ML20236L043
| ML20236L043 | |
| Person / Time | |
|---|---|
| Issue date: | 06/26/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Bangart R, Knapp M, Thompson H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF STATE PROGRAMS (OSP), NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| NUDOCS 9807100191 | |
| Download: ML20236L043 (4) | |
Text
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UNITED STATES l
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NUCLEAR REGULATORY COMMISSION l
2 WASHINGTON, D.C. 30666-4001 June 26, 1998 MEMORANDUM TO:
Hugh L. Thompson, Jr.
I Deputy Executive Director for Regulatory Programs Richard L. Bangart, Director Office of State Programs Malcolm R. Knapp, Acting Director Office of Nuclear Material Safety and Safeguards Karen D. Cyr, General Counsel Thomas T. Martin, Director Office for Analysis and Evaluation n
of Operational Data FROM:
Paul H. Lohaus, Deputy Director I g.%
Eb s
Office of State Programs
SUBJECT:
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) REVIEW OF ALABAMA RADIATION CONTROL PROGRAM This memorandum transmits to the Management Review Board (MRB) a proposed final report (Attachment 1) documenting the IMPEP review of the Alabama Radiation Control Program.
The review of the Alabama program was conducted by an interoffice team during the period April 20-23,1998. The team issued a draft report to Alabama on May 27,1998, for factual comment. A!abama sent factual comments by letter dated June 16,1998, from Kirksey E.
}
Whatley, Director, Alabama Office of Radiation Control (Attachment to proposed final report).
,(
The review team found Alabama's performance with respect to each of the common performance indicators and the non common performance indicator, Legislation and Regulations, to be satisfactory. Accordingly, the team recommends that the Management Review Board find the Alabama program to be adequate to protect public health and safety and compatible with NRC's program.
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MRB Members 2
DUN 2 619S8 The MRB meeting to consider the Alabama report is scheduled for Wednesday, July 8,1998, from 9:00 - 11:00 a.m. In Two White Flint North, Room 2 B-5. In accordance with j
Management Directive 5.6, the meeting is open to the public. The agenda for that meeting is I
attached (Attachment 2).
l If you have any questions prior to the meeting, please contact me at (301) 415-2326 or
)
Richard Blanton at (301) 415 2322.
Attachments:
l As stated cc:
Kirksey E. Whatley, Director Alabama Division of Radiation Control Steve Collins Organization of Agreement States Liaison to MRB l
MRB Members.
2 JUN 2 61988 The MRB meeting to consloer.he Alabama report is scheduled for Wednesday, July 8,1998,
" rom 9:00 = 11:00 a.m. In Two White Filnt North, Room 2-B 5. In accordance with L
Management Directive 5.6, the meeting is open to the public. The agenda for that meeting is I
attached (Attachment 2).'
l if you have any questions prior to the meeting, please contact me at (301) 415-2326 or Richard Blanton at (301) 415-2322.
l l
Attachments:
As stated l
cc:
Kirksey E. Whatley, Director Alabama Division of Radiation Control Ste <e Collins l
Organization of Agreement States Liaison to MRB L
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Distribution:
t DIR RF PLarkins, ASPO i DCD '(SP01) -
L SDroggit',.,
RWoodruff, Ril (PDR (YES_f._ NO
)
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KSchne' der JDecicco, NMSS DCool, NMSS WSilva, TX l
FCombc, NMSS.
GDeegan, NMSS L
Alabama File
- See previous concurrence.
DOCUMENT NAME: G:\\lMPEP\\AL98MRB.WPD G:\\lMPEP\\A 98P[=N.WPD i
' T e receiw a cop t of this document, Indicate in the box: "c' - Copy withotJt attachmenvenc -
t"E Copy with attachment / enclosure "N" = No cpy OFFICE OSP l
OSP-l O!F$ //
l OSP:D //d/
l NAME LRakovantk RBlanton PHLot4tY RLBangart Hl)
I DATE 06/24/98*
06/24/98*
06 7/98 06/Jh/98 L
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MRB Members 2
The MRB meeting to consider the Alabama report is schedule for Wednesday, July 8,1998, from 9:00 - 11:00 a.m. In Two White Flint North, Room 2-
-5. In accordance with Management Directive 5.6, the meeting is open to the public. The agenda for that meeting is attached (Attachment 2).
If you have any questions prior to the meeting, please conta 't me at (301) 415-2326 or Richard Danton at (301) 415-2322.
Ahachments:
As stated cc:
Kirksey E. Whatley, Director Alabama Division of Radiation Control Organization of Agreement States MRB Representative Distribution:
DIR RF PLarkins, ASPO DCD (SP01)
SDroggitis RWoodruff, pil PDR (YES_f_ NO
)
KSchneider JDecicco, NMSS DCool, NMSS WSilva, TX/
FCombs, NMSS GDeegan, NMSS FCameron, OGC HNewsome, OGC Alabama File DOCUMENT NAME: G:\\lMPEP\\AL98MF.3.WPD G:\\lMPEP\\AL98PFN.WPD To receive a copy of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E* = Copy with attachment / enclosure "N* 3_No copy OFFICE OSP jy l OSP,m C-
! OSP:DD l
OSP:D NAME LRakovan:kk U~
RBlantorUP PHLohaus RLBangart DATE 06/rl/98 06/U/98
,/
06/ /98 06/ /98 OSP FILE CODE: SP-AG-1 1
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l lNTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM MtiViEW OF ALABAMA AGREEMENT STATE PROGRAM 1
l April 20 - 23,1998 I
PROPOSED irlNAL REPORT U.S. Nuclear Regulatory Commission i
ATTACHMENT 1 0 9AA~ A/> lrA nl D' 7)
1 1.0
- INTRODUCTION This report presants the results of the review of the Alabama radiation control program. The review was conducted during the period April 20 - 23,1998, by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Texas. Team members and their assignments are identified in Appendix A. The review was conducted in accordance with the ' implementation of the integrated Materials Performance Evaluation Program and Rescission of a Final General Statement of Policy,"
published in the Federal Reaister on October 16,1997 and the November 25,1997, revised l
NRC Management Directive 5.6, " Integrated Materials Performance Evaluation Program -
(IMPEP)." The review focused on the materials program as it is carried out under the Section l
274b. (of the Atomic Energy Act of 1954, as amen?ed) Agreement between the NRC and the L
State of Alabama. Preliminary results of the review, which covered the period June 23,1995, to April 23,1998, were discussed with Alabama management on April 23,1998.
. [A paragraph on the results of the MRB meeting will be included here in the final report.]
The Alabama Agreement State program is administered by the Department of Public Health (DPH), Office of Radiathn Control (ORC). The Director of the ORC reports to the State Health Officer, who serves as the Director of the Department of Public Health. The State Board l
of Health is the designated radiation control agency. Organization charts for the DPH and the ORC are included in Appendix B. At the time of the review, the ORC regulated 404 specific licenses.
In preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the State on November 12,1997. The State provided a response to the questionnaire on March 19,1998. A copy of the response is included in Appendix C to this report.
The review team's general approach for conduct of this review consisted of: (1) examination of Alabama's response to the questionnaire; (2) review of applicable Alabama statutes and regulations; (3) analysis of quantitative information from the radiation control program licensing and inspection database; (4) technical review of selected licensing and inspection actions; (5) field accompaniments of two ORC inspectors; and (6) interviews with staff and management to
)
answer questions or clarify issues. The team evaluated the information that it gathered against the IMPEP performance criteria for each common and applicable non-common indicator and
- made a preliminary assessment of the State's performance.
t Section 2 below discusses the State's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common performance
' indicators are presented in Section 3. Section 4 discusses results of the applicable non-common indicators, and Section 5 summarizes the review team's findings,
' recommendations, and suggestions. Recommendations made by the review team are comments that relate directly to program performance by the State. A response is requested from the State to all recommendations in the final repc.t Suggestions are comments that the review team believes could enhance the State's program. The State is requested to consider suggestions, but no response is requested.
I Alabama Proposed Final Report Page 2 2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS i
.. After the previous routine review, which concluded on June 23,1995, the results were transmitted to Donald Williamson, M.D., State Health Officer, Alabama DPH on September 18,
' 1995. The review initially resulted in one recommendation, and the withholding of a finding for compatibility because the State had not adopted a regulation equivalent to the " Quality Management (QM) Program and Misadministration," 10 CFR 35.32 amendment (56 FR j
34104) that became effective on January 27,1992.
l Subsequent to the letter of September 18,1995, NRC reinitiated an evaluation of the OM rule.
L lt was decided that pending the completion of the re-evaluation, the absence of a compatible OM rule would not be used as a basis for withholding of a finding for compatibility, in a letter dated October 24,1995, the State was notified of this action and subsequently all Agreement States were notified of the results of this re-evaluation by SP-95-184 dated December 6,1995.
l The compatibility category of the OM rule under the new Commission policy on Adequacy and Compatibility, which became effective on September 6,1997, has been set as "D" with paragraphs (a), (b), and (c) of the rule identified as having provisions important to health and j
safety. Consistent with SECY 97-054 (see SP-97-057), staff will review the compatibliity of both
. draft and final Agreement State equivalent OM rules as they are promulgated. However, the results of such reviews will not affect IMPEP review findings. A separate review of the current Alabama rule equivalent to 10 CFR 35.32(a), (b), and (c) has been completed, and the rule found to meet the compatibility and health and safety category.
l Based on the above, the team determined that this recommendation should be closed.
1 3.0 COMMON PERFORMANCE INDICATORS IMPEP identifies five common performance indicators to be used in reviewing both NRC Regional and Agreement State programs. These indicators are: (1) Status of Materials
- Inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical Quality of Licensing Actions; and (5) Response to incidents and Allegations.
. 3.1 Status of Materials inspection Proaram The team focused on four factors in reviewing the status of the materials inspedon program:
inspection frequency, overdue inspections, initial inspection of new licensees, r,a timely
.j dispatch of inspection findings to the licensees. This evaluation is based on the Alabama l
questionnaire responses relative to this indicator, data gathered from reports generated from the licensee database, the examination of inspection casework and interviews with the management and staff of the ORC.
I
- A DPH' memorandum dated April 16,1998, entitled " License and Registration Inspections Priority
- requires that inspections be conducted in accordance with the priority schedu!e in NRC Inspection Manual Chapter (IMC) 2800, with the following modifications:
1)
All programs assigned to Priority 7 by NRC are cilanged to Priority 5; l
l i
l Alabama Proposed Final Report Page 3 l
E)
Medical Institutions and Medical Private Practices not requiring a QM Plan are
(
assigned to Priority 3 instead of Priority 5; 3)
Academic Type B is assigned to Priority 2 instead of Priority 3; and 4)
Stereotactic Radiosurgery is added with a Priority 1.
The April 16,1998 memorandum further established a policy and procedure for extending
~ inspection intervals on the basis of good licensee performance. The memorandum also established a policy and procedure for reducing inspection intervals, using a point system l
based on violation severity and frequency. The inspection interval extension / reduction policy differs from NRC's in two aspects: 1) in Alabama the interval extension policy "may be applied" as compared to NRC's "g.h..g![ be applied;" and 2) in Alabama the decision to grant an extension h
is made at the time the licensee's next inspection is due, versus the IMC 2800 provision for the l
decision to be made at the time the current inspection is completed. The application for an increase in interval and the documentation required are essentially the same for both Alabama and NRC. No licensees had been granted interva' extension prior to the review, however, there i
were four licensees subject to interval reduction at the time of the review.
i l
The licensee database contains fields for 43 items of information, and is accessible to both licensing branch and inspection branch staff. Certain fields, such as the next inspection date, are changed only by management. Information retrieval can be formatted to give the type of report and information desired. Fcr example, a monthly ' inspection due' report is generated for i
scheduling purposes. The report fields indicate the inspection due date, date of the last i
inspection performed, the licensee, and the State region (s) where the licensee is located. - The inspectors use this report to formulate an inspection itinerary, which is submitted for management approval prior to departure.
The Radioactive Materials Compliance Branch (RMCB) of the ORC conducts an average of 130 l
inspections per year. Currently, the ORC has no overdue inspections.- This performance meets and surpasses the IMPEP criteria for this indicator.
Initiai inspections of new licensees are scheduled for five months after the date the license is
-issued. At that time, an inspector contacts the licensee, if the licensee has not acquired material during this period, the inspector asks when the licensee expects to acquire material.
Depending on the licensee's response, the inspection due date may be extended up to another five months.- If material is not acquired during this period, an inspection is performed before the
- end of the first year post license issuance. There were 40 init:al inspections performed during the review period, all v/ thin the scheduled intervals for new licensees.
' Alabams allows 30 days of possession of materials in State under reciprocity without payment of a fee.L After 30 days, an out-of-State Alabama license (and fee payment) is required.
Holders of out-of State licenaes are required to give a 3 day notification of any planned use of radioactive material at a temporary job site in Alabama. The ORC considers the out-of State licensees to effectively be operating under reciprocity. The inspections, of Priority 1 and Priority
' 3 licensees granted reciprocity (including the Priority 1 aM Priority 3 out-of State licensees
. using materials in State) during the review period fell short of the goals !ndicated in IMC 1220.
=
Seventeen percent of the Priority 1 and 14 percent of the Priority 3 licensees were inspected.
l I
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Alabama Proposed Final Report Page 4 Inspection of teletherapy and irradiator source services licensees and Priority 2 licensees met
. IMC 1220 goals.
~
The ORC identified this shortfall in a self-audit, but noted that many of these licensees enter into the State for jobs that require only a short time, often only a few hours, and that the job sites are frequently located in remote areas of the State. The ORC indicated that this, coupled with_ the costs of travel, makes inspection of these licensees very difficult. The review team j
suggests that the Alabama ORC continue their efforts to find ways to increase the percentage of high priority reciprocity licensees, and out-of-State licensees working in Alabama, to be
-i inspected each year.
' Fifteen inspection files were reviewed for report timeliness. The procedure for reporting l-inspection results is initiated by the inspector, usually immediately upon return from the field.
[
The inspector transfers information from handwritten field notes to a computer-form, then drafts l
a cover letter to the licensee. The draft cover letter and computer-form notes comprise the draft report. Management reviews the draft report, and sends it to the secretarial staff to be l
finalized. The inspector receives the report back from the secretarial staff, assures its accuracy j
and completeness, and delivers it to the Dkector of the RMCB for signature. This procedure l
appears to be working very well. For the reports reviewed, seven were signed within two weeks -
l
. of the inspection, and all were signed within 24 days.
In summary, Alabama meets or surpasses 'the'IMPEP criteria in Management Directive 5.6 for the four areas reviewed for this performance indicator. Based on this, the review team recommends that Alabama's performance with respect to the indicator, Status of Materials L
Inspection Program, be found satisfactory.
3.2 Technical Quality of inspections The team reviewed the inspection reports, enforcement documentation, and inspection field notes, and interviewed inspectors for 12 material inspections conducted during the review L
period. The casework reviewed included inspections by three materials license inspectors, two
' of which are presently assigned to perform inspections. The third is no longer performing L
radioactive materials inspections, but is stilfwith the program.' The casework reviewed covered inspections of various license types, including: industrial radiography portable gauge, academic broad scope, nuclear pharmacy, medical private practice, and medical institution.
Appendix C lists the inspection files reviewed in depth.
I To review inspectors' performance in the field, a team member accompanied two inspectors on L
February 11,1998, and during the period February 25 - 27,1998. Each inspector was
. accompanied on two unannounced inspections. One inspector was accompanied during the
? early morning inspection of a nuclear pharmacy or) February 11,1998, and at a nuclear medicine facility on February 25,1998. The other inspector was accompanied February 26 -
27,1998, on unannounced inspections of a medical licensee with brachytherapy (including tm L
HDR therapy unit), and an industrial radiography licensee. These accompaniments are also
~ identified in Appendix C. Durfng the accompaniments, the inspectors demonstrated appropriate
-inspection techniques and knowledge of the regulations. Both inspectors were well prepared
~and thorough in their reviews of the licensees' radiation safety programs. Overall, the technical performance of the inspectors was excellent, and their inspections were adequate to assess radiological health and safety at the licensed facilities.
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Alabama Proposed Final Report Page 5 During the onsite review, the review team determined that the ORC is performing inspections of materials Ncensees on an unannounced basis, except for initial inspections. The inspectors use a packet of note forms for each major type of inspection. The inspectors used the appropriate inspection field note forms in the files reviewed. Each inspector has the forms on his computer, l
and prints the appropriate forms as necessary for the inspection. The review team observed that the inspectors were reviewing open items from previous inspections and any incidents or allegations that had occurred since the previous inspection.. Approximately half of the inspections reviewed by the team resulted in no items of non-compliance, with appropriate letters being issued to the licensees. In the other cases, the ORC issued appropriate Notices of Violation.
. During the review period, the RMCB supervisor accompanied two of the three individuals who had performed materialinspections. The accompaniment reports contained sufficient details to L
. document the areas covered. The accompanied inspector is provided a copy of the l
. accompaniment report and receives ari oral report of his performance.
l The senior materiels inspector had not been accompanied during the review period, until just before the review. The lack of accompaniment was identified during the ORC's self-audit, and i
an accompaniment of the senior materials inspector was conducted. The review team suggests
[
that the ORC accompany all material inspectors on a yearly basis.
l The review team found that the ORC maintains a sufficient number and variety of curvey l
instruments to perform radiological surveys of materiallicensees. The twiew team examined the State's instrumentation and observed that the survey instruments were calibrated and operable. Inspectors obtain instruments from the stock for each inspection. The ORC performs its own calibration at three month intervals, with a source that is NBS traceable. A copy of the procedures was examined and appeared adequate. For repairs, the instrument is l
either returned to the manufacture or is sent to a facility that performs this service.
Based on the IMPEP evaluation criteria, the revieve team recommends that Alabama's performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.
3.3 Technical Staffina and Trainino D
lasues associated with this l'ndicator include radioactive materials program staffing levels, qualification of the staff, training, and staff tumover. <To evaluate these issues, the review team
. examined the State's questionnaire responses related _to the indicator, conducted interviews
- with management and staff of the ORC, and reviewed workload for backlog.
The staff of the ORC was relatively stable over the review period. There were no new hires,'
and only two staff members departed, both due to retirement. One was the Director of Emergency Planning / Environmental Monitoring Section, the other was the Director of Naturally Occurring Radioactive Material Section. Due to fisca! constraints, the positions vacated by the retirements were lost. Thus, the ORC had no vacant positions during the review period.
However, the losses did not cause an observable reduction in the performance of the Agreement ma% rials program.'
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[T 3
Alabama Proposea Final Report Page 6 Due to a historic low rate of tumover, the staff consists of experienced personnel. The l
minimum educational requirement for a new hire is a baccalaureate degree. All current staff E
exceed the qualifications. The ORC has 14 technical positions, including branch directors, that are apportioned as follows: Radioactive Materia!s Compliance 3, Radioactive Materials Ucensing 1, Emergency Planning & Environmental Monitoring 3, Mammography 1, X Ray Compliance 5, and the Program Director. The ORC has a secretarial staff of three.
In addition to the four technical staff members in the Radioactive Materials Licensing and Compliance Branches, the Program Director spends about 23% of his time in radioactive materials licensing and inspection activities. Based on the lack of backlogs and the quality of the licensing actions and inspection reports, the team concluded that the number and
~ distribution of staff appear to be adequate to maintain the program, h
The ORC r_eceives support from the Alabama Department of Environmental Management's (ADEM) radiation measurements laboratory, which performs sample counting and assay services. Discussions with both ORC and laboratory staff established that the support is timely
' and dependable. The U.S. Environmental Protection Agency's (EPA) radiation measurements laboratory is located close to the ADEM lab, and is available for backup.
Training and qualification requirements for licensing and inspection staff are set out in a DPH memorandum dated October 20,1997, Policy No. 417. The memorandum sets forth essentially the same training and qualification recommendations developed by the NRC _ Organization of Agreement States Joint Working Group. A lead inspector is required to obtain specialized training appropriate for the type of licensees being inspected. Inspector requirements include NRC, or equivalent, training courses when available, inspectors are also required to be accompanied by a senior staff member on an inspection prior to authorizing this inspector to perform an independent inspection. Prior experience in inspecting in the specialized area (s) is required to be a license reviewer or writer.
The training requirements set forth by the October 20,1997, memorandum are presently met.
by all of the radioactive materials staff for their respective positions. - All have taken the NRC courses deemed appropriate for their tasks, including the five week health physics course. The training records demonstrate that DPH management is committed to a high degree of training for the staff. However, the State Health Officer expressed concern that the cost of training, 3
especially the five week course, may become a financial obstacle for the State in the future.
l L
The team noted the apparent benefits to the ORC from staff participation in the nationwide j
l materials regulatory program outside their regular work. The Director of the Licensing Branch j
L
- has served on committees and working groups including the joint working group currently j
considering revisions to 10 CFR Part 35. The Director of the RMCB has served previously on IMPEP review teams. The ORC Director and other staff members have participated in activities of the Conference of Radiation Control Program Directors. The knowledge and experience
- gained from these activities have been reflected back to the ORC. The team particularly notes and commends the self audit function initiated by the ORC during the review period.
J Based on the IMPEP evaluation criteria, the team recommends that Alabama's performance j
with respect to the indicator, Technical Staffing and Training, be found satisfactory.
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Alabama Proposed Final Report Page 7 3.4 Technical Quality of Licensino Actions The review team interviewed the Alabama license reviewer, evaluated the licensing process, and examined licensing casework for 30 specific licenses. The ORC reported having 404 l
specific materials licenses, issuing 51 new licenses and terminating 47 licenses since the 1995 review. The ORC utilizes one full time license reviewer, and the ORC Director performs a technical supervisory review before each licensing action is issued. Alllicenses are signed by the ORC Director and the State Health Officer. The State issues licenses for a five year period, and utilizes a timely renewal system, NRC licensing guides and policies, as appropriate, and appropriate standard licensing conditions.
The licensing casework was selected to provide a representative sample of licensing actions which were completed during the review period and included all amendments to the selected licenses since the previous review. The cross-section sampling focused on the State's major licenses, new liconses, renewals, and licenses terminated during the review per:od. The sample included the following licensing types: broad academic; broad medical; research and
~ development; source material; nuclear laundry; industrial radiography; portable gauges; institutional nuclear medicine; private clinics; mobile nuclear medicine; radioisotope and sealed source radiotherapy; and nuclear pharmacy. Licensing actions reviewed included 11 new,4 q
renewals,39 amendments and 6 termination files. A listing of the casework licenses with case specific comments can be found in Appendix D.
Licensing actions were reviewed for comp!eteness, consistency, proper radioisotopes and quantities, qualifications of authorized users, adequate facilities and equipment, adherence to good health physics practices, operating and emergency procedures, appropriateness of the license conditions, and overall technical quality. The casework files were also reviewed for use of appropriate deficiency letters and cover letters, timeliness of correspondence, reference to appropriate regulations, information notices, product certifications or other supporting documents, consideration of enforcement history, pre-licensing visits, supervisory review as
-indicated, and proper signatures. The files were checked for retention of necessary documents and supporting data including the terminated license files.
The review team found (with the exception of one termination as discussed below) that the licensing actions were consistently very thorough, complete, of high quality, with health and safety issues proper!y addressed, and sufficient to establish the basis for the licensing action.
The licensee's compliance history is taken into account when reviewing renewal applications and amendments as determined from documentation in the license files and/or discussions between the license reviewer and the inspectors. As discussed in the questionnaire, five exemptions were issued by the ORC during this review period. All were determined to be appropriate and well documented.
A review of the termination actions taken over the review period showed that most of the terminations were for licensees possessing only sealed sources and/or for uses of radiopharmaceuticals with short half lives. Six terminatio, files were selected for review based upon the potential for residual contamination, and to confirm that the State's termination procedures were being implemented. In general, the review team found that terminated licensing actions were well documented, showing appropriate transfer records or appropriate disposal methods and records, confirmatory surveys, and survey records.
~
. Alabama Proposed Final Report Page 8 One case file involved the transfer of a portable gauging device to a specific licensee located in ancther Agreement State. The records included a handwritten " Bill of Sale" from the Alabama licensee. Other documentation in the file, and the licensee's compliance history, raised a question concerning the validity (authenticity) of the transfer records. It was also undetermined if the sealed source had been leak tested prior to the transfer.
l The team considered the potential for the device to end up at an unlicensed facility, such as a l
metals processor. Following the team's discussion concerning this case, the ORC Director Initiated a call to the State program having jurisdiction over the new owner and confirmed that the new owner had a valid license. The new owner was also contacted by telephone to confirm the transfer of the device and that the device had been leak tested. The review team suggests that during terminations of licensees with poor compliance history suggesting a lack of reliability, confirmation of the validity of the license of the receiving licensee be obtained directly from the agency having jurisdiction, and that confirmation that the materials (devices) were received be obtained directly from the receiving licensee.
In discussions with the program management, the team noted that there were no major decommissioning efforts underway with regard to agreement materialin Alabama. The State is working with the NRC Region ll office concerning the decommissioning of the NRC licensed Ft. McClellan site located near Anniston, Alabama (NRC license number 01-02861-04). The -
State is assisting NRC with environmental sampling and analysis, including groundwater samples.
The sample analyses are being performed by the ADEM laboratory located in Montgomery.
Discussions were held with ORC staff concerning the adequacy and timeliness of results from samples sent to the laboratory for analysis. A visit was also conducted by the IMPEP team to evaluate the capabilities of the laboratory. The team noted that the EPA's Montgomery radiation laboratory is located in adjoining property (Gunter Air Force Base). The ORC Director related that the ORC staff has a good working relationship with the EPA staff.
Based on the IMPEP evaluation criteria, the review team recommends that Alabama's performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
3.5 Response to incidents and Allegations in evaluating the effectiveness of the ORC's actions in responding to incidents, the review team examined the response to the questionnaire relative to this indicator, reviewed the incident reports for Alabama in the Nuclear Material Events Database (NMED) against those contained in the ORC's files, and reviewed reports and supporting documentation as appropriate for six incidents. In addition, the team reviewed the files for two allegations.
The six incidents selected for review included the fcilowing incident types: stolen radioactive material, overexposure, lost radioactive material, transportation accident, improper disposal of radioactive material, and damaged equipment. A list of the incidents reviewed in depth, with comments, is included in Appendix E.
- The responsibility for the initial response and follow-up actions to material incidents may be assigned to any member of the materials program. When a report is received, it is given a
Alabama Proposed Final Report Page 9 unique number and logged into the incident log. A brief description of the incident along with the date the incident is eventually closed are also placed in the log. Documentation related to the incident is placed in an incident file and in the appropriate license file.
ORC staff responded to two of the incidents reviewed. One of the investigations was conducted on the same day the notification was received, and the other was conducted within a week of the notification. The program reviews the licensee's report of the incident at the next inspection. The review team determined that Alabama took prompt, appropriate action in response to the incidents reviewed. The team observed that Alabama consistently addressed health and safety issues in the incident follow-up. All incidents that required notification to the State were reported to the NRC. However, prior to this year, reporting was performod on a yearly basis, and this year reporting has been performed on a quarterly basis. The review team recommends that Alabama adopt a procedure providing that reports of incidents that require immediate notification to the State be provided to the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of notification, and that reports of incidents that require notification to the State within 30 days be provided to the NRC monthly.
In evaluating the effectiveness of Alabama's actions responding to allegations, the team examined Alabama's response to the questionnaire relative to this indicator and reviewed the casework for two allegations. Prior to 1997, allegations were not separated from incidents. For 1997, allegations were provided a separate tracking number. During the review period, it is estimated that Alabama received less than 12 allegations per year for both Agreement materials and other radiation regulatory programs. During 1997, elght allegations were received, of which four were related to Agreement materials.
One of the files reviewed was of an anonymous allegation which was not substantiated. In the other file, the alleger contacted the program directly and did not request confidentially. The investigation substantiated the allegation and the licensee was cited. The results were provided to the alleger.
Alabama evaluates each allegation and determines the proper level of response. The team's review of Alabama's responses and files determined that the responses are appropriate and that investigations or determinations are adequately documented.
Based on the IMPEP evaluation criteria, the review team recommends that Alabama's performance with respect to the indicator, Responu to incidents and Allegations, be found satisfactory.
4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery Program. Alabama's agreement does not authorize regulation of uranium recovery activities.
Alabama Proposed Final Report Page 10 4.1 Legislation and Procram Elements Reauired for Compatibility 4.1.1 Lealslation Along with their response to the questionnaire, the State provided the review team with the opportunity to review copies of legislation that affects the radiation control program. Legislative
. authority to create the program and enter into an agreement with the NRC was granted in 1963 i
(Acts of 1963, No. 582). The State Board of Health is designated as the State's radiation control agency. The authority to enter the Southeast Interstate Low-Level Radioactive Waste Compact was granted in 1982 (Acts ol 1982, No. 328). The team noted that the legislation had r
not changed since the previous review.
4.1.2 Proaram Elements Reauired for Compatibility in its response to the questionnaire, Alabama indicated that all of the NRC regulatory.
amendments, due for adoption through March 1998, that have been identified as needed for compatibility or as having provisions significant to health and safety, have been adopted. A L
. copy of the effective Alabama regulations, including the last amendments whbh became Leffective as of March 18,1998, was given to the team. Separately, NRC staff has reviewed the final Alabama regulations adopted March 18,1998, and as a result of the review, determined that the regulations meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.
The March 18,1998 rulemaking included two amendments, the Clarification of -
Decommissioning Funding Requirements effective for NRC licensees November 24,1995, and exempt distribution of a radioactive drug containing one microcurie of C-14 Urea effective for NRC licensees January 2,1998. Alabama has not adopted the amendmer:t to 10 CFR 19.12 contained in Radiation Protection Requirements:. Amended Definitions and Criteria (due
- 8/14/98)..The other provisions of that particular NRC rulemaking have been addressed by the State. The Program Director indicated that the change to $ 19.12 will be addressed, and that -
. generally rule changes can be completed in approximately three months.
The team noted that Alaba u provides, by law, opportunity for public comment on proposed regulation changes. Draft regulations are sent to NRC for review and comment, and when necessary, the NRC comments are incorporated. Rulemaking responsibility is assigned to the Program Director.
- The March 18,1998 rulemaking addressed three NRC amendments that were past the three-year period during which States are expected to adopt equivalent rules.- The " Decommissioning Recordkeeping
- Documentation Addition," amendments to Parts 30,40, and 70; and the
" Timeliness in Decommissioning," amendments to Parts 30,40, and 70 were overdue by 17 months and 7 months, respectively. The " Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use," amendments to Parts 30,32, and 35 were adopted more than 3 months past due. The Alabama rule equivalent to the Licensing and Radiation Safety Requirements for Irradiators,10 CFR Part 36, would have been due for adoption July 1,1996, however, the Auburn University irradiator (the only large irradiator licensee) was limited to the approximately 550 curies of Co-60 left frcm the original load. The rule was adopted when the University requested authority to reload with 15,500 curies.
1
Alabama Proposed Final Report Page 11 The team notes that the ORC underwent a reorganization during the review period and the need for rulemaking was overlooked. The ORC has initiated a self audit procedure based on l
the IMPEP criteria which is expected to prevent such slippages in the future. As a result, the team has no recommendations or suggestions.
Alabama has not yet adopted the following regulations, but intends to address them in timely rulemakings or by adopting alternate generic legally binding requirements ;
e'
" Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendment (60 FR 28323) that became effective June 30,1995.
e
" Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20, and 35 amendment (60 FR 48323) that became effective October 20,1995.
l e'
' Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective April 1,1996.
l e
" Termination or Transfer of Licensed Activities: Record Keeping Requirements,"
10 CFR Parts 20,30,40,61,70 amendments (61 FR 24669) that became effective l-June 17,1996.
e
" Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air
.l Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997.
e
" Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective January 27,1997.
e
" Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Part 20.35 amendment (62 FR 4120) that became effective May 29,1997.
e
" Fissile Material Shipments and Exemptions," 10 CFR Part 71 amendment (62 FR 5907) l that became effective February 10,1997.
o
" Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial Radiography Operations," 10 CFR Parts 30,34,71,150 amendments (62 FR 28947) that became effective June 27,1997.
" Radiological Criteria for License Termination," 10 CFR Parts 70,30,40,70 e-amendments (62 FR 39057) that became effective August 20,1997.
. It is noted that Management Directive 5.9, Handbook, Part V, paragraph (1)(c)(iii), provides that the above regulations should be adopted by the State as expeditiously as possible, but not later
. than 3 years after the effective date of the new Commission Policy Statement on Adequacy and
~ Compatibility,' l.e., September 3,2000.'
l Based on IMPEP evaluation criteria, the review team recommends that Alabama's performance L
with respect to the indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory.
Alabama Proposed Final Report Page 12 4.2 Sealed Source and Device (SS&D) Evaluation Procram I
During the review period, no SS&D certificaMs were issued by the State. The team reviewed the State's plans for reviewing a source or device if required. Although the State does not have
' staff members qualified to conduct reviews, it does have the authority to collect the full cost of
- an evaluation,' and to contract for a reviaw by qualified persons. The team did not evaluate this indicator further.
4.3 -
Low-Level Radioactive Waste Disoosal Proaram
' Alabama continues to be a member of the Southeast Interstate Low-Level Radioactive Waste Compact, and is not designated as the host State. There is no activity to establish a low level radioactive waste disposal site in the State. The team did not evaluate this indicator further.
. 5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team found that Alabama's performance with respect to each of the performance indicators to be satisfactory. Accordingly, the team recommends that the Management Review Board find the Alabama program to be adequate to protect public health and safety and compatible with NRC's program.
Below is a summary list of recommendations and suggestions, as mentioned in earlier sections of the report,'for evaluation and implementation, as appropriate, by the State.
RECOMMENDATION:
- The' review team recommends that Alabama adopt a procedure providing that reports of- -
incidents that require immediate notification to the State be provided to the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of notification, and that reports of incidents that require notification to the State within 30 dayc be provided to the NRC monthly. (Section 3.5)
SUGGESTIONS:
-1.
The review team suggests that the Alabama ORC continue their efforts to find ways to increase the percentage of high priority reciprocity licensees, and out-of State licensees working in Alabama, to be inspected each year. (Section 3.1) 2.
The review team suggests that the ORC accompany all material inspectors on a yearly basis. (Section 3.2)'
.3.
~ The review team suggests that during terminations of licensees with poor compliance history suggesting a lack of reliability, confirmation of the validity of the license of the receiving licensee be obtained directly from ti,a agency having jurisdiction, and that confirmation that the materials (devices) were received be obtained directly from the
' receiving licensee. (Section 3.4) 1 I
l
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APPENDIX A i
IMPEP REVIEW TEAM MEMBERS l
Name Area of Responsibility Richard Blanton, OSP Team Leader Technical Staffing and Training Legislation and Program Elements Required for Compatibility Sealed Source and Device Evaluation Program William Silva, Texas Technical Quality of Inspections Response to incidents and Allegations Joe DeCicco, NMSS Status of Materials inspection Program Technical Staffing and Training Richard Woodruff, Rll RSAO Technical Quality of Licensing Actions i
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[.
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l LIST OF APPENDICES AND ATTACHMENTS Appendix A iMPEP Review Team Members Appendix B Alabama Organization Chart i
Appendix C Inspection File Reviews Appendix D License File Reviews Appendix E Incident File Reviews l
Appendix F Alabama's Questionnaire Response Alabama's Response to Review Findings l
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9 APPENDIX B ALABAMA OFFICE OF RADIATION CONTROL ORGANIZATION CHARTS
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t APPENDIX C 1
lNSPECTION FILE REVIEWS i
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1
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a APPENDIX C l
l lNSPECTION FILE REVIEWS NOTE: ALL INSPECTION FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE.
File No.: 1 License No.: 1078 Licensee ' Advanced MedicalImaging Center inspection Type: Routine, Unannounced Location: Montgomery, AL Priority: 3 License Type: Medical Private Practice-Limited Inspector: BG Inspection Date: 8/30/95 File No.: 2 License No.: 391 Licensee: Couch, Inc.
Inspection Type: Routine, Unannounced Location: Dothan, AL Priority: 5 License Type: Measuring Sy7tems-Portable Gauges inspector: DT Inspection Date: 1/9/98 File No.: 3 License No.: 1204 Licensee: Perry Radiological Consulting Inspection Type: Initial, Announced Location: Mobile, AL Priority: 5 License Type:- Other Services inspector: RP inspection Date: 5/13/97 l
File No.: 4 License No.: 1191
)
Licensee: Thomas O. Paul, Jr., MD.
Inspection Type: Initial, Announced j
Location: Birmingham, AL
. Priority: 3 i
License Type: Medical Private Practice /QMP Req.
Inspector: RP Inspection Date: 12/18/96 3
File No.: 5 License No.: 1059 l
Licensee:
Inspection Type: Routine, Unannounced l
Location: Global X-Ray & Testing Corporation Priority: 1 l
License Type: Industrial Radiography-Temp Job Sites inspector: DT l
Inspection Date: 10/29/97 1
1 File No.: 6 License No.: 338 Licensee American Cast Iron Pipe Company inspection Type: Routine, Unannounced l --
License Type: Industrial Radiography, Fixed inspector: RP Location: Birmingham, AL Priority: 1 l
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Inspection Date: 4/22/97 File No.: 7 License No.: 1111 i
Licensee Cox Nuclear Pharmacies, Inc.
Inspection Type: Routine, Unannounced Location: Mobile, AL Priority: 1
. License Type: Nuclear Pharmacy inspector: RP inspection Date: 2/11/98 l
I
4-Alabama Proposed Final Report Page C.2 Inspection File Reviews l
L File No.: 8 -
License No.: 661 Licensee Four Rivers Medical Center Inspection Type: Routine Unannounced Location: Selma, AL Pilority: 3 License Type: MedicalInstitution-QMP required Inspector: RP inspection Date: 3/11/97 File No.: 9-License Nol 248
- Licensee Aubum University -
Inspection Type:- Routine, Unannounced Location: Auburn University, AL Priority: 2 License Type: Broad Scope Academic Inspector: DT Inspection Date: 6/18/97,6/23/97, 6/24/97,6/27/97 File No.: 10 License No.: 158 i
Licensee: Law Engineering & Env Svs, Inc.
Inspection Type: Routine, Unannounced Location: Birmingham, AL Priority: 1 License Type: Ind Rad - Temporary Job Site Inspector: RP Inspection Date: 9/4/97 l
File No.: 11 License No.: 834 Licensee: H & H X-Ray Services, Inc.
inspection Type: Unannounced field
. Location: West Monroe, LA Priority: 1 License Type: IR Temporary Field Sites
. inspection Date:.1/9/98
~
Inspector: DT I
File No.: 12 License No.: 1229 l
Licensee: Edwards Pipeline Testing, Inc.
Inspection Type: N/A Location: Tulsa, OK Priority: 1 License Type: Industrial Radiography-Temporary inspector: N/A l
Inspection Date: N/A Reciprocity Review l
File No.: 13 License No.: 1176 Licensee: Name Consolidated NDE,Inc.
inspection Type: N/A Location: Woodbridge, NJ Nority: 1 i
License Type: Industrial Radiography, Temporary Inspector: N/A Inspection Date: N/A Reciprocity Review
. File No.: 14 License No.: 1217 Licensee: Scientific Inspection Technology, Inc.
InspectionType: N/A Location: Soddy Daisy, TN '
inspector: N/A Priority: 1 License Type: Industrial Radiography, Temp Inspection Date: N/A - Reciprocity Review e
L
Alabama Proposed Final Report Page C.3
-Inspection File Reviews File No.: 15 License No.: 1005 i
Licensee: WellServices,Inc.
inspection Type: N/A Location: Crossville,.TN Priority: 3 License Type: Well Logging inspector: N/A inspection Date: N/A - Reciprocity Review File No.: 16 License No.: 1239
. Licensee: Soil Testing Engineers, Inc.
InspectionType: N/A l-Location: Baton Rouge, LA Priority: 5 License Type: Portable Gauges - Moisture / Density Inspector: N/A-Inspection Date: N/A Reciprocity Review File No.: 17 License No.: 160 Licensee: Halliburton Energy Services Inspection Type: N/A l
Location: Duncan, OK Priority: 5
. License Type: Well Logging inspector: N/A Inspection Date: N/A Reciprocity Review l
H in addition, the follo*.ving inspection accompaniments were made as part of the on site IMPEP -
review:
Accompaniment No.: 1 Licensee: Cox Nuclear Pharmacy License No.: 1111
' Location: Mobile, AL Inspection Type: Routine, Unannounced l'
License Type: Nuclear Pharmacy Priority: 1 Inspection Date: 2/11/98 Inspector: RP Accompaniment No.: 12 1
- Licensee: St. Clair Regional Hospital Routine, Unannounced License No.: 734 Location: Pell City, AL Inspection Type:
License Type: Institutional Madical Priority: 3 Inspection Date: 2/25/98 Inspector: RP Accompaniment No.: 3 l
Licensee: AMI Brookwood Medical Center License No.: 459 l
Location: Brookwood, AL Type inspection: Routine, Unannounced License Type: Institutional Medical Priority:.1 Inspection Date: 2/26/98 Inspector: DT L
- Accompaniment No.: 4 Licensee: Professional Services industries License No.: 368 Location: Irondale, AL-Inspection Type: Routine, Unannounced Priority: 1
- . License Type: Industrial Radiography Inspection Date: 2/27/98 Inspector: DT l
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S 4
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APPENDlX D l
LICENSE FILE REVIEWS l
e I.
APPENDIX D l
LICENSE FILE REVIEWS NOTE: ALL LICENSE FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE.
File No.: 1 i
. Licensee: Eastern Technologies, Inc.
License No.: SNM-1240 l-Location: Ashford, AL License Type: Nuclear Launday Type of Action: New Date issued: 3/17/98 License Reviewer: DW File No.: 2 Licensee: Eastern Technologies, Inc.
License No.: 947 Location: Ashford,' AL Amendment No.: 5,6,7, and 8 L
License Type: Nuclear Laundry Type of Action: Amendments Date issued: 12/29/95,4/23/96,7/2/96 and 9/9/96 License Reviewer: DW File No.: 3 Licensee: Cox Nuclear Pharmacy License No.: 1111 Location: Mobile, AL Amendment No.: 6,7, and 8 License Type: Nuclear Pharmacy Type of Action: Amendment Date issued: 2/21/96,3/25/96 and 8/20/96 License Reviewer: DW File No.: 4 Licensee: Professional Service Industries, Inc.
License No.:368 Location: Irondale, AL(Birmingham, AL)
Amendment No.: 25,26,27,28,29, and 30 License Type: Industrial Radiography Type of Action: Amendments Dates issued: 8/14/95,3/25/96,11/8/96,2/5/97,7/1/97 and 10/1/97 License Reviewer: DW File No.: 5 Licensee: American Testing Laboratory, Inc.
License No.: 1052 Location: Bessemer, AL-Amendment No.: 4 License Type: Industrial Radiography Type of Action: Amendment Date issued: 5/23/96 License Reviewer: DW
-File No.: 6 Licensee: American Cast Iron Pipe Company License No.: 338 Location: Birmingham, AL Amendment No.: 20 License Type:- Industrial Radiography Type of Action: Amendment Date issued: 12/12/95
~
License Reviewer: DW File No.: 7 Licensee: Muscle' Shoals Minerals,~ Inc.
License No.: SM-868 l
Location: Cherokee, AL Amendment No.: 6, 7 License Type: Uranium / thorium ore processor Type of Action: Amendment Date Issued: 1/19/96,3/26/98 License Reviewer: DW L
Alabama Proposed Final Report Page D.2 License File Reviews File No.: 8 Licensee: Central Pharmacy Services, Inc License No.: 1189 Location: Gadsden, AL Amendment No.: 1,2 and 3 License Type: Radiopharmacy Type of Action: New License Date issued: 5/14/96,9/6/96, and 1/22/97 License Reviewer: DW File No.: 9 Licensee: North Alabama Radiopharmacy-Huntsville License No.: 1205 Location: Huntsville, AL Amendment No.: 1 License Type: Radiopharmacy Type of Action: New Date issued: 12/3/96,9/17/97 License Reviewer: DW File No.: 10 Licensee: Bioelastics Research, Ltd.
License No.: 1238 Location: Birmingham, AL License Type: Biomedical Research Type of Action: New Date issued: 1/22/98 License Reviewer: DW File No.: 11 Licensee: BioCryst Pharmaceuticals License No.: 1095 Location: Hoover, AL Amendment No.: 3 License Type: Radiopharmaceutical rosearch Type of Action: Renewalin Entirety Date issued: 6/13/97 License Reviewer: DW File No.: 12 Licensee: Regis Engineering Solutions,Inc.
License No.: 1228 Location: Montgomery, AL License Type: Repair of portable gauges Type of Action: New Date issued: 9/29/97 License Reviewer: DW File No.: 13 Licensee: Edwards Pipeline Testing, Inc.
License No.: 1229 Location: Tulsa, OK License Type: Industrial Radiography Type of Action: Now Date issued: 9/15/97 License Reviewer: DW File No.: 14 Licensee: AMI Brookwood Medical Center License No.: 459 Location: Birmingham, AL Amendment No.: 73,74,75,76 and 77 License Type: Institutional Medical Type of Action: Amendments Date issued: 4/17/96,6/13/96,1/22/97,8/27/97 and 12/30/97 License Reviewer: DW File No.: 15 Licensee: St. Clair Regional Hospital License No.: 734 Location: Pell City, AL Amendment No.: 8 License Type: Institutional Medical Type of Action: Renewal Date of Action: 1/9/97 License Reviewer: DW
i Alabama Proposed Final Report Page D.3 License File Reviews File No.: 16 Licensee: Center for Cancer Care License No.: 1203 Location: Huntsville, AL
' License Type: Radiopharmaceutical therapy and High Dose Rate device Type of Action: New l
Date of Action: 11/25/96 License Reviewer: DW File No.: 17 l
Licensee: Nuclear Cardiovascular Imaging Center, Inc.
License No.: 1184-l Location: Florence, AL Amendment No.: 1,2,3,4,5,6, and 7 l
l License Type: Private Practice Type of Action: New Date of Action: 8/8/96,9/6/96,1/23/97,7/25/97,8/20/97,10/1/97 License Reviewer: DW and 12/31/97
.l File No.i 18 Licensee: Columbia Northridge Medical Center License No.: 1235
. Location: Prattville, AL
' License Type: Private clinic Type of Action: New j.
' Date of Action: 11/13/97-License Reviewer: DW File No.: 19
-Licensee: Valley Regional Cancer Center License No.: 1042
- Location: Sheffield, AL Amendment No.: 6,7 License Type: High Dose Rate device therapy Type of Action: Renewal Date of Action: 4/8/96, 9/9/96 License Reviewer: DW File No.: 20 Licensee: National Healthcare of Hartselle,Inc.
License No.:1209 Location: Hartselle, AL Amendment No.: 1 License Type: Private medical Type of Action: New Date of Action: 2/3/97, Amended 12/15/97 License Reviewer: DW File No.: 21 Licensee: Healthsouth Medical Center License No.: 1179 Location: Birmingham, AL Amendment No.: 1 License Type: Gammaknife Type of Action: New Date of Action: 9/14/95,3/11/97-License Reviewer: DW 1
File No.: 22 Licensee: Auburn University License No.:. 248 Location: Auburn, AL.
Amendment No.: 45,46,47
. License Type: Broad Academic Type of Action: Ronewal T
l Date of Action: 9/13/95,'12/1/97,4/9/98 License Reviewer: DW
\\
\\
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Alabama Proposed Final Report Page D.4
. License File Reviews File No.: 23 Licensee: University of South Alabama License _No.: 584 Location: Mobile, AL Amendmert No.: 40
' License Type: Broad Medical Type of Action: Amendment-Date of Action: 12/30/97-License Reviewer: DW File No.: 24 Licene.ee: Nuclear Pharmacies, Inc.
License No.: 927 Location: sabile, AL License Type: Nuclear Pharmacy Type of Action: Termination Date of Action: 2/28/97 License Reviewer: DW
' File No.: 25
- Licensee: University of North Alabama License No.: 422 Lccation: Florence, AL
_ Amendment No.: 10 License Type: Gas chromatograph Type of Action: Termination -
Date of Action: 12/1/97 License Reviewer: DW File No.:-26 Licensee: Michael R. Satchfield License No.: 1154 Location: Mobile, AL Amendment No.: 1
- License Tya: Portable gauge' Type of Action: Termination i
Date of Action: 12/18/97 License Reviewer: DW.~
Comment:
! a) -
This license was terminated by amendment after the ORC received a " Bill of Sale" and a
" receipt" dated 12/3/97 indicating that the device had been transferred to a company -
4 located in South Carolina. There was no documentation in the file that the ORC had confirmed the va'idity of the documents in view of the licensee's history.
1 File' No.: 27 Licensee: Uniroyal Goodrich Tire Company License No.: 1083
- Location: Tuscaloosa, AL Amendment No.: 3 License Type: Fixed Gauge Type of Action: Termination Date of Action: 4/15/97 License Reviewer: DW File No.: 28 Licensee: Daren E. Strickland Licer sc No.: 1061 Location Tuscaloosa, AL-Amendment No.: 2 License Type:; Service license Type of Action: Termination Date of Action: 7/9/97 License Reviewer: DW File No.: 29 Licensee: Lamar Regional Hospital License No.: 852 Location: Vernon, AL License Type: Institutional medical Type of Action: Bankruptcy Date of Action: 9/18/96 License Reviewer: KW
l ;.
Alabama Proposed Final Report Page D.5 License File Reviews File No.: 30 Licensee: Soli Testing Engineers, Inc.
License No.: 1239 Location: Baton Rouge, LA -
License Type: Portable Gauge Type of Action: New Date of Action: 3/11/98 License Reviewer: DW I
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APPENDlX E INCIDENT FILE REVIEWS J
i APPENDIX E INCIDENT FILE REVIEWS i
NOTE: ALL INCIDENT FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE /1CCEPTABLE.
i File No.: 1 Licensee: Wiregrass Construction Company Ucense No.: 1086 Incident ID No.: 95-16 I
Location: Dothan Airport, Dothan, AL i
Date of Event: 11/20/95 l
Type of Event: Damaged Equipment Investigation Date: 11/20/95 investigation Type: Cu site 1
Summary of incident and Final Disposition: On November 20,1998, a moistum density gauge i
was damaged when a asphalt roller struck it. This caused the source to be stuck in the exposed position and the source rod to be broken. An ORC inspector traveled to the incident site and assisted in returning the source to its shielded position. Wipe test failed to find any contamination. The licensee returned the device to the manufacturer. The ORC program followed up on this incident during the next routine inspection. The incident was reported to the USNRC on November 29,1995.
Comment:
a)
The incident was not closed out in the log.
File No.: 2 Licensee: Southern Earth Science,Inc.
License No.: 647 incident ID No.: 96-6 Loca:lon: Satsuma, AL Date of Event: 4/29/96 Type of Event: Stolen device containing RAM Investigation Date: None investigation Type: None - Phone interviews Summary of Incident and Final Disposition: A moisture density gauge was stolen from a pickup being used to transport the gauge. The truck was parked in front of the employee's residence. When the employee returned to the truck he found the lock had been cut and the gauge missing. The local police were notified of the theft and the licensee was required to put up posters regarding the gauge and to put out a press release. As of this date the gauge has not been recovered and the file remains open.
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Alabama Proposed Final Report Page E.2
. IncMent File Reviews I
File No.:: 3 -
Licensee: Certified Testing and inspection (now Non Destructive & Visual Inspection, Inc.)
License No.: 1174 incident ID No.: 96 Location: Cottondale, AL-Date of Event: 7/1/96 Type of Event: Overexposure -
Investigation Date: 7/3/96
-Investigation Type: On-site Summary of incident and Final Disposition: While performing industrial radiography two indwiduals received exposures in excess of that permitted by the regulations. The radiography crew was radiographing cable on a drag-line crane. The radiographer was from the licensee and the assistant was an employee of the company that hired the radiographer. There were several problems that resulted from this situation. The first was the assistant had not received the required industrial radiography safety training. Second was the company was requiring the radiographer to use a film that he was not use to. The third was that the construction of the jig, used to hold the guide tube, and the end cap were not compatible which resulted in the inability to use a collimator. When the films were devebped, they appeared to be overexposed. After several attempts to correct this, the radiographer and assistant became frustrated and this lead
= to them forgetting they were taking a radiograph and the source was exposed. After changing films they realized the source was exposed. On July 3,1906, two members of the ORC -
- program performed time and dose studies of the incident. The incident was reported to the USNRC. The occurrance did not meet the criteria for an Abnormal Occurrence Report.
File No.: 4 Licensee: Alabama Power Company-License No.: 288 incident ID No.: 97-7
. Location: Barry Steam Plant near Mobile, AL Date of Event: Unknown Type of Event: Lost / Missing RAM Investigation Date: 4/9/97 Investigation Type: Phone conversations / Licensee's report Summary of incident and Final Disposition: While removing a surge bin, the licensee found Documentation showing they had received three gauges to be used on the bin on July 9,1976.
The initial investigat on failed to find any evidence the gauge had ever been received by the licensee'. Tne gauge manufacturers records showed the gauge was received by the licensee.
The licensee continued its investigation,' but was unable to either locate the device or determine what happened to the device. The license believes the manufacturer is in error and does not believe they ever received the gauge.
f i
W Alabama Pfoposed Final Report Page E.3 incident File Reviews l
File No.: 5 i
Licensee: American Testing Laboratory
~ License No.: 1052
' incident ID No.: 97-10
- Location: Interstate 20 outside Fairfield, Al.
-Date of Event: 4/5/97 Type of Event: Traffic Accident i
investigation Date: 4/5/97-Investigation Type: Repo:t review Summary of Incident and Final Disposition: A vehicle transporting a radiographic exposure device containing a source of radiation was involved in a single vehicle accident. The radiographic crew was injured as a result'of the incident. The radiographic device was secured
. In the rear of the vehicle and was not damaged. The licensee took possession of the device.
There was no exposure in excess of that permitted by the Alabama regulations. File Closed.
File No.: 6
. Licensee: Baptist Medical Center License No.: 610
' Incident ID No.: 98-2 Location: Montgomery, AL -
'Date of Event: '12/22/97
. Type of Event: Improper disposal of RAM investigation Date:- 1/16/38
' investigation Type: Licensee's report review
. Summary of incident and Final Disposition: Bags of waste contaminated with I-131 were being
- held for decay.- The bags were not labeled as containing RAM and housekeeping disposed of the waste as biological waste. The bags were incinerated. No on site investigation was
? performed. The occurrence was reported to USNRC and file was closed.
4 1
e
.w
c APPENDIX F ALABAMA'S QUESTIONNAIRE RESPONSE j
i o
0 Approved by OMB' No. 3150-0183 Expires 4/30/98 l
i INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Name of State / Regional Program ALABAMA Reporting Period: July 1,1995, to March 1,1998 A.
COMMON PERFORMANCE INDICATORS 1.
Status of Materials insoection Proaram 1.
Please prepare a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800. The list should include initial inspections that are overdue.
insp. Frequency Licensee Name (Years)
Due Date Months O/D NONE 2.
Do you cu:rently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire.
N/A I
3.
Please identify individual licensees or groups of licensees the State / Region is inspecting more or less frequently than called for in NRC Inspection Manual l
Chapter 2800 and state the reason for the change.
- Estimated burden per response to comply with this voluntary collection request: 45 hours5.208333e-4 days <br />0.0125 hours <br />7.440476e-5 weeks <br />1.71225e-5 months <br />.
Forward comments regarding burden estimate to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, W=hingto,i, l>C 20555-0001, and to the Paperwork Reduction Project (3150-0183), Office of Management and Budget, Washington, DC 20503. If an information collection does not display a currently valid OMB control number, NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
i
1 l
NRC priority 7 licensees are inspected by the State of Alabama at an Inspection frequency of 5 years and diagnostic nuclear medicine licensees are inspected at an inspection frequency not less than 3 years.
4.
Pleas complete the following table for licensees granted reciprocity duting the reporting period.
Number of Licensees Granted Reciprocity Nunnber of Priority Permits Each Year Licensees inspected Each Year Service Licensees performing YR 1995 1
YR 1995 1
i teletherapy and irradiator YR 1996 1
YR 1996 1
l source installations or YR YR I
changes YR YR YR 1995 17 YR 1995 5 1
YR 1996 14 YR 1996 1 l
YR 1997 13 (1 TUBE YR 1997 1 l
ONLY)
YR 1998 2 YR 1998 10 YR 1995 1
YR 1995 1
2 YR 1996 0
Ya 1996 0
YR 1997 0
YR 1997 0
YR 1998 0
YR 1998 0 1
4 YR 1995 15 YR 1995 4
l 3
YR 1996 15 YR 1996 3
1 YR 1997 13 YR 1997 0
i YR 1998 6
YR 1998 0
l 4
j All Other YR 1995 2
YR 1995 0 YR 1996 17 YR 1996 0 i
YR 1997 17 YR 1997 1 YR 1998 5
YR 1998 0 l
5.
Other than reciprocity licensees, how many field inspections of radiographer l
were performed?
1996 - 3 1997-3 1998-1
,1 1
2
d 6.
For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for any differences between the goals and the actual number of inspections performed.
II.
Tpchnical Quality of Inspections 7.
What, if any, changes were made to your written inspection procedures during the reporting period?
When the most severe of any violation alleged is category V, and the licensee management acknowledges that the violation occurred, and, in the opin!on of the inspector, the licensee management understands the problems and verbally states that appropr! ate action will be taken to correct and prevent it from reoccurring, then no written response to the inspection letter is required.
8.
Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:
Insoector Suoervisor License Cat.
Date Ronald i Pass James L. McNees 3225 12/12/97 James L. McNees 2200 10/29/96 James L. McNees 3124 1/30/96 James L. McNees 3320 1/25/90 David Turberville No documented accompaniment since 5/10/95 9.
Describe intemal procedurer for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.
There are no written procedures. The supervisor reviews the files as if he were going to perform the inspection, the supervisor accompanies the inspect 0i on the inspection listening but not being an active participant, the supervisor reads the inspector's written report and draft of the inspection letter, finally the supervisor discusses his observations with the inspector and documents them in the inspector's personnel file.
10.
Describe or provide an update on your instrumentation and methods of calibration. Are allinstruments properly calibrated at the present time?
i See Attachment 1 3
o 1
1 111.
Technical Staffino and Trainina 11.
Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the l
agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: adminis,tration, materials licensing & compliance, emergency response, LLW, U-mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor work ef junior personnel. If consultartts were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:
NAME POSITION AREA OF EFFORT FTE%
i l
James L. McNees Dir. Rad. Mat. Inspection Inspection 80%
Emerg. Response 5%
Other 15%
I David Turberville Rad. Phy.11 Inspection 90%
Emerg. Response 5%
l Other 5%
Ron Pass Rad. Phy. Il inspection 50%
Other 20%
)
Emerg. Response 5%
l Gen. License 25%
l l
Karl D. Walter Dir. Rad. Mat. Licensing Licensing 75 %
)
Emerg. Response 5%
l Other 20%
l Kirksey E. Whatley Dir. Office Rad. Control Administration 40%
Licensing 15%
Inspection 8%
Emerg. Response 8%
Other 29%
Michael Cash Dir. Emerg. Planning Emerg. Planning /
j
Response
70%
Environmental 10%
Other 20%
Terry Williams Rad. Phy. II Emerg. Response 15%
Environmental 70%
Other 15%
i 4
NAME POSITION AREA OF EFFORT FTE%
Tonya Beck Rad.PhyII Emerg. Planning 90 %
Other 10%
Myron Riley Rad.Phy.I Emerg. Response 5%
Other 95 %
3 Bradley Grinstead Rad. Phy.111 Emerg. Response 5%
Other 95%
Richard Glass Rad. Safety Spec. ill Emerg. Response 5%
Other 95 %
Kenneth Thomas Rad. Safety Spec. lli Emerg. Response 5%
l Other 95 %
Curtis Franklin Rad. Safety Spec.11 Emerg. Response 5%
Other 95%
3 Beverly Carswoll Rad. Safety Spec. II Emerg, Response 5%
Other 95 %
12.
Please provide a listing of all new professional personnel hired since the last f
review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines,if appropriate.
RESPONSE: There have been no new oorsons hired since the last review.
13.
Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and Inspectors). For each, list the courses or equivalent training / experience they need to attend and a i
tentative schedule for completion of these requirements.
j
RESPONSE
i Allprofcasional staff are not directly associated with the Agreement States j
Program and do not work on a daily basis in that program. There is no intent to qualify gli professional staff in this area of work. Currently David Walter and Kirksey E. Whatley have met all of the requirements for license i
reviewer. No other staff members review licenssa. Jim McNees, David Turbervil!e, Ron Pass, Bradley Grinstead David Walter, and Kirksey j
Whatley have met all of the requirements for inspectors in the Agreement i
States Program. Myron Riley, Tonyt Beck, Terry Williams, and Mike Cash j
have received specialized training but not to the point of being able to review applications for licenses or perform complex Inspections.
Additional staff will be trained as needs dictate, and time and funds permit.
)
l 5
l 1
1..
l 14.
Please identify the technical staff who left the RCP/ Regional DNMS program during this period.
RESPONSE
l Bernis Hannah, Radiation Physicist lil, retired. Mr. Hannah directed the Emergency Planning / Environmental Monitoring Section of DRC.
Cecil Cork. Public Health Engineer Ill, retired. Mr Cork directed the NORM Section of DRC.
William Eden, Radiation Physicist lli, retired. Mr. Eden directed the X-Ray l
program of DRC.
I 15.
List the vacant positions in each program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.
RESPONSE
Currently there are no vacant positions in the Office of Radiation Control.
Positions left vacant by retirees and resignations are not intended to be filled. The entire Department is under a hiring freeze.
IV.
Technical Quality of Licensino Actions 16.
Please identify any major, unusual, or complex licenses which were issued, received a major amendment, were terminated, decommissioned, submitted a
- bankruptcy notification or renewed in this period. Also identify any new or amended licenses that now require emergency plans.
RESPONSE
NONE 17.
Discuss any variances in licensing policies and procede v A, apt!ons from the regulations granted during the review period.
RESPONSE
Some HDR licensees have been granted approval, through requested licenes amendments, to order replacement sources with activities up to 20% higher than the licensed quantity (up to 12 curies for the maximum licensed 10 curles). An additional condition prohibits the so:Irce from being installed into the HDR until the activity is at or below 10 cur!es.
C
i l
\\
j Pipeliner cameras are still being licensed provided that the maximum size l
source that can be Installed Iw a source that will not create an exposure I
rate in excess of 50 mR/hr. at two inches from any camera surface and provide precautions related to the " drop" test.
l 18.
What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
RESPONSE
None of our licensing guides have been changed, however changes in NRC 1
licensing guides that the Agency uses have been adopted.
19.
For NRC Regions, identify by licensee name, license number and type, any I
renewal applications that have been pending for one yt,ar or more.
V.
Resoonses to inciderts and Aj[90ations 20.
Please provide a list of the reportable incidents (i.e., medical misadministration, overexposure, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB clearance number 3150-0178, Nuclear Material Events Database). The list l
should be in the following format:
TYPF. OF LICENSEE NAME LICENSE #.
DATE OF INCIDENT / REPORT INCIDENT incidents prict to 1/1/98 have been previously submitted to Ms. Pat Larkin for inclusion on NMFD. NMED print out of the three 1998 incidents is attached.
21.
During this review period, did any incidents occur that involved equipment or source l
failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified? For States, was timely notification made to NRC7 For Regions, was an appropdate and timely PN generated?
incidents that occurred between July 1,1995 and February 28,1998 did not involve equipment or source failure. NRC is routinely notified.
22.
For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each case.
N/A 7
I 23.
In the period covered by this review, were there any cases involving possible i
wrongdoing that were reviewed or are presently undergoing review? If so, please I
describe the circumstances for each case.
I Shelby Contracting Company,Inc. of Huntsville, Alabama chose not to renew their license. Then one year later accepted transfer of a radioactive gauge as if their license had been renewed. They continued to send their employees for training and accept and use devices despite company management knowing that the license had expired. The State imposed a civil penalty of $12,600.00.
Cox Nuclear Pharmacy, Inc., was discovered to be operating without one of the pharmacist named on the license being present during operations. The unlicensed pharmacist had previously received the required training and experience to be licensed. However his credentials had not been submitted to the Agency or the State Board of Pharmacy for approval. The State imposed a civil l
penalty of $1,366.88.
Consolidated NDE, Inc., an NRC licensee working in Alabama under reciprocity, submitted to the Agency a certificate of training that was a forgery. NRC red on I i
assisted the state with the investigation. The State Iraposed a civil penalty of
$3,000.00.
24.
Identify any changes to your procedures for handling allegations that occurred during the period of this review.
a.
For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.
RESPONSE: None VI.
Generaj
- 25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations foiiowing the last review,
RESPONSE
Following the last NRC review of the Agreement State Program in Alabama, a letter was written to the State Health Officer identifying a noncompatibility item - failure to adopt the medical QA regulations of NRC. The management and staff believed that this " citation" was unjustified, unwarranted, and frankly very puzzling, especially in light of statements made by NRC management in public meetings and in writing to other stcte programs following review of those state programs. At the close out of I
the last review no mention of that " citation" was discussed. In fact very l
complimentary words were used to summarize the review. That " good report" was discussed with the State Health Officer, Doctor Donald Williamson. Then to 8
d everyone's shock, Doctor Willi $mson received the noncompatibility letter. That created unnecessary problems.
We believed then, and still do today, that our misadministration rules (QA program) were, at the time of the last review, far superior to those of NRC. Our rules went far beyond NRC rules to protect public health and safety - yet we were issued a noncompatibility letter?
Since the last teview, Alabama Radiation Protection Rules have been revised to include NRC's medical QA requirements. Adoption of NRC's requirements has and l
will continue to result in a decrease in the protection provided to patients.
l
- 26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.
RESPONSE
STRENGTHS:
This is a very difficult subject to discuss. Most of us know what our weaknesses are
- It's our strengths that we don't understand but here goes!
The strength of the Alabama program is attributed directly to the quality and character of the entire staff. This Agency is and has been a good place in which to work. That is evidenced by the lack of staff turn-over and the length of service of most staff members.The only loss of staff during the review period has been due to retirement. Staff members have been given the opportunity, and encouraged, to take advantage of traln!t;g courses that improve their work and work " happiness". The courses have been both technical and personal development type courses. The staff has demonstrated on numerous occasions that they have dedicated themselves to tearning in training classes. That is evidenced by staff grades on exams at NRC and other courses - 94% and 100% on final 5-week course exams. The staff is dedicated, intelligent, committed, trustworthy, very knowledgeable and informed, and believe that their work makes a difference.
Longevity of staff members has translated into a vast resource of knowledge and experience from which other staff members, the public, and other state programs can draw. Very little effort is necessary for researching how to do something. That translates in.o efficiency and accuracy, and consistency. There is also a good historical perspective on many subjects which is not available elsewhere. Longevity of staff is a strength.
When the review is done in April, you will find that inspections are up-to-date, that licensing actions are up to-date (maybe 2-weeks old at most), and that responsen have been made where needed. That is not just now - that is what you will find 9
1 anytime. We have been up-to-date all along. That is a strength of the staff and reflects staff commitment and pride in their work.
Staff members volunteer to work in areas outside those required. For example, David Walter server as the CRCPD chair of the nuclear medicine committee as well as being the QAS State representative on NRC's Medical Reaulation Workina Groug.
He has literally spent weeks in Washington and elsewhere working with NRC on Part 35 changes. David Turberville serves as chair of CRCPD's industrial radioaraohv aroup and has devoted much time in meetings on this subject. Jim McNees has served on several NRC IMPEP review teams most recently in New York during February 23-27,1998. He filled in on the Kentucky review on very short notice when a scheduled team member could not be there. He also serves as CPCPD liaison with the IAEA. Kirksev Whatley served on the Executive Board of CRCPD, a Commissioner from the State of Alabama on the Southeast Compact Commission, and several committees of the Southern States Energy Board dealing with transuranic waste disposal, spent fuel, etc. Ron Pass has served as the State resource person for radon. All of the staff involve themselves in areas of concern outside what is expected. That is a strength of this program.
Another area of strength is in the form of er port from upper management.There is a good relationship between uppe-level n. ongement and the working staff. In late January 1998, the Division of Radiation C( trol was elevated to the Office of Radiation Control with the Director answ mg directly to the State Health Officer.
Upper level management is very supportive of program activities and needs.
One area of strength that is often overlooked is the relationship that has been developed with licensees over the years. From the beginning of this program, the philosophy has been one of service to our customers - the licensees. Although regulatory by nature, that regulatory authority has been tempered with service, guidance, and assistance. That philosophy has led to trust and mutual respect between the Agency and licensees.
Strengths can be summarized by discussing the well trained, committed, dedicated and experienced staff of the Office of Radiation Control who make it work.
"IEAKNESSES:
Weaknesses are in areas other than the Agreement State Program - X-Ray.
Weaknesses are not with the staff but lack of sufficient staff to adequately survey all x-ray equipment at needed intervals.
10 l
l l
l
i
)
B. NON-COMMON PERFORMANCE INDICATORS I
1.
Legislation and Proaram Elements Reauired for Compatibility j
l l
- 27. Please list all currently effective legislation that affects the radiation control program (RCP).
1
RESPONSE
There is no known current legislation that affects the radiation control program.
- 28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the l
next expiration date for your regulations.
i
RESPONSE
Rules ste_rlot subject to a " sunset" or equivalent law.
q
- 29. Please complete the enclosed table based on NRC chronology of amendments. Identify those that have not been adopted by the State, explain why they were not adopted, and j
discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legalh ainding requirements other than regulations.
]
1
RESPONSE
See trible.
]
i
- 30. If you have not adopted all amendments within three years from the date of NRC rule i
promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normallength of time anticipated to complete each step.
II.
Sealed Source and Device Procram
- 31. Prepare a table listing new and revised SSAD registrations of sealed sources and devices issued during the review period. The table heading should be:
SS&D Manufacturer, Type of Registry Distributor or Device Date Number Custom User or Source issued RESPONSE: No SS&D registrations were issued.
l 32.
What guides, standards and procedures are used to evaluate registry applications?
)
l
- RESPONSE: None evaluated.
j 1
33.
Please include information on the following questions in Section A, as they apply to the i
Sealed Source and Device Program:
11 j
1 J
3 Technical Staffing and Training A.lll.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20 23 RESPONSE: No SS&D evaluations performed.
Ill.
Low-Level Waste Proaram 34.
Please include information on the following questions in Section A, as they apply to the
. Low-level Waste Program:
Status of Materials inspection Program - A.l.1-3, A.l.6 Technical Quality of Inspections - A.ll.7-10 Technical Staffing and Training - A.lll.11 fiS Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 l
1 RESPONSE: NA l
IV.
Uranium Mill Proaram j
35.
Please include information on the following questions in Section A, as they apply to the Uranium Mill Program:
Status of Materials inspection Program - A.I.1-3, A.l.6 Technical Quality of Inspections - A.ll.710 Technical Staffing and Training - A.lll.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 RESPONSE: NA i
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STATE OF AL AB AM A D T. P A R T M E N T O F PUBLIC HEALTH Donald E. Williamson, MD State Health Officer June 16,1998 c
55 Richard L. Bangart, Director Z
g
-2 Office of State Programs 7
United States Nuclear Regulatory Commission 3
Washington, D.C. 20555-0001 u"
Dear Mr. Bangart:
I have reviewed, with the assistance of staff, the draft IMPEP report for the State of Alabama Agreement State Program review which was held in our offices during April 20-23,1998. In your May 27,1998, letter you identified one recommendation, which requires a response and three suggestions. I will comment on the recommendation and suggestions as follows:
Recommendation:
"The review team recommends that Alabama adopt a procedure providing that reports of incidents that require immediate notification to the State be provided to the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> ofnotification, and that reports ofincidents that require notification to the State within J
30 days be provided to the NRC monthly."
c
Response
The recommendation is made not for a failure to report, but for failure to report within 30 days. Reports had previously been submitted on a quarterly basis instead of monthly. To my knowledge all required reports have been sub.nitted to NRC.
The Office of Radiation Control (ORC) recognizes the importance of submitting reports of this nature and strongly supports the process. ORC has revised internal procedures to require that the reports be submitted to NRC as recommended by the review team.
l The RsA Toner. 201 Mona Semt Momsomery, AL 36104 ATTACHMENT 1 P.O. Bos 303017 Montgomer3, AL 36130 3017
&mr n y e. ; :
o,.
Richard L. Bangart l
_ Page 2 l
June 16,1998
)
l 1
Please be advised that NRC and Agreement States will be notified as early as possible of any incident / problem that might have impact on NRC or Agreement State licensees. We will not wait 30 days. As an example, the IMPEP draft report, Page F-2, contains the report of a revicw for " File No. 33", and a statement t!at this occurrence did not meet the criteria for reporting to NRC. However, ORC did report to NRC and the event synopsis was published by NRC as an event.
The recommendation has been implemented by ORC.
Suggestion:
"The review team suggests that the Alabama ORC continue their efforts to find ways to l
increase the percentage of high priority reciprocity licensees, and out-of-state licensees working in Alabama, to be inspected each year."
j
Response
ORC recognizes the impoitance ofinspecting licensees working under reciprocal recognition of other agency licenses. ORC accepts the suggestion of the review team an will increase efforts to inspect more reciprocity and out-of-state licensees.
Several factors make this a difficult task. Examples include the thirty day reciprocity limit provided by the rules, the location of a high percentage of work done under reciprocity (City of Mobile shipyards, off-shore work, and oil & gas fields la Southwest Alabama - all of which involve 200 plus miles of travel), M1ing difficulties, short advance notification times, etc.
Again, efforts will be made to increase inspection numbers (percentages) in this area.
Suggestion:
"The review team suggests that the ORC accompany all material inspectors on a yearly basis."
Response
During an internal review of ORC, staff discovered that a required accompaniment for one inspector had not been made within the previous year as required by both ORC and NRC. The accompaniment had been scheduled previously; however, due to conflicts it had been canceled. Upon recognition of the problem, an accompaniment was immediately scheduled and conducted by management - prior to the review.
4 0
Richard L. Bangart l
Page 3 l
June 16,1998 It is the policy, and has been the policy, of ORC that supervisory accompaniments of all l
inspectors will be eaa%ed at least once each year. The failure was actually corrected prior I
to the review.
Suggestion:
"The review team suggests that during termination of licenses with poor compliance
' history.... confirmation of the validity of the license of the receiving licensee be obtained directly from the agency havingjurisdiction, and that confirmation that the materials (devices) were received be obtained directly from :he receiving licensee."
Response
The suggestion resuhed from actions taken with the termination of one license. That licensee did have a poor performance history. The license was terminated following standard office procedure. The licensee had submitted to ORC a record of transfer containing proper information, a signed record of receipt from the receiving company including the recipient's license number and a business card of the recipient. These records were in the terminated file.
That would have normally been sufficient information for termination.
Please note that this suggestion should not imniv that records were not submitted to ORC with the termination request. The problem is that ORC staff did not contact the receiving out-of-state licensee to verify receipt of the americium 241 roof gauge nor was contact made with the Agreiment State licensing staff to verify that the recipient actually had a license to possess the device.
The suggestion made by the review team is accepted and internal procedures have been implemented to apply this suggestion when terminating any license with poor compliance history. This suggestion had not previously been made.
The recommendation and three suggestions made by the review team are accepted, and each has been implemented, by the Office of Radiation Control.
For the record I would like to address several phrases and statements made in the body of the draft report as follows:
1.
The draft report, page 3, states that ORC currently has no inspections overdue by more than 25% of the established interval. That statement is factual but does not paint a true picture. There are no' overdue inanections - neriod. The 25% limit is a limit -
the standard is "to keep up-to-date."
, t, 4
Richard L. Bangan Page 4 June 16,1998 1
2.
On page 3 of the draft report a statement is made that if a new licensee does not l
possess licensed material during the first five months of the license that the inspection frequency is extended another five months. That extension is not automatic. An j
inspector contacts the licensee and depending upon the judgement of the inspector and his supervisor, the inspection may be extended for five months.
3.
On page 5 of the draft report a statement is made that ORC performs calibration of instruments at six month intervals. Actually calibrations are performed at three (3) month intervals.
4.
Refer to Appendix D, Page D.1, of the draft report, License File No. 3. The initials of the inspector should be "RP" (Ron Pass), not "DP".
5.
Refer to Page E.5 of the draft repon. The comment under File No. 26, as written, could be interpreted that no documentation was in the file, when the intent should be that ORC did r et verify the validity of the documentation which was actually in the file.
)
i 4
I would like to commend the review team of Richard Blanton, William Silva, Joe DeCicco, Richard Woodruff, and Paul Lohaus for their professionalism and courtesy. The recommendation and suggestions made by the team are accepted without contention and have, in fact, been implemented.
In Article V of the Alabama /NRC Agreement there appears the following statement:
"The State will use its best efforts to cooperate with the Commission and other Agreement States in theformulation ofstandards and regulatoryprograms....... "
.That commitment, made almost thirty two (32) years ago, remains our commitment today.
. The support and assistance ofNRC is recognized and appreciated. Please contact meifyou I
have any questions regarding this letter.
Sincerely, A& }f
.V 1
f Kirksey E. Whatley, Director l
Office ofRadiation Control KEW/jsm i
e Aaenda for Manaaement Review Board Meetina Wednesdav. Julv 8.1998. 9:00 - 11:00 a.m.. TWFN. 2-B-5 1.
Convention. MRB Chair convenes meeting (H. Thompson) 2.
New Business - Consideration of Alabama IMPEP Report A.
Introduction of Alabama IMPEP Team Members (R. Blanton) 1 B.
Introduction of Alabama representatives and other State representatives l
participating through teleconference, l
C.
Findings regarding Alabama Program (IMPEP Team) l 1
Status of Materials Inspection Program 1
Technical Quality of Inspections l
Technical Staffing and Training Technical Quality of Licensing Actions Response to Incidents and Allegations
)
Legislation and Program Elements Required for Compatibility I
l D.
Questions. (MRB Members) f E.
Comments from State of Alabama F.
MRB Consultation / Comments on issuance of Report (H. Thompson)
Recommendation for next IMPEP review 3.
Old Business - Approval of the Arizona MRB minutes l
4.
Status of Upcoming Reviews 5.
Planned IMPEP Procedural improvements Concise Final IMPEP Reports New Timeliness Goal 6.
Adjournment (H. Thompson)
Attendees:
Hugh Thompson, MRB Chair, EDO Richard Bangart, MRB Member, OSP Karen Cyr, MRB Member, OGC Malcom Knapp, MRB Member, NMSS Thomas Martin, MRB Member, AEOD Steve Collins, OAS Liaison to MRB Kirksey E. Whatley, Director, AL ORC Richard Blanton, IMPEP Team Leader, OSP William Silva, IMPEP Team Member, Texas Joe Decicco, IMPEP Team Member, NMSS Richard Woodruff, IMPEP Team Member,.Rll Paul Lohaus, OSP Kathy Schneider, OSP Lance Rakovan, OSP ATTACHMENT 2 m