ML20136E492

Forwards Legal Analysis on Licensing of Medical Institutions & Physicians Under 10CFR35.11 & 10CFR35.12.Commission Cannot Deny License Application Merely Because Applicant Does Not Operate Hosp

ML20136E492
Person / Time
Issue date:	04/29/1983
From:	Klucsik J NRC OFFICE OF THE EXECUTIVE LEGAL DIRECTOR (OELD)
To:	Webb Patricia Walker NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
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References
FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8308100755
Download: ML20136E492 (10)

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April 29, 1983 MEMORANDUM FOR: William J. Walker, Jr. ~

' Joseph De1 Medico .

Material Licensing Branch Division of Fuel Cycle and Material Safety Office-of Nuclear Material Safety and Safeguards Frui: John F. Klucsik Attorney, Regulations Division Office of the Executive Legal, Director SU3 JECT:

LICENSING OF INSTITUTIONS AND hHYSICIANS FOR THE liUMAN USE OF RADICACTIVE MATERIALS You have requested ELD's view regarding the application of 10 CFR li 35.11 and 35.12 to institutional and physician applicants for a license pemitting the hur.an use of radioactive materials. I understand that you are concerned over the adequacy of facilities and care provided outside the hospital '~

Cm settingradiodiagnosis and particularly in connection with isotopes delivered for use by a c:obile service. Your concern raises the question of whether the Comission may deny an application for a specific, human use license unde'r' .

I 35.11 solely because the applicant does not operate a hospital. You also-have asked these specific questions:

(1) whether a physician must have an ownership interest in an institution licensed under i 35.11; (2) whether a physician must be involved irr the operations of such an institutional licensee; and (3) whether a physician's ownership or operational involvement is required for the licensed provision of nuclear medicine services at a location remote from that identified by the applicant as his base of operations.

Our legal analysis addressing these questions follows.

The analysis begins with the question of whether the Comission may deny an application under 5 35.11 because the applicant does not operate a

. hospital. The analysis first focuses on the literal meaning'of tha rule.

Consideration of the apparent intent underlying the rule follows. The meaning of the companien rule, ! 35.12, is discussed and the purpose of a relevant amendment to the companion rule is reviewed. Your specific -

question on physician ownership is answered in a direct and concise way, h3 without lengthy analysis. Our response to your question on physician involvement in licensee operations reviews the evolution of the Radiation

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t Safety Comittee and the physician's role in it. Our response to your  :.

question on mobile 2,ervice is based upon the analysis done to answer your other questions. The response discusses the Consnission's ability to license - .,

institutions and individuals to provide mobile nuclear medicine service. .

Based on this analysis, we believe that .'the Conunission may not deny a license application under i 35.11 merely because tha applicant does not operate a hospital. The test is whether the applicant posseses adequate facilities for the clinical care of patients. If facilities for nursing, feeding and lodgirg patients ("hospf ts1" facilities) are,necessary for"the adequate clinical care of patients urtiergoing the radiodiagnostic or radiotherapeutic procedures covered by the application, but are not available from the applicant, the application say be denied. Our response to ycur specific questions is as follows: .a (1) No physician ownership interest in the institution applying for a license under i 35.11 is required.

(2) The physician member of the institution's radiation safety cocuittee must be involved in the irstitution's day-to-day * -

operations but need not perform ranagement or supervisory s duties other than those resulting from his radiation safety ~

consnittee membership. s (3) Dur view respecting physician ownership and participation in .

i operations is not affected by the applicant's provision of i

" mobile" nuclear medicine services' at a location remote from .

i that identified by the applicant in his application.

Institutions and individuals may be licensed to provide such

. services on the premises of host institutions.

If yes have any questions with respect to 1.he ana~ lysis please do not hesitate to call.

c Z 2 -f chn F. K ucsik Attorney

Regulations Division

-0ffice of the Executive -

1 Legal Director Attschment: '

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1 MEMORANDUM FOR: William J. Walker Fuel Cycle Medical Licensing Office of Nuclear Material Safety and Safeguards FROM: John F. Kluesik Attorney Regulations Division Office of the Executive Legal Director

SUBJECT:

LICENSING OF PHYSICIANS AND INSTITUTIONS FOR THE HUMAN USE OF RADI0 ACTIVE MATERIALS In a recent telephonc conversation you inquired about the Commission's ability to issue licenses authorizing individual physicians and institutions to use radioactive material in medicine. Your questions included whether a physician's ownership interest in the licensee was required and whether l participation by a physician in the operations of the licensee was required.

You also asked whether the response to these questions changes if the

! licensee provides nuclear medicine services at a location remote from that O

identified by the licensee as his base of operations. As- background for your I questions you supplied a copy of the application materials and license of Radiodiagnostic Imaging Affiliates of Virginia, Inc.

! A preliminary analysis follows. It explores the requirements of applicable regulations in a general way. A more specific and definitive response can l not be provided in the absence of specific facts. If you wish to provide such facts or case specific questions we would deal with them in a more detailed and more narrowly focused way. For three reasons we encourage your further consideration of questions raised by your inquiry and by our response

to it. First, until Part 35 is revised, it will be necessary to deal with the uncertainties of the current Part. Second, consideration of these existing uncertainties may help avoid perpetuating them or creating new uncertainties in the revised Part 35. Third, this consideration should also be valuable in reviewing and revising the license documents currently in use.

Section 35.11 of the Commission's rules provides for issuance of a license

, to an institution regardless of whether a physician has an ownership interest l in the institution or whether a physician participates in the operation or l management of the institution. Physician participation in the nuclear medi-cine operations of a licensed institution may be required by license condi-tion. Section 35.12 provides for the issuance of a license to a physician or groups of physicians and requires the applicant to be a physician or a group i

of physicians. Section 35.12 does not specify any legal or organizational relationship.among physicians licensed as a group. The provision of nuclear i

pb medicine service at a location remote from the licensee's base of operations does not change the requirement of a physician applicant under 6 35.12.

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Neither does it change the fact that physician ownership or participation is not a prerequisite to issuance of a license under i 35.11.

Section 35.11 does not define the term " institution." Section 35.12 does not specify a legal or organizational relationship anong the physicians of a licensed " group of physicians." As a result, it is not always clear which section should be invoked as authority for issuance of a license. Whether an applicant is treated as an institution or as a group of physicians may determine whether the applicant receives a license. Different conditions to license issuance apply under each section.

Under 5 35.12 the applicant. must be a physician or a group of physicians.E If the applicant is not, ne license may issue under 5 35.12. If the appli-cant is a group of physicians, it is unclear from the regulations who the licensee should be. Section 35.12 requires no organizational or legal relationship among the physicians comprising the group. In the absence of any legal or organizational relationship it may be that each physician of the group should be named as a licensee on a license authorizing each and all of them to handle radioactive material. Instead of issuing a number of

. identical licenses each naming a single individual as licensee, a single

't license would be issued naming a number of individuals as licensees.

.One benefit of this group licensing approach might be real' zed if all physi-pd tians used the same offices outside a medical institution (see, 6 35.12(a)(2))

and had access to the same hospital facilities (see, 9 35.Pl(a)(3)), but had no legal or organizational relationship among themselves for the purpose of providing nuclear medicine services. The benefit would flow from submitting only one application to describe all of the group members applying for a 6 35.12 license. Nothing in the history of 5 35.12 suggests that this approach or benefit was intended. If a license is to be granted in the names ofindividugphysicians,thereisno.needfortheruletomentiongroupsof physicians.- Section 35.12 seems to contemplate issuance of a license to an entity (i.e. a group) separate in identity from the individual physicians who comprise that entity. Unfortunately, 9 35.12 provides no clue to the

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1/ Neither Part 30 nor Part 35 provides a definition for the term " group of physicians," although the term " physicians" is defined. The comon meaning of " group" is a number of persons or things gathered closely together and forming a recognizable unit or classified together because of common characteristics or a comunit Webster's New World Dictionary 641 (college ed.1962)y of interest.

~~2/ The rule speaks in terms of groups of physicians. There is nothing in the rule's history to suggest that more than one group of physicians was intended. The more likely explanation is a failure to recognize that the singular includes the plural. 2A Sutherland Statutory Construction 160, 9 47.34 (4th ed. 1973).

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intended legal status' of that entity, the group. As a result, there is no clear guide to whom a group license may issue under i 35.12.

In most although not all cases, the comunity of interest which would cause physicians to form a group for purposes of licensing, causes them to define i

their organizational and legal relationships for reasons unrelated to

licensing. They do so typically by forming a firm, association, partnership or corporation, each of which may have some legal capacity apart from that of their individual participants. They solve the problem of group licensing under i 35.12 by supplying a non-human licensee. In doing so they also raise the question of whether the license isn't more appropriately issued under i 35.11.

Fims, associatpns, They partnerships almost always and corporations have varing identity have an organizational degrees of legal identity.

distinct from their principals. Whether these organizations are institutions will determine whether they should be licensed under i 35.11. That section i provides that a license may be granted to an " institution." The regulations do not define the tem. In the absence of a regulatory definition, the comon meaning applies. One comon meaning is "an organization havigg a social purpose or the structure which houses such an organization."3 Firms, associations, partnerships and corporations are organizations. Arguably, theyarealsoinstitutpns. As institutions they may apply for and receive a O

! iice#se u# der i as 11.

--3/ Individuals, corporations, partnerships, firms associations, groups, and public or private institutions are all " persons" under the Atomic Energy Act of 1954, 42 U.S.C. 5 2014s. (1976). The Comission is authorized to issue licenses to such persons. Unfortunately, neither the Act nor Part 30, which mimics its definition of person, help to tell when a group is a group and not something else. The same is true for institutions. Corporations, partnerships, firms and associations all have legally distinguishing features outside the Atomic Energy Act context. As a result, their lack of definition in the Act or regulations presents no problem.

1 4] See Webster's New World Dictionary 758 (college ed.1962) which cites a hospital as an organization which is an institution.

Sj A group may or may not be an organization i.e. a body of persons organized for some specific purpose such as the provision of nuclear

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medicine services. If a group is an organization, it may also be an institution. If a group is an institution it may be licensed under 5 35.11 as well as i 35.12. Institutional licenses and individual physician licenses are mutually exclusive. See, 42 Fed. Reg. 36240 (July 14, 1972).

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G The staff, in applying 5 35.11, often seems to think in terms of the second common ganing of " institution" i.e., the structure which houses an organi-zation.- A hospital or clinic is an institution without regard to the legal status or organization of its owner or operator. This is a convenient choice of meaning in many cases but it produces a peculiar result when used in conjunction with 5 35.11. The resu building to use radioactive r.uterials.yThis is that the is not theComission licenses a result contem-plated by either the Atomic Energy Act or the regulations. Persons are licensed to use radioactive materials. Licensed persons (individuals or organizations) may provide nuclear medicine services in a hospital or clinic (a medical institution in staff usage) or in an office (a private practice in staff parlance). Any attempt to limit the issuance of licenses under

% 35.11 to organizations (which are also persons and institutions) which provide nuclear medicine services in a particular structure (a hospital, clinic, medical institution) is not supported by the regulatory text.

Section 35.11 simply does not limit the institutions who may apply for a license to those who operate or own hospitals. As a result, an organization which does neither (e.g. one which provides nuclear medicine services at a hospital owned or operated by a different person or at some other location) may apply for 7. license under 5 35.11.

This leads to consideration of the conditions which must be met for approval of an application under 9 35.11. The applicant must appoint a radiation O safety committee. The comittee must include a representative of "the nursing staff." The NRC staff has acknowledged that a medical institution without nurses is possible. See, 47 Fed. Reg. 40150 (Sept. 13, 1982). Interpreting the regulations to require an applicant to have nurses where the applicant otherwise would not have them makes little sense and is contrary to the principals of statutory construction. The rule should be interpreted to/

mean what it says. If the applicant has a nursing staff, the nurses mur/. be represented on the radiation safety comittee. The requirement that nurses be represented should not be transfopped by interpretation into a require-ment that the applicant have nurses.r/

l 6] For an example of staff ambivalence toward the meaning of " institution,"

see, 42 Fed. Reg. 36240 (July 14, 1977). There " medical institution" 1

is used to mean the place wherein physicians practice their art and alternatively, the organization which holds a license and possesses physical premises other than private offices where physicians practice.

7/ The proposed revision of Part 35 avoids this result by defining

" institution" as an organization.

8/ This transformation is apparently what the NRC staff intends. An applicant who cannot meet the requirement for a nurse respresentative because the applicant has no nurses must seek an exemption from the rule. 47 Fed. Reg. 40150 (Sept. 13, 1982).

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V The requirement that the applicant pos',ess adequate facilities for the clinical care of patients is more troublesome. It clearly requires the successful applicant to have certain facilities. Which facilities are required is not clear. Neither the regulations nor their history provide guidance other than by reference to clinics, hospitals and medical institutions. Clinical care 'is the key tenn. One meaning of the tenn is care in a clinic. A clinic is a place where a preliminary diagnosis is made and treatment given or a center for physical examination and treatment of antulent patients who are not hospitalized. See, Taber's Cyclopedic Medical Dictionary (11th ed.1979). A broader meaning includes the obser-vation, examination and treatment of patients, including non-ambulent patients, who are hospitalized. A facility for clinical care is any place for examination, diagnosis and treatment. The regyirement that an applicant possess such facilities is not difficult to meet.a An applicant desiring to provide nuclear medicine services at a location remote from his base of operations could possess (by lease or otherwise) a place (inside or outside a hospital) where examination, diagnosis and treatment of patients could occur. This would satisfy the requirement of 9 35.11(c). Having satisfied this and other require ts of 9 35.11, the applicant should be granted a license under 1 35.11. Restrictions or requirements additional to those imposed by regulation may be imposed upon the licensee by license condition.

Typically, this is how physician involvement in licensee activities is accomplished.

O The typical medical r rials license authorizes the licensee to handle radioactive material. If the licensee is an organization, the license 9f Facilities for clinical care include places not equiped for hospitalization of non-ambulatory patients. Where access to greater medical capability is required, the requirement is specific. Section 35.12 requires the applicant to have access to a hospital possessing adequate facilities to hospitalize and monitor the applicant's radioactive patients. Not addressed here is the difference if any between having access to facilities and possessing facilities.

10/ Section 35.11(d) requires that the abysician who is designated on the application as the individual user lave appropriate experience in the proposed use of radioactive material. It does not, in tems, require that a physician be designated on the application. Where a physician is designated, thos paragraph does not require him to participate in the ownership or management of the licensee.

11/ The typical license authorizes the licensee to use material at designated places; to deliver, transfer, receive and import radioactive material.

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necessarily authorizes the organization's human agents to handle material.

If the organization includes physicians among its agents, they are authorized to handle material. Without ferther restriction, all physicians who are agents of the organization (indeed all individuals who are agents) are authorized to handle radioactive material. ,

A license condition usually speaks to who is authorized to use material. ' . " ,

m One formulation ofby thecertain license condition is thaf27adioactive material is C' '

12 authorized for use named physicians.- If the named physician "#" "'

is an agent of the licensee organization, this grant of authority is unnecessary. He already has authority to handle material under the grant to the licensee. If the physician is not an agent of the licensee organization (a private practioner with practice rights at the licensee organization' hospital), this grant of authority is necessary for his use of material.

A second formulation of the license condition potentially has a different effect. The condition provides that radioactive material shall be used by certain named physicians. Under one view this specific grant of authority limits the general, broad grant to the licensee. This prevents all the licensee's agent physicians, except those specifically authorized, from handling radioactive material. It also prevents non-physician agents from handling material if they are not specifically authorized to do so. Under the alternative view, the restrictive effect of the condition applies only Q to physicians. Only those physicians named on the license are authorized to handle material. Other non-physician agents of the licensee organization are authorized under the grant to the licensee. There are two problems with this view. First, there is no basis for limiting the restrictive effect of the condition to physicians. Second, it would prevent physicians but not others with little or no radiation safety training from handling materials.

The view which holds the general grant of authority to the licensee limited by the specific grant to the named physician is the better of the two. The authorization of non-physician material handling is accomplished by a second specific grant of authority in the license.

12/ Contrary to what might be expected of a license condition (i.e. a limitationontheexerciseofanauthority),thisformulationgrants additional or redundant authority.

13/ This grant of authority, this governmental permission to use radioactive material is a " license" to use radioactive material. This is true in spite of the fact that no separate license document is issued to the physician.

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A medical materials license typically, but not universally, authorizes use of the material by individuals who are under the supervision of a named physician. As noted above, the named physician need not be an agent of the licensee organization. The license condition which authorizes use under physician supervision typi%1y does not identify the characteristics of 4

the supervised individual.- As a result, the supervised individual need notbeanagentofthe1cgeeorganization.

the supervising physician He need not be an agent of If the broad grant to the licensee authorizes all the licensee's agents to handle material, the separate grant to supervised individuals is unnecessary in most cases. It is necessary if the broad grant is intended to be limited to the. licensee's agent who is supervised by a physician. It is also necessary to authorize material handling by a person who is not an agent of the licensee organizatior, but who uses the licensee's material under the supervision of a physician (this is the case where a technician is the agent of a supervising physician who is not an agent of the licensee).

Defining the source and scope of authority to handle radioactive material is particularly important when the licensee provides nuclear medicine services at a location remote from his base of operations. A technician agent of a licensee supplying this service may do so at a medical facility whose owner or operator is not licensed. He may be under the supervision of a pbysician 1

O who is not an agent of either the licensee or the host medical organization.

In this case the analysis of authority may be difficult but it will involve the considerations discussed above; the character of the applicant; the sections of the regulations applied to the application; the authority granted 14/ The license typically does not describe what degree of supervision is required. Neither do the current regulations. The proposed revision of Part 35 describes what constitutes supervision.

15] As a practical matter, the supervised individual would probably be the agent of either the licensee or the supervising physician. He needs to have training in requirements radiation and those ofsafety (only)as 5 35.14 a)(3 . aSection35.14(a)(3)is result of the Part 19 probably of little effect. It is unlikely that the applicant at the time of application knows all of the personnel who will be involved in i the preparation and use of material, much less whether they are trained in a manner appropriate to their prospective participation in radioactive material use.

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o DMEf the licensee and others; and the conditions imposed upon the exercise of the authority granted. The conclusions which result from the analysis will not be affected by the licensee's provision of nuclear medicine services at a i

location remote from his base of operations.

l John F. Klucsik. Attorney 1

Regulations Division l; Office of the Executive Legal Director 4 '

cc: V. Miller

.l J. Del Medico l

N. McElroy l i

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