ML20151X554

Draft Impep Review of Rhode Island Agreement State Program 980727-30

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l lNTEGRAYED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF RHODE ISLAND AGREEMENT STATE PROGRAM July 27 - 30,1998 DRAFT REPORT U.S. Nuclear Regulatory Commission l

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Rhode Island Draft Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the Rhode island radiation control program.

The review was conducted during the period July 27-30,1998, by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of New York. Team members 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 NRC Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period January 14,1994 to July 30,1998, were discussed with Rhode Island management on July 30,1998.

(A paragraph on the results of the MRB meeting will be included here in the final report.]

The Rhode Island Agreement State program is administered by the Office of Occupational and Radiological Health (ORH). The ORH Chief reports directly to the Executive Director of Environmental Health located in the Department of Health. The ORH has five employees including the chief assigned to radioactive materials regulation under the Agreement. The Radiation Control Program within ORH is responsible for the Agreement Program and the Supervising Radiation Control Specialist (SRCS) reports to the ORH Chief. An organization chart for the ORH is included as Appendix B.

At the time of the review, the Rhode Island program regulated 77 specific licenses, including limited scope medical, broad scope, industrial radiography, and nuclear pharmacy licenses.

The review focused on the material's program as it is carried out under the Section 274b.

(of the Atomic Energy Act (AEA) of 1954, as amended) Agreement between the NRC and the State of Rhode Island.

In preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the State on June 19,1998. The State provided a response to the questionnaire on July 13,1998. During the review, discussions with the State staff resulted in the responses being further developed. A copy of the final response is included in Appendix G to this report.

The review team's general approach for conduct of this review consisted of: (1) examination of Rhode Island's response to the questionnaire; (2) review of applicable Rhode Island statutes and regulations; (3) analysis of quantitative information from the radiation control program licensing and inspection data base; (4) technical review of selected licensing and inspection actions; and (5) interviews with staff and rnanagement to answer questions or clarify issues.

The team evaluated the information that it gathered against the IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of the radiation control program'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,

Rhode Island Draft Report Page 2 recommendations and suggestions. Recommendations relate directly to program performance by the State. A response is requested from the State to all recommendations in the final report.

Suggestions made by the review team 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.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS During the previous routine review, which concluded on March 3,1995, comments and recommendations were made and the results transmitted to Dr. Barbara DeBuono, Director, Rhode Island Department of Health on May 13,1994. The review resulted in six recommendations. The team's review of the current status of these recommendations is as follows:

(1)

We recommend that the following rules and any others needed for compatibility, be promulgated expeditiously as effective State radiation control regulations. As a matter separate from the review, it was noted that the State's attention be directed to other regulations that will be needed for compatibility. The rules identified were:

• " Notification of Incidents," 10 CFR Parts 20,30,31,34,39,40, and 70 amendments (56 FR 40757) needed by October 15,1994.

• " Quality Management Program and Misadministrations," 10 CFR Part 35 amendment (56 FR 153) needed by January 27,1995.

• " Licenses and Radiation Safety Requirements for irradiators," 10 CFR Part 36 (58 FR 7715) which is needed by July 1,1996.

• " Decommissioning Recordkeeping and License Termination: Documentation Additions," 10 CFR Parts 30,40,70, and 72 (58 FR 39628) which is needed by October 25,1996.

Current Status: The team reviewed the status of Rhode Island's regulations under Section 4.1.1 " Legislation" and found that the above rules required for compatibility have been implemented with the exception of the irradiator rule. The State does not have an irradiator licensee nor do they have an active application for an irradiator and under current compatibility policy an equivalent State regulation is not required.

Should an application be received, the State indicated that they will utilize binding legal requirements like license conditions to implement compatible requirements until a rule is promulgated. This recommendation is closed.

(2)

We recommend that the ORH management closely monitor the compliance program's statistical reports in order to ensure the timely inspection of licensees.

Current Status: Considerable improvement in the timeliness of inspections was noted by the team. ORH is using a computer and spread sheet to plan inspections. The team also notes that this system will be upgraded with a new computer within a short time.

The new system will allow for greater flexibility in the management of inspections (see Section 3.1). This recommendation is closed.

Rhode Island Draft Report Page 3 (3)

It is recommended that the State ensure that each application for a private practice l

human-use license be signed by the physician / authorized user.

The previous recommendation focused on the acceptance of signatures from individuals who were not " principals" in the company or business.

1 Current Shtus: A review of the licensing actions indicates that the State has made changes heir program to ensure that each license application is signed by an individual vmit the authority to represent the licensee. This recommendation is closed.

(4) a.)

It is recommended that the ORH staff document interviews of radiation workers and ancillary workers in each inspection report.

Current Status: The team confirmed that more detail on worker interviews is being provided in the inspection reports. This recommendation is closed.

b.)

It is further recommended that each report contain a clear indication of whether the inspection was unannounced or announced.

Current Status: The State's inspection reports now document the type of inspection conducted. This recommendation is closed.

(5) a.)

It is recommended that wipe samples be obtained during each inspection of facilities utilizing Tritium (H-3), Carbon-14 or where loose contamination is suspected and area surveys indicate readings greater than 2-3 times normal background. A more selective sampling approach should be employed for other facilities.

Current Status: The State has taken considerable effort to improve and implement an improved sampling and confirmatory measurements process. This recommendation is closed.

b.)

We also recommend that the ORH work with the Health Department Laboratories to insure adequate handling, processing and reporting of results from wipe samples and samples in any other physical form.

Current Status: The wipe test procedures used and contract laboratory support provides assurance that adequate confirmatory measurements are being performed, analyzed and reported. This recommendation is closed.

(6)

We recommend that the State more closely monitor licensees where serious violations have occurred. This monitoring should include the inspection of licensees at their scheduled inspection frequency and follow-up field inspections.

Current Status: The State's policy is to perform insp?:tions at the same inspection frequency as that of NRC. Since the last review, the program has made a more conscious effort to conduct routine and follow-up inspections under their policy. Since j

the last review the State has improved its tracking procedures for following up on serious violations. This recommendation is closed.

Rhode Island Draft Report Page 4 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) Ts8nical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical Quality of Liciong Actions; and (5) Response to incidents and Allegations.

3.1

. Status of Materials Insoection Proaram The team focused on four factors in reviewing this indicator: inspection frequency; overdue inspections; initial inspections of new licenses, and timely dispatch of inspection findings to licensees. The review team's evaluation is based on Rhode Island's questionnaire responses relative to this indicator, data gathered independently from the State's licensing and inspection data tracking system, the examination of completed inspection casework, and interviews with the SRCS, and the inspection staff.

The team's review of the State's inspection priorities found that the inspection frequencies for various types of Rhode Island licenses are based on NRC's inspection Manual Chapter (IMC) 2800 with inspection intervals of one through seven years in comparison with NRC guidance, the State's assignment of inspection priorities was determined to be at least as frequent as NRC'S Inspection Manual Chapter (iMC) 2800 with one exception. Rhode Island inspects its only gamma stereotactic radiosurgery facility once every three years compared to an annual inspection frequency in IMC 2800. In response to the NRC's proposed revision to program code descriptions and inspection priorities in 1997, Rhode Island responded to the NRC in writing on the proposed revision for gamma stereotactic radiosurgery by indicating that their six years of experience with this type of license had shown no significant safety or compliance issues and that an inspection priority of 3 was adequate. The review team found this acceptable.

The State has provisions to extend or shorten the interval between inspections based upon the evaluation of licensee performance. The SRCS routinely indicates if inspection frequency should be extended, shortened or remain the same on the field notes after they are reviewed.

Interviews, review of inspection reports and the inspection data base indicates that extension for good licensee performance is assigned consistent with State and NRC policy. The State uses a reduced inspection frequency as a tool to encourage improved licensee performance.

The team noted several instances of reduced inspection frequency based on poor licensee performance. The most notable was that associated with a major medicalinstitution. The review team noted that extending inspection frequency intervals has provided some workload relief and allows its primary materials inspector to pursue naturally occurring and accelerator produced radioactive materials (NARM) programs that the State is also mandated to enforce.

The normal interval between inspection and report issuance was found to be seven to 14 working days, and no report letter was issued more than 30 days post-inspection. Reports and letters are produced by the inspection staff based upon a standard set of letters and notice of violations.

The State possesses a database for inspection scheduling. The SRCS assigns inspections quarterly based on a list of licensees due for inspection from the database. During the review, the team noted that the quarterly inspection planning contributed to some licensees not being

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Rhode Island Draft Report Page5 inspected within their inspection frequency. Discussions between the review team and the SRCS revealed that the time between the data query and inspection could be a long enough I

interval to result in some initial and core inspections to be overdue when inspected. For example, a total of eight new licenses were issued during the review period and for seven that have been inspected (one is not yet due), one was done within the six-month interval and the rest were performed at seven and eight months after license issuance. The review team also noted three core inspections were overdue by one to three months when performed. The review team recommends that the State upgrade their inspection tracking system to assure that all licensees are inspected in accordance with the frequency established by the program.

In response to the questionnaire, the State indicated that one priority 1 inspection was currently overdue. Based on this review, the review team determined that the licensee indicated by the State as currently overdue was not.

The review team noted those State inspections of licensees with authorization to perform licensed activities at temporary job sites (i.e., radiographer and portable gauges) often did not include observations of activities at temporary job sites. Only one field inspection occurred during the review period. Inspections of licensees working under reciprocity at temporary job l

sites in Rhode Island were not inspected in accordance with the frequency goals of IMC 1220.

Twenty five priority 1 and 2 licensees were granted reciprocity permits during the review period.

The State conducted 4 inspections of these licensees. During discussions with the SRCS and the principal materials inspector, the State was aware of the goals in IMC 2800 and IMC 1220 with regard to inspection of licensed activities at temporary job sites. The State inspector would inquire about the location of temporary job sites during inspections or make phone calls to facilities where licensed activities are likely to occur or to the licensees themselves in an effort to identify any activities at temporary job sites. The review team concluded that there were a number of factors that contributed to the low number of temporary job sites inspections compared to the goals of IMC 2800 and IMC 1220. These included 1) the small size of the State's inspection staff; 2) the expenditure of resources in terms of time needed to locate and inspect licensees in the field; and 3) the limited amount of work that some licensees actually perform in Rhode Island. The review team suggests that Rhode Island continue to make reasonable efforts to conduct inspections at temporary and reciprocity job sites.

Based on the IMPEP evaluation criteria, the review team recommends that Rhode Island's performance with respect to the indicator, Status of Materials inspection Program, be found satisfactory.

3.2 Technical Quality of insoections j

i The review team examined a selected sample of inspection reports, enforcement documentation, and inspection field notes and interviewed inspectors for 13 materials l

Inspections conducted during the review period. The casework included both State's materials I

inspectors, and covered inspections of various types including industrial radiography, medical institutions, academic institutions, portable gauging systems, and a nuclear pharmacy.

Appendix C lists the inspection casework files reviewed for completeness and adequacy with case specific comments.

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Rhode Island Draft Report Page 6 The inspection procedures and techniques used by Rhode Island were determined by the review team to be consistent with inspection guidance in IMC 2800. The team reviewed the inspect on casework and found them to be comparable with the types of information and data collected under NRC inspection Procedure 87100. Inspections are generally performed on an unannounced basis. The inspection field notes provide consistent documentation of inspection l

findings. Rhode Island uses field notes for different types of licenses including industrial radiography, medical, fixed and portable gauges and industrial and academic, inspection reports were reviewed to determine if the reports adequately documented the scope of the licensed program, licensee organization, personnel protection, posting and labeling, l

control of materials, equipment, use of materials, transfer, and disposal. The reports were also l

checked to determine if the reports adequately documented operations observed, interviews of workers, independent measurements, status of previous noncompliance items, substantiation of all items of noncompliance, and the substance of discussion during the exit interviews with management. Routine enforcement and acknowledgment letters are drafted by the inspectors.

All inspection reports and correspondence are reviewed by the SRCS prior to being issued to the licensee.

l For the casework reviewed, documented inspection findings led to proper regulatory actions and appropriate enforcement. The SRCS stated that escalated enforcement action beyond the issuance of notice of violations (NOVs) was limited to the issuance of orders. The State does and will conduct follow-up inspection (s) of licensees to ensure their licensed operations are conducted safety and in compliance with State regulations. Each State licensee is assessed a fee for inspection of their program. Rhode Island held one enforcement conference during the review period.

On June 22 and 23,1998, a review team member accompanied the principal State inspector on an inspection of a medical broad scope facility licensed by the State. The inspection accompaniment is listed in Appendix C. The review team member determined that the inspector demonstrated appropriate inspection skills and knowledge of the regulations. The inspector was well prepared and thorough in the review of licensee's radiation safety program.

The inspector was equipped with, and used, appropriate and calibrated survey and safety equipment. Inspection techniques were observed to be performance oriented, and the technical performance of the inspector was at a high level. The inspection was adequate to assess the licensee's radiological and safety performance.

l The ORH Chief issued a memorandum this year stating that supervisory accompaniments of inspectors are performed on an annual basis. The State's principal materials inspector was accompanied this year by the ORH Chief, but had not been in previous years during the review period. The team suggests that the State adhere to their policy of performing supervisory accompaniments of all materials inspectors on an annual basis.

l The team noted that Rhode Island has an ample number of portable radiation detection instruments for use during routine inspections and response to incidents and emergencies.

Instrument calibrations are performed two to three times per year by University of Rhode Island's Nuclear Science Center using NIST traceable sources. A sampling of portable instruments maintained were found to be calibrated and operational. The State also utilizes the

Rhode Island Draft Report Page 7 radiation laboratory at University of Rhode Island's Nuclear Science Center for the analytical evaluaHon of samples routinely taken during inspections (i.e., wipes and environmental samples) or during incidents and emergencies.

Based on the IMPEP evaluation criteria, the review team recommends that Rhode Island's performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory 3.3 Technical Staffinn and Trainina items considered for evaluation of this indicator included: the radioactive materials program staffing level, technical qualifications of the staff, training and staff tumover. To evaluate these items, the review team examined the State's questionnaire responses relative to this indicator, interviewed program management and staff, and considered any possible workload backlogs.

i Program staffing remained the same, as there were no nevi hires or staff turnover since the last review. There are no vacancies with respect to the radioactive materials program, however, an Industrial Hygienist is expected to be hired within a few months to assist the x-ray program.

The minimum educational requirement for a new hire is a baccalaureate degree in physical or biological science. All current staff exceed the qualifications.

The program consists of the ORH Chief, SRCS, Radiation Health Specialist, Senior Industrial Hygienist and an Industrial Hygienist Technician each of whom contribute a portion of their time to the program for a total of 1.2 FTE. The ORH Chief spends approximately 10% of her time on the radioactive materials program, including inspector accompaniments. The SRCS of the Radiation Control Program provides daily management oversight and support in the licensing program. The Radiation Health Specialist is the principal materials inspector and the Senior Industrial Hygienist is the principal license reviewer. In addition, the Industrial Hygienist Technician, who has been working on the regulation of tanning facilities will begin work in the radioactive materials program. The ORH also'has access to an individual trained and experienced in radiation control work. This individual spends approximately.2 FTE in support of the ORH by drafting and finalizing regulation, policy and technical documents. He has conducted inspections for the ORH when necessary. The review team suggests that the program cross train staff members to meet any future contingency. The review team noted that current staffing levels are adequate and no health and safety concerns attributable to staffing were identified.

All have taken the NRC courses deemed appropriate for their tasks, including the five week health physics course. In addition, program staff regularly participates in other training opportunities available through the CRCPD and the New England Radiological Health Committee. In addition, the program conducts regular monthly in-house meetings for its staff to discuss emerging and outstanding issues. However, there is no written training program for the licensing and inspection staff. The review team recommends that the State document a training and qualifications program equivalent to that contained in NRC's inspection Manual 1246, " Formal Qualifications Programs in the Nuclear Materials Safety and Safeguards Program Area."

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l Rhode Island Draft Report Page 8 Based on the IMPEP evaluation criteria, the review team recommends that Rhode Island's l

performance with respect to the indicator, Technical Staffing and Training, be found l

satisfactory.

3.4 Technical Quality of Licensina Actions l

The review team examined completed licensing casework and interviewed the reviewers for ten l

specific licenses. Licensing actions were evaluated for completeness, consistency, proper isotopes and quantities used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for overall technical quality including accuracy, appropriateness of the license, its conditions, and tie-down conditions. Casework was evaluated for timeliness, adherence to good health physics practices, reference to appropriate regulations, documentation of safety evaluation reports, product certifications or other supporting documents, consideration of enforcement history on renewals, pre-licensing visits, peer or supervisory review as indicated, and proper signature authority. The files were checked for retention of necessary documents and supporting data.

The licensing casework was selected to provide a representative sample of leensing actions that had been completed in the review period. The cross-section sampling included four of the State's major licenses m, Mtified by the State questionnaire, and included the following types:

academic broad scope: meJical bmad scope; nuclear pharmacy; gauge; and medical specific.

Licensing actions during the review period included 11 new licenses,49 renewals, and 99 amendments (including 11 terminations), for a total of 170 licensing actions. In discussions with management, it was noted that there were no major decommissi. ling efforts underway with regard to agreement material in Rhode Island. A list of licenses reviewed with case-specific comments for license reviews can be found in Appendix D.

The licensing process was discussed with the principal license reviewer and staff. Tvpes of licensing actions selected for review included new licenses, amendments to existing licenses, renewal licenses, and terminations. License reviews were well done, well documented, detailed, and complete. All telephone conversations with applicants are well documented in the license file. The State uses NRC guides, checklists and model NRC licenses to evaluate applications and issue licenses. The scope of the license review covered the essential elements expected in a comprehensive radiation protection program.

Alllicensing actions receive supervisory review, and were signed by management. Deficiencies are addressed by detailed, well-written letters utilizing appropriate regulatory language.

Application packages containing guidance (NRC) are sent to license applicants. The applications are reviewed following standard procedures used by the NRC. The licensing guides, as well as other applicable guidance from NRC, are available. Licenses are written in the exact format as those issued by NRC, the same standard possession limits, chemical and physical form and total activity, and standard license conditions (SLCs) for that particular type of license. The same program code for each type of licensee, as used by NRC is also used.

j Licenses are issued in entirety only as new licenses or during the renewal process.

Amendments are issued only with changes as noted in the amendment request (1 or 2-page amendments). License files are several-part documents organized with the license and amendments separate from other documents and grouped in manila folders by a control

Rhode island Draft Report Page 9 number issued for each licensing action. Files contain complete information including application, deficiency letters, review check sheet, telephone documents, memoranda, inspection reports, and licensee response letters. Reviewers are conscientious about including all pertinent documents in the license tie-down.

License files have all current inspection data, in addition to incident data, providing license reviewers with incident reports and inspection reports during the renewal period. Incidents are cross-referenced in licensing files. License reviewers have adequate supporting information and documentation readily available in the file to complete license renewal reviews.

The program has a centralized computer system for tracking licensing actions. The SRCS keeps a listing of licensing actions in progress for tracking purposes. While there are only a limited number of licensing actions ongoing, approximately 40 per year, the program could benefit from a more comprehensive tracking mechanism to track licensing actions through to completion. For example, the current system keeps track of when licenses expire and date notice was sent, but it does not clearly track the action after that time. There is a code for completed licensing actions but there are no reminders that a response is overdue. While in most cases staff know (from memory) the status of each licensing action, there should be a listing of the status of each action, a date a response is expected, or tickle date to remind licensees that a response is expected and none received. The review team suggests that the State irrprove the license tracking system to assure timely processing of actions.

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

3.5 Resoonse to incidents and Alleaations In evaluating the effectiveness of the State's actions in responding to incidents, the review team examined the State's response to the questionnaire regarding this indicator, reviewed selected incidents reported for Rhode Island in the " Nuclear Material Events Database" (NMED) against those contained in the Rhode Island files, and reviewed the casework and supporting documentation for six materialincidents. The team also reviewed the State's response to two allegations referred to the State by NRC during the review period. A list of selected incident files examined along with case specific comments is contained in Appendix E.

The six incidents selected for review included a misadministration, a loss of control of radioactive materials, two lost radioactive materials, an equipment failure and a transportation event.

When notification of an incident or an allegation is received, the ORH Chief, SRCS and staff normally meet to discuss the initial response and the need for an on-site investigation. The safety significance of the incident / allegation is evaluated to determine the type of response that Rhode Island will take. The small size of the Rhode Island program allows for the prompt dissemination of information regarding the event to all persennel in the program. Radiological incidents can be reported on a 24-hour basis through the Rhode Island State Police or the Rhode Island Emergency Management Agency.

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The review team found that the State's actions were within the performance criteria. Initial responses were prompt and well-coordinated, and the level of effort was commensurate with the health and safety significance. Inspectors were dispatched for on-site investigations when appropriate and the State took suitable corrective and enforcement action. For those incidents l

not requiring on-site investigations, copies of letters to licensees were in the incident and licensing files. The review team found the State's incident files thorough and well-documented.

Detailed information on each event such as telephone conversations and close out memoranda are maintained in the incident file. The review team did note that incidents were followed up at the next inspection.

The review team found that the State consistently reported incidents to the NRC Operations Center for those that require immediate or 24-hour reporting by the State licensee. The SRCS was familiar with the guidance contained in the " Handbook on Nuclear Event Reporting in the Agreement States." The review team queried the incident information reported to the NMED system for Rhode Island for the review period which identified eight reported materials events and one NARM event. The incidents reported to NMED corresponded to incidents maintained in the State's incident files. A review of the information reported to NMED indicates, with the exception of a misadministration reported in June 1998, that all events have been closed out.

During the review period, there were two allegations referred to the State by NRC. One of the allegations was independently received by the State and action was taken by the time the NRC referred the concern to the State for action. The review of the State's allegation file indicates that the State took prompt and appropriate action in response to the concerns raised. The program utilizes NRC written guidance, Manual Chapter 1301 and SA-300, for handling both incidents and allegations. The review team observed that although ORH performance in this area is very good, their internal procedures are not well coordinated with the Departmental policy and Rhode Island laws specific to handling incidents and allegations. The review team suggests that written procedures be revised for processing incidents and allegations to reflect specific Department policy or State laws specific to Rhode Island.

Based on the IMPEP evaluation criteria, the review team recommends that Rhode Island's performance with respect to the indicator, Response 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. Rhode island's agreement does not authorize regulation l

of uranium recovery activities.

4.1 Leaislation and Proaram Elements Reauired for Compatibility 4.1.1 Leaislation The team verified that a clear statutory authority for the State's radiation control agency exists.

The authority permits the agency to promulgate regulations, license, inspect and enforce. The statutory authority which designates the Rhode island Division of Occupational and Radiological i

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Hecith as the State radiation control agency with authority to regulate agreement materials and other sources of radiation is contained in Title 23, Chapter 1.3 of the General Laws of Rhode Island. Since the last review, Chapter 23 has been amended and the agency now has responsibility for tanning facilities under Chapter 68, Tanning Facility Safety Standards Act.

The State's " sunset" requirements do not apply to the ORH.

The Rhode Island Radiation Control Program is mandated by law as a unit of Rhode Island Department of Health and is one of four offices in the office of Environmental Health.

Additionally, access to appropriate levels of State management is maintained through the Chief of the Department of Health.

4.1.2 Proaram Elements Reauired for Compatibility The team verified that the State's present regulatory agenda includes those NRC regulations that are necessary to assure the regulation compatibility criteria are satisfied. ORH regulations are reviewed every five years to determine if the requirements are still appropriate and necessary. The ORH provides, under State law, opportunity for public comment on proposed regulation changes. Draft regulations are sent to NRC for review and comment and when necessary, changes suggested by NRC are incorporated before final adoption. ORH rules are implemented by Administrative Act and do not require legislative approval before they become effective.

The team evaluated Rhode Island's responses to the questionnaire and reviewed the regulations adopted by the State since the January 14,1994 review to determine the status of the Rhode Island regulations under the new Commission Pol!cy Statement on Adequacy and Compatibility. The team also verified that the compatibility table in the States response to the questionnaire was accurate. Under the State's regulatory agenda all regulations required for compatibility have been adopted or are in rulemaking. The following regulations were promulgated in June 1995 or determined to be not applicable to the Rhode Island program as noted:

e "O ulity Management Program and Misadministrations," 10 CFR Part 35 amedment (56 FR 153) that became effective January 28,1994. The State promulgated this revision in June 1995.

" Licenses and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 (58 FR 7715) that became effective July 1,1993. As noted in Section 2, the State does not have an irradiator licensee nor do they have an active application for an irradiator and under current compatibility policy an equivalent State regulation is not required.

' Decommissioning Recordkeeping and License Termination: Documentation Additions,"

10 CFR Parts 30,40,70, and 72 (58 FR 39628) that became effective October 25, 1993. The State promulgated this revision in June 1995.

" Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards,"

(5P FR 28220) that became effective July 1,1994. The State does not have regulatory adnority under the agreement.

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" Low Level Waste Shipment Manifest Information and Reporting,"(60 FR 15649, e

60 FR 25983) that was published March 27,1995 and became effective March 1,1998.

The State promulgated this revision in June 1995.

The current schedule has nine rules that will be completed by the fall of 1998. The ORH uses a strategy of " bundling" rules into a rulemaking package. Using this method the ORH can make all identified changes in a particular regulation at one time. When this current rulemaking l

package is completed the State will have all rules implemented for compatibility through January 2000. The nine rules presently being revised are as follows:

e "Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40 and 70 amendment (58 FR 68726; 59 FR 1618) that became effective January 18,1994.

" Timeliness in Decommissioning," 10 CFR Part 30,40 and 70 amendments e

(59 FR 28220) that became effective August 15,1994.

" Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for e

Medical Use," 10 CFR Parts 30,32, and 35 amendments (59 FR 61767,59 FR 65243, 60 FR 322) that became effective January 1,1995.

" Frequency of Medical Examination for Use of Respiratory Protection Equipment,"

e 10 CFR Part 20 amendment (60 FR 7900) that became effective March 13,1995.

" Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendment e

(60 FR 28323) that became effective June 30,1995.

" Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts e

19 and 20 amendments (60 FR 36038) that became effective August 14,1995.

" Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 e

amendments (60 FR 38235) that became effective November 24,1995.

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" Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20, and 35 amendment (60 FR 48623) that became effective October 20,1995.

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

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

The State plans on sending the above proposed draft regulations to the NRC for review and comment in early Fall. The team note that " Timeliness in Decommissioning,"" Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use," and

" Performance Requirements for Radiography Equipment," are overdue at the time of the review.

Rhode Island is awaiting the publication of the Suggestion State Regulations for Transportation before preparing the following regulation revision:

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" Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 e

amendment (60 FR 50248) that became effective April 1,1996.

The ORH has identified rules that will be required in the year 2000 and will begin working on them when the current rule making initiative is completed.

" Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air e

Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997.

" Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction e

Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective January 27,1997.

" Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Part e

20.35 amendment (62 FR 4120) that became effective May 29,1997.

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

" Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial e

Radiography Operations," 10 CFR Parts 30,34,71,150 amendments (62 FR 28947) that became effective June 27,1997.

e

" Radiological Criteria for License Termination," 10 CFR Parts 20,30,40,70 amendments (62 FR 39057) that became effective August 20,1997.

The review team suggests that the State evaluate the process of revising their regulations to ensure that the State meets the three-year time frame.

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 Rhode Island's performance with respect to this indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory.

4.2 Sealed Source and Device (SS&D) Evaluation Proaram 4.2.1 Technical Quality of the Product Evaluation Proaram During the review period, one SS&D certificate was issued by the State. The SS&D certificate is identified in Appendix F. The team notes that the certificate was originally issued for a device containing non-AEA material. Although, the registration was amended to include AEA material the manufacturer has not made a device containing AEA material.

1 Rhode Island Draft Report Page 14 Review of this file and interviews with the staff indicated that Rhode Island follows the l

recommended guidance from the NRC SS&D training workshop. The registration file contained all correspondence, photographs, engineering drawings, radiation profiles, and results of tests conducted by the applicant. In addition, the SS&D review checklist received at the NRC SS&D l

workshop was used to assure all relevant materials had been submitted and reviewed. The l

checklist was contained in the registration file. The team determined that the staff will use the l

guidance in NUREG-1556, V.3, issued September 1997 for any future reviews. All pertinent l

ANSI Standards and Regulatory Guides are available and are used when performing SS&D l

reviews.

4.2.2 Technical Staffina and Trainina The principal license reviewer conducts the SS&D reviewers and has been through the current NRC training. He has been involved in the SS&D reviews in Rhode Island for several years. He has a degree in biological science and is considered fully trained under Common Indicator 3.

He also has had training in conducting SS&D reviews by attendance at an SS&D workshop.

l The second reviewer is the SCRS. This reviewer provides the required concurrence review.

The second reviewer has a degree in physical sciences and has been reviewing SS&D registrations for 18 years. The team found that the two reviewers work together closely when conducting a review and discuss issues and concerns they have identified in an application.

The ORH also has indicated that they would draw upon resources outside of their office if necessary. Outside resources could include State engineers or the local University engineering department, the NRC SS&D Section or another Agreement State. ORH is committed to maintaining a high degree of quality in their SS&D reviews and would, if necessary, send their reviewers for additional training.

The team discussed with ORH the possibility of returning the SS&D evaluation program to the NRC considering the technical staffing and training requirements and the very small number of devices that have been reviewed by the State. The State firmly indicated that it wishes to keep the SS&D evaluation program and will do what is necessary to assure that the requisite expertise and experience is maintained to conduct SS&D reviews.

4.2.3 Evaluation of Defects and incidents Reaa-dina SS&Ds No incidents related to SS&Ds occurred during the review period, nor were there any defects reported.

Based on the IMPEP evaluation criteria, the review team recommends that Rhode island's performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.

4.3 Low-Level Radioactive Waste Disoosal Proaram l

In 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement" to allow a State to seek an amendment for the regulation of LLRW as a separate category. Those l

States with existing Agreements prior to 1981 were determined to have continued LLRW l

disposal authority without the need of an amendment. Although Rhode Island has LLRW

(

disposal authority, NRC has not required States to have a program for licensing a LLRW

Rhode Island Draft Report Page 15 disposal facility until such time as the State has been designated as a host State for a LLRW disposal facility. When an Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal facility, they are expected to put in place a regulatory program which will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in Rhode Island. Accordingly, the review team did not review this indicator.

5.0

SUMMARY

As noted in Sections 3 and 4 above, the review team found Rhode Island's performance with respect to each of the performance indicators to be satisfactory. Accordingly, the team recommends that the Management Review Board find the Rhode Island 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.

RECOMMENDATIONS:

1.

The review team recommends that the State upgrade their inspection tr&cking system to assure that all licensees are inspected in accordance with the frequency established by the program. (Section 3.1) 2.

The review team recommends that the State document a training and qualifications program equivalent to that contained in NRC's inspection Manual 1246," Formal Oualifications Programs in the Nuclear Materials Safety and Safeguards Program Area."

(Section 3.3)

SUGGESTIONS:

1.

The review team suggests that Rhode Island continue to make reasonable efforts to conduct inspections at temporary and reciprocity job sites. (Section 3.1) 2.

The team suggests that the State adhere to their policy of performing supervisory accompaniments of all materials inspectors on an annual basis. (Section 3.2) 3.

The review team suggests that the program cross train staff members to meet any future contingency. (Section 3.3) 4.

The review team suggests that the State improve the license tracking system to assure timely processing of actions. (Section 3.4) 5.

The review team suggests that written procedures be revised for processing incidents I

and allegations to reflect specific Department policy or State laws specific to Rhode island. (Section 3.5) 6.

The review team suggests that the State evaluate the process of revising their regulations to ensure that the State meets the three-year time frame. (Section 4.1.2) l

l LIST OF APPENDICES AND ATTACHMENTS 1

Appendix A IMPEP Review Team Members Appendix B Rhode Island Organization Chart Appendix C Inspection File Reviews Appendix D License File Reviews Appendix E Incident File Reviews Appendix F Sealed Source and Device Reviews Appendix G Rhode Island's Questionnaire Response

APPENDIX A l

l l

IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility James Myers, OSP Team Leader Status of Materials Program Technical Staffing and Training Legislation and Program Elements Required for Compatibility Sealed Source and Device Evaluation Program Steven Gavitt, New York Technical Quality of Licensing Actions State Department of Health Duncan White, RSAO, RI Status of Materials inspection Program Technical Quality of Inspections Response to incidents and Allegations 1

6 e

i APPENDIX B RHODE ISLAND DEPARTMENT OF HEALTH ORGANIZATIONAL CHART l

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State of Rhode Island - Organizational Chart People ofRhodeIsland I

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Rhode Island Department of Health Organizational Structure - Fiscal Year 1998 I

DIRECTOR OF ERALTE MEDICAL EXAMINER I

I I

I ExCeutive Director Medical Director Medical Director Associate Director Associate Director ENVIRONMENTAL REALTE DISEASE PREVENTION FAMILY REALTE EEALTE SERVICES SUBSTANCE ABUSE AND CONTROL REGUIATION FOOD PROTECTION COMMUNICABLE DISEASE MATERNAL & CHILD HEALTH FACILITIES REGULATION PLANNING AND EVALUATION DRINKING WATER QUALITY CHRONIC DISEASE PREV.

CHILDREN WITH SPECIAL HEALTH PROFESSIONALS PREVENTION PROGRAMS s HEALTH PROMOTION HEALTH CARE NEEDS REGULATION k

OCCUPATIONAL AND PRIMARY CARE WOMEN, INFANTS MANAGED CARE REGULATION TREATMENT PROGRAMS RADIOLOGICAL HEALTH AND CHILDREN (WIC)

ENVIRodMENTAL HEALTH T.A.S.C.

RISK ASSESSMENT HEALTH LABORATORIES January 15, 1998 e

s ENVIRoteSNTAI.

HEALTH datter S. Combs,Jr.,rh.t Judy Grant ADMINISTRATIVE RADIOLOGICAL STAFT Frances Banno Marie Stoecitel. MPH.CIH Chief Clerk FISCAL CLERK Chief Lori Tamburrino e

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RADON & ASBESTOS RADIATIOtt CONTROL HYGIENE Roq.r Marinelli Charles McMahon James Gamelin Sup. Rad.

Prn. Industrial control Spec.

g Hygienist INDUSTRIAL RAD. REALTH NYGIENIST SR. INDUSTRIAL SPECIALIST INDUSTRIAL MYGIENIST Cheryl Vincent NYGIENIST John ter reto Richard Scott Donna Sousa INDUSTRIAL NYGIENIST INDUSTRIAL SR. INDUSTRIAL HYGIENIST NYGIENIST Martin Tahakjian i

INDUSTRIAL Antonio Cabral Alfrad Cabral i

BYGIENIST g g STRI

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Edmond Arcand HYGIENIST INDUSTRIAL ORGANIZATIONAL CHART nTGIEN TEenICIAN

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OCCUPATIONAL & RADIOLOGICAL HEALTH yno,,,e,,,,3, JULY 30, 1998

APPENDIX C INSPECTION FILE REVIEWS i

NOTE: NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP i

TEAM l

File No.: 1 Licensee: Niton Corporation License No.: 3G-105-02 Location: North Kingston, RI Inspection Type: Initial, announced License Type: General Distribution Priority: 5 Inspection Date: 4/15/97 Inspector: JC and JF File No.: 2 Licensee: Syncor International License No.: 3B-114-01 Location: East Providence, RI Inspection Type: Routine, unannounced License Type: Nuclear Pharmacy Priority: 1 Inspection Date: 7/1/98 Inspector: JF File No.: 3 Licensee: Rhode Island Hospital License No.: 7A-051-02 Location: Providence, RI inspection Type: Routine, announced License Type: Gamma Knife Priority: 3 Inspection Date: 6/16/97 Inspector: WD File No.: 4 Licensee: Thielsch Engineering License No.: 3D-065-01 Location: Cranston, RI inspection T rpe: Routine, unannounced License Type: Industrial Radiography Priority: 1 Inspection Date: 1/9/96 Inspector: JF Comment:

a)

No field observations of licensed activities at temporary job sites.

File No.: 5 Licensee: Brown University License No.: 3K-036-01 Location: Providence, RI Inspection Type: Routine, unannounced License Type: Academic Broad Scope Priority: 2 Inspection Date: 2/7-9/95 Inspector: JF File No.: 6 Licensee: Briggs Associates License No.: 3D-083-02 Location: Cumberland, RI Inspection Type: Routine, unannounced Ucense Type: Industrial Radiography Priority: 1 Inspection Date: 12/23/97 Inspector: JF Comment:

a)

Licensee personnel never observed performing licensed activities at temporary job sites.

l

4 Rhode Island Draft Report Page C.2 Inspection File Reviews i

File No.: 7 Licensee: Rhode Island Department of Transportation License No.: 3L-015-01 Location: Providence, RI inspection Type: Routine, unannounced License Type: Portable Gauge Priority: 5 Inspection Date: 6/9 - 7/5/94 Inspector: JF j

File No.: 8 Licensee: Paul B. Aldinger and Associates License No.: 3L-107-01 Location: East Providence, RI Inspection Type: Initial, unannounced License Type: Portable Gauge Priority: 5 Inspection Date: 2/18/97 Inspector: JF File No.: 9 Licensee: John D. Lowney, D.O.

License No.: 7B-120-01 Location: Warwick, RI Inspection Type: Initial, announced License Type: Medical-Private Practice Priority: 3 Inspection Date: 4/9/97 Inspector: JF File No.: 10 Licensee: ' Kent County Memorial Hospital License No.: 78-020-01 Location: Warwick, RI Inspection Type: Routine, unannounced License Type: Medical-Hospital Priority: 3 Inspection Date: 7/18/95 Inspector: JF File No.: 11 Licensee: CapitalImaging Group License No.: 7B-082-01 Location: Providence, RI Inspection Type: Routine, unannounced License Type: Medical-Private Practice Priority: 3 Inspection Date: 9/4/96 Inspector: JF File No.: 12 Licensee: Roger Williams Medical Center License No.: 7D-076-01 Location: Providence, RI Inspection Type: Routine, unannounced License Type: Medical Broad Scope Priority: 1 Inspection Date: 11/14 -18/96 Inspector: JF F,le No.: 13 Licensee: RUST /Cramer & Lindell License No.: generallicense Location: East Providence, RI Inspection Type: reciprocity License Type: Industrial Radiography Priority: NA inspection Date: 6/11/96 Inspector: JF INSPECTOR ACCOMPANIMENTS In addition, a review team member made the following inspection accompaniment as part of the on-site IMPEP review:

Accompaniment No.: 1 Licensee: Rhode Island Hospital License No.: 7D-051-01 Location: Providence, RI Inspection Type: Routine, unannounced License Type: Medical Broad Scope Priority: 1 Inspection Date: 6/22-23/98 Inspector: JF

l APPENDIX D LICENSE FILE REVIEWS NOTE: NOTE: ALL LICENSES LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.

File No.: 1 Licensee: Syncor License No.: 3B-114-01 Location: Providence, RI Amendment No.: 01 License Type: Pharmacy Type of Action: New, Amendment Date issued: 3/30/95;11/6/97 License Reviewer: AC File No.: 2 Licensee: RIH Cardiology Foundation License No.: 78-121-01 Location: Providence, RI Amendment No.: 0 License Type: Medical-Specific Type of Action: New Date issued: 3/3/98 License Reviewer: AC File No.: 3 Licensee: Town Asphalt License No.: 3L-075-01 Location: Providence, RI License Type: Portable Gauge Type of Action: Renewal Date issued: 6/30/98 (expiration date)

License Reviewer: CM Comment:

a)

License expired without any action taken. No documentation in the license file to indicate any response was received and the license expired 6/30/98.

File No.: 4 Licensee: John D. Lowney, D.O.

License No.: 7B-120-01 Location: Warwick, RI Amendment No.: New License Type: Medical-Specific Type of Action: New Date issued: 8/96 License Reviewer: AC File No.: 5 Licensee: Univ. of Rhode Island License No.: 3K-040-01 Location: Kingston, RI Amendment No.: 24 License Type: Academic - Broad Type of Action: Renewal Date issued: 5/2/96 License Reviewer: CM File No.: 6 Licenses: Narraganesett Improvement Co.

Licensa No. 3L-069-01 Location: Providence, RI Amendment No.: 3 License Type: Portable Gauge Type of Action: Termination Date issued: 3/7/97 License Reviewer: CM l

Comments:

l a)

The license was terminated prior to the gauge being transferred to another licensee, b)

The licensee submitted a termination form indicating that the gauge was transferred to another licensee, however additional correspondence in the file indicated that the gauge was not transferred until a few months later (after the license was terminated).

l

d i

Rhode Island Draft Report Page D.2 License File Reviews File No.: 7 Licensee: Rhode Island Hospital License No.: 7D-051-01 Location: Providence, RI Amendment No.:6 License Type: Medical-Broad Type of Action: Renewal Date issued: 4/95 License Reviewer: CM File No.: 8 Licensee: CardiCorporation License No.: 3L-068-01 Location: Warwick, RI Amendment No.: 3 License Type: Portable Gauge Type of Action: Termination Date issued: 7/7/97 License Reviewer: CM File No.: 9

!t censee: Roger Williams Medical Center License No.: 7D-026-01 Location: Providence, RI Amendment No.: 8 License Type: Medical - Broad Type of Action: Renewal Date issued: 3/16/98 License Reviewer: CM File No.: 10 Licensee: Rhode Island Hospital License No.: 7A-051-02 Location: Providence, RI License Type: Medical-Specific (Gamma Knife)

Type of Action: Renewal Date Issued: 10/23/97 License Reviewer: CM L

i i

APPENDIX E INCIDENT FILE REVIEWS NOTE: ALL INCIDENTS CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM File No.: 1 Licensee: Rhode Island Hospital incident Log No.: 98-001 Site of incident: Providence, RI Licensee No.: 7D-051-01 Date of incident: 12/31/97 Type of Incident: Misadministration investigation Date: 6/22 - 23/98 Type of Investigation: Phone and Next inspection Summary: Patient prescribed 25 mci of l-131 and pharmacy provided two capsules of 6 and 19 mci for treatment. Hospital personnel administered only the 6 mci capsule to the patient.

The second capsule was discovered on 1/15/98. Reported to the State on 1/20/08. Preliminary findings were discussed during telephone conversation. Licensee filed report on 2/15/98.

File No.: 2 Licensee: RI Atomic Energy Commission incident Log No.: 94-002 Site of incident: Nuclear Science Center, Providence NRC Licensee No.: R 95 Date of incident: 5/18/94 Type of incident: Loss of Control Investigation Date: 5/18 through 6/13/94 Type of Investigation: Telephone Summary: Radioactive waste improperly transferred in ordinary trash sets off radiation alarms at Massachusetts waste facility. Waste facility hires radiological contractor to evaluate waste.

Waste tentatively traced to licensee and transferred to them on 5/24/94. Licensee confirms waste material as originating from their facility. NRC performs inspection in 12/94 to follow up on the incident.

1 File No.: 3 Licensee: MOS Inspection incident Log No.: 94-004 Site of incident: Providence, RI Licensee No.: generallicense Date of incident: 10/3/94 Type of incident:' Equipment failure Investigation Date: 10/4/94 Type of investigation: telephone and site Summary: During radiographic operations, a 58 curie Ir-192 source became disconnected.

Licensee impkmented emergency procedure and isolated area until consultant (Amersham) successfully retumed source to a safe, shielded position. Source assembly sent to manufacture for evaluation. Licensee was performing licensed activities in RI without filing for reciprocity. State pursued escalated enforcement with licensee.

-)

File No.: 4

' Licensee: Mallinkrodt Medical incident Log No.: 94-005 Site of Incident: East Providence, RI NRC Licensee No.: 24-17450-03 Date of incident: 11/6/94 Type of incident: Transportation investigation Date: 11/6 and 7/94 Type of Investigation: Site Summary: Five packages containing Tc-99m and TI-201 fell off a delivery truck onto highway where some were hit by other vehicles and broken open. Roadway closed until RI Office of Emergency Management coordinated emergency responders to clean road and reduce radiation levels. Department of Health personnel surveyed the road the next morning to confirm i

radiation levels were reduced and allowed road to be opened.

1 Rhode Island Draft Report Page E.2 incident File Reviews File No.: 5 Licensee: Ninon Corporation Incident Log No.: 96-001 Site of Incident: North Kingston, Rl Licensee No.: 3A-105-01 Date of Incident: 1/17/96 Type of incident: Lost RAM Investigation Date: 1/22/96 Type of Investigation: Phone Summary: Licensee disposed of a 10 mci Fe-55 source in its shipping container in the ordinary trash. Licensee submitted report to State detailing action taken to locate source and corrective action taken. State inspector to follow-up on incident at next routine inspection.

File No.: 6 Licensee: Stericycle incident Log No.: 94-003 Site of incident: Woonsocket, RI Licensee No.: non-license Date of incident: 6/8/94 Type of incident: Release of RAM Investigation Date: 6/9/94 Type of Investigation: Site and phone Summary: Medical waste sets off radiation alarms at Massachusetts facility and returned to RI facility which collected it. State personnel conduct site visit, recommends facility hire a radiological consultant. Consultant identifies waste as 1-131 and TI-201 and recommends that waste be held for decay. Waste is held for decay, resurveyed by consultant and disposed as non-radiological medical waste.

i

i APPENDIX F SEALED SOURCE AND DEVICE REVIEWS NOTE: ALL SEALED SOURCE AND DEVICE CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM File No.: 1 Registry No.: Rl-164-D-101-B SS&D Type: X-ray Fluorescence Analyzer Manufacturer: NITON Corporation Model No.: NITON XL Model 309 NITON Series 790 Date issued: 9/18/96 NITON Alloy Analyzer File No.: 2 Registry No.: RI-164 D-101-B SS&D Type: X-ray Fluorescence Analyzer Manufacturer: NITON Corporation Model No.: NITON XL Model 309 Date issued: 1/30/95 l

l l

= _ -..- -. -...-.

APPENDIX G INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Rhode Island Program Reporting Period: January 14,1994 to July 30,1998 i

I l

l l

I Approved by OMB' No. 3150-0183 Expires 5/31/2001 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM OUESTIONNAIRE Name of State / Regional Program: Rhode Island Reporting Period: January 1994 to June 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 Roger Williams Hosp.

1 96-4 6

2.

Do you currently 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.

Roger Williams Hospital will be scheduled for an inspection on or before August 14, 1998.

2 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 l

Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC l

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 I

1 l

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.

Not applicable.

4.

Please complete the following table for licensees granted reciprocity during the reporting l

period.

Numberof Licensees Granted Reciprocity Numberof Licensees Priority Permits Each Year Inspected Each Year Service Licensees performing No SOURCE INSTALLATIONS oR YR teletherapy and irradiator source CHANGES, 1994-1998.

YR installations or changes YR YR YR YR l

YR 1994 4

1 1

1995 5

0 1996 6

1 1997 5

1 1998 3

1 1994 0

0 2

1995 0

0 1996 1

0 1997 0

0 1998 1

0 1994 3

0 3

1995 3

0 1996 0

0 1997 1

0 1998 1

0 4

All Other 1994 6

0 1995 4

1 1996 3

0 1997 1

0 1998 1

0 4

5.

Other than reciprocity licensees, how many field inspections of radiographers were performed?

One inspection of a RI licensed radiographer included a field site visit: Thielsch Engineering, Inc., inspection No. 94-01. (The majority of offsite jobs performed by RI licensed radiography firms are located out of state.)

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.

ll.

Technical Quality of insoections i

7.

What, if any, changes were made to your written inspection procedures during the reporting period?

No changes since the previous review.

j 8.

Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:

Inspector Suoervisor License Cat.

Date J. Ferruolo M. Stoeckel 02500 7/1/98 9.

Describe internal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.

Effective July 1998, the Director will accompany t5e inspector (s) on at least one inspection per 12-month period.

10.

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

No change since the previous review. All calibrations are current.

3

Ill.

Technical Staffina 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 *'.

No change since the previous review.

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.

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.

14.

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

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.

12 -15.

Not applicable.

i 4

l

\\

e IV.

Technical Quality of Licensina 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.

A nuclear pharmacy license was issued to Syncor International Corporation in March 1995. Five broadscope licenses were renewed: RI Hospital,7D-051-01/06,4/95; Brown University,3K-036-01/19,12/95; URI,3K-040-01/24,5/96; RI Nuclear Science Center,3K-063-01/11,8/97; Roger Williams Hospital,7D-026-01/08, 3/98.

17.

Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

Not applicable.

18.

What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

The state uses NRC Regulatory Guides wherever feasible, as guidance for both applicant and reviewer. We continue to use Regulatory Guide 10.8/Rev 2 with minor supplemental instructions for medical licensing, and have begun utilizing NRC DG-0005 for broadscope licensing.

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.

Responses to incidents and Alleaations 20.

Please provide a list of the reportable incidents (i.e., medical misadministration, overexposures, 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:

Licensee Name License #

Date of incident / Report Tvoe of incident All renortable incidents were reported to NRC via NMED reports.

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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 NRC? For Regions, was an appropriate and timely PN generated?

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.

21 & 22.

A leaking source incident was reported to NRC in a timely manner via NMED report number RI-95-01. California was not formally notified but may have been contacted informally. The licensee returned the source to the source manufacturer (North l

American Scientific), who also may have informed the state of California.

l 23.

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

Not applicable.

24.

Identify any changes to your procedures for handling allegations that occurred during the period of this review.

No changes since the last review, a.

For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.

Not applicable.

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VI.

General l

25. Please prepare a summary of the status of the State's or Region's actions taken in l

response to the comments and recommendations following the last review.

25.

Status of open items:

2. Status of inspection program: Inspections are scheduled to be completed within calendar quarter time frames. For example, a priority 1 'icense, which was last inspected during the first quarter of 1998 and is on normal cycle inspection frequency, is next due in the first quarter of 1999. Since the third quarter of 1994, the RCP has generated at least a quarterly schedule of inspections which are due or overdue. A review of these schedules through the first quarter of 1998 indicates that the average number of more-than-25%-overdue core license inspections was 2.2. There are approximately 30 core licenses.

3. Technical quality of licensing actions: For non " institutional" medical use applications, we have continued to ascertain that the signer is a principal of the applicant entity or an individual designated to represent the applicant.

4. Inspection Reports: Information contained in inspection reports which has been obtained through interviews with radiation workers or ancillaries is identified as such.

5. Confirmatory Measures: Wipe samples are routinely obtained during inspections wherever area surveys or other information indicates a potential for contamination. All samples are analyzed by the RI Nuclear Science Center.

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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.

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A program's strengths and weaknesses often develop from the same source, as follows:

a) Small Staff Size: Five professional staff make up the program for a total of 1.2 FTE's, with no one person contributing more than 50% of his time. Because of the small numbers of staff and the large scope of work, the program has to operate extremely efficiently with each staff member becoming a specialist in his individual area of activity. Although each professional's level of expertise is a strength, the program has limited flexibility in rotation of job duties.

b) Time Management: Staff size mandates that each individual focus on the critical activities of licensing, inspecting or updating regulations. While staying current with key tasks is a strength, the weakness results from the shortage of time needed to stand back and assess the program's needs and those of the community. For example, there is not enough time for program members to perform ongoing review and development of standards, guides and procedures.

c) Multiple Responsibilities: Each of the professional staff work on multiple programs. For example, Al Cabral performs inspections for the x-ray program and does licensing for the radioactive materials program; Jack Ferruolo performs inspections at facilities using radioactive materials and is our certified MOSA inspector, it is a strength for the radiation control agency to have individuals with several areas of expertise, but it is a challenge for them to meet all the deadlines required by our various mandates, resulting in occasional delays of the "more-than-25Woverdue" magnitude, d) Organization: The Director of the radiation control agency supervises multiple programs, all located in the same office. This results in both the opportunity for shared resources (i.e., administrative support) and the challenge of having a Director who must divide her time among diverse regulatory and consultative programs.

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a B. NON-COMMON PERFORMANCE INDICATORS l

1.

Leaislation and Proaram Elements Reauired for Comoatibility

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

Only the following change has occurred: The RCP has been assigned responsibility for implementation of Title 23, Chapter 68 of the General Laws: Tanning Facility Safety Standards Act.

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

No (No change since the last review).

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 discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.

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.

The state's procedures for amending regulations.are as previously described. Amendments are adopted in batches in order to minimize the time demands placed on RCP staff, the Radiation Advisory Commission, and others. The RCP considers the three year requirement in scheduling the process; however, we also consider including amendments which NRC has I

more recently adopted that involve compatibility requirements. Additivnally, any amendments to the state's x-ray regulations which are pending are proposed for adoption at the this time.

Depending on the number and complexity of the proposed changes, the overall process usually requires at least several months and may take more than a year to complete.

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Sealed Source and Device Proaram

31. Prepare a table listing new and revised SS&D 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 RI-164-D-101-S Niton Corp XRF Analyzer 2/9/94 (Amended: 5/31/94,11/15/94, 9/18/96 (Rl-164-D-101 B), and 4/8/97)

RI-152-D-101-G Advanz Measurement Gauge Rev. 2/27/95 1

& Control Systems RI-8064-D-801-G Term. 8/16/96 32.

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

The RCP uses NRC Regulatory Guides 10.10,10.11, and standards referenced therein to evaluate registry applications.

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.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20 23 The information provided in section A applies to SS&D evaluations. A. Cabral has performed the SS&D evaluation work listed above. Currently there are no manufacturers that utilize AEA materials.

Revision of the Advanz Measurement & Control Systems evaluation listed above was limited to minor changes to the document prior to transfer of ownership to an Ohio (NRC) licensee.

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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.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 IV.

Uranium Mill Proaram i

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.I.6 Technical Quality of Inspections - A.ll.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 l

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- TABLE FOR QUESTION 29.

OR DATE DATE

'10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION Any amendment due prior to 1991. Identify each regulation (refer to the Chronology of Amendments)

Decommissuming; 7/27/91 8/91 Parts 30,40,70 Emergency Planning; 4/7/93 12/93 Parts 30,40,70 Standards for Protechon Against Raoiation; 1/1/94 12/93 Part 20 Safety Requirements for Radiographic Equipment;1/10/94 12/93 Part 34 Neinstion of incidents; 10/15/94 12/93 Parts 20,30,31,34,39,40,70 Quality Management Program and 1/27/95 6/95 Misadministrations; Part 35 Licensing and Radiation Safety Requirements for 7/1/96 No plans to adopt (no irradiatiors)

Irradiators; Part 36 Definition of Land Disposal 7/22/96 No plans to adopt (no site) and Waste Site QA Program; Part 61 Decommissioning Recordkeeping: Documentation 10/25/96 6/95 Additions; Parts 30,40,70 Self-Guarantee as an Additional Financial 1/28/97 Draft givvcsed regulation Fall /98 Mechanism; Parts 30,40,70 Uranium Mill Tailings: Conforming to EPA 7/1/97 No uranium authonty Standards; Part 40 12

• e Timehness in Decommescrung 8/15/97 Draft proposed reguishon Fall /98 Parts 30,40,70 Preparation, Transfer for Commercial Distribuhon,1/1/98 Draft proposed regulation Fs11/98 and Use of Byproduct Matenal for Medical Use; Parts 30,32,35 Frequency of Medcal Examinahons for Use of 3/13/98 Draft proposed regulation Fall,98 Respiratory Protechon Equement Low-Level Waste Shipment Manifest 3/1/98 6/95 Information and Reporting Performance Requirements for Red;0yophy 6/30/98 Per draft proposed rewrite of Part 34 Fall /98 Equipment Radiation Protection Requerements: Amended 8/14/98 Draft proposed regulation Fall /98 Definitions and Criteria Clarification of Decommissioning Funding 11/24/98 Draft proposed regulation Fall /98 Requirements 10 CFR Part 71: Compatibility with tile Intemationa8/1/99 Pending issuance of SSRCR Part T

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Atomic Energy Agency Medcal Admmistration of Radiation and Radioactn40/20/98 Draft proposed regulation Fall /98 Materials.

Termination or Transfer of Ucensed Activities:

6/16/99 Draft pivinn,wd regulation Fall /98 Recordkeeping Requirements Resolution of Dual Regulation of Airbome 1/9/00 Effluents of Radioactive Materials; Clean Air Act Fissile Material Shipments and Exemptions 2/10/00 Recognition of Agreement State Licenses in Areas 2/27/00 Under Exclusive Federal Jurisdiction Within an Agreement State Criteria for the Release of Indnnduals 5/29/00 Administered Radioactive Material 13

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e Uces W Industrial Radography and 6/27/00 Draft proposed reguishon FaW98 I

i Radehon Safety Requwements for Induetnel Radography Opershons: Final Rule Radologk:al Criteria for ucense Temunahon BrM00 1

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MATERIALS REQUESTED TO BE AVAILABLE FOR THE ONSITE PORTION OF AN IMPEP REVIEW ORGANIZATION CHARTS l

Clean, sized 8% X 11" including names and positions One showing positions from Governor down to Radiation Control Program Director (RCPD) o o One showing positions of current radiation control program with RCPD as Head a Equivalent charts for LLRW and mills programs, if applicable LICENSE LISTS O Printouts of current licenses, showing total, as follows.

j Name License #

Location License Type Priority Last inspection Due Date i

Sort alphabetically Also, sort by due date and by priority 7 vssible)

THE FOLLOWING LISTS l

a List of open license cases, with date of original request, and dates of follow up actions o List of licenses terminated during review period, o Copy of current log or other document used to track licensing actions o Copy of current log or other document used to track inspections j

o List of Inspection frequency by license type i

a Listing or log of all incidents and allegations occurring during the review period. Show whether incident is open or closed and whether it was reported to the NRC THE FOLLOWING DOCUMENTS o Ali State regulations a

Records of results of supervisory a Statutes affecting the regulatory authority of accompanimems of inspectors the state program o

Emergency plan and communications a Standard license conditions list a Technical procedures for licensing, model o

Procedures for investigating allegations licenses, review guides o

Enforcement procedures, including a SS&D review procedures procedures for escalated enforcement, o instrument calibration records severity levels, civil penalties (as o inspection procedures and guides applicable) o inspection report forms a

Copies of job descriptions 15