ML20214G294

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Confirms 870306 Discussion W/Rl Woodruff,K Davis,C Prather & Le Jerrett Re NRC Evaluation of State Radiation Control Program.Overall Regulation of Agreement Matls Comparable to Nrc.Areas Requiring Improvement Noted in Encl Evaluation
ML20214G294
Person / Time
Issue date: 05/18/1987
From: Kammerer C
NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA)
To: Coler G
FLORIDA, STATE OF
References
NUDOCS 8705270004
Download: ML20214G294 (6)


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~ WAY 181937 Hr. Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1317 Winewcod Boulevard Tallahassee, Florida 32301

Dear Secretary Coler:

This is to confim the discussion Mr. Richard L. Woodruff held with Mr. King Davis, Dr. Carlton Prather, and Dr. Lyle E. Jerrett on March 6, 1987, following our review and evaluation of the State's radiation control program. The review covered the principal administrative and technical aspects of the program and included an examination of the program's legislation and regulations, organization, management, administration, personnel, licensing and compliance actions, and the field evaluation of three State inspectors.

As a result of our review of the State's progran and the routine exchange of information between the Nuclear Regulatory Comission and the State of Florida, the staff detemined that overall the Florida program for regulation of agreement materials is adequate to protect the public health and safety and is compatible with the Comission's program. However, tho staff also noted the need for improvement as

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noted below.

l Staff continuity continues to be an area of concern. Staff continuity is a Category II Indicator. Following our 1985 review, the State undertook a study to review the current salaries of the health physicists and to reclassify and make adjustments as warranted.

Considerable progress in this area was achieved; however, it is our understanding that the State still has plans to further upgrade the Public Health Physicist positions and the Public Health Physicist Supervisor positions. We fully support this action and we believe this action will help minimize the turnover of your trained people. We would appreciate receiving your plans and conments regarding staff continuity in the Office of Radiation Control.

{ contains coments regarding the technical aspects of our review of the progran. These coments were discussed with Dr. Jerrett and his staff during our exit meeting with him. Dr. Jerrett was advised at the tine that a response to these findings would be requested by th office and you may wish to have Dr. Jerrett address the Enclosure 1 comments.

g An explanation of our policies and practices for reviewing Agreemnt 5 tate programs is a1.tachea as t.nciosure z.

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s Mr. Gregory L. Coler 2

On April 12,1987, !!RC reorganized its staff. The State Agreement Progran is now a part of the new Office of Governmental and Public Affairs, which reports to the Comission. One purpose of this organizational change was to provide an improved focus for NRC relationships with the St6tes. Our regional offices will continue to adninister and inplement flRC's regulatory prograns. He encourage you and your staff to continue to look to the Regional Administrator and his stoff as the primary contact with NRC.

I appreciate the courtesy and cooperation extended by your staff to tir. Woodruff during the review.

Sincerely, Original Signed by Carlton Kammerer Carlton Kamerer, Director State Local and Indian Tribe Prograns

Enclosures:

As stated cc: Chairnan Zech Comissioner Robarts Comissioner Asselstine Comissioner Bernthal Cnmissioner Carr Victor Stello, Executive Director for Operations,flRC J. !!elson Grace, Regional Administrator, RII King Davis, Deputy Assistant Secretcry for Prograns Carlton Prather, it.D.,

State Health Officer Lyle E. Jerrett, Ph.D., Director, Office of Radiation Contrcl NRC Public Document Roon Distribution:

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ENCLOSURE 1 COMMENTS AND RECOMMENDATIONS ON TECHNICAL ASPECTS OF THE FLORIDA RADIATION CONTROL PROGRAM FOR AGREEMENT MATERIALS I.

MANAGEMENT AND ADMINISTRATION Administrative Procedures is a Category II Indicator. The following comment with our recommendation is made:

COMMENT The Radiation Control Program should establish written internal procedures to assure that the staff performs its duties as required and to provide a high degree of unifomity and continuity in regulatory practices. These procedures should address internal processing of license applications, inspection policies and procedures, decomissioning, and other functions required of the program. We noted that the program has procedures entitled

" General Criteria for Enforcement Actions Regarding Radioactive Materials." However, these procedures do not incorporate other mechanisms used for enforcement, such as a " Letter of Intent," the issuance of an " Administrative Complaint," or a " Final Order."

RECOMMENDATION We recomend that the State revise their administrative procedures to include all mechanisms used for enforcement actions, such as the issuance of a Letter of Intent, an Administrative Complaint, or a Final Order.

II. LICENSING Licensing Procedures is a Category II Indicator. The following coment with our recommendation is made.

COMMENT I

Standard license conditions and procedures comparable with those of the NRC should be used to expedite and provide uniformity in the l

licensing process.

1.

The standard " user" condition utilized for " private practitioners" stipulates that "... material shall be used by, or under the supervision of (the individual physician)." The i

phrase "...under the supervision of..." should be reserved for institutional licensees who may be authorized to train i

i other physicians.

2.

Some of the State's " fixed gauge" licensees do not have an inventory requirement in their license. The NRC uses a l

standard license condition (number 78, dated November 1985) on all fixed gauge licenses to require a six month inventory of.

l all sources and devices received under the license.

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Medical licensees utilizing a " portable imaging service" should only use licensed material.that has been assayed in a fully calibrated dose calibrator system. Dose calibrators that are transported from location to location should not be used to assay patient doses until the full calibration requirements of Reg. Guide 10.8 have been met at each location.

RECOMMEf!DATION' We recomend that the State utilize the following procedures:

1.

Licenses issued to individual physicians or practitioners should clearly indicate that the license does not authorize the individual user to train other physicians or practitioners in the use of the material.

2.

Licenses authorizing the use of " fixed gauges" should have a standard requirement to inventory all sources and devices received under the license.

3.

Licensees utilizing " portable imaging services" should have clearly established procedures for assuring that patient dotes have been assayed in a fully calibrated, accurate, and reliable system prior to the dose administration.

III. COMPLIANCE A.

Inspection Reports is a Category II Indicator. The following comment is made with our recomendation.

COMMENT:

Findings of inspections should be documented in a report describing the scope of the inspections, describing the scope l

of the licensee's program, and indicating the substance of I

discussions with licensee management and the licensee's c

response. The following coments were developed from the reports:

l 1.

Additional information was needed in one report to document what items of noncompliance were discussed at the exit meeting.

2.

Additional information was needed in one report to l

determine if bioassays were needed due to the use of liquid iodine-131 and phosphorus-32.

l 3.

More infonnation was needed in one report to detemine the scope of the inspection.

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RECOMMENDATION We recomend that the inspectors receive additional instructions as to the information needed in the report to clearly establish the scope of the inspection, scope of the licensee program and the items discussed at the exit meeting.

B.

Confimatory Measurements is a Category II Indicator. The following coment is made with our recomendation.

COMMENT Confirmatory measurements should be sufficient in number and type to ensure the licensee's control of materials and to validate the licensee's measurements. From our review of the

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inspection reports, we noted that in one instance, the inspector did not have a survey meter that was working properly; in three other instances, a meter calibrated in CPMs was used for surveys and it was not clear if other instrumentation was available or used; and in three reports, additional measurements were needed to verify air flow rates.

RECOMMENDATION We recomend that inspectors receive additional instruction in the types of confimatory measurements needed, such as P-l exposure rates, smears, and air flow measurements, and the

.i documentation of confimatory measurements in the reports.

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3 ENCLOSURE 2 APPLICATION OF "GUIDELIflES FOR NRC REVIEW OF AGREEMENT STATE RADIATION CONTROL PROGRAMS" The " Guidelines for NRC Review of Agreement State Radiation Control Programs," were published in the Federal Register on Decenber 4, 1981, as an NRC Policy Statement. The Guide provides 30 Indicators for evaluating Agreement State program areas. Guidance as to their relative importance to an Agreetnent State program is provided by categorizing the Indicators into two categories.

Category I Indicators address program functions which directly relate to the State's ability to protect the public health and safety.

If significant problems exist in several Category I Indicator areas, then the need for improvements may be critical.

Category II Indicators address program functions which provide essential technical and administrative support for the primary program functions.

Good perfonnance in meeting the guidelines for these Indicators is essential in order to avoid the development of problems in one or more of the principal program areas, i.e., those that fall under Category I Indicators. Category II Indicators frequently can be used to identify underlying problems that are causing, or contributing to, difficulties in Category I Indicators.

It is the NRC's intention to use these categories in the following manner.

In reporting findings to State management, the NRC will indicate the category of each coment made.

If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety.

If at least one significant Category I coment is provided, the State will be notified that the program deficiency may seriously affect the State's ability to protect the public health aad safety and should be addressed on a priority basis. When more than one significant Category I coment is provided, the State will be notified that the need of improvement in the particular program areas is critical. The NRC would request an imediate response, and may perform a followup review of the program within six months. If the State program has not improved or if additional deficiencies have developed, the NRC may institute proceedings to suspend or revoke all or part of the Agreement.

Category II comments would concern functions and activities which support the State progran and therefore would not be critical to the State's ability to protect the public. The State will be asked to respond to these coments and the State's actions will be evaluated during the next regular program review.