ML18208A246
| ML18208A246 | |
| Person / Time | |
|---|---|
| Site: | 03038279 |
| Issue date: | 07/12/2018 |
| From: | Harvey E NRC/RGN-III |
| To: | Bjurstrom R Jubilant DraxImage Radiopharmacies, Triad Isotopes |
| References | |
| IR 2018001 | |
| Download: ML18208A246 (2) | |
Text
NRC FORM 591M PART 1 U.S. NUCLEAR REGULATORY COMMISSION (07-2012) 10 CFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
- 1. LICENSEE/LOCATION INSPECTED:
- 2. NRG/REGIONAL OFFICE Region III Jubilant Draximage Radiopharmacies, Inc. d/b/a Triad Isotopes 790 Township Line Road, STE. 175, Yardley, PA 19067 Location Inspected:
2795 Universal Drive, Saginaw, MI U.S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 REPORT NUMBER(S) 20] 8001 3. DOCKET NUMBER(S)
- 4. LICENSE NUMBER(S)
- 5. DATE(S) OF INSPECTION 030-38279 09-3278 l-03MD July 12, 2018 LICENSEE:
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: 0 1. 0 2. D 3. D 4. Based on the inspection findings, no violations were identified.
Previous violation(s) closed. 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):
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 with 10 CFR 19.11. (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 PRINTED NAME SIGNATURE DATE LICENSEE'S REPRESENTATIVE NRC INSPECTOR Edward Harvey BRANCH CHIEF Aaron T. Mccraw NRC FORM 591M PART 1 (07-2012) 7/12/2018 NRC FORM 591M PART 3 U.S. NUCLEAR REGULATORY COMMISSION (07-2012) 10 CFR 2.201 Docket File Information SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
- 1. LICENSEE/LOCATION INSPECTED:
Jubilant Draxlmage Radiopharmacies, Inc. d/b/a Triad Isotopes 2. NRG/REGIONAL OFFICE Region III 790 Township Line Road, STE. 175, Yardley, PA 19067 Location Inspected:
2795 Universal Drive, Saginaw, MI U. S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 REPORT NUMBER(S) 2018001 3. DOCKET NUMBER(S) 030-38279
- 6. INSPECTION PROCEDURES USED 87127 4. LICENSE NUMBER{S)
- 5. DATE(S) OF INSPECTION 09-3278 l-03MD July 12, 2018 7. INSPECTION FOCUS AREAS All SUPPLEMENTAL INSPECTION INFORMATION
- 1. PROGRAM CODE(S) 02500 2. PRIORITY 2 IZ] Main Office Inspection D Field Office Inspection D Temporary Job Site Inspection
- 3. LICENSEE CONTACT Robert B jurstrom, RSO Next Inspection Date: 4. TELEPHONE NUMBER (989) 799-7669 No Change ---------------------
PROGRAM SCOPE This was an unannounced, enforcement follow-up inspection of a radiopharmacy located in Saginaw, Michigan.
The licensee employed two pharmacists, two pharmacy technicians, and five drivers. The pharmacist began drawing doses for the first run at approximately 0100 and doses were out for delivery at 0230, 0400, 0600, and 0830, depending on the customer location.
The scope of this inspection was limited to the review of the corrective actions implemented as a result of two escalated enforcement violations identified during the previous inspection.
The first violation concerned the licensee's failure to use a containment system securely closed by a positive fastening device that could not be opened unintentionally during normal transport when shipping radioactive material, as required by 49 CFR l 73.412(d).
As a result, the shielding surrounding a bulk dose of Tc-99M was compromised during transport, which caused the external radiation levels to exceed the limits of a WHITE-I label, as defined by 49 CFR l 72.403(c).
The elevated radiation levels resulted in a violation of 49 CFR l 72.403(c).
These two violations were categorized as a Severity Level III problem due to their common root cause. The inspector verified that the licensee implemented corrective actions to prevent these violations from recurring.
These corrective actions included ( 1) revising their procedures for outgoing packages to include a statement for individuals to ensure the top lid to vial shield containers are properly closed and secured by challenging the lid before placement into packages; and (2) training all pertinent staff on the updated procedure.
The inspector reviewed the updated procedure and training documentation during the inspection.
In addition, the inspector observed licensee personnel implementing the procedure while packaging doses. No additional examples of these violations were identified during this inspection.
As such, these violations are closed. No additional violations of NRC requirements were identified during this inspection.
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