ML19350A268
| ML19350A268 | |
| Person / Time | |
|---|---|
| Issue date: | 03/09/1981 |
| From: | Stello V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| Shared Package | |
| ML19350A269 | List: |
| References | |
| EA-81-016, EA-81-16, NUDOCS 8103130364 | |
| Download: ML19350A268 (4) | |
Text
_ _.
O Appendix A NOTICE OF VIOLATION Pharmatopes, Incorporated License No. 21-17189-01MD EA 81-16 Based on the investigation conducted on September 24-26 and October 2-3, 1980, it appears that certain of your activities were in noncompliance with NRC requirements, as noted below.
1.
10 CFR 71.5(a) requires that NRC licensees comply with the applicable packaging and transportation requirements of the Department of Trans-portation (DOT) in 49 CFR Parts 170-189.
A.
49 CFR 177.842(d) requires that packages of radioactive material must be so blocked and braced that they cannot change position during conditions normally incident to transportation.
Contrary to the above, on July 29, 1980, a package containing 100 millicuries of technetium-99m transported by Pharmatopes, Incorporated, Oak Park, Michigan, was neither blocked nor braced in a manner which would preclude its changing position in that the package was left unsecured on the bumper of a delivery vehicle and lost frcm the vehicle after leaving the Detroit Central Hospital, Detroit, Michigan.
This is a Severity Level II violation.
(Civil Penalty - 51,000)
B.
49 CFR 173.395(a)(1) requires that Type A quantities of radioactive material must be packaged in 00T Specification 7A general packaging, and further requires that each shipper of a Specification 7A package must maintain a certification and safety analysis demonstrating that the package meets DOT Specification 7A requirements.
Contrary to the above, the package involved in the incident on July 29, 1980, was nct in accordance with the specific certification and safety analysis on file with the licensee, in that the internal component of the package was not a model IC-008 or IC-004, as required by the certification.
Further, the leather belt, as required by the Specification 7A certification, was not secured to the midpoint of the exterior of the package.'
This is a Severity Level II violation.
(Civil Penalty - $500)
C.
49 CFR 173.393(b) requires that the outside of each package incor-porate a feature, such as a seal, which is not readily breakable and which, while intact, will be evidence that the package has not been illicitly opened.
810 818 0 3(aY
o Appendix A (Continued) Contrary to the above, on July 29, 1980, packages being transported from the licensee's Oak Park, Michigan, facility to Detroit Central Hospital did not have a security seal feature.
This is a Severity Level III violation.
The following items of noncompliance werc not related to the transportation activities as set forth in Item No.1 above and are characterized as infrac-tions or deficiencies.
2.
License Condition 22 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in an application dated September 8, 1976.
A.
Item No. 11, Attachment 5, states that the following tests wi?1 be performed on the dose calibrator at the time specified.
a.
daily constancy checks b.
annual linearity checks c.
annual accuracy tests d.
quarterly tests on commonly used settings Item H of the above referenced application, states calibration checks which do not agree within 5% indicate that the instrument should be repaired or adjusted.
A log will be kept of these calibration checks.
Contrary to the above, at the time of the investigation,1) no rect:rds of an annual linearity check performed on June 2,1980 were maintained; 2) the annual accuracy tests performed on June 6, 1977 and January 11, 1978, showed fluctuations greater than 5%, and the dose calibrator was not adjusted or repaired; 3) the record main-tained of the annual accuracy test performed on June 2,1980, did not provide sufficient information to determine if the instrument was calibrated to operate within plus or minus five percent accuracy;
- 4) quarterly checks on commonly used radionuclide settings have not been performed since the inception of this requirement on October 15, 1976; and, 5) a daily constancy check was not performed on September 24, 1980.
This is an infraction.
B.
Item 11, Attachment 5-C, states radiation survey instruments will be calibrated at six (6) month intervals, t
Contrary to the above, instruments were not calibrated within six month intervals as required.
Specifically, Victoreen Model 493, Serial No. 650 survey instrument was calibrated June 1977, April 1978, and January 1980; Victoreen Model 491, Serial No. 881 survey instrument, was not calibrated from June 1977 to the date of this
Appendix A (Continued) 3-investigation; Victoreen Model 740F survey instrument, Serial No.
1762, was calibrated in June 1977 and April 1980; and, Victoreen Frisker survey instrument, Serial No. 3319, was not calibrated from February 1978 to the date of this investigation.
This is an infraction.
C.
Item 12, Attachment 6-B, states bioassay procedures will be performed within one week following single operations involving high level quantities of radionuclides, and at weekly intervals for continuing operations for individuals handling high levels (100 mci to 10 Ci) of iodine-131.
For individuals handling intermediate levels (10 mci to 1 Ci) of technetium-99m, bioassay procedures will be performed every six (6) months.
Contrary to the above, from December 13, 1979 to January 16, 1980, only two of four individuals routinely handling high levels of '
I-131 received thyroid bioassays.
During the period May 2, 1980 to May 30, 1980, only one of five individuals routinely handling high levels of I-131 received a thyroid bioassay.
- Further, semiannual biossays for individuals handling intermediate levels of technetium-99m have never been performed by the licensee since the issuance of the license on October 15, 1976.
This is an infraction.
D.
Item 14, Attachment 8-0(1), states each sealed source containing byproduct material will be tested for leakage and/or contamination at intervals not to exceed six months.
Contrary to the above, a sealed calibration source of cesium-137 containing 201 microcuries (vial-E), Serial No. 231-141-15, was not leak tested from April 1977 to January 15, 1980.
l This is an infraction.
3.
10 CFR 20.203(f)(4) requires licensees, prior to disposal of an empty uncontaminated container to unrestricted arecs, to remove or deface the radicactive material label.
l Contrary to the above, on September 24-26, 1980, the licensee failed to remove or deface the radioactive material labels on empty uncontaminated containers before disposal to the general trash.
This is a deficiency.
Pursuant to the provisions of 10 CFR 2.201, Pharmatopes, Incorporated is hereby required to submit to this office within twenty-five days of the date of this Notice, a written statement or explanation in reply, including for each violation; (1)' admission or denial of the alleged violation; (2) the m
m.
A 4
9
Appendix A (Continued) reasons for the violation if admitted; (3) the corrective steps which have been taken und the results achieved; (4) corrective steps which will be taken to avoid further non:ompliance; and (5) the date when full compliance will be achieved.
Under the authority of Section 182 of the Atomic Energy Act of 1954, as amended, this response shall be submitted under oath or affirmation.
,y VictorSheIio,'Ir.
Director Office of Inspection and Enforcement Dated at Bethesda, Maryland this 9th of March 1981 I
m