demands the demonstration of malpractice. Acts money. In all cases. It is important that hospital adminis- of negligence constituted only a small proportion of the

- tration and risk management be involved in decialons anri errors in the Harvard Medical Practice Study ' and only a negotiations about billing. small proportion of injunes resulted in compensation for A physiciso who had presenbed a sulfonamide to a the patient.1hus, the cutient system obstructs detechon paucnt known to be allergic to sulfa. causing an anaphy, and just compensation for errors and inhibus disclosure.

' lactoid rescuon, might say "Mrs. Smith. I have discovered %e need to report and reduce errort constitutes a major what has caused you to become so ill. I regret to say that I ethicalImpetus for reform to a system of no-fault, nonad.

made a mistake. Before prescribing the mcdtcauon for versartal patient compensation. Such a system would fa.

your infeellon. I failed to check whether you were allergic cilitate a move to a systems approach incorporating hu.

to it. You are. The Rehy rash. Joint pains, and fever you man factors research to reduce errors.2 now have are due to the allergy. ! nm giving you tbuprofen The fear of damage to reputation and loss of respect and diphenhydramine to help you feel better, and I expect from peers may also inhibit physicians from disclosing you will gradually improve over the next s:veral days. I rmstakes. To overcome this barrier will require increased feel very badly that my not checking h.as caused you to recocln(Llon and acceptance of mistakes as part of chnical have th(n reaction. t orn sony. Of course. there will he no practice. Guidelines should be rrented to describe what charges for the antibiotic or the medicallons I am now physicians should do when they niake a ruistake. Such prescribing to remedy my misinke. Do you have nny ques- guidelines should also describe what to do when a col.

Lions for mc7 league tells you about a mistake you have made or a mis.

take he or she has made. The importante of providing Ovefcoming Barriers to Disclosute eni tional supp ri needs to be emphasized. It is particu.

larly important to help physicians ir training cope with From a pragmatic point of view. physicians are often their mistakes in such a way as to help them maintnin rnost conceme.d about the potentially harmful personal their con 0dence and develop professionally.U.

consequences of disclosing a mistake. In blunt tenus, physicians may question whether any possible benefits t the paGent are worth the possible risks of a lawsua to Disclosure of Mistokes Mode by Other Physicions their career or livehhood. This clash between ethical ide A physician who,in the care of one of his or her own als and prugmalle reality is a dilTicult one, il may sound patients learns of or witnesses a major erroc (e.g., a sur.

.. .... ......,. - . . p..y.n.... w w -.e.iin vem sur prai misnapt mace by another physician, has several op.

the pauent. However, the AMA's Counc61 on Ethical and lions. %ese include walung for the other physichn to dis.

Judicial Affairs states. ' Concern regarding legal liahthly close the mistake, advising lht DLhcr nhvalchm in ritarine

...a.. unum icaun suuuwmu truimui oisciosure snoulh the mistake, arranging a joint rmeeting to discuss the mis.

not affect the physician's honesty with a patient." take. or telung the patient directly.' Insofar as the doctor.

We would make several responses to physicians who pahent relationship obtains in such a case, physicians hesitaic to disclose mistakes that cause significant harm have an obligation to farttitate disclosure. However. they to pauents because of fears of lHigation. First. disclosmg may be reluctant to say anythmg because of lack of clefin.

4 NOTIFICATION FOLLOWiNG A MEDICAL EVENT l

The January 30,1998, 'strawman" version of the proposed revision of 10 CFR Part 35, which was put on the Internet for public comment, included the fo"owing draft rule text for reporting medical events:

(a) A licensee shall report any administration of byproduct material or radiation therefrom that:

(1) Results in a dose that is greater than 5 rem effective dose equivalent or 5G rem to an organ, and (2) Represents either:

(i) A total dose or dosage that differs by at least 20 percent from that presenbed in a written directive; (ii) A fractioned dose that differs by at least 30 percent from that prescribed in a written directive; QI (iii) A prescribed dost. or dosage that is the wrong pharmaceutical; delivered to the wrong patient; delivered by the wrong route of administration; delivered to the wronj treatment site; (iv) delivered by the wrong treatment mode; or from a leaking source (s); and (3) is not the direct result of patient intervention that could have been reasonably prevented by the licensee.

That version stated that the issue of whom should be notified following a medica; event was still under d!scussion, and therefore, the current notification requirements were included. As noted in the Commission paper, staff has identified three possible attematives for notification of the U.S. Nuclear Regulatory Commission, the referring physician, and individuals in the case of a medical event.

Altemative 1 Retain the current reporting requirements in 10 CFR Part 35 with minor changes intended to clarify the term ' responsible relative."

The requirement to inform individuals about a medical event is consistent with other NRC requirements (e.g.,10 CFR 19.13(d) and 20.2205) for licensees to provide reports to individuals receiving radiation exposure when licensees are required to report such exposure to NRC. As articulated by the Commission at the time the misadministration r*Jle Wa9 promulgated (and later modified), patient notification "... recognizes the right of individuals to know information about themselves which is contained in records both inside and outside the Federal sector."

" Misadministration Reporting Requirements," 45 rederal RegiateI 31701, at 31702 (May 16, 1980) and " Basic Quality Assurance Program, Records, and Reports of Misadministration or Events Relating to the Medical Use of Byproduct Material," 55 Federal Reaister 1439, at 1444 (January 11,1990). This attemative recognizes physician discretion to withhold information from the patient if, based on medical judgment, such information would be ' harmful' to the patient. Patient notification also enables patients, in consultation with their personal physicians, to make timely decisions regarding their remedial and prospective medical care.

• Quality Management Program and Mir, administrations," 56 Federal Reaister 34104, at 34117 (July 25, 1991). In addition, this attemative codifies existing industry standards (American Medical Attachment 6

, i c

$l 2

Association (AMA) Principles of Medical Ethics] ' obligating physicians to provide complete and accurate information to their patients.

4 As stated on numerous occasions, the medical community perceives the current requirements to be an unnecessary intrusion into the practice of medicinc cnd asserts that this is the only area of medcine where there are Federal Govemment requirements for notifying individuals of

' medical errors.

If the Commission prefers this attemative, staff recommends that the current rule text be revised to clarify the provision for notifying the individual's " responsible relative," in lieu of the 1 individual, in certain circumstances (e.g., the individual is a minor or unconscious) because that term is not defined legally, and therefore may be subject to different interpretations by the medical community.

The 1996 OMB submittal estimated that the regulatory burder NRC and Agreement State licensees to report misadministration (medical events) to NRL c, the appropriate Agreement 1

State, the referring physician, and the individual is approximately $214,200/ year (based on 105 misadministration / year); and for NRC to respond to and follow-up on the events, and to review .

the written reports is approximately $288,000/ year. Staff does not anticipate any change in the regulatory burden for licensees and the NRC if this attemative is pursued.

ALTERNATIVE 2- Revise the current reporting requirement to require a licensee to inform only NRC and the referring physician (but not the patient) of the medical event.

gThis altemative would rely on the authorized user or referring physician's voluntary compliance iwithfethical principles" and " standards of care" to present complete and accurate medical facts ,

! to patients. This approach, as compared with Altemative 1, could be viewed as intruding less l Into the practice of medicine. Staff Delieves that requiring licensees to inform the referring 'l physician of the medical event would help to assure that individuals, in consultation with their personal physicians (referring physicians), will have the needed information to make timely decisions about their remedial and prospective medical care. Staff does recognize that in some cases there will be not be a referring physician and the responsibility to inform the individual will fall to the authorized user physician.

1 This ettomative does not ensure that individuals will be informed of a medical event and, -1 therefore, might not receive information, viewed necessary by NRC, to make informed medical J ,

care decisions. This altemative is not consistent with other NRC requirements, in 10 CFR  ;

' Parts 19 and 20, regarding reporting radiation exposures to individuals when such reports are

• Although AMA discusses patents' rights to receive information from physicians as Fundamental E:ements of the Patient-Physician Relationship" and to effectuate " informed consent," _AMA ethical standards for informing patients of physicians' mistakes refle'ct a threshold of "significant complications" to the patient that may have resulted from the ,

j physician's mistake or judgmente"AMA Council on Ethical and Judicial Affairs, Code of Medical J Ethics," Current Opinions with Annotations at xxxix,120,125 ($8.12),1996-1997.

a. gin irsi i i

r I

l 3 l

made to NRC. Also, if the referring physician does not follow the " ethical principles," this

! approach would not effectuate, the specific Commission determination that individuals have a tight to know when they have been involved in a misadministration. 45 Fed. Reg, at 31702.

Regulatory burden would be approximately the same as Altemative 1 if this attemative is l pursued. Although the Federal govemment would no longer require licensees to provide <

l Information to individuals or responsible relatives, there would still be a requirement for j licensees to report to NRC, notify the referring physician, and document the event. I I

ALTERNATIVE 3: Revise the current repo ting requirement to require a licensee to inform only NRC of a medical event.

This alternative has many of the benefits previously discussed under Altemative 2: (1) it is l

consistent with NRC's policy of recognizing that physicians have the primary responsibility for the protection of patients and that they wi;l act in the best interest of their patients, " Regulation j of the Medical Uses of Radioisotopes; Statement of General Policy," 44 Fed. Reg. 8242, at l 8244 (February 9,1979); (2) it would not require that the referring physician be informed of a '

medical event; and (3) it reflects the viewpoint of the medical community members noted in the l Commission paper under the general discussion of patient notification.

I This alternative does not contain a Federal requirement that would ensure that patients are l informed of a medical event; therefore, individuals may not have information necessary for  !

l- making informed medical care decisions. In addition, individuals who are the subject of medical  ;

events would not be accorded the same protection as occupational workers and members of l the public, in terms of the requirements to be informed of radiation exposures when licensees are required to report such exposures to NRC (see discussion following Altemative 1 above),

Also, this attemative does not effectuate a specific Commission determination that patients j have a tight to know when they have been involved in a misadministration.

]

The regulatory burden on licensees would be decreased if this attemative is pursued. I Licensees would no longer be required, by the Federal govemment, to provide information to individuals or responsible relatives and the referring physician. No change in burden on staff is anticipated.

i

~

i I

t.

PRECURSOR EVENTS l

The staff has identified three possible attematives for capturing precursor events.

Altemative 1: Revise 10 CFR Part 35 to require reporting of "significant precursors."

Part 35 would be revised to: (1) define "significant precursor" in 10 CFR 35.2; (2) recuire that j licensees report "significant precursors" to the U.S. Nuclear Regulatory Commission; and  !

(3) require that licensees keep records of significant precursors. In addition, the statements of l consideration for the revised rule would contain examples of conditions and incidents that staff l would consider to be "significant precursors" [e.g., failure of computer hardware or software,

' l interlock systems, or source containment systems (afterloaders)); malfunction of a treatment '

l timer system; or mislabeling of a therapeutic radiopharmaceutical).

This altemative was included in the "strawman rule" that was made publicly available January '

f 1998 and was based on the definitions used by the Food and Drug Adrninistration (FDA) in the  !

medical device reporting area. A significant precursor was defined as "a condit:on or incident, l except for a medical event, related to the use of radionuclides in medicine that caused or could cause serious injury to a patient, human research subject, worker, or the public." Although

,. " serious injury" was not defined in the January 1998 version, subsequent versions of the draft

! rule text have defined it to mean an injury or illness that: (1) is life-threatening; (2) results in

' permanent impairment of a body function or permanent damage to body structure; or (3) necessitates medical or surgicalintervention to preclude permanent impairment of a body function or permanent damage to a body structure.

t This attemative would capture a range of precursor events and, therefore, would fully meet the objective of the Staff Requirements Memorandum (SRM) COM SECY-96-057,

, " Materials / Medical Oversight," March 20,1997, to " capture" precursor events. However, if the l Intent of identifying precursor events is to improve licensees' radiation protection programs,-

l then this attemative could potentially go beyond the intended objective (e.g., NRC would L

receive reports involving certain human errors that could not be applied to improvements in other licensees' programs). This attemative is risk-based, in that a reporting threshold is set, for significant precursors, that is similar to the FDA's threshold for medical device reporting.

It is anticipated that this attemative will increase the regulatory burden on licensees and NRC.

However, staff did attempt to limit reporting of precursors to only those events that could have a l . significant impact on public health and safety, and, consequently limit the increase in regulatory burden. Licensees may need to revise operating procedures and would need to report and record "significant precursors." NRC resources would be needed to process, review, and investigate reported precursor events. (NOTE: if Attemative 1 is preferred, the estimated resources for this attemative will be addressed in the Regulatory Analysis.)

Altemative 2: Revise Part 35 to require reporting of deficiencies in equipment (hardware and/or software), byproduct material, or procedures supplied by a manufacturer or vendor that, in the opinion cf the radiation safety officer (RSO), could lead to a medical event at that facility or could heve detrimental health and safety Attachment 7

4 2

implications beyond the licensee's facility.

Part 35 would be revised to require reporting of deficiencies in eouipment (e.g., hardware and/or software failures), byproduct material (e.g., the wrong material in a container), or procedures supplied by a manufacturer or vendor (e.g., vendor-supplied operating procedures that could result in a source being exposed for a time period beyond that anticipated by the licensee) that, in the opinion of the licensee, could lead to a medical event at that facility or could have implications beyond the licensee's facility. Licensees would be required to keep records of incidents reported to NRC.

. This attemative would limit the number of precursor events reported to NRC, but would still meet the objective of capturing precursor incidents or conditions ht at could improve licensees' radiation protection programs.

It is anticipated that this attemative will increase the regulatory burden on licensees and NRC.

However, it is expected that the increase for licensees and NRC will be about the same as that

-associated with Altemative 1 because, although the types of reports to be submitted in Altemative 2 arn more limiting, the threshold for reporting events is set lower than the level in Altemative 1, i.e., NRC would receive approximately the same number of reports under Altematives 1 and 2. (NOTE: if Attemative 2 is preferred, the estimated resources for this alternative will be addressed in the Regulatory Analysis.)

Enforcement action under Alternative 2 would only occur if it is demonstrated that the RSO concluded that the requisite standard was met. Where individual licensee employees believed the standard was met, investigations might be needed to determine if the RSO had reached the same conclusion and did not report it. This would be similar to enforcement of 10 CFR 30.g(b).

Altemative 3 Rely on current NRC reporting requirements in 10 CFR Parts 20,21, and 30, and the Memorandum of Understanding (MOU) with the FDA and monitor / establish system wlth U.S. Pharmacopeia (USP) to review its database.

This attemative relies on the existing regulatory framework in Parts 20,21, and 30 and 21 CFR Part 803 to capture precursor events. Staff recognizes that all precursor events may not be captured under this altemative. This attemative captures: (1) precursors that would have

, significant implications for public health and safety or common defense and security, pursuant

'to 10 CFR 30,g; (2) events that prevent taking immediate protective actions necessary to avoid exceeding the regulatory limits because of exposures to radiation or radioactive materials, and certain other events involving licensed material pursuant to 10 CFR 30.50; (3) Information provkled to the FDA, which is currently available to NRC via the FDA/NRC MOU, pursuant to 21 CFR Part 803, " Medical Device Reporting"; and (4) reporting requirements pursuant to Parts 20 and 21. In addition, staff would recommend that NRC monitor, on an ongoing basis,

, information errors that are available via voluntary reporting systems, such as the voluntary Medication Errors Reporting Program at USP (see Enclosure for information on USP). Note, staff discussions with both USP and the medical community have noted that voluntary reporting ,

systems do not capture all events.

There is no increased burden on licensees assovated with this alternative. NRC medical use 4

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licensees are already required to report specified events to NRC and the FDA, and many of I them already participate in the USP voluntary reporting system. It is not anticipated that this approach would result in an significant increase in expenditure of NRC resources. Some minor i j resources (less than 0.1 full time equivalent) would be required to monitor information provided l by USP. If this attemative is pursued, staff believes that an Information Notice should be issued l describing the NRC position on capturing precursor events, using existing mechanisms.

Enclosure:

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1. Information on USP and its Initiatives and Programs '

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USP (U.S. Pharmacopeia)

FY1 Information on USP and its s - U,-

USP, established in 1820, is a voluntary, not-for-profit organization that promotes the public health by establishing and disseminating officially Initia tive s and Programs recognized standards of quality and authoritative information for the'use of medicines and health care technologies by health professionals, patients.

U. S. Pharma:opeia and consumers.

Who is involved with USP?

More than 1,000 pharmaceutical scientists, academicians, health care professionals, government officials, and consumers serve as USP +

volunteers to assure the accuracy and current relevance of USP product quality standards and medical infonnation. A staff of more than 250 supports the activities of the volunteers.

12601 Twinbrook Parkway Rockville. MD 20852 What are USP's primary activities?

= Product Quality Standards for Drugs and Other

! IIcalth-related Articles l USP is responsible for establishing legally recognized product quality l standards for drugs and other health-related articles in the United States.

The United States Pharmacopeia and the National Formadary (USP-NF) contain product quality standards for more than 3,400 drug substances and 250 pharmaceutical ingredients used in making drugs.

(301) 816-8223 FAX (301) 770 5193 Many state and federal statutes, including the 1938 federal Food, Drug, and Cosmetic Act, make USP-NF standards legally enforceable. In a unique public/ private relationship, the Food and Drug Administration (FDA) is i responsible for new drug approval and USP establishes public standards of strength, quality, purity, packaging, and labeling. Once the ' standards are published in the USP-NF, they are enforced by FDA.

= Authoritative Drug Information The USP Di* database includes clinically relevant, consensus-based medical and therapeutic drug information for health care professionals, patients, and consumers. The printed USP Dicomprises three volumes, Drug Informationfor the Health Care Professional, Advicefor the Patient . and Approved Drug Products and Legal Requirements. USP D1is recognited as a source of medically accepted indications, including off-label-uses. drug utilization review, and patient counseling in the Omnibus Budget Reconciliation Acts of 1990 and 1993, in 1994, a strategic alliance was formed between the USP and the American Medical Association to combine the USP Di and AMA Drug Evaluations databases.

= Learning from Practitioner Experience USP initiated the USP Practitioners' Reporting Networksu (USP PRN) to help USP learn from practitioner experience through a network of four separate reporting programs for drugs, medication errors, radiopharmaceuticals, and veterinary medicine products. Once a report is received by USP PRN, the manufacturer and the Food and Drug Administration are alerted to drug product problems or medication errors.

The information assists in the development and revision of the USP-NF and the USP DI database, and is disseminated to health care professionals who report to the program, and to pharmacy, medicine, and nursing organizations through USP's publication, the Drug Product Quality Review.

FYl9701 June 1997 Enclosure l

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