ML20032B173
| ML20032B173 | |
| Person / Time | |
|---|---|
| Issue date: | 10/22/1981 |
| From: | Stello V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Tiffany Fields MICA IMAGING, INC.(FORMERLY IML IMAGING; ISOTOPE |
| Shared Package | |
| ML20032B174 | List: |
| References | |
| EA-81-032, EA-81-32, NUDOCS 8111050034 | |
| Download: ML20032B173 (3) | |
Text
-
A f(;IL(L
> v OCT 2 21981 A
//[
/ D@
License No. 12-13568-01
)
EA-81-32 4
gcrea c_
Isotope Measurements Laboratories,
- % 'gu19g7 v
u c$
'E-Incorporated
(
c ATTN: Mr. Theodore Fields, President K
y 3304 Commercial Avenue
' sf gy\\g Northbrook, IL 60062 sf Gentlemen:
This is in response to your June 24, 1981 letter in response to the Notice of Violation and Proposed Imposition of Civil Penalty and the Order to Show Cause why your license should not be suspended, sent to you on May 28, 1981.
In your response to tne Order to Show Cause you described changes in manage-ment controls, responsibilities of the Radiation Safety Officer and training of personnel, which together with procedural changes, were intended to assure adequate control of your licensed activities.
Your letter states that you agree to comply with NRC requirements and you apparently have done so since November 1980.
After careful consideration of your letter dated June 24, 1981 in respon u to the Grder to Show Cause why your license should not be suspended, we have found that you have shown sufficient cause why the license should not be suspended.
Accordingly, the proceeding on the Order to Show Cause is terminated.
.ifter careful review of your June 24, 1981 letter in reponse to the Notice of Violation and Proposed Imposition of Civil Penalty we have determined that the item of noncompliance did occur as stated.
No adequate reasons have been given as to why the penalty for the item should not be imposed as proposed in the Notice of Proposed Imposition of Civil Penalty. Accordingly, we hereby serve the enclosed Order on Isotope Measurements Laboratories, Incorporated (IML) imposing a civil penalty in the amount of Five Thousand Seven Hundred Dollars. The basis for the Order imposing a civil penalty is:
(1) IML was aware of the regulatory requirements since 1979; (2) an enforcement conference was held on June 20, 1980, to explain the regulatory requirements and the NRC's position; (3) IML continued distributing byproduct material despite receipt of an Immediate Action Letter on August 8, 1980, confirming NRC's understanding that IML would cease the unauthorized distribution at all locations, and (4) IML was aware of the NRC policy and regulatory requirements and continued to engage in the unauthorized procurement and distribution of radiopharmaceuticals.
In the past the NRC has waived the requiremer.ts for a Part 32 license and has granted authorization for hospitals to share eluate obtained from a generator located in one hospital for use in a second hospital.
The criteria for granting CERTIFIED MAIL RETURN RECEIPT REQUESTED 8111050034 811022 NMS LIC30 12-13568-01 PDR
.b',
Isotope Measurements Laboratories, Incorporated this type of authorization have been explained to you on numerous occasions, the most recent of which being in the denial of your request for a license amendment for Hopedale Medical Complex, Hopedale, Illinois, dated November 11, 1980.
The Regional Licensing Section denied this request on August 5, 1981.
This was also explained to you as a result of your request to the NRC for authorization to elute radiopharmaceuticals and distribute these eluates to other IML client hospitals.
This amendment request was denied by NRC's Office of Nuclear Material Safety and Safeguards on April 27, 1979. This denial was based upon IML's failure to submit the necessary information required by 10 CFR 32.72.
In your June 24, 1981 letter in response to the Proposed Imposition of a Civil Penalty, you indicated that you would request a hearing in the event that an Order was issued imposing the proposed penalty.
If you still wish to request a hearing in this matter, please follow tne instructions in Section V of the enclosed Order Imposing a Civil Penalty.
We will continue unannounced inspections of your licensed activities.
The results of these inspections, including your implementation of the corrective actions described in your letters, will be considered in determining whether any further enforcement action, such as modification, suspension, or revocation of your license, is appropriate.
i With regard to the regtest in your June 10, 1981 letter that certain informa-tion contained in Inspecticn Report No. 030-0429/80-02 and the correspondence regarding the Notice of Violation be withheld from public disclosure pursuant to 10 CFR 2.790, for the reasons set forth in the Appendix to this letter, your request is denied.
hr1SnEbt'l B7 n, c. myoung Victor Stello, Jr., Director Office of Inspection and Enforcement
Enclosures:
1.
Order Irposing a Civil Penalty 2.
Appendix cc:
A. Sidney Johnston, Attorney Distribution VStello, IE TIC Order Book SEE PREVIOUS WHITE RCDeYoung, IE SECY EI Reading File FOR CONCURRENCES DThompson, IE CA IE Reading File HThornburg, IE APuglise L-316, CON JMurray, ELD Regional Enforcement Coordiantors JLieberman, ELD RI, RII, ilIII, RIV, RV KCyr, ELD FIngram, PA Department of Public Health VMiller, NMSS JCummings, 0IA ATTN:
Maury Neuweg, Chief PDR JCrooks, AE0D Division of Radiation Protection NSIC CP Book 535 W. Jefferson Street Springfield, IL 62761 WPU:JD EI:IE EI:IE ELD D:EI:IE DD:IE D:IE 10/21/81 TBrockett RWessman JMurray DThompson RCDeYoung VStello 5520 10/ /81 10/ /81 10/ /81 10/ /81 10/ /81 10/ /81
F
[. t Isotope Measurements Laboratories, Incorporated this type of authorization has been explained to you on numerous occasions, the most recent being your request for a license amendment for Hopedale Medical Complex, Hopedale, Illinois, dated November 11, 1980, and the written denial of this request by the Regional Licensing Section on August 5, 1981.
This was also explained to you as a result of your request to the NRC for authorization to elute radiopharmaceuticals and distribute these eluates to other IML client hospitals.
This amendment request was denied by NRC's Office of Nuclear Material Safety and Safeguards on April 27, 1979.
This denial was based upon IML's failure to submit the necessary information required by 10 CFR 32.72.
In your June 24, 1981 letter in response to the Proposed Imposition of a Civil Penalty, you indicated that you would request a hearing in the, event that an Order was issued imposing the proposed penalty.
If you still wish to request a hearing in this matter, please follow the instructions in Section V of the enclosed Oroer Imposing a Civil Penalty.
We will continue unannounced inspections of your licensed activities.
The results of these inspections, including your implementation of the corrective actions described in your letters, will be considered in determining whether anj further enforcement action, such as modification, suspension, or revocation of your license, is appropriate.
With regard to the request in your June 10, 1981 letter that certain informa-tion contained in Inspection Report No. 030-0429/80-02 and the correspondence regarding the Notice of Violation be withheld from public disclosure pursuant to 10 CFR 2.790, for the reasons set forth in the Appendix to this letter, your request is denied.
Sincerely, Victor Stello, Jr., Director Office of Inspection and Enforcement
Enclosures:
1.
Order Imposing a Civil Penalty 2.
Appendix Mh
'Ki"wgm g(
Distribution VStello, IE TIC Order Bork RCDeYoung, IE SECY EI Reading File DThompson, IE CA IE Reading File 4 io NHSS 60/6 HThornburg, IE APuglise L-316, CON ogteQgg JMurray, ELD Regional Enforcement Coordiantors JLieberman, ELD RI, RII, RIII, RIV, RV KCyr, ELD FIngram, PA Department of Public Health VMiller, NMSS JCummings, OIA ATTN:
Maury Neuweg, Chief PDR JCrooks, AEOD Division of Radiation Protection N5IC CP Book 535 W. Jefferson Street Sprin field, IL 62761 I
/
f
/p WPU:JD EI:IE ELD D:EI DD:
D:I 10/9/81 tt RWessman JMurray DThompson RC oung VSt' ell 5520 10/q/81 10/g/81 10/11 /81 10 Q/81
-10/6/81 10/p /81
i 1
Attachment i
EVALUATION AND CONCLUSION Regarding the item of noncompliance and associated civil penalty identified in the Notice of Violation (dated May 28,1981), the original item of noncompliance is restated and the Office of Inspection and Enforcement's evaluation and conclusion regarding the licensee's response (dated June 24, 1981) to the item is presented.
STATEMENT OF NONCOMPLIANCE License Condition 16 requires that licensed material be possessed and used in i
accordance with statements, representations, and procedures contained in i
application dated January 17, 1980.
Item 13 of this application provides for the licensee to receive "bvproduct material from licensed suppliers and deliver l
them to NRC licensed users '.
10 CFR 32.72 sets forth requirements for a licensee to manufacture and distribute radiopharmaceuticals (i.e., to become a licensed supplier).
Contrary to the above, during the period June 1978 to August 8, 1980 the licensee routinely received material as radiopharmaceuticals from licensees (hospitals) who were not licensed radiopharmaceutical suppliers and transferred these materials to other hospitals.-
Further, following receipt of an Immediate Action Letter dated August 8, 1980 l
tros the NRC confirming that this activity would be discontinued as of August 8,1980, t,he licensee received radiopharmaceuticals containing technetium-99m, from Mason District Hospital, Havana, Illinois, and delivered them to Hopedale Medical Complex, Hopedale, Illinois on August 26, September 2, 16, and 23, t
October 4, 7, 21, and 28, and November 4, 1980.
Also, on August 11, 14, 18, 21 and September 2, 8, 9, 12, 13, 20, 22, and 23, 1980, the licensee received twelve doses of radiopharmaceuticals containing technetium-99m from Pana Community Hospital, Pana, Illinois, and delivered this material to Hillsboro Hospital, Hillsboro, Illinois.
Mason District hospital and Pana Community Hospital are not licensed to manufacture and distribute byproduct material in accordance with 10 CFR 32.72.
Each day of unauthorized receipt and distribution is considered to be a separate infraction and a penalty of $300 is proposed for each (cumulative civil penalties t
- 19 days x $300 = $5,700).
In its response to the Notice of Violation the licensee admits that it eluted Mo/Tc99m generators at client hospitals and then transferred the eluate from i
the hospital in which the generator was situated to another hospital in which the eluate was utilized.
However, Isotope Measurements Laboratories, Incor-porated (IML) asserts that such conduct does not violate any NRC requirements.
In its view,10 CFR 32.72 only governs the " manufacture" of radiopharmaceuticals.
IML submits that all radiopharmaceuticals received by client hospitals of IML had been manufactured by persons properly licensed under 10 CFR 32.72.
In its view, the elution of a Mo/Tc99m generator does not constitute manufacturing i
i
~-nzn 1
. Attachment within the meaning of 10-CFR 32.72. Therefore, IML concludes, all radiophar-maceuticals received by-IML from hospitals were properly manufactured and a hospital with a generator does not need a 10 CFR 32.72 license in order to transfer eluate to IML.
Section 32.72 of the Commission regulations sets forth the requirements to manufacture and distribute radiopharmaceuticals containing byproduct material for certain groups of medical uses of byproduct material.
The terms of the section set forth requirements not only for the manufacture of radiopharmaceu-ticals but also for the labeling, packaging and distribution of these materials.
In the circumstances of concern here, a Mo/Tc99m generator was installed in a hospital under a license issued to the hospital.
IML then would extract doses of Tc99m and ship the eluate (by means of a truck driven by an IML technologist) for use in other hospitals.
In light of these facts, IML's focus on whether the elution of these generators constitutes manufacturing misses the point.
Whether or not elution of a generator is considered " manufacturing" under 10-CFR 32.72, other activities were being conducted which required a specific license.
A 10 CFR 32.72 license is needed in order to label, package and distribute radiopharmaceuticals.
For example, nuclear pharmacies receive generators from licensed manufacturers and repackage and distribute the eluate.
All of these pharmacies are required to have and do have licenses under 10 CFR 32.72.
Under its License Condition 16, IML can only receive byproduct material from entities with a license to supply materials.
The hospitals from which IML received the eluate on the occasions cited in the Notice of Violation did not have the required Part 32.72 license.
Consequently, the procurement actions of IML were contrary to its license.
IML notes in its response that it recognizes that NRC interprets 10 CFR 32.72 to mean that eluting a generator at.one hospital and transferring the eluate to another hospital requires a 10 CFR 32.72 license.
The licensee has been aware of this NRC interpretation of the applicability of 10 CFR 32.72 since at least April 1979.
Moreover, on at least two subsequent occasions the licensee was notified formally to stop all transfers and deliveries of byproduct material from facilities not licensed by the NRC for distribution under 10 CFR 32.72.
The civil penalty was proposed in this case not because of a significant_ impact on the public health and safety from the practices of IML, but rather because, despite its awareness that such practices constituted noncompliance, IML continued conducting its activity in nonconformance with the Commission requirements.
This deliberate failure to comply with regulatory requirements is unacceptable.
If a licensee believes that a regulation or license condition is unjustified, the solution is to seek its change, not to violate it.
j CONCLUSION The item asl stated is an item of noncon.pliance.
The licensee has not presented any information which would provide a basis for mitigation of the proposed civil penalty.
t 4
L
~ ~ ~
[
- y..;
,s t
s s
.,.y(.
\\'
~,
i N
s l-MPINDI/
gy
[
}
g By. letter dated June 10, 1981, Isotore Measur'emants Labbatorie.;, Iricorporated (IML) requested that certain inforn.? tion col>tained in Report No.' 030-0429/80-02, and in the letter and Appendix A (Notice of' Violation) dated May 28, 1981, to n
IML from Mr. Victor Stello, Director cf the' Office of Irspection and Enforcement, be withheld from pt.blic :disclosur6,;ur,suant tc 10 CFR:2.790.
For the reascas set forth below, this request has 'been denied'except for the withholding of thenameofthetechnic'anassociatedsiththefalsificationo(certainofficial l
hospital records.
IML contends that the ;iAlic release'1 q
q
~
i x
of the above cited documents wo: tid dis-close its confidential. o.storrer list,' tat the release of ipr emo3oy$es' names would espose the employees to recruitiin by competitors, and tilatstt:c disclosure of other IML employee naes would unnecessarily embarrass tinse' individuals.
Under certain circumsthces each of.these claims could have !cerit, but the facts in this case do rsit'provi,de 'a tiasi,s for'a blanket witpic9 ding of all of the information., y f
T x
ss g;-
T c
\\
J' First, IML and,iss pHncipal officar,)Mr. William B. Rivkin, are listed on each '
t of their client hospits1's Medical Ma,terials Liceniing documents as the
- I s
" person to contact reg'arding thiQppl.ic; tion.",3ML is also listed as the i, e.
contact fat hospital tmergencieg and radhtion continuing education; Mr. Rivkin j
is listed on th'e RadiOsotope Comittee for'each of the hospitals serviced by IML.
In shod.,SIML ib elready on etie public recor5f in these licensing documents b
i s
as being_ directly \\ tie.d ta and a service representative of those hospitals. Con-sequently, withholding Yrom the public ailist of hnspitais to which IHL has a professional relationship would not. prevent thef.incvery of IML's customer list.
Any perscn, let' alcne a competitor, could publicly ascertain the Fospitals within a geographic area which have commercial re,1htionships ytVIML.
s s
(
Second, withholding the identity of empisyees ia order to protect the:n from recruitment by 3 conpetitor usually protects highly qualified. individuals who i
would be assets'-to bny organization.
The esplve singlki outlIn the NRC y
meports in questicri;aere is mentioned becauce of his falsificatfon of official hospital recor's 'a;at tha. withholding of tnein; cme df that' individual is hereby l
d granted.
~
) 'i s(
Lastly, IML contends that the' disclosure.of the names of other individuals employed by or associated with IML would unnecessarily embarrass those indi-viduals. Recer.ticsse la on the, standard for withholding information because its disclosure'would constitute an unwarranted invasion of personal privacy have made a distinction between information that contains " intimate details of s
a highly personal nature" and information that is limited to " professional or proprietary" qualities. The reports to the business activities of.IML and.and documents in question here only. relate its employees; they do not deal in personal or intimate information.f Furthermore, as indicated above, the names of most of these individuals and the ashociation 'of these individuals with IML and I
the hospitals identified on the'subjectLdccuments are already in the public domain.
l l