ML19263H255
| ML19263H255 | |
| Person / Time | |
|---|---|
| Issue date: | 06/27/1980 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| Shared Package | |
| ML19263H254 | List: |
| References | |
| NUDOCS 8007090412 | |
| Download: ML19263H255 (5) | |
Text
.
Appendix A NOTICE OF VIOLATION Nuclear Pharmacy, Inc.
License No. 12-18044-01MD EA-80-33 This refers to the inspection conducted by representatives of the Region III (Chicago) office on January 22 and February 27, 28, and 29,1980.
Based on this inspection, it appears that certain of your activities were in noncom-pliance with NRC requirements, as noted below.
1.
10 CFR 20.201(b) requires that each licensee make or cause to be made such surveys as may be necessary to comply with the regulations.
10 CFR 20.201(a) states that a " survey" is an evaluation of the radiation hazards.
When appropriate, such an evaluation may require a physical measurement.
10 CFR 20.101 is a regulation whi~h limits exposures to individuals in restricted areas.
Contrary to the above:
No evaluation was made of whole body and extremity exposures during a.
March 1979 for at least ten (10) individuals working in the restricted area.
The required measurement of exposure was not
'm.
in that dosimeters assigned to workers during this period were nc t returned to the vendor for readout and no other evaluation was made to determine compliance with 10 CFR 20.101.
b.
No evaluation was made of whole body exposures for nine individuals whose August, 1979, dosimeters were damaged and could not be evaluated by the dosimeter vendor to determine compliance with 10 CFR 20.101.
c.
No evaluation was made of the extremity exposures of six individuals for wriom hand dosimeter results were missing during at least one (1) quarter during 1979, to determine compliance with 10 CFR 20.101.
Dosimeters were either not provided, not used, or not returned for evaluation.
This is an infraction.
(Civil Penalty - $1,500) 2.
10 CFR 20.101(a) limits the extremity dose of an individual in a restricted area to 18.75 rems per calendar quarter.
Contrary to the above, an individual working in the restricted area received an extremity dose of 21.8 rems during the 4th calendar quarter of 1979.
This is an infraction.
(Civil Penalty - $1,000) 8007090flo(
l
Appendix A 3.
10 CFR 20.103(a)(3) requires that the licensee measure the airborn concentration of radioactive material and, as appropriate, use bic' ;ay to determine compliance with 10 CFR 20.103 limits.
License Condit i 15 of NRC License No. 12-18044-01MD requires that the licensee posse; and use licensed material in accordance with statements, representations, and procedures contained in a letter dated July 5, 1979, which presents the licensee's thyroid bioassay program for iodine-131.
Contrary to the above, since February 1979, the licensee had no air sampling or bioassay program capable of deter mining compliance with 10 CFR 20.103.
As of February 21, 1980, the licensee's thyroid counting system had not been calibrated in accordance with the procedures described in the July 5, 1979, letter; and the total activity in the thyroid was not being determined from the monthly gross thyroid counts to determine compliance with 10 CFR 20.103 as described in the letter.
This is an infraction.
(Civil Penalty - $1,000) 4.
10 CFR 20.201(b) requires each licensee to make or cause to be made such surveys as may be necessary for him to comply with the regulations in this part.
10 CFR 20.106 limits the amount of licensed material that can be released to the unrestricted area.
Contrary to the above, during 1979 and as of February 29, 1980, the licensee had not made surveys to determine that the concentrations of iodine 131 released in airborne effluents fron. fume hoods in its facilities, were within the limits set forth in 10 CFR 20.106.
This is an infraction.
(Civil Penalty - $1,000) 5.
10 CFR 20.405(a) requires that each licensee make a written report to the Regional Office within 30 days of each exposure of an individual to radiation in excess of the applicable limits in 10 CFR 20.101.
Contrary to the above, the licensee's report of the fourth quarter 1979 overexposure to an individual's extremity as identified in Item 2 above, was not made until March 7, 1980, and then only after the inspector brought it to the attention of the Assistant Manager on January 22, 1980, and again to the company President on February 29, 1980.
This is a deficiency.
(Civil Penalty - $300) 6.
License Condition 15 of NRC License No. 12-18044-01MD requires that the licensee possess, use, package, label and distribute licensed material in accordance with statements, representations, and procedures contained in letters dated November 21, 1977, and March 21, 1978.
Item 4 of the
" Radiation Protection Program" attached to the November 21, 1977 letter, states that a monitor will be placed at all access entrances and exits
'or hand and shoe monitoring.
The letter dated March 21, 1978, states that monitoring of hands and clothing is required beforc leaving the restricted area.
Appendix A Contrary to the above, on the days of this inspection, inspectors observed that; a.
no monitor was provided for the rear exit of the Ontario Street facility.
b.
some individuals exited the front exit of the restricted area at the Ontario Street Facility without monitoring hands and clothing.
This is a deficiency.
(Civil Penalty - $300) 7.
License Condition 15 of NRC License No. 12-18044-01MD requires that the licensee shall possess, use, package, label and distribute licensed material in accordance with statements, representations, and procedures contained in a letter dated November 21, 1977.
Item 5 of the " Radiation Protection Program" attached to this letter states that daily wipe surveys will be performed in designated areas of the laboratory and storage Item 12 states that the restricted area will be monitored using a areas.
low level survey meter along with the wipe surveys and that readings will be recorded as described in the original application.
Contrary to the above, from February 9,1979 through January 28, 1980, wipe surveys were performed on only 40 dates at the Water Tower Place Facility.
From January 4, 1979 through January 28, 1980, wipe tests were performed on only 41 dates at the Elmhurst Facility.
Direct surveys were not performed and recorded on January 15 and 18, 1979, at the Elmhurst Facility and on February 25, 1980, at the Ontario Street facility.
This is a deficiency.
(Civil Penalty - $300) 8.
10 CFR 20.401(a) requires that each licensee maintain records showing the radiation exposures of all individuals fur whom personnel monitoring is required.
Such records shall be kept on Form NRC-5, in accordance with the instructions contained in that form or on clear and legible records containing all the information required by Form NRC-5.
Form NRC-5 requires a running total for exposure during the calendar quarter.
Contrary to the above, the licensee did not maintain adequate exposure a
records for August and September, 1979 with all the information required by Form NRC-5.
When the licensee switched dosimeter vendors in the beginning of August, the July exposure measured by the original vendor was not included in the running total for the calendar third quarter 1979.
Consequently, the August and September running totals were not correct.
This is a deficiency.
(Civil Penalty - $300) 9.
License Condition 15 requires that material be possessed and used in accordance with statements, representations, and procedures contained in a letter dated November 21, 1977.
Item 2 of the " Radiation Protection
Appendix A Program," attached to this letter, states that drivers of delivery vehicles" will wear wrist badges or equivalent and be processed on a monthly basis, the results being recorded and becoming a matter of record."
Contrary to the above, from June 1979 to February 1979, twenty-nine individuals worked as drivers for the licensee and were not assigned any wrist badges or equivalent.
This is a deficiency.
(Civil Penalty 0) 10.
License Condition 15 of f4RC License No. 12-18044-01MD requires that the licensee possess, use, package, label and distribute licersed material in accordance with statements, representations, and procedur contained in a letter dated flovember 21, 1977.
Item 1 of the " Radiatio. Protection Program" attached to this letter states that all incoming shipments of radiopharmaceuticals will be monitored.
The monitoring w;11 be accom-plished by taking a wipe test of both the outside and inside of the packaging container.
Results of this survey will be kept for permanent record.
Contrary to the above, from February 1, 1980, through February 15, 1980 62 packages received at the Ontario Street Facility, were not wipe tested for contamination.
These packages were excluded from wipe test based on instructions to employees which were in contradiction to the procedure established by the license condition.
This is a deficiency.
(Civil Penalty - 0) 11.
10 CFR 20.407 requires all persons specifically licensed by the Commission to submit within the first quarter of calendar year 1980 to the Director of Management and Program Analysis, U.S. fluclear Regulatory Commission, a statistical summary report of the personnel monitoring information recorded by the licensee for individuals for whom personnel monitoring was provided in calendar year 1979.
Contrary to the above, the licensee did not provide this report within the first quarter of 1980 as required.
This is a deficiency.
(Civil Penalty - 0)
This Notice of Violation is sent to Nuclear Pharmacy, Inc., pursuant to the provisions of Section 2.201 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations.
Nuclear Pharmacy, Inc., is hereLy required to submit to this office, within twenty-five (25) days of the date of this notice, a written statement or explanation in reply, including for each item of noncompliance, (1) admission or denial of the alleged item of noncompliance; (2) the reasons for the item of noncompliance if admitted; (3) the corrective steps which will be taken and the results achieved; (4) corrective steps which will be taken to avoid further noncompliance; and (5) the date when full compliance will be achieved.
Appendix B NOTICE OF PROPOSED IMPOSITION OF CIVIL PENALTIES Nuclear Pharmacy, Inc.
License No. 12-18044-01MD EA-80-33 This office proposes to impose civil penalties pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (42 USC 2282) and to 10 CFR 2.205, in the cumulative amount of Five Thousand Seven Hundred Dollars ($5,700) for the specific items of noncompliance set forth in Appendix A to the cover letter.
In proposing to impose civil penalties pursuant to this section of the Act and in fixing the proposed amount of the penalties, the factors identified in the Statements of Consideration published in the Federal Register with the rule making action which adopted 10 CFR 2.205 (36 FR 16894) August 26,1971, and the " Criteria for Determining Enforcement Actions," which was sent to NRC licensees on December 31, 1974, have been taken into acount.
Nuclear Pharmacy, Inc., may within twenty-five (25) days of the date of this notice pay the civil penalties in the cumulative amount of Five Thousand Seven Hundred Dollars ($5,700) or may protest the imposition of the civil penalties in whole or in part by a written answer.
Should Nuclear Pharmacy, Inc., fail to answer within the time specified, this office will issue an order imposing the civil penalties in the amount proposed above.
Should Nuclear Pharmacy, Inc., elect to file an answer protesting the civil penalties, such answer may (a) deny the items of noncompliance listed in the Notice of Violation in whole or in part, (b) demonstrate extentuating circumstances, (c) show error in the Notice of Violation, or (d) show other reasons why the penalties should not be imposed.
In addition to protesting the civil penalties in whole or in part, such answer may request remission or mitigation of the penalties.
Any written answer in accordance with 10 CFR 2.205 should be set forth separately f rom the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate by specific reference (e.g., giving page and paragraph numbers) te avoid repetition.
Nuclear Pharmacy, Inc.'s attention is directed to the other provisions of 10 CFR 2.205 regarding, in particular, failure to answer and ensuing orders; answer, consideration by this office, and ensuing orders; requests for hearings, hearings and ensuing orders; compromise; and collection.
Upon failure to pay any penalty due, which has been subsequently determined in accordance with the applicable provisions of 10 CFR 2.205, the matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Atomic Energy Act of 1954, as amended (42 USC 2282).