ML20029E732
| ML20029E732 | |
| Person / Time | |
|---|---|
| Issue date: | 05/13/1994 |
| From: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Debuono B RHODE ISLAND, STATE OF |
| References | |
| NUDOCS 9405200008 | |
| Download: ML20029E732 (46) | |
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NUCLEAR REGULATORY COMMISSION r4 WASHING TON, D.C. N555-0001 May 13, 1994 Dr. Barbara DeBuono, Director Rhode Island Department of Health 3 Capitol Hill Providence, RI 02908
Dear Dr. DeBuono:
This is to transmit the results of the NRC review and evaluation of the Rhode Island radiation control program conducted by Mr. Lloyd Bolling, Health Physicist, Office of State Programs and Mr. Craig Gordon, NRC Region I State Agreements Officer, which was concluded on January 14, 1994.
The results of this review were discussed with Dr. William J. Waters Jr., Deputy Director, Department of Health, Ms. Marie Stoeckel, Chief, Office of Occupational and Radiological Health, Mr. Charles McMahon, Supervising Radiation Control Specialist and other members of your staff.
As a result of our review of the Rhode Island radiation control program and 1
the routine exchange of information between the NRC and the State, we believe
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that the State's program for regulating agreement materials, at this time, is adequate to protect the public health and safety and is compatible with the regulatory program of the NRC.
We believe that the continued findings of this type are a clear indication of your commitment to protecting public health from the hazards of radiation, i
Please note that there has been a change made in the format of this letter from our previous review letters.
This letter summarizes the findings regarding all 30 program indicators as opposed to only discussing those indicators where deficiencies were noted.
Enclosure I contains an explanation of our policies and practices for reviewing Agreement State programs. is a summary of the review findings where recommendations are made for improvements in the radiation control program. Minor deficiencies were noted in four indicators and recommendations were offered for two other indicators, as well. None of the recommendations are considered significant enough to affect the findings of adequacy and compatibility.
We
. request specific responses from the State on'the findings and recommendations in Enclosure 2 within 30 days of this letter.
We recognize the delay in our issuance of this letter; if you require more than 30 days to respond, please inform us of your revised response date. presents a summary of the review findings where the State has adequately satisfied the indicator. A response to the items in Enclosure 3 is not required.
In accordance with NRC practice, I am also enclosing a copy of this letter for placement in the State's Public Document Room or otherwise to be made available for public review.
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Dr. Barbara DeBuono 2
.AIAY 13154 I appreciate the courtesy and cooperation extended to the NRC staff during the review.
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Richard L. Bangart, Director Office of State Prograras j
Enclosures:
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cc w/encls-Marie Stoeckel, State of Rhode Island Richard A. Bouchard, State Liaison Officer i
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.MM 13 1994 I appreciate the courtesy and cooperation extended to the NRC staff during the review.
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PLEASE REVIEW THE ENCLOSED DOCUMENT AND PROVIDE YOUR RECOMMENDATIO!1 FOR CONCURRENCE OR NONCONCURRENCE TO R. BERNER0 BY THE ASSIGNED DATE BELOW MEMORANDUM FOR:
Dr. Barbara DeBuono, Director, Rhode Island Department of Health FROM Richard Bangart, Director, OSP SUBJECT REVIEW OF RHODE ISLAND RADIATION CONTROL PROGRMt DATE RECOMMENDATION IS DUE TO BERNER0:
4/22/94 RECOMMENDATION:
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I appreciate the courtesy and cooperation extended to the NRC staff during the review.
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Richard L. Bangart, Director Office of State Programs
Enclosures:
As stated cc w/encls:
Marie Stoeckel, State of Rhode Island Richard A. Bouchard, State Liaison Officer bec w/encls.
The Chairman Commissioner Rogers Commissioner Remick Commissioner de Planque Distribution:
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I appreciate the courtesy and cooperation extended to the NRC staff during the review.
Sincerely, Richard L. Bangart, Director Office of State Programs
Enclosures:
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The Chairman Commissioner Rogers Commissioner Remick Commissioner de Planque Distribution:
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h apolicatica of " Guidelines for NRC Review of Aareement State Radiation Control Proarams" The " Guidelines for NRC Review of Agreement State Radiation Control Programs,"
were published in the federal Reaister on May 28, 1.992, as an NRC Policy Statement. The Guidelines provide 30 indicators for evaluating Agreement State program areas.
Guidance as to their relative importance to an Agreement State program is provided by categorizing the indicators into two categories.
Cateoory I indicators address program functions which directly relate to the State's ability to protect the public health and safety.
If significant problems exist in several Category I indicator areas, then the need for improvements may be critical.
Category II indicators address program functions which provide essential technical and administrative support for the primary program functions.
Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or more of the principal program areas, i.e., those that fall under Category I indicators.
Category II indicators frequently can be used to identify underlying problems that are causing, or contributing to, difficulties in Category I indicators.
It is the NRC's intention to use these categories in the following manner.
In reporting findings to State management, the NRC will indicate the category of each comment made.
If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety and is compatible with the NRC's program.
If one or more significant Category I comments are provided, the State will be notified that the program deficiencies may seriously affect the State's ability to protect the public health and safety and that the need of improvement in particular program areas is critical.
If, following receipt and evaluation, the State's response appears satisfactory in addressing the significant Category I comments, the stMf may offer findings of adequacy and compatibility as appropriate or defer such offering until the State's actions are examined and their effectiveness confirmed in a subsequent review.
If additional information is needed to evaluate the State's actions, the staff may request the information through follow-up correspondence or perform a follow-up or special, limited review.
NRC staff may hold a special meeting with appropriate State representatives.
No significant items will be left unresolved over a prolonged period. The Commission will be informed of the results of the reviews of the individual Agreement State programs and copies of the review correspondence to the States will be placed in the NRC Public Document Room.
If the State program does not improve or if additional significant Category I deficiencies have developed, a.
staff finding that the program is not adequate will be considered and the NRC may institute proceedings to suspend or revoke all or part of the Agreement in accordance with Section 274j of the Act, as amended.
ENCLOSURE 1
SUMMARY
OF ASSESSMENTS AND RECOMMENDATIONS FOR THE RHODE ISLAND RADIATION CONTROL' PROGRAM NOVEMBER 23, 1991 TO JANUARY 14, 1994 SCOPE OF REVIEW This program review was conducted in accordance with the Commission's Policy Statement for reviewing Agreement State Programs published in the Federal Register on May 28, 1992, and the internal procedures established by the Office of State Programs.
The State's program was reviewed against the 30 program indicators provided in the policy statement. The review included discussions with the radiation control program (RCP) program management and staff, and technical evaluations of selected license and compliance files.
The program review with Rhode Island representatives was held during the period January 11 - 14, 1994 in Providence, Rhode Island.
The State was represented by Ms. Marie Stoeckel, Chief, Office of Occupational and Radiological Health and Mr. Charles McMahon, Supervising Radiation Control i
Specialist.
The NRC was represented by Mr. Craig Gordon, Region I State l
Agreements Officer (RSA0) and Mr. Lloyd Bolling, Health Physicist, Office of State Programs.
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A summary meeting to present the results of the review was held with Dr. Waters, Ms. Stoeckel, and Mr. McMahon.
The NRC was represented at the j
meeting by Mr. Gordon and Mr. Bolling.
CONCLUSION The program for control of agreement matericls, at this time, is adequate to protect the public health and safety and is compatible with the regulatory program of the NRC.
STATUS OF PROGRAM REtATED TO PREVIOUS NRC FINDINGS The results of the previous review were reported to the State in a letter to Dr. Barbara DeBuono, dated February 6, 1992.
All 29 indicators' were reviewed and the State fully satisfied 25 of these indicators.
Specific minor l
comments were made on 4 indicators.
These issues were discussed with the State staff and are as follows:
l ENCLOSURE 2 1
' Prior to the revision of the " Guidelines for the NRC Review of Agreement State Radiation Control Programs" on May 29, 1992, there were 29 indicators as opposed to the current 30 indicators.
The 1992 revision added an indicator on contractual assistance to address this aspect of low level waste regulatory programs.
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4 1.
Quality of Emeraency Plannino (Category I)
The issue addressed in the following comment has been satisfactorily resolved and is considered closed.
j Recommendation from the November 22. 1941 Review The State's Emergency Operations Plan, Annex G, and emergency contacts list I
should be revised during the first quarter of 1992 to reflect the role of i
Health Department personnel in responding to radiological emergencies.
1 Current Status The State's Emergency Operations Plan, Annex G, has been revised. The State's Emergency Operations plan is in draft form awaiting review and approval by the Federal Emergency Management Aaency (FEMA) before being finalized.
Department of Health personnel including the RCP staff utilize the draft Plan to respond to emergencies in their areas of responsibility and to address inquires on potential radiological hazards.
The emergency contacts list has been updated to reflect the RIDOH responsibility for radiological hazards. The State continues to update this list periodically and distributes it to the appropriate State, Local and Federal Agencies. The Department of Health RCP staff are identified as contacts and as a resource on radiological matters throughout the State's Emergency Operations Plan. The RCP staff's ability to parform technical assessments and to interface with the Rhode Island Emergency Management Agency was demonstrated during the December 1993 Pilgriin Nuclear Station Emergency exercise, which was observed by FEMA. Although the final FEMA evaluation has not as yet been issued, preliminary results indicate that the RCP has effectively used the draft emergency operations plan and that the RCP communications and decisionmaking skills on radiological emergencies are effective. This item has been adequately addressed with regard to the materials program.
2.
Enforcement Procedures (Category I)
The issue addressed in the following comment has been satisfactorily resolved and is considered closed.
Recommendation from the November 22. 1991 Review The State should update its enforcement procedure to include guidance for enforcement actions for severity levels I-III violations. These could include enforcement conferences, follow-up inspections, and stronger language in the inspection cover letters in addition to enforcement actions such as orders to modify or suspend licenses.
Current Status The State has revised its enforcement procedures. The revised enforcement procedures became effective July 1, 1992. The procedures were revised to I
incorporate Severity levels I, II, and III violations and adds a section on enforcement conferences.
Enforcement conferences can be held for cases in 2
which escalated enforcement actions are being considered.
During the review period no enforcement conferences were held.
Orders are authorized by Law and may be signed by the Health Department Director, her designee or the RCP administrator.
Follow-up inspections are performed when numerous and/or serious violations are identified.
The issue of adopting an agency-wide civil penalty policy is being studied by a committee appointed by the Health Department.
To date no determination has been made regarding a civil penalty policy.
There is however, a provision for criminal penalties in the State's radiation control act.
3.
Status of Inspection proaram (Category I)
The issue addressed in the following comment has been satisfactorily resolved and is considered closed.
Recommendation from the November 22. 1991 Review The RCP should increase its efforts to inspect reciprocity licensees, 1
especially those performing radiography.
Current Status During the review period November 1991 to December 1993 the State received 34 reciprocity requests.
Inspections were performed on 5 of these operations.
This represents an inspection effort of approximately 15% which exceeds the State's commitment to inspect 10% of reciprocity licensees.
4.
Administrative Procedures (Category II)
The issue addressed in the following comment has been satisfactorily resolved and is considered closed.
Recommendation from the November 22. 1991 Review The RCP should develop administrative procedures to identify those licensees i
which are required by the decommissioning rule to submit financial assurance funding and assure compliance with the decommissioning rule.
Current Status The State has developed a screening procedure to identify applicants and licensees who may be subject to the decommissioning funding regulations.
The screening process revealed that there are five licensees (all broadscope licenses) that are subject to the rule. These licensees were notified by letter that they are required to submit decommissioning funding plans or certificates of financial assurance. All five licensees have responded with the following results:
Letters of intent were received from the two broadscope licensees that a.
are administered by State agencies (University of Rhode Island and Rhode Island Nuclear Science Center).
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The State has verified that financial assurance has been secured by
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two privately owned institutional licensees ( Rhode Island Hospital &
Brown University ).
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The fifth broad licensee (Roger Williams Hospital) has requested an c.
i exemption from certain requirements in the rule and the State has requested assistance from NRC. This request is currently under review by OSP staff.
Upon receipt of guidance from NRC the State will resolve this matter.
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[URRENT REVIEW ASSESSMENTS AND RECOMMENDATIONS I
All 30 program indicators were reviewed and tFe State satisfies all 30 of these indicators. Hinor deficiencies were noted for four indicators and recommendations were made for two other indicators, as well.
None of the comments are considered significant enough to affect the findings of adequacy and compatibility.
A questionnaire containing the thirty policy guideline indicators with specific questions addressing each indicator was sent to the State prior to the review.
The assessments and recommendations below are based upon the evaluation of the State's written response to the questionnaire, comparison with previous review information, discussions with the program managers and staff members, review team observations, and licensing and inspection casework file reviews.
1.
Status and Compatibility of Reaulations (Category I) 2 NRC Guidelines The State should adopt regulations to maintain a high degree of uniformity
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with NRC regulations.
For those regulations deemed a matter of compatibility by NRC, State regulations should be amended as soon as practicable, but no later than 3 years after the effective date.
Assessment The State's regulations are compatible with NRC regulations.
The State has implemented the new 10 CFR Part 20, " Standards for Protection Against Radiation," regulations by an emergency rulemaking measure. The new rules were effective on January 1,1994, as required.
In addition, as a matter separate from this review, we would like to bring to-the State's attention other regulations that will be needed for compatibility.
These rules are:
2The guideline statements are a summary of the guideline provisions i
provided in the May 28, 1992 policy statement, " Guidelines for NRC Review of l
Agreement State Radiaticn Control Programs."
4
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" Notification of Incidents," 10 CFR Parts 20, 30, 31, 34, 39, 40, and 70'
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i amendments (56 FR 40757) needed by October 15, 1994.
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" Quality Management Program and Hisadministrations," 10 CFR Part 35 amendment (56 FR 153) needed by January 27, 1995,
" Licenses and Radiation Safety Requirements for Irradiators," 10 CFR a
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.
Recommendation We recommend that the above rules and ony others needed for compatibility, be promulgated expeditiously as effective State radiation control regulations.
2.
Status of Inspection Program (Category I)
NRC Guidelines The State RCP should maintain an inspection program adequate to assess licensee compliance with State regulations and license conditions. When backlogs occur, management should develop and implement a plan to reduce the
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backlog.
Assessment At the time of this review, there were no inspection backlogs in any category.
However, during the review period four Priority-I licensees and a Priority-Il licensee were not inspected in a timely fashion. These licensees had been overdue for inspection by as much as 22 months.
The RCP has a i
computer based information system which can be used to schedule and track inspection activities.
'During the review period November 1991 to December 1993 the State received 34 reciprocity requests.
Inspections were performed on 5 of these operations.
This represents an inspection effort of approximately 15% which exceeds the State's commitment to inspect 10% of reciprocity licensees.
Recommendation 4
We recommend that the RCP. management closely monitor the compliance program's statistical reports in order to insure the timely inspection of licensees.
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4 3.
Technical Quality of Licensino Actions (Category I) i NRC Guidelines The RCP should assure that essertial elements of applications have been submitted to the agency, and which meet current regulatory guidance for describing the isotopes and quantities to be used, qualifications of persons who will use material, facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions.
Assessment A review of nine selected license files was completed during the review. The license files reviewed included:
two private practice nuclear cardiolog/
licenses; two industrial radiography licenses; an irradiator license; an x-ray i
fluorescence analyzer; an industrial research and development license; a nuclear medicine license; and a nuclear pacemaker license. The review I
revealed one minor deficiency.
This deficiency was the lack of a signature by the physician / authorized user on a private practice human-use license application.
i Recommendation It is recommended that the State ensure that each application for a private i
practice human-use license be signed by the physician / authorized user.
4.
Inspection Reports (Category II)
NRC Guidelines Inspection reports should uniformly and adequately document the results of inspections and identify areas of the licensee's program which should receive special attention at the next inspection. Reports should also show the status of previous noncompliance and the independent physical measurements made by the inspector.
Assessment During this review 10 selected compliance files were reviewed.
The inspection reports indicated a thorough and consistent examination of licensee activities.
The report format needs updating to require better documentation of inspector observations and worker interviews. Although the RCP policy is to perform unannounced inspections, among the 10 reports reviewed, there were 3 reports that did not indicate whether the inspections were announced versus unannounced.
The RCP staff reported that these 3 inspections were in fact unannounced.
This does not appear to be a consistent pattern and may have been an oversight, because a review of the 7 remaining inspection reports indicated that these inspections were all unannounced.
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Recommendation It is recommended that the RCP staff document interviews of radiation workers l
and ancillary workers in each inspection report.
It is further recommended that each report contain a clear indication of i
whether the inspection was unannounced or announced.
1 5.
Confirmatory Measurements (Category II)
NRC Guidelines l
Confirmatory measurements should be sufficient in number and type to ensure the licensee's control of materials and to validate the licensee's j
l measurements.
Assessment The RCP is equipped to obtain and analyze radiological data from the entire spectrum of tctivities licensed by the State. A review of selected compliance files indicated that, while area radiation surveys are obtained during each j
inspection, wipe samples are obtained only when area surveys show positive readings.
Some delays were encountered by the RCP staff regarding the j
handling and analysis of wipe samples provided to the Health Department Laboratories. As a result, there was reluctance on the part of the RCP staff l
to routinely obtain wipe samples. The RCP staff stated that they would work internally to resolve this matter.
Recommendation 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.
We also recommend that the RCP work with the Health Department Laboratories to insure adequate handling, processing and reporting of results from wipe j
samples and samples in any other physical form.
I 6.
Enforcement Procedures (Category I)
NRC Guidelines Enforcement Procedures should be sufficient to provide a substantial deterrent to licensee noncompliance with regulatory requirements.
Written procedures should exist for handling escalated enforcement cases of varying degrees.
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t as.sessment s
i The State has revised its enforcement procedures.
The revised enforcement procedures became effective July 1, 1992. The procedures were revised to i
incorporate Severity levels I, II, and III violations and add a section on enforcement conferences.
Enforcement conferences are held for cases in which l
escalated enforcement actions are being considered. Orders are authorized by law and may be signed by the Health Department Director, her designee or the RCP administrator.
Follow-up inspections are performed when numerous and/or serious violations are identified. The issue of adopting an agency-wide civil penalty policy is being studied by a comittee appointed by the Health Department.
To date no determination has been made regarding a civil penalty policy.
There is however, a provision for criminal penalties in the State's radiation control act.
During this review, a concern was expressed regardirx) a priority-I inspection.
i In 1992, NRC inspected Grinnell Corporation, a Rhode Island licensee, for activities performed under reciprocity at various job locations in Massachusetts.
Communications with the licensee in February 1992 and NRC j
inspections conducted ir. March and July 1992 resulted in safety violations for l
failure to meet reciprocity requirements, performance of work without NRC authorization, ineffective radiation controls while performing field work, inadequate training program for radiographers, failure to meet training commitments, and lack of independent audits.
Other violations were also found as identified in NRC inspection report Nos. 9999-0001/92-009 and 9999-0001/92-016. These violations resulted in escalated enforcement action against the i
licensee in September 1992.
NRC provided copies of inspection reports and related documentation to the State for information, and the NRC reviewers noted that a complete file on the enforcement actions was maintained by the RCP office.
i The last Rhode Island inspection performed at Grinnell Corporation in August l
1992 was confined to corporate offices and did not include field observations.
Inspection results showed only minor non-compliance items and overall good I
program implementation.
Rhode Island staff stated they believed Grinnell conducted an acceptable program within the State.
At the time of the review, January 1994, this priority-I licensee was overdue for inspection by 5-months. As noted above, the previous Rhode Island RCP inspection of the licensee's corporate office was conducted on August 7,1992.
Rhode Island's policy to conduct follow-up inspections is not formal and occurs when serious or potentially serious violations are discovered. Since the last Rhode Island inspection no site or field inspection activities or licensee communications have occurred which consider NRC's findings.
Due to the seriousness of the NRC results, it appears that additional follow-up action by Rhode Island is warranted, particularly with regard to licensee field radiography.
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Recommendation 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.
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I 9
SUMMARY
OF ASSESSMENT OF INDICATORS ADEQUATELY SATISFIED BY THE RH0DE ISLAND RADIATION CONTROL PROGRAM NOVEMBER 23, 1991 TO JANUARY 14, 1994 The assessments below are based upon the evaluation of the State's written response to the questionnaire, comparison with previous review information, discussions with the Program managers and staff members, review team observations, and licensing and inspection casework file ~ reviews.
The State fully satisfies the following indicators:
1.
Legal Authority (Category I)
NRC Guideline 1 Clear statutory authority should exist, designating a State radiation control agency and providing for promulgation of regulations, licensing, inspection and enforcement.
Assessment Clear statutory authority exists which designates the Rhode Island Division of Occupational and Radiological Health as the State radiation control agency with authority over agreement materials. The statutory 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.
2.
Location of the Radiation Control Proaram Within the State Oraanization (Category II)
NRC Guidelines The RCP should be located in a State organization parallel with comparable health and safety programs.
The Program Director should have access to appropriate levels of State management.
Assessment The Rhode Island Radiation Control Program is mandated by law as a unit of the Rhode Island Department of Health, which is one of the four offices in the Office of Environmental Health.
The RCP is comparable to other health and safety programs.
In addition, adequate access to appropriate levels of State management is maintained through the Chief of the Department of Health.
ENCLOSURE 3 w
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3.
Internal Orcanization of the RCP (Category II) l.
NRC Guideling The RCP should be organized with the view toward achieving an acceptable degree of staff efficiency, place appropriate emphasis on major program functions, and provide specific lines of supervision from program management for the execution of program policy.
Assessment The Rhode Island RCP is organized with adequate lines of supervision for l
effective execution of program policy.
During the review period, Ms. Marie Stoeckel joined the State as chief of the Office of Occupational and l
Radiological health. Ms. Stoeckel administers three sections, one of which is the radiation control program. Mr. Charles McMahon, Supervisor, Radioactive Materials and X-ray Programs supervises the RCP and reports directly to Ms. Stoeckel.
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4.
Legal Assistance (Category II) 11RC Guidelines Legal staff should be assigned to assist the RCP or procedures should exist to obtain legal assistance expeditiously.
Legal staff should be knowledgeable regarding the RCP program, statutes, and regulations.
j Assessment The Department of Health, which the RCP is under, has a full time legal staff which is familiar with RCP activities and is available to provide legal assistance to the RCP.
During the review period, legal assistance was provided in the review of draft RCP regulations and in enforcement activities.
5.
Technical Advisory Comittees (Category II)
NRC Guidelines Technical Committees, Federal Agencies, and other resource organizations should be used to extend staff capabilities for unique or technically complex problems.
Assessment The State Radiation Advisory Comission (RAC) was established under Rhode Island General Laws 23-1.3 and its members are appointed by the Director of Health.
Categories of representation and terms of appointment are prescribed by the law.
The RAC meets annually, their last meeting was held on March 31, 1993. A copy of the meeting minutes was reviewed and the topics discussed at that tire were nominations for memberrhip, activities of the RAC's Part 20 task group and the State's low-level wete disposal scenario.
2
0.
Budget (Category II)
NRC Guideline Operating funds should be si'fficient to support program needs such as staff travel necessary to conduct an effective compliance program, including routine inspections, follow-up or special inspections (including pre-licensing visits) and responses to incidents and other emergencies, instrumentation and other equipment to support the RCP, administrative costs in operating the program including rental charges, printing costs, laboratory services, computer and/or word processing support, preparation of correspondence, office equipment, hearing costs, etc. as appropriate.
i Assessment RCP activities are supported almost entirely with State funds.
Fees associated with program activities (Registration, Licensing and Compliance) are paid to the State general fund and do not directly support RCP activities.
In the radioactive, materials program fees support approximately 1/3 of program costs.
This level of funding has been sufficient to date to support routine licensing, compliance and administrative activities.
7.
.Qu_ality of Emergency Plannina (Category I)
NRC Guidelines The State radiation control program (RCP) should have a written plan for response to such incidents as spills, overexposures, transportation accidents, fire or explosion, theft, etc.
Periodic drills should be performed to test the plan.
Assessment The State's Emergency Operations Plan, Annex G, has been revised. The State's Emergency Operations plan is in draft form awaiting review and approval by the Federal Emergency Management Agency (FEMA) before being finalized.
Department of Health personnel including the RCP staff utilize the draft Plan to respond to emergencies in their areas of responsibility and to address inquires on potential radiological hazards. The emergency contacts list is contained in the main portion of the State's Emergency Plan and is maintained by the Rhode Island Emergency Management Agency (RIEMA).
The list has been updated and the RIEMA staff is responsible for the periodic updates to the list and its distribution to the appropriate State, Local and Federal Agencies.
The Department of Health RCP staff are identified as contacts and as a resource on radiological matters throughout the State's Emergency Operations Plan.
The RCP staff's ability to perform technical assessments and to interface with the Rhode Island Emergency Management Agency was demonstrated during the December 1993 Pilgrim Nuclear Station Emergency exercise, which was observed by Mr. Gordon.
Although the final FEMA evaluation has not as yet been issued, preliminary results indicate that the RCP has effectively used the draft emergency operations plan and that the RCP communications and decisionmaking 3
h.
skills on radiological emergencies are effective.
I 8.
Laborator_y Support (Category II)
NRC Guidelingl The RCP should have the laboratory support capability in-house, or readily available through established procedures, to conduct bioassays, analyze environmental samples, analyze samples collected by inspectors, etc., on a priority established by the RCP.
Assessment Laberatory support is obtained through the Rhode Island Department of Health's Division of Laboratories (DOH) and the Rhode Island Nuclear Science Center (RINSC).
The RCP reported that the DOH laboratories are equipped with liquid scintillation counters, gas flow proportional counters, and gamma spectroscopy instrumentation, which are standard counting equipment for_ analyzing gross beta, alpha, and gamma radionuclides.
The labs can handle samples in any physical form, wipe samples, filters, liquids and other material are collected by inspectors. When more precise quantitative evaluations are required, the RINSC is used.
The DOH lab participates in the EPA gross alpha and beta counting program.
The RINSC participates in the EPA gamma counting program and also utilizes NIST reference standards.
9.
Contractual Assistance (Category II)
NRC Guidelines States regulating the disposal of low-level radioactive waste in permanent disposal facilities should have procedures and mechanisms in place for l
acquisition of t'echnical and vendor services necessary to support these functions that are not otherwise available within the RCP.
The RCP should avoid the selection of contractors which have been selected to provide services associated with the low-level radioactive waste facility development or operations.
Assessment This indicator was not evaluated because the State, at present, does not have a low-level waste disposal regulatory program.
l 0
4
10.
Administrative Procedures (Category II)
NRC Guidelines The RCP should establish written internal procedures to assure that the staff performs its duties as required and to provide a high degree of uniformity and continuity in regulatory practices. These procedures should address internal processing of license applications, inspection policies, decommissioning and license termination, fee collection, contacts with communication media, conflict of interest policies for employees, exchange of information and other functions required.of the program. Administrative procedures are in addition to the technical procedures utilized in licensing, inspection, and enforcement.
Assessment There are Departmental policies and procedures governing office administration, fee collection, press inquiries, and conflicts of interest.
Continuity and uniformity in other areas which are more specific to RCP daily radiological activities are maintained through frequent information exchanges among the small staff.
11.
Management (Category II)
NRC Guidelines Program management should receive periodic reports from the staff on the status of regulatory actions (backlogs, problem cases, inquiries, regulation revisions).
Supervisory review of inspections, reports and enforcement actions should also be performed.
Assessment Management is aware of RCP activities by review of incoming and outgoing correspondence and reviews licensing and inspection statistics on a quarterly basis.
In addition, status reports are obtained through monthly staff meetings.
The technical staff and the RCP supervisor are consulted on unusual or complex license applications.
Each licensing and compliance action as wel: as other regulatory correspondence receives supervisory review which is documented with an attachment to the action.
12.
Office Ecuipment and Support Services (Category II)
NRC Guidelines The radiation control program (RCP) should have adequate secretarial and clerical support.
States should have a license document management system that is capable of organizing the volume and diversity of materials associated with licensing and inspection of radioactive materials.
5
Assessment The RCP has adequate secretarial and clerical support, through one full time administrative position.
All program staff have access to computer terminals.
Licensing and compliance actions are prepared and maintained on the RCP's computer system.
Statistical data is also generated frSm the system which utilizes several of the most up-to-date word processing, data base and spread sheet software programs-- Wordperfect 5.0; Filepro 16 Plus (database); SCO Professional (spreadsheet); Wordperfect 6.0; and Lotus 1-2-3 (R2.4).
13.
Public information (Category II)
NRC Guidelines Inspection and licensing files should be available to the public consistent with State administrative procedures.
It is desirable, however, that there be provisions for protecting from public disclosure proprietary information and information of a clearly personal nature.
Assessment Inspection and licensing files, which are considered final actions of the agency, are tvailable to the public.
Proprietary information and documents which do not represent final actions by the RCP may De withheld under Chapter 38-2 of the Rhode Island General Laws; however, the release or withholding of documents is at discretion of the Department of Health.
14.
Staffina level (Category II)
Professional staffing level should be approximately 1 to 1.5 person-year per 100 licenses in effect.
The RCP must not have less than two professionals available with training and experience to operate the RCP in a way which provides continuous coverage and continuity. The two professionals available to operate the RCP should not be supervisory or management personnel.
Assessment The current RCP staffing level is 1.0 person-years per 100 licenses (State currently has 80 licenses) for the technical staff which is within the NRC-suggested range of 1.0 to 1.5 FTE per 100 licenses.
The 1.0 person-years per 100 licenses is provided through the combined efforts of three persons.
15.
Qualifications of Technical Staff (Category II)
NRC Guidelines Professional staff should have a bachelor's degree or equivalent training in the physical and/or life sciences. Additional training and experience in radiation protection for senior personnel including the director of the radiation protection program should be commensurate with the type of licenses issued and inspected by the State.
6
1 1
l Assessment The technical staff all have at least a bachelor's degree or equivalent in the physical and/or biological sciences.
The staff have specific training in radiological science with emphasis on radioactive materials control. The aggregate RCP staff experience in radiation control is about 40 years.
l 16.
Staff Supervision (Category II)
NRC Guidelines Supervisory personnel should be adequate to provide guidance and review the work of senior and junior personnel.
Senior personnel should review applications and inspect licenses independently, monitor work of junior i
personnel, and participate in the establishment of policy. Junior personnel I
should be initially limited to reviewing license applications and inspecting small programs under close supervision.
Assessment All licensing and compliance actions of the RCP staff receive supervisory review which is documented with an attached form with each action.
The newest staff member has been with the program for seven years; thus, the monitoring of junior personnel is not necessary.
However, supervisory inspector accompaniments are conducted at least annually and are documented in the compliance program's files.
17.
Traini_n_g (Category II)
NRC Guideline Senior personnel should have attended NRC core courses in licensing orientation, inspection procedures, medical practices and industrial radiography practices.
The RCP should have a program to utilize specific short courses and workshops to maintain an appropriate level of staff technical competence in areas of changing technology.
The RCP staff should be afforded opportunities for training that is consistent with the needs of the program.
Assessment The RCP staff has attended all of the NRC core courses.
In addition, since the last review, the staff has attended two NRC sponsored training sessions on 10 CFR Part 20 implementation. The staff and program managers also routinely attend technical and management workshops offered by the Conference of Radiation Control Program Directors, Inc. and the New England Radiological Health Conference and the National and local chapters of the Health Physics Society.
7
l 18.
Staff Continuity (Category II)
NRC Guideline The RCP organization structure should be such tFat staff turnover is minimized and program continuity maintained through opportunities for training, promotions, and competitive salaries.
Salary levels should be adequate to recruit and retain persons of appropriate professional qualifications and should be comparable to similar employment in the geographical area.
Assessment i
Staff continuity has been a strong point of this program.
The newest member of the RCP staff has been with the State seven years.
19.
Adecuacy of Product Evaluations (Category I)
NRC Guidelines RCP evaluations of manufacturer's or distributor's data on sealed sources and devices outlined in NRC, State, or appropriate ANSI Guides, should be sufficient to assura integrity and safety for users.
Approval documents for sealed source or device designs should be clear, complete and accurate as to isotopes, forms, quantities, uses, drawing identifications, and permissive or restrictive conditions.
Assessment There were no sealed source and devices (SS&D) evaluations issued by the RCP during this review period. The RCP has SS&D evaluation training and experience in performing evaluations.
The RCP staff is utilizing NRC guidance documents to evaluate devices containing radioactive material. A copy of the NRC draft regulatory guide on quality assure for SS&D manufacturers was given to the RCP during the review, which is an update of earlier guidance provided to the State.
20.
Licensino Procedures (Category II)
NRC Guidelines The RCP should have internal licensing guides, checklists, and policy memoranda consistent with current NRC practice.
Assessment The RCP is effectively utilizing NRC guides, checklist, policy memoranda, and standard license conditions in regulatory actions. The RCP maintains a file of NRC Division 8 and 10 Regulatory Guides for use for license application review.
In addition, the State maintains a file of standard review plans and actual licenses issued by the NRC, which is also used as guidance material.
8
21, Inspection Freauency (Category I)
NRC Guidelines The RCP should establish an inspection priority system.
The specific frequency of inspections should be based upon the potential hazards of licensed operations. The minimum inspection frequency including for initial inspections should be no less than the NRC system.
Assessment The RCP utilizes an inspection priority system which is the same as the NRC's system.
22.
Inspector's Performance and Capability (Category I)
NRC Guidelines Inspectors should be competent to evaluate health and safety problems and to determine compliance with State regulations.
Inspectors must demonstrate to supervision an understanding of regulations, inspection guides, and policies prior to independently conducting inspections.
Assessment No NRC accompaniment of the inspectors was conducted during this review.
The inspection staff is trained and qualified and has been with the RCP for several years. They were accompanied by the NRC reviewer during previous reviews and have been found to be competent to evaluate health and safety problems and compliance with regulatory requirements.
In addition, RCP supervisory accompaniments of inspectors are conducted annually.
23.
Responses _to Incidents and Alleged Incidents (Category I)
NRC Guidelines Inquiries should be promptly made to evaluate the need for on-site investigations.
Investigation (or inspection) results should be documented and enforcement action taken when appropriate.
State licensees and the NRC should be notified of pertinent information about any incident which could be j
relevant to other licensed operations.
Assessment During the review period, there were 5 incidents reported to the RCP for calendar year 1992 and no incidents reported for calendar year 1993.
All 5 reports were reviewed by the NRC reviewer and the RCP's handling of the incidents was found to be both prompt and thorough.
On-site investigations were conducted on 4 of the 5 cases reported.
9
24.
Inspection Procedures (Category II)
NRC Guidelines j
Inspection procedures and guides, consistent with current NRC guidance, should be used by inspectors to assure uniform and complete inspection practices and provide technical guidance in the inspection of licensed programs.
Assessment The RCP uses NRC inspection guides and follows NRC policies and practices to the extent they are appropriate. The NRC review of 17 selected compliance files found the RCP inspection procedures to be adequate.
SUMMARY
OF DISCUSSIONS WITH STATE REPRESENTATIVES Mr. Gordon and Mr. Bolling presented the results of the program review to Dr. Waters, Ms. Stoeckel and Mr. McMahon during a summary meeting held on January 14, 1994.
The State was informed that the NRC considered the radioactive materials program to be adequate and compatible.
It was recommended that the RCP management closely track the inspection statistical reports in order to avert inspection backlogs and to meet the i
stated goal of 30 inspections per year, it was recommended that the RCP staff obtain wipe samples, confirming licensee compliance with the regulations and terms of their license, during each inspection.
It was further recommended that discussions be held with the laboratories division to improve the timeliness of wipe sample analyses.
Specific minor comments on the licensing and inspection casewcrk reviews were made to Ms. Stoeckel, Mr. McMahon and the RCP staff.
Dr. Waters was informed that the results of the review would be reported in a letter to Dr. DeBuono from the Director, Office of State Programs and that a written response would be requested.
10 l
4 9 e m
NRC FORM 88 (4-79)
NRCM O240 BACKGROUND AND SIGNATURE TAB Use this side of the sheet to precede the background material when assembling correspondence.
(USE REVERSE SIDE FOR SIGNATURE TAB) 4
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NRC FORM 8B (4-79)
NRCM O240 l
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BACKGROUND AND SIGNATURE TAB Use this side of the sheet to precede the signature page when assembling correspondence, (USE REVERSE SIDE FOR BACKGROUND TAB)
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s REVIEW REFERENCES FOR REPORT OF THE EVALUATION OF AGREEMENT STATE PROGRAM RH0DE ISLAND NOVEMBER 22, 1991 TO JANUARY 14, 1994 l
PREPARED BY LLOYD BOLLING AND CRAIG GORDON DATE: FEBRUARY 28, 1994 s
CONTENTS APPENDIX A PROGRAM GUIDELINES AND STATE QUESTIONNAIRE APPENDIX B STATE ORGANIZATION CHARTS i
APPENDIX C LICENSE FILE REVIEW APPENDIX D COMPLIANCE FILE REVIEW I
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~
APPENDIX A EVALUATION OF AGREEMENT STATE RADIATION CONTROL PROGRAM PART I PROGRAM GUIDELINES AND COMPREHENSIVE STATE QUESTIONNAIRE Name of State Program RHODE ISLAND Date report prepared December 17 1993 I.
LEGISLATION AND REGULATIONS A.
Leoal Authority (Category I)
NRC Guidelines Clear statutory authority should exist, designating a State radiation control agency and providing for promulgation of regulations, licensing, inspection and enforcement.
[
Questions:
1.
Please list all currently effective legislation that affects the radiation control program (RCP).
Ans:
The statutory 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.
2.
Does your State have the authority tot a.
apply civil penalties?
b, collect fees?
require performance bonds or sureties for decommissioning c.
licensed facilities?
d.
require performance bonds or sureties.for clean-up of licensed facilities after a contamination accident?
1 (Please provide separate answers for low-level waste or uranium mill rules)
Ans: The state has the authority to collect fees and to require financial asourance for decommissioning.
3.
Are your regulations subject to a " Sunset" or equivalent law?.
If so, explain and include the next expiration date for your regulations.
Ans: Regulations are not subject to a. sunset law.
A.2 B.
Status and Compatibility of Reculationn (Category I)
NRC Guidelines:
The State must have regulations essentially identical to 10 CFR Part 19, Part 20 (radiation dose standards, ef fluent limits, waste manifest rule and certain other parts), Part 61 (technical definitions and requirements, performance objectives, financial assurances). The State should adopt other regulations to maintain a high degree of uniformity with NRC regulations. For those regulations deemed a matter of compatibility by
- NRC, State regulations should be amended as soon as practicable but no later than 3 years. - The RCP should have established procedures for effecting appropriate amendments to State regulations in a timely manner, normally within 3 years of adoption by NRC.
Opportunity should be provided for the public to comment on proposed regulation changes. Pursuant to the terms of the Agreement, opportunity should be provided for the NRC to comment on draft changes in State regulations.
Questions:
1.
What is the effective date of the last compatibility-related amendment to the state's regulations?-
Ans: August, 1991.
2.
Referring to the latest 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.
Ans:
Standards for Protection Against Radiation, and Emergency Planning for Materials Licensees, compatible with 10 CFR 20 and 10 CFR 30.32, respectively, are currently in the state's adoption process and will'become effective January 1, 1994.
The state should be in compliance with Agreement program compatibility requirements at that time.
1 3.
Briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC within the three year time frame, showing the normal length of time anticipated to complete each step.
Ans: The adoption procedure is described in the Protocol for the Development of Rules and Reculations, a Health Department document which provides guidance for conformity with the state's Administrative Procedures Act.
The process includes these steps:
1.
Identify purpose of action 2.
Develop draft regulations 3.
Departmental review 4.
Approval by the Director of Health 5.
Review with representatives of affected persons j
A.3 6.
Public hearing notice 7.
Public hearing 8.
Review of comments 9.
Decision of Director on final action The entire process typically requires several months, depending on the complexity of the issues.
4.
How is the public involved in the process of adopting new regulations?
Ans:
The public is involved through steps 6 and 7 above.
5.
At what stage does the NRC have the opportunity to comment on draft changes to State regulations?
Ans:
NRC is provided with draft proposals as early as possible and at least prior to the public hearing stage.
6.
Identify the person responsible for developing new or amended regulations affecting agreement materials.
Ans:
William P.
Dundulis.
II.
ORGANIZATION Under the Appendix B title sheet provided at the end of this document, please enclose copies of your organization charts as follows:
a) organization chart (s) showing the position of the RCP within the State organization and its relationship to the Governor and comparable health and safety programs.
b)
RCP internal organization charts.
If applicable, include regional offices and contract agencies.
All charts should be current, dated, and include names and title, for all positions.
A.
Location of the Radiation Control Procram Within the State Oraanization (Category II)
NRC Guidelines The RCP should be located in a State organization parallel with comparable health and safety programs.
The Program Director should have access to appropriate levels of State management.
Where regulatory responsibilities are divided between state agencies, clear understandings should exist as to division of responsibilities and requirements for coordination.
Questions:
1.
Is the RCP on a level within the State organization so as to compete effectively for funds and staff with other health and
A.4 safety programs?
Ans: The RCP is comparable with other health and safety programs in terms of competing for staff and funding.
The RCP is mandated by law as a unit wihin the Health Department. It is positioned in the office of Occupational and Radiological Health, one of four of fices under the Office of Environmental Health.
2.
If the RCP shares regulatory responsibilities with other agencies a.
Identify the agencies and describe their responsibilities.
b.
How are their responsibilities set out (e.g., by statute, MOU, contract, etc.)?
Ans: Not applicable.
B.
Internal Oraanization of the RCP (category II)
NRC Guidelines:
The RCP should be organized with the view toward achieving an acceptable degree of staff efficiency, place appropriate emphasis on major program functions, and provide specific lines of supervision from program management for the execution of program policy. Where regional of fices or other government agencies J
are utilized, the lines of communication and administrative control between these offices and the central office (Program Director) should be clearly drawn to provide uniformity in licensing and inspection policies, procedures and supervision.
l Questions:
1 1.
If applicable, list the RCP's regional offices, showing the responsibilities of each office, and describe the e.ethods of communication and administrative control between the regions and the program director.
2.
Identify other agencies contracted to perform services for the RCP, indicate their responsibilities, and describe the methods of communication and administrative control between the agency personnel and the program director.
Ans 1 & 2:
Not applicable.
C.
Lecal Assistance (category II)
NRC Guidelines:
Legal staff should be assigned to assist the RCP or procedures should exist to obtain legal assistance expeditiously.
Legal staff should be knowledgeable regarding the RCP program, statutes, and regulations.
A.5 l
Questions:
1.
Is legal assistance by knowledgeable staff available to the RCP7 Ans: The Health Department has a full time legal staff which is familiar with RCP activities and is available for assistance.
2.
By what method is legal assistance provided?
l Examples would be review of draft regulations for conformity Ans:
with Departmental and state requirements, and preparation of i
and representstion in enforcement activities.
3.
If legal assistance was utilized during the reporting period, j
briefly describe the circumstances.
Ans:
Legal assitance is being utilized in reviewing draft regulations currently proposed for adoption by the RCP.
D.
Technical Advisory Committees (Category II)
NRC Guidelines: Technical Committees, Federal Agencies, and other resource organizations should be used to extend staff capabilities for unique or technically complex problems. A State Medical Advisory Committee should be used to provide broad guidance on the uses of radioactive drugs in or on humans.
The Committee should represent a wide spectrum of medical disciplines. The Committee should advise the RCP on policy matters and regulations related to use of radioisotopes in or on humans.
Procedures should be developed to avoid conflict of interest, even though Committees are advisory. This does not mean that representatives of the regulated community should i
not serve on advisory committees or not be used as consultants.
Questions 1.
What technical advisory committees have been established to assist the RCP?
i Ano:
The State Radiation Advisory Commission (RAC) is established under 23-1.3 of tha General Laws and is appointed by the Director of Health.
Categories of representation and terms of appointment are prescribed in the law.
2.
Are regular meetings scheduled? If so, what is the frequency?
If not, how are committee members utilized?
Ans:
The RAC meets at least annually.
Additional meetings are scheduled as needed and may be called by the RCP or any member of the RAC.
3.
What procedures exist to avoid areas of conflict of interest-by members of the committees?
A.6 Ans The RAC has written procedures for avoiding conflict of interest.
4.
Please list the names, affiliations and terms of the technical committee (s) members.
l Ans: A list of Commissioners in attached.
5.
If an advisory committee or consultant was used during the reporting period, briefly describe each circumstance (i.e.,
the subject, the need, the result and the manner o'otained -
by meeting, phone call, or letter).
Ans:
The regulations subcommittee reviewed the currently proposed amenda.ents to the regulations and recommended their approval to the full Commission.
The review process included several meetings with RCP staff.
III.
MANAGEMENT AND ADMINISTRATION A.
Quality of Emeroency Plannina (Category I)
NRC Guidelines:
The State RCP should have a written plan for response to such incidents as spills, overexposures, transportation accidents, fire or explosion, theft, etc.
The Plan should define the responsibilities and actions to be taken by State Agencies. The Plan should be specific as to persons responsible for initiating response actions, conducting operations and cleanup.
Emergency communication procedures should be adequately established with appropriate local, county and State agencies.
Plans should be distributed to appropriate persons and agencies.
NRC should be provided the opportunity to comment on the Plan while 'in draf t form.
The plan should be reviewed annually by Program staff for adequacy and to determine that content is current.
Periodic drills should be performed to test the plan.
Questions:
1.
What written plan does the RCP use for response to incidents involving radioactive materials (other than plans for fixed nuclear facilities)?
l Ans: Plans for emergencies involving radioactive materials are l
contained in Annex G to the Rhode Island Emergency Operations
]
Plan.
2.
In some states, the emergency response responsibilities are not assigned to the radioactive materials office. If this is the case in your State, describe how the efforts of the emergency response team are coordinated with the materials staff, including MOU's, letters of agreement, etc.
Ans:
The Director of the Emergency Management Agency evaluates each
A.7 incident and determines which agencies' assistance is appropriate or necessary. The P~an identifies the state and federal resources which are available for emergency response activities (including the RCP).
3.
To whom is the plan distributed?
Ans: A distribution list is attached (RIEOP/ Distribution).
4.
Describe your emergency communications procedures.
Ans:
Communications procedures are described in Annex A of the EOP.
5.
At wl.at stage is the NRC provided the opportunity to comment on the plan or the revision while it is in draft-form?
Ar.s :
The current draft revision has been forwarded to FEMA for review. We suggest that NRC contact the State Liaison Of ficer if interested in reviewing the EOP.
6.
What procedures exist for providing annual reviews of the plan?
Ans:
The Emergency Management Agency (EMA) supplies forms and instructions for cognizant agencies to provide their input for revisions. EMA reviews the EOP on an annual basis.
1 7.
How is the plan tested? how frequently?
Ans:
The plan in tested whenever it is activated, or an exercise is conducted at least annually.
8.
Other than the communications list, when was the emergency plan j
last revised?
i Ans: December 31, 1992.
9.
When was the emergency communication list last reviewed or revised?
Ans:
Nover.ber 1993.
B.
pudoet (Category II)
NRC Guidelines:
Operating funds should be sufficient to support
~
program needs such as staf f travel necessary to conduct an effective compliance program, including routine inspections, follow-up or special inspections (including pre-licensing visits) and responses to incidents and other emergencies, instrumentation and other equipment to support the RCP, administrative costs in operating the program including rental charges, printing costs, laboratory cervices, computer and/or word processing support, preparation of correspondence, of fice equipment, hearing costs, etc. as appropriate.
Principal operating funds should be from sources which provide
A.8 continuity and reliability, i.e.,
general tax, license fees,.etc.
Supplemental funds may be obtained through contracts, cash grants, etc.
Questions.
1.
How does your funding provide continuity and reliability?
Anst RCP activities are supported almost entirely with state funds.
Fees associated with program activities (registration, licensing, inspection) are paid to the state general fund and therefore do not directly support RCP programs.
2.
Show the amount for funds for the RCP for the current fiscal year obtained from a.
State general fund
$248,400 (Includes professional / clerical salaries, fringes and operating costs) b.
Fees (90,000) c.
Federal grants and contracts (identify) 5,500 (FDA X-ray compliance testing)
~I i
d.
Other 0
e.
Total:
$253,900 3.
Show the total amounts in the current RCP budget allocated for the following (if contract costs are incurred, e.g, in LLW regulation, please include).
j a.
Administration
$20,900
.)
b.
Radioactive materials 78,400 c.
X-ray 149,100 d.
Environmental surveillance 0
e.
Emergency planning 0
1 f.
LLW regulation (regulation only, do'not include site development)
O g.
U-mill regulation 0
h.
Other (radon, non-ionizing, operator credentialing, etc.
Please identify).
Equipment / travel 5,500 1.
Total:
5253,900
J.9 J
4.
What percentage of your radioactive materiale program is supported by fees?
Ans: The entire radiation control program is supported by state funds. Fees collected in association with all RCP regulatory activities equal about 1/3 of program costs.
5.
Overall, is funding sufficient to support all of the program needs? If not, what are the problem areas?
Ans:
Funding has been sufficient for routine licensing and inspection activities and related administrative costs.
Funding is insufficient for regulations development and emergency planning.
C.
Laboratory Support (Category, II)
NRC Guidelines:
The RCP should have the laboratory support capability in-house, or readily available through established procedures, to conduct bioassays, analyze envir,onmental samples, analyze samples collected by inspectors, etc.,
on a priority established by the RCP.
Questions:
1.
Are laboratory services readily available in-house or through other departments within the State organization?
Ans:
Laboratory services are available from the Division of Laboratories (Health Department) and the RI Nuclear Science Center (RINSC).
2.
If services are provided by other departments, discuss the arrangements, supervision, charges and interdepartmental communications.
Ans:
Routine survey instrument calibrations and occasional sample analyses are performed without charge by RINSC. Calibrations are done by RCP staff under RINSC supervision; analysis by RINSC staff.
Communication between RCP and RINSC is usually direct and informal.
3.
If laboratory services are provided by a non-State agency:
Discuss the contractual arrangements.
a.
b.
Is the party providing the service a State licensee?
If a State licensee provides the service or equipment, c.
what are the costs?
Ans:
Not applicable.
A.10 l
4.
Describe the capability of the laboratory as follows:
a.
Describe the method and equipment available to qualitatively and quantitatively analyze low-energy beta emitters?
Ans:
Standard liquid scintillation counting methods.
b.
Describe the method and equipment available to qualitatively and quantitatively analyze alpha emitters?
Ans:
Gas flow proportional counting (Canberra Model 2404).
c.
Describe the method and equipment available to selectively determine the presence and quantity of gamma emitters?
Ans:
Gamma spectroscopy (NaI and Ge(Li) detectors).
d.
Can it handle samples in, any physical form
- wipes, filters, liquids,' solids, gaseous?
Ans:
Any form of sample can be counted.
Does the lab participate in a periodic quality control e.
program? If so, please identify the program.
Ans:
The Health laboratory participates in the EPA gross alpha and beta program.
The RINSC laboratory satisfies. multiple quality assurance requirements as research and support laboratory for the research reactor. Included are participation in EPA's gamma counting program and use of NIST reference standards.
5.
Please list any other types of laboratory services and instrumentation available.
6.
What is the normal time for sample analysis, both on a routine and emergency basis?
Ans:
Routine work is completed within 3-5 days. Emergency requests can usually be accommodated within one day.
D.
Administrative Procedures (Category II)
NRC Guidelines: The RCP should establish written internal procedures to assure that the staff performs its duties as required and to provide a high degree of uniformity and continuity in regulatory practices. These procedures should address internal processing of license applications, inspection policies, decommissioning and license termination, fee collection, contacts with communication media, conflict of interest policies for employees, exchange of information and other functions required of the program.
i A.ll l'
l I
Administrative procedures are in addition to the technical procedures utilized in licensing, and inspection and enforcement.
i 1
Questions:
l 1.
Have administrative procedures and polices been established, I
documented and made available to RCP staff regarding a.
Office administration?
b.
Receipt, assignment and tracking of licensing actions, including new applications, renewals and amendmente?
Assigning or announcing inspections?
c.
d.
Terminating licenses and decommissioning licensed facilities?
e.
Collecting fees?
f.
Responding to press inquiries?
g.
Conflict of interest for RCP employees?
h.
Exchange-of-Information with NRC and other Agreement States?
i.
Distribution (as appropriate) to staf f and licensees of j
All Agre2 ment State Letters and Information Notices?
l
)
Ans:
Statewide and/or Departmental policics and proceduree govern office adminjstration, fee collection,. press inquiries, and conflict of interest. Continuity and uniformity of other areas which are more specific to the RCP have been. assured through frequent information exchange among the small' staff.
(There has been almost no staf f turnover within the materials program since its inception).
Relevant NRC materials are generally consulted whenever questions arise and a reference model is desired.
2.
Have copies of these procedures been distributed to regional offices and to other appropriate agencies?
9.
How are personnel and regional offices (if applicable) kept informed of changes in regulatory policies and practices?
E.
Manacement (Category II)
NRC Guidelines: Program management should receive periodic reports from the staff on the status of regulatory actions (backlogs, problem cases, inquiries, regulation revisions). RCP management should periodically assess workload trends, resources and changes in l'
A.12 legislative and regulatory responsibilities to forecast needs for increased staff, equ ipme nt,
services and fundings.
Program management should perform periodic raviews of selected license cases handled by each reviewer and document the results. Complex licenses (major manufacturers, large scope - Type A Broad, or ones with the potential for significant releases to environment) should receive second party review (supervisory, committee, or consultant).
Supervisory review of inspections, reports and enforcement actions should also be performed. When regional of fices or other government agencies are utilized, program management should conduct periodic I
audits of these offices.
Questions:
1.
How does management track the status of the licensing and
{
inspection programs?
Ans: Hanagement is aware of program status through ntaff meetings and review of incoming and outgoing correspondence.
2.
How often are meetings held between program management and staff?
Ans:
Staff meetings are held at least monthly.
3.
How often is a statistical tabulation of licensees, licensing actions, inspection data, etc., prepared?
Ans:
Licensing and inspection statistics are reviewed approximately quarterly.
4.
Explain how program management keeps abreast of changes in legislative and regulatory responsibility.
Ans: The RCP reviews changes in Federal regulations as they are published or communicated by NRC/OSP.
Senior Management is informed of significant developments.
The Department's legislative liaison keeps RCP management informed of legislative action within the state.
5.
What license review practices are followed for unusual or co.mplex license applications?
Ans:
Unusual or complex applications are at least discussed /revicwed by reviewer and supervisor. Management is made aware of the issues and may provide direction or guidance.
We have frequently consulted informally with OSP on unusual or difficult matters.
A more formal request for NRC technical assistance would be made if necessary, 6.
How are licensing cases selected for periodic management review, (i.e., randomly, major licensees, percentage, etc.)?
A.13 All licensing actions (and license review correspondence) are Ans:
at least discussed with the reviewer before signing of f.
Major licensing actions are reviewed / discussed in greater detail.
Others actions are reviewed at random.
7.
Do all inspection reports receive supervisory review?
Ans:
Yes.
8.
Does all enforcement correspondence receive supervisory review prior to dispatch?
Ans:
Yes.
9.
What audita were made of regional and contract of fices in this period?
10.
How many management reviews of license cases were performed in this period?
Ans:
See answer to question 6 above.
11.
Were all license reviewers included in the cases selected for management review? If not, explain.
Ans:
Yes.
12.
What audits were made of regional and contract offices?
F.
Office Equipment and support Services (Category II)
NRC Guidelines:
The RCP should have adequate secretarial and clerical support.
Automatic typing and Automatic Data Processing and retrieval capability should be available to larger (300-400 licenses) programs. Similar services should be available to regional i
of fices, if utilized. Professional staff should not be used for fee collection and other clerical duties.
Questions:
1.
Describe the secretarial and clerical support for the radioactive materials program including, if appropriate, any problem areas.
Ans: The office employs 4 full time clerical staff. Two positions support (part-time) the radioactive materials program.
2.
If your program has regional offices, discuss the clerical support for those offices.
3.
In cases of unusual workloads or vacancies, can supplementary secretarial / clerical support be obtained?
A.14 Ans:
The Office has more than adequate clerical staff for any situation.
4.
What licensing functions are on your computer system?
What compliance functions are on ycur system?
a.
6.
Are computers or terminals available to the professional staff, and if so, what use is made of them?
Ans(4-6):
All staff have access to terminals. They are routinely used for preparation of license review correspondence, licenses, and inspection / enforcement correspondence.
They may also be used to access the radioactive materials database (license and inspection data).
7.
Describe the fee collection system and identify the staff resources assigned to it.
Ans:
Fee collection is handled internally by the fiscal clerk (one of the four clerical positions) 8.
What word process g, data base and spread sheet programs are you using?
Ans:
Unix: Wordperfect 5.0, Filepro 16 Plus (database), and SCO Professional (spreadsheet similar to Lotus 123).
DOS:
Wordperfect 6 and Lotus 123R2.4.
l G.
Public Information (Category II)
NRC Guidelines: Inspection and licensing files should be available to the public consistent with State administrative procedures.
It is desirable, however, that there be provisions for protecting from public disclosure proprietary information and information of a clearly personal nature. Opportunity for public hearit.gs should be 1
provided in accordance with UMTRCA and applicable State administrative procedure laws.
Questions:
1.
Are licensing and inspection files available for inspection by the public?
Ans: Documents which are considered to be final actions of the Agency may be released to the public.
2.
If so, what information may be withhold, and what regulations or procedures govern this? Please provide reference citations.
Ans:
Documents which do not represent final actions may be released or withheld in accordance with Chapter 38-2 of the General Laws, as interpreted under the Rules and Regulations Governing
A.15 the Practices and Procedures Before the Rhode Island Department of Health.
IV.
PERSONNEL A.
Oualifications of Technical Staff (Category II)
NRC Guidelines: Professional staff should have a bachelor's degree or equivalent training in the physical and/or life sciences.
Additional training and experience in radiation protection for senior personnel including the director of the radiation protection program should be commensurate with the type of licenses issued and inspected by the State.
Written job descriptions should be prepared so that professional qualifications needed to fill vacancies can be readily identified.
Questions:
1.
Do all professional personnel hold a bachelor's degree or have equivalent training in the physical or life sciences?
2.
What additional training and experience does the RCP director have in radiation protection?
3.
What additional training and experience are required of the senior personnel?
4.
Do written position descriptions describe the duties, responsibilities and functions of each professional position in the RCP and the qualifications needed by applicants?
Ans:
Training and experience requirements for all positions are described in the written position descriptions which were previously submitted.
The aggregate staff experience in the Agreement program is about 40 years.
B.
Staffine Level (Category II)
NRC Guidelines: Professional staf fing level should be approximately 1-1.5 person-year per 100 licenses in ef fect. RCP must not have less than two professionals available with training and experience to operate RCP in a way which provides continuous coverage and continuity.
For States regulating uranivan mills and mill tailings current indications are that 2-2.75 professional person-years' of effort, including consultants, are needed to process a new mill license (including in situ mills) or major renewal, to meet requirements of Uranium Mill Tailings Radiation Control Act of 1978.
This effort must include expertise in radiological matters, hydrology, geology, and structural engineering.
Questions:
1.
Complete a table listing the professional (technical) person-years of effort applied to the agreement or radioactive
A.16
{'
material program by individual.
Include the name, position, t
i f raction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U-3 l
mills, other. If these regulatory responsibilities are divided j
between offices, the table should be consolidated to include all personnel contributing to the radioactive material program.
{
If consultants were used to carry out the program's RAM responsibilities, include their efforts.
The table heading should bei NAME POSITION AREA OF EFFORT FTE%
M.
Stoeckel Chief Director 0.10 C.
McMahon Supervisor Supervision / Licensing 0.50
'I J.
Ferruolo Rad Health Spec Inspection 0.20 A.
Cabral Sr Ind Hygienist Licensing 0.30 W.
Dundulis Toxicologist Standards 0.10 2.
Is the staf fing level adequate to meet normal and special neede
{
and backup? If not, explain.
Ans:
Staf fing is adequate for routine licensing, inspection, related activities, and backup.
The program could benefit from additional staf fing for development of standards, guides, and procedures, and various additional ef forts and activities which j
are worthwhile but not possible with the current staffing level.
l 3.
Do you currently have vacancies?
If so, when do you expect to fill them?
Ans:
An Industrial Hygienist position will be filled within a few months.
The position will probably be utilized for x-ray facility inspections.
4.
Does your state maintain the minimum staffing level of 1 person year for each 100 specific licenses?
Ans:
Yes.
5.
Does your staff always include a minimum of two trained professional members to provide continuous coverage for the radioactive materials program?
Ans:
Yes.
A.17 C.
Staff Supervision (category II)
NRC Guidelines Supervisory personnel should be adequate to provide guidance and review the work of senior and junior personnel. Senior personnel should review applications and inspect licenses independently, monitor work of junior personnel, and participate in the establishment of policy. Junior personnel should be initially limited to reviewing license applications and inspecting small programs under close supervision.
Questions:
1.
What duties are assigned to junior personnel?
2.
How is their work monitored?
1 i
3.
How do senior personnel participate in the developnent of program policy?
4.
Identify your senior personnel assigned to monitor the work of junior personnel.
Ans:
Please refer to the table in IV.B.1 above.
Only three inJividuals work routinely in the materials program, the least senior (Cabral) having about seven years' experience.
D.
Irainino (Category II)
HRC Guidelines Senior personnel should have attended NRC core courses in licensing orientation, inspection procedures, medical practices and industrial radiography practices. The RCP should have a program to utilize specific short courses and workshops to maintain appropriate level of staf f technical competence in areas of changing technology.
Questionss 1.
Prepare a table listing the year each of your technical personnel attended the following NRC training courses NAME LICENSING INSPECTION MEDICAL RAD /OGRAPHY Example:
J.
Oldtimer 3976 1973 1972 1979 H.
Kidd 1990 1991 2.
' Prepare a similar table listing the year each of your technical personnel attended the following NRC training courses:
NAME 5 WK HP WELL LOGGING ENGINEERING TRANS.
A.18 Ans:
No staff have attended core courses since the last review.
Please refer to previous review questionnaires for core course dates.
3.
Please list the course name and year each of your staff attended any other NRC courses or workshops.
Ans:
Since the last review, J. Ferruolo and A. Cabral attended the 20 CFR 20 regional training sessions in January 1992 and August 1993.
4.
If any of your materials staff currently need NRC training, please identify the employees and the courses needed.
Ans: With reference to the Industrial Hygienist position vacancy mentioned above, we may request core course training for the new hire at some point, depending on program workloads and trends.
5.
Other than the NRC training courses, describe training opportunities offered to your staff.
Ans:
With respect to radioactive materials regulation, no training has been available, other than that provided by NRC.
6.
Explain how new employees are trained.
Ans:
Training would be provided by appropriate staf f, depending on the employee's previous training and experience. NRC sponsored courses would also be requested.
E.
Staff Continuity (Category II)
NRC Guidelines: Staff turnover should be minimized by combinations of opportunities for training, promotions, and competitive salaries.
Salary levels should be adequate to recruit and retain persons of appropriate professional qualifications.
Salaries should be comparable to similar employment in the geographical area. The RCP organization structure should be such that staff. turnover is minimized and program continuity maintained through opportunities for promotion.
Promotion opportunities should exist from junior level to senior level or supervisory positions. There also should be opportunity for periodic salary increases compatible with experience and responsibility.
Questions:
1.
Identify the technical etaff who left the Agreement program during this period and, if possible, give the reasons for the turnovers.
Ans:
No technical staff have left the Agreement program since the
{
last review.
)
l
A.19 2.
Is your salary schedule adequate to recruit and retain staf f ?
Ans: Within state service the salaries are competitive.
Past experience indicates that state salaries are not attractive to individuals with options in the private sector.
3.
If not, compare your salary schedule with similar employment alternatives in the same geographical area, such as industrial, medical, academic employers or other State agencies.
4.
What opportunities are there for promotion withir the RCP organizational structure without a staff vacancy occurring?
Ans: The only opportunities for promotion would occur through creation of new, higher classifications, or vacancies.
V.
LICENSING A.
Technical Ouality of Licensino Actions (Category I)
NRC Guidelines:
The RCP should essure that essential elements of applications have been submitted to the agency, and which meet current regulatory guidance for describing the isotopes and quantities to be used, qualifications of persons who will use material, facilities and equipment, and operating and emergency procedures suf ficient to establish the basis for licensing actions.
Prelicensing visits should be made for complex and major licensing actions.
Licenses should be clear, complete, and accurate as to isotopes, forms, quantities, authorized uses, and permissive or restrictive conditions. The RCP should have procedures for reviewing j
licenses prior to renewal to assure that supporting information in the file reflects the current scope of the licensed program.
j j
Questions:
1.
Prepare a table showing the State's major licensees listing licensee name, number and type.
INCLUDE:
o Broad Licenses LLW Disposal o
o LLW Brokers (All Types) o Manufacturers and Distributors o
Uranium Mills o
Irradiators (other than Self-Contained) o Nuclear Pharmacies o
other Licenses With a Potential Significance for Environmental Impact The table heading should be:
A.20 Licensee Name License Number License Tvoe Ans:
Please refer to the attached " License Listing-NRC Program Review."
2.
Identify any major, unusual or complex licenses issued or renewed in this period.
Ans:
New License #3A-105-01 to Niton, an XRF device manufacturer.
3.
List the licensees (name and license number) subject to contingency plans requirements and give the status of their plans (approved, under review, etc.).
Ans:
The state's regulation for contingency plans does not become effective until 1 January 1994.
4.
Discuss any variances in licensing policies and procedures or j
exemptions from the regulations granted during the period.
)
Ans:
Not applicable.
5.
What criterion does the State use to determine the need for a prelicensing visit?
Ans:
- Unusual or complex activity or use requested
- Questions which are not satisfactorily resolved through review correspondence, or about which the Agancy has reservations j
- Verification of an applicant's measurements or calculations where necessary or prudent.
- Actual or potential public interest in the proposed activities 6.
How do you ensure up-to-date information has been submitted prior to a license renewal?
Ans: Renewal applications are compared to previous application (s) and compliance history.
Any submission which appears to be out of date or incongruous would be questioned.
B.
Adecuacy of Product Evaluations (Category I)
NRC Guidelines: RCP evaluations of manuf acturer's or distributor's data on sealed sources and devices outlined in NRC, State, or appropriate ANSI Guides, should be suf ficient to assure integrity and safety for users.
The RCP should review manufacturer's information on label s and brochures relating to radiation health and safety, assay, and calibration procedures for adequacy.
Approval documents for sealed source or device designs should be clear, complete and accurate as to isotopes, forms, quantities, uses, drawing identifications, and permissive or restrictive conditions.
A.21 Questions:
1.
Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the reporting period.
The table heading should be:
SS&D Manufacturer, Type of Indicate Indicate if Registry Distributor or Device if Agreement Number Custom User or Source NARM Material Ans:
No registrations were issued since the last review.
2.
List the applications for SS&D registrations for which registry documents have not yet been issued.
Ans:
The information submitted for registration of Niton's XRF device is incomplete.
3.
What guides and procedures are used to evaluate registry applications?
Ans: NRC guides, standard review plans, and available technical standards (e.g., ANSI) are used for safety evaluations.
4.
Please describe the procedures for supervisory review of SS&D registrations.
Ans:
The supervisor is f amiliar with the evaluation via discussions with the reviewer and review of correspondence generated throughout the evaluation process, as well as reviewing and signing off on the registration sheet.
C.
Licensino Procedures (Category II)
MRC Guidelines:
The RCP should have internal licensing guides, checklists, and policy memoranda consistent with current NRC practice.
License applicants (including applicants for renewals) should be furnished copies of applicable guides and regulatory positions.
The present compliance status of licensees should be considered in licensing actions.
Under the NRC Exchange-of-Information program, evaluation sheets, service licenses, and licenses authorizing distribution to general licensees and persons exempt from licensing should be submitted to NRC on a timely basis.
Standard license conditions comparable with current NRC standard license conditions should be used to expedite and provide uniformity in the licensing process. Files should be n,aintained in an orderly fashion to allow fast, accurate retrieval of information and documentation of discussions and visits.
Questions:
1.
Are current NRC Regulatory Guides furnished to reviewers?
A.22 Ans: The RCP maintains a file of NRC Division 8 and 10 Regulatory j
guides for use by license application reviewers.
i 1
2.
Other than Reg Guides, list any NRC or State review plans and model licenses used by your reviewers.
3.
We maintain a file of standard review plans and actual licenses issued by NRC for guidance.
We are not aware of any model licenses prepared for this purpose by NRC with the exception of those relating to decommissiong funding.
3.
Are checklists used by the reviewers maintained in the files?
Ans: The checklist remains with ?.he file, along with a reviewer-annotated copy of the appljcation in some cases.
4.
What internal licensing guides and procedures has the State developed?
Ans:
The state uses NRC guides and procedures.
{
5.
What NRC or State licensing guides and regulatory positions are furnished to new and renewal license applicants?
Ans:
NRC Regulatory Guides are furnished to new and renewal license applicants whenever appropriate guidance is available for the proposed activity.
6.
How do reviewers determine the present compliance status of licensees when considering licensing actions?
Ans: The present compliance status of licensees is determined through review of inspection files and discussion with the inspector.
7.
For what length of time are licenses issued?
Ans: Licenses are normally issued for five years.
8.
Explain how soon-to-expire licenses are tracked to assure either timely applications are received or procedures initiated to terminate the license.
Ans: A license database is maintained from which a variety of reports can be generated, including the expiration date of each license. The report is printed periodically and licenses are given about 90 days' notice regarding their license expiration.
9.
What mechanism exists to assure that SS&D registrations, advisories to licensees and service licenses issued by the State are distributed to the NRC7
A.23 Ans:
Copies of SS&D registrations and other information which may af fect out of state interests are forwarded to NRC as soon as they are completed or effected.
10.
Have you developed your own standard license conditions?
Ans: We continue to utilize NRC standard conditions.
I 11.
How do you verify that your standard conditions are comparable to the current NRC conditions?
12.
How is your SS&D registry kept current?
\\
Ans:
SS&D registration sheets are filed in the catalog as soon as received.
13.
Describe the system used to advise licensees of pertinent changes in regulations and regulatory procedures, l
Ans:
Copies of regulations are mailed to af fected licensees and/cc registrants.
14.
Describe your procedures for maintaining the license files (How
{
are files and folders arranged?
Are telephone contacts and i
visits documented?
Who is responsible for filing materials
{
in folders?).
Ans: License files are arranged alphabetically by licensee name.
They contain present and previous licenses, current new/ renewal and any amendment applications (usually by control number in separate folders), and all past inspection reports and enforcement correspondence. Records of telephone contacts or visits are also maintained in these files.
15.
In what circumstances do license reviewers accompany inspectors?
Ano: License reviewers may accompany the inspector at the license reviewer's discretion.
VI.
COMPLIANCE A.
_ Status of Inspection Procram (Category I)
NRC Guidelines: The State RCP should maintain an inspection program adequate to assess licensee compliance with State regulationo and license conditions.
The RCP should maintain statistics which are adequate to permit Program Management to assess the status of the inspection program on a periodic basis.
Information showing the number of inspections conducted, the number overdue, the length of time overdue and the priority categories should be readily available.
A.34 There should be at least semiannual inspection planning for the number of inspections to be performed, assignments to senior versus.
junior staf f, assignments to regions, identification of special needs and periodic status reports. When backlogs occur the program should develop and implement a plan to reduce the backlog. The plan should identify priorities for inspections and establish target dates and
~
milestones for assessing progress.
Questions:
1.
Prepare a table identifying the Priority 1, 2, and 3 licenses with inspections that are overdue by more than 50% of their scheduled f requency.
Include the licensee name, inspection pciority, the due date, and the number of months the inspection is _verdue.
The list should include initial inspections that are overdue. The table heading should be:
Insp. Freq.
Licerme_e Name (Yearst Due Date Months O/D Ans:
Not applicable.
2.
Describe your action plan for completing your overdue inspections.
If there is a backlog of (1) inspections with an inspection frequency of 3 years or less that are overdue by more than 50% of their I
scheduled frequency, or-(2) inspections with lower inspection frequencies that i
are overdue by'more than 100% of their scheduled frequency, i
1 please include with the questionnaire a written action plan j
for eliminating the backlog.
The written action plan should contain inspection priorities, numerical and time frame goals for reducing the backlog, provide a method to measure the program's progress, and provide l
for management review of the program's success in meeting the goals.
3.
How many on-site close-out inspections prior to license i
termination were made during the reporting period?
j i
Ans:
- None, j
4.
How many on-site close-out inspections are pending at this time?
Ans:
None.
5.
How many reciprocity notices were received in the reporting
A.25 period?
Ans:
34.
6.
How many reciprocity inspections were conducted?
Ans:
5.
i 7.
Other than reciprocity licensees, how many field inspections i
i of radiographers were performed?
Ans:
3 8.
What percentage is this of your total number of radiographer licensees 7 t
Ans:
60%.
i 9.
How is statistical information about the inspection program maintained?
Ans:
The license database contains fields regarding the most recent inspection and next inspectior. due date.
Statistical infomation is available by querying the database.
10.
Project the total number of inspections needed to be done annually to meet your inspection priorities.
Ans: About 30.
11.
Project the number of inspections per inspector required per month and per year in order to avoid backlogs.
Ans: 30 per yee.r or 2.5 per month.
12.
How are inspection schedules planned, how are the dates and personnel assignments made, and how frequently are the plans updated?
Ans:
Inspections are scheduled by calendar quarters and reviewed / updated quarterly. Almost all inspections have been performed by one inspector.
13.
How are initial inspections identified when they become overdue?
Ans:
Initial inspection due dates are entered in the license database along with cther'information when the new license is issued.
Overdue initial inspections would therefore be identified in the same manner as overdue routine inspections 14.
Describe your inspection priorities for inspecting terminating licenses.
A.26 1
1 Ans: License termination inspections are done if indicated o.'
the basis of the information submitted by the licensee when requesting termination, and RCP knowledge of the actual type and extent of use of licensed materials.
l l
B.
Inspection Precuency (Category I) 1 NRC Guidelines The RCP should establish an inspection priority 1
system. The specific frequency of inspections should be based upon the potential hazards of licensed operations, e.g., major processors, broad licensees, and industrial radiographers should be inspected approximately annually -- smaller or less hazardous operations may be inspected less frequently.
The minimum inspection frequency including for initial inspections should be no less than the NRC system.
1 Questions:
1.
Identify individual licensees or groups of licensees the State is inspe-ting more frequently than called for in the State's j
inspection priority system and discuss the reason for the
- change, l
Ans:
No licensees are on an accelerated inspection frequency.
2.
How are inspection priorities assigned to licenses, and where are they recorded?
j Ans:
Inspection priorities are assigned in accordance with the category / priority system and recorded in the license database.
l 3.
Discuss any variances in the State's prioritics from the NRC i
priority system and the reasons for the variances.
Ans: Not applicable.
4.
Describe the State's policy for unannounced inspections and exceptions to the policy.
)
\\
Ans:
Except for initial inspections of new licenses, all routine inspections are unnanounced.
5.
Describe the State's policy for conducting follow-up inspections, j
Ans:
Follow-up inspections are conducted whenever serious or potentially serious violations are discovered, or when the RCP has reservations about a licenaee's ability or willingness to j
implement corrective actions they have consented to.
I
A.37 C.
Inspector's Performance and Capability (Category I)
HRC Guidelines:
Inspectors should be competent to evaluate health and safety problems-and to determine compliance with State regulations.
Inspectors must demonstrate to supervision an understanding of regulations, inspection guides, and policies prior to independently conducting inspections. The compliance supervisor (may be RCP manager) should conduct annual field evaluations of each inspector to assess performance and assure application of appropriate and consistent policies and guides.
Questions:
1.
Prepare a table showing the number and types of supervisory accompaniments made during the reporting period. Include:
Supervisor Inspector License Cateaory Date M.
Stoeckel J.
Ferruolo 03121 1/7/94 2.
Were all inspectors accompanied at least, annually by the compliance supervisor during the reporting period?
If not, explain.
3.
How do new inspectors become qualified to conduct independent inspections?
Ans:
New inspectors would become qualified to conduct inspections independently by attending NRC courses and by accompanying an experienced state inspector on a variety of inspections.
D.
Responses to Incidente and Alleced Incidents (Category I)
NRC Guidelines:
Inquiries should be promptly made to evaluate the need for on-site investigations. On-site investigations should be promptly made of incidents requiring reporting to the Agency in less than 30 days (10 CFR 20.403 types).
For those incidents not requiring reporting to the Agency in less than 30
- days, investigations should be made during the next scheduled inspection.
On-site investigations should be promptly mada of non-reportable incidents which may be of significant public interest and concern, e.g.
transportation accidents.
Investigations should include in-depth reviews of circumstances and should be completed on a high priority basis.
When appropriate, investigations should include reenactments and time-study measurements (normally within a few days).
Investigation (or inspection) results should be documented and enforcement action taken when appropriate. State licensees and the NRC should be notified of pertinent information
- e. bout any incident which could be relevant to other licensed operations (e.g.,
equipment failure, improper operating procedures). Information on incidents involving failure of equipment should be provided to the agency responsible for evaluation of the device !or an assessment of possible generic design deficiency. The RCP should have access
A.38 i
to medical consultants when needed to diagnose or treat radiation injuries. The RCP should use other technical consultants for special problems when needed.
Questions:
1.
In this reporting period, did any incidents occur that involved
)
equipment or source failure or approved operating procedures that were deficient? If so, l
Ans:
No.
.I a.
How and when were other State licensees.who might be affected notified?
l i
b.
Was the NRC notified?
j 2.
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.
3.
If the RCP utilized medical or technical consultants for an emergency during the reporting period, please describe the circumstances for each case.
4.
In the reporting period, were there any cases involving possible criminal wrongdoing that were looked into or are presently undergoing review?
If so, please describe the circumstances for each case.
5.
What criteria is used to determine the need and response time for on-site inspections of reported incidents?
Ans: Whenever an incident is reported, the RCP attempts to ascertain the nature and severity of the incident.
An on-site investigation would be made of any bona fide incident or any alleged incident which cannot be ruled out as such in the initial assesment, and of any incident which would likely cause public interest or concern.
6.
Are there written procedures for looking into allegations or other reports of possible wrong doing by licensees, for
- example, Protecting the identity of allegers or persons requesting a.
that their identities not be made available for public disclosure?
b.
obtaining docu antation (e.g., signed statements, copies of records)?
A.39 c.
Obtaining the services of persons with specialized training and experience such as conducting and documenting formal interviews?
d.
Obtaining necessary legal counsel for inquires into wrong doing?
e.
Guidance for staff when allegations or inspections disclose the possibility of willful violations of regulatory requirements or other evidence of criminal wrong doing?
Ans:
There are no_ written procedures specific to this Agency.
In cases where willfulness or criminality is evident, we would seek the assistance of legal counsel in'determing the appropriate course of action.
E.
Enforcement Procedures (Category I)
NRC Guidelines:
Enforcement Procedures should be sufficient to provide a substantial deterrent to licensee noncompliance with regulatory requirements.
Provisions for the luvying of monetary penalties are recommended.
Enforcement letters should be issued within 30 days following inspections and should employ appropriate regulatory language clearly specifying all items of noncompliance and health and safety matters identified during the inspection and referencing the appropriate regulation or license condition being violsted.
Enforcement letters should specify the time period for the licensee to respond indicating corrective actions and actions taken to prevent recurrence (normally 20-30 days).
The inspector and compliance supervisor should review licensee responses.
Licensee responses to enforcement letters should be promptly acknowledged as to adequacy and resolution of previously unresolved items.
Written procedures should exist for handling escalated enforcement cases of varying degrees. Impounding of material should be in accordance with State administrative procedures. Opportunity for hearings should be provided to assure impartial administration I
of the radiation control program.
Questions:
1.
If during the reporting period the State issued orders, applied civil penalties, sought criminal penalties, impounded sources, or held formal enforcement hearings, identify these cases and give a brief summary of the circumstances and results for each case.
Ans:
Not applicable.
2.
What enforcement measures are available to the State to provide a deterrent to licensee noncompliance. with regulations or licence provisions?
I
i A.30 l
s 1
3.
Are there written procedures establishing severity levels for violators?
-l I
4.
Are there written procedures for escalated enforcement?
5.
If the RCP can apply civil penalties, have procedures been established to determine when they apply and the amounts?
l 6.
Describe the State's provisions for criminal penalties.
l Ans (2-6):
The RCP enforces its regulations in accordance with the 1
provisions of the Radiation Control Act, section A.7 of the regulations, and the state's Administrative Procedures Act. Enforcement options and procedures are described in the RCP's written enforcement policy
{
(previously provided to NRC).
Criminal penalties are provided in the Radiation Control Act.
7.
Are enforcement letters issued within 30 days following inspections?
Ars:
Yes.
8.
Do you have a standard format for enforcement letters?
Ans:
Yes.
l 9.
How are recommendations, items of concern, or matters of interest differentiated from items of non-compliance in the i
letters?
l Ans: Violations are generally identified in a separate notice of violation.
Deviations from accepted practice and recommendations are cleary noted as such.
l l
10.
Do the letters reference the appropriate regulation or license condition being violated?
Ano:
Yes.
11.
What time period is specified in the enforcement letters for
)
the licensee to respond with corrective actions taken?
Ans:
The licensee is required to respond to a notice of violation within 10 days of their receipt of same.
12.
Do inspectors write enforcement letters? If so, do the letters undergo supervisory review before they are sent to the licensee?
Ans:
The inspector drafts the enforcement correspondence which is reviewed and edited by the supervisor.
A.31 l
13.
Who reviews licensee responses?
Anst Both inspector and supervisor review licensee responses, j
14.
What is the time limit for the State's acknowledgement of licensee responses and what tracking system exists for assuring resolution of the items of non-compliance and unresolved items?
l Ans: Licensee responses are promptly reviewed for adequacy of proposed corrective actions.
If acceptable, the response is acknowledged in a close-out letter.
If a response is inadequate, the deficiencies are usually discussed with cognizant licensee personnel and a follow up letter issued.
A tickler file is used to track these actions until satisf actorily resolved. Unresolved items are revisited during the next inspection.
15.
Does the State have the authority to impound radioactive material?
Ans:
Radioactive material could be impounded under the general powers of the Director of Health.
16.
Can the State issue Orders, including Emergency Orders?
If so, who must sign them?
Ans: Orders, including emergency orders, are authorized by law and may be signed by the Director of Health / designee or the RCP administrator / designee.
17.
Do State administrative procedures permit the opportunity for hearings in major enforcement cases?
Ans: Hearings are permitted both under the administrative procedures and the radiation control regulations.
18.
Describe the State's policy for conducting follow-up inspections.
Ans:
Follow up inspections are appropriate where numerous and/or serious violations are identified, and especially if the violations are associated with f ailures of managerial controls.
F.
Innpection Procedures (Category II)
NRC Guidelines:
Inspection guides, consistent with current NRC guidance, should be used by inspectors to assure uniform and complete inspection practices and provide technical guidance in the inspection of licensed programs.
NRC, Guides may be used if properly supplemented by policy memoranda, agency interpretations, etc.
Written inspection policies should be issued to establish a policy f or conducting unannounced inspections, obtaining corrective action,
p n.,
n a
y A.32 following up and closing out previous violations, interviewing workers and observing operations, assuring exit interviews with management, and issuing appropriate notification of violations of health and safety problems.
Procedures should be established for maintaining licensees compliance histories.
Oral briefing of supervision or the senior inspector should be performed upon return from nonroutine inspections. For States with separate licensing and inspection staffs, procedures should be established for feedback of information to license reviewers.
Questions:
1.
Do you use inspection guides that are specific to categories of licensees?
2.
Has the RCP developed its own inspection guides or does it use NRC guides?
3.
Discuss the use of inspection policy memoranda, interpretations, etc., to supplement inspection guides.
4.
Are there written policies and procedures for:
a.
unannounced inspections?
b.
obtaining corrective action?
c.
following-up and closing out previous citations of
)
violations?
J d.
interviewing workers?
e.
observing operations?
l f.
exit interviews with management?
l g.
issuing notices of violations and findings of health and
' i l
safety problems?
Ans:
The RCP uses NRC inspection guides and follows NRC policies and practices to the extent that they are useful, applicable, and appropriate.
5.
Describe the procedures for maintaining licensee's compliance histories.
Ans:
Compliance histories are maintained through written inspection reports which are zacained on file with all enforcement correspondence.
6.
Explain your policy for supervisors oebriefing inspectors upon return from inspections.
-A.33 Ans:
All inspections are reviewed with supervisory staf f inunediately on return from each inspect.. on.
7.
What procedures exist for providing feedback of compliance information to licensing?
Direct contact between licensing and inspection personnel, and Ans:
review of compliance histories during license application reviews.
G.
Insnection Reoorts (Category II) l NRC Guidelines Findings of inspections should be documented in a report describing the scope of inspections, substantiating all items of noncompliance and health and safety matters, describing the scope of licensees
- programs, and indicating the substance of discussions with licensee management and licensee's response.
Reports should uniformly and adequately document the results of inspections and identify areas of the licensee's program which should receive special attention at the next inspection.
Reports should show the status of previous noncompliance and the independent physical measuremants made by the inspector.
Questions:
1.
Describe the format (s) used by the RCP for documenting inspections.
Ans:
Standard forms are used for all routine inspections. Several forms are available covering the common license types.
The forms include all inspection areas required by the inspection guides and are designed to facilitate notation of the inspector's comments.
Items of noncompliance are document 2d on the form, and substantiating details are included in the Items of Noncompliance Appendix.
Narrative type inspection reports are sometimes used for limited inspections.
2.
Do the reports document:
a.
the entrance and exit discussions held with license management?
b.
follow-up of previous citations of violations?
c.
results of interviews of workers, including ancillary workers 7 d.
results of observations of operations?
confirmatory measurements conducted by the inspector?
e.
f.
areas of the licersee's program needing special attention
A.34 at the next inspection?
g.
the items of non-compliance found in the inspection?
h.
Items of non-compliance versus items of concern?
Ans: All of the above subjects are addressed in the inspection reports.
H.
Confirmatory Heasuremente (Category II)
NRC Guidelines:
Confirmatory measurements should be sufficient in number and type to ensure the licensee's control of materials and to validate the licensees measurements. RCP instrumentation should be adequate for surveying license operations (e.g.,
survey meters, air samplers, lab counting equipment for smears, identification of isotopes, etc.).
RCP instrumentation should include the following types:
GM Survey Meter:
0-50 mr/hr Ion Chamber Survey Meter: up to several R/hr Neutron Survey Meter:
Fast & Thermal Alpha survey Meter:
0-100,000 c/m Air Samplers: Hi and Low Volume Lab Counters: Detect 0.001 pc/ wipe Velometers Smoke Tubes Lapel Air Samplers Instrument calibration services or facilities should be readily available and appropriate for instrumentation used.
Licensee equipment and facilities should not be used unless under a service contract.
Exceptions for other State Agencies, e.g.,
a State University, may be made.
Agency instruments should be calibrated at intervals not greater than that required to licensees being inspected.
(Note: Addition types of instrumentation that are highly desirable are thin window plastic or NaI detectors for low energy gammas and
" micro-R" meters with audio signal for searching for lost gamma emitter sources.)
Questions:
1.
Discuss the State's policy for conducting confirmatory measurements as a part of each inspection (e.g., air samples, l
wipe samples, air flows, dose rates).
l l
Ans:
Confirmatory measurements are made during inspections to verify licensee measuremens and/or to confirm compliance with allowable exposure rates, contamination levels, ventilation
A.35 rates, etc.
2.
List the equipment that is readily available to the RCP for surveying licensed operations and ' conducting appropriate confirmatory measurements.
Ans: A list of available survey equipment is attached.
3.
Describe the method used for calibrating survey instruments and the frequency of calibration.
Ans:
Survey instruments are calibrated at the RINSC facility using traceable sources and a variable distance method. Calibrations are scheduled such that instruments are always in calibration "l
with respect to the calibration frequency required of'the licensee.
l i
1
A.36 PART II PROGRAM STATISTICS as of (
date
)
- l.
How many specific licenses are currently in effect?
80 2.
During the last calendar year, a.
how many new licenses were issued?
10 b.
how many licenses were terminated?
4 c.
how many licenses were renewed?
8 d.
how many amendments were issued?
22 how many SS&D evaluations were completed?
e.
O 3.
How many prelicensing visits were made during this past calendar year?
1 4.
How many new licenses (or major amendments) were hand delivered to the licensee?
O 5.
How many materials incidents, other than unfounded allegations, occurred during the last calendar year?
O 6.
How many on-site investigations of incidents were conducted during the last calendar year?
O
- 7.
How many incidents required NRC notification, either by telephone or by written report?
O
- B.
How many of the incidents required Abnormal Occurrence Reports?
O
- 9.
How many of the incidents involved leaking from sealed sources?
O
- 10.
How many misadministrations occurred during the last calendar year?
O 11.
How many civil penalties were imposed during the last calendar year?
O 12.
How many orders were issued during the last calendar year?
O
- tiot e :
If the information requested in the questions marked with an asterisk has been submitted to State Programs for the prior year, please answer these questions for the date of this review or the period since January 1 of this year as appropriate.
A.37 i
- 13.
How many' technical FTE's (not including administrative, clerical or unfilled vacancies) are currently assigned to the Radioactive materials program?
i l
i Ans:
1.0 FTE.
Low-Level waste program?
Ans:
O FTE.
l
- 14.
Compute the professional / technical person-year effort of person years per 100 licenses (excluding management above the direct RAM supervisor, vacancies and personnel assigned to mills and burial site licenses).
Count only time dedicated to radioactive materials.
Ans:
1.0 FTE/80 licenses = 1.25 FTE/100 licenses.
- 15.
List the RCP salary schedule as follows:
I Position Title Annual Salary Rance Chief
$46,685 - 63,485 I
supervising Radiation 35,846 - 48,462
{
Control Specialist 1
Radiological Health Specialist 33,296 - 44,957 Senior Industrial Hygienist 33,296 - 44,957 Toxicologist 40,636 - 55,226 j
- 16.
Please complete the following table using the license categories as shown, and including the total number of specific licenses in each category, the priority or inspection f requency, the number of inspections made during the review period, and the number of overdue inspections in each category.
{
(In Priorities 1-3, include those overdue by more than 50% of their j
scheduled inspection f requency; in lower priorities, include those overdue j
by more than 100% of their scheduled frequency. )
Insp.
No.
No.*
No. of Freg.
Insps.
Overdue License Cateoory Licenses (years)
Made Innos.
Broad A Academic (Medical)
- Note:
If the information requested in the questions marked with an asterisk
{
has been submitted to State Programs for the prior year, please answer these j
questions for the date of this review or the period since January 1 of this year as appropriate.
i
'I
A.38 Insp.
No.
No.*
No. of Preq.
Insps.
Overdue
~
j j
License Catecorv Licenses
_fvears)
Made Insos.
j Broad A Industrial Broad A Medical 2
1 1
0 Broad A Mfg. & Dist.
Industrial Radiography 5
1 3
0 Irradiator - Pool or Large LLW Broker or Service - Processing, Incineration, Repackaging LLW Disposal & Burial
)
Nuclear Pharmacy Source Material Processing Teletherapy (Human Use) 3 1
3 0
U-Mill Operation other Priority 1 Broad A Academic (Non-Medical) 3 2
2 0
)
Bread B Academic Broad A B & D Decontamination Services LLW Disposal Service (pre-packaged)
Mobile Nuclear Services 1
2 1
0 SNM (unsealed)
Other Priority 2 Broad B Industrial Broad B Mfg. & Dist.
i Broad B R & D In vitro Distribution Irradiators, Self-Contained, Small 1
3 0
1 Leak Test & Calibration Services Medical Product Distribution Medical, Institutional 8
3 5
0 (Hospitals & Clinics)
I Nuclear Laundry Source Material, Rare Earth U-Mill Tailings Well Logging, Field Flooding Other Priority 3 2
3 0
0 GL Distribution 1
4 0
0 i
Lixiscopes, Bone Mineral Analyzer, Sr Eye Applicator Medical, Private Practice 8
4 1
0 Limited Diagnostic or Therapy Portable Gauge 31 4
1 3
Services - Teletherapy, Gauge, or
- Note:
If the information requested in the questions marked with an acterisk has been submitted to State Programs for the prior year, please answer these questions for the date of this review or the period since January 1 of this year as appropriate.
A.39 1
i Insp.
No.
No.*
No. of Freq.
Insps.
Overdue License catecory Licensen fyears)
Hade Insos.
Irradiator other Priority 4 4
4 0-0
)
i Broad C Academic Broad C Industrial Broad C Mfg. & Dist.
Broad C R & D 1
5 0
0 Fixed Gauge 2
5 0
0 In vitro Labs SNM (sealed)
Veterinary Hedicine Other Priority 5 1
Gas Chromatographs &
)
other Measuring Systems 4
7 0
2 Leak Test only Shielding, Depleted Uranium Other Priority 6 and 7 3
7 0
0 TOTALS 79 17 6
I l
i
- Note:
If the information requested in the questions marked with an asterisk has been submitted to State Programs for the prior year, please answer these questions f or the date of this review or the period since January 1 of this year as appropriate.
/fb{
b56)l DISTRIBUTION ORGANIZATION NUMBER OF COPIES Governor's Office 1
Lieutenant Governor 1
Adjutant General i
Division of State Police 1
National Weather Service i
i Registry of Motor Vehicles 1
Secretary of State t
Treasury Department i
Department of Administration 1
Department of Education 1
Departme,nt of Social and Rehabilitative Services 1
Department of Mental Health, Retardation and Hospitals 1
Department of Labor 1
Department of Transportation 1
Department of Employment Security 1
Department of Environmental Management 1
Department of Health 1
Department of Business Regulation 1
Heads of Local Governments 39 Local Emergency Management Agency Directors 39 Region One FEMA 2
Regional Administrator, Region One, HUD 1
Commander, 1st Coast Guard District, Boston, MA 1
American Red Cross 1
Department of Agriculture, State Defense Board i
Naval War College President 1
7%
s
1
~
Nominated November, 1993 as a replacement 2
Membership of these individuals recommended by cognizant society Mr. Charles McMahon and Ms. Marie Stoeckel Department of Health Office of Occupational and Radiological Health 206 Cannon Building 3 Capitol Hill Providence, RI O2908 Telephone 277-2438 (Judy Grant)
Mr. William Dundulis Department of Health Office of Environmental Health Risk Assessment 208 Cannon Building 3 Capitol Hill Providence, RI 02908 Telephone 277-3424 Revised 12/21/93
RADIATION ADVISORY COMMISSION MEMBERS 1
ALL MEMBERS AND CHAIRMAN APPOINTED BY DIRECTOR OF HEALTH
- 1) Rhode Island Atomic Terry Tehan,1 25 March 1995 Designee of Energy Commission Director Rhode Island RI Nuclear Science Atomic Energy South Ferry Road Commission Narragansett, RI 02882 Telephone 789-9391
- 2) Physical Science Wm. Roventine, M Sc 25 March 1995 Radiological or Engineering Radiation Physics Serv.
Physicist and Recording 228 Steere Farm Road Secretary Harrisville, RI 02830 Telephone 568-2287
- 3) Diagnostic Sanford Schatz, M.D.2 25 March 1996 Affiliated on Radiology The Miriam Hospital full-time Department of Radiology basis with 164 Summit Avenue voluntary, Providence, RI 02906 non-profit.
Telephone 274-3700, hospital l
extension 4400 1
- 4) Nuclear Medicine Patricia Spencer, M.D.2 25 March 1996 Affiliated on Dept. of Nuclear full-time Medicine basis with FI Hospital voluntary, 593 Eddy Street non profit Providence, RI 02902 hospital Telephone 444-5281/
331-1110
- 5) Dentistry and Joseph Yacovone D.M.D.
25 March 1994 Designee of Vice Chairman 74 Bent Road Director of Rumford, RI 02916 Health Telephone 434-8011 l
l 1
y
.. - -.. ~.. _..
l
- 6) Veterinary Medicine catherine Pointek DVM1'2 25 March 1996 Portsmouth Vet. Clinic 85 Middle Road Portsmouth, RI 02840 i
Telephone 683-0803
- 7) Industrial Ronald Stevens 25 March 1996 Radiation Radiation 86 Greenwood Drive Protection Peace Dale, RI 02883 Telephone (203)433-5818 1
2
- 8) Radiologic Charles Abate 25 March 1995 Registered Technology Radiolgy Associates Technologist 38 Hamlet Avenue
{
Woonsocket, RI 02895 Telephone 766-4224 1
- 9) Undesignated Vincent DiSpigno, Ph.D.
25 March 1995 Nuclear-40 Shore Drive Pharmacist I
Johnston, RI 02919 Telephone (508)695-4600 2
10)Undesignated Wayne Cotnoir 25 March 1995 Nuclear 106A Pleasant Street
' Medicine
.l Cranston, RI 02910
. Technologist Telephone 456-4265 affiliated on full-tine basis -
with non-profit ho@ ital 11)Undesignated, Douglas Shearer, Ph.D.
25 March 1995 Fbdical Phpics Chairman Main Bldg., Rm. 305 Nacimr Ihysics Rhode Island Hospital affilliated 593 Eddy Street on full-time' 1
Providence, RI 02903 basis with
{
Telephone 444-5961 voluntary,rr.tr profit hocpital
m
.w A
J w
A
-4.e.
J e
4&>*
a Ah 4
A.+
l.
RCP SURVEY EQUIPMENT AS OF 12/93 MANUFACTURFR TYPE MODEL/PPOBES RADIATION LUDLUM PULSER 500 LUDLUM SCALER /S.C.A.
2200 LUDLUM SCINT 44-21 BETA / GAMMA ATLANTIC NUCLEAR G-M PANCAKE ASD-248 BETA / GAMMA LUDLUM SCINT 60 ALPMA LUDLUM SCINT 3
(44-2;44-3)
LOW E GAMMA G-M (44-7;44-9)
BETA / GAMMA LUDLUM G-M 2 (44-7)
BETA / GAMMA LUDLUM SCINT 12 S GAMMA EBERLINE G-M E-120/HP190 BETA / GAMMA-HP-270 VICTOREEN ION CHAMBER 470A & 450P BETA / GAMMA KEITHLEY ION CHAMBER 36155 BETA / GAMMA BICRON G-M RADIOGRAPHER GAMMA 2
av.._me+d.3-p4m a e, m nun ep+ eaeesseas
.m-emaamJ-4 iw m eve 4 Fem-d.aam.aMe.m-4a-.mw-46-p,e.=*.
me
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GOVERNOR I
DIRECTOROF HEALT!!
Medic 1 Examiner i
i l
llealth Information
!!ealth Policy Management Services i
& Assessment
& Planning l
I I
ENVIRONMEf4TAL I
DISEASE CONTROL
.__l-...___.._
' ItEALTl!
PREVENTIVE ItEALTII PAHILY llEALT!!
IIE ALTil SERVICES REGULATION SERVICES Food Protection Communicable Disease Chronic Disease Maternal & Child 11eal th Facilities Regulation
- Prevention & Ilealth Promotion DEinking water AIDS /STD Quality Primary Care Children with Special Professional l
Regulation Needs 1
k occupational &
Environmental llealth School IIealth RadLological itealth Risk Assessment Women, Infantkand Drug Control Children (WIC)
Health Laboratories Oral llealth Medical Licensure &
Discipline ORGANIZATIONAL CitART Rl! ODE ISLAND DEPARTHEllT OF IIEALTil AUGUS7 27, 1993 i,
.w__
- - ^ ' ~ ~ ^ ^ ^ ~ ~
L l
[
ENVIRONMENTAL HEALTH Walter S.
- Combs, Jr.,
Ph.D.
Associate Director Clerk Secretary OCCUPATIONAL &
ADMINISTRATIVE Pen. Clerk I
RADIOLOGICAL HEALTH STAFF Stenographer Marie Stoeckel, Chief Frances Banno 277-438 Chief Clerk Data Entry Clerk
=
l l
RADON &
INDUSTRIAL RADIATION i
ASBESTOS HYGIENE CONTROL I
Roger Marinelli James Gamelin Charles McMahon Sup. Rad.
Prn. Industrial Sup. Rad.
Control Spec.
Hygienist Control Spec.
Industrial Prn. Occupational Rad. Health Hygienist Industrial Safety Spec.
Specialist Hygienist 4
Industrial Industrial Sr. Industrial Hygienist.
Industrial Hygienist Hygienist Hygienist Industrial Sr.Ind. Hygiene Industrial Hygienist
.ech.
Hygienist t
(vacant)
(vacant)
Organizational Chart Occupational & Radiological Health
APPENDIX D REVIEW 0F SELECTED COMPLIANCE FILES THE STATE STAFF UTILIZES A FIELD INSPECTION FORM TO DOCUMENT INFORMATION THEY l
OBTAINED DURING THEIR INSPECTIONS.
IN GENERAL THE FILES WERE REVIEWED TO DETERMINE IF THE INSPECTIONS WERE COMPLETE AND SUBSTANTIATED ALL ITEMS OF NONCOMPLIANCE AND RECOMMENDATIONS. THE FILES WERE REVIEWED TO DETERMINE: (1)
IF APPROPIATE ENFORCEMENT ACTIONS WERE TAKEN; (2) WRITTEN IN APPROPIATE REGULATORY LANGUAGE; (3) TIMELINESS OF CORRESPONDENCE; (4) IF ADEQUATE RESPONSES WERE RECEIVED FROM THE LICENSEE TO CLOSE OUT THE ENFORCEMENT 3
ACTIONS; (5) IF THE REPORTS WERE SUFFICIENTLY DETAILED TO DOCUMENT THAT THE i
LICENSEE'S PROGRAM WAS SUFFICIENT TO COMPLY WITH THE RULES AND REGULATIONS, AND TO PROTECT HEALTH AND SAFETY.
INCIDENT AND ALLEGATION FILES WERE REVIEWED j
FOR PROMPT EVALUATION OF THE NEED FOR AN ON-SITE INVESTIGATION, TIMELINESS OF l
STATE RESPONSE, DOCUMENTATION OF INVESTIGATION FINDINGS, TIMELINESS AND q
COMPLETENESS OF LICENSEE RESPONSE, APPROPRIATE ENFORCEMNET ACTION AND NOTIFICATION TO THE NRC AND STATE LICENSEES.
THE RESULTS OF SELECTED FILE REVIEWS WERE DISCUSSED WITH THE RADI0 ACTIVE MATERIALS PROGRAM STAFF, THE SUPERVISING RADIATION CONTROL SPECIALIST AND THE CHIEF 0F THE DIVISION OF OCCUPATIONAL AND RADIOLOGICAL HEALTH.
l
- 1. R0GER WILLIAMS HOSPITAL 825 CHALKSTONE AVENUE PROVIDENCE, RHODE ISLAND 20908 LICENSE # 7B-226-01 PRIORITY l TYPE: INSTITUTIONAL NUCLEAR MEDICINE & BRACHYTHERAPY ROUTINE UNANNOUNCED INSPECTION DATE: 2/16-17/93
- 2. RADIATION ONCOLOGY ASSOCIATES BANICE M. WEBBER, M.D.
825 NORTH MAIN STREET PROVIDENCE, RH0DE ISLAND 02904 LICENSE # 7A-038-01 PRIORITY l TYPE: TELETHERAPY ROUTINE DATE: 9/13/93
- 3. RHODE ISLAND HOSPITAL 593 EDDY STREET PROVIDENCE, RHODE ISLAND 02903 i
LICENSE # 7A-051-02 PRIORITY l TYPE: GAMMA-KNIFE INITIAL INSPECTION DATE: 1/6/94
- 4. PHILIP G. MADDOCK, M.D.
450 TOLLGATE ROAD WARWICK, RH0DE ISLAND 02886 LICENSE # 7A-053-01 PRIORITY 1 TYPE: TELETHERAPY ROUTINE DATE: 9/8/93
- 5. UNIVERSITY OF RH0DE ISLAND NARRAGANSETT, RHODE ISLAND 02882 LICENSE # 3K-040-01 PRIORITY 2 TYPE: ACADEMIC ROUTINE UNANNOUNCED DATE: 3/24-25/93
- 6. GENERAL DYNAMICS / ELECTRIC BOAT DIVISION QUONSET POINT FACILITY NORTH KINGSTOWN, RHODE ISLAND 02852 LICENSE # 3D-005-01 PRIORITY 1 TYPE: INDUSTRIAL RADIOGRAPHY ROUTINE UNANN0UNCED DATE: 10/28/93
- 7. MEDIQ IMAGING SERVICES, INC.
300 WILLOW STREET SOUTH NORTH AND0VER, MASSACHUSETTS 01845 LICENSE # 7B-086-01 PRIORITY 2 TYPE: NUCLEAR CARDIOLOGY ROUTINE UNANNOUNCED DATE: 11/30/93 & 12/7/93
- 8. GRINNELL CORPORATION 1341 ELMWOOD AVENUE CRANSTON, RHODE ISLAND 02910 LICENSE # 3D-064-01 PRIORITY 1 TYPE: INDUSTRIAL RADIOGRAPHY ROUTINE UNAisNOUNCED DATE: 8/7/93 & 8/11/93
- 9. RH0DE ISLAND NUCLEAR SCIENCE CENTER RH0DE ISLAND ATOMIC ENERGY COMMISSION SOUTH FERRY ROAD NARRAGANSETT, RHODE ISLAND 02882 LICENSE # 3K-063-01 PRIORITY 1 TYPE: BROAD SCOPE LABORATORY / ACADEMIC ROUTINE UNANN0UNCED DATE: 3/9/93 a
- 10. RHODE ISLAND HOSPITAL 593 EDDY STREET PROVIDENCE, RH0DE ISLAND 02902 LICENSE # 78-051-01 PRIORITY 1 TYPE: BROAD-SCOPE HEDICAL ROUTINE UNANNOUNCED DATE: 10/14-15/93 INCIDENT AND ALLEGATION FILE REVIEW
- 11. TRUCK AWAY FILE # 92-01 WARWICK, RHODE ISLAND TYPE: NON-LICENSEE TRASH REMOVAL SERVICE DATE: 3/13/92
- 12. TRUCK AWAY FILE # 92-02 WARWICK, RHODE ISLAND TYPE: NON-LICENSEE TRASH REMOVAL SERIVICE DATE: 3/18/92
- 13. ROGER WILLIAMS HOSPITAL FILE # 92-03 825 CHALKSTONE AVENUE PROVIDENCE, RHODE ISLAND 02908 LICENSE # 7B-026-01 TYPE: BRACHYTHERAPY DATE: 5/15/92
- 14. RHODE ISLAND DEPT. OF HEALTH-LEAD PROGRAM FILE # 92-04 3 CAPIT0L HILL PROVIDENCE, RHODE ISLAND 02908-5097 LICENSE # 3L-006-01 TYPE: X-RAY FLUORESCENCE ANALYZER DATE: 5/6/92
- 15. HOME0WNER COMPLAINT FILE # 92-05 BURRILLVILLE, RHODE ISLAND NON-LICENSEE DATE: 8/28/92
- 16. CITIZEN COMPLAINT FILE # 92-06 NARRAGANSETT, RH0DE ISLAND NON-LICENSEE DATE: 11/12/92 YN
- 17. ROGER WILLIAMS HOSPITAL FILE # 92-07 LICENSE # 78-026-01 825 CHALKSTONE AVENUE PROVIDENCE, RHODE ISLAND 02908 TYPE: INSTITUTIONAL NUCLEAR MEDICINE DATE: S/27/92
SUMMARY
TABLE THE FOLLOWING TABLE LISTS THE SPECIFIC COMMENTS DEVELOPED DURING THE REVIEW OF THE NUMBERED CASEWORK FILES LISTED AB0VE.
SPECIFIC COMMENTS CASEWORK NUMBER A. NEED BETTER DOCUMENTATION OF INSPECTOR 1
OBSERVATIONS B. NEED BETTER DOCUMENTATION OF WORKER 1
AND/0R ANCILLARY STAFF INTERVIEWS C. OVERDUE FOR INSPECTION BY > 50% OF THE 1, 2, 4, 5 INSPECTION FREQU[NCY D. REPORT DOES NOT INDICATE WHETHER THE 2,3,4 INSPECTION WAS ANNOUNCED OR UNANNOUNCED E. INSPECTION REPORT OVERDUE BY > 30 DAYS 2,3,4 F. ZNFORCEMENT LETTER OVERDUE BY > 30 DAYS 2
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