ML20248F766

Draft Rept, Integrated Matls Performance Evaluation Program Review of Alabama Agreement State Program, for April 20-23

ML20248F766
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Issue date:	05/27/1998
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REV EW OF ALABAMA AGREEMENT STATE PROGRAM April 20 - 23,1998 i

i DRAFT REPORT l

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U.S. Nuclear Regulatory Commission

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9906040412 900527 PDR 4

STPRO ESGAL PDR .

1.0 INTRODUCTION

This report presents 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 ;n the Federal Reaister on October 16,1997 and the November 25,1997, revised 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 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Alabama. Preliminary results of the review, wtich 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 Radiation 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 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 se!ected 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 tMt it gathered against the IMPEP performance criteria for each common and applicable non-corr ,non indicator and made a preliminary assessment of the State's performance.

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 and recommendations. 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 report. 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.

Alabama Draft Report Page 2 2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 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. Tne 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 (50 FR 34104) that became effective on January 27,1992.

Subsequent to the letter of September 18,1995, NRC reinitiated an evaluation of the QM rule.

It was decided that pending the completion of the re-evaluation, the absence of a compatible i QM 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, i The compatibility category of the QM rule under the new Commission policy on Adequacy and

' Compatibility, which became effective on September 6,1997, has been set as "D" with l paragraphs (a), (b), and (c) of the rule identified as having provisions important to health and

( safety. Consistent with SECY 97-054 (see SP-97-057), staff will review the compatibility of both i draft and final Agreement State equivalent QM 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) is being conducted.

r i l Based on the above and because Part 35 is being amended in its entirety, the team determined .

l that this recommendation should be closed. l l 3.0 COMMON PERFORMANCE INDICATORS j l

l IMPEP identifies five common performance indicators to be used in reviewing both NRC l Regional and Agreement State programs. These indicators are: (1) Status of Materials ,

l 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 insoection Proaram The team focused on four factors in reviewing the status of the materials inspection program:

inspection frequency, overdue inspections, initial inspection of new licensees, and timely dispatch of inspection findings to the licensees. This evaluation is based on the Alabama 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.

' A DPH memorandum dated April 16,1998, entitled " License and Registration inspections Priority" requires that inspections be conducted in accordance with the priority schedule in NRC Inspection Manual Chapter (IMC) 2800, with the following modifications:

1) All programs assigned to Priority 7 by NRC are changed to Priority 5:

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Alabama Draft Report Page 3

2) 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 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 "aball be applied;" and 2) in Alabama the decision to grant an extension is made at the time the licensee's next inspection is due, versus the IMC 2800 provision for the decision to be made at the time the current inspection is completed. The application for an i increase in interval and the documentation required are essentially the same for both Alabama and NRC. No licensees had been granted interval extension prior to the review, however, there >

were four licensees sub,iect to interval reduction at the time of the review.

The licansee 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. For example, a monthly ' inspection due' report is generated for scheduling purposes. The report fields indicate the inspection due date, date of the last 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 inspections per year Currently, the ORC has no inspections overdue by more than 25% of the established interval.

Initial inspections of new licensees are scheduled for five months after the date the license is i

issued. If the licensee does not acquire material or initiate license operations during this five month period, a note is entered in the file, and the inspection due date extended another five ,

months. If material is not acquired during this period, an inspection is performed before the end j of the first year post license issuance. There were 40 initial inspections performed during the review period, all wdhin the scheduled intervals for new licensees.

l Alabama allows 30 days of possession of materials in State under reciprocity without payment j l

of a fee. After 30 days, an out-of-State Alabama license (and fee payment) is required.

Holders of out-of-State licenses 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 inspecuons of Priority 1 and Priority 3 licensees granted reciprocity (including the Priority 1 and Priority 3 out-of-State licensees  !

using materials in State) during the review period fell short of the goals indicated in IMC 1220.

Seventeen percent of the Priority 1 and 14 percent of the Priority 3 licensees were inspected. 4 1

Alabama Draft Report Page 4 Inspection of te:etherapy 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 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 ba inspected each year.

Fifteen inspection files were reviewed for rewrt timeliness. The procedure for reporting inspection results is initiated by the inspector, usually immediately upon retum frov the field.

The inspector transfers information from handwritten field notes to a computer 4ch, then drafts 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 finalized. The inspector receives the report back from the secretarial sta#, assures its accuracy and completeness, and delivers it to the Director of the RMCB for signature. This procedure appears to be working very well. For the reports reviewed, seven were signed within two weeks 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 thet Alabama's performance with respect to the indicator, Status of Materials 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 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 radioactive materials inspections, but is still with 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 D lists the inspection files reviewed in depth.

To review inspectors' performance in the field, a team member accompanied two inspectors on 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 moming inspection of a nuclear pharmacy on 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 an HDR therapy unit), and an industrial radiography licensee. These accompaniments are also identified in Appendix D. During 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

Alabama Draft Report Page 5 -

performance of the inspectors was excellent, and their inspections were adequate to assess radiological health and safety at the licensed facilities.

During the onsite review, the review team determined that the ORC is performing inspections of materials licensees on an unannounced oasis, 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, 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 material inspections. The accompaniment reports contained sufficient details to document the areas covered. The accompanied inspector is provided a copy of the accompaniment report and receives an oral report of his performance.

The senior materials inspector hed 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 an accompaniment of the senior materials inspector was conducted. The review team suggests that the ORC accompany all material inspectors on a yearly basis.

The review team found that the ORC maintains a sufficient number and variety of survey instruments to perform radiological surveys of material licensees. The review team examined the State's instrumentation and observed that the survey instruments were calibrated anc; operable. Inspectors obtain instruments from the stock for each inspection. The ORC performs its own calibration at six month intervals, with a source that is NBS traceable. A copy of the procedures was examined and appeared adequate. For repairs, the instrument is either returned to the manufacture or is sent to a facility that performs this service.

Based on the IMPEP evaluation criteria, the review team recommends that Alabama's performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.

3.3 Technical Staffino and Trainina issues associated with this indicator 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.

l 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 fiscal constraints, the positions vacated by the

Alabama Draft Report Page 6 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 materials program.

Due to a histcac low rate of tumover, the staff consists of experienced personnel. The minimum educational requirement for a new hire is a baccalaureate degree. All current staff exceed the qualifications. The ORC has 14 technical positions, including branch directors, that are apportioned as follows: Radioactive Materials Compliance 3, Radioactive Materials Licensing 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.

The ORC receives support from the Alabama Department of Environmental Management's (ADEM) radiation measurements laboratory, which performs sample counting and assay 1 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.

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Training and qualification requirements for licensing and inspection staff are set out in a DPH

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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 'Norking 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, t 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, especially the five week course, may become a financial obstacle for the State in the future.

The team noted the apparent benefits to the ORC from staff participation in the nationwide materials regulatory program outside their regular work. The Director of the Licensing Branch has served on committees and working groups including the joint working group currently 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 s.ctivities of the Conference of Radiation Control Program Directors. The knowledge and experience

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Alabama Draft Report Page 7 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.

Based on the IMPEP avaluation criteria, the team recommends that Alabama's performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.

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 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 previou; "iew. The cross-section sampling focused on the State's major licenses, new licenses, reneo , and licenses terminated during the review period. 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 renewals,39 amendments and 6 termination files. A listing of the casework licenses with case specific comments can be found in Appendix E.

Licensing actions were reviewed for completeness, 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 properly 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.

Alabama Draft Report Page 8 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 termination files were selected for review based upon the potential for residual contamination, and to con'irm 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.

One case file involved the transfer of a portable gauging device to a specific licensee located in another 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 conceming the validity (authenticity) of the transfer records. It was.also undetermined if the sealed source had been leak tested prior to the transfer.

The team considered the potential for the device to end up at an unlicensed facility, such as a 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 his'~y suggesting a lack of reliability, confirmation of the validity of the license of the rec mng licensee be obtained directly from the agency having jurisdiction, and that confirmation tha _ 'ne 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 tne NRC Region ll office conceming the decommissioning of the NRC licensed Ft. McClellan site located near Anniston, Alabama (NRC license number 01-02861-04). The State it, 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 Resoonse 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 l

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Alabama Draft Report Page 9 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. t The six incidents selected for review included the following 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 F.

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 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 performed 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 indkator and reviewed the casework for two allegations. Pr;or 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, eight 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 i' to the alleger.

Alabama evalue'es 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, Response to incidents and Allegations, be found j satisfactory.

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' 4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legis!ation 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.

4.1- Laaial=* ion and Proaram Elements Reauired for Comantihilifv 4.1.1 Legislation 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 wi+h the NRC was granted in 1963 (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 of 1982, No. 328). The team noted that the legislation had not chaaged since the previous review.

4.1.2 Proaram Elements Reauired for Comontibility in its response to the questionnaire, Alabama indicated that all of the NRC regulatory amendments through March 1998 that have been identified as needed for compatibility or as having provisions significant to health and safety, have been adopted. A copy of the effective Alabama regulations, including the amendments which became effective as of March 18,1998, was submitted separately to NRC for review. NRC staff is currently reviewing the final March 18,1998 amendments for compatibility with NRC regulations.

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 amendment 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 addresced by the State. The Program Director indicated that the change to $ 19.12 will be addressed, and thet generally rule changes can be completed in approximately three months.

The team noted that Alabama 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.

l. The March 18,1998 rulemaking addressed three NRC amendments that were past the three I year period during which States are expected to adopt equivalent rules. The Decommissioning Recordkeeping; Documentation Additions; amendments to Parts 30,40,70 and the Timeliness in Decommissioning, amendments to Parts 30,40,70 were overdue by 17 months and seven

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f' Alabama Draft Report Page 11 months, respectively. The Preparation, Transfer for Commercial Distribution, and Use of l Byproduct .Aaterial for Medical Use; amendments to Parts 30,32,35 was adopted more than 3 i months past due. The Alabama rule equivalent to the Licensing and Radiation Safety l Requirements for Irradiators,10 CFR Part 36, would have been due for adoption July 1,1996, I however, the Auburn University irradiator (the only large irradiator licesee) was limited to the

. approximately 550 curies of Co-60 left from the original load. The rule was adopted when the l University requested authority to reload with 15,500 curies.

l 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 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 attemate 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 48623) that became effective on October 20,1995.

• " Compatibility with the intemational Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective A;,jl 1,1996.

e " Termination or Transfer of Licensed Activities: Record Keeping Requirements,"

10 CFR Parts 20,30,40,61,70 (61 FR 24669) that became effective on June 17,1996.

e " Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act," 10 CFR Part 20 amendn ent (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 on January 27,1997.

• Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Part 20.35 amendment (62 FR 4120) that became effective on May 29,1997.

• Fissile Material Shipments and Exemptions," 10 CFR Part 71 amendment (62 FR 5907) that became effective on February 10,1997.

e " Licenses for industrial Radiography and Radiation Safety - Requirements for Industrial Radiography Operations," 10 CFR Parts 30,34,71,150 amendment (62 FR 28947) that '

became effective on June 27,1997.

I e " Radiological Criteria for License Termination," 10 CFR Parts 20,30,40,70 amendment j (62 FR 39057) that became effective on August 20,1997. l l

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Alabama Draft Report Page 12 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, i.e., September 3, 2000.

Based on IMPEP evaluation criteria, the review team recommends that Alabama's performance with respect to the indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory.

4.2 Sealed Source and Device (SS&D) Evaluation Prooram During the review period, no SS&D certificates 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 review by qualified persons. The team did not evaluate this indicator further. ,

l 4.3 Low-Level Radioactive Waste Disoonal Proaram l Alabama continues to be a member of the Southeast Interstate Low-Level Radioactive Waste 1 Compact, and is not designated as the host State. There is no activity to establish a low-level I radioactive waste disposal site in the State. The team did not evaluate this indicator further.

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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 days 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 j working in Alabama, to be inspected each year. (Section 3.1) l i

l I

Alabama Draft Report Page 13

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 obtnined directly from the agency having jurisdiction, and that confirmation that the matenab (devices) were received be obtained directly from the receiving licensee. (Section 3.4)

LIST OF APPENDICES AND ATTACHMENTS Appendix A IMPEP Review Team Members Appendix B Alabama Organization Chart Appendix 0 Alabama's Questionnaire Response Appendix D inspection File Reviews Appendix E License File Reviews Appendix F Incident File Reviews I

APPENDIX A IMPEP REVIEW TEAM MEMBERS 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 Progrern 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, Ril RSAO Technical Quality of Licensing Actions i

0 i

i APPENDIX B ALABAMA OFFICE OF RADIATION CONTROL ORGANIZATION CHARTS 1

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APPENDlX C ALABAMA'S QUESTIONNAIRE RESPONSE

4 Approved by OMB' No. 3150-0183 Expires 4/30/g8 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. Statue of Maiarials in=raction Prooram

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.

lasp. Frequency Licensee Name (Years) Due Data Months O/D NONE

2. Do you currently have an action plan for completing overdue inspections? If so, 1 please describe the plan or provide a written copy with your response to this questionnaire.

N/A

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 Chapter 2800 and state the reason for the change.

i

• 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, Washington, DC 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.

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. Please complete the following table for licensees granted reciprocity during the reporting period.

i Number of Licensees Granted Reciprocity Number of Priority Permits Each Year Licensees inspected Each Year Service Licensees performing YR 1995 1 YR 1995 1 teletherapy and irradiator YR 1996 1 YR 1996 1 source installations or YR YR changes YR YR YR 1995 17 YR 1995 5 1 YR 1996 14 YR 1996 1 YR 1997 13(1 TUBE YR 1997 1 ONLY) YR 1998 2 YR 1998 10 YR 1995 1 YR 1995 1 2 YR 1996 0 YR 1996 0 YR 1997 0 YR 1997 0 YR 1998 0 YR 1998 0 YR 1995 15 YR 1995 4 3 YR 1996 15 YR 1996 3 YR 1997 13 YR 1997 0 YR 1998 6 YR 1998 0 4

All Other YR 1995 2 YR 1995 0 YR 1996 17 YR 1996 0 YR 1997 17 YR 1997 1 YR 1998 5 YR 1998 0

5. Other than reciprocity licensees, how many field inspectior.s of radiographer were performed?

1996 - 3 1997 - 3 1998 -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. Technical 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 opinion of the inspector, the licensee management understands the problems and verbally states that appropriate 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 riumber 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 1/29/96 David Turberville No documented accompaniment since 5/10/95

9. Describe intemal procedures 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 inspector 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.

l 10. Describe or provide an update on your instrumentation and methods of calibration. Are all instruments properly calibrated at the present time?

See Attachment i 3

l

Ill. 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 agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, 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 of junior personnel. If consultants 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%

James L. McNees Dir. Rad. Mat. Inspection Inspection 80%

Emerg. Response 5%

Other 15%

David Turberville Rad. Phy. Il inspection 90 %

Emerg. Response 5%

Other 5%

Ron Pass Rad. Phy. Il Inspection 50 %

Other 20 %

Emerg. Response 5%

Gen. License 25%

Karl D. Walter Dir. Rad. Mat. Licensing Licensing 75%

Emerg. Response 5%

Other 20 %

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 / 70 %

Response

Environmental 10%

Other 20 %

Terry Williams Rad. Phy. ll Emerg. Response 15%

Environmental 70 %

Other 15%

4

- \

NAME POSITION AREA OF EFFORT FTE%

Tonya Beck Rad.Phyll Emerg. Planning 90 %

Other 10%

Myron Riley Rad.Phy.I Emerg. Response 5%

Other 95%

Bradley Grinstead Rad. Phy. til Emerg. Response 5%

Other 95%

Richard Glass Rad. Safety Spec.111 Emerg. Response 5%

Other 95%

Kenneth Thomas Rad. Safety Spec. lli Emerg. Response 5%

Other 95%

Curtis Franklin Rad. Safety Spec. II Emerg. Response 5%

Other 95%

Beverly Carswell Rad. Safety Spec. ll Emerg. Response 5%

Other 95%

12. Please provide a listing of all new professional personnel hired since the last 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 persons 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 tentative schedule for completion of these requirements.

RESPONSE

ALLprofessional staff are not directly associated with the Agreement States Program and do not work on a daily basis in that program. There is no intent to qualify all 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 licenses. Jim McNees, David ,

Turberville, Ron Pass, Bradley Grinstead, David Walter, and Kirksey 1 Whatley have met all of the requirements for inspectors in the Agreement States Program. Myren Riley, Tonya Beck, Terry Williams, and Mike Cash 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.

1 5 )

l

14. Please identify the technical staff who left the RCP/ Regional DNMS program during this period.

RESPONSE

Bernis Hannah. Radiation Physicist lit, retired. Mr. Hannah directed the Emergency Planning / Environmental Monitoring Eaction of DRC.

Cecil Cork, Public Health Engineer lil, retired. Mr Cork directed the NORM Section of DRC.

William Eden. Radiation Physicist 111, redred. Mr. Eden directed the X-Ray program of DRC.

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 r najor 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 procedures or exemptions from j the regulations granted during the review period.

]

1

RESPONSE

Some HDR licensees have been granted approval, through requested {

license amendments, to order replacement sources with activities up to j 20% higher than the licensed quantity (up to 12 curies for the maximum licensed 10 curies). An additional condition prohibits the source from  :

being installed into the HDR until the activity is at or below 10 curies.

6

....m-

Pipeliner cameras are still being licensed provided that the maximum size source that can be installed is a source that will not create an exposure rate in excess of 50 mR/hr. at two inches from any camera surface and provide precautions related to the " drop" test.

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 licensing guides that the Agency uses have been adopted.

19. For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.

V. Resoonses to incidents and Allegations

20. Please provide a list of the reportab!e 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 Agreernent 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 should be in the following format:

TYPE OF LICENSEE NAME LICENSE # DATE OF INCIDEMT/ REPORT INCIDENT Incidents prior to 1/1/98 have been previously submitted to Ms. Pat Larkin for inclusion on NMED. NMED print out of the three 1998 ir cidents is attached. 1

21. During this review period, did any incidents occur that involved equipment or source 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 appropriate 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 l

1 7

~

23. In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently ur ergoing review? If so, please describe the circumstances for each case.

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 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 Region I assisted the state with the investigation. The State imposed 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. General

25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following 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 state programs following review of those state programs. At the close out of the last review no mention of that " citation" was discussed. In fact very complimentary words were used to summarize the review. That " good report" was discussed with the State Health Officer, Doctor Donald Williamson. Then to 8 ,

i

everyone's shock, Doctor Williamson 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 tha 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 review, Alabama Radiation Protection Rules have been revised to include NRC's medical QA requirements. Adoption of NRC's requirements has and will continue to result in a decrease in the protection provided to patients.

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 ur.derstand but here goes!

The strength of che Alabama program is attributed directly to the quality and character of the entire staff. This Agency is and has been a good place in whic.h 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 i retirement. Staff members have been given the opportunity, and encouraged, to take {

advantage of training courses that improve their work and work " happiness". no l courses have been both technical and personal development type courses. The staff f has demonstrated on numerous occasions that they have dedicated themselves to learning in training classes. That is evidenced by staff grades on exams at NRC and other courses - 94% and 100% on final 5-week coursa 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 s'.aff members, the public, and other state programs can draw. Very little effort is necessary for researching how to do something. T hat translates into 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 responses have been made where needed. That is not just now - that is what you will find 9

anytime. We have been up-to-date all along. That is a strength of the staff and l

reflects staff commitment and pride in their work.

Staff members volunteer to work in areas outside those required. For example, David Walter serves as the CRCPD chair of the nuclear medicine committen as well as being the OAS State representative on NRC's Medical Reaulation Workina Group.

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 No.v York during February 23-27,1998. He filled in on the Kentucky review on very short notico when a scheduled team member could not be there. He also serves as CPCPD liaison with the IAEA. Kirksev Whatiev served on the Executive Board of CRCPD, a Comm!ssioner 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 Paan has served as the State resource person for radon. All of the staffinvolve 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 support from upper management. There is a good relationship between upper level management and the working staff. In late January 1998, the Division of Radiation Control was elevated to the Office of Radiation Control with the Director answering 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 ;t work.

WEAKNESSES:

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

D. NON-COMMON PERFORMANCE INDICATORS

1. Legislation and Proaram Elements Reauired for Compatibility

27. Please list all currently effective legislation that affects the radiation control program (RCP).

RESPONSE: ,

i There is no known current legislation that affects the radiation control program.

28. An a your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations. j

RESPONSE

i Rules are not subject to a " sunset" or equivalent law.

29. Please complete the enclosed table based on NRC chronology of amendments. Identify l those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.

RESPONSE: See table.

l 30. If you have not adopted all amendments within three years from the date of NRC rule 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.

11. Sealed Sourt.e and Device Proaram l 31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices l issued during the review period. The table heading should be:

SS&D Manufacturer, Type of l

Registry Distributor or Device Date Number Custom User or Source lasued RESPONSE: No SS&D registrations were issued.

32. What guides, standards and procedures are used to evaluate registry applications?

RESPONSE: None evaluated.

11 l

w___- __ _ _ _ _ _ _ _ - _ _ _ - _ _ _ _ _ _ _ _ _ _ _ - _ _ . . _ _ _ _ _ _ __ . _ _ _ _ _ _ _ _ _ _ _

33. Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:

Technical Staffing and Training - A.lil.11-15 Technical Quality of Licensing Actions - A.IV.16-18 l

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.I.6 Technical Quality of Inspections - A.II.7-10 Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 RESPONSE: NA IV. Uranium Mill Proaram

35. Piease 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.I.6 Technical Quality of Inspections - A.ll.7-10 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 12

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i APPENDlX D INSPECTION 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 Medical Imaging Center inspection Type: Routine, Unannounced Location: Montgomery, AL Priority: 3 License Type: Medical Private Practice-Limited Inspector: BG l

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 Systems-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: DP inspection Date: 5/13/97 File No.: 4 License No.: 1191 Licensee: Thomas O. Paul, Jr., MD. Inspection Type: Initial, Announced Location: Birmingham, AL Priority: 3 License Type: Medical Private Practice /QMP Req. Inspector: RP inspection Date: 12/18/96 File No.: 5 License No.: 1059 Licensee: Inspection Type: Routine, Unannounced Location: Global X-Ray & Testing Corporation Priority: 1 License Type: Industrial Radiography-Temp Job Sites inspector: DT Inspection Date: 10/29/97 File No.: 6 License No.: 338 Licensee American Cast iron Pipe Company inspection Type: Routine, Unannounced Location: Birmingham, AL Priority: 1 License Type: Industrial Radiography, Fixed Inspector: RP inspection Date: 4/22/97 File No.: 7 License No.: 1111 Licensee Cox Nuclear Pharmacies, Inc. Inspection Type: Routine, Unannounced Location: Mobile, AL Priority: 1 License Type: Nuclear Pharmacy Inspector: RP inspection Date: 2/11/08

Alabama Draft Report Page D.2 Inspection File Reviews l File No.: 8 License No.: 661 Licensee Four Rivers Medical Center Inspection Type: Routine Unannounced Location: Selma, AL Priority: 3 License Type: MedicalInstitution-QMP required Inspector: RP inspection Date: 3/11/97 File No.: 9 License No. 248 Licensee Auburn University inspection Type: Routine, Unannounced Location: Aubum 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 l

File No.: 10 License No.: 158 Licensee: Law Engineering & Env Sys, Inc. Inspection Type: Routine, Unannounced Location: Birmingham, AL Priority: 1 License Type: Ind Rad - Temporary Job Site inspector: RP inspection Date: 9/4/97 File No.: 11 License No.: 834 Licensee: H & H X-Ray Services, Inc. Inspection Type: Unannounced field Location: West Monroe, LA Priority: 1 LL.snse Type: IR-Temporary Field Sites inspector:' DT Inspection Date: 1/9/98 File No.: 12 License No.: 1229 Licensee: Edwards Pipeline Testing, Inc. Inspection Type: N/A Location: Tulsa, OK Priority: 1 i License Type: Industrial Radiography-Temporary . Ir,spector: N/A Inspection Date: N/A - Reciprocity Review File No.: 13 License No.: 1176 Licensee: Name Consolidated NDE, Inc. Inspection Type: N/A Location: Woodbridge, NJ Priority: 1 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. Inspection Type: N/A Location: Soddy Daisy, TN Priority: 1 License Type: Industrial Radiography, Temp Inspector: N/A i inspection Date: N/A- Reciprocity Review

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6 Alabama Draft Report Page D.3 Inspection File Reviews File No.: 15 License No.: 1005 Licensee: Well Services, Inc. Inspection Type: N/A Location: Crossville, TN Priority: 3 License Type: Well Logging inspector N/A -

inspection Date: N/A- Reciprocity Review l

! File No.: 16 License No.: 1239 l Licensee: Soil Testing Engineers, Inc. Inspection Type: N/A l Location: ' Baton Rouge, LA Priority: 5 l 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 Location: Duncan, OK Priority: 5 License Type: Well Logging Inspector: N/A Inspection Date: N/A - Reciprocity Review In addition, the following 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: Routino, Unannounced License Type: Nuclear Pharmacy Priority: 1 Inspection Date: 2/11/98 inspector: RP Accompaniment No.: 2 Licensee: St. Clair Regional Hospital License No.: 734 Location: Pell City, AL Inspection Type: Routine, Unannounced License Type: . Institutional Meascai Priority: 3 Inspection Date: 2/25/98 Inspector: RP Accompaniment No.: 3 Licensee: AMI Brookwood Medical Center License No,: 459 Location: Brookwood, AL Type inspection: Routine, Unannounced

- License Type: Institutional Medical Priority: 1 Inspection Date: 2/26/98 Inspector: DT

- Accompaniment No.:. 4 Licensee: Professional Services Industries License No.: 368 Location: Irondale, AL Inspection Type: Routine, Unannounced License Type: Industrial Radiography Priority: 1 Inspection Date: 2/27/98 Inspector: DT

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i APPENDIX E LICENSE FILE REVIEWS

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, APPENDlX E LICENSE FILE REVIEWS NOTE: ALL LICENSE FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE.

File No.: 1 Licensee: Eastem Technologies, Inc. License No.: SNM-1240 Location: Ashford, AL License Type: Nuclear Laundry Type of Action: New Date issued: 3/17/98 License Reviewer: DW File No.: 2 Licensee: Eastern Technologies, Inc. License Nc.: 947 Location: Ashford, AL Amendment No.: 5,6,7, and 8 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: 2/21/98,3/25/96 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: Indestrial Radiography Type of Action: Amendment Date issued: 12/12/95 License Reviewer: DW 1

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Alabama Draft Report Page E.2 License File Reviews File No.: 7 Licensee: Muscle Shoals Minerals, Inc. License No.: SM-868

! 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 File No.: 8 Licensee: Central Pharmacy Services, Inc License No.: 1189 4 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 1 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 research Type of Action: Renewalin Entirety Date issued: 6/13/97 License Reviewer: DW File No.: 12 Licensee: Regis Engineering Solutions, Inc. License No.: 1228 I 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 I Location: Tulsa, OK License Type: Industrial Radiography Type of Action: New Date issued: 9/15/97 License Reviewer: DW i

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4 Alabama Draft Report Page E.3 License File Reviews File No.: 14 Licensee: AMI Brookwood Medical Center License No.: 459 i Location: Birmingham, AL Amendment No.: 73,74,75,76 and 77 l

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 i License Type: Institutional Medical Type of Action: Renewal Date of Action: 1/9/97 License Reviewer: DW 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 Date of Action: 11/25/96 License Reviewer: DW l

File No.: 17 Licensee: Nuclear Cardiovascular Imaging Center, Inc. License No.: 1184 )

Location: Florence, AL Amendment No.: 1,2,3,4,5,6, and 7 License Type: Private Practice Type of Action: New Date of Action: 8/6/96, 9/6/96,1/23/97, 7/25/97, 8/20/97,10/t'97 License Reviewer: DW j and 12/31/97 File No.: 18 Licensee: Columbia Northridge Medical Center License No.: 1235 Location: Prattville, AL License Type: Private clinic _ Type of Action: New Date of Action: 11/13/97 License Reviewer: DW File No.: 19

' Licensee: Valley Regioal 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 i 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 l l

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4 Alabama Draft Report Page E.4 License File Reviews File No.: 21 Licensee: Healthsouth MedicalCenter 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 File No.: 22 Licensee: Aubum University License No.: 248 Location: Auburn, AL Amendment No.: 45,46,47 License Type: Broad Academic Type of Action: Renewal Date of Action: 9/13/95,12/1/37,4/9/98 License Reviewer DW File No.: 23 Licensee: University of South Alabama License No.: 584 Location: Mobile, AL Amendment No.: 40 License Type: Broad Medical Type of Action: Amendment Date of Action: 12/30/97 License Reviewer:. DW File No.: 24 Licensee: Nuclear Pharmacies, Inc. License No.: 927 Location: Mobile, 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 Location: Florence, AL Amendment No.: 10 License Type: Gas chromatograph Type of Action: Termination Date of Action: 12/1/97 License Reviewer: DW l

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Alabama Draft Report Page E.5 License File Reviews File No.: 26 Licensee: Michael R. Satchfield License No.: 1154 Location: Mobile, AL Amendment No.: 1 License Type: Portable gauge Type of Action: Termination Date of Action: 12/18/97 License Reviewer: DW Comment:

a) This license was terminated by amendment after a " Bill of Sale" and a " receipt" dated 12/3/97 indicating that the device had been transferred to a company located in South Carolina. There was no documentation in the file that would confirm the receipt of the device by the South Carolina firm, that the firm had a valid South Carolina license to receive and possess the device at the time of transfer, or that the device had been tested for leakage within six months of transfer, as required by license condition.

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 License 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 File No.: 30 l Licensee: Soil Testing Engineers, Inc. License No.: 1239 Location: Baton Rouge, LA Ucense Type: Portable Gauge Type of Action: New Date of Action: 3/11/98 License Reviewer: DW

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APPENDIX F INCIDENT FILE REVIEWS l

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APPENDIX F

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INCIDENT FILE REVIEWES NOTE: ALL INSPECTION FILES LISTED WITHOUT COMMENT WERE DETERMINED BY I THE IMPEP TEAM TO BE ACCEPTABLE, i

File No.: 1 Licensee: Wiregrass Construction Company License No.: 1086 incident ID No.: 95-16 Location: Dothan Airport, Dothan, AL Date of Event: 11/20/95 Type of Event: Damaged Equipment investigation Date: 11/20/95 investigation Type: On site Summary of incident and Final Disposition: On November 20,1998, a moisture density gauge 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: Southem Earth Science, Inc.

License No.: 647 incKient ID No.: 96-6 Location: 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 l I

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 i up posters regarding the gauge and to put out a press release. As of this date the gauge has l not been recovered and the file remains open. j

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.O Alabama Draft Report Page F.2 incident File Reviews File No.: 3 Licensee: Certified Testing and Inspection (now Non Destructive & Visual Inspection, Inc.)

i License No.: 1174 l Incident ID No.: 96-11 l Location: Cottondale, AL l 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 individuals 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 developed, 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 3,1996, two members of the ORC program performed time and dose studb s of the incident. The incident was reported to the USNRC. The occurrence 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  !

i 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 investigation failed to find any evidence the gauge had ever been received by the licensee. The gauge manufacturers records showed the gauge was received by the licensee.  !

The iicensee 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.

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l File No.: 5 Licensee: American Testing Laboratory License No.: 1052 incident ID No.: 97-10 i

Location: Interstate 20 outside Fairfield, AL Date of Event: 4/5/97

! Type of Event: Traffic Accident l Investigation Date: 4/5/97 investigation Type: Report 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 l in the rear of the vehicle and was not damaged. The licensee took possession of the device.

l There was no exposure in excess of that permitted by the Alabama regulations. File Closed.

i File No.: 6 I 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: 1/16/98 investigation Type: Licensee's report review Summary of Incident and Final Disposition: Sags of waste contaminated with I-131 were being i held for decay. The bags were not labeled as containing RAM and housekeeping disposed of l 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.

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