ML20044G261
| ML20044G261 | |
| Person / Time | |
|---|---|
| Issue date: | 05/25/1993 |
| From: | Woodruff R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | Miller V NRC OFFICE OF STATE PROGRAMS (OSP) |
| References | |
| NUDOCS 9306020245 | |
| Download: ML20044G261 (10) | |
Text
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o May 25, 1993 MEMORANDUM FOR:
Vandy L. Miller, Assistant Director for State Agreements Program, Office of State Programs FROM:
Richard L. Woodruff, Regional State Agreements Officer
SUBJECT:
KENTUCKY REVIEW-VISIT Visit Date:
May 4-7, 1993 Last Review Date: April 17, 1992 Next Review Date: April 1994 Scope of Visit A mid-cycle review meeting (visit) was held with personnel responsible for the Kentucky Radiation Control program on May 4-7, 1993. The visit consisted of a follow-up on the status of NRC comments dated June 16, 1992, to the_ State following our 1992 program review; and the status of reviewer selected Program Elements and Indicators derived from observations made during the visit and discussions with program management and program staff.
1 The following persons were contacted during the meeting:
Donald R. Hughes, Sr., Director, Division of Community Safety John A. Volpe, Ph.D., Manager, Radiation Control Branch Vicki D. Jeffs, Supervisor, Radioactive Materials Section Michael Cleaver, Radioactive Materials Specialist Michael Wilcoxson, Radioactive Materials Specialist j
Sue Osborne, Radioactive Materials Specialist Status of Comments To Mr. Leonard E. Heller dated June 16. 1992 1.
Status and Compatibility of Rego)ations is a Category I Indicator. The following comment with our reccmmendation is of major significance.
Comment:
The State's regulations are compatible with the NRC regulations through the 10 CFR Part 20 Amendment on certifications of dosimetry processors by the National Voluntary Accreditation Program (NVLAP) that became effective on February 20, 1988.
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2 The State's regulations meet the three year policy requirement for'the adoption of regulations needed for compatibility, except for the
" Decommissioning" regulations of 10 CFR Parts 30, 40, and 70 that became effective on July 27, 1988. The Program has drafted new regulations that address the " Decommissioning" regulations. and these new State regulations were projected to become effective in September of 1992. A finding of compatibility was offered, contingent upon the adoption of these new State regulations.
The Program managers were also reminded that additional regulations are needed for compatibility as follows:
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" Emergency Planning" regulations of 10 CFR Parts 30, 40, and 70 that need to be adopted by April 7, 1993.
o
" Safety requirements for radiographic equipment" regulations of 10 CFR Part 34 that need to be adopted by January 10, 1994.
o
" Standards for Protection Against Radiation" revision to 10 CFR Part 20 regulations that need to be adopted by January 1,1994.
Program managers related that the above regulations that are needed for compatibility would be drafted later on this calendar year.
Recommendation:
We recommend that the State give priority to the adoption of regulations that are needed to maintain compatibility.
Current Status:
The State has adopted regulations on Financial Assurance and Recordkeeping for Decommissioning that are compatible with NRC regulations. Other regulations that.are needed for compatibility are being drafted. The regulations (equivalent to the new Part 20) are being drafted and the other regulations needed for compatibility are also projected to be adopted by the January of 1994.
The status of this comment remains open.
2.
Staff Continuity is a Category II Indicator. The following comment with our recommendation is made.
Comment:
Salary levels should be adequate to recruit and retain persons of appropriate professional qualifications. The Program lost another senior, trained, professional staff member since the last review. We believe that this was directly related to the salary structure and job classification of the Consumer Health Inspector series. During'our 1991 review, we recommended that every effort be made to upgrade the salaries to a competitive level with those salaries of other Radiation
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3 Specialists and Health Physicists found in other Agreement-States and the industry. During 199I, the Program Manager developed a comparative analysis on the Program's job classifications and proposed three separate job classifications for the professional staff. However, official action on the proposal was never complettd.
Recommendation:
We recommend that the State take action on the reclassification package for the Radiation Control Branch technical staff, and upgrade the ' job series classification.
Current Status:
The Program Manager related that the Personnel Department had taken action on the package to the extent that the new reclassifications had been approved. Also, entry level "new hires" can be hired at the mid-range level of the salary range. However, salary increases for the existing staff have not been approved at this time.
This comment will be reviewed again during the next review.
3.
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 such as enforcement procedures to assure that the staff performs its duties as required and to provide a high degree of uniformity and continuity in regulatory practices._ The State developed enforcement procedures. However, during our casework review and the t
review of the enforcement procedures, we noted that the procedures do not clearly identify when a licensee is to be called into the Program office for an " Informal Hearing" to resolve regulatory issues.
Recommendation:
f We recommend that the State's internal procedures on enforcement procedures (Section 301) be revised to clearly identify when a licensee is to be considered for the escalated enforcement procedure " Informal I; earing. "
Current Status:
l The Program's enforcement procedures were revised and implemented.
These procedures were reviewed during the visit.
This comment is closed.
4.
Office Equipment and Support Services is a Category II Indicator. The following comment with our recommendation is made.
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i Comment:
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The State has an IBM computer in the Division; however, this equipment -
l is not under the administrative control of the Program. The Program Manager related that plans were being made to upgrade the computer to a Local Area Network (LAN) type system for use by the Program staff. The reviewers had several discussions with the staff and Program managers concerning the efficient use of the computer, and information that could be made available to the Program for license reviews, inspections, l
enforcement, and tracking functions. Although the State satisfies the-minimum criteria stated in the indicator guideline, the reviewers i
believe that the computer upgrade is needed for staff efficiency and that State monies will be saved in the long term.
Recommendation:
l We recommend that the State expedite their plans to upgrade the computer 5
system for utilization by the Program's staff.
Current Status:
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A new LAN computer system was purchased, and employees are in the process of receiving training, and the program data is being placed on the system. Copies of NRC licensing checklist, standard deficiency letter examples, standard enforcement paragraphs, inspection field notes, and the medical licensing guide were provided to the Program on i
diskette for their use, j
This comment is closed.
1 5.
Licensing Procedures is a Category II Indicator. The following comment with our recommendation is made.
Comment:
During our review of the licensing casework, we noted that two licenses contained conditions which were redundant to specific rules in the i
regulations. One of these licenses also had seven other minor comments, and this license was identified to the Section Supervisor. The Section Supervisor related that these conditions were incorporated into the license before the rules became effective, and that the license i
conditions would be revised when the license is renewed in its entirety.
The Supervisor also related that all new licenses are transmitted with a-
- cover letter that-specifies certain regulatory requirements that are binding on the licensee. This procedure is not always done with
" renewals in their entirety."
t Recommendation-We recommend that the State renew the identified license in its entirety, and that the State's licensing procedures be modified to j
1 provide for cover letters on renewal licenses that also specify certain j
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5 regulatory requirements that need to be brought to the licensee's attention, such as new or revised regulatory requirements.
1 Current Status:
l The Program has made the necessary modifications to their licensing procedures as requested.
This comment is closed.
l 6.
Inspection Reports is a Category II Indicator. The following comment with our recommendation is made.
Comment:
1 Findings of inspections should be documented in the report clearly describing the scope of the inspection, the scope of the licensee's programs, and substantiating all items of noncompliance-As a rule, items of noncompliance should be documented with "what" requirement was violated, "when" the requirement was violated, and "how" the requirement was violated. One report needed more details describing the scope of the inspection and the scope of the licensee's program. Two other reports needed more documentation clearly describing "how" a requirement was violated.
Recommendation:
We recommend that the inspection reports clearly document the details of the report that describe the scope of inspection, scope of the licensee's program, and clearly substantiate all items of noncompliance.
Current Status:
The Program developed additional written procedures that address this issue, and discussions were reportedly held with the inspectors. These new procedures were reviewed during the visit. The new procedures have been implemented as observed during the inspector accompaniment.
This comment is closed.
Status of Selected Program Elements and Indicators The following program changes are provided as an update to the Status of some of the Program Elements and Indicators, and were obtained from discussions with Program staff, observations, and the review of documents as appropriate.
A.
Status and Compatibility of Regulations The State regulations are compatible with NRC regulations through the
" Financial Assurance and Recordkeeping for Decommissioning" 10 CFR Parts 30, 40, and 70 (54 FR 18051) amendments that became effective on l
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3 April 7, 1990.
(See comment number 1 above.)
The importance of updating the State's regulations for compatibility with NRC's regulations and uniformity with other States was discussed.
Program management related that the regulations needed for compatibility were being drafted, and that the (new) Part 20 standards would be adopted by the first of the year.
i B.
Oroanization
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There has been no change in the organizational structure of the Radiation Control Branch or the organizational relationship of the l
Branch to the Department. The Department is expected to be reorganized in July of 1993, but details were not available at this time.
C.
Personnel l
i One new staff person has been added to the Materials staff, Ms. Sue Osborne. Ms. Osborne has a BS degree in Environmental Health Science l
and a BS degree in Industrial Technology.
t D.
Salaries.
There have been no changes in the salaries for the employees since the last review; however, new job classification salary ranges I
were provided as follows:
Radiation Control Program Manager..........
27,072 to 43,368 l
Radioactive Materials Section Supervisor......
24,552 to 39,336 l
t Radioactive Materials Specialist Chief.......
22,272 to 35,668
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i Radioactive Materials Specialist Principal 20,196 to 32,376 Radioactive Materials Specialist Senior.......
16,608 to 26,592 Radioactive Materials Specialist..........
15,072 to 24,144 The Program has received permission to recruit employees at the mid-range level of the respective salary range.
E.
Budaet. A revised budget for FY 92 (July 1,1992 to June 30,1993) was received and provided as follows:
General Fund 410,800 Agency Fund (license fees, x-ray fees, certification)......
558,900
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l Grants:
EPA Radon........................
207,000' DOE (Paducah facility) 184,300 I
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Total............................
1,361,000 l
Estimated funds needed for Materials program 220,000 Estimated funds from Materials fees..............
125,000 I
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The Program manager provided the above estimates, which indicates that l
approximately 57 percent of the Materials Program is funded through the i
collection of materials license fees.
The State increased the fee l
schedule for material licenses by approximately 25 percent; however, the State General Fund allocation to the Program was reduced to offset the fee revenues to the Program.
.j F.
Staffino Level. The State has four full time technical personnel in the Radioactive Materials Program to regulate 386 licenses. This is equivalent to 1.0 persons per 100 licenses. The Program has tentative 1
plans to hire one additional person in the materials section during this next fiscal year.
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G.
Licensino Procedures. Standard licensing procedures are being followed.
The " major license" listing was updated.
The State appears to be i
current on their licensing workload. A summary of the licenses by
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I license category was obtained as follows:
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Broad Academic 2
t B ro ad Med i c al............................ 3 Gas Chromatograph.........................
27 Gauge, Fixed 59 i
G aug e, Po rt a bl e..........................
119 I
-l Laboratories 19 l
1 Manufacturing & Distribution 7
l Nuclear Pharmacy 2
t Medical, Institutional 72 l
Medical, Private Practice....................
16 l
1 Medical, Teletherapy 9
Radiography............................. 9 Well Logging
. 12
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Other...............................
30 l
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Total......
386 H.
Compliance. The status of the inspection program appears to fluctuate from month to month depending upon the availability of trained inspectors. However, the State does not have a backlog that is in excess of the NRC policy guidance and-the State appears to manage their technical resources very effectively.
I.
Inspectors Performance and Capability An inspector a companiment was conducted on May 5, 1993 at a Kentucky licensed facility as follows-a Inspector:
Michael Wilcoxson Licensee:
Saints Mary and Elizabeth Hospital l
1850 Bluegrass Avenue l
Louisville, Kentucky 40215 License No.:
202-096-25 License Type:
Institutional Medical with Cardiology i
The inspector was found to be fully prepared and qualified to perform the inspections in accordance with the job description and State procedures. This person has also received some formal training in "investicative procedures" while employed as an investigator with another Aaency (CDC).
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All of the current inspectors in the Materials Section have been i
accompanied within the last 3 years, with exception of Ms. Sue Osborne.
i Ms. Osborne is currently in training and will be accompanied during the next review.
t J.
Response to incidents and Alleaed incidents i
The program has responded well to incidents since the last review and incident reports are being provided to NRC on a timely basis.
Discussions were held with the Program manager and the Materials Section Supervisor regarding the importance of responding to incidents and allegations, and reporting accurate and timely event data to the NRC.
The Program has developed internal procedures for reporting abnormal
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occurrences and other events to NRC. These procedures were reviewed during the visit.
All events and allegations are evaluated on a case-by-case basis and i
follow-up actions are taken as needed to protect public health and safety, and to provide the proper regulatory osersight.
Program actions for responding to events and the documentation thereof were discussed in detail with the Section Manager.
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All reports are filed in an Incident Binder and also copies are placed in the licensee's file as appropriate.
The summary reports for the 1992 d
calendar year and for 1993 were reviewed. Thus far in 1993, only four i
diagnostic misadministration reports have been received, and would not have been reportable under NRC's current regulations.
On January 11, 1993, the Program sent a memorandum to all radioactive i
material licensees that reminded the licensee of Kentucky's requirements j
for reporting incidents, and provided emergency notification telephone numbers.
On April 9, 1993 the Program sent a memorandum to all "KY Radioactive f
Material Medical Licensees" that reminded the licensee of the requirements for reporting misadministrations.
j Management Discussions An informal exit meeting was held with Dr. Volpe and Ms. Jeffs on Thursday J
afternoon.
We discussed the program in general, staffing, resources, adoption of regulations, incident reporting, and the status of the Maxey flats LLRW i
burial site remedial actions. Dr. Volpe emphasized that the adoption of l'
regulations was becoming increasingly more difficult because the program did not have people that could be dedicated specifically to the revision of regulations. He requested that new regulations be provided to him in a word i
j processing format at the earliest time possible. Dr. Volpe is also concerned
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that nobody from NRC has contacted him about NRC's involvement at the DOE Paducah site. The Program has a DOE grant for environmental monitoring activities around the Paducah site, and would like to coordinate the State's site monitoring activities with those of the NRC. This concern was provided by telephone to the Region III, State Liaison Officer on May 12, 1993.
j Conclusion 1
i Based upon this visit and the previous review, it is recommended that the next i
full review be conducted in April of 1994.
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i Richard L. Woodruff Regional State Agreements Officer l
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i Stewart D. Ebneter, Regional Administrator i
NRC, Region 11 i
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R. E. Trojanowski, Region II l
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