ML20126B633
| ML20126B633 | |
| Person / Time | |
|---|---|
| Issue date: | 06/03/1985 |
| From: | Murley T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Axelrod D NEW YORK, STATE OF |
| References | |
| NUDOCS 8506140160 | |
| Download: ML20126B633 (6) | |
Text
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June 3, 1985
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David Axelrod, M.D., Commissioner New York State Department of Health Empire State Plaza Tower Building Albany, New York 12237
Dear Dr. Axelrod:
This is to confirm the discussion Mr. John McGrath, Region I State Agreements Office and Mr. Donald A. Nussbaumer, Assistant Director for State Agreements Program, Office of State Programs held with you and your staff on April 5, 1985 following our review and evaluation of the Department's radiation control pro-gram.
This review covered the principal administrative and technical aspects of this program and included an examination of the program's legislation and regulations, organization, management and administration, personnel, licensing and compliance.
The review also included field evaluations of inspectors in your Rochester and New Rochelle regional offices.
The review was performed in accordance with the NRC policy defined in the
" Guidance for NRC Review of Agreement State Radiation Control Programs."
These guidelines were published in the Federal Register on December 4, 1981, and define the 30 indicators that are used for evaluating Agreement State Programs.
A description of how the indicators are used in reporting the results of, program reviews to State management is enclosed (Enclosure 1).
As a result of our review of the Department's program and the routine exchange of information between the NRC and the Department, the staff believes that the Department's program for regulating agreement materials is adequate to protect t.he public health and safety.
A finding of compatibility is again not being diade due to the status of the Department's radiation control regulations.
'. Dufing our two previous reviews, we commented on the need to update the Department's regulations.
Although some effort has been made to prepare revised drafts of amendments, final action has not been completed.
We recommend that the Department give this project priority consideration in 1985.
Dr. Rimawi has indicated his staff will be providing a copy of the most recent draft to this office for review.
Please be assured that we will expedite our review and provide you with our comments as soon as possible.
If there are any other ways we can assist you in expediting the adoption of these regulations please let us know.
Status of Regulations is a Category I indicator.
We were pleased to note improvement in the management of the inspection program.
Coordination between Headquarters and the field offices is good and supervisory accompaniment of inspectors is being carried out.
There has been a continued reduction in the inspection backlog and we believe that the remaining backlog can be eliminated by the end of the yeari We would suggest that emphasis be placed on the five Priority I licenses that were overdue according to your
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priority system at the time of our review.
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David Axelrod 2
Clerical support in the New Rochelle regional office has improved over that noted during our last previous review.
However, professio'nal personnel are still required to do their own filing. We note that the New Rochelle office has the largest workload of any of the regional offices and currently has the largest inspection backlog.
Additional effort to reduce the administrative burden on the professional staff should be made.
We would appreciate your review and response to our comments and recommendations.
In addition, Enclosure 2 contains comments regarding the technical aspects of our review.
We would appreciate Dr. Rimawi's review and response to these comments.
In accordance with NRC practice, I am erlosing a copy of this letter for placement in the State Public Document Room, or otherwise to be made available for public review.
I appreciate the courtesy and cooperation extended by you and your staff to our representatives during the review.
Sincerely, Origihal nignedby Thocas E. L!urley Thomas E. Murley Regional Administrator
Enclosures:
As Stated cc:
(w/ Encl.)
Distribution:
L. Randolph, NYSH TMurley W. Stasiuk NYSH JAllan L. Hetling, NYSH JMcGrath K. Rimawi, NYSH DNussbaumer D. Sencer, NYCH SP01 L. Roberts, NYSL H. Williams, NYDEC G. W. Kerr, OSP NRC Public Document Room State Public Document Room RI:SA
- S ED A:RI JMcGrath/m WK WJ i ks J
lan TEMurley 5/ 9 /85 5/D/85 5/ /85 5/l.8/85 5/J//85 0FFICIAL RECORD COPY
t Application of " Guidelines 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 December 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 Agreement State program is provided by categorizing the
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Indicators into 2 categories.
Category I indicators address program functions which directly reiste to the State's ability to protect the public health and safety.
If significant problems exist in several Category I indicator areas, tien 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.
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' Good performance 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 i
indicators. Category II indicators frequently can be used to identify underlying problems that are causing, or contributing to, difficulties in Category I indicators.
1 It is the NRC's intention to use these categories in the following i
manner.
In_ reporting findings to State management, the NRC will indicate the category of each comment made.
If no significant Category I connents are provided, this will indicate that the program is adequate to protect the public health and safety.
If at least one significant I
Category I comment is provided, the State will be notified that the l__
program deficiency may seriously affect the State's ability to protect the public health and safety and should be addressed on a priority basis. When more than one significant Category I comment is provided, I
the State will be notified that the need of improvement in the particular program areas is critical.
The NRC would request an immediate response, and may perform a follow-up 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 11 comments would concern functions and activities which support the l
State program and therefore would not be critical to the State's ability I
to protect the public. The State will be asked to respond to these comments and the State's actions will be evaluated during the next regular program review.
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ENCLOSURE 2 TECHNICAL COMMENTS AND RECOMMENDATIONS ON THE NEW YORK STATE DEPARTMENT OF HEALTH RADIATION CONTROL PROGRAM I.
Technical Quality of Licensing Actions Technical Quality of Licensing Action is a Category I indicator.
The following is of minor significance Comment Licensing actions were for the most part adequately supported.
Some minor deficiencies were noted however, such as missing standard conditions and inadequate supporting documentation in the following areas:
facility descriptions, dose calibrator procedures, and brachytherapy procedures.
One particular license application for a brachytherapy license was deficient in the lack of a number of important safety procedures.
Recommendation We recommend that additional care be taken in the review of license appli-cations to assure that all necessary supporting documentation is submitted prior to issuance of a license.
We believe that the referenced brachy-I therapy licensee should be requested to submit the required procedures.
i II.
Enforcement Procedures Enforcement procedures is a' Category I indicator.
The following comments are of minor significance.
Comment The review of a number of enforcement letters revealed that in some cases violations of regulations or license conditions were addressed as recommendations rather than cited as violations.
Recommendation We believe that all violations of the code and specific license conditions should be referred to as such in enforcement correspondence.
Comment In the review of enforcement actions, two cases were noted where the State could have taken stronger enforcement action.
In the first case, involving a type C broad academic license in the Buffalo area, the
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licensea has had a poor compliance record for 10 years, with continuous repeat violations.
The second case involved a medical licensee in the New Rochelle region where numerous violations, some of which were addressed as recommendations rather than items of noncompliance, were contested by the licensee.
Although the State plans escalated enforcement action in this case, the delay in taking such action may have weakened the State's case.
Recommendation We recommend that in cases where repeat or uncorrected violations from the last previous inspection indicate a licensee's continued poor compliance record, escalated enforcement action should be instituted.
All enforcement actions should be taken on a timely basis.
III Inspection Reports Inspection reports is a Category II indicator.
Comment In Agreement States where inspection activities are conducted from regional offices, we believe that it is important for management to review inspection reports on a timely basis to assure that enforcement actions are consistent with State policy.
Our review noted that in the past, inspection reports did not always receive attention in Albany on a timely basis.
Recommendation Although recent inspection reports have shown definite improvement in this area, the Department should monitor these reviews to assure that they continue to be conducted on a timely basis.
Comnient Inspection reports do not always provide adequate documentation to support items of noncompliance, e.g., some reports contained statements to the effect that records were " incomplete."
Recommendation Inspection reports should provide sufficiently detailed information to support enforcement actions.
Supervisory review of reports should include an examination of this aspect of inspection documentation.
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Comment The State has, on occasion, cited licensees for failure to keep exposures as low as reasonably achievable (ALARA), however, inspection reports do not always indicate the status of the licensee's ALARA program.
Recommendation
-We suggest that a section be added to your inspection form for inspectors to document the status of the licensee's ALARA program.}