ML20155G661

Final Rept, Impep Review of Rhode Island Agreement State Program,980727-30

ML20155G661
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Issue date:	10/29/1998
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4 INi_ GRATED MATER!ALS PERFORMAt .1/ALUATION PROGRAM f

REVIEW OF RHODE ISLAND AGREEMENT STATE PROGRAM July 27 - 30,1998 J

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z FINAL REPORT l l

1 U.S. Nuclear Regulatory Commission 4

9811090139 PDR STPRO Es f9 f PDR ..

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Rhode Island Final Report Page 1

1.0 INTRODUCTION

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

j 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 l

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 draft of this report was issued to Rhode Island for factual comment on September 4,1998.

The State responded in a letter dated September 29,1998 (Attachment 1). The Rhode Island's factual comments were considered by the team and accommodated in the report. The Management Review Board (MRB) met on October 19,1998 to consider the proposed final report. The MRB found the Rhode Island radiation control program was adequate to protect public health and safety and compatible with NRC's program. '

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 l 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  ;

Supentising Radiation Control Specialist (SRCS) reports to the ORH Chief. An organization <

chart for the ORH is included as Appendix B.

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1 At the time of the review, the Rhode Island program regulated 77 specific licenses, including l 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.

l 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 bahg further developed. A copy of the final response is included in Appendix G to the draft repc.t 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 management 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.

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Rhode Island Final Report Page 2 Section 2 below discusses the State's actions in rnponse to recommendations made following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common indicators, and Section 5 summarizes the review team's findings, recommendations and suggestions. Recommendations 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.

Z 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 radiction 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.

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

• "Ucenses 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 l October 25,1996.

i 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 J under current compatibility policy an equivalent State regulation is not required.

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

4 (2)- We recommend that the ORH management closeiy monitor the compliance program's statistical reports in order to ensure the timely inspection of licensees.

..o Rhode Island Final Report Page 3 Current Status: Considerable improvement in the timeliness of inspections was noted by the team. ORH is using a computer data base 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.

l -(3) It is recommended that the State ensure that each application for a private practice 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.

Current Status: A review of the licensing actions indicates that the State has made changes in their program to ensure that each license application is signeo by an individual with 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 racommended 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 i 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 inspect;ons.

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l Rhode Island Final Report Page 4 Current Status: The State's policy is to perform inspections at the same inspection l

' 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 l

' the last review the State has improved its tracking procedures for following up on serious violations. This recommendation is closed. 1 i

3.0 COMMON PERFORMANCE INDICATORS 1

IMPEP identifies five common performance indicators to be used in reviewing both NRC 1

! Regional and Agreement State programs. These indicators are: (1) Status of Materials inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; i (4) Technical Quality of Licensing Actions; and (5) Response to incidents and Allegations. I

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l' 3.1 Status of Materials insoection Proaram j

{ The team focused on four factors in reviewing this indicator: inspection frequency; overdue l'

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 l j relative to this indicator, data gathered independently from the State's licensing and inspection i i data tracking system, the examination of completed inspection casework, and interviews with l the SRCS, and the inspection staff. I a

i The team's review of the State's inspection priorities found that the inspection frequencies for various types of Rhode isbmi licenses are based on NRC's inspection Manual Chapter (IMC) 2800 with inspection interva 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 i 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. During' discussions with the MRB, the review team noted that the facility is located at a broad scope licensee, which the State inspects more frequently for both radioactive materials and x ray equipment. In response to the NRC's proposed i revision to program code descriptions and inspection priorities in 1997, Rhode Island responded l' 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.

l 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 l 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 indicate that extension for I good licensee performance is assigned consistent with State and NRC policy. The State uses l a reduced inspection interval as a tool to encourage improved licensue performance. The team noted several instances where the State reduced inspection interval based on poor licensee performance. The most notable was that associated with a major medical institution. The review team noted that extending inspection intervals has provided some workload relief and allows its primary materials inspector to pursue naturally occurring and accelerator produced l radioactive materials (NARM) programs that the State is also mandated to enforce. ,

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Rhode Island Final Report Page 5 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 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 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.

1 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 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 ter.m 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.

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1 Rhode Island Final Report Page 6 3.2 Technical Quality of Insoections The review team examined a selected sample of inspection reports, enforcement documentation, and inspection field notes and interviewed Inspectors for 13 materials j inspections conducted during the review period. The casework included both State's materials j 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.

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 inspection 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 findings. Rhode Island uses field notes for different types of licenses including industrial  !

radiography, medical, fixed and portable gauges and industrial and academic.  !

4 Inspection reports were reviewed to determine if the reports adequately documented the scope I of the licensed program, licensee organization, personnel protection, posting and labeling, control of materials, equipment, use of materials, transfer, and disposal. The reports were also checked to determine if the reports adequately documented operations observed, interviews of workers, independent measurements, status of previous noncompliance items, substantiation of allitems of noncompliance, and the substance of discussion during the exit interviews with 1 management Routine enforcement and acknowledgment letters are drafted by the inspectors.

i All inspection reports and correspondence are reviewed by the SRCS prior to being issued to e

the licensee.

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 i technical performance of the inspector was at a high level. The inspection was adequate to

assess the licensee's radiological and safety performance.

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Rhode Island Final Report Page 7 I 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 I j ..

period. The team suggests that the State adhere to their policy of performing supervisory i accompaniments of all materials inspectors on an annual basis.  ;

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 ,

laland'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 I radiation laboratory at University of Rhode Island's Nuclear Science Center for the analytical l evaluation of samples routinely taken during inspections (i.e., wipes and environmental samples) or during incidents and emergencies, i 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 Staffino and Trainina items considered for evaluation of this indicator included: the radioactive materials program l staffing level, technical qualifications of the staff, training and staff turnover. To evaluate these i

items, the review team examined the State's questionnaire responses relative to this indicator, 4

interviewed program management and staff, and considered any possible workload backlogs.

4 Program staffing remained the same, as there were no new hires or staff turnover since the last review. There are no vacancies with respect to the radioactive materials program, however, ORH management indicated that they are attempting to create two (2) additional positions.

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, Radiological 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 Progrem provides daily management oversight and support in the licensing program. The Radiological Health Specialist is the principal materials inspector and the Senior Industrial Hygienist is the principallicense 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 supports ORH by drafting a id finalizing j regulations. He has conducted inspections and licenses reviews for the ORH wh en necessary. l The review team suggests that the program continue to cross train staff memberc !n various job functions 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.

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. l Rhode Island Final Report Page 8 During the MRB discussion, the ORH Chief noted that the RCP was funded through general appropriation although RCP collected fees. The ORH Chief noted that the State was challenged to find funding for travel and training. '

Alllicense reviewers and inspectors 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 l 4

meetings for its staff to discuss emerging and outstanding issues. However, there is no written j training program for the licensing and inspection staff. The review team recommends that the l

State document a training and qualifications program equivalent to that contained in the  ;

"NRC/OAS Training Working Group Recommandations for Agreement State Training )

Programs."

Based on the IMPEP evaluation criteria, the review team recommends that Rhode Island's performance with respect to the indicator, Technical Staffing and Training, be found satisfactory, l 3.4 Technical Quality of Licensina Actions The review team examined completed licensing casework and interviewed the reviewers for ten ,

specific licenses. Licensing actions were evaluated for completeness, consistency, proper I 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 Scense,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 licensing actions that had been completed in the review period. The cross section sampling included four of the State's major licenses as identified by the State questionnaire, and included the following types:

academic broad scope; medical broad scope; nuclear pharmacy; gauge; and medical specific.

Licensing actions during the review period included 11 new licenses,49 renewals, and 120 amendments (including 11 terminations), for a total of 180 licensing actions. In discussions with management, it was noted that there were no major d3 commissioning 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. Types 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 l applications and issue licenses. The scope of the license review covered the essential elements expected in a comprehensive radiation protection program.

l Rhode Island Final Report Page 9 Alllicensing actions receive supervisory review, and were signed by management. Deficiencies are addressed by detailed, well-written letters utilizing appropriate regulatory language.

i 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.

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 I

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 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 l

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, i

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 1

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 1

most cases staff know (from memory) the status of each licensing action, there should be a 4

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 improve the license tracking system to assure timely processing of actions.

Based on the IMPEP evaluation criteria, the review team recommends that Rhode Island's j 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 !n the Rhode Island files, and reviewed the casework and supporting documentation for six material incidents. 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.

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Rhode Island Final Report Page 10 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 j

Rhode Island will take. The small size of the Rhode Island program allows for the prompt dissemination of information regarding the event to all personnel in the program. Radiological incidents can be reported on a 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> basis through the Rhode Island State Police or the Rhode Island Emergency Management Agency.

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 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 L 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 1 porting in the Agreement States." The review team queried the incident information reporteu 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 1

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 rolsed. The program utilizes NRC written guidance, IMC 1301,2800 (which references Management Directive 8.8) and SA 300, for handling both incidents and allegations. The review team 4

observed that although ORH performance in this area is very good, their internal procedures l 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 incider,ts 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.

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Rhode Island Final Report Page 11 4- 4.0 - NON-COMMON PERFORMANCE INDICATORS i IMPEP identities four non-common performance indicators to be used in reviewing Agreement

! State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed  ;

i Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; i and (4) Uranium Recovery Program. Rhode Island's agreement does not authorize regulation

of uranium recovery activities, i

! 4.1 Leaislation and Proaram Elements Reauired for Comoatibility

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j' 4.1.1 Legislation 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 L Health as the State radiation control agency with authorhy 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 Division of Environmental Health Services. Additionally, access to appropriate levels of State management is maintained through tha Director of the Department of Health.

4.1.2 Proaram Elements Reauired for Comoatibility 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 as necessary 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 I regulations adopted by the State since the January 14,1994 review to determine the status of the Rhode Island regulations under the new Commission Policy 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:

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e- " Quality Management Program and Misadministrations," 10 CFR Part 35 ,

amendment (56 FR 153) that became effective January 28,1994. The State '

promulgated this revision in June 1995.

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Rhode Island Final Report Page 12 4

e, " 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.

e " Decommissioning Recordkeeping and License Termination: Documentation Additions,"

1 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, o " Uranium Mill Tallings Regulations: Conforming NRC Requirements to EPA Standards,"

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

e " Low-Level Waste Shipment Manifest Information and Reporting," (60 FR 15649, 60 FR 25983) that was published March 27,1995 and became effective March 1,1998.

The State promulgated this revision in June 1995, i

The current schedule has nine rules that will be completed in the fall of 1998. The ORH uses a strategy of " bundling" rules into a rulemaking package. Using this method the ORH can make allidentified changes in a particular regulation at one time. When this current rulemaking package is completed the State will have all rules implemented for compatibility through January 2000. The nine rules presently being revised are as follows:

o "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.

e " Timeliness in Decommissioning," 10 CFR Part 30,40 and 70 amendments (59 FR 28220) that became effective August 15,1994.

4

e " Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for 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, o "Frequencyof Medical Exanination for Use of Respiratory Protection Equipment,"

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

• " Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendment (60 FR 28323) that became effective June 30,1995.

e " Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts i 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 amendments (60 FR 38235) that became effective November 24,1995.

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

s

, , ,-.-.- -. . . --,..-,----.... . ---n .,n.-n.. -- - a

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l Rhode Island Final Report Page 13 l

e " Termination or Transfer of Licensed Activities: Record Ke6 ping Requirements,"

l 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.

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

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

l l e " Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air i 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 Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became l effective January 27,1997.

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

1

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

l e " Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial Radiography Operations," 10 CFR Parts 30,34,71,150 amendments (62 FR 28947) that became effective June 27,1997.

i e " Radiological Criteria for License Termination," 10 CFR Parts 20,30,40,70 l 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.

l

. . . . . . . - . . - - ~, - - _ - . - - - - - - . - . - - . -

.s Rhode Island Final Report Page 14 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 i-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.

Review of this file and interviews with the staff indicated that Rhode Island follows the 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 workshop was used to assure all relevant materials had been submitted and reviewed. The E checklist was contained in the registration file. The team determined that the staff will use the guidance in NUREG 1556, V.3, issued September 1997 for any future reviews. All pertinent ANSI Standards and Regulatory Guides are available and a're used when performing SS&D reviews.

4.2.2 Technical Staffina and Trainina . .

The principal license reviewer conducts the SS&D reviews 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 the common performance indicator, Technical Staffing and Training. He also has had training in conducting SS&D reviews by attendance at an SS&D workshop. The second reviewer is the SRCS. 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 revi. ewers 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.

i The team discussed with ORH the possibility of retuming 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 whatever is necessary to assure that the requisite expertise and experience is maintained to conduct SS&D reviews.

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

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Rhode Island Final Report .Page 15 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.

6 4.3 Low-Level Radioactive Waste Disposal Proaram 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 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 d

disposal authority, NRC has not required States to have a program for licensing a LLRW 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 j recommended and the MRB concurred in finding the Rhode Island program to be adequate to l

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:

l i

1. 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 l the program. (Section 3.1)

, 2. The review team recommends that the State document a training and qualifications

program equivalent to that contained in the "NRC/OAS Training Working Group j Recommendations for Agreement State Training Programs." (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) d i 2. The team suggests that the State adhere to their policy of performing supervisory j accompaniments of all materials inspectors on an annual basis. (Section 3.2)

^

3. The review team suggests that the program continue to cross train staff members in various job functions to meet any future contingency. (Section 3.3) l

. - . . .. .. .. - . _ . . - . ~ . . .

e Rhode Island Final Report Page :6

.4. The review team suggests that the State improve the license tracking system to assure timely processing of a :tions. (Section 3.4)

5. 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. (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)

-4 LIST OF APPENDICES AND ATTACHMENTS 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 Attachment 1 Rhode Island's Comments on the Draft IMPEP Report dated September 29,1998, i

l

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility James Myers, OSP Team Leader l Status of Materials inspection Program  !

Technical Staffing and Training Legislation and Program Elements Required for Compatibility l Sealed Source and Device Evaluation Program l 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 i

f

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APPENDIX B RHODE ISLAND DEPARTMENT OF HEALTH ORGANIZATIONAL CHART

^

i State of Rhode Island - Organizational Chart .

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\ People ofRhodeIsland 9

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l Secretary Legislative Attorney Ileutenant General Judicial "S General Governor Treasurer Branch Branch State 3 l

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i i . Haase Executive j senate of neoresentarins Branch l

1 Governor I 1 General Human Natural Services N"'"#*" '

Resources N*"#E*#"##"

Government hatrams n &ge 3 Programs N'*** Program, i

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Rhode Island Departnient of IIealth Organizational Structure - Fiscal Year 1998 BIRECTOR OF REALTR MEDICAL EXAMINER I i i I

Medical Pirector Medical Director Associato Director Associate Director Czecutive Director REALTE SERVI MS SUBSTANCE ABUSE ENVIRONMENTAL REALTE -

BISEASE PREVENTIOtt - PAMILT REALTE - -

AND CONTROL REGULATION COMMUNICABLE DISEASE MATERNAL & CHILD HEALTH FACILITIES RECULATIDIt PLANNING AND FOOD PROTECTION -

EVALUATION CHILDREN WITH SPECIAL MEALTft PROFESSIONALS PREVENTION PROC 1L%MS DRINKINC NATER QUALITT CHRONIC DISEASE PREY.

S REALTH PROMOTION -

HEALTH CARE NEEDS -

RE3ULATION -

PRIMART CARE WOMEN, INFANTS MANAGED CARE REGULATIOlt TREATftEltT PftOGRANS OCCUPATIONAL AND -

RADIOLOGICAL HEALTfl -

AND CHILDREN (NIC) -

T.A.S.C.

ENVIRONMENTAL REALTS '

RICA ASSESSMENT HEALTH LABOIULTORIES January 15, 1998

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SEITImoeBestf5LL . . . . . . ..

M TE detter S.comewe.Jr..Ph.t gg Judy Grant AE2tINISTRATITE . . . . - . . .

EtaDIO!ASICAL MU Frances Banno sentie Stoecket.sweE.CIII Chief Clerk U Chief ,

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IIIDUSTRIAL DADIATIcel CostTROL 3t20088 & ASBESTOS Cheries secteshon

%r sesrine111 Janes Camella sup. stad.

g, stad. Prn. Imhsstrial Control Spec. 5 Control Spec. Ilygieniet StAD. REALTIE IEWOSTRIAL -

Sgt.13eOST5tIAL SPECIALIST NYOIEstIST 13eOSTetht. _ NTGIEstIST John Ferruolo .

Chery! vincent Nf91EstIST .

I Richard Scott conna souse 3 i

IEWUST5tIAL i SETGIENIST 11WUST5tIAL SR. ISWOSTRIAL '  ;

NYGIEstIST _ .

NYG'IENIST Antanto Cabral Altra.f Catwet  ;

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JULY 30s 1998 i

1 .

APPENDIX C INSPECTION FILE REVIEWS NOTE: NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM File No.: 1 Licensee: Niton Corporatio'n 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: SyncorInternational License No.: 38 114-01 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 Type: 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 License 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-O Rhode Island Proposed Final Report Page C.2  ;

l- Inspection File Reviews  !

File No.: 7 Licensee: Rhode Island Department of Transportation License No.: 3L-015 01 l Location: Providence, RI Inspection Type: Routine, unannounced I Ucense Type: Portable Gauge

Priority: 5 Inspection Date: 6/9 - 7/5/94 Inspector: JF File No.: 8 Ucensee: Paul B. Aldinger and Associates License No.: 3L-107-01  ;

Location: East Providence, RI Inspection Type: Initial, unannounced l License Type: Portabie Gauge Priority: 5 Inspection Date: 2/18/97 Inspector: JF File No.: 9 Licensee: John D. Lowney, D.O. License No.: 78-120-01 Location: Warwick, RI inspection Type: Initial, announced Ucense 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.: 78-082-01 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 Med%: Genter License No.: 70 076 01 Location: Providence, RI inspection Type: Routine, unannounced License Type: Medical Broad Scope Priority: 1 Inspection Date: 11/14 -18/96 Inspector: JF File 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: Rh'de Island Hospital License No.: 7D-051-01 Location: Providence, RI Inspection Type: Routine, unannounced l License Type: Medical Broad Scope Priority: 1

Inspection Date: 6/22-23/98 Inspector: JF

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.: 38-114-01 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.: O 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: 6/50/98 (expiration date) . License Reviewer: CM Cortment: I a) License expired without any action taken. No documentation in the license file to l indicate any response was received and the license expired 6/30/98. j l

File No.: 4 Licensee: John D. Lowney, D.O. License No.: 78-120-01 Location: Warwick, Rl Amendment No.: New ,

License Type: Medical- Specific Type of Action: New I 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 l License Type: Academic- Broad Type of Action: Renewal Date lasued: 5/2/96 License Reviewer: CM File No.: 6

' Licensee: Narraganosett Improvement Co. License 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 i Comments:

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).

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' Rhode Island Proposed Final Report Phi;e D.2 License File Reviews File No.: 7 Licensee: Rhode Island Hospital License No.: 7D-051-01 Location: Providence, RI Amendment No.:6 Ucense Type: Medical- Broad . Type of Action: Renewal Date issued: 4/95 License Reviewer: CM File No.: 8 Licensee: Cardi Corporation License No.: 3L-068-01 Location: Warwick, RI Amendment No.: 3 License Type: Portable Gauge Type of Action: Termination Date lasued: 7/7/97 License Reviewer: CM File No.: 9 Licensee: 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-05102 Location: Providence, RI License Type: Medical- Specific (Gamma Knife) Type of Action: Renewal Date issued: 10/23/97 License Reviewer: CM 1

+ . - . . - .- - - . - , , , , , - - - . - . , , - - . . - - - , . . . - , - ,

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i i f APPENDlX E I INCIDENT FILE REVIEWS i

NOTE: ALL INCIDENTS CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR i

, COMPLETENESS ONLY; NO SIGNIFICA'rC COMMENTS WERE IDENTIFIED BY THE

IMPEP TEAM 4

File No.: 1 l' Licensee: Rhode Island Hospital incident Log No.: 98-001 Site of Incident: Providence, RI Licensee No.: 70-051-01 i Date of incident: 12/31/97 Type of incident: Misadministration

j. Investigation Date: 6/22 - 23/98 Type of Investigation: Phone and Next inspection

Summary

Patient prescribed 25 mci of I 131 and pharmacy provided two capsules of 6 and

i. 19 mci for treatment. Hospital personnel administered only the 6 mci capsule to the patient.

. The secend capsule was discovered on 1/15/98. Reported to the State on 1/20/98. Preliminary

findings were discussed during telephone conversation. Licensee filed report on 2/15/98.'

1 l File No.: 2 i' Licensee: RI Atomic Energy Commission Incident Log No.: 94 002

! Site of incident: Nuclear Science Center, Providence NRC l.icensee No.: R-95 j Date of Incident: 5/18/94 Type of incident: Loss of Control

Investigation Date: 5/18 througg 6/13/94 Type of Investigation: Telephons I

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 mcterial as originating from their facility NRC performs inspection in 12/94 to follow up

i. . on the incident.

! File No.: 3 i - Licensee: MOS Inspection incident Log No.: 94-004 Site of incident: Providence, RI Licensee No.: generallicense

1Date of incident::10/3/94 Type of incident: Equipment failure Investigation Date: 10/4/94 Type of Investigation: telephone and site l - Summary: During radiographic operations, a 58 curie Ir-192 source became disconnected.

Licensee implemented emergency procedure and isolated area unti! consultant (Amersham) successfully returned 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.

l-

^'

File No.: 4 Licensee: Mallinkrodt Medical incident Log No.: 94-005

Site of Incident: East Frovidence, Rl 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 feil off a delivery truck onto highway where some were hit by other veh!cles and broken open. Roadway closed until ril 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 4 -radiation levels were reduced and allowed road to be opened.-

~. _ . _ __ __ .. _ . _. . . _ . _ _ _ _ _

9 Rhode Island Proposed Final Report Page E.2 Incident File Reviews File No.: 5 Licensee: Ninon Corporation Incident Log No.: 96 001 Site of incident: North Kingston, RI 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 j Summary: Licensee disposed of a 10 MCI Fe 55 source in its shipping container in the ordinary trash. Licenses submitted report to State detailing action taken te locate source and corrective l action taken. State inspector to follow-up on incident att next routine inspection.

File No.: 6 l licensee: Stericycle incident Log No.: 94-003 i 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

, Summe.ry: Medical waste sets off radiation alarrt .issachusetts facility and returned to RI l facility which collected it. State personnel conduct ,mo visit, recommends facility hire a radioicgical consultant. Consultant Mentifies waste as 1 131 and TI-201 and :ccommends that

.; war.te be held for decay. Waste is held for decay, resurveyed by consultant and disposed as

." on radiological medical waste.

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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.: RI-164-D-101-B SS&D Type: X-ray Fluorescence Analyzer Manufacturer: NITON Corporation Model No.: NITON XL Model 309 NITON Series 700 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 e

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.- ) STATE OF RHODE ISLAND a" VIDENCE PLANTATIONS

/ DEPARTME i OF HEALTH 4

Sqfe and Realthy Lim la Sqfe end Healthy I'===M*s Patricia A. Nelas, MD, MPH Director of Beakk september 29, 1998 Richard L. Bangart, Director office of state Programs l

U.s. Nuclear Regulatory Commission j Washington, D.C. 2055-0001 Dear Mr. Bangart We have reviewed the draft Integrated Materials Performance Evaluation Program (IMPEP) report documenting the Agreement State review of the Rhode Island program, our thanks to Jim Myers, Team Leader, and his colleagues, Duncan White

and Steven Gavitt, for their guidance during our first IMPEP review and for their professionalism throughout this process.

I am aware that Marie stoeckel, chief of occupational and Radiological Health, has discussed several corrections and edits with Jim Myers. My understanding is that these comments will be incorporated into the draft IMPEP report.

In anticipation of Marie Stoeckel's meeting with the management review board (MRB) during the second week of october, we are enclosing our response to the two recommendations in the draft report.

We are pleased to be able to continue our long tradition as an Agreement State.

Very truly yours,

,Y Patricia A. Nolan, MD, MPH Director $

b -4 Enclosure - o D l g O t cc: Walter S. Combs, Jr., PhD Executive Director, Environmental Health 9 5"

Marie Stoeckel, MPH, CIH Chief, occupational & Radiological Health i

CANNON BUILDING, 'Ihree Capitol Hill, Providence, Rhode Island 02908 5097 Telephone 401-222 2231, FAX 222 6548 - Web Site: www. health. state.ri.us Hearing / Speech Impaired, Call 1-800 745 5555 (ITY)  !

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l RESPONSE TO RECOMMENDATIONS INCLUDED IN 1 I

" INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM:

REVIEW OF REODE ISLAND AGREEMENT STATE PROGRAM i a July 27-30, 1998" Recommendation it The review team recommends that the State upgrade their inspection tracking system to assure that all licensees are in accordance with 1

, the frequency established by the program. (Section 3.1)

! I

' Response la In the past, licenses have been scheduled for routine  !

inspection by calendar quarters in order to allow flexibility and to make efficient use of staff time. This system allowed the inspector to schedule j inspections anytime within the indicated calendar quarter. However, coopeting RCP requirements have at times led to deferral of radioactive materials j inspections towards the end of the quarter, which in turn has led to slippage of l some inspections beyond their due dates.

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To ensure the performance of inspections in accordance with the priority

schedule, inspection due dates will be firmly scheduled within windows around their anniversary dates, as described in NRC Inspection Manual Chapter 2800-05.03. The schedule will be routinely reviewed for adherence to this requirement. In the event of any missed datws, inspections will be rescheduled l such that they are still performed within the allowed windows. If it is not ,

possible to perform an inspection before it becomes overdue, it will be rescheduled at the earliest possible time, and a note will be placed in t! e file ,

indicating the reason (s) for the delay.  !

New licenses will be issued only when the licensee indicates that they are ready to possess materials or to begin licensed activities. Initial inspections will .

then be scheduled at the time of license issuance in accordance with the performance requirement.s specified in MC 2800-04.03(a).

Recommendation 2: The review team recommends that the State document a training and qualifications program equivalent to that in NRC's Inspection Manual 1246,

" Formal Qualifications Pregrams in the Nuclear Materiala safety and safeguards Program Area." (Section 3.3)

Response 2 The State will develop a training and qualifications program l for license reviewers and inspectors. We will utilize the NRC/0AS TRAINING WORKING GROUP RECOMMENDATIONS F0k AGREEMENT STATE TRAINING PROGRAMS as a guide l and resource for identifying appropriate program elements and contents.

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