ML20203G374
| ML20203G374 | |
| Person / Time | |
|---|---|
| Issue date: | 04/22/1986 |
| From: | Martin J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| To: | Kizer K CALIFORNIA, STATE OF |
| References | |
| NUDOCS 8604290046 | |
| Download: ML20203G374 (10) | |
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WALNUT CREEK, CALIFoRNI A 94596 April 22,1986 Dr. Kenneth W. Kizer, Director California Department of Health Services 714 P Street Sacramento, California 95814
Dear Dr. Kizer:
This is to confirm the discussion Mr. Jack W. Hornor, NRC State Agreement Representative, held on March 19, 1986, with you and your staff following our review and evaluation of the State's radiation control program.
The results of our review indicate that the California Radiation Control Program is adequate to protect the public health and safety. However, we are unable to offer a statement of compatibility pending the State's corrective actions for a Category I deficiency.
Status of Regulations is a Category I Indicatar. The California Rules and Regulations for Radioactive Material, Title 17, have not been
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revised to incorporate NRC changes in radiation protection and licensing provisions since 1974. While some progress has been made since the last review, continued attention is necessary to complete the revision
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process. We were told that the necessary regulation changes have been prepared and are being reviewed by the Office of Administrative Law and l
that after their approval the Attorney General's Office needs thirty days to make them effective. At that time we understand the State will distribute them to its licensees. When the revised regulations are issued, we will be in a position to consider a finding of compatibility for the program.
Following our last three reviews, we commented on the need to develop a workable inspection tracking system and to increase the inspection staff in order to cope with the inspection workload. While these needs still exist, some progress has been made in climinating the backlog of overdue inspections. The Radiological Health Branch has now developed action plans to further improve the program and eliminate all overdue inspectiot.s within the next year. Your assistance will be needed to provide adequate technical and administrative staffing, to change the three temporary staff positions to permanent and to provide support to aid in the development of the data processing system. We will be monitoring the State's progress in these areas.
The need for upper management attention is also indicated in improving communication between levels of management within the Department and internally within the Radiological Health Branch. Further details on this aspect are included in Enclosure 1.
Overe'1, we were pleased to note continued improvement in the program.
We b.*ieve your personal support and the efforts of your staff have contriouted significantly to this improvement. In particular, we were pleased by the improvements made in the licensing program, the increased number of inspections performed and in the resolution of problems with the administration of the enforcement program.
8604290046 860422' PDR STPRQ ESGC 48 '7
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. April 22,1986 We would appreciate your reviewing our comments and responding with your-specific plans and target dates for improving the State radiation control program.
, contains additional comments regarding the technical and administrative aspects of our review. While most of these comments concern Category II items in our guidelines for program review, we believu their resolution will add further improvement to that already achieved. We suggest they be included in the Branch action plan. These comments were discussed with Mr. Ward during our exit meeting with him and his staff. Mr. Ward was advised at that time that a response to these findings would be requested by this office and you may wish to have Mr. Ward address the Enclosure ~1 comments to be included in your response. contains an explanation of our policies and practices for reviewing Agreenent State programs.
~ is a copy of this letter for placement in the State's Public Document Room or otherwise to be made available for public review.
I appreciate the courtesy and cooperation extended by your staff to Ms. Riedlinger, Mr. Daggett and Mr. Hornor of our staff during the review.
Sincerely,
,, el (1_ -
g Joh'n. Mart'in N
Regional Administ r
Enclosures:
1.
Comments and Recommendations on Technical and Administrative Aspects of the California Radiation Control Program 2.
Application of " Guidelines for NRC Review of Agreement State Radiation Control Programs" 3.
Letter to Dr. Kenneth W. Kizer, from John B. Martin, dated 04/22/86 cc w/ enclosures:
Joseph 0. Ward, Chief Radiological Healti Branch Harvey Collins, PhD., Chief Environmental Health Division G. Wayne Kerr, Director Office of State Programs, NRC ERC Public-Document: Room, Document Control Desk (SP01) 1
,s.
ENCLOSURE 1 COMMENTS AND RECOMMENDATIONS ON TECHNICAL AND ADMINISTRATIVE ASPECTS OF THE CALIFORNIA RADIATION CONTROL PROGRAM FOR AGREEMENT MATERIALS
.I.
MANAGEMENT AND ADMINISTRATION A.
Administrative Procedures and Management are Category II Indicators. Internal communication encompasses guidelines from both of these related program areas. The following comment with our recommendation is made.
Comment The Radiation Control Program (RCP) should have procedures t
that assure the staff performs its duties as required with a high degree of uniformity and continuity in regulatory practices, and program management should receive information from the staff pertaining to backlogs, problem cases, inquirien, etc. NRC reviewers found in this and past reviews that insufficient communication between levels of management I
in the Department, Division and Branch diminishes effectiveness of the RCP. In some cases upper level management is not aware of problems within the Branch, and within the Branch, information necessary for proper program functioning is not always made available to either the staff or supervisors.
Recommendation We recommend periodic staff meetings at appropriate levels be used to discuss information, policies, ideas and problems.
Within the Branch, periodic meetings should be held by the Branch Chief and the supervisory staff and between the supervisors and the licensing acd compliance staffs. While the semi-annual meetings held by the Branch with the regional and contract personnel have been beneficial, we believe more frequent meetings of the headquarters staff are indicated.
B.
Management is a Category II indicator. The following comments with our recormendations are made.
Comment Program management should perform periodic reviews of selected license cases handled by each reviewer and document the resulte. This type of quality assurance review is not being performed by the Branch.
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. Recommendation We recommend program management perform selected reviews of licenses issued by each reviewer, focusing on as many different types of licenses as possible and document them.
C.
Office Equipment and Support Services is a Category II Indicator. The following comments with our recommendations are made.
1.
Comment The RCP should have adequate secretarial and clerical support. The size of the support staff has not kept abreast of increased workloads, such as occurred when the materials inspection staff transferred to Sacramento from Berkeley and when the number of technical staff increased. As a result, backlogs of typing and filing are occurring which impede functioning of the program.
This matter was also discussed at the last follow-up review.
Recommendation The support staff should be increased sufficiently to, cope with the increased workload.
2.
Comment Large f/ograms, such as California's, should have autoratic data processing and retrieval capabilities. A system using IBM PC's was delivered in August 1984, but the software is not fully functional and the staff has not been adequately trained. The assistance obtained thus far has not been successful in solving this problem.
As a result the State is having difficulties in assessing the status of the inspection program, tracking compliance histories of licensees and otherwise obtaining the benefits of a fully operational system.
Recommendation We recommend assistance be sought from sources with the proper expertise. An alternate measure would be to provide in-depth training to a current member of the RCP staff who would then be responsible for the development and use of the system, as well as training other staff members.
a e II.
PERSONNEL A.
Staffing level is a Category II Indicator. The following comment with our recommendation is made.
Comment The staffing level should be approximately 1-1.5 person-years per 100 licenses in effect. California is a large state with many complex licenses and sealed source and device evaluations. A staffing level close to the higher figure may be needed to properly administer the program. The current professional staffing level in the Agreement Materials program is 0.83 staff per 100 licenses. Three of the professional staff positions are temporary. There is a current backlog of overdue inspections and a projected schedule of approximately 650 routine inspections per year. Without additional inspection staff, it does not appear that the inspection schedule can be met.
Recommendation f
We recommend the temporary staff positions be made permanent, existing vacancies be filled, and the staff be increased to a level adequate to meet the inspection frequency schedule.
III. LICENSING A.
Licensing Procedures is a Category II Indicator. The following comments with our recommendations are made.
1.
Comment License applicants should be furnished copies of applicable guides and regulations. New licensees are not being furnished copies of the regulations nor are they advised how to obtain copies.
Recommendation We recommend that copies of the applicable regulations and licensing guides be furnished to license applicants and that the revised version of Title 17 be distributed to all licensees as soon as it is printed.
2.
Comment Standard license conditions comparable with current NRC standard license conditions should be used to expedite and provide uniformity in the licensing process.
In some cases, existing standard conditions are not used by licensee reviewers (e.g., teletherapy licenses).
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I w other cases, largely because the California regulations are not compatible with those of the NPC, the list of conditions provided to the license reviewers is not adequate to cover the situations where they are needed.
As a result, several reviewers compose their own conditions, which leads to inconsistencies.
Recommendation The list of standard license conditions used by the State should be re-evaluated and modified to meet the needs of the program. Staff input should be sought in this effort. The standard license conditions should then be used by all reviewers.
I 3.
Comment The RCP should have internal licensing guides, checklists
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and policy memoranda consistent with NRC practices. The State made policy changes in the memorandum issued after the previous review that significantly improved the overall quality of licenses issued since that time.
During this review, the RCP staff voiced the need for clarification in policies dealing with use and retention of checklists, the need for prelicensing visits, documents to be referenced in the tie-down condition and documentation of telephone conversations with applicants.
Recommendation We recommend program management clarify the licensing procedures in the following areas:
a.
Checklists should be reviewed to determine that they contain the essential elements for each type of license issued by the State'.
Model licenses should be used as guides. Disposition of the completed checklists should be specified.
b.
Criteria should be established to determine the need for pre-licensing visits.
c.
Guidance should be developed on the proper documents to reference in the standard license tie-down condition.
d.
Telephone discussions with applicants and licensees should be documented and maintained in the case file.
o 4.
Comment License reviewers assign the license inspection priority.
Several licenses were found to have the priority incorrectly assigned.
Recommendation We recommend supervisory review of all priority assignments.
5.
Comment A number of license cases were noted to be under timely renewal for extended periods of time. As an example, a major manufacturer and distributor has been under timely renewal for ten years. The application is no longer current and the existing license does not reflect current regulatory practices.
Recommendation We recommend that California review all licenses in timely renewal status and develop a program to complete action on the renewal applications. We suggest a target date of one year for completion of pending renewals. In cases where existing licenses and backup applications and correspondence no longer reflect current operations, the licensees should be requested to resubmit complete applications with up-to-date information.
IV.
COMPLIANCE A.
Status of Inspection Program is a Category I Indicator. The following minor comment with our recommendation is made.
Comment During the review, a defect was revealed in the method used to produce the due/ overdue listing used to assign inspections and to assess the status of the inspection program. The due date for an inspection was based on the length of time elapsed since the last inspection, with no means to pick up newly issued licenses. Thus, if an initial inspection was not performed, the license would not be in the tracking system.
When the Branch staff prepared a listing of " licenses never inspected," they identified about 200 licenses overdue for their initial inspection (based on the initial inspection schedule in effect at the time the license was issued), 76 due for a routine inspection, and 17 overdue for their routine inspection. None of these cases appeared on the due/ overdue list because the initial inspections were not performed.
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, Recommendation We recommend that the inspection tracking system be modified to account for all licenses. After this is accomplished, we recommend a manual check of each license file against the computer file.
Following this action the initial inspections should be completed in a reasonable time and in any case not later than the date the routine inspection woald be due (not overdue) under the current priority schedule.
B.
Responses to Incidents and Alleged Incidents is a Category I Indicator. The following minor comments with our recommendations are made.
1.
Comment The NRC should be notified of pertinent information about any incident which could be relevant to other licensed
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operations. Criteria for reporting significant incidents were outlined in an All Agreement State Letter dated November 23, 1984. Cases in which the reporting requirements were exceeded but which were not reported were found in the files, and the reviewer was advised the State has no written procedures for reviewing the incident file against the reporting criteria.
Recommendation We recommend written procedures be developed to ensure proper reporting of significant incidents.
2.
Comment Information on incidents involving licensees is not cross-referenced to license or compliance files and thus license reviewers and inspectors may be unaware of any incidents which may have occurred at a particular facility where an application is under review or an inspection is being planned.
Recommendation We recommend the State provide a cross-referencing system between the incident file and license and compliance files so that license reviewers and inspectors can readily identify reported incidents which may have occurred at a particular facility.
I C.
Inspection Reports is a Category II Indicator. The following comment with our recommendation is made.
Comment Reports should uniformly and adequately document the results of inspections, substantiate all items of noncompliance and health and safety matters and indicate the substance of discussions with licensee management. Eleven of the fifteen reports reviewed contained errors or omissions, such as not completing all sections of the uniform inspection form, short forms (2514) that were not properly signed and dated, items of noncompliance downgraded to recommendations, no indication of interviews with ancillary workers, and no indication of exit interviews with management.
Recommendation
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We recommend more thorough supervisory review to assure that inspectors adhere to program policy.
D.
Independent Measurements is a Category II Indicator. The following comment with our recommendation is made.
Comment RCP instrumentation should be adequate for surveying licensee operations, and instrumant calibration services or facilities should be readily available and appropriate for instrumentation used. There are air flow velometers that have not been calibrated according to Department standard practice and therefore have not been used for licensee inspections.
Recommendation We recommend that velometer calibration, in accord with Department standard practice, be obtained and that veloseters be used for conducting independent measurements as necessary i
during inspections.
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ENCLOSURE 2 APPLICATION OF " GUIDELINES FOR NRC REVIEW OF AGREEMENT STATE RADIATION CONTROL PROGRAMS" l
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 pre ided by categorizing the Indicators into 2 categories.
Category I Indicators address program functions which directly relate to l
the State's ability to protect the public health and safety. If a
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 edministrative support for the primary program functions.
Good performance in meeting the guidelines for these indicators is i
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 at that are causing, or contributing to, l
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 i
the category of each comment made. If no significant Category I i
, comments are provided, this will indicate that the program is adequate to protect the public health and safety.
If at least one significant i
e Category I comment is provided, the State will be notified that the 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, the State will ba 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 i
within six months. If the State program has not improved or it additional deficiencies have developed, the NRC may institute l
proceedings to suspend or revoke all or part of the Agreement. Category II comments would concern functions and activities which support the l
State program and therefore would not be critical to the State's ability l
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 f
regular program review.
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