[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9336]


[[Page Unknown]]

[Federal Register: April 19, 1994]


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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-01204, License No. 01-00643-02 EA 92-204]

 

Department of Veterans Affairs Medical Center, Birmingham, AL; 
Order Imposing Civil Monetary Penalty

I

    The Department of Veterans Affairs Medical Center, Birmingham, 
Alabama (Licensee) is the holder of Byproduct Material License No. 01-
00643-02 (License), issued by the U.S. Nuclear Regulatory Commission 
(NRC or Commission) pursuant to 10 CFR parts 30 and 35. The Licensee is 
authorized to possess and use byproduct material for diagnostic and 
therapeutic nuclear medicine procedures, and for research and 
development purposes. This is a broad scope license and use of licensed 
material on humans is permitted by or under the supervision of a 
physician authorized by the Licensee's Radiation Safety Committee, 
subject to the training and experience requirements in 10 CFR Part 35, 
Subpart J. The License was most recently amended on April 10, 1992, and 
was due to expire on July 31, 1992. The License is currently under 
timely renewal.

II

    On September 13, 1991, an allegation was received by the NRC 
relating to possible administrations of radiopharmaceuticals in excess 
of prescribed dosages and possible falsification of records to conceal 
the misadministration. As a result, an investigation was conducted by 
the NRC Office of Investigations from October 9, 1991, through 
September 14, 1992.
    The results of the investigation indicated that the Licensee had 
not conducted its activities in full compliance with NRC requirements. 
A written Notice of Violation and Proposed Imposition of Civil Penalty 
(Notice) was served upon the Licensee by letter dated September 13, 
1993. The Notice addressed the nature of the violations, the provisions 
of the NRC's requirements that had been violated, and the amount of the 
civil penalty proposed for the violations.
    The Licensee responded to the Notice by two letters dated November 
9, 1993. In its response, the Licensee admitted Violations A and C.1, 
denied Violations B and C.2, and requested partial mitigation of the 
civil penalty based on its prior performance.

III

    After consideration of the Licensee's response and the statements 
of fact, explanation, and argument for partial mitigation contained 
therein, the NRC staff has determined, as set forth in the Appendix to 
this Order, that the violations occurred as stated and that the penalty 
proposed for the violations designated in the Notice should be imposed.

IV

    In view of the foregoing and pursuant to Section 234 of the Atomic 
Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205, 
it is hereby ordered That: The Licensee pay a civil penalty in the 
amount of $10,000 within 30 days of the date of this Order, by check, 
draft, money order, or electronic transfer, payable to the Treasurer of 
the United States and mailed to the Director, Office of Enforcement, 
U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, 
Washington, DC 20555.

V

    The Licensee may request a hearing within 30 days of the date of 
this Order. A request for hearing should be clearly marked as a 
``Request for an Enforcement Hearing'' and shall be addressed to the 
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555, with a copy to the Commission's Document Control 
Desk, Washington, DC, 20555. Copies also shall be sent to the Assistant 
General Counsel for Hearings and Enforcement at the same address and to 
the Regional Administrator, NRC Region II, 101 Marietta Street, NW., 
suite 2900, Atlanta, Georgia 30323.
    If a hearing is requested, the Commission will issue an Order 
designating the time and place of the hearing. If the Licensee fails to 
request a hearing within 30 days of the date of this Order, the 
provisions of this Order shall be effective without further 
proceedings. If payment has not been made by that time, the matter may 
be referred to the Attorney General for collection.
    In the event the Licensee requests a hearing as provided above, the 
issues to be considered at such a hearing shall be:
    (a) Whether the Licensee was in violation of the Commission's 
requirements as set forth in Violation B and Violation C.2 of the 
Notice referenced in Section II above, and
    (b) Whether, on the basis of such violations and the additional 
violations set forth in the Notice of Violation that the Licensee 
admitted, this order should be sustained.

    Dated at Rockville, Maryland, this 8th day of April 1994.

    For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.

Appendix--Evaluations and Conclusion

    On September 13, 1993, a Notice of Violation and Proposed 
Imposition of Civil Penalty (Notice) was issued for three violations 
identified during an investigation conducted by the NRC Office of 
Investigations (OI) from October 9, 1991 through September 14, 1992. 
Department of Veterans Affairs (Licensee) responded to the Notice in 
two letters dated November 9, 1993. In its responses, the Licensee 
admitted Violations A and C.1, denied Violations B and C.2, and 
requested partial mitigation of the civil penalty based on its prior 
performance and lack of evidence of actual harm to any patient or 
member of the public. The NRC's evaluations and conclusion regarding 
the Licensee's requests are as follows:

Restatement of Violation B

    10 CFR 35.53 requires, in part, that a licensee measure the 
activity of each radiopharmaceutical dose that contains more than 10 
microcuries of a photon-emitting radionuclide before medical use.
    Contrary to the above, the technologist failed to measure three 
radiopharmaceutical doses that contained more than 10 microcuries of 
a photon-emitting radionuclide administered to patients on July 22, 
1991.

Summary of Licensee Response to Violation B

    The Licensee denied this violation and indicated that the 
evidence does not support the technologist's alleged failure to 
measure the radiopharmaceutical doses on July 22, 1991. In support 
of its denial, the Licensee stated that the count rates of these 
doses when compared with the count rates of seven doses administered 
within sixty days of July 22, 1991, reflect doses within acceptable 
limits. Therefore, argues the Licensee, it is not credible that this 
could be a chance result in the absence of measuring by the 
technologist.

NRC Evaluation of Licensee's Response to Violation B

    The Licensee presented data to indicate that the doses 
administered on July 22, 1991, had count rates similar to those 
previously administered. This data, however, provides no information 
which would indicate that the does administered to patients on July 
22, 1991, were measured in a dose calibrator at the appropriate 
setting for Technetium-99m. The information is not material to 
Violation B in that your analyses provides information relating to 
the activity of material as measured during the scans themselves, 
but not whether activity was measured in the dose calibrator prior 
to administration.
    As stated in the NRC letter transmitting the Notice, the NRC's 
conclusion that the technologist failed to measure the dosages was 
based on: (1) The setting of a different isotope channel on both 
dose calibrators during the time the technologist stated he measured 
three patient doses, (2) the missing radioactive material, (3) the 
high volume of radioactive material recorded by the technologist on 
the patient dose log, and (4) the technologist's past history of 
committing errors and omissions in patient dose records.
    If proper measurements had occurred, the technologist would have 
noticed the improper radionuclide channel (i.e., Thallium) and reset 
it when measuring the doses. The technologist would not have 
recorded the high volumes on the patient dose log. The technologist 
admitted that the volumes in the records were fabricated, indicating 
that he had no knowledge of the amount of doses administered 
providing further evidence that he has not measured the doses. The 
Licensee's response did not address any of the evidence which 
indicated that the dosages had not been measured prior to 
administration.
    Moreover, the staff disagrees with the Licensee's argument that 
it is not credible to have the count rate of the seven doses 
favorably compare with the doses administered on July 22, 1991, in 
the absence of measuring the dose in the dose calibrator. An 
experienced technologist, knowing a prescribed radiopharmaceutical 
dose, may approximate with some success the radiopharmaceutical dose 
by approximating the volume of the material. However, this method is 
not reliable to assess the radiopharmaceutical dose and does not 
meet the requirement in 10 CFR 35.53(a) to measure each 
radiopharmaceutical dosage in a dose calibrator.
    The preponderance of the evidence in this case indicates that 
the technologist failed to measure the doses. The NRC concludes that 
the violation did occur as stated in the Notice.

Restatement of Violation C.2

    10 CFR 35.21 requires, in part, that the licensee, through the 
Radiation Safety Officer (RSO): (1) Ensure that radiation safety 
activities are being performed in accordance with approved 
procedures and regulatory requirements in the daily operation of the 
licensee's byproduct material program; and (2) that the RSO 
investigate misadministrations and other deviations from approved 
radiation safety practice and implement corrective actions as 
necessary.
    Contrary to the above, the licensee failed to conduct a prompt 
and adequate investigation of possible misadministrations of 
radiopharmaceuticals to patients during the week of July 22 through 
26, 1991. Specifically, once notified of the allegation, the RSO 
failed to obtain a copy and review a letter from the acting 
supervisor describing the possible misadministrations or to 
interview individuals who had first-hand knowledge that was material 
to the investigation.

Summary of Licensee's Response to Violation C.2

    The Licensee denied that Violation C.2 constituted a breach of 
regulations. While it admitted that the regulations require the RSO 
to investigate misadministrations, the Licensee stated that the 
regulations provide no standard for the performance of the 
investigation and do not require that the investigation be performed 
in a ``prompt or adequate'' manner or to the satisfaction of the 
NRC. The Licensee stated that it conducted an investigation 
concerning this matter.
    The Licensee also stated that during the enforcement conference 
held on February 16, 1993, Mr. Ebneter, Regional Administrator, 
Region II, pointed out that there was no regulation that tells the 
Licensee what has to be included in an investigation. The Licensee 
also stated that Dr. Mallett, Deputy Director, Division of Radiation 
Safety and Safeguards, Region II, indicated that he was comfortable 
with the Licensee's statement that it has looked at the rates (as 
part of the investigation) and expressed satisfaction with the 
results of the Licensee's investigation.
    The Licensee denied that the investigation was not prompt or 
thorough, since the RSO was summoned back to duty from vacation to 
look into the matter, the technologist at fault was counseled, and 
the NRC notified. The Licensee's investigation concluded from 
statistical studies that there was no misadministration and that the 
errors were ones of record-keeping. In addition, the Licensee stated 
that the NRC has not suggested what additional information or result 
could have been obtained had the investigation been performed 
differently.

NRC Evaluation of Licensee's Response to Violation C.2

    The need for the Licensee to perform investigations that are 
prompt and adequate is implicit in 10 CFR 35.21. One purpose of the 
requirement for an investigation of a possible misadministration is 
to determine whether there has, in fact, been any misadministration. 
Further, the Commission's regulations require the licensee to 
implement as necessary and, ensure corrective actions are taken. 
This protects individual patients and prevents future or potential 
misadministrations. An investigation that is not prompt and not 
adequate cannot achieve these goals nor preclude potential or 
recurring violation. Accordingly, the NRC rejects the Licensee's 
argument. In view of the above, the issue is whether the Licensee's 
investigation was in fact prompt and adequate.
    The NRC recognizes that the RSO was summoned back from vacation 
and initiated an investigation within a few days of the request for 
his return, that the technologist at fault was counseled, and that 
the NRC was notified.
    However, the NRC maintains that the Licensee's investigation was 
not adequate as defined in the NRC regulations. Section 35.21 of 10 
CFR part 35, requires, in part, that a Licensee investigate 
misadministrations and other deviations from approved radiation 
safety practices and ``* * * implement corrective actions as 
necessary'' (emphasis added). The NRC does expect, and the 
regulations do require, that such investigations be adequate to meet 
the purpose of the investigations--the implementation of effective 
corrective actions.
    The investigation conducted by the Licensee was not adequate to 
determine the root cause of the problems and thus, the Licensee's 
corrective actions were ineffective, as evidenced by the 
technologist's continual failures to record the administered 
radiopharmaceutical activity and volume and the lack of supervisory 
oversight (see pages 75 and 76 of the transcribed enforcement 
conference). During the enforcement conference referenced in the 
Licensee's response, the NRC pointed out that the Licensee did not 
perform an adequate investigation (P 75 and 76). The two specific 
issues contained in the Notice, failure to review the letter that 
described the possible misadministration and failure to interview 
individuals who had first-hand knowledge of this matter, are 
examples of inadequacies in the investigation that led to the 
Licensee's inability to determine the root cause and take effective 
corrective actions.
    With regard to Mr. Ebneter's statement that there was no 
regulation that tells the Licensee what has to be included in 
investigations, it is true that the NRC regulations do not prescribe 
the exact methodology for conducting investigations. As discussed 
above in this section and by Mr. Ebneter during the enforcement 
conference, however, the investigation results are important and the 
regulations do prescribe that the investigation must be adequate to 
implement effective corrective actions.
    Concerning Dr. Mallett's statement that he was comfortable with 
the Licensee's review of the count rates, the NRC notes that Dr. 
Mallett's statement was not intended to suggest that the NRC 
considered the investigation adequate; the statement was limited to 
what it said--that Dr. Mallett was comfortable with that one aspect 
of the investigation (i.e., the Licensee's review of the count 
rates). The Licensee's assertion that this meant Dr. Mallett was 
satisfied with the investigation as a whole appears to have been 
taken out of context. Within the context of the full meeting, it is 
clear the NRC did not conclude that the investigation had been 
adequate.
    The NRC concludes that the violation did occur as stated in the 
Notice.

Summary of Licensee's Request for Mitigation

    The Licensee stated that Violation B and Violation C.2 did not 
occur. The Licensee stated that there is no evidence of harm to any 
patient or member of the public, even of a minor nature. The 
Licensee further stated that the evidence does not demonstrate a 
misadministration of dosages on July 22, 1991 and that the 
technologist who administered the doses denied administering 
excessive doses to patients on July 22, 1991.
    The Licensee further contended that the errors were essentially 
record-keeping errors of the Severity Level IV or V type that might 
be aggregated to Severity Level III or IV but are not Severity Level 
II violations. In addition, the Licensee stated that its performance 
has improved over the past year as demonstrated by the last two NRC 
inspections. Thus, the Licensee argues, in accordance with the 
Enforcement Policy, the NRC should not have escalated the penalty 50 
percent for poor past performance because its performance is 
improving.

NRC Evaluation of Licensee's Request Mitigation

    The arguments made by the Licensee concerning the acceptability 
of the doses and the lack of evidence of harm to patients or members 
of the general public do not relate to the requirement to measure 
dosages prior to administration or to the requirements to perform 
adequate investigation of possible misadministrations. Further, the 
Licensee's contention that the evidence does not demonstrate 
misadministration of doses, or excessive or inadequate doses, is not 
pertinent to the violation cited. The Licensee was not cited for 
administering excessive or inadequate doses, or misadministrations. 
These arguments only provide information that the Licensee believes 
that excessive dosages were not administered.
    With regard to the Licensee's request to reduce the severity 
level from a Severity Level II to a Severity Level III or Severity 
Level IV, the NRC notes that Section IV of the Enforcement Policy 
(i.e., 10 CFR part 2, Appendix C) states, in part, that 
``Supplements I through VIII provide examples and serve as guidance 
in determining the severity level for violations in each of the 
eight activity areas. However, the examples are neither exhaustive 
nor controlling * * *. The NRC reviews each case being considered 
for enforcement action on its own merits to ensure that the severity 
of the violation is characterized at the level best suited to the 
significance of the particular violation. In some cases special 
circumstances may warrant an adjustment to the severity level 
characterization.''
    In this case, the NRC had a very significant regulatory concern 
as noted in the cover letter to the Notice. There were numerous 
instances where patient dosages were not measured, numerous 
instances where patient dosages were not accurately recorded prior 
to administration, and for an extended period of time, effective 
corrective actions were not taken. The severity of the violations 
was exacerbated by the technologist's continual failures to 
accurately record patient dosages despite repeated counseling, and 
by the failure on the part of the Chairman of the Radiation Safety 
Committee to take strong and effective corrective actions in the 
face of the known repeated violations on the part of the 
technologist. Given these circumstances and the very significant 
regulatory concern surrounding this case, a Severity Level II 
Problem categorization was warranted, in accordance with Section IV 
of the Enforcement Policy.
    With reference to the Licensee's performance, the NRC recognizes 
that inspections of the Licensee during the period of late 1992 and 
1993 have not shown the same level of poor performance as identified 
in 1991 and early 1992. The Enforcement Policy statement regarding 
improved performance relates to performance during the period of 
either the last two years prior to the inspection at issue or the 
period of the last two inspections prior to the inspection at issue, 
whichever is longer. Thus, any improvement in performance subsequent 
to the inspection at issue may not be considered as part of any 
mitigation for the licensee performance factor.

NRC Conclusion

    Based on its evaluation of the Licensee's responses, the NRC 
concludes that Violations B and C.2 did occur as stated, that all 
violations delineated in the Notice were properly categorized in 
aggregate as a Severity Level II problem, and that an adequate basis 
for mitigation of the proposed civil penalty has not been provided 
by the Licensee. Accordingly, a civil monetary penalty in the amount 
of $10,000 should be imposed by order.

[FR Doc. 94-9336 Filed 4-18-94; 8:45 am]
BILLING CODE 7590-01-M