ML20132G599

Discusses MD Impep

ML20132G599
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Issue date:	12/16/1996
From:	Newsome H NRC OFFICE OF THE GENERAL COUNSEL (OGC)
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NUDOCS 9612260312
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l 1 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM i

REVEW OF MARYLAND AGREEMENT STATE PROGRAM l

l SEPTEMBER 23-27, 1996 l

DRAFT REPORT U.S. Nuclear Regulatory Commission

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e-12/12/96 l

9612260312 961216 PDR STPRO ESGMD PDR

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1.0 INTRODUCTION

l This report presents the results of the review of the Maryland radiation control l program. The review was conducted during the period September 23-27,1996, by a review team comprised of technical staff members from the Nuclear l-Regulatory Commission (NRC) and the Agreement State of Washington. Team members are identified in Appendix A. The review was conducted in accordance j with the " interim implementation of the integrated Materials Performance j Evaluation Program Ponding Final Commission Approval of the Statement of i Principles and Policy for the Agreement State Program and the Policy Statement on I Adequacy and Compatibility of Agreement State Programs," published in the

Federal Register on October 25,1995, and the September 12,1995,NRC .

I Management Directive 5.6, " integrated Materials Performance Evaluation Program I (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.

4 I [ Paragraph on Results of MRB meeting will be included in final report. Attachment j 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.

j 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 1 Administration. The Maryland Department of the Environment and the Air and i Radiation Management Administration organization charts are included as Appendix B. During the review period the Maryland program regulated 561 specific licenses, i which include commercial irradiators, manufacturers, 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 i emergency response for 2 nuclear power plants. The review focused on the j materials program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of 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, i

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

J examination of Maryland's response to the questionnaire, (2) review of applicable 1 Maryland statutes and regulations, (3) analysis of quantitative information from the radiation control program licensing and inspection data base, (4) technical review j of selected files, (5) field accompaniments of three Maryland inspectors,

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i l Maryland Draft Report Page 2

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 j preliminary assessment of the radiation control program's performance.

l Section 2 belok biscusses the State's actions in response to recommendations i made following the previous review. Results of the current review for the IMPEP i common perfortpance 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 I The previous routine review was conducted August 30 -- September 4,1993, with j follow-up activities conducted at select times through April 7,1994. The results of this review were transmitted to Ms. Jane Nishida, Secretary Designee, j 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 i 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, l MD, (MD-01-OO2-02) was conducted in late 1993 and early 1994, in response to

issues raised during an August 1993 Congressional hearing that questioned

i (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.

i I 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 j

to 13 regulations not having been adopted within the 3 year period required by i NRC. The team noted that the definition of " person" in Maryland's low-level waste  !

regulations included jurisdiction over Federal facilities which is not consistent with  !

i 10 CR 150.10. Section 274 contains no explicit waivar of the sovereign immunity of the United States; therefore, the agreement does not convey any authority for l

2 the State to regulate Federal agencies. Agencies of the Federal government are i DD.1 exempted and continue to be subject to NRC regulation, not State regulation. i

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, 1 l 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 j " person," with regard to Agreement materials, Federal agencies are not subject to 1, ,

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Maryland Draft Report Page 3 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 NAC's intention to conduct a follow-up review. Some of the recommendationg 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 i Maryland program had taken additional actions to close open recommendations. l (1) Status of the 13 overdue regulations is as follows:

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 effective October 9,1995. See the next section for a continued discussion.

(2) Status of the State's definition of " person" in the LLW regulations to include Federal entities is as follows:

As of the 1993-1994 review this item was pending the result of discussions between the State and NRC legal staff. See the next section for a continued discussion.

This item remains open.

(3) Status of the effort to renew the NPI license, in January 1994, a court settlement was reached which required certain actions by the licensee (NPI). With regard to the NPI license renewal, the state maintained discussions with NPI and, on August 1,1994, NPI submitted a renewal application. However, in their preliminary screening, the state found the application to be deficient in several procedural areas including some of the requirements identified in the January 1994 court settlement. Discussion between the state and NPI continued in an attempt to resolve the issues. In the June 6,1995 response letter to the 1993-1994 review, the State had committed to a schedule for issuance or renewal of the four (4) NPl licenses. The two irradiator licenses and the teletherapy service license were issued essentially on schedule. The source manufacturing 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 section.

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l Maryland Draft Report Page 4 i

2.2 Status of items identified Durino the 1995 Followun Review l The 1995 follow-up review, conducted November 7-8,1995, identified once j again, that the definition of " person" in Maryland's low-level waste regulations

included jurisdiction over Federal facilities. The State had been requested during i the 1993-1994 review to either remove or clarify that with regard to Agreement l materials, Federal agencies are not subject to these regulations. The follow-up

review team also noted that NRC staff would complete a final compatibility l determination of the " Maryland Regulations for Control of ionizing Radiation j (1994)" in late April 1996; and identified an additional regulation, " Licenses and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 (58 FR 7715),

I effective 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 continued to recommend the importance of state action to renew the NPI license.

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

In an August 25,1995, letter to Ms. Marilyn Zaw-Mon, Director, Air and Radiation Management Administration (MDE), the NRC requested reconsideration of the 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 and "to the extent authorized by federal law, federal government," which is acceptable to NRC, as of May 1996.

The IMPEP team found that although the State revised the definition of

" person" in the Radiation Program regulations, no action has been taken by the Waste Management Administration to revise the definition of " person" in the low-level weste 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 shotMd provide clarification of the use of the term " person" in the low-level wake regulations, as it relates to Federal agencies, from the legal staff.

This item remains open.

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Maryland Draft Report Page 5 (2) Current status of any remaining issues regarding regulations is as follows:

l 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 been 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 Maryland's Part 20 equivalent rule and to existing sections of Maryland regulations that were not modified by the 13 amendatory actions. Staff is completing documentation of these concerns and plans to meet separately with Maryland staff to discuss these issues. Also at the time of the IMPEP review, the State had not completed their process for adoption of " Licenses and Radiation Safety Requirements for Irradiators," 10 CFR Part 36, within the three year period of adoption which became due 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 State has not established legally binding requirements equivalent to NRC requirements in 10 CFR Part 36 that are required for compatibility.

The State revised the " Regulation Adoption Management Plan," but no action has occurred on the ten rules or amendments due for adoption by the l 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:  ;

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 getting NPI cooperation in resolving issues such as financial assurance, the

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shielding of onsite radioactive waste held in storage (a significant contributor l to exposures for both onsite personnel and members of the public) and a

courtyard cover to minimize releases of contaminated materials to the

, environment.

I i Due to the continued recommendation from NRC to renew the NPI license, j th State unilaterally reissued license MD-31-025-01 on January i8,1996.

i This license was prepared from the previous license which has been in timely renewal since 19_u, the subsequent amendments and documents and i

information collected over the years. The draft was reviewed by a j committee consisting of inspectors, license reviewers, and program i

management and revised to reflect the participants' cumulative history of

! the site. The licensee appealed the issuance of the license to the Office of l Administrative Hearings. According to Maryland Administrative law, the

i. 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 l 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 i 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 been a further exchange of l correspondence on the license conditions, however, essentially no further i

progress has been made. The State notified the licensee on August 30, f 1996 that the State would not agree to further delay and an administrative i hearing wouid be scheduled as soon as possible.

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The 1996 IMPEP review consisted of a review of the license file for MD-31-025-01 (the source manufacturing license), interviews of the MD l program inspector, license reviewer, and management, and an on site visit '

i to NPl.

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l The 1993-1994 review observed that the State had not been effective in handling the NPI waste storage problem, high fenceline doses, and on and i

off site 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, it does exceed the NRC inspection

frequency for this type license. The State also notes that contact with this j 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 j least a quarterly basis.

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Maryland Draft Report Page 7 I

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! 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 mrom per year). In April 1996, the State approved the conceptual i design for a courtyard enclosure to reduce worker and public exposures and

on and off site contamination. In August 1996, the State demanded the

! licensee submit the detailed plans for the courtyard enclosure as required by

! court order. The licensee, in accordance with the court order, submitted plans to the County and State in September 1996. Subsequently, the team found that upon technical review the plans were found incomplete.

The licensee has agreed to use concrete stab shielding to reduce worker and public exposures from the storage areas. The licensee has taken some action to reduce exposures to workers involved in hot cell cleanup work compared 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 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 NPl 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 the licensee's most significant activities dealing with radiation safety and reliability. The 2-year plan (1996-98) provides for quarterly i inspection frequency, reviews of health physics consultant reports, team I 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 Hospital is 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

Maryland Draft Report Page 8 Heart Hospital (SHH) located in Cumberland, MD, (MD-01-002-02) was conducted in late 1993 and early 1994, in response to issues raised during i

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 ev'e,ntf (3) inconsistencies in the records; and (4) the State's agreement to limit a,c, cess to the records.

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In a report dated March 5,1996, that was transmitted April 15,1996, to

Ms. Marilyn 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 j 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 1 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 Attorney 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.

This recommendation remains open.

e The IMPEP team recommends that the State take action to have the Waste Management Administration revise the definition of " Person" in the low-level

Maryland Draft Repert Page 9 waste regulations COMAR 26.14.01.02B(28)(e) that was identified in both the 1993-94 review and the 1995 follow up review.

e The IMPEP team recommends that the State take action to ensure that SHH complies with the referring physician / patient notification requirements of Meryland law as identified in a report dated March 5,1996, that was transmitted to the State April 15,1996.

i j 3.0 COMMON PERFORMANCE INDICATORS

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

Materials inspection Program, (2) Technical Staffing and Training, (3) Technical

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

3.1 Status of Materials inspection Proaram

) The team focused on four factors in reviewing this indicator: inspection frequency, overdue inspections, initial inspection of new licenses, and timely dispatch of i

inspection findings to licensees. This evaluation is based on the Maryland questionnaire responses relative to this indicator, data gathered independently from i the State's licensing and inspection data tracking system, the examination of j licensing and inspection casework files, and interviews with managers and staff.

! Review of the State's inspection priorities showed that, with the exception of j medical private practice licenses with a QMP, the State's inspection frequencies

! for various types or groups of licensees are at least as frequent, or more frequent j than, similar license types or groups listed in the frequency schedule in the NRC 4

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 quarterly frequency compared to the NRC 1-year frequency; Type A broad scope academic licenses have a 1-year,fre,quency compared with an NRC 2-year frequency; teletherapy and j gamma knife licenses have a 1-year frequency compared with the NRC 3-year l frequency; research and development licenses, podable lead paint analyzers and I j portable gauges have a 4-year frequency compared with the NRC 5-year frequency; and licenses authorizing other measuring systems such as gas  ;

chromatographs have a 5-year frequency compared to the NRC 7-year frequency. l j

However, the state was not distinguishing between medical private practice licenses that required a Quality Management Program and those that did not.

Consequently, all medical private practices were scheduled for inspection at a 4

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Maryland Draft Report Page 10

-year frequency which exceeds the NRC's 5-year frequency for "non-QMP"  !

licenses but falls short of the 3-year frequency specified in IMC 2800 for medical l' 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 i correct the oversight. 4 i

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

In their response to the questionnaire, Maryland indicated that as of September 20, l 1996, no licensec 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 l new licenses issued during the review period, none of the initial inspections were '

conducted within the first six months following issuance of the license. However, i more than half (7 of 12) were completed from 6 to 8 months following issuance 1 and essentially all (11 of 12) were inspected from 6 to 12 months following l issuance (that is, within 6 months of scheduling the inspection). One new license l was inspected approximately 32 months following issuance due to an administrative error in assigning the first due date.

While the initial inspection timing is a significant deviation from the programmatic indicator, 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 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.

> o in reviewing .he 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 t then the compliance letter was not issued within 30 days, program l managemoot indicated this occurred because more information was known to be forthcoming ' rom the licensee or greater care, and thus more time, was needed to document cirz.umstances 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 j l

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i Maryland Draft Report Page 11 industrial radiography, others included well-logging, mobile nuclear medicine, and

other service licensees. The State conducted 56 inspections of reciprocity licensees during the review period, which met the inspection frequency for

conducting inspections of reciprocity licensees contained in IMC 1220, " Processing ,

of NRC Form 241, Report of Proposed 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 i 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 found satisfactory.

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3.2 Technical Staffina and Trainina

, 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, and any staff turnover that may have occurred throughout the assessment period. To evaluate these i; sues, 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.

The Radiological Health Program has responsibility for the control of radiation in Maryland. 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 j positions and combined the responsibilities of the three supervisor positions into one. The RHP program went from a total staffing level of 11, which included one program manager, three supervisor health physicists (licensing, licensing and low level waste, and inspection and enforcement), six health physicists, and one x-ray and regulations specialist; to a total staffing level of (9), 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 radioactive j materials program (RAM) is divided into two sections, the inspection and Enforcement S6ction comprised of four health physicist responsible for all inspection 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, sealed source and device evaluations. A third HP, recently transferred from Radon, is currently 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.

Additionally, the RAM supervisor is often called upon to Act for the RHP manager,

i Maryland Draft Report Page 12 j who is involved in several Agreement State technical organirations and task groups

in support of Agreement State activities. In discussions with the RAM program supervisor the team found that one of the health physicists was recently i transferred to the RAM program from the former Radon program and is currently in '

{ training, anotherhP is currently being assigned increasing inspection duties, and

another health physicist with 5 years of experience had not fully demonstrated consistent quality as a materials inspector.

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l According to information provided in the State's response to the questionnaire, the l training program requires all newly hired inspectors to attend the NRC core training courses, in licensing, inspection procedures, industrial radiography, nuclear l

! medicine, and the 5-week health physics course. At the time of the review, one 1 i HP-inspector with 5 years experience, had not taken the licensing course, and one i newly transferred staff member had not taken the industrial radiography course. l The team noted that one inspector primarily performing medical license inspections  !

could benefit from attending the teletherapy / brachytherapy course, which is a new I

, NRC course. The RHP manager stated 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. MD currently has no formal training plan. Future plans

depend on the final resolution of NRC action regarding funding for travel to NRC training courses. The team suggests that the State consider development of a i formal professional training plan through the use of university and industry

educational programs for training new staff and retuining or refresh for long-term 4

staff.

J In discussions with the RAM supervisor, the team found that new staff are assigned increasingly complex duties under the direction of senior staff and accompany experienced inspectors during increasingly complicated inspections.

When time allows, the RAM supervisor accompanies newly qualified staff. There is no formal program in place for the supervisor to perform an annual inspection  !

accompaniment with each inspector. This issue is further addressed in Section i i 3.4.

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 accompaniment it was not identified that the potential existed for radiation exposure to non-radiation workers in the immediate area where field j radiography was being performed, which posed a health and safety hazard. '

Additionally, the primary focus during both inspections was paperwork rather than a performance based inspection. Interviews were 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 the  ;

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Maryland Draft Report Page 13 team found that the inspector did not have a physical or life science background, but had taken all of the core courses recommended by NRC, as well as additional health physics training during his five years with the program. Additionally, the supervisor had never accompanied the inspector. The team found that the inspector's weak performance after five years of experience demonstrated a deficiency in the, evaluation of training and qualification of the technical staff of the program. This,does not meet the IMPEP evaluation criteria for personnel making prompt progressin completing all of the training and qualification requirements, and provides some evidence of management inattention or inaction to deal with staffing problems. One to two years would be an acceptable time frame in which to train and qualify an inspector.

e The team recommends that management 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 new staff that includes an appropriate 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-term staff.

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l e The team suggests that MD assess whether a reinspection or revision to l 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 whose accompaniment was unsatisfactory.

Staff turnover is stable, however the team noted that the recent reorganization strategy combining two separate position into one and the loss of two staff positions in the recent reorganization, which included the regulation review l specialist, places considerable effort and a heavy workload on the existing staff l

members to manage, control, and review all of the health and safety related work l of the program. The team questioned the staffing balance regarding the expansion of the duties of the RAM supervisor that already included supervisory responsibilities for inspection and enforcement activities, participating in complex

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

Additionally, subsequent to the review, the team found that an HP staff member l 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 of one FTE managing such an unusually large area of responsibility with a technical staff of six (total 7 FTE) should be closely monitored by MD due to the number and complexity of licensees

[ in the MD program. The team discussed increased use of automated systems to

l i Maryland Draft Report Page 14 i

provide increased control through tracking actions, wider access and more efficient l

retrieval of information. The State has several complex licensees, including NPI, l which consumes an inordinate amount of staff time, in the preparation of legal i documents, and technical analysis of corrective action plans; additionally there has j been no action, as of the period of our review, taken on ten rules or amendments j l that should be adopted by December 1997, in order for the RAM program to  !

! remain compatible with the NRC regulatory program. The team questioned the j adequacy of program staff to ensure the long-term ability of the program to j maintain adequacy and compatibility to protect public health and safety.

o Based on the teams findings, the 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 program to protect public health and safety l and complete the pending rules and amendments for adoption to remain compatible.

l 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 l The review team examined casework and interviewed the reviewers for forty l l

1 specific licenses. Licensing actions were reviewed for completeness, consistency, i

! proper isotopes and quantities used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to l

! establish the basis for licensing actions. Casework was reviewed for timeliness, l adherence to good health physics practices, reference to appropriate regulations, j documentation of safety evaluation reports, product certifications or other supporting documents, consideration of enforcement history on renewals, pre-l licensing visits, peer or supervisory review as indicated, and proper signature

, authorities. Licenses were reviewed for accuracy, appropriateness of the license l and of its conditions and tie-down conditions, and overall technical quality. The

{ files were checked for retention of necessary documents and supporting data.

] The cases were, selected to provide a representative sample of licensing actions i which had bee 6 completed in the review period and to include work by all reviewers. The cross-section sampling included five of the State's major licenses

and the total included the following types

nuclear pharmacy, high dose rate i afterloader, academic broad scope, portable gauges, hospital nuclear medicine, j private practice and cardiology limited, research and development laboratory, fixed j gauges, blood irradiator, sales demonstration of devices, radiography, service / leak

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Maryland Draft Report Page 15 l

! test, and sample analysis. Licensing actions included eight new licenses, nine

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

i l The review team found that the licensing actions were generally thorough, complete, consistent, and of acceptabis quclity with health and safety issues properly oddressed. Special license tie-down conditions were almost always stated 4 clearly, backed by information contained in the fh. and inspectable. The licensee's compliance history was taken into account when reviewing renewal

applications. The State's licensing guides and license policy procedures are l currently being revised and updated, and reviewers were observed to have good

! research skills in using these and other licensing documents. With few exceptions,

! reviewers appropriately used the new licensing guides and accompanying check l sheets, although the check sheets are not routinely signed and dated. Licensing i action authorship is indicated by initials and date. At least one, but occasionally i two peer reviews, are documented by initials and dates. All licensing actions are

! signed by the Radiological Health Program Manager. Pre-license-issue visits are i now routinely noted in the file. This visit enables the license reviewer to ascertain the status of licensed facilities and use, as applied 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 materials possession and use, recent actions have been to evaluate and document in a timely manner, and to visit and perform a closeout evaluation which may or may not include a survey. In the earlier portion of the review period, some ,

extended intervals occurred between the termination request and closeout l evaluation. The verification survey could benefit from consideration of Draft l 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 licenses. One termination, identified under the NRC Site Decommissioning Management 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 appropriately to verify licensee actions and terminated properly.

e The tehm' suggested that the Radiological Health Program could benefit from j a guidance document on termination of licenses.  !

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 extensive deficiency discussions or letters have been exchanged.

Maryland Draft Report Page 16  ;

This has the benefit that all the currently agreed to items have been included in l one source document. While telephone deficiency conversations are common, their documentation is often only in the licensee's response that indicates "as a result of our conversation on." The reviewer noted that one license had a long lead time review item (weste storage) separated from the renewal, enabling j issuance of an up-to-date license sooner than would have been otherwise possible.

i 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 license actions in the near future. Both license reviewers have an l

inspection background.

! Based on the IMPEP evaluation criteria, the review team recommends that

! Maryland's performance with respect to the indicator, Technical Quality of

Licensing Actions, be found satisfactory.

3.4 Technical Quality of Inanactions l

j The team reviewed the inspection reports, enforcement documentation, and j inspection field notes, and interviewed inspectors for sixteen materials inspections

{ conducted during the review period. The casework included all 5 of the State's i material inspectors and covered higher priority inspections of various types 1 including hospitals, nuclear medicine facilities, academic institutions, research and

development facilities, industrial use, an instrument calibration service, and a j nuclear pharmacy. Attachment E lists the inspection cases reviewed in depth with I case-specific comments. Prior to the review, a team member performed accompaniments of three state inspectors on four separate inspections of high.

I priority facilities. The first inspector was accompanied at a pool-type irradiator, the j second inspector was accompanied twice, first at a hospital followed by field site 5 radiography, and the third inspector was accompanied at a nuclear pharmacy.

j inspection procedures and techniques utilized by the State were reviewed and j determined to be consistent with the inspection guidance identified in NRC i inspection Manuel Chapter 2800. The procedures were used to help inspectors

! identify root causes and poor licenses performance. The State's policy is to j conduct inspections on an unannounced basis. NRC inspection Procedure 87100 l field notes weretlectronically reproduced in State' format and used for routine j materials inspections in the categories of medical, academic, teletherapy, j commercial irradiators, gauges, industrial radiography, and research and j development.

l The review team found the level of detail provided in inspection reports was l consistent with respect to the scope of the licensed program, licensee i

j

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! Maryland Draft Report Page 17 I

l organization, management structure, radiation protection program, training and ,

instructions to workers, personnel protection, posting and labeling, radioactive  !

material control, material transfer and disposal, and exit interviews with management. To assure consistency and quality assurance of reports the RAM l Supervisor provided review, comment, and initialed all inspection documents and l

field notes.

t l Reports were also reviewed for inspector documentation of operations observed, l management and worker interviews, independent measurements, followup to

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

l The review team discussed documenting in reports what inspection areas and j information were reviewed to close out previous items of noncompliance. Other  ;

j reports contained only minor discrepancies from standard practice which were j related to insufficient detail. i l

l Field notes, inspection forms, and enforcement correspondence were found to be i complete. Documented inspection findings generally led to appropriate l enforcement and prompt regulatory actions. Routine enforcement latters were

! drafted by the inspector, signed off by the RAM Supervisor, and issued to the i

licensee by the RHP Manager. With the exception of NPI (currently under court l order), the team determined the State's enforcement policies to be effective in

achieving licensee compliance. Enforcement correspondence was timely for files l reviewed by the team. Licensee responses to items of noncompliance were also i 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.

l I

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 l was informal. Inspectors discussed inspection findings with the RAM Supervisor,

! who served as the intermediary between license and compliance staffs for

information sharing.

! r i The State's practice calls for annual supervisory accompaniments of all inspectors.

] in response to the questionnaire, the State reported that the RAM Supervisor i 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 l period. The review team considered the unusually high work demands placed upon

t l

Maryland Draft Report Page 18  !

i the RAM Supervisor position during this review period because of the licensing and

! compliance efforts related to NPI, two reassignments of individuals into the l position within a three month period in 1995, and the need to maintain inspection l schedules at the appropriate level to prevent development of a program backlog.

i However, supervisory accompaniments provide management with important insight j into the quality of the inspection program.

4 l . -

1 e The review team recommends that the State adhere to the practice of l annual supervisory accompanimentssof all inspectors. l i'

i Four inspector accompaniments of three of the program's five inspectors were i performed by a review team member as follows: the first inspector was reviewed i' i on June 25-26,1996, at a pool irradiator facility; the second inspector was j reviewed on July 16-17,1996 at a hospital and again on September 19,1996, at i a field radiography site. A third inspector was reviewed on August 7,1996, at a i nuclear pharmacy. These accompaniments are also identified in Appendix E. The l second inspector (who had been performing inspections of high priority licensees) j was accompanied twice because a State supervisory accompaniment was not

! performed during the review period, an NRC riccompaniment was not performed in j previous assessments, and, following the initbl accompaniment of the individual,

the team was unable to reach a determination 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 j assessments, and the other was a new trainee.

t

On the accompaniments, two of the three inspectors demonstrated strong

inspection techniques, knowledge of the regulations, and overall satisfactory i technical performance. However, accompaniments did not show a comparable j_ level of performance by another State-qualified inspector either to conduct a performance-based inspection or in inspection thoroughness to address potentially l

l 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 ins,pections included failure to take l'

independent wipe samples at all hospital material storage and waste locations, not  !

conducting interviews with the hospital radiation safety officer and nursing staff l 5

until prompted by the team member, incomplete follow-up of licensee corrective l

! actions resulting from a 1994 hospital contamination incident, inadequate walk l

! 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 i

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Maryland Draft Report Page 19 i

! to non-radiation workers in the immediate area where field radiography was j performed, and inadequate check of radiation workers for proper dosimetry.

i

As noted in Section 3.2 of this report, interviews of compliance staff indicated that i field qualification for a new inspector consisted primarily of demonstrations for l supervisory staff'until supervisors were able to make a subjective determination j that the inspector.was able to perform independently. Criteria were not clearly

established which allowed State management to determine when inspectors were i qualified for different types of program inspections.

i f e To ensure consistency in performance among inspection staff, the review

! team recommends that the State develop a program outlining the necessary l steps to be followed by staff for full inspector qualification.

}

! The team found that the State maintains an ample number of portable mdiation j detection instruments for use during routine inspections and response to incidents

! and emergencies. Included in the State's meter inventory were ion chambers, i micro R meters, high range detectors, GM tubes, ratemeters, scintillation

detectors, high and low range pocket dosimeters, alpha meters, calibration check l sources, and air sampling equipment. Calibrated portable equipment was located in i kits contained in emergency vehicles assigned to the RHP. Inspectors use these l vehicles for routine inspections with the portable instruments used by inspectors for confirmatory measurements. The inventory list showed staggered annual due j! 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 j spectrometers (multichannel analyzer) for full capability to analyze wipe, water, j and soil samples for the RHP.

I j Based on the IMPEP evaluation criteria, the review team recommends that  !

i Maryland's performance with respect to the indicator, Technical Quality of l l Inspections, be found Satisfactory, with Recommendations for improvement.

3.5 Rannorias ta incidents and Allegations s i

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 this4necator 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 i for ten incidents. The team reviewed the State's response to five allegations. In  !

j addition, the review team interviewed the RHP Manager, the RAM supervisor, and j s the health physicists assigned to incident response. i x

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! Maryland Draft Report Page 20 1 .

! l l It was found that within the RHP, responsibility for initial response and follow up I l actions to materials incidents and allegations rests solely with the Inspection and i Enforcement Section (lES) of RAM. Written procedures require a prompt response i to incidents by the staff and provide additional procedural guidance. The RAM i

supervisor reviews each incoming event notification or allegation prior to

, assignment to $e IES staff or when appropriate, referral to another agency. All

l. complex events or ellegations 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 varies based on the I safety significance of the event, from resolution through telephone discussion, to j immediate response by a team of 2 health physicists, and, in some cases, issuance j of a press release to the media. In many instances, the RAM supervisor

! participated in investigations of complex or high media interest events. Review of l the files indicated that this approach provided effective response actions, i

a The review team examined the State's response to 10 events chosen from events identified as significant in the State's response to the questionnaire and events found in the NMED database system. Events reviewed included two squipment

problems, one transportation event, three lost or stolen radioactive material, three j loss of control, and one misadministration. The team found that the State could j not provide a listing of allegations received by the State during the period. Six i allegations involving a variety of technical and administrative issues, five of which I had been referred by NRC to the State, were reviewed. A list of the incident casework with comments is included in Appendix F.

l i

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 j the level of effort was commensurate with health and safety significance. The l

State assured that licensees took suitable corrective actions, and followed the

progress 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 j 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 l l

l to the Questionnaire had not been provided to NRC and were not found in the i 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 State greements 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 ification requirement) rather than the hlRC Operations Center, as identified in the ' Handbook on Nuclear Material Event Reporting in the Agreement

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States," Draft Report, March 1995.

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o The team recommends that the State begin voluntary reporting of all j reportable events to the NRC Operations Center and begin participating in i

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i i Maryland Draft Report Page 21 I the NMED database system collection of material events by providing event l l

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 i Agreement States," Draft Report, March 1995.  ;

e The teem 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 MD State Highway event, (2) 5/26/95 Soil Safe Inc. event, and (3) 5/30/96 Aerosol Monitoring event. ,l i

l 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 l 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 alleger's 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. i 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, 53-101-102) prohibiting intentional acts of reprisal against any employee who has filed a complaint, grievance, or other administrative or legal action involving State employment.

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. ,

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u 4.0 NON-COMMON PERFORMANCE INDICATORS a

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

i i

Maryland Draft Report Page 22 not cover uranium recovery operations, so only the first three non-common l performance indicators were applicable to this review.

4.1 Legislation and Regulations 4.1.1 Legislative and Legal Authority 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, i l " Hazardous Materials and Hazardous Substances". There are no sunset laws in I i Maryland and the State indicated that regulations have no expiration date. l 4.1.2 Status and Comnatibility of Reaulations i

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 followup 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 effective on October 25,1993, and will need to be adopted 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 the 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 i scheduled to be adopted in November 1996. The team found that the State has I not established legally binding requirements equivalent to NRC requirements in 10 i

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i l Maryland Draft Report Page 23 j CFR Part 36 that are required for compatibility.

i Frorn interviews with staff assigned to the RHP regulations development committee, thf 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 aeoption by the end of 1997:

e " Timeliness,in Decommissioning of Material Facilities, " 10 CFR Parts 30, j 40, and 70 amendments (59 FR 36026) that became effective August 15,

1994 and will need to be adopted by August 15,1997.

o " Preparation, Transfer for Commercial Distribution, and Use of Byproduct l Material for Medical Use, " 10 CFR 30, 32, and 35 amendments (59 FR 1 61767, 59 FR 65243, and 60 FR 322) that because effective January 1, l 1995 and will need to be adopted by January 1,1998, o " Frequency of Medical Examinations for Use of Respiratory Protection

! Equipment," 10 CFR Part 20 amendments (60 FR 7900) that became i 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 i requirements so that the national manifest system will go into effect at one

time. j l I j e " Performance Requirements for Radiography Equipment," 10 CFR 34  !

amendments (60 FR 28323) that became effective June 30,1995 and will need to be adopted by June 30,1998.

e " Radiation Protection Requirements: Amended Definitions and Criteria," 10 4

CFR Parts 19 and 20 amendments (60 FR 36038) that became effective

! August 14,1995 and will need to be adopted by August 14,1998.

j 1

e "Clerification of Decommissioning Funding Requirements," 10 CFR Parts 30, 40, and70 amendments (60 FR 38235) that became effective November

! 24,1995 and will need to be adopted by November 24,1998.

e " Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that will become effective April 1,1996 and will need to adopted by April 1,1999. NRC delayed the effective date of

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i Maryland Draft Report Page 24 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. j

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e " 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. ,

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

l i 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, based on that review, found that our earlier comments have been addressed.

However, in completing the review staff identified issues in other sections of l Maryland regulations that have potential compatibility significance. Issues identified by the staff relate to Maryland's Part 20 equivalent rule and to existing sections of Maryland regulations that were not modified by the 13 amendatory actions. Staff is completing documentation of these concerns and plans to meet separately with Maryland staff to discuss these issues.

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 comments are considered by the rules committee prior to public notice.

l e 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.

l e The team recommends that the State address the process for handling multiple rulemakings to ensure that they are completed within the three j years of the effective date.

Based on the IMPEP evaluation criteria, the review team recommends that Maryland's performance with respect to this indicator, Legislation and Regulations, be found Unsatisfactory due to the State's failure to adopt 10 CFR Part 36 or  ;

equivalent legally binding requirements within the specified period of time.

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! Maryland Draft Report Page 25 l

4.2 e--%d Source and Device Evaluation Prooram l

j in assessing the State's Sealed Source & Device (SS&D) evaluation program, the i review team examined information provided by the State in response to the IMPEP questionnaire on this indicator. A review of selected new and amended SS&D i evaluations and supporting documents covering the review period was conducted.

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

i 4.2.1 Technical 0"-uty of the Product Evaluation Proaram v

l 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 i efforts to revise an additional SS&D registry certificate for a device involved in an

{ incident. The certificates reviewed covered the period since the last program I

review in April 1993 and represented cases completed by three reviewers. The i SS&D certificates issued by the State and evaluated by the review team are listed j 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 of the applicants and in j the detail of the evaluations when comparing 1994 to 1995 certificates.

The State does have procedures in place to protect proprietary information l

submitted in support of an evaluation. Policy and guidance documents were on file i 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 j second reviewer's audit of the application and the original reviewer's conclusions l

for future certificates. This is a change in the previous policy of the State.

1

{ The review of SS&D casework files revealed that five of the seven files had

' comments on detailed Quality Assurance / Quality Control (QA/QC) programs.

Specifically, the staff did not obtain detailed QA/QC program commitments for 4

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/QC) programs re0erding the SS&D product manufacturing process. The l review toom noted that the staff had obtained detailed QA/QC program information 1 on the HDR presently under review and had reviewed the information according the procedures and guidance documents.

{

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j 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 j

Maryland Draft Report Page 26 Maryland 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 I 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.

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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.

l improvements in the nationwide effort to evaluate SS&Ds containing radioactive material led to NRC adoption of 10 CFR 30.32 (g) on " Application for Specific l Licenses" and 10 CFR 32.210 entitled, " Registration of Product Information."

These regulations were not initially identified as items of compatibility for l Agreement States with SS&D evaluation programs.

e All Agreement States letter SP-95-116 dated July 25,1995, announced Commission approval of minimum standards for Agreement States desiring to maintain authority to evaluate SS&Ds. In keeping with this guidance, the review team recommends that the State adopt regulations 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 permits 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 recommended core training courses for materials licensing personnel and more advanced training such as the SS&D

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j Maryland Draft Report Page 27

! 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 revtewedi 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 l criteria. Although the lead health physicist is newly assigned to the SS&D reviews, he is an experienced senior inspector with a Bachelor's degree in biological sciences and has had all the NRC 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.

e The staff performing SS&D evaluations is dedicated to a quality product, the program uses a two person team approach to performing the evaluations, 1

the SS&D evaluation program has management support, and has the ability to seek outside assistance from NRC as needed. However, 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.

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 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 j SS&D certificate for the HDR to take into account the new design and programming implemented for the interlock and the OA/QC program. A draft version of this cohificate has been sent to the licensee for comment. j i

Based on the lhIPl!P evaluation criteria, the review team recommends that Maryland's Orf'ermance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.

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., .y _ <- . - . .. - . . _ . - - . .

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

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l Maryland Draft Report Page 28 i

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! 4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

! In 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States l 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 j LLRW as a separate category. Those States with existing Agreements prior to

! 1981 were determined to have continued LLRW disposal authority without the '

i need of an amendment. Although Maryland has LLRW disposal authority, NRC i has not required States to have's program for licensing a LLRW disposal facility '

) until such time as the State has been designated as a host state for a LLRW i disposal facility. When an Agreement State has been notified or becomes aware of l the need to regulate a LLRW disposal facility, they are expected to put in place a i 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.

l' 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 due to the fact that the State has not adopted " Licensing and Radiation Safety Requirements for Irradiators, "10 CFR Part 36 amendments (58 FR 7715) that became effective July 1,1993, and should have been adopted by the State by July 1,1996.

Accordingly, the team recommends the MRB find the Maryland program to be adequate to protect public health and safety but nsads improvement and not compatible due to the failure to adopt 10 CR Part 36 or equivalent legally binding requirements within the specific period of time.

I 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 Manag6 ment Administration revise the definition of " Person" in the low-level weste regulations COMAR 26.14.01.02B(28)(e) that was identified in both j 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

l l Maryland Draft Report Page 29 1

i review team report dated March 5,1996, that was transmitted to the State )

l April 15,1996. (Section 2.0) j 3. The review team recommends that the State incorporate the April 1995

! revisions to IMC 2800 into their inspection Procedures Manual. (Section 3.1) 1

! 4. The team suggests that the State consider development of a formal l l professional training plan through the use of university and industry j

educational programs for training new staff and retraining or refresh for i

! long-term staff. (Section 3.2) i

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

plan to address the issue of qualifying staff. The team also recommends j that management provide a training and qualification plan for new staff that j includes an appropriate 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-term staff.

{ (Section 3.2)

- 6. The team suggests that MD assess whether a reinspection or revision to

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

priority licensees, i.e.,HDRs, radiographers, previously inspected by the HP-1 inspector whose accompaniment was unsatisfactory. (Section 3.2)

! 7. The review team recommends that the State assess the adequacy of the I

program staff to ensure the long-term ability of the program to maintain an

adequate program to protect public health and safety and complete the l pending rules and amendments for adoption to remain compatible. (Section j 3.2) i 8. The team suggested that the Radiological Health Program could benefit from l a guidance document on termination of licenses. (Section 3.3)  !

1 7 -

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9. The rekiew team recommends that the State adhere to the policy of annual l supervl&Myaccompaniments of allinspectors. (Section 3.4) l 10. To ensore' consistency in performance among inspection staff, the review j team recommends that the State develop a program outlining the necessary ,

steps to be followed by compliance staff for full inspector qualification.

{ (Section 3.4) i j 11. The review team recommends that the State begin voluntary reporting of all l i reportable events to the NRC Operations Center and begin participating in I

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! Maryland Draft Report Page 30

$ 1 j the NMED database system collection of material events by providing event information directly into the NMED system electronically or providing l 2

compatible information in written form in accordance with guidance '

i contained in the " Handbook on Nuclear Material Event Reporting in the I

Agreement States," Draft Report, March 1995. (Section 3.5) l 12. The team recommends that the State provide event information for three

events identified by the State in response to the Questionnaire, as follows

l (1) 1/23/95 MD State Highway event, (2) 5/26/95 Soil Safe Inc. event, and j (3) 5/30/96 Aerosol Monitoring event. (Section 3.5) l l 13. The team recommends that the State provide close out information to NRC l on allegations referred to the State by NRC. (Section 3.5)

14. The review team recommends that the State improve the effectiveness of j the Regulation Adoption Management Plan by providing a realistic schedule l 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) l 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) i

16. The review team recommends that the State implement a plan to review all

! registration sheets, based on the risk associated with the device, especially j detailed QA/QC program information. (Section 4.2)

, 17. The review team recommends that the State adopt regulations compatible l with 10 CFR 30.32 (g) and 10 CFR 32.210. (Section 4.2) i l 18. The review team recommends that an additional senior staff member be i should be trained to perform the SS&D evaluations to supplement the l program as it matures. (Section 4.2) i i

i

UST OF APPENDICES AND ATTACHMENTS Appendix A iMPEP Review Team Members Appendix B , Maryland Organization Charts Appendix C Maryland's Questionnaire Response Appendix D License File Reviews Appendix E Inspection File Reviews Appendix F Incident File Reviews Appendix G Incident File Reviews Attachment 1 Maryland's Response to Review Findings l

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i APPENDIX A iMPEP REVIEW TEAM MEMBERS P

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Name Area of Responaltdlity l Patricia Larkins, OSP On-Site Team Leader Technical Staffing and Training Response to incidents and Allegations Terry Frazee, Washington Technical Quality of Licensing Actions at NPI Status of Materials inspection Program i

Dave Collins, Ril Technical Quality of Licensing Actions l Craig Gordon, RI Technical Quality of Inspections Legislation and Regulations Kathleen Schneider, OSP Sealed Source and Device Evaluations

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! APPENDIX B l MARYLAND DEPARTMENT OF THE ENVIRONMENT I

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' AIR AND RADIATION MANAGEMENT ADMINISTRATION, RADIOLOGICAL HEALTH PROGRAM i

j ORGANIZATION CHARTS i

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MARYLAN D DEPART MENT OF THE ENVIROX ME .

GOVERNOR .

Ih>=mJ Hichisissm oc,,,,e Fag ri m sm.eliasd Jane T.Nishida. Secretary s.,ier.ish.s Ammi.er nnopalCmmsel ,___

631-3084 _ Ennre=#cmal Connes 18mie Atheney Genesars OfTce "dp e11 3053 j sH-so29 g ,,,y99 Arthur W Rey. Deputy Secrefery 6]I-3086

-Orawine lhdees L Charles Fox Assistanl Secretary

-Copie.1 th.dges

- neimd .t h blic Wo.no 631 4I87 -

- Wsees Queiny Financing OfHee of the Secretary Iesticser es.meom C""'**""*=I IV'n" .

s,.,n w,,,4,, 96,,,,,, - l'elecy Coordinatiose 5""ce Cemn OfEce of C_-. _ . . _ - Sleategic l'lanning 6H 3m .

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- I egistmion - resune Om=Jmasion

- Ai de - Peeneis lesanig

- Media Relemas - 1%Ihelem hevemeen

- 3:vems Cece ? -Smaallt.insesess Assissante

- lAsseenal Omresch

.C_ "y Relanms/Usereoch

-:.-....__ ! Cesedmessen Elkfiseillaire lbreeser I esim CQ,threcent II. Blenne. fhrator Aenheisesmis # sad I{mednyve RichardCoMins Direcser Tecimical smi Regalm =y Sevvices Wmee klanagenseed Smkes Admansamien Mendre Zew Mme. Oneeser Wnee Managenicoe A d==nsu mann 438-)H6 Air a R s4sseen Bismogemem A4.nnkasseen 6il h80 Ad==inisnenen SJf.)M7 Aansd nasms 619-1304 639 3251

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- A> IJeald?1%sm#s . Waees5 ewer ths -f.eengeagh I 6emme no speems I'lanning smlCompdiance . WascenFaseenmer Caenpleance - Ceaseal Services

. Ak Qesidy lianmng -I nurnmacneal Ri4 klanagement -IIces Managemene

- Soled Wesse - Capieal hojects.firants & I naus

. Ah Quality C wngdesace . Imks Reduses.wi Inwne==y -5eundy

. Ilararenes Wesse - Water $nggdy

- AdiestosQ Imbeserial -Ilarmenes Mwerids 1ranspersseien -RegalmnwiC edmmne - tienidmg itrce ssions 813 giene . Int.d/N.m. lklal Weslands . l ectenn ed luf wraker Att

-Iln.Iergnomilank Remediasnm - Wmes Agq=.gwiarnes

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. Ak Hensoorms & Information . Ilmlevgv.unni lank I cans I me.hnate..n - Inl.wmmhm 51sseins and Speems -Finwng - lii4As $ngg ins

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- R mindock al liealth - Sevele ines Menegemene -IWillish mcerenoi.n e.de m - 1%mnees & Campaigns

- Sninnene i ensnas renered -k hhmenha testmetalSapg=we

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h APPENDIX C i

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j INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) QUESTIONNAIRE a

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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE l

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Maryland Department of the Environment Radiological Health Program Reporting Period: April 8,1994, to September 20,1996

A. COMMON PERFORMANCE INDICATORS

1. Status of Materials insoection Protmam

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 l should include initial inspections that are overdue.

I Insp. Frequency j Licensee Name (Years) Due Date Months O/D l

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

] 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 i with your response to this questionnaire.

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

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

l answer: All RHP inspections are conducted as frequently or more frequently than

the NRC Chapter 2800 inspection frequencies.

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

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

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MD IMPEP Questionnaire Page C. 2 answer: 708 licensees filed reciprocity notices in the reporting period. 498 of l those requests were for types of licensees which have inspection frequencies of 3 '

years or less. l l

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

j answer: 56 reciprocity inspections within the reporting period.

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

l answer: 4 field inspections of radiographers were performed, h

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

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

number of inspections performed.

answer: N/A

ll. Technical Staffiria and Trainino l i  !

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:

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MD IMPEP Questionnaire Page C. 3 l

1 i NAME POSITION AREA OF EFFORT i

l Carl E. Trump, Jr. Program Administration, 25%; Materials Manager Licensing & Compliance,65%;

n ,,

Emergency Response, 5%; *LLRW,

5%

Administration,15%; Materials

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Raymond E. Health Physicist i Manley Lead Licensing & Compliance,70%;

j Emergency Response,10%; LLRW, l 5%

l Alan D. Jacobson Health Physicist Administration,10%; Materials l Lead Licensing & Compliance,80%;

Emergency Response,8%; LLRW,

! 2%

Robert K. Nelson Health Physicist Administration, 5%; Materials ll Licensing & Compliance,85%;

i Emergency Response,8%; LLRW,

. 2%

i Frank A. Kasper Health Physicist Administration 0%, Materials

! I Licensing & Compliance 95%,

j Emergency Response 5%

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

j Emergency Response 2%

Douglas K. Health Physicist Administration 10 %, Materials

! McAboe il Licensing & Compliance 88%,

! Emergency Response 2% ,

! Nathaniel A. Health Physicist Administration 5%, Materials

{' 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 i his time on LLRW.

2 l 8. Please provide a listing of all new professional personnel hired since i 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.

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i answer: No new professional personnel have been hbed glace the last review.

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MD IMPEP Questionnaire Page C. 4 1

! 9. Please list all professional staff who have not yet met the qualification

! requirements of license reviewer / materials inspection staff (for NRC, i 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.

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

Leon Rachuba needs to attend Safety Aspects of industrial Radiography. He will attend course provided funding is avs.llable or NRC sponsorship continues.

INSPECTOR TRAINING Inspectors must attend all NRC core courses.

A. Inspections B. Diagnostic and Therapeutic Nuclear Medicine C. Five-Wetk Health Physics D. Safety Aspects of industrial Radiography 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.

LICENSING REVIEWER License reviewers must attend all NRC core courses.

A. Inspections B. Diagnostic and Therapeutic Nuclear Medicine l C. Rve-Week Health Physics l D. Safety Aspects of industrial Radiography l E. Licensing Practices and Procedures License reviewers must be trained and aware of relevant NRC licensing guidance and pertinent technical documents. I

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

answer: Retirement of Charles R. Flynn as tjsernsing Program Manager on 6/95.

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

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MD IMPEP Questionnaire Page C. 5 i'

ill. Technical On=lity of Licensina Actions

!I

11. Please identify any major, unusual, or complex licenses which were issued, received a rnajor amendment, terminated or renewed in this j period.

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i LICENSEE NAME LICENSE LICENSE TYPE ACTION i s < NUMBER Neutron Products MD-31-025-01 Manufacturer Renewal

Neutron Products MD-31-025-03 Teletherapy Renewal 1

Service l Neutron Products MD-31-025-04 Irradiator Renewal j Neutron Products MD-31-025-05 Irradiator Renewal l Eastern isotopes MD-03-068-01 Nuclear Pharmacy New I Mallinckrodt MD-05-105-01 Nuclear Pharmacy Renewal Medical l

l Terumo Medical MD-15-007-01 Irradiator Renewal

Corp l Adaptive MD-21-026-01 Sealed Source Renewal Technologies Inc Design H&H X-ray MD-03-047-01 Industrial Terminated i Services Radiography i

Law Engineering MD-27-060-01 Industrial Terminated i Inc. Radiography 1

I Measurex-DMC MD-31-088-01 Sealed Source Renewal i Design l Measurex-DMC MD-31-088-02 Service Renewal Mid-Atlantic MD-05-148-01 Nuclear Pharmacy New i i isotopes j Oncology Center MD 25-026-01 HDR New

. at Riverside Montgomery MD-31-217-01 HDR New General Hospital l Cancer Treatment Center a

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MD IMPEP Questionnaire Page C. 6 Chesapeake MD-37-010-01 HDR New Regional Cancer Center GTS Duratek MD-27-059-01 Industrial Terminated

< Radiography Veterinary Imaging MD-05-145-01 Therapy New Veterinary Referra! MD-31-242-01 Therapy New Service P North Arnerican MD-43-019-01 Industrial Terminated inspections Radiography Maryland General MD--07-177-01 HDR New Cancer Center TABLE OF MAJOR LICENSEES licensee Name License Number License Tvoe 1 Eastern isotopes Inc MD-03-068-01 Nuclear Pharmacy Syncor Corp MD-05-059-01 Nuclear Pharmacy 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 Johns Hopkins Medical MD-07-005-03 Broad Scope Institute University of Maryland MD-07-014-01 Broad Scop <

at Baltimore University of, 4aryland MD-07-014-04 incinerator at Baltimore .,

Maryland General Cancer MD-07-177-01 HDR Center Union Memorial MD-07-181-01 HDR Oncology Center I

Terumo Medical Corp MD-15-OO7-02 trradiator l

MD IMPEP Questionnaire Page C. 7 l

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. Therapy Services MD-21-007-01 Therapy Source Service l and Distribution l l

Adaptive Technologies MD-21-026-01 Service and Distribution inc.

Oncology Center at MD-25-026-01 HDR Riverside Neutron Products MD-31-025-01 Manufacturer

) Neutron Products MD-31-025-03 Service Neutron Products MD-31-025-04 Irradiator 4.

l Neutron Products MD-31-025-05 Irradiator Nucletron Inc. MD-27-035-01 Therapy Source Service j 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 Pettit Applied MD-31-252-01 Service and Distribution Technologies of GL Devices 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

12. Please identify any new or amended licenses added or removed from the list of licensees requiring emergency plans?

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

MD IMPEP Ouestionnaire Page C 8

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

. answer: There were none.

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

answer: Lloonsing 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:

i Suoervisor Insoector License Cat. (code) Data Carl E. Trump, Jr. Randall Haack 03121 6/20/94  ;

Carl E. Trump, Jr. Alan Jacobson 02305 8/30-31/94 Carl E. Trump, Jr. Ray Manley 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 1

MD IMPEP Questionnaire Page C. 9 i

l l Carl E. Trump, Jr. Ray Manley 03320 incident 1/25/95 Alan Jacobson Reenactment i Bob Nelson j Frank Kasper Tom Ferguson i

! Carl E. Trump, Jr. Alan Jacobson 02120 1/31/95 Thomas Ferguson Leon Rachuba 03121 11/14/95

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

answer: Accompaniment involves on-site evaluation by senior supervisor for competency and knowledge of a selective license category. Each inspector was verbally critiqued by the supervisor upon completion of the inspection.

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

answer:

Number of instruments Manufacturer Model 16 Eberline E-520 ,

2 Eberline ASP-1  ;

l 2 Bicron mRom 1 1 Eberline E-120 9 Eberline Prm-7 i

4 Ludlum 12S 1 Ludium 14A 1 Ludlum 19 4 Eberline MS2 3 Ebertine Pac 4G 3 Eberline Pic 6a 12 Eberline Pic 68 1 Victoreen 470 A

l MD IMPEP Ouestionnaire Page C.10 ,

l Meters are cellbrated at Radiation Services Organization or by BGE (Calvert Cliffs Nuclear Facility). All innruments used by personnel for compliance or investigatory purposes are rulibrated.

1 V. Responses to incidents and Alleastions l 20. Please provide a list of the most sinnificant incidents (i.e., medical

misedministration, overexposures, lost and abandoned sources, i 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, Information included in previous submittals to NRC need not be repeated. The list should be in the following format: J LICENSEE NAME LICENSE # DATE OF TYPE OF INCIDENT \REPOR INCIDENT I T

Private Paint Shop GL Device 7/11/94\\7/20/94 Stolen Device Material Testing NRC-45-17151- 10/6/94\\12/12/9 Industrial Laboratories 01 4 Radiography (loss of control) 12/14/94 12/23/94 Atac Assoc. MD-31-189-01 8/31/94\\9/22/94 Damaged Gauge 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 Ares & DOT Contamination Maryland State MD-05-049-01 1/23/95\\1/24/95 Stolen Gauge Highway Soil Safe Inc. MD-07-172-01 5/26/95\\7/10/95 Lost Gauge l Nucietron MD-27-035-01 1/9/96\\2/22/96 System Fellure Corporation Aerosol Monitoring MD-03-056-01 5/30/96\\6/10/96 Stolen Paint Analyzer Johns Hopkins MD-0546743 S/E/SS\ Wending Brachytherapy Medical institutions (loss of control)

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i MD IMPEP Questionnaire Page C.11 I

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

a. For States, was timely notification made to tte Office of State

{ Programs? For Regions, was an appropriate ard timely PN  ;

! generated?  !

answer: a. Notification to RHP by NRC regarding failure of Nuclotron HDR's i

door interlock system to always retract the source when the l l Westment 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 transport 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

i

)

i-j- MD IMPEP Ouestionnaire Page C.12 I

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

I arnswer: Of the 30 program indicators that were evaluated during the 1993 propam review,.19 were found satisfactory. NRC recommendations and RHP's l < current status is indicated below:

i .

l-j 1. Status and Compatibility of Regulations (Category 1) i 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 i regulations, and obtain the necessary support needed to adopt the j regulations in an expeditious manner. The RHP should develop and submit l to NRC a management plan for eliminating the current rulemaking backlog l and a schedule for adoption'of revisions to the regulations.

t l RHP STATUS: On September 21,1995 RHP submitted to NRC a regulations l

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

adopted September 9,1995 and effective October 9,1995, incorporated the thirteen (13) compatibility regulations 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 j regulation committee is near completion regarding the adoption of regulations j governing the licensing and radiation safety requirements for irradiators and i anticipates adoption in November,1996.

2. Budget (Category ll) l NRC RECOMMENDATION: The RHP should assess programma. tic needs i and, if determined to be necessary, a supplemental budget increase i requested to provide sufficient operating funds for the program. j i

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

i

MD IMPEP Ouestionnaire Page C.13

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 regulations;

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

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

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 areas of licensing, reporting of events, and misedministrations. Inspection procedures were revised and implemented in November of 1995.

4. Trainina (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 I sealed sourcafarId 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, inpordance with the revised Part 20, was held on October 12, 1 1995. Specific aspects of the licensing staff training program include:

i

a. training of licensing personnel in the areas of general licensing practices and SS&D evaluations; and,

b. explaining segments of ticonsing procedures to all personnel, i

.__-y i

MD IMPEP Ouestionnaire Page C.14 i l

5.- Adenuncv of Product Evaluations (Category I) i NRC RECOMMENDATION: j

a. The RHP and vendors should replace missing information and review outdated registration sheets in accordance with the standard format and content guidance. Maryland should obtain and maintain sufficient  !

documentation on file to establish a complete health and safety basis for l the integrity of the product designs.  !

I

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 l and device acceptance evaluation that authorizes a manufacturer,  !

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 by the RHP. Unless a cooperative arrangement can be made with the l affected State, this practice should be discontinued.  !

RHP STATUS:

l a. RHP has followed specific guidance received from Steve Baggett of NRC l Headquarters regarding this issue,

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

c. The RHP has never had a policy of writing registry sheets for out-of-state l 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 l 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

deleting the West Coast distributor.

l l 6. Licensino, Procedures (Category 11)

NRC RECOMMENDATION: The RHP should revise their licensing procedures to provide for the routine use of letters to: (a) transmit licenses and

( amendments; and, (b) bring to management's attention, highlights of license changes or related information.

l

i 1

MD IMPEP Questionnaire Page C.15 RHP STATUS: The RHP began using a transmittal letter to forward new licenses 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 originally requested. This will facilitate communication with licensees and enhance cornpliance.

7. Technical Quality of Licensing Actions (Category 1)

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  !

response to this recommendation, include a discussion of the current status  !

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 comments in future licensing actions. ,

i 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. NPI license MD-31-025-03 (teletherapy service) l was renewed on l 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.

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

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

8. Ananaction Fennuancy (Category Il i

NRC IECOMMENDATION: The RHP should fewise 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 I indicator. The RHP revised the inspection frequency l for afterloader licensees from a three (3) year frequency to an annual frequency during the NRC's September 1999 review, because NRC guidelines regarding this l

l

i i

! MD IMPEP Ouestionnaire Page C.16 i

f 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 j Robert Percissepe, 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 1 l license and all were within one year of that inspection at the time of the review. ,

j 9. Enforcement Proceduras (Category l}

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

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

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

l

RHP STATUS

The RHP has continued with the implementation of the April 4,

! 1994 strategic plan for NPl inspection and compliance activities. The RHP has l revised enforcement procedures to address routine enforcement policy, the use of

} the Notice of Violations, and the MDE E-1 form. The RHP began issuing j acknowledgement letters for routine enforcement actions in March 1994.

l 10. Insoection Procedures (Category ll) l NRC RECOMMENDATION: The RHP should update inspection procedures to reflect current program operations.

RHP STATUS: RHP has revie 1 existing inspection procedures and revised them accordingly. The review incluc evaluation of NRC guidance regarding inspection procedures and guidelines. The L . dated procedures were implemented by November,1995.

11. Innoaction Reports (Category ll)

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 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 tirr.ely review by the Compliance Supervisor. The Compliance Supervisor vvlu eeview these for uniformity, accuracy,

N l MD IMPEP Questionnaire Page C.17 l i l and completeness within ten (10) working days of receipt. Routine inspections will l require each inspector to complete the report within twenty (20) working days l l after completion of the inspection. For team inspections, the lead inspector will be l required to complete the report within thirty (30) working days after completion of 4

7 the inspection.

I i in November,1995 NRC conducted a follow-up Inspection to the 1993 audit. NRC l recommendations and RHP's current status is indicated below.

i l 1

l a

l l

I

, l i

I I

i l

i i

)

i I ,

k 1

E i

4 l

_ . . _ _ . _ _ . _ . . . _ . _ . _ . _ . _ _ _ _ _ _ ___.____.______m__.

MD IMPEP Ouestionnaire Page C.18  ;

item 1. Status and Comnatibility of Regulations (Category l}

i NRC RECOMMENDATIONS:

{

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

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

(2) NRC recommends that the State revise the " Regulation i Adoption Management Plan" to address the points in the letter ,

specifically to begin rule development sooner and, if the SSRCR has not been developed in parallel with the NRC rule, the State should proceed without the SSRCR.

(3) NRC also recommends that the definition of person be amended to make it explicit that the inclusion of Federal entities in the Maryland definition is limited to that allowed by Federal law.

RHP STATUS:

1 (1) Maryland regulations specific to NRC's irradiator rule are on track for j adoption in November of 1996 '

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

(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 (1994)" is acceptable to NRC. The definition is: " Person" means an individual , receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.

• Person" includes any public or municipal corporation and any agency, burea,u, department, or instrumentality of state or local gdyprnment and, to the extent authorized by federal law, federal government.

Item 4. TachMal (bality of L*mensina 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.

i i

j MD IMPEP Questionnaire Page C.19 i

l RHP STATUS:

i j On March 18,1996 a management meeting was held between RHP, NPI and j Montgomery County. As a direct result of this meeting, on April 8,1996, RHP i 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 j enclosure should significantly reduce radiation lowels in and around the facility.

l 26. Provide a brief description of your program's strengths and weaknesses.

i These strengths and weaknesses should be supported by examples of l successes, problems or difficulties which occurred during this review i period.

j 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

environment. Furthermore, RHP has established an aggressive and effective l compliance program. Examples of the above can be seen in enforcement actions j specific to NPI, Mallinckrodt Pharmacy and Material Testing Laboratories. The l program is currently conducting ongoing evaluations in procedures used for j inspections, licensing and investigatory actions. RHP staff time is still being i significantly impacted by compliance and licensing overview associated with j Neutron Products Inc.

! B. NON-COMMON PERFORMANCE INDICATORS j Regulations and Leoal Authority i

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

control program (RCP).

j answer:

i Annotated Code of Maryland, Environmental Article, Title 8," Radiation" and Title j 7," Hazardous Materials and Hazardous Substances"(only those portions that deal

with low level weste issues).

l Comer 26.12.01.01 titled " Regulations for Control of lonizing Regulations" 1 Comer 28.1Filtled " Disposal of Controlled Hazardous Substances-Radioactive i Hazardous Sub's tanoes"

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

4

! answer: Regulations have no expiration date. Our procedure is to review the 4

regulations for compatibility and revise the appropdeep part of COMAR within the 3 i year deadline.

MD IMPEP Ouestionnaire Page C.20

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

answer: see chart

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 normal length of time anticipated to complete each step.

answer: Regulations for the licensing and radiation safety requirements of irradiators are in the final stages of promulgation 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.  ;

l l

ll. Saaled Source and Device Procram

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:

answer: l 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 l 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-101-0 Wallac LSC sources

i .

l MD IMPEP Questi:nnaira Pcge C.21

}

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

answer:

l f USNRC Reg Guide 10.10 i USNRC Reg Guide 10.11

) USNRC Reg Guide S.9

! Policy and Guidance Directive S4-22 ANSI Standards .

l Workbook from USNRC " Sealed Source and Device Workshop" September 12-5, i .1995. -

) 33. Please include information on the following questions in Section A, as l

they apply to the Sealed Source and Device Program:

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

answer

l Technical Staffing & Training:

I j 7. Two individuals (Nathaniel Owrutsky & Raymond Manley) within the

{

program have been assigned and trained in the review of SS&Ds.

1

! 8. N/A

9. N/A

10. Cheries R. Flynn Technical Quality of Licensing Actions:

11. Nuclotron amendments will most likely be issued prior to NRC audit (change in safety systems for HDR)

13. Nuclotron was eBowed to upgrade HDR safety systems prior to amendment of HDRs.

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

Responses to incidents and Allegations:

20. Nuclotron Corporation (see above)

21. Nuclotron Corporation (see above)

22. Nucietron Corporation (see above)

23. NONE

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

1 MD IMPEP Questionnaira P ge C.22 lli. Low-Level Wasta Proaram

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

Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.lli.11, A.lil.13-14 Technical Quality of Inspections - A.IV.16-19 Responses to incidents and Allegations - A.V.20-23 answer: RHP does not have a Low-level Waste Propam. Overview of such areas as decommissioning, NPI radioactive waste storage, licensing of decay in storage, and special projects such as the DLA Curtis Bay clean-up have been generally distributed among staff.

IV. Uranium Mill Proaram

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

Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.Ill.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 i

MD IMPEP Questionnaire P;ge C. 23 TABLE FOR QUESTION 29.

OR DATE DATE DUE ADOFTED CURREDIT . EXPECTED 10 CFR RULE

, STATUS ADOPTION Any amendment due prior to 1991.

Identify each regdeden trofer to the Chrenaiegy of Amendmentel IAEA Congestamety 10 CFR Part 71 9/SIE8 9/9/95 Addressed in Section T, of Regdedens for Centrol of lenking Radiation (19941 Glass Enemel and Oless Ffft 9/11/87 9/9/95 Addressed in Secdon C.3(cM210lil industrial Radleysphy Surveys 7/16/89 9/9/95 Addressed in Section E.201 Bankruptcy FNing Nedricetten 2/11/90 9/9/95 Addressed in Section C.31(el Nettficatione, Reports, and Record of 411/90 9/9/95 Addressed in Section D.1209

_ Itihadmkestretten iMell Logging 7/1450 9/9/95 Addressed in Sectlen W

_ Doolmstry Pr% 2/12/91 9/9/95 Addressed in Section D.5015cHN) l Decommleelening: 7/27191 9/9/95 Addressed in Secdon C.29 Ports 30,40,70

Emergency Planning

417/93 9/9/95 Addressed in Section C.23 Parte 30,40,70 Standerde for Protection Agelnet Radiation: 1I1/94 919195 Addressed in Section D & Section A.2 l

Part 20 Safety Requirements for Redegraphic 1/10/94 9/9/95 Addressed in Section E.308 l

Equipment: Part 34 l

Notifkast.a a beidents: 10/15/94 9/9195 Addressed in Section D.1202 PsFtsf!C. *% 31,34,39,40,70 Oshy #' 2easment Program and 1/27195 95/95 Addressed in Section G.76 htiseth thstretiene: Part 35 Licensing and Redstion Safety 7/1/96 propeeed Section X 11/96 l

Requirements for Irremotors: Part 36

i MD IMPEP.Questionnalra Pcge C. 24 OR DATE DATE DUE ADOPTED CURREFfT EXPECTED 10 CPR RULE STATUS ADOPTION l

Defteden of Land Diepeal 7/22/96 N/A and weste sne oA noyam: Pedet s 4

Decommissisados asumandphig' Doom. 10/2ses 9/9/95 Addressed In Seceen C.29tfM31 meneesen Adamens; Pete 30,40,70 t Self4Buereneet es en Asseensi Phoeneisi 1128/97 feet ooneistent w0th conclusions reeshed by RAerytmid's N/A R4eehenism; Parte 30,40,70 Legislative Austers t

Uranium RAE Tennge: Conforming to EPA 711/97 N/A j Stenderde: Port 40 I

TimeAmeos In Decommissioning Sf15/97 No action taken S/97 Parts 30,40,70 Preparoeien, Transfer for Commercial Die- 111/98 No action taken 1257  !

senesen, and use of S,mrm Ressories 9er R8edeaf Use: Parte 30,32,38 naquency of MeeBeel ExamineWene for Use 3I13/98 No action taken 1237 d Respiratory Protection Egulpment leur.Lavel Weste W Manifest 3/1/98 No action taken 12/97

_Informoden and Reporting i Performenee Requirements for Redeyephy 8/30/98 No action taken 1257 l Redleden Protocelen Requirements: 8/14/98 No action taken 1237 Amended Dennitions and Cetterie i Clertncselon of De e ud.. M "emding 11124/98 No action taken 1227 [

Requirements 10 CFR Put 71: PM th 411/99 No action taken 12/97 Intemational Atesele Energy Agency ,

i Reeseel Admhteereden of Redaden and 41/20/98 No action toisen 1257 ,

Redoeceve RAstedele. t i

4_

Termineelen er Transfer of IJoensed ' ,11 8199 No actlen toisen 1257  ;

Aca Meo: Res=esoph.e Reg *=nents. l

1 1

1 APPENDIX D i

I LICENSE FILE REVIEWS

]

i File No: 1 Licensee: Eastern laotopes, Inc. License No. 03-068-01

. Location: Hanover, MD Amendment No. 0 l License Type: Nuclear Pharmacy Type of Action: NEW

! Date Amendment lasued: 4/7/95 License Reviewers: CRF/NAO i

i Comments:

j a) Checklist not in docket file j b) Ownership verified, not the same name as operator l c) Applicant stated use of certified packages, submitted acceptable response, reviewer 4

asked for more information i d) Application stated use of independent audits by RSO, approved; because another J

company committed to outside audits, an inspector asked company and reviewer to amend licensee to do the same i File No. 2 l Licensee: G.T.T. Incorporated License No. 31-246-01 Location: Bethesda, MD )

Amendment No. O '

{ License Type: Portable Gauges Type of Action: NEW i Date Amendment issued: 4/26/95 License Reviewers: CRF/NAO File No. 3

Licensee

K.M.Lindgren, M.D. et al License No. 31-120-01 Location: Rockville, MD Amendment No.4

• l License Type: Nuclear Medicine Type of Action: Renewal Date Amendment issued: 11/27/95 License Reviewers: NAO/CET i

i File No. 4 l Licensee: PSI, Inc. License No. 03-036-01 Location: Linthicum, MD Amendment No.18 I License Type: Portable Gauges Type of Action: Amendment l Date Amendment issued: 3/7/96 License Reviewers: NAO/ REM i

! Comment: .

! ' a) Licensee requested extension of renewal preparatioa time for business reasons. l Extension granted, renewal submitted within time extemsion.

l

l 1 File No. 5 1' Licensee

Schnabel En0i neering Assoc. License No. 047-141-01 l

! Location: Baltimore, MD Amendment No. 20 I License Type: Portable Gauges Type of Action: Renewal j j Date Amendment issued: 6/26/96 License Reviewers: NAO/CET  !

i i

._.-J

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

i Maryland Draft Report Page D.2 I 4

License File Reviews ,

i l j File No. 6 i Licensee: Oncormed, Inc. License No. 31-237-01 )

Location: Geithersburg MD Amendment No. 2 )

License Type: R & D Laboratory Type of Action: Amendment Date Amendment lasued: 6/26/96 License Reviewers: NAO/CET Comment:

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) Waste 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 omments:

a) Registry sheet allows leak test at 1 year, license condition is 6 months. l b) COMAR D.401 allows change of leak test, State does not use option.

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 lasued: 9/12/96 License Reviewers: NAO/CRF File No.10 Licensee: Patriot Mining Co., Inc. License No. 23-007-01 Location: Star Chy, WV Amendment No. 2 License Type: Fixed Gauges Type of Action: Amendment Date Amendmerit issued: 6/14/95 License Reviewers: NAO/TDF Comment:

a) Mine in MD, home office in WV

Maryland Draft Report Page D.3 License File Reviews File No.11 Licensee: Chesapeaks Reg. Cancer Ctr. License No. 37-010-01 Location: Mechanicsville, MD Amendment No. O

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

, Location: Bettsville, MD Amendment No. 6 i License Type: R&D Lab Type of Action: Renewal

) Date Amendment lasued: 2/21/95 License Reviewers: NAO/CRF f

Comments:

a) Deficiency phone call only documented in licensee response b) Liquid scintillation analyzer doesn't show MDA for wipe results File No.13 l Licensee: American Red Cross License No. 07-177-01 Location: Baltimore, MD Amendment No. 7 I License Type: Blood irradiator Type of Action: Renewal l Date Amendment issued: 6/19/95 License Reviewers: NAO/CET 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 meteriel 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 l

c

l i

Maryland Draft Report Page D.4 License File Reviews 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 File No.17 '

Uconsee: BG&E (Celvert Cliffs) License No. 030 027-01 Location: Lusby MD Amendment No.16 License Type: Radio 9raphy Type of Action: Terminate Date Amendment lasued: 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 Date Amendment issued: 11/3/95 License Reviewers: NAO/TDF j l

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 lasued: 6/10/96 License Reviewers: NOA/CET Comments:

a) All materials transferred properly b) Inspected and documented adequately

l Maryland Draft Report Page D.5

, License File Reviews i

i File No. 21 Licensee: Washington Radiology Assoc. License No. 31-227-01 Location: Bethesda M D Amendment No.1 License Type: Nuclear Medicine Type of Action: Terminate Date Amendment issued: 5/17/96 iconse Reviewers: NAO/CET Comments:

a) Meterials decayed-in-storage, transferred to another licensee b) Licenese's clomeout 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 b) Closeout survey 1/6,21,28/93 summary documented adequately File No. 23 Licensee: Oboler, Kaufman et al License No. 31-121-01 Location: Silver Spring MD Amendment No.18 License Type: Nuclear Medicine Type of Action: Renewal Date Amendment issued: 10/20/96 License Reviewers: CRF/NAO 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 i License Type: Nuclear Medicine Type of Action: Amendment i Date Amendment issued: 6/29/95 License Reviewers: TDF/NAO Comment:

a) Amend deletes Xe-133 rooms since they don't use it. Complete l File No. 25 Licensee: Pnnoe 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: 4/25/93 License Reviewers: CRF/NAO

i i  !

! Maryland Draft Report Page D.6 License File Reviews i

File No. 26 .

Licensee: Nuclear Imaging Systems, Inc. License No. 33-130-01 f

Location: Riverdale MD Amendment No. 3

} License Type: Nuclear Medicine Type of Action: Renew q Date Amendment lesued: 7/12/94 License Reviewers: CRF/NAO File No. 27 Licensee: Chektec Corporation License No. 07-171-01 i Location: Baltimore Amendment No. 7 License Type: Type of Action: Terminate 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 l l Licensee: Potomac Engineering & Surveying License No. 23-004-01 l

! Location: Amendment No.1

License Type

Portable Gauge Type of Action: Terminate Date Amendment issued: 2/23/95 License Reviewers: NAO/CRF Comments:

J a) No record of action to verify transfer of gauges l b) No closeout survey i

File No. 29 i 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: Louisiene-Pacific Corp. License No. 27-049-01 Location: Savage MD Amendment No. 4

) License Type: tFixed Gauge Type of Action: Terminate l

Date Amendment lasued: 7/23/96 License Reviewers: NAO/CET Comments:

l a) Licensee states re'.urned to manufacturer l l' b) No record of ver8ication  !

l

l l

Maryland Draft Report Page D.7 License File Reviews  !

File No. 31 Licensee: Domes & Moore License No. 03-039-01  ;

Location: Annapolis MD Amendment No. 8 License Type: Portable Gauges l Type of Action: Terminate 1 Date Amendment lasued: 6/5/96 License Reviewers: NAO/CET Comments:

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

l b) License at recipient office amended prior to actual transfer. l i

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 Date Amendment issued: 3/4/96 License Reviewers: NAO/CET Comments: l a) No standard locking condition when not in use, and no locking instruction in l Operating & Emergency instructions

)

l File No. 33 i 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 Issut,d: 5/7/96 License Reviewers: NAO/CET l 1

Comments:

a) No materials received, no work done, no verification in record File No. 34 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 clomeout, 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 Date Amendment lasued: 6/25/96 License Reviewers: NAO/CET

l t

Maryland Draft Report Page D.8 License File Reviews 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 lasued

7/11/96 License Reviewers: DKM/CET File No. 37 i Licensee: Dames & Moore License No. 31-245-01

Location: Ant)epolis MD Amendment No. 4 i License Type: Portable Gauge Type of Action: Amend Date Amendment lasued: 9/13/96 License Reviewers: DKM/CET j File'No. 38 Licensee: Oncology Center at Riverside License No. 25-026-01 4 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 11/15/95, and 1/3/96.

Comments:

a) Content of original application was Omnitron information b) Amend 1 provides information on Nucletron installed device

c) Amend 2 authorizes move with letter File No. 39 Licensee

Mid-Atlantic Isotopes License No. 05-148-01

Location: Baltimore MD Amendment No. O l

License Type: Nuclear Pharmacy Type of Action: NEW i Date Amendment issued: 10/12/95 License Reviewers: NAO/TDF 1 4

Comments:

j a) Licensee submitted full re-application after deficiency letters License condition requires submission of proposed changes, does not require 4

b)

Op;,roval prior to implementation c) Person to do internal audits not specified, no frequency specified, see Standard Review Pian.

File No. 40

! Licensee: Univ. of MD (Environmental Safety) License No. 33-004-01 2 Location: College Park MD Amendment No.100 i' License Type: Brood Scope Type of Action: Amend Data Amendment issued: 8/29/96 License Reviewers: NAO/CET a

4 i

l )

4 1 4

i i

j APPENDIX E i

l i INSPECTION FILE REVIEWS i

l 4

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

d Comment:

i a) Report doesn't identify what was reviewed to correct previous item of non-l compliance i b) Radiation Safety Committee meeting minutes not reviewed i

i

! File 103.: 2 i Licensee: Terumo Medical Corporation License No. 15-007-02 j Location: Elkton, MD inspection Type: Routine, unannounced

License Type: Irradiator Priority: Annual j inspection Date: 06/25 26/96 Inspectors: RN/AJ

Comment:

$ a) Separate interviews not held with management to determine prograrn involvement.  ;

l l

l File No.: 3 ,

Licensee: NW Radiation Oncology Center License No. 05-034-02 l 1

Location: Randalistown, MD inspection Type: Routine, unannounced, follow-up l l License Type: HDR Priority: Annual

inspection Date

06/27/96 and 07/03/96 Inspector: FK )

l d i

Comment

i a) Field note descriptions not indicative of a performance-based inspection in that the 4

licensee demonstrations or walk-throughs not identified for radiation detectors, 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 violetion issued. ' ,;

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

last inspection. '

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

4 i File No.: 4 i Licensee: University of Maryland at Baltimore License No. 07-014-05 Location: Baltimore, MD inspection Type: Routine, unannounced, follow-up

]

License Type

Gamma Knife Priority: Annual

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

i l

Maryland Draft Report E.2 Inspection File Reviews inspection Date: 06/23/95 Inspector: RM i ,

! Comment: i j a) Unable to determine from report involvement of Radiation Safety Committee. l File No.: 5 l Licensee: MKM En0 ineers License No. 27-064-01 l Location: Columtma, 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) ltem of non-compliance for not maintaining usage logs identified during inspection but not included in enforcement letter.

File No.: 6 Licensee: Syncor international Corporation License No. 33-061-01 Location: Lanham, MD Inspection Type: Routine, unannounced License Type: Pharmacy Priority: A Inspection Date: 04/12-13/95 Inspector: RN Comment:

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

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

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

File No.: 7 )

Licensee: Ravinder Singh, M.D. License No. 33-064-01 i Location: Greenbelt, MD inspection Type: Routine, announced, follow-up License Type: Priority: 4 inspection Date: 04/11/96 Inspector: FK J

Comment:

a) Independent measurements inc. only one smear sample.

File No.: 8 Licensee: Nucletron Corporation License No. 27-035-01 Location: Columbia, MD inspection Type: Announced, follow-up

-- m .-- - e

1 Maryland Draft Report E.3 inspection File Reviews l

License Type: Service / Mfg Priority: A Inspection Date: 02/07/96 Inspector: RM l Comment:  ;

None l

}

File No.: 9 -

Licensee: Cohort 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 File No.: 10 Licensee: Bon Secours Hospital License No. 07-002-01 Location: Baltimore, MD inspection Type: Routine, unannounced License Type: Nuclear Medicine Priority: 3 i 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 License Type: Nuclear Medicine - HDR Priority: 1 Inspection Date: 02/06-07/96 Inspector: FK Comment:

None

i

)

Maryland Draft Report E.4 Inspection File Reviews l

} 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 i inspection Date: 01/23-24/96 Inspector: RM

Comment

{ a) Complete, thorou0h inspection i

E 2

l File No.: 13 l Licensee: Eastom isotopes, Inc. License No. 03-068-01 i Location: Hanover, MD inspection Type: Initial, unannounced follow-up

License Type: Pharmacy Priority: 1

! Inspection Date: -10/03/95 Inspector: RN I.

Comment

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

]

4

! File No.: 14 i 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 t

i Comment:

a) Report indicates previous non-compliance items " corrected" but does not indicate

! information or operations reviewed.

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

c) Lab results report only one wipe sample taken.

{

a

File No.: 15

! Licensee: ATEC Assoc License No. 27-005-01 l Location: Colgmbia, MD inspection Type: Routine, unannounced follow-up

. License Type: 1 Portable Gauges Priority: 4 Inspection Date:

• 06/19/95 Inspector: AJ Comment: .

None 1

File No.: 16

) Licensee: Guilford Pharmaceuticals,Inc. License No. 07-186-01

Maryland Draft Report E.5 inspection File Reviews Location: Baltimore, MD inspection Type: Initial, unannounced, follow-up 2

License Type: Research and Development Priority: 4 Inspection Date: 04/30/96 Inspector: AJ Comment:

a) License termeneted 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:

Inanection Accomnaniments 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 Good, complete performance-oriented inspection of licensee operations. Inspection consisted of licensee walkthroughs of scheduled (daily, weekly, monthly, ouarterly, 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 Location: Cheverly, MD inspection Type: Routine, unannounced License Type: Medical Priority: 3 inspection Date: 07/16-17/96 Inspectors: FK inspection preparation did not include interview of RSO or opportunity to observe 1-131 therapy procedure.

No follow-up or discussion with licensee about corrective actions taken in response to 1994 incident.

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

Interviews with nursing staff treating therapy patients not performed.

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

Field notes used as reference to identify inspection areas.

! Maryland Draft Report E.6 Inspection File Reviews

, Accompanimant No. 3 Licensee: Medi-Physics, Inc. License No. 31-222-01 Location: Cheverly, MD inspection Type: Romine, unannounced License Type: Nuclear Pharmacy Priority: 1 Inspection Date: 08/07/96 inspectors: AJ inspector demonstrated tNwough control over inspection activities.

Preparation and inspection plan complete.

Licensee requested to demonstrate acceptability of various procedures including equipment reliability and opgineenng 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 i Location: Cheverly, MD inspection Type: Routine, unannounced,  ;

License Typei: 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.

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 (si te foreman) not consulted or interviewed to determine knowledge of site operations.

j l APPENDIX F i

j MARYLAND INCIDENT FILES REVIEWED >

File No.1 l

. Licensee: Nuclotron Oldelft Corp. (Mallincrodt Medical)

Location: BWI Airport

! License #: MD27 035-01 i

Date of Event: 05/28/96 Type of Event: Transportation i Summary of incident: Package containing a 9.74 Ci Ir-192 sealed source, shipped from i Mallinckrodt Medical in Holland with Nucletron as shipper of record, was received at BWI l Airport in damaged condetion with survey readings of 45 mR/hr. MD RAM and HAZMAT

team responded and performed cleanup and recovery.

~

File No. 2 Licensee: Nucletron Oldefit Corp.

1 Location: Memorial Medical Center, Springfield, IL License #: MD27-035-01

, Date of Event: 02/01/96 l 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 emergency hand crank which retracted source. Generic problem j identified and State requested Nucletron to modify design with hardware change to hardwire unit to console and revise software program. Nuclotron is currently making the i changes to all service customers.

File No. 3

Licensee: ATEC Associates, Inc.

j Location: Baltimore-Washington International airport light rail jobsite l License #: MD31-189-01 i Date of Event: 07/18/96

! Type of Event: Lost / Stolen RAM j Summary of incident: Troxler gauge stolen from BWIlight rail jobsight. Persons broke

! into house next door to }obsight 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 Evers- 07/19/96

Type of Event

Release of RAM q Summary of incident: Trash truck and driver set off radiation alarm at entrance to solid 2

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

i 4

a

l Maryland Draft 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 l Type of Event: Modecal Event Summary of incident: A brachytherapy interstitial implant catheter containing 30 mci of ten Ir-92 seeds,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 Licensee: Rad America l Location: Baltimore, MD License #: MD05-051-01 Date of Event: 08/96 4 Type of Event: Equipment or Procedure Failure Summary of Event: A teletherapy machine malfunctioned by sticking "on," at end of l treatment for patient scheduled to receive fractionated treatments 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), i File No. 7 Licensee: Laurel-Beltsville Hospital Location: Montgomery Co. Solid Waste Transfer, Rockville, MD i

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

File No. 8 Licensee: Secred Heart Hospital Location: Cumberland, MD License #: M001-002-02 Date of Event: 04/13/94

, Type of Event: Lost /abendoned 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.

i

Maryland Draft Report Page F.3 Incident File Reviews File No. 9 Licensee: MD State Highway Administration License #: MDO5-049-01 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 raisese 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.

I

+

Maryland Draft Report Page G.1  ;

SS&D Evaluation ReviewA APPENDIX G i

SEALED SOURCE AND DEVICE EVALUATION hEVIEWS t

File No.: 1 <1  !

Registry No.: MD 0263-D-101-G SS&D Type: lon Mobility

! Manufacturer: Environmental Technologies Spectrometry Cell Group, Inc. Date issued: 12/16/94 j

( Comments:

e) 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 I

comparison to previous sheet, a different company was identified as the distributor.

l Manufacturer is now listed as distributor, c) Last sheet of registration not reissued to indicate a change in references. l d) No supervisor or reviewer signature supporting the amendment. '

e) Single reviewer.

File No.: 2 Registry No.: MD-0105-D-101-G SS&D Type: Fluorotracer analyzer Manufacturer: Conco Services Corporation Date issued: 6/6/95 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 e 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.

1 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 t

Comments: ,

a) Diagram attached to the registry sheet is marked confidential. I b) This is a similar device manufactured by a different company, where the president l 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.

l l

1

d 1

1 i

j Maryland Draft Report Page G.2 i SS&D Evaluation Reviews  ;

i j c) Ahhough only the manufacture can perform source changes per inforniation in the

~

backup documentation, information regarding limitations of use on the registry aheet should be revised to indicate the radiation source will be installed or removed 4 by the manufacturer.

i .

File No.: 4  !

j Registry No.: MD-0113-D-107-G SS&D Type: Thickness / density gauge l

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

l Comments:

a) Smgle reviewer performed review. l

b) No documentation in the file on protype testing or QA manual. Note, this device '

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 l little information on the OA/QC program.

File No.

5 i Registry No.: MD-0113-D-108-G SS&D Typs: Gamma gauge

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

i a) Single reviewer performed review.

b) No documentation in the file on protype testing or QA manual. Note, this device .

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 i little information on the OA/OC program.

! File No.: 6 Registry No.: MD-0113-D-110-G SS&D Type: Beta gauge

Manufacturer

Adaptive Technologies Date issued: 7/1/96 i

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.

i File No.: 7 -

Registry No.: MD-497-D-104-S SS&D Type: Remote Afterloading i ,

brachethorapy unit Manufacturer: Nuclotron 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.

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