ML20138Q263

Impep Review of MD Agreement State Program Sept 23-27,1996, Proposed Final Rept

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l INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF MARYLAND AGREEMENT STATE PROGRAM SEPTEMBER 23-27, 1996 l

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PROPOSED FINAL REPORT l i

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i U.S. Nuclear Regulatory Commission 02/28/97 9703060237 970228 PDR ATTACHMENT 1 STPRC ESGMD

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1.0 INTRODUCTION

This report presents the results of the review of the Maryland radiation control program.

The review was conducted during the period September 23-27,1996, by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Washington. Team members are identified in Appendix A. The review was conducted in accordance with the " Interim implementation of the Integrated

, Materials Performance Evaluation Program Pending Final Commission Approval of the 1

Statement of Principles and Policy for the Agreement State Program and the Policy Statement on Adequacy and Compatibility of Agreement State Programs," published in the Federal Reaister on October 25,1995, and the September 12,1995, NRC Management

, Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period April 4,1994 to September 20,1996, were discussed with Maryland management on September 27,1996.

[ Paragraph on Results of MRB meeting will be included in final report. Attachment 1, State's response will be included in final report.]

The Maryland Department of the Environment (MDE) is the agency within the State of Maryland that regulates, among other public health issues, radiation hazards. The Secretary, MDE, is appointed by and reports directly to, the Governor. Within MDE, the Maryland radiation control program is located in the Radiological Health Program Office, which is located in the Air and Radiation Management Administration. The Maryland Department of the Environrpent and the Air and Radiation Management Administration organization charts are included as Appendix B. During the review period the Maryland

program regulated 561 specific licenses, which include commercial irradiators, manufact;rers, broad academic, broad medical, radiopharmacy and radiographers. In addition to its radioactive materials program, MDE is responsible for the control of machine produced radiation, and emergency response for 2 nuclear power plants. The review focused on the materials program as it is carried out under the Section 274b. (of the l Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of j Maryland.

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! In preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the State on August 9,1996. Maryland provided its response to

, the questionnaire on September 16,1996. A copy of that response is included as Appendix C to this report.

1 The review team's general approach for conduct of this review consisted of:

(1) examination of Maryland's response to the questionnaire, (2) review of applicable Maryland statutes and regulations, (3) analysis of quantitative information from the radiation control program licensing and inspection data base, (4) technical review of selected files, (5) field accompaniments of three Maryland inspectors, and (6) interviews with staff and management to answer questions or clarify issues. The team evaluated the information that it gathered against the IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of the radiation control program's performance.

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Section 2 below o'iscusses the State's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common indicators, and Section 5 summarizes the review team's findings

and recommendations.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS The previous routine review was conducted August 30 - September 4,1993, with follow-up activities conducted at selected times through April 7,1994. The results of this review were transmitted to Ms. Jane Nishida, Secretary Designee, Maryland Department of the Environment on March 3,1995. A follow up to this review was conducted November 7-8,1995, and the results transmitted to Secretary Nishida on April 17,1996.

A special joint U.S. Nuclear Regulatory Commission (NRC) and State of Maryland review of 33 misadministrations that occurred in 1987-1988 at the Sacred Heart Hospital (SHH) located in Cumberland, Maryland, (MD-01-002-02) was conducted in late 1993 and early 1994,in response to issues raised during an August 1993 Congressional hearing that questioned: (1) the adequacy of the State's 1988-1989 review: (2) why NRC had not previously reviewed the event: (3) inconsistencies in the records; and (4) the Stata's agreement to limit access to the records.

2.1 Status of items identified Durina the 1993-1994 Routine Review A number of recommendations were identified as part of the 1993-1994 review. The 1993-1994 review resulted in the withholding of a finding of compatibility due to 13 regulations not having been adopted within the 3 year period required by NRC. The team noted that the definition of " person" in Maryland's low-level radioactive waste (LLRW) regulations included jurisdiction over Federal facilities which is not consistent with 10 CFR 150.10. Section 274 contains no explicit waiver of the sovereign immunity of the United States; therefore, the agreement does not convey any authority for the State to regulate Federal agencies. Agencies of the Federal government are D91 exempted and continue to be subject to NRC regulation, not State regulation. The 1993-94 report stated that the definition of person in an Agreement State's regulations should not include agencies of the Federal government. Therefore, The State was requested to either remove or provide clarification to explain that, in COMAR 26.14.01.02B(28)(e), which includes Federal agencies in the definition of " person," with regard to' Agreement materials, Federal agencies are not subject to these regulations. In addition, it was recommended that the state continue its efforts to renew the Neutron Products, Inc. (NPI) license to establish a clear set of license requirements against which the state can assess continued operations at NPI and against which enforcement action can be taken,if required. Specific milestones and schedules for completion of actions were requested. The State was notified of NRC's intention to conduct a follow-up review. Some of the recommendations were closed at the time of the 1995 follow-up review. The review team looked at each remaining item to determine whether or not the Maryland program had taken additional actions to close open recommendations.

I Maryland Proposed Final Report Page 3 (1) Status of the 13 overdue regulations is as follows:

4 i NRC conducted a follow-up review November 7-8,1995. The 1995 follow-up review noted that the 13 overdue regulations were incorporated in the revised

" Maryland Regulations for the Control of lonizing Radiation (1994)" which became affective October 9,1995. See the next section for a continued discussion.

! (2) Status of the State's definition of " person" in the LLRW regulations to include i

Federal entities is as follows

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$ As of the 1993-1994 review t'his item was pending the result of discussions between the State and NRC legal staff. See the next section 2.2(1) for a continued discussion.

(3) Status of the effort to renew the NPI license, i i in January 1994, a court settlement was reached which required certain actions by I the licensee (NPI). With regard to the NPI license renewal, the state maintained i discussions with NPI and, on August 1,1994, NPI submitted a renewal application.

j However, in their preliminary screening, the state found the application to be l deficient in several procedural areas including some of the requirements identified in 5

the January 1994 court settlement. Discussion between the state and NPI i continued in an attempt to resolve the issues. In the June 6,1995 response letter 4

' to the 1993-1994 review, the State had committed to a schedule for issuance or

, renewal of the four (4) NPI licenses. The two irradiator licenses and the teletherapy i

service license were issued essentially on schedule. The source manufacturing i

license (MD-31-025-01) renewal was expected to be issued on schedule although the state noted difficulties in resolving issues with NPI management. See following i section 2.2(2). t 3

2.2 Status of items identified Durina the 1995 Follow-un Review j The 1995 follow-up review, conducted November 7-8,1995, identified that the definition

of " person" in Maryland's low-level radioactive waste regulations included jurisdiction over Federal facilities. The State had been requested during the 19931994 review to either remove or clarify that with regard to Agreement materials, Federal agencies are not subject i to these regulations. The follow-up review team also noted that NRC staff would j complete a final compatibility determination of the " Maryland Regulations for Control of

j. lonizing Radiation (1994)" in late April 1996; and identified an additional regulation, 1

" Licenses and Radiation Safety Requirements for irradiators," 10 CFR Part 36 (58 FR i-7715), effectiva July 31,1993, that would become due for adoption by the Agreement States by July 31,1996. NRC recommended that the State take action to revise the

" Regulation Adoption Management Plan," for review during the next scheduled audit, and j continued to recommend the importance of state action to renew the NPI license.

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(1) Current status of the State's definition of " person" in Maryland's low-level l i radioactive waste regulations that included jurisdiction over Federal facilities is as i follows:

l In an August 25,1995, letter to Ms. Merrylin Zaw-Mon, Director, Air and Radiation j Management Administration (MDE), the NRC requested reconsideration of the a State's position on clarifying or changing the definition of " person" to clearly

,. exclude the regulation of Federal agencies located in the State. The State took

action to revise the definition of " person" in Section 2.A of COMAR 26.12.01.01, titled " Regulations for Control of lonizing Radiation." The definition now includes l and "to the extent authorized by federal law, federal government," which is i l acceptable to NRC, as of May 1996.

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The IMPEP team found that although the State revised the definition of " person" in  !

j. the Radiation Program regulations, no action has been taken by the Waste ,

4 Management Administration to revise the definition of " person" in the low-level  !

radioactive waste regulations COMAR 26.14.01.02B(28)(e) that was identified in

} both the 1993-94 review and the 1995 follow-up review. The State should provide  ;

j clarification of the use of the term " person" in the low-level radioactive waste j regulations, as it relates to Federal agencies, from the legal staff.

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] This item remains open. j l (2) Current status of any remaining issues regarding regulations is as follows: ,

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! NRC staff has reviewed the 13 amendments to the final COMAR regulations i adopted by the State of Maryland, that became effective October 9,1995, and, j based on that review, found that our earlier comments have been addressed.

! However, in completing the review staff identified issues in other sections of

Maryland regulations that have potential compatibility significance. Issues identified j by the staff relate to existing sections of Maryland regulations that were not

. modified by the 13 amendatory actions. Staff completed documentation of these ,

i' concerns and will transmit the concerns to the State separately by letter. These I l concerns are further addressed in Section 4.1 below. Also at the time of the IMPEP j review, the State had not completed their process for adoption of " Licenses and 1 Radiation Safety Requirements for Irradiators," 10 CFR Part 36, within the three

year period of adoption which became due July 31,1996, j The team noted that the State of Maryland regulates irradiator facilities which would be subject to the regulations in " Licenses and Radiation Safety Requirements

for Irradiators," 10 CFR Part 36. At the time of the review, equivalent rules were in j the final stages of promulgation and were scheduled to be adopted in November 4 1996. Subsequent to the review, the State informed the team that Part X of the i Maryland Code covering, " Licenses and Radiation Safety Requirements for 4 Irradiators," was adopted on November 19,1996, with an effective date of j December 16,1996, i

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d Maryland Proposed Final Report Page 5 The State revised the " Regulation Adoption Management Plan," but no action has occurred on the ten rules or amendments due for adoption by the end of 1997.

The State needs to act on the plan and provide a realistic schedule of milestones for completion of the rules identified in the plan.

This item remains open.

(3) Current status of the effort to renew the NPI license is as follows:

l A specific concern, during the 1995 follow-up review, resulted in a recommendation that the State work with Montgomery County in evaluation and approval of the NPI proposal for construction activities which should reduce the unnecessary radiation levels in and around the facility.

The 1995 follow-up review also commented on the prescriptiveness of the draft license (MD-31-025-01) and the concern that specifically tying the licensee's detailed procedures to the license would preclude the necessary flexibility for the licensee to satisfy and promptly address emergent conditions at the facility.

However, the State experienced difficulty in Detting NPI coopection in resolving issues such as financial assurance, the shielding of onsite radioactive waste held in l storage (a significant contributor to exposures for both onsite personnel and members of the public), and a courtyard cover to minimize releases of contaminated materials to the environment.

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In part, due to the continued recommendation from NRC to renew the NPIlicense, the State unilaterally reissued license MD-31-025-01 on January 18,1996. This license was prepared from the previous license which has been in timely renewal since 1980, the subsequent amendments and documents and information collected

, over the years. The draft was reviewed by a committee consisting of inspectors, license reviewers, and program management and revised to reflect the participants' cumulative history of the site. The licensee appealed the issuance of the licenso to i

the Office of Administrative Hearings. According to Maryland Administrative law,

the license cannot be enforced until the case is resolved at hearing. The State agreed to place the appeal on the inactive list as long as progress was being made in resolving the issues. A management conference was held in March 1996, and a few points of contention were resolved. The State believes the prescriptive nature of the license is warranted given the licensee's past history and the continuing

, difficulty in resolving issues with licensee management. The licensee is resistant to any regulatory actions that take away the ability to operate freely. There has i been a further exchange of correspondence on the license conditions, however, essentially no further progress has been made. The State notified the licens6a on August 30,1996 that the State would not agree to further delay and an administrative hearing would be scheduled as soon as possible.

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Maryland Proposed Final Report Page 6 The 1996 IMPEP review consisted of a review of the license file for MD-31-025-01 (the source manufac.turing license), interviews of the Maryland program inspector, license reviewer, and management, and an onsite visit to NPl.

The 1993-1994 review observed that the State had not been effective in handling j the NPI waste storage problem, high fenceline doses, and on and offsite I contamination. Since the previous review and follow up, the State has inspected )

the facility three times in 1994, twice in 1995 and twice to date in 1996. While -  !

this does not meet the State's intended quarterly unannounced inspection schedule, - I it does exceed the NRC inspection frequency for this type license. The State also i notes that contact with this licensee is quite extensive and time consuming and that when these other contacts are taken into consideration the State does interact -

with NPI on at least a quarterly basis.

The State has performed an independent assessment of the internal exposure potential (much less than the amount requiring monitoring and summation of doses) and the dose to the nearest residents (probably near 100 mrem per year). In April 1996, the State approved the conceptual design for a courtyard enclosure to reduce worker and public exposures and on and offsite contamination in August 1996, the State demanded the licensee submit the detailed plans for the courtyard i enclosure as required by court order. The licensee,in accordance with the court

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order, submitted plans to the County and State in September 1996. Subsequently, I the team found that upon technical review the plans were found incomplete.

The licensee has agreed to use concrete slab shielding to reduce worker and public exposures from the storage areas. The licensee has takm f.ome action to reduce exposures to workers involved in hot cell cleanup work cornpared to previous years.

Finally, the State has succeeded in requiring the licensee to reduce the volume of waste storage by sorting and shipping lightly contaminated combustible material to l SEG for incineration.

The team believes slow but steady progress has been made in dealing with NPI despite the unwillingness of NPI management. Although the very prescriptive renewal license issued in January 1996 has been appealed and held in abeyance  ;

pending the outcome of an administrative hearing, significant progress has been made for the most serious health and safety issues. The Maryland program continues to maintain a strong licensing and enforcement stance with respect to NPI yet has indicated to the review team a willingness to work with NPI to resolve issues and produce a less prescriptive and more performance oriented licensing  !

document. A well thought out and documented strategic plan is in place to implement a performance-based inspection plan at NPI which emphasizes the achievement of quality in all facets of NPI's operations. These inspections will emphasize direct observation and surveillance of licensed activities and will stress I the licensee's most significant activities dealing with radiation safety and reliability.

The 2-year plan (1996 98) provides for quarterly inspection frequency, reviews of 1

Maryland Proposed Final Report Page 7 health physics consultant reports, team inspections, and outlines more than 30 specific areas for review. This previous recommendation should be closed.

(4) Current status of the results of the joint NRC and State review of 33 misadministrations that occurred in 1987 88 at Sacred Heart Hospitalis as follows:

A joint U.S. Nuclear Regulatory Commission (NRC) and State of Maryland review of 33 misadministrations that occurred in 1987-1988 at the Sacred Heart Hospital (SHH) located in Cumberland, Maryland, (MD-01-002-02) was conducted in late 1993 and early 1994, in response to issues raised during an August 1993 Congressional hearing that questioned: (1) the adequacy of the State's 1988-1989 review; (2) why NRC had not previously reviewed the event; (3) inconsistencies in the records; and (4) the State's agreement to limit access to the records.

In a report dated March 5,1996, that was transmitted April 15,1996, to Ms. Merrylin Zaw Mon, Director, Air and Radiation Management Administration, Maryland Department of the Environment, the review team concluded that the direct cause of the misadministrations was the use of an incorrect computer file.

There were a number of factors contributing to the misadministrations including, for example, inadequate communications and failure to verify procedures and calculations. The review concluded that the root cause was lack of management oversight of the SHH radiation safety program. The special review team found that SHH did not provide all the notifications to referring physicians and patients as required by Maryland law. The special review team recommended that the State of Maryland take some actions, and the State's Department of the Environment reviewed the report and agreed to implement those actions the review team recommended the State take. The recommendations included actions the State should take to ensure that SHH complies with the referring physician / patient notification requirements of Maryland law. The IMPEP review team was tasked to follow up on the State's action. In discussions with the Director, RHP, the team found that the State discussed the recommendations of the joint NRC/MD review, including the referring physician / patient notification requirement with the new SHH staff (NOTE: SHH has a new CEO Administrator, who was not a member of the SHH staff during the joint NRC Maryland team review). In a telephone discussion in June 1996, the legal counsel for SHH expressed concern that some of the joint report recommendations were overly burdensome. The legal counsel was concerned that an upcoming merger between SHH and Cumberland Memorial Hospital might be jeopardized if the new affiliate had to adhere to the terms of the recommendations placed on SHH. The SHH legal counsel requested that the State delay action on the 4/15/96 letter through the State Attomey General's office. As of the date of the IMPEP review, the IMPEP team found that the State had taken no additional follow-up action with SHH staff and legal counsel.

Subsequent to the review, the State informed the team that a letter had been sent to SHH on November 25,1996, that included the NRC recommendations resulting from the 1987-88 misadministrations. SHH responded and will folluw through with

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physicians information regarding notification to misadministered patients, families or

next-of-kin.

This recommendation remains open.

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The IMPEP team recommends that the State take action to have the Waste Management Administration revise the definition of " Person" in the low-level j radioactive waste regulations COMAR 26.14.01.02B(28)(e) that was identified in both the 1993 94 review and the 1995 follow-up review.

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!- e The IMPEP team recommends that the State take action to ensure that SHH I

complies with the referring physician / patient notification requirements of Maryland

law as identified in a report dated March 5,1996, that was transmitted to the State l April 15,1996.

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! 3.0 COMMON PERFORMANCE INDICATORS IMPEP identifies five common performance indicators to be used in reviewing both NRC j Regional and Agreement State programs. These indicators are: (1) Status of Materials f'

Inspection Program, (2) Technical Staffing and Training, (3) Technical Quality of i.icensing

Actions, (4) Technical Quality of Inspections, and (5) Response to incidents and j Allegations.

j 3.1 Status of Materials insoection Proaram I The team focused on four factors in reviewing this indicator: inspection frequency,

overdue inspections, initial inspection of new licenses, and timely dispatch of inspection j findings to licensees. This evaluation is based on the Maryland questionnaire responses

relative to this indicator, data gathered independently from the State's licensing and

, inspection data tracking system, the examination of licensing and inspection casework i files, and interviews with managers and staff.

l Review of the State's inspection priorities showed that, with the exception of medical private practice licenses with a OMP, the State's inspection frequencies for various types j or groups of licensees are at least as frequent, or more frequent than, similar license types

! or groups listed in the frequency schedule in the NRC Inspection Manual Chapter 2800 (IMC 2800). Inspection frequencies under the State's system range from quarterly to

{ 5-year intervals. More frequent inspections are required by the State in the following license categories: licensees manufacturing sealed sources for irradiator use have a

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- quarterly frequency compared to the NRC 1-year frequency; Type A broad scope academic

. licenses have a 1-year frequency compared with an NRC 2-year frequency; teletherapy and 3

gamma knife licenses have a 1-year frequency compared with the NRC 3-year frequency;

{ research and development licenses, portable lead paint analyzers and portable gauges

have a 4-year frequency compared with the NRC 5 year frequency; and licenses j authorizing other measuring systems such as gas chromatographs have a 5-year frequency compared to the NRC 7-year frequency. However, the state was not distinguishing l

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between medical private practice licensos that required a Quality Management Program and those that did not. Consequently, all medical private practices were scheduled for inspection at a 4 -year frequency which exceeds the NRC's 5-year frequency for "non OMP" licenses but falls short of the 3-year frequency specified in IMC 2800 for I

medical private practice licenses where a OMP is required. The team noted that the State was referencing a previous version of IMC 2800 and had not incorporated the April 1995 revisions to IMC 2800. Management indicated action would be taken to correct the oversight.

I o The review team recommends that the State incorporate the April 1995 revisions to i IMC 2800 into their inspection Procedures Manual. l

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i in their response to the questionnaire, Maryland indicated that as of September 20,1996, j j no licenses identified for core inspections in IMC 2800 were overdue by more than 25

} percent of the NRC frequency. With respect to initial inspections of new licenses, the team reviewed the inspection data tracking system and noted that the initial inspections are entered into the tracking system with a 6 month date for scheduling. In reviewing {

twelve initial inspections from among the 81 new licenses issued during the review period, i none of the initialinspections were conducted within the first six months following issuance of the license. However, more than half (7 of 12) were completed from 6 to 8 months following issuance and eesentially all (11 of 12) were inspected from 6 to 12 months following issuance (that is, within 6 months of scheduling the inspection). One new license was inspected approximately 32 months following issuance due to an j administrative error in assigning the first due date. '

While the initial inspection timing is a significant deviation from the programmatic ind;cator, the State's program for new licenses contains an element which, in total, makes it equally as effective as the IMPEP program indicator would achieve. This element is j completion of a pre-licensing inspection which helps assure that licensees are equipped and knowledgeable before receiving radioactive materials thus helping licensees to achieve early success in complying with the requirements of the license. The high percentage of initial inspections in which no items of non-compliance are found appears to validate this methodology. )

In reviewing the inspector's work logs for the period since the last review, the team found that the vast majority of inspections resulted in communication of the findings to the licenses within thirty days following the inspection, in those rare instances whan the compliance letter was not issued within 30 days, program management indicated this occurred because more information was known to be forthcoming from the licensee or greater care, and thus more time, was needed to document circumstances relative to a potential enforcement action.

The State reported that 136 license requests for reciprocity were processed during the period of review. Approximately 50% of the reciprocity requests included industrial radiography, others included well-logging, mobile nuclear medicine, and other service

!Mensees. The State conducted 56 inspections of reciprocity licensees during the review

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g period, which met the inspection frequency for conducting inspections of reciprocity licensees contained in IMC 1220, " Processing of NRC Form 241, Report of Proposed 4

Activities in Non-Agreement States, and inspection of Agreement State Licensees

Operating Under 10 CFR Part 150.20."

Based on the IMPEP evaluation criteria and the acceptability of the State's equally j

. effective method of handling new licensees, the review team recommends that Maryland's

performance with respect to the indicator, Status of Materials inspection Program, be j found satisfactory.

I 3.2 Technical Staffino and Trainina i

A review of this indicator includes consideration of the adequacy of the concept and balance of the radioactive materials program staffing strategy which includes training, technical qualifications of the staff, any staff tumover, and prompt management attention l to any problem areas. To evaluate these issues, the review team examined the State's questionnaire responses relative to this indicator, interviewed program management and staff, and considered any possible backlogs in licensing or compliance actions.

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The Radiological Health Program (RHP) has responsibility for the control of radiation in j Maryland. Total staff positions in the RHP, which includes the Radiation Machines Division and the Radioactive Materials Licensing, Compliance and Safeguards Division, hereafter j referred to as RAM program, are 27, with a current fill of 25. The number of positions

directly applied to Agreement State activities, is nine. The program has undergone a reorganization since the last program review conducted in 1993 and 1994. As a result of

the reorganization, the Radon program was eliminated and, in December 1995, the

program lost two supervisory positions and combined the responsibilities of the three i supervisor positions into one. The RAM program went from a total staffing level of 11,

, which included one program manager, three supervisor health physicists (licensing,

! licensing and low-level radioactive waste, and inspection and enforcement), six health physicists, and one x-ray and regulations specialist; to a total staffing level of nine, which includes one program manager, one supervisor health physicist, and seven health

! physicists as shown on the RHP organization chart found in Appendix B. The RAM i

program is divided into two sections, the inspection and Enforcement Section comprised of four health physicists responsible for allinspection and enforcement activities, and the Licensing and Environmental Radiation Section comprised of three health physicists, two are responsible for all licensing and environmental activities, as well as, seaied source and

, device evaluations. A third health physicist, recently transferred from Radon, is currently j performing less complex inspections, i.e. gauge manufacturers, and is in training for licensing and environmental activities. The team noted that the RAM program supervisor

! and two of the more senior personnel appear to handle most of the inspections.

l Additionally, the RAM supervisor is often called upon to Act for the RHP manager, who is j involved in several Agreement State technical organizations and task groups in support of l Agreement State activities. In discussions with the RAM program supervisor the team i

found that one of the health physicists was recently transferred to the RAM program from j the former Redon program and is currently in training, another health physicist is currently

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l. being assigned increasing inspection duties, and another health physicist with 5 years of experience had not fully demonstrated consistent quality as a materials inspector. -

! According to information provided in the State's response to the questionnaire, the training i

program requires eli newly hired inspectorr, to attend the NRC core training courses, in licensing, inspection procedures, industriri radiography, nuclear medicine, and the 5-week j

health physics course. At the time of th6.aview, one HP-inspector with 5 years

experience, had not taken the licensing course, and one newly transferred staff member i

had not taken the industrial radiography course. The team noted that one inspector primarily performing medicallicense inspections could benefit from attending the 'i j teletherapy / brachytherapy course, which is a riew NRC course. The RHP manager stated

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they can no longer send staff to NRC courses held outside of the local area due to NRC's '

recent policy change that eliminated funding for travel to training courses and budget constraints that limit funds for State travel. Maryland currently has no formal training l- plan. Future plans depend on the final resolution of NRC action regarding funding for j

travel to NRC training courses. The team suggests that the State consider development of

a formal professional training plan through the use of university and industry educational

programs for training new staff and retraining or refresh for long-term staff.

i in discussions with the RAM supervisor, the team found that new staff are assigned l

' increasingly complex duties under the direction of senior staff and accompany experienced inspectors during increasingly complicated inspections. When time allows, the RAM i

supervisor accompanies newly qualified staff. There is no formal program in place for the j supervisor to perform an annual inspection accompaniment with each inspector. This ,

issue is further addressed in Section 3.4. '

1 l The team found that during two accompaniments the inspections conducted by a health physicist-l inspector, with 5 years of experience were not satisfactory. During one i accompaniment it was not identified that the potential existed for radiation exposure to  ;

non-radiation workers in the immediate area where field radiography was being performed, l j which posed a health and safety hazard. Additionally, the primary focus during both  ;

inspections was paperwork rather than a performance based inspection. Interviaws were l not conducted with management. This issue is discussed in greater depth in Section 3.4, Technical Quality of Inspections. Through discussions with the RAM program supervisor 4- the team found that the inspector did not have a physical or life science background, but j had taken all of the core courses recommended by NRC, as well as additional health l physics training during his five years with the program. Additionally, the supervisor had j never accompanied the inspector. The team found that the inspector's weak performance i

after five years of experience demonstrated a deficiency in the evaluation of training and j qualification of the technical staff of the program. This does not meet the IMPEP L evaluation criteria for personnel making prompt progress in completing all of the training and qualification requirements, and provides some evidence of management inattention or i

! inaction to deal with staffing problems. One to two years would be an acceptable time j frame in which to train and qualify an inspector.

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j e i The team recommends that management provide a corrective action plan to address j

the issue of qualifying staff. The team also recommends that management provide ,

i a training and qualification plan for new staff that includes an appropriate education i background, and a requalification plan for staff that do not meet the initial  ;

qualifications, and staff who are reassigned from another technical area, and continued training for long term staff.

1 i e The team suggests that Maryland assess whether a reinspection or revision to 1

move-up the next inspection date should be considered for any higher priority j

licensees, i.e., HDRs, radiographers, previously inspected by the HP-l inspector l whose accompaniment was unsatisfactory.

Staff turnover is stable, however the team noted that the recent reorganization strategy

combining two separate positions into one and the loss of two staff positions in the recent

reorganization, which included the regulation review specialist, places considerable effort '

i and a heavy workload on the existing staff members to manage, control, and review all of i

the health and safety related work of the program. The team questioned the staffing balance regarding the expansion of the duties of the RAM supervisor that already included j supervisory responsibilities for inspection and enforcement activities, participating in t

complex inspections, along with Acting in the absence of the RHP manager, to now also 1 include supervising an additional licensing and environmental radiation section.

j i Additionally, subsequent to the review, the team found that an HP staff member has

} resigned. This leaves the radiation control program with a total staffing level of (8) FTE.

! The team is concerned that the loss of 2 FTE due to the reorganization, and the recent loss

! of an additional staff member jeopardizes the program's ability to maintain an adequate  !

and compatible program to protect health and safety. The team noted that the adequacy j of one FTE managing such an unusually large area of responsibility with a technical staff of

alz (total 7 FTE) should be closely monitored by Maryland due to the number and complexity of licensees in the Maryland program. The team discussed increased use of i

automated systems to provide increased control through tracking actions, wider access and more efficient retrieval of information. The State has several complex licensees, '

I including NPI, which consumes an inordinate amount of staff time,in the preparation of ,

legal documents, and technical analysis of corrective action plans; additionally there has

! l been no action, as of the period of our review, taken on ten rules or amendments that  !

! shou.,1 be adopted by December 1997,in order for the RAM program to remain compatible l with the NRC regulatory program. The team questioned the adequacy of program staff to ensure the long-term ability of the program to maintain adequacy and compatibility to j_ protect public health and safety.

} e Based on the teams findings, the team recommends that the State assess the i j adequacy of the program staff to ensure the long term ability of the program to j maintain an adequate program to protect public health and safety and complete the i i pending rules and amendments for adoption to remain compatible. '

i

j i

i Maryland Proposed Final Report Page 13 1

1

! Based on the team's finding and the IMPEP evaluation criteria, the review team

recommends that Maryland's performance with respect to this indicator, Technical Staffing

and Training, be found Satisfactory with Recommendations for improvement.

l 3.3 Technical Quality of Licensina Actions 1

i The review team examined casework and interviewed the reviewers for forty specific j licenses. Licensing actions were reviewed for completeness, consistency, proper isotopes and quantities used, qualifications of authorized users, adequate facilities and equipment, j and operating and emergency procedures sufficient to establish the basis for licensing

. actions. Casework was reviewed for timeliness, adherence to good health physics l practices, reference to appropriate regulations, documentation of safety evaluation reports, product certifications or other supporting documents, consideration of enforcement history

, on renewals, pre-licensing visits, peer or supervisory review as indicated, and proper

] signature authorities. Licenses were reviewed for accuracy, appropriateness of the license

!- and of its conditions and tie-down conditions, and overall technical quality. The files were I checked for retention of necessary documents and supporting data, i

The cases were selected to provide a representative sample of licensing actions which had

! been completed in the review period and to include work by all reviewers. The cross-l section sampling included five of the State's major licenses and the total included the i following types: nuclear pharmacy, high dose rate afterloader, academic broad scope, ,

i portable gauges, hospital nuclear medicine, private practice and cardiology limited,  !

research and development laboratory, fixed gauges, blood irradiator, sales demonstration

of devices, radiography, service / leak test, and sample analysis. Licensing actions included

)

l eight new licenses, nine renewals, ten amendments, and fourteen terminations. A list of j i these licenses with significant case-specific comments can be found in Appendix D. j

( The review team found that the licensing actions were generally thorough, complete, j consistent, and of acceptable quality with health and safety issues properly addressed. l

Speciallicense tie-down conditions were almost always stated clearly, backed by information contained in the file, and inspectable. The licensee's compliance history was j taken into account when reviewing renewal applications. The State's licensing guides and i i license policy procedures are currently being revised and updated, and reviewers were l

observed to have good research skills in using these and other licensing documents. With  ;

i few exceptions, reviewers appropriately used the new licensing guides and accompanying  ;

check sheets, although the check sheets are not routinely signed and dated. Licensing  ;

action authorship is indicated by initials and date. At least one, but occasionally two peer i l reviews, are documented by initials and dates. All licensing actions are signed by the

Radiological Health Program Manager. Pre-license-issue visits are now routinely noted in

. the file. This visit enables the license reviewer to ascertain the status of licensed facilities  ;

i and use, as apphed for by the applicant. It also allows an explanation of the licensing and inspection process prior to the start of licensed activities.  ;

i

! No potentially significant health and safety issues were identified. On terminations of i materials possession and use, recent actions have been to evaluate and document in a i

l 2

1 j I Maryland Proposed Final Report Page 14 timely manner, and to visit and perform a closeout evaluation which may or may not l include a survey. In the earlier portion of the review period, some extended intervals  !

occurred between the termination request and closeout evaluation. The verification survey l e

could benefit from consideration of Draft NUREG/CR 5846 " Manual for Conducting Radiological Surveys in Support of License Termination" with respect to required information and the use of appropriate information gathering. The team noted that the Radiological Health Program could benefit from a guidance document on termination of l licenses. One termination, identified under the NRC Site Decommissioning Management i Plan (SDMP) as an SDMP site during the 1993 program review, was evaluated at the

! request of the NRC's Office of State Programs and was found to have been surveyed ,

j appropriately to verify licensee actions and terminated properly.  ;

4 1 l e The team suggested that the Radiological Health Program could benefit from a i guidance document on termination of licenses. l i

The Radiological Health Program requires a full replacement application for renewal. On  !

occasion a new licensee has been requested to submit a full replacement application when  ;

1- extensive deficiency discussions or letters have been exchanged. This has the benefit that I

{ all the currently agreed to items have been included in one source document. While

)

i telephone deficiency conversations are common, their documentation is often only in the i j licensee's response that indicates "as a result of our conversation on." The reviewer  ;

I noted that one license had a long lead time review item (waste storage) separated from l l the renewal, enabling issuance of an up-to-date license sooner than would have been '

i otherwise possible. l

! The-review team found that a new reviewer was gaining experience through less

complicated licensing reviews and will be brought into reviewing the more complicated y license actions in the near future. Both license reviewers have an inspection background.

j Based on the IMPEP evaluation criteria, the review team recommends that Maryland's i

performance with respect to the indicator, Technical Quality of Licensing Actions, be l found satisfactory.

l 3.4 Technical Quality of Insoections i

i The team focused on the following factors in evaluating this indicator: results of i accompanying inspectors on field site inspections, inspection field notes, inspection

! reports, inspection findings, enforcement documentation and current procedures. The team also interviewed inspectors for 16 materials inspections conducted during the review

{ period. The casework included all five of the State's material inspectors and covered

. higher priority inspections of various types including hospitals, nuclear medicine facilities,

[ academic institutions, research and development facilities, industrial use, an instrument calibration service, and a nuclear pharmacy. Attachment E lists the inspection cases

reviewed in depth with case-specific comments. Prior to the review, a team member l performed accompaniments of three state inspectors on four separate inspections of high  ;

j priority facilities. The first inspector was accompanied at a pool-type irradiator, the second i

1

}

__ _ _ _ . _ . . __. .. ._____ _ _ . . . . _ _ _.- _ . _ ___ -~

4 l Maryland Proposed Final Report Page 15 4

inspector was accompanied twice, first at a hospital followed by field site radiography, and l the third inspector was accompanied at a nuclear pharmacy.

! Inspection procedures and techniques utilized by the State were reviewed and determined I

to be consistent with the inspection guidance identified in NRC Inspection Manual Chapter

, 2800. The procedures were used to help inspectors identify root causes and poor licensee

performance. The State's policy is to conduct inspections on an unannounced basis. NRC

Inspection Procedure 87100 field notes were electronically reproduced in State format and i used for routine materials inspections in the categories of medical, academic, teletherapy,

{ commercial irradiators, gauges, industrial radiography, and research and development.

i

! The review team found the level of detail provided in inspection reports was consistent l with respect to the scope of the licensed program, licensee organization, management j structure, radiation protection program, training and instructions to workers, personnel protection, posting and labeling, radioactive material control, material transfer and i

! disposal, and exit interviews with management. To assure consistency and quality l i assurance of reports the RAM Supervisor provided review, comment, and initialed all  !

inspection documents and field notes.

] Reports were also reviewed for inspector documentation of operations observed, I j management and worker interviews, independent measurements, follow up to previous

items of non-compliance, and discussion of inspection findings at exit interviews. Overall, j the review team found inspection reports showed good quality. Four reports contained l sections which identified closure of previous, items of noncompliance but did not indicate

how items were followed up and corrected. The review team discussed documenting in

! reports what inspection areas and information were reviewed to close out previous items

! of noncompilance. Other reports contained only minor discrepancies from standard l l practice which were related to insufficient detail. l Field notes, inspection forms, and enforcement correspondence were found to be complete. Documented inspection findings generally led to appropriate enforcement and prompt regulatory actions. Routine enforcement letters were drafted by the inspector, l signed off by the RAM Supervisor, and issued to the licensee by the RHP Manager. With the exception of NPI (currently under court order), the team determined the State's enforcement policies to be effective in achieving licensee compliance. Enforcement correspondence was timely for files reviewed by the team. Licensee responses to items of noncompliance were also timely and assigned by the RAM Supervisor to inspectors for review. In cases where inspection results indicated a need for escalated enforcement action, enforcement conferences were held with licensees to discuss inspection findings and possible enforcement action against them.

From staff interviews and some inspection reports the team found that inspectors were aware of the need to provide inspection information affecting licensing to license reviewers, but the process for ensuring inspector feedback to licensing staff was informal.

Inspectors discussed inspection findings with the RAM Supervisor, who served as the intermediary between license and compliance staffs for information sharing.

Maryland Proposed Fina: Report Page 16 i

j. .

I The State's practice calls for annual supervisory accompaniments of allinspectors. In response to the questionnaire, the State reported that the RAM Supervisor performed supervisory accompaniments of four of five inspectors in 1994, and two of five inspectors in 1995. One inspector was not accompanied during the review period. The review team considered the unusually high work demands placed upon the RAM Supervisor position during this review period because of the licensing and compliance efforts related to NPI, two reassignments of individuals into the position within a three month period in 1995, and the need to maintain inspection schedules at the appropriate level to prevent development of a program backlog. However, supervisory accompaniments provide management with important insight into the quality c: the inspection program.  ;

o The review team recommends that the State adhere to the practice of annual supervisory accompaniments of allinspectors.

Four inspector accompaniments of thret. of the program's five inspectors were performed by a review team member as follows: the first inspector was reviewed on June 25-26, 1996, at a pool irradiator facility; the second inspector was reviewed on July 16-17,1996 at a hospital and again on September 19,1996, et a field radiography site. A third inspector was reviewed on August 7,1996, at a nuclear pharmacy. These accompaniments are also identified in Appendix E. The second inspector (who had been performing inspections of high priority licensees) was accompanied twice because a State supervisory accompaniment was not performed during the review period, an NRC accompaniment was not performed in previous assessments, and, folkwing the initial l accompaniment of the individual, the team was unable to reach a deturmination with respect to the inspector's performance. Two of the program inspectors were not accompanied due to the fact that one, a senior inspector, had been accompanied during previous assessments, and the other was a new trainee.

On the accompaniments, two of the three inspectors demonstrated strong inspection techniques, knowledge of the regulations, and overall satisfactory technical performance.

However, accompaniments did not show a comparable level of performance by another State-qualified inspector either to conduct a performance based inspection or in inspection thoroughness to address potentially important radiological safety concerns. The team observed inspector performance issues related to the areas of facility walk throughs,  !

conduct of licensee operations and licensee demonstrations, worker and management interviews, and independent measurements. Areas not fully covered during inspections included failure to take independent wipe samples at all hospital material storage and waste locations, not conducting interviews with the hospital radiation safety officer and nursing staff until prompted by the team member, incomplete follow up of licensee corrective actions resulting from a 1994 hospital contamination incident, inadequate walk through and site observation at the beginning of the field radiography inspection to verify storage and inventory of radiographic cameras, lack of an independent radiation survey surrounding the site which confirmed the licensee's posting of radiation boundaries, deficiencies in recognizing the potential for radiation exposure to non-radiation workers in the immediate area where field radiography was performed, and inadequate check of radiation workers for proper dosimetry.

i l Maryland Proposed Final Report Page 17

As noted in Section 3.2 of this report, interviews of compliance staff indicated that field

) qualification for a new inspector consisted primarily of demonstrations for supervisory staff 4

until supervisors were able to make a subjective determination that the inspector was able l to perform independently. Criteria were not clearly established which allowed State j

management to determine when inspectors were qualified for different types of program inspections.

I e To ensure consistency in performance among inspection staff, the review team recommends that the State develop a program outlining the necessary steps to be followed by staff for fullinspector qualification.

The team found that the State maintains an ample number of portable radiation detection instruments for use during routine inspections and response to incidents and emergencies.

Included in the State's meter inventory were ion chambers, micro R meters, high range detectors, GM tubes, ratemeters, scintillation detectors, high and low range pocket dosimeters, alpha meters, calibration check sources, and air sampling equipment.

Calibrated portable equipment was located in kits contained in emergency vehicles assigned to the RHP. Inspectors use these vehicles for routino inspections with the portable instruments used by inspectors for confirmatory measurements. The inventory list showed staggered annual due dates for calibrations of instruments so that meters were always available when needed for inspections. The State laboratory was reviewed and found to include liquid scintillation spectrometers, gas flow proportional counters, and gamma spectrometers (multichannel analyzer) for full capability to analyze wipe, water, j and soil samples for the RHP. '

Based on the IMPEP evaluation criteria, the review team recommends that Maryland's performance with respect to the indicator, Technical Quality of Inspections, be found Satisfactory, with Recommendations for Improvement.

3.5 Response to incidents and Alleaations in evaluating the effectiveness of the State's actions in responding to incidents and allegations, the review team examined the State's response to the questionnaire relative to this indicator and reviewed the incidents reported for Maryland in the " Nuclear Material Events Database (NMED)" against those contained in the Maryland casework and license files, and supporting documentation, as appropriate for ten incidents. The team reviewed the State's response to five allegations. In addition, the review team interviewed the RHP Manager, the RAM supervisor, and the health physicists assigned to incident response.

The incident and allegation investigations were reviewed for responsiveness, coordination, health and safety significance, level of effort, investigative procedures, corrective actions, follow up, compliance, notifications and documentation, as necessary.

It was found that within the RHP, responsibility for initial respc.nse and follow-up actions to materials incidents and allegatione rests solely with the inspection and Enforcement Section (lES) of RAM. Written procedures require a prompt response to incidents by the

e f

i i

l Maryland Proposed Final Report Page 18 l

staff and provide additional procedural guidance. The RAM supervisor reviews each i incoming event notification or allegation prior to assignment to the IES staff or when appropriate, referral to another agency. All complex events or allegations or those with the potential for impacting public safety are evaluated by the RAM supervisor, the RHP

! manager, and RAM staff, in order to determine the appropriate response. The response i varies based on the safety significance of the event, from resolution through telephone l discussion, to immsdiate response by a team of 2 health physicists, and, in some cases,

! issuance of a press release to the mdia. in many instances, the RAM supervisor 1

participated in investigations of coisiplex or high media interest events. Review of the files indicated that this approach provided effective response actions.

} The review team examined the State's response to 10 events chosen from events i identified as significant in the State's response to the questionnaire and events found in

[ the NMED database system. Events reviewed included two equipment problems, one

! transportation event, three lost or stolen radioactive material, three loss of control, and i one misadministration. The team found that the State could not provide a listing of allegations received by the State during the period. Six allegations involving a variety of j technical and administrative issues, five of which had been referred by NRC to the State, a

were reviewed. A list of the incident casework with comments is included in Appendix F.

In the cases reviewed in depth, the review team found the States's response was well within the performance criteria. Incident response was well-coordinated, and the level of effort was commensurate with health and safety significance. The State assured that licensees took suitable corrective actions, and followed the progrest, of the investigation through until close out. Although the State was unable to provide a complete listing or complete events file, all of the events found in the NMED database were either in the State events file or licensee compliance files. The team noted that three of the events identified by the State in response to the Questionnaire had not been provided to NRC and were not found in the NMED database (1/23/95 Maryland State Highway, 5/26/95 Soil Safe Inc.,

5/30/96 Aerosol Monitoring). The team also noted that the State is notifying the Regional Stato Agreements Officer of the occurrence of a significant event (24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification requirement) rather than the NRC Operations Center, as identified in the

" Handbook on Nuclear Material Event Reporting in the Agreement States," Draft Report, March 1995.

e The team recommends that the State begin voluntary reporting of all reportable events to the NRC Operations Center and begin participating in the NMED database system collection of material events by providing event information directly into the NMED system electronically or providing compatible information in written form m accordance with guidance contained in the " Handbook on Nuclear Material Event Reporting in the Agreement States," Draft Report, March 1995.

e The team recommends that the State provide event information for three events identified by the State in response to the Questionnaire, as follows: (1)1/23/95 Maryland State Highway event, (2) 5/26/95 Soil Safe Inc. event, and (3) 5/30/96 Aerosol Monitoring event.

4

Maryland Proposed Final Report Page 19 Allegations were responded to promptly with appropriate investigations and follow-up actions. Proper procedures were used for the control of information. The team found that the results of allegations received directly by the State were promptly related to the alleger. But, the results of the investigations of allegations referred by NRC to the State were not provided to NRC in a timely manner. The team found that the State had not provided close out information to NRC on allegations referred to the State by NRC. When NRC does not receive close out information from the State on investigation results, NRC cannot provide a response to allegers who request and receive anonymity.

e The team recommends that the State provide close out information to NRC on allegations referred to the State by NRC in which the alleger was granted

, confidentiality.

Subsequent to the review, the State informed the team that they have provided close out information on all allegations referred to the State to NRC.

The team found that the State has completed and begun implementation of procedures for

' handling allegations. The team noted that the State has a Law (Chapter 160 of the 1995 Laws of Maryland, codified as State Personnel and Pensions Article, 63-101-102) 4 prohibiting intentional acts of reprisal against any employee who has filed a complaint, grievance, or other administrative or legal action involving State employment.

j Based on the IMPEP evaluation criteria, the review team recommends that Maryland's performance with respect to the indicator, Response to incidents and Allegations, be found Satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Regulations, (2) Sealed Source and Device Evaluation Program, (3) Low-Level Radioactive Waste Disposal Program, and (4) Uranium Recovery. Maryland's agreement does not cover uranium recovery operations, so only the first three non-common performance indicators were applicable to this review.

4.1 Leoislation and Reaulations 4.1.1 Leoislative and Leaal Authofity in response to the questionnaire, the State reported the legislation which authorizes the Maryland Radiological Health Program is identified in the Annotated Code of Maryland, Environmental Article, Title 8, " Radiation", and Title 7, " Hazardous Materials and Hazardous Substances." There are no sunset laws in Maryland and the State indicated that regulations have no expiration date.

l l

Maryland Proposed Final Report Page 20 4.1.2 Status and Comoatibility of Reaulations j By letter of September 25,1995, the State committed to a Regulation Adoption Management Plan (RAMP) to eliminate rulemaking backlog identified during previous assessments and prevent future backlogs from developing. In the November 1995 3 follow-up program review NRC found the State completed a revision to the RAMP updating all regulations required for compatibility which were identified as due or overdue. The regulations became effective on October 9,1995. Also included in this revision was the following amendment:

e " Decommissioning Recordkeeping, and License Termination: Documentation ,

Additions, "10 CFR Parts 30,40, and 70 amendments (58 FR 39628) that became l effective on October 25,1993, with adoption needed by October 25,1996.

Current NRC policy on adequacy and compatibility requires that Agreement States adopt certain equivalent regulations or legally binding requirements no later than three years after they become effective in tha November 1995 review NRC recommended the State address adoption as soon as possible of the following rule needed for compatibility:

e " Licensing and Radiation Safety Requirements for Irradiators," 10 CFR 36 amendments (58 FR 7715) that became effective July 1,1993, and due for adoption by the State by July 31,1996.

The State of Maryland regulates irradiator facilities which would be subject to the regulations in " Licenses and Radiation Safety Requirements for Irradiators,10 CFR Part 36.

Equivalent rules were in the final stages of promulgation and were scheduled to be adopted in November 1996. The team found that the State had not established legally binding requirements equivalent to NRC requirements in 10 CFR Part 36 that are required for compatibility, at the time of review. Subsequent to the review, the State informed the team that Part X of the Maryland Code covering, " Licenses and Radiation Safety Requirements of Irradiators," was adopted on November 19,1996, with an effective date of December 16,1996.

From interviews with staff assigned to the RHP regulations development committee, the team found the RAMP was in place, but its effectiveness with respect to beginning rule development was incomplete. In response to the questionnaire the State reported that no action has been taken on the following compatibility rules, but expected adoption by the end of 1997:

e " Timeliness in Decommissioning of Material Facilities, " 10 CFR Parts 30,40, and 70 amendments (59 FR 36026) that became effective August 15,1994 and will need to be adopted by August 15,1997.

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

. for Medical Use, " 10 CFR 30,32, and 35 amendments (59 FR 61767,59 FR

Maryland Proposed Final Report Page 21 65243, and 60 FR 322) that became effective January 1,1995 and will need to be adopted by January 1,1998.

o " Frequency of Medical Examinations for Use of Respiratory Protection Equipment," 1 10 CFR Part 20 amendments (60 FR 7900) that became effective March 13,1995 and will need to be adopted by March 13,1998.

e " Low. Level Waste Shipment Manifest Information and Reporting," 10 CFR Part 20 and 61 amendments (60 FR 15649 and 60 FR 25983) that becomes effective March 1,1998 and will need to be adopted by March 1,1998. The NRC delayed  ;

its effectiveness until the States could adopt compatible requirements so that the

national manifest system will go into effect at one time.

j

• " Performance Requirements for Radiography Equipment," 10 CFR 34 amendments (60 FR 28323) that became effective June 30,1995 and will need to be adopted l

J by June 30,1998. l

• " Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective August 14, 1 1995 and will need to be adopted by August 14,1998. I a

e " Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995 and  ;

will need to be adopted by November 24,1998. 1

• " Compatibility with the international Atomic Energy Agency," 10 CFR Part 71 I amendment (60 FR 50248) that became effective April 1,1996 and will need to adopted by April 1,1999. NRC delayed the effective date of this rule until April 1, 1996 so that the DOT companion rule could be implemented at the same time.

Since this rule involves the transport of materials across state lines, the States are encouraged to adopt compatible regulations as soon as possible.

4

• " Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20 and 35 amendments (60 FR 50248) that became effective October 20,1995 and will need to be adopted by October 20,1998.

The proposed schedule will not meet the three year limit for the Timeliness of Decommissioning of Materials Facilities rule, which will need to be adopted by August 15, 1997.

NRC staff has reviewed the 13 amendments to the final COMAR regulations adopted by the State of Maryland, that became effective October 9,1995, and, based on that review, found that our earlier comments have besn addressed. However, in completing the review staff identified issues in other sections of Maryland regulations that have potential compatibility significance. Issues identified by the staff relate to existing sections of

1 1

i Maryland Proposed Final Report Page 22 l

j Maryland regulations that were not modified by the 13 amendatory actions. Staff has j completed documentation of these concerns and will transmit the concerns to the State.

A review of the State's Administrative Procedures Act showed it provides the opportunity for public comment in public hearings on proposed regulations. According to staff the RAMP process included submittal of draft regulations to NRC for comment. NRC li comments are considered by the rules committee prior to public notice.

i i e The review team recommends that the State improve the effectiveness of the

! Regulation Adoption Management P!an by providing a realistic schedule of

! milestones for development and adoption of the 10 rules currently identified in the

plan for adoption by the end of 1997.

I j e The team recommends that the State address the process for handling multiple i rulemakings to ensure that they are completed within the three years of the

! effective date.

i e The team recommends that the State address the staff's comments relating to Maryland's COMAR final rules that will be transmitted to the State.

j Based on the IMPEP evaluation criteria, the review team recommends that Maryland's performance with respect to this indicator, Legislation and Regulations, be found y 's O at that rentm ife by h 13 am atory actions j adopted by the State, that became effective October 9,1995. Also, subsequent to the

! review, the State informed the team that Part X of the Maryland Code, " Licenses and i Radiation Safety Requirements for Irradiators," was adopted effective December 16,1996.

l Additionally, the State needs to resolve the issue regarding the term " person" in the LLRW

{ regulations.

1 j 4.2 Sealed Source and Device Evaluation Procram i

j in assessing the State's Sealed Source & Device (SS&D) evaluation program, the review

! team examined information provided by the State in response to the IMPEP questionnaire i- on this indicator. A review of selected new and amended SS&D evaluations and j supporting documents covering the review period was conducted. The team observed the

! Staff's use of guidance documents and procedures, and interviewed the staff and Program l Manager involved in SS&D evaluations.

i-

! 4.2.1 Technical Quality of the Product Evaluation Proaram

}

{ The review team examined six new or revised SS&D registry certificates and their j supporting documentation. In addition, the review team examined the State's efforts to a revise an additional SS&D registry certificate for a device involved in an incident. The i certificates reviewed covered the period since the last program review in April 1993 and j j represented cases completed by three reviewers. The SS&D certificates issued by the l

4 1

Maryland Proposed Final Report Page 23  !

State and evaluated by the review team are listed with case-specific comments in Appendix G. The overall quality of the evaluations shows improvement of the program since the review conducted in 1993. There was a noticeable improvement in documentation required nf the applicants and in the detail of the evaluations when comparing 1994 to 1995 certificates.

The State does have procedures in place to protect proprietary information submitted in support of an evaluation. Policy and guidance documents were on file and being utilized by the staff. The review team observed that both SS&D reviewers will be signing each completed SS&D registry certificate to verify the second reviewer's audit of the application and the original reviewer's conclusions for future certificates. This is a change in the previous policy of the State.

The review of SS&D casework files revealed that five of the seven files had comments on detailed Quality Assurance /Ouality Control (QA/QC) programs. Specifically, the staff did not obtain detailed QA/OC program commitments for devices previously approved (prior to 1995) or new devices similar to previously approved devices. When manufacturer / distributors are amending their certificate, they should be required to submit detailed Quality Assurance / Quality Control (QA/OC) programs regarding the SS&D product manufacturing process. The review team noted that the staff had obtained detailed QA/OC program information on the HDR presently under review and had reviewed the information according the procedures and guidance documents.

During the 1993 review, NRC recommended that the State and vendors should replace missing information and review outdated registration sheets in accordance with the standard format and content guidance. It was recommended that Marytand obtain and maintain sufficient documentation on file to establish a complete health and safety basis for the integrity of the product designs. This item was closed out based on the State's response to the 1993 review. With the assignment of new staff to the program in 1995, the review team requested the documentation of the State's actions to this previous comment. The present staff was not aware of this commitment and management was not able to produce documentation of actions taken by Maryland in response to the 1993 review, e The review team recommends that the State implement a plan to review all registration sheets, based on the risk associated with the device, especially detailed QA/QC program information.

Improvements m the nationwide effort to evaluate SS&Ds containing radioactive material led to NRC adoption of 10 CFh 30.32 (g) on " Application for Specific Licenses" and 10 CFR 32.210 entitled, " Registration of Product Information." Thess regulations were not initially identified as items of compatibility for Agreement States with SS&D evaluation programs.

o All Agreement States letter SP-95-116 dated July 25,1995, announced Commission approval of minimum standards for Agreement States desiring to

d Maryland Proposed Final Report Page 24 maintain authority to evaluate SS&Ds. In keeping with this guidance, the review team recommends that the State adopt reputations compatible with 10 CFR 30.32 (g) and 10 CFR 32.210.

These regulations require manufacturers / distributors to submit certain key product information in support of an SS&D evaluation and permite the State to enforce against those commitments. More specific guidance in this area is contained in Regulatory Guide 6.9 dated February 1995 entitled, " Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources Containing Byproduct Material." It should be noted that the two new SS&D evaluations and certificates issued in 1996 had either a specific license condition on the manufacturers / distributors addressing these requirements

or the through a tie down condition to documents submitted by the licensee.

4.2.2 Technical Staffino and Trainino During the period of April 1993 to June 1995, all SS&D reviews were conducted by the program manager, who retired in June 1995. On the retirement of the program manager, responsibility for SS&D reviews was assigned to the new program manager and a lead health physicist, who is a senior license reviewer. Both staff members had a Bachelor's degree in physical or biological sciences. Both staff members had completed the NRC i recommended core training courses for materials licensing personnel and more advanced 4

training such as the SS&D evaluation workshop, in December 1995, the program manager was reassigned as the program manager for the X-ray program. Another lead health

, physicist was assigned the program manager's responsibilities for SS&D reviews. This staff member has reviewed the course material from the SS&D workshop, has become familiar with the processes and had demonstrated the ability to understand and interpret the information submitted by applicants as described in the performance criteria. Although the lead health physicist is newly assigned to the SS&D reviews, he is an experienced i

senior inspector with a Bachelor's degree in biological sciences and has had all the NRC i

recommended core training courses for materials licensing personnel. An offer was extended to the State for this reviewer to work with the Sealed Source Safety Section at NRC Headquarters, and his management is considering that option.

' The review team is aware that recent retirement and reassignment of the program manager presents potential for weaknesses to develop. During the 1993 review, NRC recommended that Maryland develop a program for cross-training senior staff members in other areas, specifically SS&D evaluations.

The review team recommends that an additional senior staff member should be trained to perform the SS&D evaluations to supplement the program as it matures.

i 4.2.3 Evaluation of Defects and incidents Recardino SS&Ds The State is following up on two SS&D-related incidents which occurred in other jurisdictions concerning the Nucletron microselectron HDR and its interlock system. The State's response to these incidents (with regard to manufacture) was evaluated by the i

i

J Maryland Proposed Final Report Page 25 review team and is included in the incidents reviewed in section 3.5 of this report. The staff is working with the licensee to issue a revision to the SS&D certificate for the HDR to take into account the new design and programming implemented for the interlock and the QA/OC program. A draft version of this certificate has been sent to the licansee for comment.

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

, 4.3 Low-Level Radioactive Waste (LLRW) Disoosal Proaram in 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement" to allow a State to seek an amendment for the regulation of LLRW as a separate category. Those States with existing Agreements prior to 1981 were determined l to have continued LLRW disposal authority without the need of an amendment. Although J

Maryland has LLRW disposal authority, NRC has not required States to have a program for licensing a LLRW disposal facility until such time as the State has been designated as a host state for a LLRW disposal facility. When an Agreement State has been notified or

, becomes aware of the need to regulate a LLRW disposal facility, they are expected to put in place a regulatory program which will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in Maryland.

Accordingly, the review team did not review this indicator.

5.0

SUMMARY

As noted in Sections 3 and 4 above, the review team found the State's performance with respect to each of the performance indicators to be Satisfactory with the exception of 3.2 Technical Staffing and Training and 3.4 Technical Quality of Inspections, both of which were found Satisfactory with Recommendations for Improvement, and the non-common indicator, 4.1.2 Status and Compatibility of Regulations, which was found Unsatisfactory.

Accordingly, the team recommends the MRB find the Maryland program to be adequate to protect public health and safety but needs improvement and not compatible.

Below is a summary list of suggestions and recommendations, as mentioned in earlier sections of the report, for consideration by the State.

1. The review team recommends that the State take action to have the Waste Management Administration revise the definition of " Person" in the low-level radioactive waste regulations COMAR 26.14.01.02B(28)(e) that was identified in both the 1993-94 review and the 1995 follow-up review. (Section 2.0)

2. The review team recommends that the State take prompt action to ensure that Sacred Heart Hospital complies with the recommendations of the joint review team

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

4 i

Maryland Proposed Final Report Page 26 1

i report dated March 5,1996, that was transmitted to the State April 15,1996.

(Section 2.0) i

! 3. The review team recommends that the State incorporate the April 1995 revisicns to l IMC 2800 into their inspection Procedures Manual. (Section 3.1) i j 4. The team suggests that the State consider development of a formal professional j training plan through the use of university and industry educational programs for i j training new staff and retraining or refresh for long term stsff. (Section 3.2)

5. The review team recommends that management provide a corrective action plan to

] address the issue of qualifying staff. The team also recommends that management i

provide a training and qualification plan for new staff that includes an appropriate j education background, and a requalification plan for staff that do not meet the I i initial qualifications, and staff who are reassigned from another technical area, and continued training for long-term staff. (Section 3.2)

! 6. The team suggests that Maryland assess whether a reinspection or revision to i

move-up the next inspection date should be considered for any higher priority ,

licensees, i.e.,HDRs, radiographers, previously inspected by the HP-l inspector l l whose accompaniment was unsatisfactory. (Section 3.2) l l

7. The review team recommends that the State assess the adequacy of the program  ;

staff to ensure the long term ability of the program to maintain an adequate l program to protect public health and safety and complete the pending rules and amendments for adoption to remain compatible. (Section 3.2) l

. 8. The team suggested that the Radiological Health Program could benefit from a guidance document on termination of licenses. (Section 3.3) j 9. The review team recommends that the State adhere to the policy of annual j supervisory accompaniments of allinspectors. (Section 3.4) i i

1 10. To ensure consistency in performance among inspection staff, the review team recommends that the State develop a program outlining the necessary steps to be followed by compliance staff for fullinspector qualification. (Section 3.4)

11. The review team recommends that the State begin voluntary reporting of all reportable events to the NRC Operations Center and begin participating in the NMED database system collection of material events by providing event information directly into the NMED system electronically or providing compatible information in written form in accordance with guidance contained in the " Handbook on Nuclear Material Event Reporting in the Agreement States," Draft Report, March 1995.

(Section 3.5) i

Maryland Proposed Final Report Page 27

12. The team recommends that the State provide event information for three events identified by the State in response to the Questionnaire, as follows: (1) 1/23/93 Maryland State Highway event, (2) 5/26/95 Soil Safe Inc. event, and (3) 5/3C/96 Aerosol Monitoring event. (Section 3.5)

13. The team recommends that the State provide close out information to NRC on allegations referred to the State by NRC. (Section 3.5)

14. The review team recommends that the State improve the effectiveness of the Regulation Adoption Management Plan by providing a realistic schedule of milestones for development and adoption of the 10 rules currently identified in the plan for adoption by the end of 1997. (Section 4.1)

15. The review team recommends that the State address the process for handling multiple rulemakings to ensure that they are completed within three years of the effective date. (Section 4.1)

16. The team recommends that the State address the staff's comments relating to Maryland's COMAR final rules that will be transmitted in a separate letter to the State.

17. The review team recommends that the State implement a plan to review all registration sheets, based on the risk associated with the device, especially detailed QA/OC program information. (Section 4.2)

18. The review team recommends that the State adopt regulations compatible with 10 CFR 30.32 (g) and 10 CFR 32.210. (Section 4.2)

19. The review team recommends that an additional senior staff member be should be trained to perform the SS&D evaluations to supplement the program as it matures.

(Section 4.2)

I l

1 LIST OF APPENDICES AND ATTACHMENTS l Appendix A iMPEP Review Team Members Appendix B Maryland Organization Charts i Appendix C Maryland's Questionnaire Response Appendix D Ucense File Reviews Appendix E Inspection File Reviews 2

Appendix F Incident File Reviews Appendix G Incident File Reviews Attachment 1 Maryland's Response to Review Findings 4

i

)

I i

i d

J

4 s

4 APPENDIX A IMPEP REVIEW TEAM MEMBERS

, Name Area of Responsibility Patricia Larkins, OSP On-Site Team Leader

' Technical Staffing and Training Response to incidents and Allegations )

1 Terry Frazee, Washington Technical Quality of Licensing Actions at NPI 4

Status of Materials inspection Program 1 Dave Collins, Ril Technical Quality of Licensing Actions i i

Craig Gordon, RI Technical Quality of Inspections l Legislation and Regulations 4

Kathleen Schneider, OSP Sealed Source and Device Evaluations 4

4 1

i

l i

t i

l i

l APPENDIX B i

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APPENDIX C INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) QUESTIONNAIRE

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Maryland Department of the Environment Radiological Health Program Reporting Period: April 8,1994, to September 20,1996 4

l A. COMMON PERFORMANCE INDICATORS l 1. Status of Materials insoection Procram j 1. Please prepare a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800 (issued 4/17/95). The list should include initial inspections that are overdue.

insp. Frequency j Licensee Name Wears) Due Date Months O/D

answer: There are no inspections that are overdue by more than 25% as outlined i

in NRC inspection manual 2800.

I

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

answer: No action plan is currently required at this time.

3. Please identify individual licensees or groups of licensees the State / Region is inspecting less frequently than called for in NRC Inspection Manual Chapter 2800 (issued 4/17/95) and state the reason for the change.

answer: All RHP inspections are conducted as frequently or more frequently than the NRC Chapter 2800 inspection frequencies.

4. How many licensees filed reciprocity notices in the reporting period?

a. Of these, how many were industrial radiography, well-logging or other users with inspection frequencies of three years or less?

answer: 708 licensees filed reciprocity notices in the reporting period. 498 of those requests were for types of liceasees which have inspection frequencies of 3 years or less.

i MD IMPEP Questionnaire Page C. 2 i 1

s

b. For those identified in 4a, how many reciprocity inspections

} were conducted?

answer: 56 reciprocity inspections within the reporting period.

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

answer: 4 field inspections of radiographers were performed.

6. For NRC Regions, did you establish numerical goals for the number of

inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for any differences between the goals and the actual j number of inspections performed.

answer: N/A II. Technical Staffino and Trainina l

7. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U-mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

NAME POSITION AREA OF EFFORT Carl E. Trump, Jr. Program Administration, 25%; Materials Manager Licensing & Compliance,65%; '

Emergency Response,5%; *LLRW, 5%

Raymond E. Health Physicist Administration,15%; Materials Manley Lead Licensing & Compliance,70%;

Emergency Response,10%; LLRW, 5%

l l

MD IMPEP Questionnaire Page C. 3 Alan D. Jacobson I Health Physicist Administration,10%; Materials Lead Licensing & Compliance,80%;

Emergency Response,8%; LLRW, 2% ]

1 Robert K. Nelson Health Physicist Administration, 5%; Materials 11 Licensing & Complianco,85%; )

Emergency Response,8%; LLRW,

, 2%

Frank A. Kasper Health Physicist Administration 0%, Materials I Licensing & Compliance 95%,

Emergency Response 5%

Leon J. Rachuba Health Physicist Administration 0%, Materials Lead Licensing & Compliance 98%,

Emergency Response 2%

Douglas K. Health Physicist Administration 10 %, Materials McAbee il Licensing & Compliance 88%, l Emergency Response 2%

Nathanial A. Health Physicist Administration 5%, Materials i Owrutsky Lead Licensing & Compliance 93%,

Emergency Response 2%

LLRW responsibilities are shared between RHP and Mr. Alvin Bowles (Hazardous & Solid Waste Management Administration) who spends 5% of his time on LLRW.

8. Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.

answer: No new professional personnel have been hired since the last review.

9. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, Inspection Manual Chapters 1245 and 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

A b

i j MD IMPEP Questionnaire Page C. 4  :

answer: Frank Kasper needs to attend the Licensing Practices and j Procedures. He will attend course provided funding is available or NRC

sponsorship continues.

I Leon Rachuba needs to attend Safety Aspects of Industrial Radiography. He

will attend course provided funding is available or NRC sponsorship continues.

j INSPECTOR TRAINING

! inspectors must attend all NRC core courses. l l A. Inspections  !

! B. Diagnostic and Therapeutic Nuclear Medicine l l C. Five Week Health Physics D. Safety Aspects of industrial Radiography l E. Licensing Practices and Procedures

{ Each inspector receives and continues to receive one-on-one training by

{ supervisor and senior staff. In addition, the inspector will be accompanied

by a senior staff or supervisor prior to independent inspections, investigations or emergencies.

l LICENSING REVIEWER 1

License reviewers must attend all NRC core courses.

A. Inspections l B. Diagnostic and Therapeutic Nuclear Medicine i C. Five-Week Health Physics D. Safety Aspects of Industrial Radiography l E. Licensing Practices and Procedures 5

License reviewers must be trained and aware of relevant NRC licensing ,

i guidance and pertinent technical documents. i 1

l 10. Please identify the technica! staff who left the RCP/ Regional DNMS l l program during this period.

answer

Retirement of Charles R. Flynn as Licensing Program Manager on 6/95.

Transfer of Thomas Ferguson to X-Ray Program Manager on 12/95.

ll1. Technical Quality of Licensina Actions l 11. Please identify any major, unusual, or complex licenses which were i issued, received a major amendment, terminated or renewed in this  !

period.

j I

i  ;

a

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

MD IMPEP Questionnaire Page C. 5 LICENSEE NAME LICENSE LICENSE TYPE ACTION NUMBER Neutron Products MD-31-025-01 Manufacturer Renewal Neutron Products MD-31-025-03 Teletherapy Renewal Service j l Neutron Products MD-31-025-04 Irradiator Renewal Neutron Products MD-31-025-05 Irradiator Renewal Eastern isotopes MD-03-068-01 Nuclear Pharmacy New Mallinckrodt MD-05-105-01 Nuclear Pharmacy Renewal Medical Terumo Medical MD-15-007-01 Irradiator Renewal i Corp Adaptive MD-21-026-01 Sealed Source Renewal 1 Technologies Inc Design H&H X-ray MD-03-047-01 Industrial Terminated Services Radiography Law Engineering MD-27-060-01 Industrial Terminated inc. Radiography Measurex-DMC MD-31-088-01 Sealed Source Renewal Design Measurex-DMC MD-31-088-02 Service Renewal Mid-Atlantic MD-05-148-01 Nuclear Pharmacy New isotopes Oncology Center MD-25-026-01 HDR New at Riverside i Montgomery MD-31-217-01 HDR New i General Hospital Cancer Treatment Center Chesapeake MD-37-010-01 HDR New Regional Cancer Center

^

GTS Duratek MD-27-059-01 Industrial Terminated Radiography

MD IMPEP Qu2stionnrirs Page C. 6 i

Veterinary Imaging MD-05-145-01 Therapy New 1

Veterinary Referral MD-31-242-01 Therapy New

, Service North Amarican MD-43-019-01 Industrial Terminated inspectiens _ _ _

Radiography Maryland General MD--07-177-01 HDR New j Cancer Center i

l TABLE OF MAJOR LICENSEES licensee Name License Numbg.[ License Tvoe Eastern Isotopes Inc MD-03-068-Oi Nuclear Pharmacy l Syncor Corp MD-05-059-01 Nuclear Pharmacy i Mallinckrodt Inc. MD-05105-01 Nuclear Pharmacy

MOS Inspection Inc. MD-05-128-01 Industrial Radiography Veterinary Imaging MD-05-145-01 Therapy Mid-Atlantic isotopes MD-05-148-01 Nuclear Pharmacy j Johns Hopkins Medical MD-07-005-03 Broad Scope

institute i University of Maryland MD-07-014-01 Broad Scope i at Baltimore University of Maryland MD-07-014-04 incinerator at Baltimore Maryland General Cancer MD-07-177-01 HDR Center 4

~

Union Memorial MD-07-181-01 HDR Oncology Center Terumo Medical Corp MD-15-007-02 Irradiator Therapy Services MD-21-007-01 Therapy Source Service and Distribution 4

, Adaptive Technologies MD-21-026-01 Service and Distribution Inc.

MD IMPEP Questionnaire Page C. 7 4

Oncology Center at MD 25-026-01 HDR l

Riverside Neutron Products MD-31-025-01 Manufacturer Neutron Products MD-31-025-03 Service Neutron Products MD-31-025-04 Irradiator i

Neutron Products MD-31-025-05 Irradiator Nucletron Inc. MD-27-035-01 Therapy Source Service 1 and Distribution Measurex-DMC MD 31-088-01 Sealed Source Design Measurex-DMC MD-31-088-02 Service

! Montgomery General MD-31-217-01 HDR Hospital Cancer

] Treatment Center Mediphysics MD-31-222-01 Nuclear Pharmacy Veterinary Referral MD-31-242-01 Therapy

Associates 1 Pettit Applied MD-31-252-01 Service and Distributior.

Technologies of GL Devices 4 University of Maryland MD-33-004-01 Broad Scope Radiation Service MD-33-021-02 Waste Disposal Organization

! Chesapeake Regional MD-37-010-01 HDR

Cancer Center Washington County MD-43-001-03 HDR Hospital i

12. Please identify any new or amended licenses added or removed from 4

the list of licensees requiring emergency plans?

answer: Neutron Products Inc. MD-31-025-01 Manufacturer of teletherapy sealed sources.

i

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

answer: There were none.

MD IMPEP Ouestionnaire Page C. 8

14. What, if any, changes were made in your written licensing procedures ,

(new procedures, updates, policy memoranda, etc.) during the reporting period?

1 answer: Licensing procedures are currently being updated. Draft procedures are in the review process.

15. For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more, answer: N/A IV. Technical Quality of Insoections

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

answer: On 11/95 a revision of inspection procedures was implemented which includes use of updated inspection fieldnotes and new formatting for report writing and supervisory overview,

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

Supervisor insoector License Cat. (codel Data Carl E. Trump, Jr. Randall Haack 03121 6/20/94 Carl E. Trump, Jr. Alan Jacobson 02305 8/30 31/94 i Carl E. Trump, Jr. Ray Mantay 02120 9/15/94 Carl E. Trump, Jr. Ray Manley Emergency 9/22/94

Response

Carl E. Trump, Jr. Bob Nelson 02120 10/31/94 11/1/94 Carl E. Trump, Jr. Randall Haack 03121 11/29/94 Carl E. Trump, Jr. Ray Manley 03320 incident 1/25/95 Alan Jacobson Reenactment Bob Nelson Frank Kasper Tom Ferguson Carl E. Trump, Jr. Alan Jacobson 02120 1/31/95 Thomas Ferguson Leon Rachuba 03121 11/14/95

i I

! MD IMPEP Questionnaire Page C. 9 3

1

18. Describe internal procedures for conducting supervisory i

accompanimants of inspectors in the field. If supervisory  !

i accompaniments were documented, please provide copies of the l documentation for each accompaniment.

} answer: Accompaniment involves on-site evaluation by senior supervisor for  ;

i competency and knowledge of a selective license category. Each inspector was  ;

j verbally critiqued by the supervisor upon completion of the inspection. i i

19. Describe or provide an update on your instrumentation and methods  !

of calibration. Are all instruments properly calibrated at the present

,i 3

time?

i e

answer:

1 Number of instruments Manufecturer Model i

i 16 Eberline E-520 <

{ 2 Eberline ASP-1  ;

) 2 Bicron mrem l 1 Eberline E-120 9 Eberline Prm-7 l

) 4 Ludlum 12S 1 Ludlum 14A 1 Ludlum 19

\

4 Eberline MS2 3 Eberline Pac 4G f 3 Eberline Pic 6a i 12 Eberline Pic 6B i

i 1 Victoreen 470 A

$ Meters are calibrated at Radiation Services Organization or by BGE (Calvert

! Cliffs Nuclear Facility). Allinstruments used by personnel for compliance or

investigatory purposes are calibrated.

t 4

5 i

3 i

l

MD IMPEP Questionnaire Page C.10 j l

! V. Resoonses to incidents and Alleaations I

j 20. Please provide a list of the most sianificant incidents (i.e., medical

misadministration, overexposures, lost and abandoned sources, j ~ incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc.) that occurred in

the Region / State during the review period. For Agreement States, l

! information included in previous submittals to NRC need not be repeated. The list should be in the following format:

i

LICENSEE NAME LICENSE # DATE OF TYPE OF  !

j INCIDENT \ REPORT. INCIDENT l Private Paint Shop GL Device 7/11/94\\7/20/94 Stolen Device i

! Material Testing NRC-45-17151- 10/6/94\\12/12/94 Industrial i j Laboratories 01 Radiography 3 12/14/94 (loss of control) 12/23/94 j

! Atoc Assoc. MD-31-189-01 8/31/94\\9/22/94 Damaged Gauge .

i i

Schnabel Eng. MD-07-141-01 11/3/94\\3/3/95 Damaged Gauge Assoc. .

Mallinckrodt Inc. MD-33-088-01 1/10- Unrestricted

11/95\\2/1/95 Area & DOT l Contamination Maryland State MD-05-049-01 1/23/985\\1/24/95 Stolen Gauge Highway I:

Soil Safe Inc. MD-07-172-01 5/26/95\\7/10/95 Lost Gauge j Nucletron MD 27-035-01 1/9/96\\2/22/96 System Failure j Corporation i- Aerosol Monitoring MD-03-056-01 5/30/96\\6/10/96 Stolen Paint Analyzer i Johns Hopkins MD-05-007-03 6/5/96\\Pending Brachytherapy Medical Institutions (loss of control)

)

i 21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees l who might be affected notified?

I j

MD IMPEP Questionnaire Page C.11

a. For States, was timely notification made to the Office of State Programs? For Regions, was an appropriate and timely PN generated?

answer: a. Notification to RHP by NRC regarding failure of Nuclotron HDR's door interlock system to always retract the source when the treatment room door is opened. NRC notified other states that might be affected by an abnormal occurrence report. US, Canadian and Mexican users also notified via safety alert issued by the manufacturer.

b. Multiple dose vial breakage during pharmaceutical preparation at Mallinckrodt pharmacy causing contamination of pharmacy, surrounding unrestricted areas and DOT transpott packaging.

Proper notification was made to NRC Region 1.

22. For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design

' deficiency? Please provide details for each case.

answer: For 21a. NRC and the manufacturer supplied appropriate information to Maryland. For 21b. a manufacturing notice had been sent to most recipients regarding a bad batch of vials prior to the incident.

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

answer: No.

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

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

answer: Draft allegation procedure is under review.

a. None VI. General

25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.

3 '

i l MD IMPEP Ouestionnaire Page C.12

• answer: Of the 30 program indicators that were evalustod during the 1993 program review,19 were found satisfactory. NRC recommendations and RHP's i current status is indicated below:

l 1. Status and Comoatibility of Reaulations (Category l}

}

j NRC RECOMMENDATION: The RHP should continue their efforts to amend

State regulations that are needed for compatibility including revision to the l

! definition of " person" set out in the Maryland low-level radioactive waste 3 regulations, and obtain the necessary support needed to adopt the l j regulations in an expeditious manner. The RHP should develop and submit I i to NRC a management plan for eliminating the current rulemaking backlog

and a schedule for adoption of revisions to the regulations, i

l RHP STATUS: On September 21,1995 RHP submitted to NRC a regulations i adoption management plan indicating Maryland's commitment to expeditiously evaluate and update pertinent radiation regulations falling under the NRC i compatibility designation. This mandates the actions of a regulation committee j whose mission is to coordinate, evaluate and implement the expedient adoption of l~ required regulations. An extensive update of the Code of Maryland Regulations i (COMAR) 26.12.01.01 titled, " Regulations for Control of lonizing Radiation,"

l adopted September 9,1995 and effective October 9,1995, incorporated the _

j thirteen (13) compatibility agulations which had exceeded the three (3) year i incorporation deadline. The definition of " person" as given in COMAR

! 26.12.01.01 Section A.2 meets the compatibility standard. Currently the  !

regulation committee is near completion regarding the adoption of regulations )

{ governing the licensing and radiation safety requirements for irradiators and i anticipates adoption in November,1996. I i l I 2. Budget (Category 11) i i NRC RECOMMENDATION: The RHP should assess programmatic needs  !

l and, if determined to be necessary, a supplemental budget increase l

! requested to provide sufficient ope 9 ting funds for the program. '

i RHP STATUS: The RHP has been assessing program needs annually during the budget preparation process. Specific considerations that impact available resources during the year are being addressed as they occur. Program needs have j been impacted by:

i i a. the requirement to allocate staff in order to keep the Maryland program

! adequate to protect the public health and safety, and compatible with NRC i regulations; i

i b. the attention and diligence needed to deal with the licensing and compliance j issues associated with regulating Neutron Products, Inc.; and,

1 i

i

! MD IMPEP Questionnaire Page C.13

c. the importance of responding appropriately to implement the NRC's j recommendations resulting from the audit of Maryland's program.

l Fees were increased an average of 60% in July 1994 to assist in meeting these

and other needs. Currently the need for additional fee increases is being evaluated.

Programmatic reassessment will continue as requirements change.

3. Administrative Procedures (Category ll)

NRC RECOMMENDATION: The RHP should review their administrative procedures for licensing, inspection, and event reporting (including incidents, allegations and misadministrations), develop or update the procedures accordingly, and make them available to the staff for implementation.

RHP STATUS: RHP is currently undergoing the review and evaluation process regarding administrative procedures in the arew of licensing, reporting of events, and misadministrations. Inspection procedures were revised and implemented in November of 1995.

4. Trainino (Category ll)

NRC RECOMMENDATION: The RHP should develop a program for cross-training senior staff members in other RHP areas, specifically in the area of SS&D evaluations and registrations. The RHP should also provide additional training to staff in internal radiation exposure and dose assessment evaluations in accordance with the revised Part 20.

RHP STATUS: RHP has conducted cross training for licensing staff in the area of sealed source and device evaluations and registrations. An overall assessment of training requirements and needs within the Agency is an ongoing process and includes a review of training needs of administrative staff. Staff training in dose assessment, in accordance with the revised Part 20, was held on October 12, 1995. Specific aspects of the licensing staff training program include:

a. training of licensing personnelin the areas of generallicensing practices and SS&D evaluations; and,

b. explaining segments of licensing procedures to all personnel.

. l

5. Adecuacy of Product Evaluations (Category l}

NRC RECOMMENDATION:

a. The RHP and vendors should replace missing information and review .

outdated registration sheets in accordance with the standard format and l l

i

i 4

i MD IMPEP Questionnaire Page C.14 9

} content guidance. Maryland should obtain and maintain sufficient i documentation on file to establish a complete health and safety basis for the integrity of the product designs.

l b. The RHP should re-evaluate the Nucletron Microselectron HDR

considering the deficiencies and questions identified in Appendix B.

, c. The RHP should discontinue the practice of performing a sealed source

[ and device acceptance evaluation that authorizes a manufacturer, j located in another State, to routinely distribute that source or device.

! (See Registration sheets MD-327-D-101-G, MD-0691-S-101-S, MD-

! 0691-D-102-S). The RHP would have no basis to inspect the manufacturer to determine if the product is being manufactured and

distributed in accordance with the information submitted and evaluated j by the RHP. Unless a cooperative arrangement can be made with the j affected State, this practice should be discontinued.

i RHP STATUS:

I i a. RHP has followed specific guidance received from Steve Baggett of NRC

} Headquarters regarding this issue.

l b. The NRC's 25 questions concerning Nucletron's high dose rate (HDR) j remote afterloader were sent to Nucletron. Nucletron's responses were reviewed and confirmed the accuracy of the registry sheet as written.

j c. The RHP has never had a policy of writing registry sheets for out-of-state j licensees. Two registry sheets (MD-0691-S-101-S, and MD-0691-S-102-S) were written for a licensee who immediately moved out of the State. A third registry sheet (MD-327D-101-G) was written for a Maryland licensee

acting as the East Coast distributor. The sheet has been rewritten, thereby l deleting the West Coast distributor.

i-i 6. Licensina Procedures (Category 11)  !

I I

NRC RECOMMENDATION: The RHP should revise their licensing procedures

to provide for the routine use of letters to

(a) transmit licenses and ,

i amendments; and, (b) bring to management's attention, highlights of license {

changes or related information.  !

> 1

! RHP STATUS: The RHP began using a transmittal letter to forward new licenses l and explain MDE annual radioactive materials user fees in July 1994. Beginning on July 1,1995, transmittal letters have been attached to simple amendments, i.e.,

! . the amendment which authorizes the change in the license which the licensee l originally requested. This will facilitate communication with licensees and enhance l compliance.

f i 4

i

i l

[

MD IMPEP Ouestionnaire Page C.15  ;

4 4

i j 7. Technical Quality of Licensina Actions (Category l} '

j

' NRC RECOMMENDATION: The RHP should continue its efforts to renew the NPI license to include a clear set of license requirements against which the ,

RHP can assess continued operations at NPI, and against which enforcement '

action can be taken, if required. We also request that the RHP, as part of its i response to this recommendation, include a discussion of the current status s l of NPI license renewal activities and the steps and schedule for issuance of a

renewed license. .

l The RHP should update and use the most current standard license conditions

for the molybdenum 99 breakthrough licensed activity, and reflect the other l comments in future licensing actions.

j RHP STATUS: NPI's MD-31-025-01 (manufacturing) license was renewed on '

. January 18,1996. The licensee has requested and been granted an administrative

! hearing regarding license content. Until resolution of the hearing the licensee is operating under the old license. NPl license MD 31-025-03 (teletherapy service) t i was renewed on i September 7,1995. NPI licenses MD-31-025-04 & MD-31-025-05 (irradiator)

were renewed on October 16,1995 and October 26,1995 respectively.

l .

l The RHP has reviewed all license conditions under current NRC guidelines.  !

} Specifically, the standard condition for molybdenum-99 breakthrough has been j modified to 0.15 microcuries of molybdenum-99 per one millicurie of technetium-l 99m and will be used on all nuclear medicine and pharmacy licenses when issued ,

j or renewed.

• i

! 8. Insoection Freauency (Category I)

NRC RECOMMENDATION: The RHP should revise the inspection frequency for all afterloader licensees to a one-year inspection frequency.

RHP STATUS: This NRC recommendation was misdirected and should not have been included as a Category 1 indicator. The RHP revised the inspection frequency for afterloader licensees from a three (3) year frequency to an annual frequency during the NRC's September 1993 review, because NRC guidelines regarding this inspection frequency change had not been received by the RHP prior to the NRC's review. As emphasized during the March 4,1994 outbriefing with MDE Secretary Robert Perciasepe, MDE would certainly have implemented this policy sooner, had the NRC provided this information. Please note, however, that all afterloader devices in Maryland were inspected within six (6) months of the issuance of the license and all were within one year of that inspection at the time of the review.

1 i

MD IMPEP Questionnaire Page C.16 1

9. Enforcement Procedures (Category l}

NRC RECOMMENDATION: The RHP should continue with implementation of l the April 4,1994 strategic plan for NPI inspection and compliance activities. {

The RHP should revise and implement enforcement procedures to: (1)  !

address the routine enforcement policy, the use of the Notice of Violations I and the MDER-E-1 form; and (2) include use of acknowledgement letter in routine enforcement actions.

1 RHP STATUS: The RHP has continued with the implementation of the April 4, 1994 strategic plan for NPI inspection and compliance activities. The RHP has revised enforcement procedures to address routine enforcement policy, the use of l the Notice of Violations, and the MDE E-1 form. The RHP began issuing l acknowledgement letters for routine enforcement actions in March 1994.

10. Insoection Procedures (Category ll)

NRC RECOMMENDATION: The RHP should update inspection procedures to ,

reflect current program operations. I RHP STATUS: RHP has reviewed existing inspection procedures and revised them accordingly. The review includes evaluation of NRC guidance regarding inspection procedures and guidelines. The updated procedures were implemented by November,1995.

11. Insoection Reoorts (Category ll) l NRC RECOMMENDATION: The RHP should consider the comments identified in Appendix C relating to inspection reports and should ensure that inspection reports receive timely review by the Compliance Supervisor for l uniformity and quality control purposes, i.e., soon after the inspection and prior to any enforcement actions.

RHP STATUS: The RHP has considered the comments identified in Appendix C relating to inspection reports and will continue to ensure (as is our present policy) that all inspection reports are received for timely review by the Compliance Supervisor. The Compliance Supervisor will review these for uniformity, accuracy, and completeness within ten (10) working days of receipt. Routine inspections will require each inspector to complete the report within twenty (20) working days after completion of the inspection. For team inspections, the lead inspector will be required to complete the report within thirty (30) working days after completion of the inspection.

i I

i j MD IMPEP Questionnaire Page C.17 '

in November,1995 NRC conducted a follow-up inspection to the 1993 audit. NRC j s recommendations and RHP's current status is indicated below:  ;

J j ltem 1. Status and Comoatibility of Raoulations (Category l}

l .

NRC RECOMMENDATIONS:

i 4

(1) NRC recommends that the RHP staff address rulemaking for the I i

irradiator rule as soon as possible in order to meet the July 31, j i 1996 deadline.

h

} (2) NRC recommends that the State revise the " Regulation 1

} ~

Adoption Management Plan" to address the points in the letter , j specifically to begin rule development sooner and, if the SSRCR i

has not been developed in parallel with the NRC rule, the State 1 i should proceed without the SSRCR.

J b (3) NRC also recommends that the defiaaon of person be amended

, to make it explicit that the inclusion of Federal entities in the 4

Maryland definition is limited to that allowed by Federallaw.

)

RHP STATUS:

l f (1) Maryland regulations specific to NRC's irradiator rule are on track for

adoption in November of 1996 i

4 (2) RHP is in agreement with NRC's recommended revisions to the " Regulation Adoption Management Plan."

w (3) It is RHP's opinion that this issue has been resolved. It is RHP's

! understanding that the definition of " Person" as found in Section A.2 of

{ COMAR 26.12.01.01 titled, " Regulations for Control of lonizing Radiation i (1994)" is acceptable to NRC. The definition is: " Person" means an l individual , receiver, trustee, guardian, personal representative, fiduciary, or

. representative of any kind and any partnership, firm, association, j corporation, or other entity. " Person" includes any public or municipal corporation and any agency, bureau, department, or instrumentality of state  ;

j or local government and, to the extent authorized by federal law, federal '

a government. l 2 '

i i

b U i

MD IMPEP Questionnaire Page C.18

! item 4. Technical Quality of Licensina Actions (Category l}

NRC RECOMMENDATION:

NRC recommends that the RHP continue to work with Montgomery County in evaluating and approval of the NPI proposal for construction activities which should reduce the unnecessary radiation levels in and around the facility.

RHP STATUS:

On March 18,1996 a management meeting was held betweeri RHP, NPI and Montgomery County. As a direct resu6t of this meeting, on April 8,1996, RHP approval (with specific conditions) was given to NPI for the construction of a

courtyard enclosure. NPI is currently working on detailed engineering plans for submittal to Montgomery County. RHP feels that the construction of this enclosure should significantly reduce radiation levels in and around the facility.

26. Provide a brief description of your program's strengths and weaknesses. l These strengths and weaknesses should be supported by examples of l successes, problems or difficulties which occurred during this review period.

, answer: The program has the full support of the Program Administrator. RHP's feels confident that it has fulfilled the MDE mission to insure the safety and protection of occupational workers, members of the general public and the  ;

i environment. Furthatmore, RHP has established an aggressive and effective  !

compliance program. Examples of the above can be seen in enforcement actions

{

specific to NPI, Mallinckrodt Pharmacy and Material Testing Laboratories. The program is currently conducting ongoing evaluations in procedures used for inspections, licensing and investigatory actions. RHP staff time is still being significantly impacted by compliance and licensing overview associated with Neutron Products Inc.

B. NON COMMON PERFORMANCE INDICATORS Reaulations and Leaal Authority i

27. Please list all currently effective legislation that affects the radiation

control program (RCP).

answer:

i

MD IMPEP Questionnaire Page C.19 Annotated Code of Maryland, Environmental Article, Title 8," Radiation" and Title

, 7," Hazardous Materials and Hazardous Substances"(only those portions that deal

] with low evel waste issues).

Comor 26.12.01.01 titled " Regulations for Control of ionizing Regulat!ons" Comar 26.15 titled " Disposal of Controlled Hazardous Substances-Radioactive Hazardous Substances" i

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

answer: Regulations have no expiration date. Our procedure is to review the

) regulations for compatibility and revise the appropriate part of COMAR within the 3 year deadline.

l

29. Please complete the enclosed table based on NRC chronology of amendments. Identify those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being 4

taken to adopt them.

answer: see chart l 30. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the

] NRC, showing the normallength of time anticipated to complete each step.

answer: Regulations for %a licensing and radiation safety requirements of 4

Irradiators are in the fh.ru t,tages of promulgatio,e and are scheduled to be published in the Maryland Register in 10/96. The proposed regulations have been reviewed by the NRC. Current schedule estimates the date of adoption to be 11/96.

4 l

}

l

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

MD IMPEP Qurstionnalra Psg3 C.20 11.

Sealed Source and Device Proaram

31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the review period. The table heading should be:

SS&D Manufacturer, Type of Registry Distributor or Device Number Custom User or Source MD-0113-D-104-G AdaptiveTechnologies Thickness / density MD-0113-D-107-G Adaptive Technologies Thickness / density MD-0113-D-108-G Adaptive Technologies Gamma MD-0113-D-109-G Adaptive Technologies Beta MD-0113-D-110-G Adaptive Technologies Beta MD-0105-D-101-G Conco Services Corp Fluorotracer MD-0263-D-101-G Environmental Tech Analytic MD-0177-D-102-G Evenlite inc Self Luminous Marker MD-0205-D-101-G Food Instrument Corp Fill Gauge MD-1003-D 101-G Pettit Applied Thickness / density MD-0541-S-101-G Wallac LSC sources

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

answer:

USNRC Reg Guide 10.10 USNRC Reg Guide 10.11 USNRC Reg Guide 6.9 Policy and Guidance Directive 84-22 ANSI Standards Workbook from USNRC " Sealed Source and Device Workshop" September 12-5, '

1995.

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

Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.lli.11, A.lli.13-14 Responses to incidents and Allegations - A.V.20-23 answer: ,

Technical Staffing & Training:

7. Two individuals (Nathaniel Owrutsky & Raymond Manley) within the program have been assigned and trained in the review of SS&Ds.

8. N/A

9. N/A

10. Charles R. Flynn

! MD IMPEP Qu:stinnnalra Pags C.21 i 4

Technical Quality of Licensing Actions:

I  ;

1 11. Nuclotron amendments will most likely be issued prior to NRC audit (change

{ in safety systems for HDR) i 13. Nucletron was allowed to upgrade HDR safety systems prior to amendment '

of HDRs.

4

14. N/A Reviewers are using NRC SS&D procedures.

I j Responses to incidents and Allegations:

20. Nucletron Corporation (see above)

21. Nucletron Corporation (see above) j 1

i 22. Nuclotron Corporation (see above) '

i l 23. NONE l

til. Low-Level Waste Procram i

34. Please include information on the following questions in Section A, as j they apply to the Low-level Waste Program:

L Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Staffing and Training - A.ll.7-10 4 Technical Quality of Licensing Actions - A.lli.11, A.Ill.13-14 l Technical Quality of Inspections - A.lV.16-19 Responses to incidents and Allegations - A.V.20-23 4

3 answer: RHP does not have a Low-level Waste Progra'm. Overview of such areas

! as decommissioning, NPI radioactive waste storage, licensing of decay in storage, i and special projects such as the DLA Curtis Bay clean-up have been generally i distributed among staff.

j IV. Uranium Mill Proaram 1

35. Please include information on the following questions in Section A, as i they apply to the Uranium Mill Program:

Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.lli.11, A.lli.13-14

Technical Quality of Inspections - A.IV.16-19 Responses to incidents and Allegations - A.V.20-23 answer

N/A r

1

MD IMPEP Questionnaire P;ge C. 22 5

TABLE FOR QUESTION 29.

DATE DATE .

10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION Any amendment due pdor to 1991.

identify soch regulation (refar to the ,

Chronology of Amendments)

IAEA Competitety 10 CFR Part 71 9/6/86 9/9/95 Addressed in Section T, of Regulatione for Control of ionialng Radletion (1994)

Glees Enemel and Glees Frit 9/11/87 9/9/95 Addressed in Section C.3(cH2 Mill)

Industrial Radiography "3urveys 7/16/89 9/9/95 Addressed in Section E.201 Bankruptcy Filing Notificotton 2/11/90 9/9/95 Addressed in Section C.31(el Notifications, Reports, and Record of 4I1190 9/9/95 Addressed in Section D.1209 Misedministration wen Logging 7/14/90 9/9/95 Addressed in Section W Dosimetry Processing 2/12/91 9/9/95 Addressed in Sectiott D.501(cNil)

Decommissioning: 7/27/91 9/9/95 Addressed in Section C.29 Ports 30,40,70 Emergency Planning: 417/93 9/9/95 Addressed in SectM C.23 Parts 30,40,70 Standards for Protection Against Radletion: 1/1/94 9/9/95 Addressed in Section D & Section A.2 Part 20 Safety Requirements for Radiograp& 1/10/94 9/9/95 Addressed in Section E.308 Equipment: Port 34 ,

Notification of incidents: 10/15194 9/9/95 Addressed in Section D.1202 Parts 20, 30, 31, 34, 39, 40, 70 Questy Menegement Propem and 1/27/95 9/9/95 Addressed in Section G.76 Misedministrations: Port 35 Licensing and Radletion Safety 7/1/96 p u- z f Section X 11/96 Mr-

• _._.^. for Irradiators: Part 36

MD IMPEP Questionnalra Pcge C. 23 i

OR DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED '

STATUS ADOPTION Definition of Land Disposal 7/22/96 N/A and Weste Site OA Program: Part 61 Decommissioning Recor6eeping: Docu- 10/26/90 9/9/95 Addressed in Section C.29(fM31 mentation Additions: Parts 30,40,70 Self-Guerentee as en Additional Financial 1/28/S7 Not consistent with conclusions reached by Maryland's N/A Mechanism: Ports 30,40,70 Legislative Aoditors Urenlum MIN Tallings: Conforming to EPA 7/1/97 N/A Standards: Part 40 Timeliness in Cocommissioning 8/15/97 No action taken 8/97 i Parts 30,40,70 l

Properstfort, Transfer for Commercial Die- 1/1/98 No action taken 12/97  !

tribution, and Use of Byproduct Motorial i for Medical Use: Ports 30,32,35  !

l Frequency of Medical Examinations for Use 3/13/98 No action taken 12/97 of Respiratory Protection "- c.a; l Low-Level Weste Shipment Manifest 3/1/98 No action fthen 12/97 l

l Information and Reporting Performance Requirements for Radiography 6/30/98 No action taken 12/97  !

Ea ', .2: ,

Radletion Protection Requireraasits: 8/14/98 No action taken 12/97 Amended Definitions and Criteria j r

Clarification of Decommissioning Funding 11/24/98 No action taken 12/9) I R n' _ . ._.;.

10 CFR Part 71: C_. J 3 with the 4/1/99 No action taken 12/97 Intemational Atomic Energy Agency Medical Administration of ResNotion and 10/20/98 No action taken 12/97 Radioactive Meterleis.

Termination or Transfer of Licensed 5/16/99 No action taken 12/97 ActMties: Recordkeeping M " ..._.:..

i

APPENDIX D LICENSE FILE REVIEWS File No: '1 Licansee: Eastern Isotopes, Inc. License No. 03-068-01 Location: Hanover, MD Amendment No. O l License Type: Nuclear Pharmacy Type of Action: NEW i Date Amendment Iseued: 4/7/95 License Reviewers: CRF/NAO Comments:

a) Checklist not in docket file b) Ownership verified, not the same name as operator c) Applicant stated use of certified packages, submitted acceptable response, reviewer asked for more information d) Apglication stated use of independent audits by RSO, approved; because another company committed to outside audits, an inspector asked company and reviewer to amend licensee to do the same File No. 2 i

Licensee: G.T.T. Incorporated License No. 31-246-01 l Location: Bet;1esda, MD Amendment No. O License Type: Portable Gauges Type of Action: NEW l Date Amendment issued: 4/26/95 License Reviewers: CRF/NAO File N.- 3 Licensee: K.M.Lindgren, M.D. et al License No. 31-120-01 Locatic.n: Rockville, MD Amendment No.4 License Type: Nuclear Medicine Type of Action: Renewal Date Amendment issued: 11/27/95 License Reviewers: NAO/CET File No. 4 Licensee: PSI, Inc. License No. 03-036-01 Location: Linthicum, MD Amendment No.18 License Type: Portable Gauges Type nf Action: Amendment Date Amendment issued: 3/7/96 License Reviewers: NAO/ REM Comment:

a) Licensee requested extension of renewal preparation time for business reasons.

Extension granted, renewal submitted within time extension.

File No. 5 Licensee: Schnabel Engineering Assoc. License No. 047 141-01 Location: Baltimore, MD Amendment No. 20 License Type: Portable Gauges Type of Action: Renewal Date Amendment issued: 6/26/96 License Reviewers: NAO/CET

i l

} l

• 1 1

l Maryland Proposed Final Report Page D. 2

License File Reviews l File No. 6 j Licensee

Oncormed, Inc. License No. 31-237-01 i

! Location: Gaithersburg MD Amendment No. 2

} License Type: R & D Laboratory Type of Action: Amendment

Date Amendment issued

6/26/96 License Reviewers: NAO/CET

Comment:

l a) Action requested increases, provided sufficient information to make safety

determination

! File No. 7

}

^

Licensee: Biomedical Research Inst. License No. 31-102-01 Location: Rockville, MD Amendment No.16 & 17 License Type: R&D Lab Type of Action: Renew & Amend Date Amendment issued: 8/30/94 & 9/23/94 License Reviewers: NAO/CRF NAO/CRF Comment:

a) Weste storage issue separated from renewal, issued upon resolution. Good decision File No. 8 Licensee: Potowmac Engineers License No. 33-131-01 Location: Capitol Heights, MD Amendment No. O License Type: Portable Gauge Type of Action: NEW Date Amendment issued: 10/24/94 License Reviewers: CRF/NAO l

omments-a) Registry sheet allows leak test at 1 year, license condition is 6 months. i b) COMAR D.401 allows change of leak test, State does not use option. I File No. 9 Licensee: Campbell & Nolan Assoc. License No. 25-030-01 Location: Amendment No. 5 License Type: Portable Gauges Type of Action: Amendment Date Amendment issued: 9/12/96 License Reviewers: NAO/CRF I File No.10 Licensee: Patriot Mining Co., Inc. License No. 23-007-01 Location: Star City, WV Amendment No. 2 License Type: Fixed Gauges Type of Action: Amendment Date Amendment issued: 6/14/95 License Reviewers: NAO/TDF Comment:

a) Mine in MD, home office in WV l

1 i

Maryland Proposed Final Report Page D. 3 License File Reviews i l

File No.11 )

Licensee: Chesapeake Reg. Cancer Ctr. License No. 37-010-01 Location: Mechanicsville, MD Amendment No. 0

License Type: HDR Afterloader Type of Action NEW Date Amendment issued: 5/31/94 License Reviewers: NAO/CRF File No.12 i Licensee: AMVAX, Inc. License No. 33-108-01

Location

Beltsville, MD Amendment No. 6 License Type: R&D Lab Type of Action: Renewal Date Amendment issued: 2/21/95 License Reviewers: NAO/CRF Comments:

a) Deficiency phone call only documented in licensee response b) Liquid scintillation analyzer doesn't show MDA for wipe results File No.13 '

Licensee: American Red Cross License No. 07-177-01 Location: Baltimore, MD Amendment No. 7 License Type: Blood Irradiator Type of Action: Renewal Date Amendment issued: 6/19/95 License Reviewers: NAO/CET I File No.14 Licensee. Gene Logic, Inc. License No. 27-066-01 Location: Columbia, MD Amendment No. O License Type: R&D Laboratory Type of Action NEW Date Amendment issued: 8/12/96 License Reviewers:NAO/RKN ,

File No.15 Licensee: Wallac License No. 31-071-01 Location: Gaithersburg, MD Amendment No. 38 License Type: Demonstration of devices Type of Action: Renewal Date Amendment issued: 8/14/96 License Reviewers: NAO/RKN Comments:

a) Distribution, manufacturer's service representative b) No material possessed.

File No.16 Licensee: GTS Duratek License No. 27-059-01 Location: Beltsville MD Amendment No. 3 License Type: Radiography Type of Action: Terminate Date Amendment issued: 9/14/94 License Reviewers: NAO/CRF Comments:

a) Material transferred to corp. operation in Florida b) Inspector verified sources moved c) No records related to personnel or possible public exposure discussed

\

l Maryland Proposed Final Report Page D. 4 License File Reviews File No.17 Licensee: BG&E (Calvert Cliffs) License No. 030-027-01 Location: Lusby MD Amendment No.16 License Type: Radiography Type of Action: Terminate Date Amendment issued: 1/5/95 License Reviewers: CRF/NAO Comments:

a) Licensee's close-out survey not complete b) Agency survey doesn't include SN or calibration date of instrument used .

File No.18 Licensee: Med Industry Sys. Consultants License No. 03-022-01 Location: Millersville MD Amendment No. 6 License Type: Service / Leak Test Type of Action: Terminate 1 Date Amendment issued: 11/3/95 License Reviewers: NAO/TDF I Comments:

a) Letter states no materials, no action on letter for 1 year b) No closeout action by Program to verify File No.19 Licensee: Engineering Technologies Assoc. License No. 27-045-01 Location: Ellicott City MD Amendment No. 5 License Type: Portable Gauge Type of Action: Terminate Date Amendment issued: 4/10/95 License Reviewers: NAO/CRF Comments:

a) No copy of recipient's license forwarded (MD licensee) b) No verification all materials transferred File No. 20 Licensee: Sopha Medical License No. 27-038-01 Location: Columbia MD Amendment No.16 License Type: Service License Type of Action: Terminate Date Amendment Issued: 6/10/96 License Reviewers: NOA/CET Comments:

a) All materials transferred properly b) inspected and documented adequately File No. 21 Licensee: Washington Radiology Assoc. License No. 31-227-01 Location: Bethesda MD Amendment No.1 License Type: Nuclear Medicine Type of Action: Terminate Date Amendment issued: 5/17/96 License Reviewers: NAO/CET

l i

1 Maryland Proposed Final Report Page D. 5 License File Reviews Comments:

a) Materials decayed-in-storage, transferred to another licencee b) Licensee's closeout survey adequate c) Program's survey and termination adequate File No. 22 Licensee: SAIC License No. 31-076-01 Location: Rockville & Gaithersburg MD Amendment No.31 License Type: Analytic samples Type of Action : Terminate Date Amendment issued: 2/8/93 License Reviewers:CRF/NAO

Comments

. a) Continuous monitoring through weekly reports from licensee l

b) Closeout survey 1/6,21,28/93 summary documented adequately l 4

^

File No. 23 Licensee: Oboler, Kaufman et al i License No. 31-121-01 i Location: Silver Spring MD Amendment No.18 I License Type: Nuclear Medicine Type of Action: Renewal Date Amendment Issued: 10/20/96 License Reviewers: CRF/NAO l

Comment:

a) Deficiency phone call not documented File No. 24 Licensee: St. Agnes Hospital License No. 07-010-01 Location: Baltimore MD Amendment No. 38 License Type: Nuclear Medicine l Type of Action: Amendment  ;

Date Amendment issued: 6/29/95 License Reviewers: TDF/NAO Comment:

a) Amend deletes Xe-133 rooms since they don't use it. Complete File No. 25 Licensee: Prince George's County License No. 33-109-1 Location: Upper Marlboro MD Amendment No.

License Type: Portable Gauge Type of Action: Renewal Date Amendment issued: 4/25/95 License Reviewers: CRF/NAO File No. 26 Licensee: Nuclear imaging Systems, Inc. License No. 33-130-01 Location: Riverdale MD Amendment No. 3 License Type: Nuclear Medicine Type of Action: Renew Date Amendment issued: 7/12/94 License Reviewers: CRF/NAO

Maryland Proposed Final Report Page D. 6 License File Reviews File No. 27 1 Licensee: Chektec Corporation License No. 07-171-01 Location: Baltimore l Amendment No. 7 i License Type: Type of Action: Terminate l Date Amendment issued: 4/3/95 License Reviewers: CRF/NAO Comments:

a) Licensee survey adequate b) Program's inspection timely, no calibration listed on survey document for survey meter File No. 28 Licensee: Potomac Engineering & Surveying License No. 23-004-01 Location: Amendment No.1 License Type: Portable Gauge Type of Action: Terminate Date Amendment issued: 2/23/95 License Reviewers: NAO/CRF Comments:

a) No record of action to verify transfer of gauges I b) No closeout survey File No. 29 Licensee: Isorad Limited License No. 31-209-01 Location: Bethesda MD Amendment No. 2 License Type: Type of Action: Terminate Date Amendment issued: 2/5/96 License Reviewers: NAO/CET Comments:

a) No materials possessed b) Verified by visit File No. 30 Licensee: Louisiana-Pacific Corp. License No. 27-049-01 Location: Savage MD Amendment No. 4 License Type: Fixed Gauge Type of Action: Terminate Date Amendment Issued: 7/23/96 License Reviewers: NAO/CET Comments:

a) Licensee states returned to manufacturer b) No record of verification File No. 31 Licensee: Dames & Moore License No. 03-039-01 Location: Annapolis MD Amendment No. 8 License Type: Portable Gauges Type of Action: Terminate Date Amendment issued: 6/5/96 License Reviewers: NAO/CET

l l

l Maryland Proposed Final Report Page D. 7 License File Reviews Comments:

a) Transferred to another corporate office, not authorized to possess portable gauges on submitted copy.

b) License et recipient office amended prior to actual transfer.

File No. 32 Licensee: Engineering Technologies License No. 027-065-01 Location: Ellicott City MD Amendment No. O License Type: Portable Gauge Type of Action: NEW i Date Amendment issued: 3/4/96 License Reviewers: NAO/CET l Comments:

a) No standard locking condition when not in use, and no locking instruction in Operating & Emergency instructions File No. 33 Licensee: Engineering Technologies License No. 27-065-01 Location: Ellicott City MD Amendment No.1 ,

License Type: Portable Gauges Type of Action: Terminate l Date Amendment issued: 5/7/96 License Reviewers: NAO/CET l

Comments: l a) No materials received, no work done, no verification in record j 4

File No. 34 i Licensee: H&H X-ray Services, Inc. License No. 03-047-01 Location: Baltimore MD Amendment No.

License Type: Radiography Type of Action: Terminate Date Amendment issued: 10/2/95 License Reviewers: NAO/TDF ,

Comments:

a) Letter request, discussion with Co. President, transfer to NRC license.

b) No closecut, no verification File No. 35 Licensee: Laurel Regional Hospital License No. 33-37-01 Location: Laurel MD Amendment No. 29 License Type: Nuclear Medicine Type of Action: Amend j Date Amendment issued: 6/25/96 License Reviewers: NAO/CET File No. 36 Licensee: kcl Technologies License No. 05-150-01 Location: Hunt Valley MD Amendment No.

License Type: Portable Gauge Type of Action: Amend Date Amendment issued: 7/11/96 License Reviewers: DKM/CET

l i

Maryland Proposed Final Report Page D. 8 )

License File Reviews l 1

File No. 37 l Licensee: Dames & Moore License No. 31-245-01 i Location: Annapolis MD Amendment No. 4 License Type: Portable Gauge Type of Action: Amend Date Amendment issued: 9/13/96 License Reviewers: DKM/CET

, File No. 38 Licensee: Oncology Center at Riverside License No. 25-026-01 Location: Belcamp MD Amendment No. 0; 1; 2

^

License Type: HDR Afterloader Type of Action: NEW, Amend Date Amendment issued: 5/3/94, License Reviewers: CRF/NAO, NAO/TDF, NAO/CET 4 11/15/95, and 1/3/96. I Comments:

] a) Content of original application was Omnitron information b) Amend 1 provides information on Nucletron installed device i c) Amend 2 authorizes move with letter l

File No. 39 )

Licensee: Mid-Atlantic isotopes License No. 05-148-01 Location: Baltimore MD Amendment No O j License Type: Nuclear Pharmacy Type of Action: NEW Date Amendment issued: 10/12/95 License Reviewers: NAO/TDF l 4

Comments: l a) Licensee submitted full re-application after deficiency letters i b) License condition requires submission of proposed changes, does not require approval prior to implementation c) Person to do internal auMts not specified, no frequency specified, see Standard Review Plan.

File No. 40 Licensee: Univ. of MD (Environmental Safety) License No. 33-004-01

Location: College Park MD Amendment No.100 License Type: Broad Scope Type of Action: Amend l Date Amendment issued: 8/29/96 License Reviewers: NAO/CET J

I APPENDIX E

[ INSPECTION FILE REVIEWS

File No.: 1

Licensee

University of Maryland at Baltimore License No. 07-014-05 1 Location: Baltimore, MD inspection Type: Routine, unannounced, follow-up j License Type: Gamma Knife Priority: Annual i inspection Date: 06/11/96 inspector: RN i

Comment:

a) Report doesn't identify what was reviewed to correct previous item of non- <

[ compliance b) Radiation Safety Committee meeting minutes not reviewed

{

File No.: 2 I Licensee: Terumo Medical Corporation License No. 15-007-02 Location: Elkton, MD inspection Type: Routine, unannounced i License Type: Irradiator Priority: Annual i inspection Date: 06/25-26/96 inspectors: RN/AJ

$ Comment: '

a) Separate interviews not held with management to determine program involvement.

l i

File No.: 3 Licensee: NW Radiation Oncology Center License No. 05-034-02 Location: Randalistown, MD inspection Type: Routine, unannounced, follow-up i License Type: HDR Priority: Annual

Inspection Date: 06/27/96 and 07/03/96 Inspector: FK i

Comment

i a) Field note descriptions not indicative of a performance-based inspection in that the i

licensee demonstrations or walk-throughs not identified for radiation detectors, l

interlocks, afterloader operation, or emergency alarms.

b) Emergency drills described as conducted quarterly, but drill dates not shown.

! c) Inspector measurements were 11 mR/hr outside, but no follow-up with licensee or

, violation issued.

. d) Report does not indicate whether license or program changes were made since the

! last inspection.

9 e) Methodology to implement ALARA program not shown in field notes.

4

! File No.: 4 i Licensee: University of Maryland at Baltimore License No. 07-014-05 Location: Baltimore, MD inspection Type: Routine, unannounced, follow-up i License Type: Gamma Knife Priority: Annual j inspection Date: 06/23/95 Inspector: RM i Comment:

a) Unable to determine frorn report involvement of Radiation Safety Committee.

1 l

i a

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l Maryland Proposed Final Report Page E2

Inspection File Review File No.: 5

! Licensee: MKM Engineers License No. 27-064-01 Location: Columbia, MD inspection Type: Initial, unannounced

, License Type: Gauge (portable) Priority: 4

' inspection Date: 05/16-17/96 Inspector: LR Comment:

a) Cannot determine whether employee interviews were conducted.

b) Licensee response to NOVs - enclosures of leak test results, survey meter procurement, and security measures not in file.

c) Item of non-compliance for not maintaining usage logs identified during inspection  !

l but not included in enforcement letter. I File No.: 6

., Licensee: Syncor International Corporation License No. 33-061-01 l

l l Location: Lanham, MD Inspection Type: Routine, unannounced License Type: l l Pharmacy Priority: A l

Inspection Date

04/12-13/95 Inspector: RN l Comment: '

a) Report does not differentiate between items of non-compliance and recommendations.

b) Cannot determine how previous items of non-compliance were corrected.

j c) E-1 form does not identify non-compliance items.

) File No.: 7 Licensee: Ravinder Singh, M.D. License No. 33-064-01 Location: Greenbelt, MD inspection Type: Routine, announced, follow-up License Type: Priority: 4 Inspection Date: 04/11/96 Inspector: FK i Comment: I a) Independent measurements inc. only one smear sample.

i File No.: 8 Licensee: Nucletron Corporation License No. 27-035-01 Location: Columbia, MD )

inspection Type: Announced, follow-up l License Type: Service / Mfg Priority: A inspection Date: 02/07/96 Inspector: RM Comment: l None File No.: 9 Licensee: Calvert Memorial Hospital License No. 09-003-01 Location: Prince Frederick, MD inspection Type: Unannounced, follow up License Type: Nuclear Medicine Priority: 3 inspection Date: 03/21/96 Inspector: RN  !

Comment:

None i

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Maryland Proposed Final Report Page E3 Inspection File Review

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File No.: 10

, Licensee: Bon Secours Hospital License No. 07-002-01

Location: Baltimore, MD inspection Type: Routine, uncanounced License Type: Nuclear Medicine Priority: 3 inspection Date: 02/28/96 and 03/05/96 Inspector: FK Comment:

None )'

File No.: 11 Licensee: Washington County Hospital Assn. License No. 43-001-03 ,

Location: Hagerstown, MD inspection Type: Routine, unannounced, follow-up 1 License Type: Nuclear Medicine - HDR Priority: 1 Inspection Date: 02/06-07/96 Inspector: FK Comment:

None i

File No.: 12 Licensee: Greater Baltimore Medical Center License No. 05-002-03 Location: Baltimore, MD inspection Type: Routine, unannounced, follow-up License Type: Brachytherapy Priority: 3 Inspection Date: 01/23-24/96 Inspector: RM Comment:

a) Complete, thorough inspection .

l File No.: 13 Licensee: Eastem isotopes, Inc. License No. 03-068-01 )

Location: Hanover, MD inspection Type: Initial, unannounced follow-up j License Type: Pharmacy Priority: 1 '

inspection Date: 10/03/95 Inspector: RN Comment:

a) No indication in report whether independent measurements included smear samples.

File No.: 14 Licensee: Duebriss Hospital of PG County License No. 33-029-01 Location: Lanham, MD Inspection Type: Routine, unannounced follow-up License Type: Hospital Priority: 3 Inspection Date: 07/18-19/95 Inspector: FK Comment:

a) Report indicates previous non-compliance items " corrected" but does not indicate information or operations reviewed.

b) No acknowledgement letter in response to licensee's enforcement letter from previous inspection.

c) Lab results report only one wipe sample taken.

l Maryland Proposed Final Report Page E4 inspection File Review ,

i File No.: 15 '

Licensee: ATEC Assoc License No. 27-005-01 i Location: Columbia, MD inspection Type: Routine, unannounced follow-up l License Type: Portable Gauges Priority: 4 '

inspection Date: 06/19/95 Inspector: AJ Comment:

None File No.: 16 Licensee: Guilford Pharmaceuticals, Inc. License No. 07-186-01 Location: Baltimore, MD inspection Type: Initial, unannounced, follow-up License Type: Research and Development Priority: 4 Inspection Date: 04/30/96 inspector: AJ Comment:

a) License terminated and survey performed after April 96 inspection but license not amended.

In addition, the following inspection accompaniments were made as part of the on-site IMPEP review:

Insoection Accomoaniments Accompaniment No.1 Licensee: Terumo Medical Corporation License No. 15-007-02 Location: Elkton, MD inspection Type: Routine, unannounced License Type: Irradiator Priority: Annual inspection Date: 06/25-26/96 Inspectors: RN(lead)/AJ l

Good, complete performance-oriented inspection of licensee operations. Inspection

{

consisted of licensee walkthroughs of scheduled (daily, weekly, monthly, quarterly, and semi annual) surveillances.

Inspector well-prepared and demonstrated proficiency to direct and lead inspection effectively.

Verification of worker training not fully confirmed through interviews.

Safety issues adequately covered.

Accompaniment No. 2 Licensee: Prince Georges Hospital Center License No. 33-003-01 l Location: Cheverly, MD Inspection Type: Routine, unannounced License Type: Medical Priority: 3 inspection Date: 07/16-17/96 Inspectors: FK  :

1 Inspection preparation did not include interview of RSO or opportunity to observe 1-131 therapy procedure, j No follow-up or discussion with licensee about corrective actions taken in response to 1994 incident.

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iu i

l Maryland Proposed Final Report Page E.5 Inspection File Review -

4 f Radiation surveys and wipe samples not taken in waste holding or material storage (loading dock) areas.

Interviews with nursing staff treating therapy patients not performed.

Last inspection conducted 1993 but personnel dosimetry records, dose calibrator records, waste shipments, and leak test records reviewed only for previous year.

Field notes used as reference to identify inspection areas.

Accompaniment No. 3 Licensee: Medi-Physics, Inc. License No. 31-222-01 Location: Cheverly, MD inspection Type: Routine, unannounced i License Type: Nuclear Pharmacy Priority: 1 l Inspection Date: 08/07/96 Inspectors: AJ

Inspector demonstrated thorough control over inspection activities.

4 Preparation and inspection plan complete.

Licensee requested to demonstrate acceptability of various procedures including equipment reliability and engineering controls.

Wipe samples not taken in all areas where radioactive materials used.

Information clearly communicated to licensee during inspection and at exit interview.

Accompaniment No. 4 Licensee: North American inspection Co. NRC License No. 37-23370-01 Location: Cheverly, MD inspection Type: Routine, unannounced,  ;

License Type: Nuclear Pharmacy under reciprocity l Priority: 1 Inspection Date: 09/19/96 Inspectors: FK Inspection concentrated on review of licensee documentation and recordkeeping; observation of licensee operations very limited.

Area radiation survey not taken in all directions while source exposed.

Exposure rate to non-rad workers in immediate area not determined. 4 Inventory of radiography cameras verified.

Personnel dosimetry for assistant radiographer not checked.

Inspector unable to readily identify radiation exposure limits in unrestricted areas per COMAR 26.12.01, Section D.301 (equivalent to 10 CFR 20.1301) and discuss concerns with licensee.

Ancillary worker (site foreman) not consulted or interviewed to determine knowledge of site operations.

! APPENDIX F MARYLAND INCIDENT FILES REVIEWED l

1 File No.1 Licensee: Nuclotron Oldelft Corp. (Mallincrodt Medical)

} Location: BWI Airport l License #: MD27-035-01

Date of Event: 05/28/96 Type of Event: Transportation Summary of incident: Package containing a 9.74 Ci Ir-192 sealed source, shipped from

Mallinckrodt Medical in Holland with Nucletron as shipper of record, was received at BWI Airport in damaged condition with survey readings of 45 mR/hr. MD RAM and HAZMAT

team responded and performed cleanup and recovery.

a i File No. 2

) Licensee: Nucletron Oldefit Corp.

Location: Memorial Medical Center, Springfield, IL License #: MD27-035-01 Date of Event: 02/01/96 Type of Event: Equipment failure Summary of incident: Nucletron HDR console malfunctioned during patient treatment.

Computer froze and source failed to return to shielded position. Attending physician entered room and started emaigency hand crank which retracted source. Generic problem identified and State requested Nucletron to modify design with hardware change to l hardwire unit to console and revise software program. Nucletron is currently making the l changes to all service customers.

File No. 3 Licensee: ATEC Associates,Inc. ,

Location: Baltimore-Washington International airport light rail jobsite {

License #: MD31-189-01 Date of Event: 07/18/96  ;

Type of Event: Lost / Stolen RAM Summary of incident: Troxler gauge stolen from BWI light rail jobsight. Persons broke into house next door to jobsight where gauge kept in a case in locked basement. Gauge recovered as a result of State issued Press Release.

File No. 4 Licensee: N/A Location: Bresco Solid Waste Plant, Baltimore, MD License #: N/A Date of Event: 07/19/96 Type of Event: Release of RAM Summary of incident: Trash truck and driver set off radiation alarm at entrance to solid

_ waste plant. Investigation concluded there was no contamination or loss of RAM; the Bresco plant's radiation monitors malfunctioned. Monitors sent for repair.

Maryland Proposed Final Report Page F. 2 incident File Reviews File No. 5 Licensee: John Hopkins Hospital Location: Baltimore, MD License #: MD07-005-03 Date of Event: 07/23/96 Type of Event: Medical Event Summary of incident: A brachytherapy interstitial implant catheter containing 30 mci of ten Ir-92 aseds,0.3 mci ca., dislodged during patients treatment resulting in an underdose of approximately 7.6% less than prescribed. Ongoing investigation into unauthorized entry of the public into a restricted treatment area, and to determine if patient intervention caused the source to dislodge.

File No. 6 Licensce: Rad America Location: Baltimore, MD License #: MD05-051-01 Date of Event: 08/96 Type of Event: Equipment or Procedure Failure Summary of Event: A teletherapy machine malfunctioned by sticking "on," at and of treatment for patient scheduled to receive fractionated treatmer'ts of 50 rad of Co-60, resulting in a 50 rad overdose, with dose to be adjusted during next four treatments. A nurse attendant manually closed the source by turning hand crank, and received approximately 200 mR to hand (less than 1.5 rem).

File No. 7 Licensee: Laurel-Beltsville Hospital Location: Montgomery Co. Solid Waste Transfer, Rockville, MD License #: MD33-037-01 Date of Event: 08/05/95 Type of Event: Release of RAM Summary of incident: " Hot trash" set off radiation monitor at waste transfer station.

County office building trash had been contaminated by county employee who had recently received 8-12 millicuries of I 131 during thyroid therapy treatment at Laurel-Beltsville Hospital.

File No. 8 Licensee: Sacred Heart Hospital Location: Cumberland, MD License #: MD01-002-02 Date of Event: 04/13/94 Type of Event: Lost / abandoned RAM Summary of incident: Discarded lead pig and vial containing radioactive label found on local street in Cumberland, MD by Columbia Gas Co. representative. Through investigation State found that the hospital failed to follow standard disposal procedures.

Maryland Proposed Final Report Page F. 3 incident File Reviews File No. 9 Licensee: MD State Highway Administration l License #: MDOS-049-01 l

Date of Event: 01/25/95 '

Type of event: Lost stolen RAM Summary of incident: Troxler moisture / density gauge stolen overnight from locked field site trailer. Press release issued by State.

File No.10 Licensee: MD Dept. of Transportation License #: N/A Date of Event: 07/31/95 Type of Event: Damaged to Equipment Summary of incident: During road work Troxler thin layer asphalt gauge containing 8 mci Cs-137 sealed source, hit and run over by auto., which left source laying unshielded in road. Washington Beltway closed for 2.5 hrs. during recovery and cleanup.

1 l

APPENDIX G i 1

SEALED SOURCE AND DEVICE EVALUATION REVIEWS i

File No.: 1 l Registry No.: MD-0263-D-101-G SS&D Type: Icn Mobility Manufacturer: Environmental Technologies Spectrometry Cell Group, Inc. Date lasued: 12/16/94 Comments:

a) First page of registry sheet was amended dated 12/16/94.

b) No information in file as to the reason the registry sheet was amended. On comparison to previous sheet, a different company was identified as the distributor.

Manufacturer is now listed as distributor.

c) Last sheet of registration not reissued to indicate a change in references.

d) No supervisor or reviewer signature supporting the amendment.

e) Single reviewer.

Fiie No.: 2 Registry No.: MD-0105-D-101-G SS&D Type: Fluorotracer analyzer  !

Manufacturer: Conco Services Corporation Date issued: 6/6/95 i i

Comments:  !

a) This is a request for a name change due to a company reorganization. The registry  !

sheet was reissued under the new name. '

b) Licensee supplied a new diagram for the registry sheet containing one hydrogen valve versus the two valves on diagram with previous registry sheet. No evaluation of the impact of the design was documented in the file.

c) Original registry sheet issued in 1986. Although this is a low risk device, no safety product evaluation or discussion of quality assurance program was requested during this reissuance of the registry sheet.

d) Single reviewer.

File No.: 3 Registry No.: MD-1003 D-101-G SS&D Type: Thickness / density gauge Manufacturer: Pettit Applied Technologies Date issued: 7/11/96 Comments:

a) Diagram attached to the registry sheet is marked confidential.

b)- This is a similar device manufactured by a different company, where the president was previously employed. For this new license, the licensee is should be required to submit more comprehensive manufacturing QA/OC program. The licensee was required to manufacture and distribute devices according the approved certificate through commitment made and the tie down license condition.

c) Although only the manufacture can perform source changes per information in the backup documentation, information regarding limitations of use on the registry

l Maryland Proposed Final Report Page G.2 SS&D Evaluation Reviews sheet should be revised to indicate the radiation source will be installed or removed

] by the manufacturer.

File No.: 4 Registry No.: MD-0113-D-107-G SS&D Type: Thickness / density gauge '

Manufacturer: Adaptive Technologies, Inc. Date issued: 6/3/94 i

Comments:

) a) Single reviewer performed review.

b) No documentation in the file on protype testing or QA manual. Note, this device i was similar to devices manufactured previously by this company and appears to not been treates as new device. Older devices manufactured by this company have j j little information on the QA/OC program.

L File No.: 5 Registry No.: MD-0113-D-108-G )

SS&D Type: Gamma gauge

Manufacturer

Adaptive Technologies, Inc. Date issued: 7/12/94  :

1 1

i Comments: 1 i

a) Single reviewer performed review.

l b) No documentation in the file on protype testing or QA manual. Note, this device l was similar to devices manufactured previously by this company and appears to not '

been treated as new device. Older devices manufactured by this company have

little informadon on the QA/OC program. I File No.: 6 Registry No.: MD-0113 D-110-G SS&D Type: Beta g%Qd j Manufacturer: Adaptive Techr'aiogies Date issued: 7/1/96 j

Comments:

a) Second review performed, but not documented.

b) {

No documentation of response to 6/26/96 deficient letter on request for Quality Assurance Manual.

File No.: 7 Registry No.: MD-497-D 104-S SS&D Type: Remote Afterloading brachetherapy unit Manufacturer: Nucletron Corporation Date issued: under review Comments:

a) One of the reference documents was not listed in the draft certificate.

b) No response to deficiency letter dated 5/24/96 in the file.

i tftE FW Fa :410431-3198 Feb ? '97 14:42 P. 02 W  ; m .;

y L.- '

" "l'9,,

MARYI AND DEPARTMENT OF THE ENVIRONMENT MM, 2300 areening aithway . saitimo, . Maryiand 2 224 (410) 631-3000 '

Parris N. Glendening Governor Jane T. Nishida 1 Secretary !

FEB 81997 l l

Mr. Richard L. Bangart, Di. rector Office of State Programs United States Nuclear Regulatory Commission ,

Dear Mr. Bangart:

This correspondence responds to your letter of December 16,1996 which fmvarded your draft " Integrated Materials Performance Evaluation Program" (IMPEP) repon for Maryland.

Enclosed are the Maryland Department of the Envisomnent's (MDE) comments and explanations regarding the IMPEP team's observations and findings as contained in the draft repon. MDE appreciates this opportunity to provide commems to you.

In general, we fuuy support the Nuclear Regulatog Commission's (NRC) revised Apeement State periodic review process. It is a significant improvement over the previous process. However, we think that the two week time period initially provided to the State for response was not adequate. Though your office granted the requested extensions without hesitation, MDE recommends that additional time to respond to IMPEP conunents (even a draft repon) should be m:orporated in the initial correspondence to the State.

Regarding the IMPEP team's general concerns over staffing, please be assured that Radiological Health Program (RRP) staffing wiU be maintained at a level sufficient to ensure that Maryland's program continues to be adequate to protect the public health and safety, as required by the NRC. As with other government agencies in an era of re-engineering and downsizing. the Air and Radiation Management Administration (ARMA) has made difficult staffing decisions to ennform to budgetary limitations. Staffing of the RHP has been impacted by titis phenomenon as has virtually every other MDE program. Under no circumstatces, however. has public health and safety suffered because of needed fiscal constraints, nor wiD n be in the future.

An additional concern raised by the team relates to the cutTent status of adoption of compatibuity regulations. The regulation, " Licensing and Radiation Safety Requhements of Irradiators", covered in 10 CFR Pan 36 of NRC regulations, has become Pan X in Maryland's

• Regulations for the Control of Ionizing Radiation." Your office was prosided with a timetable for the promulgation of this regulation, which forecasted adoption by November 11,1996.

The regulations were actually adopted on November 19.1997 with an effectise date of December 16.1906. A copy of the final adoption verification is enclosed. The P.egulations Adoption Management Plan is being implemented and eveg effort will be made to pubbsh compatibihty regulations within the required thiee year time frame.

"Together We Can Clean Up . ATTACHMENT 2 g TDD FoR THE DEAF H10) 01 X109 ruww tw Oh0ED r fY

' ~

M!E U W Fa<:410-631-31 C ~ Tei> T 'M idid} ~ P'. C6 ]

-)

Mr. Richard L. Bangart Page 2 On behalf of the Department, please extend our appreciation for the way the IMPEP was conducted. All participants have stated that the IMPEP experience was a very positive one, and Ms. Patricia Larkin and her team are to be conunended for their courtesy, professionalism and consideration. It is also very satisfying to have a irpresentative from another state radiation program as a member of the team. Mr. Te:Ty Frazee of Wasilington did a great job.

Specific responses to concerns, findings and observations are enclosed. If you should have any questions, please feel free to contact me at (410) 631-3255, or Mr. Roland G. Fletcher, Manager, Radiological Health Program at (410) 631-3300. You may also reach our offices toll-free by dialing 1-800-633-6101 and requesting the appropriate four-digit extension.

Sincerely.

AfbDL NYD Merrylin Zaw-Mon, Director Air and Radiation Management Administration MZM:dpn Enclosure l

l l

ggngy (Fa x :410-631-31*:4 Feb 3 '97 14:43 P.04 i l

. ]

l l

y MARYLAND DEPARTAENT OF THE ENVIRONNENT COM3ENTS ON APPROPRIATE PORTIONS OF THE SUMNIARY LIST OF SUGGESTIONS AND RECOMhENDATIONS

1. NRC RECOMMENDATION:

1 The State should take action to have the Waste Management Administration revise the i j

definition of " Person" in the low-level radioactive waste (LLRW) regulations j COMAR 26.14.01.02B(28)(c) that was identified in both the 1993-94 review and the follow up teview.

RIIP RESPONSE:

i Maryland questions the need for a change in the definition of " person" in the LLRW l regulations. Although the definition in the LLRW regulations does not explicitly exempt federal facilities, if federal law does not allow application of the LLRW requirements to federal facilities, they would, in fact, be exempt. However, MDE will pursue the change with the Waste Management Administration, as a clarification. )

2. NRC RECOMMENDATION:

The State should take prompt action to ensure that Sacred Heart Hospital (SHH) complies I with the reconunendations af the joint review team report dated March 5,1996, that was transmitted to the State April 15, 1996.

RHP RESPONSE:

A letter (enclosed) was sent to SHH. dated November 25,1996, that included the NRC recommendations resulting from their review of the 1987-88 misadmiitistrations. SHH responded with a letter dated December 17,1996 (also enclosed) which requested a meeting between SHH and MDE for a discussion of those recommendations. During a telephone conversation on January 10,1997 between Mr. Carl Tmmp of the RHP and Mr. George Tyler, legal counsel for SHH, Mr. Tyler stated that SHH will follow through by seeking all the physicians' input to those patients that were misadministered. The physicians will report back to the hospital aaministration, in writing, the status of the reponing requirements of thosc patients' families or next of k.in. After receidng all physicians' reports, SHH will send a draft repon to MDE for review, possibly followed by a meeting to discuss the repon. Mr. Tyler has also requested a complete copy of the NRC's report from Dr. Griem.

3. NRC RECOMNIENDATION:

The State should incorporate the April 1995 revisions to IMC 2800 into their Inspection Procedures Manual.

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-Fa :410431-319s'- Feb 3 '97 14:43 F.05 {

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, Enclosure i 1

, Page 2 I

I I

l RHP RESPONSE: '

MDE has received a copy of the April 1995 revisions to IMC 2800. Although NRC has reduced their frequency of inspection of certain programs, medical facilities requidng a 4 Quality Management Program (QMP) were increased from a 4 year frequency to a 3 year frequency. MDE has implemented this change effective January 1997 under the code 2

02200. Those private medical programs not requiring a QMP wi.lJ remain at the 4 year inspection frequency and have been coded as 02201.

4. NRC RECOMMENDATION:

The State should consider the development of a fonnal professional training plan through the use of university and industry educational programs for training new staff and retraining or refresh for long-term staff.

RIIP RESPONSE:

MDE will review and evaluate current traiaing needs for existing staff and any additional staff that may be hired. The NRC's decision to discontinue full trairdng support will severely limit participation in all NRC courses. However. MDE will continue to investigate all options, including private industry and university training, to maintain the perfonnance proficiency of radioactive materials staff members. MDE strongly recommends that the NRC recognize the negative impact its suspension of training sponsorsidp will have, and that it expeditiously reverse this decision.

5. NRC RECOABIENDATION:

1 Management should provide a corrective action plan to address the issue of qualifying staff.

The team also recommends that management provide a training and qualification plan for i new staff that inchides an appropdate education background, and a requalification plan for staff that do not meet the initial qualifications, and staff who are reassigned from another technical area, and continued training for long-tenn staff.

RHP RESPONSE:

Training pdorities and procedures are understood and followed by all radioactive materials health physicists. Fonnal training such as the five week Health Physics and other core courses are documented and kept in a binder. Radioactive Materials Licensing and Compliance Division (RAMLCD) staff will document all training activities into a comprehensive plan by June 1997, incorporating the following components:

a. Staff assigned to the RAMLCD will read pertinent parts of state and federal regulations, regulatory raides, ANSI standards and other relevant documents and vedfy understanding w ru a signature.

b.

Existing training log will be expanded to include formal and informal training. )

tie HF Fax:410-631-3199 Feb 3 '97 14:44 P. 06  !

i .

Enclosure 1 i

Page 3 i I

c. Senior inspector accompaniments of lower level inspectors will be doenmented on pre-approved fonus completed by the senior inspector.

d. A protocol outlining the purpose, frequency and resolution of supervisory

accornpaniments by the RAMLCD Chief will be established.

vi. NRC RECOMMENDATION:

4 Maryland should assess whether a reinspection or revision to move-up the next inspection I

date should be considered for any higher priority licensees, i.e.. HDRs. radiographers, pieviously inspected by the HP-1 inspector whose accompaniment was unsatisfactory.

1 4

RHP RESPONSE:

i The two inspections for which NRC accompaniments were pertonned and for which the inspedi.d performance was deemed unsatisfactory will be reinspected by another RHP staff member no later than April 1,1997. Other previous inspections of priority III or higher that were done by the inspector who performed below cxpectation during the accompaniment are being evahiated to detennine the need for a reinspection sooner than the prescribed frequency. This evaluation will be completed by April 1,1997. Upon l completion, any licensee requiring reinspection will be completed by August 1.1997.

7. NRC RECOMMENDATION:

The State should assess the adequacy of the program staff to ensure the long-term ability of the proFram to maintain an adequate program to protect public health and safety and complete the pending mles and amendments for adoption to remain compatible.

RHP RESPONSE:

ARMA believes that the current allocation of staff positions to the RHP is sufficient to maintain an effective program. In addition, the RHP is currently conducting a strategic planning exercise aimed at identifying the key functions and responsibilitics of each program in order to ensure that adequate resources are available to satisfy program nhligations. It should also be pointed out that the staffing description on page 11 of the draft repon is only panially accurate. Total staff positions in the RHP. which includes the Radiation Machines Division and the RAMLCD is twenty-seven, with a current fill of twenty-five. The number of positions directly applied to Agreement State staff activities.

including the RHP Program Manager and the RMILCD Chief, is nine. This is a decrease of two positions from the prior review, but ARMA believes the restmeturing of the RAMLCD has minimized the impact of these losses. Also, in addition to assigned staff, the RAMLCD receives support from five administrative and/or clerical positions and a Progam Assistant responsible for regulatory assistance.

MIC FW Fex:410-631-3193 Feb 3 '97 14:44 P.07  !

l

. Enclosure Page 4

8. NRC RECOMMENDATION:

The RHP could benefit from a guidance document on tem 1ination of licenses.

RIIP RESPONSE:

MDE will obtain dmft NUREG/CR 5846 " Manual for Conducting Radiological Surveys in Suppon of License Tennination" and develop a guidance document. The document will be available within 120 days of manual receipt.

9. NRC RECOMMENDATION:

The State should adhere to the policy of annual supervisory accompaniments of all inspectors.

RHP RESPONSE:

MDE will adhere to the annual supervisory accompaniments of all inspection staff.

Subsequent to the September 1996 NRC audit and prior to March 31, 1997, all radioactive

{

materials inspectors will have been accompanied by the RAMLCD Chief.  !

i 10 NRC RECOMMENDATION:  !

l The State should develop a program outlining the necessary steps to be followed by compliance staff for full inspector qualification.  ;

RHP RESPONSE:

MDE will review current inspectors' qualifications and will develop a program by

~

June 1,1997 that will reflect the inspectors' competence and progression in the different skill levels of inspection.

II. NRC RECOMMENDATION:

The State should b(gin voluntary reporting of all reportable events to the NRC Operations Center and begin participating in the NMED data base of material events.

RIIP RESPONSE:

MDE will attempt to supply this vohmtary infonnation to maintain this database in accordance with the guidance contamed in the " Handbook on Nuclear Material Event Reporting in the Agreement States," Draft Repo11, March 1995.

MIE FF Fax :410-631-?.191: Feb 3 '97 14:45 P. Oi:

i Enclosure Page 5

12. NRC RECOMMENDATION:

The State should pmvide event infonnation for three events identified by the State in

, response to the IMPEP Questionnaire.

RHP RESPONSE:

MDE will supply investigation reports for these events under separate cover.

f 13. NRC RECOMNENDATION:

The State should provide close-out information to NRC on allegations referred to the State by NRC.

RHP RESPONSE:

To our knowledge, information has been provided to the NRC on all allegations through NRC Region I. The RAMLCD is reviewing this area and will institute procedures that ensure more efficient Inicking of all allegations to closure.

14. NRC RECOMMENDATION:

The State should improve the effectiveness of the Regulation Adoption Phm by providing a realistic schedule of milestones for development and adoption of 10 mies currently identified in the plan for adoption by the end of 1997.

RHP RESPONSE:

The schedule as previously submitted to the NRC is being reviewed to incorporate additional mdestones. A revised version will be provided by April 1.1997.

15. NRC RECOMMENDATION:

The State should address the process for multiple nalemakings to ensure that they are completed within three years of the effective date.

RHP RESPONSE:

The RHP has already committed to the time inune for multiple nilcmaking and has established a process (copy enclosed).

16. NRC RECONBENDATION:

The State should implement a plan to review all registration sheets, based on the risk associated with the device, especially detailed QA!QC program infonnation.

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

KCFW Fa c410-631-319i: Feb 3 '97 14:45 P.09 ,

I 4

Enclosure Page 6 '

RHP RESPONSE:

)

hfDE wiU evaluate Maryland's SS&D sheets for safety, adequacy and QA in accordance l

with associated risk. Those found deficient will be further evaluated for amendment in  :

their entirety. The implementation date will be August I,1997. l

17. NRC RECOSBIENDATION:

The State should adopt regulations compatible with 10 CFR 30.32(g) and 10 CFR 32.210.

I. RHP RESPONSE:

The RHP is committed to the adoption of these regulations. The adoption of these i

regulations is on the Regulations Committee agenda and has an implementation deadline of  ;

December 1997 for 10 CFR 30.32(g) and July 1998 for 10 CFR 32.210. I t

18. NRC RECO5BIENDATION: -

An additional senior staff should be trained to perfonn the SS&D evaluations to supplement the program as it maturcs. {

i 1

RHP RESPONSE:

! An additional staff member will be trained in SS&D reviews.

l i

MIE FW Fa e

410-631-3191: Feb 7 '97 14: P.1v 1

i,

l

! I 2

l l l

l l

Enclosures 1

d

MIE FW Fa e :410-6?.1-3191: Feb  ?. '97 14:46 F.11

/ Sl3//$6 $fT LAW OFFICES

. . or i 1

GEppEnT, McMULLEN. PAYE & GETTY A PROFESSIONAL CORPORATION 24 PFeOSPECT SQUAR E CU M BEFILAN D, M ARY L AN D 21502 i HU6W A.usuvLLEN wtLLtAu M. C C PPtrtt C C Avw GETTY somu J.usput Lg n,sm. he so FAE (200 777 0532 December 17, 1996 ---- 7 .

• J..k DEC I 91996 h.

i i

Roland G. Fletcher, Environmental Manager II, '

- ' i i

. Radiological Health Program,  ??"!01.CCICA1 HEALI:-: PGPM i Maryland Department of the Environment, - ~ ~ ~ ~

2500 Broenig Highway, Baltimore, Maryland. 21224.

l Re: Radioactive Material License No.: MD 01-002-02 i i

NRC Review of Misadministrations at Sacred Heart Hospital (1987-88) l

Dear Mr. Fletcher:

1 1 am general counsel for Sacred Heart Hospital and a new parent organization, Western Maryland Health System, as a result of a hospital af filiation concluded in the spring of 1996. On behalf of the Hospital and the System, I acknowledge your letter dated {

November 25, 1996 (received by the Hospital on or about December 11, 1996).

I am confirming that the Hospital desires to confer with you and your staff in detail to review the existing compliance information and to reach clear, mutual resolution in regard to any f urther compliance measures. In f act, we had asked Attorney George Tyler (who continues to represent the Hospital as special counsel  ;

in this matter) to contact you, discuss any preliminary issues involved in the past actions of the parties, and to arrange a conference. We understood that he had contacted Mr. Trump several months ago. We desire to work effectively with you to resolve any lingering problems, and ask that you contact Attorney Tyler so that we can get started.

Although we are anxious to resolve matters, we do have a short-term scheduling problem. Mrs. Candace Geatz, the Hospital Quality Assurance Manager, is on medical leave and will not return until January 6. She is the primary custodian with knowledge of documentation regarding past compliance activity. We would like to have several weeks following her return to assemble the documentation for review with you.

Under the circumstances, we would like an extension until the end of January to respond with the agreed documentation.

tie FW Fa . :410-631-3193 Feb 3 '97 14:47 P.1 "

Roland G. Fletcher, Environmental Manager II December 17, 1996 Page No. Two Then, your staff. we would like to have a detailed conf erence with you and At that time, we could review together the agreed documentation and any further compliance requirements.

We ask that you contact George Tyler with any comments or suggestions, and to arrange a conference. Also, please let me have a copy of future correspondence regarding this matter.

Very truly yours, GEPPERT, M, LLEN, PAYE & GETTY By_

w 44 . ( uw RSP:st.

cc: George T. Tyler, Esq.

Edward M. Dinan, President Dorothy Winner, Vice President

. , .F . _'E

_ . If {l M (( rl.! ,

p,

{ '

DEC l 91996 {y:

i ij

; HEALTH PROGRA!'

./. 0!UE' .U.

Mg igp Fa x :410-631-31% Feb 7 T 14:47 F.13

~ ' - ~ ~

MARYLAND DEPARTMENT OF THE ENVIRONMENT

(( 5 B oeni Highway e Bahimore, Maryland 21224 Parris N. Glendening  !

Governor hne T. Nishida Secretary November 25,1996 h

DEC CERTIFIED Mall.

U l9pg 440 Dorothy Winner, Vice-President U CAL Patient and Administrative Services Ray Sacred Heart Hospital (SHH)

P.O. Box S39,900 Seton Drive ~

Cumberland MD 21502 RE:

Radioactive Material Ucense Number: MD-01-002-02 Questions Remaining from NRC Review of Misadministrations at Sacred Heart Hospital in 1987-1988

Dear Ms. Winner:

This letter refers to the Nuclear Regulatory Commission's (NRC) Executive Summary of their review of the SHH misadministrations that occurred in 1987-1988 and whether the ter uired actions, notifications and follow up activities have been taken or are scheduled to occur as recommended by the NRC. Copies of this report were sent to your hospital and M. , George Tyler, Attorney representing the hospital.

As part of the report, the NRC specifically identified five (5) topics included under Enclosure 1 that have not been answered sufficiently by SHH staff. As a follow-up to this observation, the Maryland Department of the Environment's (MDE) Radiological Health Program (RHP) is committed to obtain the necessary information.

Therefore, MDE requests that the SHH staff carefully review each of the topics and address all issues and concerns listed under each topic. Specifically, MDE requir+s the assurance from SHH that all of the 33 patients whoincurred misadministrations at SHH during the 19871988 period were notified in accordance with the requirements of COMAR 26.12.01.01. Section D.1209 titled.

• Notifications, Records and Reports of Misadministrations." Each referring physician should have notified each patient, the family or the next of kin. However, the referring physicians were required to inform SHH that they notified their patients, or that, based on medical judgement, informing their patients would have been harmful.

Each attending physician is required to provide the appropriate documentation f or each patient and submit their reports to SHH. In tum, MDE requires that copies of these reports be submitted to the Department within thirty (301 ds. "pon receipt of this letter.

"Together We Can Clean Up" @

T00 FoR THE DEAF H10) 631Juw ann. 9m

MIE Fif Fax:410-631-315G Feb 3 '97 14:47 P.14

)

l Ms. Dorothy Winner 1 page two l

Should you have any questions concerning this letter please contact Mr. Carl Trurnp, Jr. or me at (410) 631-3302. Ycu may also reach our office by calling toll free 1-800 633-6101 and requesting ext. 3302.-

Sincerely, I ' '

kk Roland G. Fletcher, nvironmental Manager it i Radiological Health Program ,

d.[b RGF/CET/edjg cc: George Tyler, Esquire  !

Christine Buesch, Assistant, Attorney General's Office Each referring physician should have notified each patient who incurred the i misadministration. '

ahe

MIE H P a :410- 31-3199 Fe 3 '97 14:49 f 15 4 .

FINAL ACTION ON REGULATIONS 1787

• ente to 300 animal units has been added to ugree more com-pletely with federal language. cause a discharge. and because water cuality violations or Regulation .09Nr.2 dchiiir Language has been repeated for the hkelihond to discharge have previously been accu.

mented.

clarity " Site conditions including elope, lack of vegetative cover and proximity tn surface waters have been included .09-1 Fees for General Discharge Permits to match the federal language more closely and (or more A. -- G. (text unchanged) {

11. Fee for Discharges from Swimming Puols and Spas; Rg tion .09-1H: Language has been added to clarifv ec of ntent i ee.

that ND1 fees need not be paid for the regnstration of mu-thss general permit shall submit an NOl together with mcipal, State or county owned pool, and syss- of $100 fur cach facilitv. A fee is not required with the NO! I Regulutlun .091' In place of a $500 fee for each marm.a- Minission for the redistration ut pools owned bv munsci- 1 a sliding fee scale has been adopted, reducmg fees for all pohties. counties. nr the state. Owners ofponts or spas urv-marinas with fewer than 200 slips. The phrate *the lesser of ing sndsesdsul residences are not required to submit an NCE f,

the above fee or $350" was added to "Facihties aircady reg.

l 1stered under 92 OP-0001 shall pay ,. "#"ge f for Discharga trom Morina.. NOI Fee.

+

Regulation .0913 mal Waste Facslitnes,The title has been changed from "Ani' W Persons seeking coverage under this general permit to

• Concentrated Animal Feeding Op- shall submit an NOI together wsth lla fee of 5500 for each erations" for consistency with federal regulations and defi. fanlity the followsng fee depending up<.m the number of

                                                                            ,yj p,< neodabic at the manna:                                       :

nitions. Permittees with 300 or fewer animal units have  ! been exempted from paying discharge permit fees. Numbe.,fSlips

        .09 General Discharge Perms.ts                                                         200 or more shps                        Ff
                                                                                                                                      $500 A. -M. sproposed text unchanged)                                       100 or more and fewer than 200 slips                STD5       l N. General Diuharge Fermit for (Vns, mal %te Facih-                    m ,.<>

rnorc and fewer than 100 shns TiOD tics}} Concentrated Animal Fredine Optrationt y o o, mo,c ang few,, ghan So ,pp, yya fI) Exce y,,,,, ggo, jo ,yy, 3 jog diulmrges, ptums. This permit does not cover the follows,ng  !?) Facshties already regtdered under 92-GP GUQIihall lu.* Posnt source dwcharges of wastewater to surfacc pay the lesser of the above fee or a fee of $350 before Septem-water except in the case of a storm water event greater than ber.1997, to register for thss permit. the 25. year, 2& hour storm; lland)) or: J Fu for Discharges from (Vnumal Wnste Facilitscsll tv) Dsscharges from fecdlots Fr duck.' C&centrated Animal Feeding Operations. I (2) Ehgable Discharges. This permit covers ground wo. (1) (propot.ed text unchangeds ter dhcharges llcompuced;}} ria application <.f hot,sd waste. (2) D:scharge Permit Fee. w) The Department shall calculate the discharge per. t dischargepermit-watre to the soil surface. The followsne mitfauh_ (ce und ries shall shall havepermittee]) bill \\the a permittees with mort to) \\Entsrely of ans.mul wastewater from concen. than 300 u nimal units. This fee shall hepaid by July 1 of the trated animal ferasng operatsons)) Operations with more Mh * > ear than 1,000 ansmal unsts([i & c.) ipropused text unchangeds ib) Of animal wastewater from facilities wtth; (31 (p osed text unchanged * (s) More than)) or 55.000 turkeys ((.)): iM Operations wails 30.000 or more chickens which JANE T. NISHIDA Secretary of Environment prodluS5uid waste stream M t>ertent or more hausde ll'io 20h000 laying hens or broilers and a continu-ous overflow watering, o' (isis 30,000 laying has or brotters and a hquid mu. Subtitle 12 RADIATION MANAGEMENT nure system)), and 26.12,01 Radiation Protection (c) \f 0f wastewater from animal}} Animal feeding fa-cilities whnh have been or are u threat to surface water qual- m, 7,,,_m gn,g,, gg_, ,,3 9ng, sty because: ,nn%,,,d (ug 07 M,,y,,,g (i> Confined animals come into direct contact with surface waters. Nottce of Final Action (((ii) There es a potentic/ to discharge into rurface ps.mn

    '   waters of this State through a man. mode conveyaruc, or                On November 19,1996, the Secretary of the Environment tiiii Prevsous surface water discharges hace been       adopted amendments to Regulation .01 under COMAR j   documented ))                                                       26.12.01 Radiation Protection These amendments, (ii) The Department determines. cfter o ss.te inspec-  which were proposed for adoption in 23:20 Md. R.1131 lion. that the animal feedsng facihtses are isheb to discharce      (September 27.1996), have been adopted as proposed snto waters vi this State thrcuch a man made c<mvevance                Eficctlvc date: December 1G,1996, Inneludsng sprov irragations because the sisc of the annmal feeding operattan exceeds 300 ansmal unitt: and Luastewater                                                           JANE T. NISHIDA is hkelv to be discharged. or                                                                                 Secretary of Envirunment inii) The Department determmes. ofter a site unspec.

tion, that the animal fiedsng facshties are hkely to discharge into uwsters of thus State through a man made convevance h lincludsn e spray srrtratsons because the means of wa>.tewa-ter converance and site condstsons mclwisne slopr, lock of vegctaure enser, and proximsts to surface waters are bkcl_v tn MARYLAND REGISTER, VOL. 23. ISSUE 25 FRIDAY DECEMBER 6.1996 emuu G-

TABLE FOR QUESTION 29. OR --, DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION q Any amendment due prior to 1991. Identify each regulation trefer to the Chronology of Amendments) 1AEA Compatibility 10 CFR Part 71 916/8 6 9/9/95 Addressed in Section T, of Regulations for Control of lonizing Radiation (1994) Glass Enemet and G! ass Frit 9/11/87 9/9/95 Addressed in Section C.3(c)(2Hiii)  % Industriel Radiography Surveys 7/16189

                                                                                                                                                                                                     ?

9/9!95 Addressed in Section E.201 g-Bankruptcy Filing Notification 2/11190 9/9/95 Addressed in diection C.31(e)

                                                                                                                                                                                                    ?q' Notificaticns, Reports, and Record of      4i1/90   9/9/95     Addressed in Section D.1209                                                                                                 A Misadministration                                                                                                                                                                           .[a
                                                                                                                                                                                                    '7.

Wet! Logging 7114/90 9/919 5 Addressed in Section W #' Dosimetry Processing 2/12/91 9/919 5 Addressed in Secti on D.501(chiil Decommissioning: 7/27/91 9/9/95 Addressed in Section C.29 Parts 30. 40. 70 Emergency Pf anning; 4/7/93 9/9/95 Addressed in Section C.23 Parts 30,40,70 y cr Standards for Protection Against Radiation; 1/1/94 9/9/95 Addressed in Section D & Section A.2

• 8:

Part 20 -

                                                                                                                                                                                                   'O Safety Requirements for Radiographic        1110/94  9/9/95    Addressed in Section E.308 Equipment; Part 34 n

Notification of incidents: 10/15i94 9/9/95 Addressed in Section D.1202 E. Parts 20, 30, 31, 34, 39, 40, 70

• Quality Management Program and 1/27/95 9/9/95 Addressed in Section G.76 Misadminrstrations: Part 35

Licensing and Radiation Safety 7/1/96 proposed Section X 11/96 ' Requirements for Irradiators; Part 36 20

                                .. .a OR                                                                                   i DATE                                     DATE 10 CFR RULE                                                                                     DUE                                ADOPTED                                                                CURRENT                                                                            EXPECTED STATUS                                                                            ADOPTION                                di Mi DeCnition of Land Disposal                                                                7/22/96 and Waste Site QA Program: Past 61 NfA                                     ml Decommissioning Recordkeeping- Docu-                                                      10/25/96                                 9/9/95             Addressed in Section C.29(fM3) mentation Additions: Parts 30,40,70 Self-Guarantee as an Additional Financial                                                 1/28197                                                     Not consistent with conclusions reached by Maryland's l_egislative                                                                    N/A Mxnenism; Parts 30,40,7D                                                                                                                              Auditors l Uranium Mill Tailings: Conforming to EPA                                                         7/1/97                                                                                                                                                                                             N/A                                          i Standards; Part 40 Timeliness in Decommissioning                                                             8/15/97                                                     No action taken 2i 8/97                                    3j Ports 30. 40, 70 h!

Preparation, Transfer for Commercial Dis- X! 1/1/99 No action taken 12/97 tribution, and Use of Byproduct Material for [! u Medical IJse: Parts 30,32,35 Y Frequency of Medical Eneminations for Use 3113/98 di No action taken of Respiratory Protection Equipment 12/97 ${ ' Low Level Weste shipment Manifest 311/9 8

• No .Jon taken 12197 ,

Information and Reporting Performance Requirements for Radiography 6/30/98 No action taken 12/97 Equipment e'1 . Radiation Protection Requirements: C7 & 8/14/98 No action taken 12/97 f Amended Definitions and Criteria a_*J f Clarification of Decommissioning Funding 11/24!99 No action taken 12/97 Rsquirements $[ , 10 CFR Part 71: Compatibility with the 411/99 Intemational Atomic Energy Agency No action taken 12/97 E Ei 9  ; Medical Administration of Radiation and 10/20/93 No action taken 12/97 Radioactive Materials. L Termination or Transfer of Licensed 5116/99 7 i No action taken 12/97 L; Activities: Recordkeeping Requirements.

                                                                                                                                                                                                                                                                                                                                                                                       'J /  !

L 21 i ._.______.__._._____..___..__.m. _ _ _ _ _ _ _ _ . _ . . _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ . . _ _ . _ . _ _ . _ _ _ _ _ _ _ _ _ .___._.m_ _____._.,_.____e.____.._.._m_m.______ . _ _ _ _ _ _ _ _ . ___m_._____-. __m_. _._._____._.-_____._m_.__..____._.____.____.____.__.___.__m.____________m__.___ _ _ _ . _ _ _ - _ _ _ _

Aaenda for Manaaement Review Board Meetino Thursdav, March 6,1997.10:00 a.m., OWFN,10-B-11

1. Convention. MRB Chair convenes meeting. (HThompson)

2. Old Business - Approval of the Nebraska MRB Minutes. (KSchneider)

3. New Business - Consideration of Maryland IMPEP Report.

A. Introduction of Maryland IMPEP Team Members. (PLarkins) B. Introduction of Maryland representative and other State representatives participating through telephone bridge. (PLarkins) C. Findings regarding Maryland Program. (IMPEP Team) Status of Inspection Program Technical Staffing / Training Technical Quality of Licensing Technical Quality of Inspections Response to incidents / Allegations l Legislation and Regulations Seal'd Source and Device Program Low 4evel Radioactive Waste Program

      ') . Questions. (MRB Members)

E. Comments from State of Maryland. (RFletcher) F. MRB Consultation / Comments on issuance of Report. (HThompson) l

4. Status of Upcoming Reviews. (OSP)

5. Adjournment. (HThompson)

Invitees: Hugh Thompson, MRB Chair, DEDR Karen Cyr, MRB Member, OGC Carl Paperiello, MRB Member, NMSS

                            , Richard Bangart, MRB Member, O SP Denwood Ross, MRB Member, A'dOD Edgar D. Bailey, California, Agreement State Liaison to MRB Roland Fletcher, Maryland Paul Lohaus, OSP                                               ,

Kathleen Schneider, OSP I Don Cool, NMSS Patricia Larkins, IMPEP Team Leader, OSP Craig Gordon, IMPEP Member, RSAO, RI , Terry Frazee, IMPEP Member, WA J Dave Collins, IMPEP Member, Region 11 { Kathy Schneider, IMPEP Member, OSP l ATTACHMENT 3

                                                                                            )}}