ML18110A613
| ML18110A613 | |
| Person / Time | |
|---|---|
| Site: | 03031150 |
| Issue date: | 04/05/2018 |
| From: | O'Dowd D NRC/RGN-III |
| To: | Davidson B Covance Central Lab Services |
| References | |
| IR 2018001 | |
| Download: ML18110A613 (2) | |
See also: IR 015000201/1980001
Text
NRC FORM 591M PART 1
U.S. NUCLEAR REGULATORY COMMISSION
(07-2012)
1ocFRz.2o1
SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
1. LICENSEE/LOCATION INSPECTED:
Covance Central Laboratory Services, Inc.
8211 SciCor Drive
Indianapolis, IN 46214
REPORT NUMBER(S) 2018001
3. DOCKET NUMBER(S)
030-31150
LICENSEE:
2. NRG/REGIONAL OFFICE
Region III
U. S. Nuclear Regulatory Commission
2443 Warrenville Road, Suite 210
Lisle, IL 60532-4352
4. LICENSE NUMBER(S)
5. DATE(S) OF INSPECTION
April 5, 2018
13-26058-01
The inspection was an examination of the activities conducted under your license as they relate to radiation safety and to compliance with the Nuclear
Regulatory Commission (NRC) rules and regulations and the conditions of your license. The inspection consisted of selective examinations of
procedures and representative records, interviews with personnel, and observations by the inspector. The inspection findings are as follows:
Based on the inspection findings, no violations were identified.
Previous violation(s) closed.
IZl 1.
IZl 2.
D 3.
The violations(s), specifically described to you by the inspector as non-cited violations, are not being cited because they were self-identified,
non-repetitive, and corrective action was or is being taken, and the remaining criteria in the NRC Enforcement Policy, to exercise
discretion, were satisfied.
Non-cited violation(s) were discussed involving the following requirement(s):
D 4.
During this inspection, certain of your activities, as described below and/or attached, were in violation of NRC requirements and are being
cited in accordance with NRC Enforcement Policy. This form is a NOTICE OF VIOLATION, which may be subject to posting in accordance
with10CFR19.11.
(Violations and Corrective Actions)
Statement of Corrective Actions
I hereby state that, within 30 days, the actions described by me to the Inspector will be taken to correct the violations identified. This statement of
corrective actions is made in accordance with the requirements of 10 CFR 2.201 (corrective steps already taken, corrective steps which will be taken,
date when full compliance will be achieved). I understand that no further written response to NRC will be required, unless specifically requested.
TITLE
LICENSEE'S
REPRESENTATIVE
PRINTED NAME
NRC INSPECTOR
Dennis P. O'Dowd
BRANCH CHIEF
Aaron T. Mccraw
NRC FORM 591M PART 1 (07-2012)
SIGNATURE
DATE
I
NRC FORM 591 M PART 3
(07-2012)
u.s_ NUCLEAR REGULATORY COMMISSION
Docket File Information
SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
1. LICENSEE/LOCATION INSPECTED:
Covance Central Laboratory Services, Inc.
8211 SciCor Drive
Indianapolis, IN 46214
REPORT NUMBER(S) 2018001
3. DOCKET NUMBER(S)
030-31150
6. INSPECTION PROCEDURES USED
86126
2. NRG/REGIONAL OFFICE
4. LICENSE NUMBER(S)
13-26058-01
Region III
U.S. Nuclear Regulatory Commission
2443 Warrenville Road, Suite 210
Lisle, IL 60532-4352
5. DATE(S) OF INSPECTION
April 5, 2018
7. INSPECTION FOCUS AREAS
3.01-3.07
SUPPLEMENTAL INSPECTION INFORMATION
1. PROGRAM CODE(S)
02410
2. PRIORITY
5
[l] Main Office Inspection
D Field Office Inspection
D Temporary Job Site Inspection
3. LICENSEE CONTACT
Brian Davidson, RSO
Next Inspection Date:
PROGRAM SCOPE
4. TELEPHONE NUMBER
(317) 273-5369
April 5, 2023
This was an unannounced, routine inspection of a laboratory testing service company authorized for millicurie quantities
of iodine-25 (1-125), tritium (H-3), and carbon-14 (C-14), for use in benchtop testing to support medical trials of
products for pharmaceutical clients. The licensee was a large company, employing around 1500 employees; however,
only approximately 5 laboratory personnel were trained to use licensed material, and of these, only 2 actively used
material on a regular basis. Licensed material was used in the Radioimmunoassay (RAI) Area located within a larger lab
called the "Central Laboratory." The licensee used 1-125 kits exclusively; H-3 had not been used in over 7 years, and as
of the inspection date, C-14 had never been possessed or used by the licensee. Each 1-125 kit contained about 4-5 µCi of
1-125, and approximately 2 kits were utilized per week. The licensee only generated and stored solid waste for decay in
storage, and had not used sanitary sewage for disposal since approximately 2012.
PERFORMANCE OBSERVATIONS
The inspector toured the RAI lab area, the waste storage room, and interviewed licensee staff. The inspector observed
staff demonstrate package receipt procedures, the licensee's inventory tracking system, proper usage of radioactive
material labels and postings, security of radioactive materials (i.e., 1-125 kits were secured in a refrigerator designated for
radioactive material), and staff demonstration of material handling and survey procedures. The inspector reviewed
selected records, including quarterly audits, package receipt records, materials inventory, disposal logs, and weekly wipe
tests and survey results.
The licensee was previously cited during a routine inspection conducted on August 14, 2013, (ref. IR 03031150/2013001
(DNMS)) for a violation of a regulatory requirement, specifically, for failure determine the presence or absence of
radioactive contamination during and after the use ofl-125 RIA kits, as required by the license (i.e., Condition 17 of the
license (renumbered as Condition 15 in the current amendment), and application dated July 12, 2010, referenced in
Condition 17). Through review of licensee's documentation, discussions with licensee staff, and observations of
licensee's staff demonstrations of procedures followed during use of radioactive material, the inspector confirmed that
the violation was corrected, and that the licensee's actions to prevent recurrence were effective in ensuring that no further
violation of the survey requirement occurred. This violation is therefore considered closed.
No violations ofNRC requirements were identified during this inspection.
NRG FORM 591M PART 3 (07-2012)