ML20010G028

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Notice of Violation from Insp on 810721.Noncompliance Noted: Personnel Failed to Use Syringe Shields for Preparation of Radiopharms from Reagent Kits & Patient Doses Per App G to Reg Guide 10.8
ML20010G028
Person / Time
Issue date: 08/26/1981
From: Kinneman J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20010G019 List:
References
RTR-REGGD-10.008 30-02469-81-01, 30-2469-81-1, NUDOCS 8109150248
Download: ML20010G028 (2)


Text

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APPENDIX A NOTICE OF VIOLATION Bergen Pines County Hospital Docket No. 30-2469 Paramus, New Jersey 07652

_icense No. 29-03217-01 As a result of the inspection conducted on July 21, 1981, and in accordance with the Interim Enforcement Policy, 45 FR 66754 (October 7, 1980), the following violations were identified.

A.

10 CFR 20.201(b) requires that you make such surveys as may be necessary for you to comply with all sections of Part 20. As defined in 10 CFR 20.201(a), " survey" means an evaluation of the radiation hazards incident to the production, use, release, disposal, or presence of radioactive materials or other sources of radiation under a specific set of conditions.

Contrary to this requirement, as of the day of the inspection, July 21, 1981, you failed to make such surveys as were necessary to assure compliance with 10 CFR 20.101, a regulation which limits radiation exposure to the extremities of individuals.

Specifically, you failed to evaluate.the radiation dose to the right hand and fingers of an individual who used that hand to pickup vials and syringes containing millicurie quantities of technetium-99m.

This is a Severity Level IV Violation.

(Supplement VII)

B.

Condition 17 of your license requires that licensed material be possessed i

and used in accordance with statements, representations, and procedures contained in your application dated February 28, 1978.

1.

Block 15 of this application requires that you follow the " General Rules for Safe Use of Radioactive Materials," contained in Appendix G of Regulatory Guide 10.8.

a.

Item 4 of Appendix G requires that syringe shields be used for the preparation and administration of patient doses.

Contrary to this requirement, on the day of the inspection, July 21, 1981, personnel preparing radiopharmaceuticals failed to use syringe shields for the preparation of radiopharmaceuticals from reagent kits and the preparation of patients doses.

This is a Severity Level IV Violation.

(Supplement VII) 0FFICIAL RECORD COPY 8109150248 810826 NMS LIC30 29-03217-01 PDR

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Appendix A 2

b.

Item 2 of Appendix G requires that disposable gloves be worn at all times while handling radioactive materials.

Contrary to this requirement, on the day of the inspection, July 21, 1981, personnel in your Nuclear Medicine and Cardiology Departments failed to wear disposable gloves while injecting radiopharmaceuticals.

This is a Severity Level IV Violation.

(Supplement VII)

Pursuant to the provisions of 10 CFR 2.201, the Bergen Pines County Hospital is hereby required to submit to this office, within thirty days of the date of this Notice, a written statement or explanation in reply, including:

(1) the corrective steps which have been taken and the results achieved; (2) corrective steps which will be taken to avoid further violations; and (3) 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. Where good cause is shown consideration will be given to extending your response time.

The responses directed by this Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.

2 G AUG 1981 i

Dated

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'ohn D~. Kinneman, Chief aterials Radiological Protect ha Section t

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0FFICIAL RECORD COPY

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