ML20054C275
| ML20054C275 | |
| Person / Time | |
|---|---|
| Issue date: | 04/12/1982 |
| From: | Sreniawski D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20054C268 | List: |
| References | |
| NUDOCS 8204200298 | |
| Download: ML20054C275 (2) | |
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Appendix NOTICE OF VIOLATION Miami Valley Hospital License No. 34-00341-06 As a result of the inspection conducted on March 10 and 29,1982, and in accordance with the NRC Enforcement Policy, 45 FR 9987 (March 9, 1982),
the following violations were identified:
1.
10 CFR 35.14(b)(6) requires that for Groups I, II and III any licensee using byproduct material for clinical procedures other than those specified in the product labeling (package insert) shall comply with the product labeling regarding:
(1)
Chemical and physical form; (ii)
Route of administration; and (iii)
Dosage range.
The Union Carbide /Cintichem package insert for the HSA Multidose and HSA Unit Dose (Technetium Tc-99m Albumin) Kits, which are used by the licensee's supplier of radiopharmaceuticals, states, " Diagnostic -
For Intravenous Use."
Contrary to this requirement, the licensee injected technetium-99m HSA into the peritoneal cavity on October 7, 1981. This procedure is not described in the manufacturer's package insert as an authorized route of administration.
This is a Severity Level V violation (Supplement VI).
2.
10 CFR 35.14(b)(5)(v) requires a quarterly physical inventory to account for all Group VI sealed sources and devices received and possessed.
Contrary to this requirement, no quarterly physical inventories were conducted to account for a strontium-90 eye applicator source from the last inspection in May 1978 to October 1, 1981.
This is a Severity Level V violation (Supplement VI).
License Condition No. 16 requires licensed material to be possessed and used in accordance with statements, representations, and procedures contained in certain referenced application, letters, and ALARA Program.
8204200298 820414 NMS LIC30 34-00341-06 PDR
Appendix 2
3.
In a supplementary sheet entitled " Area Survey Procedure," which l
was submitted with letter dated September 15, 1981, it states that a GM survey of the hot lab and injection area will be performed daily.
Contrary to this requirement, the injection area has not been surveyed on a daily basis from September 15, 1981, to March 9, 1982.
This is a Severity Level V violation (Supplement VI).
4.
In a supplementary sheet submitted with letter dated February 20, 1978, it states that within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> after opening a vial of liquid lodine the technologist will have her thyroid counted with a scintillation probe and the results recorded.
Contrary to this requirement, technologists failed to count their thyroid within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> after opening vials of iodine-131 in liquid form on October 26, October 31, and November 16, 1979.
This is a Severity Level V violation (Supplement VI).
No reply to this item is required since the opening of vials containing liquid iodine was discontinued when the procedure was changed in about January 1980.
Pursuant to the provisions of 10 CFR 2.201, you are required to submit to this office within thirty days of the date of this Notice a written state-ment or explanation in reply, including for each item of noncompliance:
(1) corrective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full com-pliance will be achieved. Consideration may be given to extending your response time for good cause shown.
l /2 [L-l.
l Dated D. J. Sreniawski, Chief Materials Radiation Protection Section 2
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