ML20137W077

Final Rept, Integrated Matls Performance Evaluation Program,Review of Maryland Agreement State Program, Dtd 960923-27

ML20137W077
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Issue date:	09/27/1996
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM l

} REVIEW OF MARYLAND AGREEMENT STATE PROGRAM l 1

SEPTEMBER 23-27,1996 I I

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FINAL REPORT l

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l U.S. Nuclear Regulatory Commission i l

03/18/97 l

9704180030 970321 -

1 PDR STPRG ESGMD i PDR j i

1.0 INTRODUCTION

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

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

Statement of Principles and Policy for the Agreement State Program and the Policy j Statement on Adequacy and Compatibility of Agreement State Programs," published in the l Federal Reaister on October 25,1995, and the September 12,1995, NRC Management i Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary )

results of the review, which covered the period April 4,1994 to September 20,1996,  !

were discussed with Maryland management on September 27,1996. 1 A draft of this report was issued to Maryland for factual comment on December 16,1996. l The State of Maryland responded in a letter dated February 3,1997 (attached). The l State's comments were incorporated into the final report. The Management Review Board "

(MRB) met on March 6,1997, to consider the proposed final report. Due to the unsatisfactory performance of a HP-inspector during two on-site field inspections at a i radiography site and an HDR facility, the team recommended Satisfactory with  !

Recommendations for Improvement for Section 3.4 Technical Quality of Inspections. The  !

MRB considered the overall satisfactory performance of the other three inspectors and the  ;

fact that the one inspector with unsatisfactory performance is no longer with the program, j and revised the team's recommendation to a Satisfactory for this indicator. The MRB '

considered and concurred in the team's overall recommendation and found the Maryland radiation control program was adequate to protect public health and safety but needs i improvement, and not compatible with NRC's program. j Several compatibility issues were identified by NRC just prior to the MRB meeting. In a letter dated February 28,1997, to the State of Maryland, NRC identified compatibility i issues in the States final equivalent rules, that became effective October 9,1995, for Parts I 20.1703, 20.1801, 20.2202, 30.50, 39.49, and 39.51, that had not been previously l identified by NRC during previous reviews of the regulations in question. The State indicated at the MRB meeting that they would revise the Maryland regulations within a ,

reasonable period of time. The MRB stated that NRC will reevaluate the compatibility  !

determination upon Maryland's final promulgation of the revisions to specific regulations that were identified by NRC as not compatible, in the February 28,1997, letter to the State.

The Maryland Department of the Environment (MDE) is the agency within the State of Maryland that regulates, among other public health issues, radiation hazards. The Secretary, MDE, is appointed by and reports directly to, the Governor. Within MDE, the Maryland radiation control program is located in the Radiological Health Program Office, which is located in the Air and Radiation Management Administration. The Maryland Department of the Environment and the Air and Radiation Management Administration organization charts are included as Appendix B. During the review period the Maryland program regulated 561 specific licenses, which include commercialirradiators, manufacturers, broad academic, broad medical, radiopharmacy and radiographers. In I

Maryland Final Report Page 2 addition to its radioactive materials program, MDE is responsible for the control of machine produced radiation, and emergency response for 2 nuclear power plants. The review focused on the materials program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Maryland, 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 1 Appendix C to this report.

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

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

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

A special joint U.S. Nuclear Regulatory Commission (NRC) and State of Maryland review of 33 misadministrations that occurred in 1987-1988 at the Sacred Heart Hospital (SHH) located in Cumberland, Maryland, (MD-01-002-02) was conducted in late 1993 and early 1994, in response to issues raised during an August 1993 Congressional hearing that i

questioned: (1) the adequacy of the State's 1988-1989 review; (2) why NRC had not previously reviewed the event; (3) inconsistencies in the records; and (4) the State's l agreement to limit access to the records.

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Maryland Final Report Page 3 l

2.1 Status of items identified Durino the 1993-1994 Routine Review A number of recommendations were identified as part of the 19931994 review. The 19931994 review resulted in the withholding of a finding of compatibility due to 13 regulations not having been adopted within the 3 year period required by NRC. The team noted that the definition of " person" in Maryland's low-level radioactive waste (LLRW) regulations included jurisdiction over Federal facilities which is not consistent with 10 CFR 150.10. Section 274 contains no explicit waiver of the sovereign immunity of the United States; therefore, the agreement does not convey any authority for the State to regulate Federal agencies. Agencies of the Federal government are p_ql exempted and continue to be subject to NRC regulation, not State regulation. The 1993-94 report stated that the definition of person in an Agreement State's regulations should not include agencies of the .

Federal government. Therefore, the State was requested to either remove or provide clarification to explain that, in COMAR 26.14.01.02B(28)(e), which includes Federal

, agencies in the definition of " person," with regard to Agreement materials, Federal l agencies are not i V ^ to these regulations, in addition, it was recommended that the I

State continue its uorts to renew the Neutron Products, Inc. (NPI) license to establish a clear set of license requirements against which the state can assess continued operations at NPI and against which enforcement action can be taken, if required. Specific milestones and schedules for completion of actions were requested. The State was notified of NRC's intention to conduct a follow-up review. Some of the recommendations were closed at the time of the 1995 follow-up review. The review team looked at each remaining item to I

determine whether or not the Maryland program had taken additional actions to close open' recommendations.

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

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

As of the 19931994 review this item was pending the result of discussions between the State and NRC legal staff. See the next section 2.2(1) for a continued l

discussion.

(3) Status of the effort to renew the NPIlicense.

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, NPl . 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 t

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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) NPI 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 i l the State noted difficulties in resolving issues with NPI management. See following l section 2.2(3).

2.2 Status of items identified Durino the 1995 Follow-uo Review The 1995 follow-up review, conducted November 7-8,1995, identified that the definition of " person" in Maryland's low-level radioactive waste regulations included jurisdiction over Federal facilities. The State had been requested during the 1993-1994 review to either remove or clarify that with regard to Agreement materials, Federal agencies are not subject to these regulations. The follow-up review team also noted that NRC staff would complete a final compatibility determination of the " Maryland Regulations for Control of lonizing l

Radiation (1994)" in late April 1996; and identified an additional regulation, " Licenses and  ;

Radiation Safety Requirements for irradiators," 10 CFR Part 36 (58 FR 7715), 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 l

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 l radioactive waste regulations that included jurisdiction over Federal facilities is as i follows:

l l In an August 25,1995, letter to Ms. Merrylin 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 l action to revise the definition of " person" in Section 2.A of COMAR 26.12.01.01, j titled " Regulations for Control of lonizing Radiation." The definition now includes

! and "to the extent authorized by federal law, federal government," which is l acceptable to NRC, as of May 1996.

The review 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 radioactive waste regulations COMAR 26.14.01.02B(28)(e) that was identified in both the 1993-94 review and the 1995 follow-up review. The State should provide clarification of the use of the term " person" in the low-level radioactive waste

, regulations, as it relates to Federal agencies, from the legal staff.

Maryland Final Report Page 5

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

This item remains open.

(2) Current status of any remaining issues regarding regulations is as follows:

NRC staff has reviewed the 13 amendments to the final COMAR regulations adopted by the State of Maryland, that becarne 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 existing sections of Maryland regulations that were not modified by the 13 amendatory actions. Stafr c.ompleted documentation of these concerns and transmitted the concerns to ine Stete separately by letter, dated, February 28,1997 (attached). The.% concerns are further addressed in Section 4.1 below. 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 team noted that the State of Maryland regulates irradiator facilities which would be subject to the regulations in " Licenses and Radiation Safety Requirements for l Irradiators," 10 CFR Part 36. At the time of the review, equivalent rules were in the final stages of promulgation and were scheduled to be adopted in November 1996. ,

Subsequent to the review, the State informed the team that Part X of the Maryland l Code covering, " Licenses and Radiation Safety Requirements for irradiators," was adopted on November 19,1996, with an effective date of December 16,1996.

NRC will notify the State of the results of a final review, in a separate letter.

The State revised the " Regulation Adoption Management Plan," but no action has occurred on the ten rules or amendments due for adoption by the end of 1997. The State needs to act on the plan and provide a realistic schedule of milestones for completion of the rules identified in the plan.

This item remains open.

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

A specific concern, during the 1995 follow-up review, resulted :n 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 l levels in and around the facility.

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i Maryland Final Report l Page 6 The 1995 follow-up review also commented on the prescriptiveness of the draft l

license (MD 31-025-01) and the coacern 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 shielding of on-site radioactive waste held in storage (a significant contributor to exposures for both on-site personnel and '

members of the public), and a courtyard cover to minimize releases of contaminated materials to the environment.

! in part, due to the continued recommendation frcm NRC to renew the NPIlicense, the State unilaterally reissued license MD-31-025-01 on January 18,1996. This license was prepared from the previous license which has been in timely renewal since 1980, the subsequent amendments and documents and information collected over the years. The draft was reviewed by a committee consisting of inspectors, license reviewers, and program management and revised to reflect the participants' cumulative history of the site. The licensee appealed the issuance of the license to the Office of Administrative Hearings. According to Maryland Administrative law, the license cannot be enforced until the case is resolved at hearing. The State agreed to place the appeal on the inactive list as long as progress was being made in resolving the issues. A management conference was held in March 1996, and a few points of contention were resolved. The State believes the prescriptive nature of the license is warranted given the licensee's past history and the continuing difficulty in resolving issues with licensee management. The licensee is resistant to any regulatory actions that take away the ability to operate freely. There has been a further exchange of correspondence on the license conditions, however, essentially no further progress has been made. The State notified the licensee on August 30,1996 that the State would not agree to further delay and an administrative hearing would be scheduled as soon as possible.

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

The 1993-1994 review observed that the State had not been effective in handling the NPI waste storage problem, high fenceline doses, and on and off-site contamination. Since the previous review and follow up, the State ha:, inspected the f acility 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 licensee is quite extensive and time consuming and that t

when these other contacts are taken into consideration the State does interact with l NPI on at least a quarterly basis.

The State has performed an independent assessment of the internal exposure potential (much less than the amount requiring monitoring and summation of doses) and the dose to the nearest residents (probably near 100 mrem per year), in April l

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Maryland Final Report Page 7 1996, the State approved the conceptual design for a courtyard enclosure to reduce l worker and public exposures and on and off site contamination. in August 1996, ,

l the State demanded the licensee submit the detailed plans for the courtyard enclosure as required by court order. The licensse, 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.

L The licensee has agreed to use concrete slab 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.

i 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 j l SEG for incineration.

The team believes slow but steady progress has been made in dealing with NPI despite the unwillingness of NPI management. Although the very prescriptive renewallicense 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 l NPI yet has indicated to the review team a willingness to work with NPI to resolve l

issues and produce a less prescriptive and more performance oriented licensing i document. A well thought out and documented strategic plan is in place to )

implement a performance-based inspection plan at NPI which emphasizes the 1 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 inspection frequency, reviews of health physics consultant reports, team inspections, and outlines more than 30 specific areas for review.

l- This recommendation is 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 Heart Hospital (SHH) located in Cumberland, Maryland, (MD-01-002-02) was conducted in late 1993 and early 1994,in response to issues raised during an August 1993 Congressional hearing that questioned: (1) the' adequacy of the State's 1988-1989 review; (2) why NRC had not previously reviewed the event; (3) inconsistencies in

j. the records; and (4) the State's agreement to limit access to the records.

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

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' cause of the misadministrations was the.use of an incorrect computer file. There were a number of factors contributing to the misadministrations including, for j

example, inadequate communications and failure to verify procedures and calculations. The review concluded that the root cause was lack of management oversight of the SHH radiation safety program. The special review team found that SHH did not provide all the notifications to referring physicians and patients as I j required by Maryland law. The special review team recommended that thi State of 1

Maryland take some actions, and the State's Department of the Environment ,

reviewed the report and agreed to implement those actions the review team j

recommended the State take. The recommendations included actions the State j should take to ensure that SHH complies with the referring physician / patient

notification requirements of Maryland law. The IMPEP review team was tasked to I

E follow up on the State's action, in discussions with the Director, RHP, the team '

j found that the State discussed the recommendations of the joint NRC/MD review, j

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 i SHH staff during the joint NRC Maryland team review). In a telephone discussion in June 1996, the legal counsel for SHH express'ed concern that some of the joint

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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.

e l The IMPEP team recommended that the State take action to ensure that SHH

] complies with the referring physician / patient notification requirements of Maryland j law as identified in a report dated March 5,1996, that was transmitted to the State i

April 15,1996. Subsequent to the review, the State informed the team that a letter

had been sent to SHH on November 25,1996, that included the NRC j recommendations resulting from the 1987 88 misadministrations. SHH responded j and will follow through with physicians information regarding notification to q misadministered patients, families or next-of kin.

- This recommendation is closed.

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• The review team recommends that the State of Maryland inform NRC when the

referring physician / patient notification requirement has been completed by SHH. ,

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3.0 COMMON PERFORMANCE INDICATORS  !

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

inspection Program, (2) Technical Staffing and Training, (3) Technical Quality of Licensing l Actions, (4) Technical Quality of Inspections, and (5) Response to incidents and Allegatioris.

3.1 Status of Materials inspection Proaram l

The team focused on four factors in reviewing this indicator: inspection frequency, overdue inspections, initialinspection of new licenses, and timely dispatch of inspection findings to licensees. This evaluation is based on the Maryland questionnaire responses  !

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

inspection data tracking system, the examination of licensing and inspection casework  !

files, and interviews with managers and staff. I Review of the State's inspection priorities showed that, with the exception of medical l 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 than, similar license types or groups listed in the frequency schedule in the NRC Inspection Manual Chapter 2800 l (IMC 2800). Inspection frequencies under the State's system range from quarterly to l' l 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 frequency compared with an NRC 2-year frequency; teletherapy and gamma knife licenses have a 1-year frequency compared with the NRC 3-year frequency;

research and development licenses, portable lead paint analyzers and portable gauges l 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. However, the state was not distinguishing j

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

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

I in their response to the questionnaire, Maryland indicated that as of September 20,1996, no licenses identified for core inspections in IMC 2800 were overdue by more than 25 percent of the NRC frequency. With respect to initial inspections of new licenses, the team reviewed the inspection data tracking system and noted that the initialinspections l

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j. are entered into the tracking system with a 6 month date for scheduling. In reviewing

' twelve initialinspections from among the 81 new licenses issued during the review period, j none of the initialinspections were. conducted within the first six months following

issuance of the license. - However, more than half (7 of 12) were completed from 6 to 8 j months following issuance and essentially all (11 of 12) were inspected from 6 to 12 2

months following issuance (that is, within 6 months of scheduling the inspection). One new license'was inspected approximately 32 months following issuance due to an 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 j a pre-licensing inspection which helps assure that licensees are equipped and j knowledgeable before receiving radioactive materials thus helping licensees to achieve early success in complying with the requirements of.the license. The high percentage of 4

initial inspections in which no items of non-compliance are found appears to validate this

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j in reviewing the inspector's work logs for the period since the last review, the team found

! that the vast majority of inspections resulted in communication of the findings to the i l licensee within thirty days following the inspection, in those rare instances when the compliance letter was not issued within 30 days, program management indicated this j occurred because more information was known to be forthcoming from the licensee or greater care, and thus more time, was needed to document circumstances relative to a ,

I potential enforcement action.

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The State reported that 136 license requests for reciprocity were processed during the j period of review. Approximately 50% of the reciprocity requests included industrial l radiography, others included well-logging, mobile nuclear medicine, and other service 4

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

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 4 Operating Under 10 CFR Part 150.20."

! Based on the IMPEP evaluation criteria and the acceptability of the State's equally 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 4- found Satisfactory.

j 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 strat,egy which includes training, j . technical qualifications of the staff, any staff turnover, and prompt management attention i to any problem areas. To evaluate these issues, the review team examined the State's i

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Maryland Final Report Page 11 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 (RHP) has responsibility for the control of radiation in Maryland. Total staff positions in the RHP, which includes the Radiation Machines Division and the Radioactive Materials Licensing, Compliance and Safeguards Division, hereafter referred to as RAM program, are 27, with a current fill of 25. The number of positions directly applied to Agreement State activities, is nine. The program has undergone a reorganization since the last program review conducted in 1993 and 1994. As a result of the reorganization, the Radon program was eliminated and, in December 1995, the program lost two supervisory positions and combined the responsibilities of the three supervisor positions into one. The RAM program went from a total staffing level of 11, which included one program manager, three supervisor health physicists (licensing, licensing and low-level radioactive waste, and inspection and enforcement), six health

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physicists, and one x-ray and regulations specialist; to a total staffing level of nine, which includes one program manager, one supervisor health physicist, and seven health physicists as shown on the RHP organization chart found in Appendix B. The RAM l program is divided into two sections, the inspection and Enforcement Section comprised of {

four health physicists responsible for allinspection and enforcement activities, and the Licensing and Environmental Radiation Section comprised of three health physicists, two are responsible for alllicensing and environmental activities, as well as, sealed source and l

device evaluations. A third health physicist, recently transferred from Radon, is currently j performing less complex inspections, i.e. gauge manufacturers, and is in training for

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licensing and environmental activities. The team noted that the RAM program supervisor i and two of the more senior personnel appear to handle most of the inspections.

Additionally,_the RAM supevisor is often called upon to Act for the RHP manager, who is involved in several Agreer:en.' State technical organizations and task groups in support of Agreement Otate activities, in discussions with the RAM program supervisor the team found that one of the health physicists was recently transferred to the RAM program from the former Radon program and is currently in training, another health physicist 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.

According to information provided in the State's response to the questionnaire, the training program requires all newly hired inspectors to attend the NRC core training courses, in licensing, inspection procedures, industrial radiography, nuclear medicine, and the 5-week health physics course. At the time of the review, one HP-inspector with 5 years experience, had not taken the licensing course, and one newly transferred staff member had not taken the industrial radiography course. The team noted that one inspector i primarily performing medicallicense inspections could benefit from attending the j teletherapy / brachytherapy course, which is a new 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. Maryland currently has no formal training plan.

Future plans depend on the final resolution of NRC action regarding funding for travel to NRC training courses.

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Maryland Final Report Page 12 e

The team suggests that the_ State consider development of a formal professional ,

training plan through the use of university and industry educational programs for i training new staff and retraining or refresh for long-term staff.

In discussions with the RAM supervisor, the team found that new staff are assigned j  ;

increasingly complex duties under the direction of senior staff and accompany experienced l inspectors during increasingly complicated inspections. When time allows, the RAM l 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 3.4.

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

non-radiation workers in the immediate area where field radiography was being performed, l l

which posed a health and safety hazard. Additionally, the primary focus during both  !

inspections was paperwork rather than a performance based inspection. Interviews were l not conducted with management. This issue is discussed in greater depth in Section 3.4, l

Technical Quality of Inspections. Through discussions with the RAM program supervisor  !

the 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. The team found that the  !

inspector's weak performance after five years of experience demonstrated a deficiency in l 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 progress in completing all of the training and qualification requirements, and provides some evidence of .

I management inattention or inaction to deal with staffing problems. One to two years j

would be an acceptable time frame in which to train and qualify an inspector. i

.1 o 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.

e The team suggests that Maryland 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-l inspector l

whose accompaniment was unsatisfactory.

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

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

the health and safety related work of the program. The team questioned the staffing balance regarding the expansion of the duties of the RAM supervisor that already included t

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Maryland Final Report Page 13-supervisory responsibilities for inspection and enforcement activities, participating in complex inspections, along with Acting in the absence of the RHP manager, to now also  :

include supervising an additional licensing and environmental radiation section.

Additionally, subsequent to the review, the team found that an HP staff member has resigned. This leaves the radiation control program with a total staffing level of (8) FTE.

The team is concerned that the loss of 2 FTE due to the reorganization, and the recent loss of an additional staff member jeopardizes the program's ability to maintain an adequate ar.d compatible program to protect health and safety. The team noted that the adequacy of i one FTE managing such an unusually large area of responsibility with a technical staff of 1 six (total 7 FTE) should be closely monitored by Maryland due to the number and complexity of licensees in the Maryland program. The team discussed increased use of j automated systems to provide increased control through tracking actions, wider access  ;

and more efficient retrieval of information. The State has several complex licensees, l including NPI, which consumes an inordinate amount of staff time, in the preparation of

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legal documents, and technical analysis of corrective action plans; additionally there has been no action, as of the period of our review, taken on ten rules or amendments that

, should be adopted by December 1997, in order for the RAM program to remain compatible j .

with the NRC regulatory program. The team questioned the adequacy of program staff to L ensure the long-term ability of the program to maintain and complete pending rules and

amendments for adoption to remain compatible.

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• Based on fne teams findings, the team recommends that the State assess the i adequacy of the program staff to ensure the long-term ability of the program to

complete the pending rules and amendments for adoption to remain compatible.

l l Based on the team's finding and the IMPEP evaluation criteria, the review team l recommends that Maryland's performance with respect to this indicator, Technical Staffing and Training, be found Satisfactory with Recommendations for improvement.

3.3 Technical Quality of Licensina Actions

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

I actions. Casework was reviewed for timeliness, adherence to good health physics  !

. practices, reference to appropriate regulations, documentation of safety evalustion reports, j

[ product certifications or other supporting documents, consideration of enforcement history l on renewals, pre-licensing visits, peer or supervisory review as indicated, and proper signature authorities. Licenses were reviewed for accuracy, appropriateness of the license and of its conditions and tie-down conditions, and overall technical quality. The files were l l checked for retention of necessary documents and supporting data, i

[ The cases were selected to provide a representative sample of licensing actions which had i i been 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 totalincluded the

[ following types: nuclear pharmacy, high dose rate afterloader, academic broad scope, l

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t Maryland Final Report Page 14 l l 1

portable gauges, hospital nuclear medicine, private practice and cardiology limited, l

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

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

eight new licenses, nine renewals, ten amendments, and fourteen terminations. A list of l

these licenses with significant case specific comments can be found in Appendix D.

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The review team found that the licensing actions were generally thorough, complete, j consistent, and of acceptable quality with health and safety issues properly addressed. l Speciallicense tie-down conditions were almost always stated clearly, backed by l information contained in the file, 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 currently being revised and updated, and reviewers were observed to have good research skills in using these and other licensing documents. With l i

few exceptions, reviewers appropriately used the new licensing guides and accompanying l check sheets, although the check sheets are not routinely signed and dated. Licensing l

action authorship is indicated by initials and date. At least one, but occasionally 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 now routinely noted in l

the file. This visit enables the license reviewer to ascertain the status of licensed facilities l and use, as applied for by the applicant. It also allows an explanation of the licensing and l inspection process prior to the start of licensed activities. l The current status of the license renewal action for Neutron Products, Inc. (NPI), which is on hold pending the outcome of a State Administrative Hearing, is covered in Section 2.0, Status of items identified in Previous Reviews. NRC will continue to monitor the status of NPl's timely license renewal action in future reviews of the radiation control program.

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 closecut evaluation. The verification survey could benefit from consideration of Draft NUREG/CR 5846 " Manual for Conducting Radiological Surveys in Support of License Termination" with respect to required information and the use of appropriate information gathering. The team noted that the Radiological Health Program could benefit from a guidance document on termination of licenses. One tumination, 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.

• The tea.m suggested that the Radiological Health Program could benefit from a l 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. This has the benefit that

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l Marylend Final Report Page 15 l

all the currently agreed to items have been included in 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 (waste storage) separated from the

! renewal, enabling issuance of an up-to-date license sooner than would have been otherwise possible.

l The review team found that a new reviewer was gaining experience through less l complicated licensing reviews and will be brought into reviewing the more complicated license actions in the near future. Both license reviewers have an inspection background.

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

l 3.4 Technical Quality of Insoections l The team focused on the following factors in evaluating this indicator: results of accompanying inspectors on field site inspections, inspection field notes, inspection reports, inspection findings, enforcement documentation and current procedures. The team also interviewed inspectors for 16 materials inspections conducted during the review period. The casework included all five of the State's materialinspectors and covered higher priority inspections of various types including hospitals, nuclear medicine f acilities, academic institutions, research and development facilities, industrial use, an instrument calibration service, and a nuclear pharmacy. Attachment E lists the inspection cases reviewed in depth with case-specific comments. Prior to the review, a team member performed accompaniments of three state inspectors on four separate inspections of high priority facilities. The first inspector was accompanied at a pool-type irradiator, the second inspector was accompanied twice, first at a hospital followed by field site radiography, and the third inspector was accompanied at a nuclear pharmacy.

Inspection procedures and techniques utilized by the State were reviewed and determined to be consistent with the inspection guidance identified in NRC Inspection Manual Chapter 2800. The procedures were used to help inspectors identify root causes and poor licensee performance. The State's policy is to conduct inspections on an unannounced basis. NRC Inspection Procedure 87100 field notes were electronically reproduced in State format and used for routine materials inspections in the categories of medical, academic, teletherapy, commercialirradiators, gauges, industrial radiography, and research and development.

The review team found the level of detail provided in inspection reports was consistent with respect to the scope of the licensed program, licensee 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 Supervisor provided review, comment, and initialed allinspection documents and field notes.

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Maryland Final Report Page 16 Fuports were also reviewed for inspector documentation of operations observed, management and worker interviews, independent measurements, follow up to previous items of non-compliance, and discussion of inspection findings at exit interviews. Overall, the review team found inspection reports showed good quality. Four reports contained sections which identified closure of previous items of noncompliance but did not indicate how items were followed up and corrected. The review team discussed documenting in reports what insp3ction areas and information were reviewed to close out previous items of noncompliance. Other reports contained only minor discrepancies from standard practice which were related to insufficient detail.

Field notes, inspection forms, and enforcement correspondence were found to be complete. Documented inspection findings generally led to appropriate enforcement and l

prompt regulatory actions. Routine enforcement etters were drafted oy the inspector, l signed off by the RAM Supervisor, and issued to the licensee by the RHP Manager. With I the exception of NPI (currently under court order), the team determined the State's enforcement policies to be effective in achieving licensee compliance. Enforcement '

correspondence was timely for files reviewed by the team. Licensee responses to items of noncompliance were also timely and assigned by the RAM Supervisor to inspectors for review. In cases where inspection results indicated a need for escalated enforcement action, enforcement conferences were held with licensees to discuss inspection findings l and possible enforcement action against them. 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 was informal, inspectors discussed inspection findings with the RAM Supervisor, who served as the intermediary between license and compliance staffs for information sharing.

The State's practice calls for annual supervisory accompaniments of allinspectors. In response to the questionnaire, the State reported that the RAM Supervisor performed supervisory accompaniments of four of five inspectors in 1994, and two of five inspectors in 1995. In discussions at the MRB the State informed the team that allinspectors had been accompanied in 1994. The review team considered the unusually high work demands placed upon the RAM Supervisor position during this review period because of the licensing and compliance efforts related to NPI, two reassignments of individuals into the position within a three month period in 1995, and the need to maintain inspection schedules at the appropriate level to prevent development of a program backlog. However, supervisory accompaniments provide management with important insight into the quality of the inspection program.

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

Four inspector accompaniments of three of the program's five inspectors were performed l by a review team member as follows: the first inspector was reviewed on June 25-26, 1996, at a pool irradiator facility; the second inspector was reviewed on July 16-17,1996 t

at a hospital and again on September 19,1996, at a field radiography site. A third

Maryland Final Report Page 17 inspector was reviewed on August 7,1996, at a nuclear pharmacy. These accompaniments are also identified in Appendix E. The second inspector (who had been performing inspections of high priority licensees) was accompanied twice because a State supervisory accompaniment was not performed during the review period (according to the State's response to the Questionnaire), an NRC accompaniment was not performed in previous assessments, and, following the initial 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 assessments, and the other was a new trainee.

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

However, accompaniments did not show a comparable level of performance by another State qualified inspector either to conduct a performance-based inspection or in inspection thoroughness to address potentially important radiological safety concerns. The team observed inspector performance issues related to the areas of facility walk-throughs, conduct of licensee operations and licensee demonstrations, worker and management interviews, and independent measurements. Areas not fully covered during inspections included failure to take independent wipe samples at all hospital material storage and waste locations, not conducting interviews with the hospital radiation safety officer and nursing staff until prompted by the team member, incomplete follow up of licensee corrective actions resulting from a 1994 hospital contamination incident, inadequate walk through l 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 1 recognizing the potential for radiation exposure to non-radiation workers in the immediate area where field radiography was performed, and inadequate check of radiation workers for proper dosimetry.

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As noted in Section 3.2 of this report, interviews of compliance staff indicated that field qualification for a new inspector consisted primarily of demonstrations for supervisory staff until supervisors were able to make a subjective determination that the inspector was able to perform independently. Criteria were not clearly established which allowed State management to determine when inspectors were qualified for different types of program inspections. ,

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

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

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

Calibrated portable equipment was located in kits contained in emergency vehicles assigned to the RHP. Inspectors use these vehicles for routine inspections with the portable instruments used by inspectors for confirmatory measurements. The inventory list

f Maryland Final Report '

Page 18 showed staggered annual due dates for calibrations of instruments so that meters were always available when needed for inspections. The State laboratory was reviewed and t

found to include liquid scintilktion spectrometers, gas flow proportional counters, and gamma spectrometers (multichannel analyzer) for full capability to analyze wipe, water, and soil samples for the RHP.

Based on the findings and the IMPEP evaluation criteria, the review team recommended that Maryland's performance with respect to the indicator, Technical Quality of Inspections, be found Satisfactory, with Recommendations for improvement. After review and consideration of the unsatisfactory performance of one HP-inspector during two accompaniments, who is no longer with the program, and the overall satisfactory performance of the other three inspectors during accompaniments, the MRB revised the team's recommendation. The MRB final recommendation for Section 3.4, Technical Quality of Inspections is Satisfactory.

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

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

It was found that within the RHP, responsibility for initial response and follow-up actions to materials incidents and allegations rests solely with the Inspection and Enforcement Section (lES) of RAM. Written procedures require a prompt response to incidents by the staff and provide additional procedural guidance. The RAM supervisor reviews each incoming event notification or allegation prior to assignment to the IES staff or when appropriate, referral to another agency. All complex events or allegations or those with the potential for impacting public safety are evaluated by the RAM supervisor, the RHP manager, and RAM staff, in order to determine the appropriate response. The response varies based on the safety significance of the event, from resolution through telephone discussion, to immediate response by a team of 2 health physicists, and, in some cases, issuance 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 the files indicated that this approach provided effective response actions.

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 four.d in the NMED database system. Events reviewed included two equipment problems, one transportation event, three lost or stolen radioactive material, three loss of control, and one I

Maryland Final Report Page 19 misadministration. The team found that the State could not provide a listing of allegations received by the State during the period. Allegations are filed in the applicable case file.

The team found that allegations could only be researched by identifying the specific licensee involved and looking up the case file. .Therefore, the review was limited to those cases referred to the Ftate by NRC, and one allegation found during a review of case files.  !

Six allegations involving a variety of technical and administrative issues, five of which had l been referred by NRC to the State, were reviewed. During the MRB, a suggestion was J made that the State consider implementing a tracking system for allegations. l l

e The review team suggests that the State consider implementing a tracking l system for allegations.

The State's participation in the NMED database system would provide tracking of material events. A list of the incident casework with comments is included in Appendix F.

In the cases reviewed in depth, the review team found the States's response was well within the performance criteria. Incident response was well-coordinated, and the level of-effort was commensurate with health and safety significance. The State assured that licensees took suitable corrective actions, and followed the progress of the investigation through until close out. Although the State was unabla to provide a complete listing or

, complete events file, all of the events found in the NMED database were either in the State

events file or licensee compliance files. The team noted that three of the events identified l

by the State in response to the Questionnaire had not been provided to NRC and were not found in the NMED database (1/23/95 Maryland State Highw3y, 5/26/95 Soil Safe Inc.,

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

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

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

• The team recommends that the State provide event information for three events

! identified by the State in response to the Questionnaire, as follows: (1)1/23/95 l Maryland State Highway event, (2) 5/26/95 Soil Safe Inc. event, and (3) 5/30/96 j Aerosol Monitoring event.

l Allegations, that the team could identify, were responded to promptly with appropriate

! investigations and follow up actions. Proper procedures were used for the control of l information. The team found that the results of allegations received directly by the State i -were promptly related to the alleger. But, the results of the investigations of allegations l referred by NRC to the State were not provided to NRC in a timely manner. The team i

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I Maryland Final Report Page 20 found that the State had not provided close out information to NRC on allegations referred to the State by NRC. When NRC does not receive close out information from the State on investigation results, NRC cannot provide a response to allegers who request and receive anonymity.

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

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

The team found that the State has completed and begun implementation of procedures for handling allegations. The team noted that the State has a Law (Chapter 160 of the 1995 Laws of Maryland, codified as State Personnel and Pensions Article, 93-101-102) l prohibiting intentional acts of reprisal against any employee who has filed a complaint, grievance, or other administrative or legal action involving State employment.

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

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

4.1 Leaisfation and Reaulations 4.1.1 Leaislative and Leaal 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, " Hazardous Materials and Hazardous Substances." There are no sunset laws in Maryland and the State indicated that regulations have no expiration date.

4.1.2 Status and Comoatibility of Reaulations

, 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

Maryland Final Report Page 21 follow-up program review NRC found the State completed a revision to the RAMP updating all regulations required for compatibility which were identified as due or overdue. The regulations became effective on October 9,1995. Also included in this revision was the following amendment:

e " Decommissioning Recordkeeping, and License Termination: Documentation Additions, "10 CFR Parts 30,40, and 70 amendments (58 FR 39628) that became effective on October 25,1993, with adoption needed by October 25,1996.

Current NRC policy on adequacy and compatibility requires that Agreement States adopt certain equivalent regulations or legally binding requirements no later than three years after i

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:

l e " Licensing and Radiation Safety Requirements for irradiators," 10 CFR 36 l

amendments (58 FR 7715) that became effective July 1,1993, and due for adoption by the State by July 31,1996.

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

Equivalent rules were in the final stages of promulgation and were scheduled to be adopted l in November 1996. The team found that the State had not established legally binding requirements equivalent to NRC requirements in 10 CFR Part 36 that are required for I l

compatibility, at the time of review. Subsequent to the review, the State informed the team that Part X of the Maryland Code covering, " Licenses and Radiation Safety Requirements of Irradiators," was adopted on November 19,1996, with an effective date of December 16,1996.

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

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

e " Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use, " 10 CFR 30,32, and 35 amendments (59 FR 61767,59 FR 65243, and 60 FR 322) that became effective January 1,1995 and will need to be adopted by January 1,1998.

e

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

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

and will need to be adopted by March 13,1998, i

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Maryland Final Report Page 22

" 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 coropatible requirements so that the national manifest system will go into effect at one time.

" 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 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.

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" Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995 and will need to be adopted by November 24,1998.

e

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

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

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

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

NRC staff has reviewed the 13 amendments to the final COMAR regulations adopted by the State of Maryland, that became effective October 9,1995, and, based on that review, found that our earlier comments have 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 existing sections of Maryland regulations that were not modified by the 13 amendatory actions. Staff completed documentation of these concerns and transmitted the concerns to the State, separately by letter, dated February 28,1997.

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.

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Maryland Final Report Page 23 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 i plan for adoption by the end of 1997.

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

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

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

performance w'th i respect to this indicator, Legislation and Regulations, be found i Unsatisfactory due to issues identified by the staff related to existing sections of i Maryland's final COMAR regulations that were not modified by the 13 amendatory actions I adopted by the State, that became effective October 9,1995.' Also, subsequent to the )

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

l NRC will notify the State of the results of a final review, in a separate letter. Additionally,

! the State needs to resolve the issue regarding the term " person" in the LLRW regulations.

l l 4.2 Sealed Source and Device Evaluation Procram In assessing the State's Sealed Source & Device (SS&D) evaluation program, the review

team examined information provided by the State in response to the IMPEP questionnaire i i

on this indicator. A review of selected new and amended SS&D evaluations and supporting documents covering the review period was conducted. The team observed the l l

Staff's use of guidance documents and procedures, and. interviewed the staff and Program )

j Manager involved in SS&D evaluations. i l 4.2.1 Technical Quality of the Product Evaluation Proaram i

The review team examined six new or revised SS&D registry certificates and their supporting documentation, in addition, the review team examined the State's efforts to revise an ad#itional SS&D registry certificate for a device involved in an incident. The certificates ieviewed covered the period since the last program review in April 1993 and l represented cases completed by three reviewers. The SS&D certificates issued by the State and evaluated by the review team are listed with case-specific comments in Appendix G. The overall quality of the evaluations shows improvement of the program since the review conducted in 1993. There was a noticeable improvement in documentation required of the applicants and in the detail of the evaluations when comparing 1994 to 1995 certificates.

l The State does have procedures in place to protect proprietary information submitted in support of an evaluation. Policy and guidance documents were on file and being utilized l

4 by the staff. The review team observed that both SS&D reviewers will be signing each

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Maryland Final Report Page 24 completed SS&D registry certificate to verify the second reviewer's audit of the application l and the original reviewer's conclusions for future certificates. This is a change in the previous policy of the State.

The review of SS&D casework files revealed that five of the seven files had comments on  !

detailed Quality Assurance / Quality Control (QA/QC) programs. Specifically, the staff did

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not obtain detailed QA/QC program commitments for devices previously approved (prior to i 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 regarding the SS&D product manufacturing process. The review team noted that the staff had obtained detailed i QA/QC program information on the HDR presently under review and had reviewed the information according the procedures and guidance documents.

During the 1993 review, NRC recommended that the State and vendors should replace  !

missing information and review outdated registration sheets in accordance with the '

standard format and content guidance. It was recommended that 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 l

comment. The present staff was not aware of this comrnitment and management was not  :

able to produce documentation of actions taken by Marylend in response to the 1993 I review.

• The review team recommends that the State implement a plan to review all registration sheets, based on the risk associated with the device, especially detailed QA/QC program information.

Improvements 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 Licenses" and 10 CFR 32.210 entitled, " Registration of Product Information." These regulations were not

. initially identified as items of compatibility for Agreement States with SS&D evaluation programs. All Agreement States letter SP-95-116 dated July 25,1995, announced l Commission approval of minimum standards for Agreement States desiring to maintain l 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.

l These regulations require manufacturers / distributors to submit certain key product l 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 i i 6.9 dated February 1995 entitled, " Establishing Quality Assurance Programs for the I 1

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 l

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Maryland Final Report Page 25 )

specific license condition on the manufacturers / distributors addressing these requirements ,

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

l 4.2.2 Technical Staffir,a anc' Trainina l i

During the period of April 1993 to June 1995, all SS&D reviews were conducted by the i 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 l

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

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

recommended core training courses for materials licensing personnel. An offer was l 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 l 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 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 Reoardina 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 renart. The staff is working with the licensee to issue a revision to the SS&D certificate for the HDR to take into account the new design and programming implemented for the interlock and the QA/QC program. A draft version of this certificate has been sent to the licensee for comment.

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

) .

{

I Maryland Final Report Page 26 l

4.3 Low-Level Radioactive Waste (LLRW) Disoosal Proaram i

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

to have continued LLRW disposal authority without the need of an amendment. Although j Maryland has LLRW disposal authority, NRC has not required States to have a program for

licensing a LLRW disposal facility until such time as the State has been designated as a j host state for a LLRW disposal facility. When an Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal facility, they are expected to put in place a regulatory program which will meet the criteria for an adequate and compatible LLRW disposal program. - There are no plans for a LLRW disposal facility in Maryland.

Accordingly, the review team did not review this indicator.

]

[ 5.0

SUMMARY

i z' As noted in Sections 3 and 4 above, the review team found the State's performance with j respect to each of the performance indicators to be Satisfactory with the exception of 3.2 i Technical Staffing and Training and 3.4 Technical Quality of inspections, both of which I

were found Satisfactory with Recommendations for improvement, and the non-common

) indicator,4.1.2 Status and Compatibility of Regulations, which was found Unsatisfactory.

l The MRB, after considering the unsatisfactory performance of one HP-inspector during two  !

J on-site field inspection accompaniments, and the overall satisfactory performance of three i j other inspectors during accompaniments, revised the team's recommendation for Section l

3.4 Technical Quality of Inspections. The final MRB recommendation for Section 3.4, I Technical Quality of Inspections is Satisfactory.

{

The team recommended, and the MRB concurred, to find the Maryland program to be j adequate to protect public health and safety but needs improvement and not compatible.

l Below is a summary list of suggestions and recommendations, as mentioned in earlier l sections of the report, for consideration by the State. As previously indicated, the State j responded to the suggestions and recommendations in a letter dated February 3,1997.

! 1. The review team recommends that the State take action to have the Waste 5

Management Administration revise the definition of " Person" in the low-level radioactive waste regulations COMAR 26.14.01.02B(28)(e) that was identified in both the 1993-94 review and the 1995 follow up review. (Section 2.0) a

2. The review team recommends that the State of Maryland inform NRC when the referring physician / patient notification requirements has been completed by SHH.

i (Section 2.0) i 3. The review team recommends that the State incorporate the April 1995 revisions to l l lMC 2800 into their inspection Procedures Manual. (Section 3.1) i i

1 J

Maryland Final Report Page 27

4. The team suggests that the State consider development of a formal professional training plan through the use of university and industry educational programs for training new staff and retraining or refresh for long term staff. (Section 3.2)

5. The review team recommends that management provide a corrective action plan to address the issue of qualifying staff. The team also recommends that management provide a training and qualification plan for new staff that includes an appropriate education background, and a requalification phn 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 Maryland 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-l inspector whose accompaniment was unsatisfactory. (Section 3.2)

7. The review team recommends that the State assess the adequacy of the program staff to ensure the long-term ability of the program to complete the pending rules and amendments for adoption to remain compatible. (Section 3.2)

8. The team suggested that the Radiological Health Program could benefit from a guidance document on termination of licenses. (Section 3.3)

9. The review team recommends that the State adhere to the policy of annual . l supervisory accompaniments of allinspectors. (Section 3.4)

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

11. The review team suggests that the State consider implementing a tracking system for allegations. (Section 3.5)

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

(Section 3.5) l 13. The team recommends that the State provide event information for three events identified by the State in response to the Questionnaire, as follows: (1) 1/23/95 Maryland State Highway event, (2) 5/26/95 Soil Safe Inc. event, and (3) 5/30/96 Aerosol Monitoring event. (Section 3.5) l l

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

l l

l Maryland Final Report Page 28

14. The review team recommends that the State improve the effectiveness of the  ;

Regulation Adoption Management Plan by providing a realistic schedule of milestones for development and adoption of the 10 rules currently identified in the .

plan for adoption by the end of 1997. (Section 4.1)

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

16. The team recommends that the State address the staff's comments relating to Maryland's COMAR final rules that were transmitted to the State. (Section 4.1) l

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

18. The review team recommends that the State adopt regulations compatible with 10 ,

CFR 30.32 (g) and 10 CFR 32.210. (Section 4.2) l

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

(Section 4.2)

I 1

i a

l l - LIST OF APPENDICES AND ATTACHMENTS Appendix A IMPEP Review Team Members Appendix B Maryland Organization Charts l

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

l f

i i

i

\

l APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Patricia Larkins, OSP On-Site Team Leader Technical Staffing and Training Response to incidents and Allegations Terry Frazee, Washington Technical Quality of Licensing Actions at NPI  !

I Status of Materials inspection Program l

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

L L 5

! I l

l l

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

l 1

1 b

i

.I i

4

APPENDIX B l

j MARYLAND DEPARTMENT OF THE ENVIRONMENT 4

AND i.

)'

AIR AND RADIATION MANAGEMENT ADMINISTRATION, RADIOLOGICAL HEALTH PROGRAM ORGANIZATION CHARTS i

j 4

4 4

i a

't

MARYLAE D DEPARTMEST OF THE ESVIRONMENT .

~

GOVERNOR .

lh>=arJ Hicholson Jane T. Nishida. Secretary oca.se reignson samli=J secesisins Asse=ey 63I-3084 _ _ _ _ _ _ rimoralCounsel ~ ~ ~ ~ ~

Eu*i<amcedal Connes linie F*"". . C'* sbr D*' Assuency Gcacsars Olrece cla2s OfTice of Blenisce 61b3053 Arthur W. Ray. Deputy Secretary 1 631-3086

- Opasing nuJees

- Capital 13ndges 1. Charles Fox, Assistant Secretary

.timmJorp,atic wo,Ls 631 4187

. Warc:Senlay Fina.cing -

Ollice of the Secrclary

! "I'* 3'P#5>"

1.uvna mueneal Pcen iss Susan wouJa. Ikccsur - l'olicy Coosdination Sasue Cenia Office of Connenunication - Strategic l'lanning 631lM2 ,

638 D101 - l'ans l*ractice

- I cgesIJtion Pesemia Ome&nmiuse

. Ainjig

- kicJea Itclackms

.Pcsas leadeng

- I.= cess Cua.Jmation - Poll.mL= 1%csemian

- B Ancaseanal Outreasti - Small finansens Assistanse Conteninsey Relasams/Ouucech

-Inte masionalCoosJinmaion 1 eslic Caentpell. Derecent

&lestuect 18ane. Iluca scr Riched Collins. Ikector iI. liearm.I)erator inimkal an.1 Mcgule.ey Sosices AJudahuashf anJl'nsplayce kicesdyn Zaw klues. Disector Wan klan.egenwns Scesices A&mmeneskus Wade Atanagement A&seanseemenee Air & Radiadun klanascenens Adneinisteessen Adnambee asmen 639 1816 611 34.82 A&ede4smaakm 681-1567 631 3104 6)l-32

                                                                                                                                                                                                                                   . I isset/Acconensing
                                                                                                                                                                             -I useeinuna. sal Anww.csms
                                                                                        - W.esec htmugeancut Pulasy.
                                                                                                                                - Waso Pulinsane Cunnut resunts                                                                    . I'cesannel
                                                                                                                                                                             - CanagJa.nece ktimis.neg & Saengdeng

- Na tjewiry resensas Wates/Sessee 1*lms . liucusemient Planning anJ CoengJimice - WAes/Wastendes Cun plianse .(ee.aceagJek luf wmarum Spacens - Ns Quality d'lanning - I usnemmcaul itist kl.m.egeenene .Cennat Sersices

                                                                                        - Suted Wasse                                                                                                                               - I lect klanageinent Na Quality C ungJimece                                                                                                        - Cagneat l'enicos. Ormes & 1 naus           - Insks Rceesse.m lascus.my
                                                                                        - flumams Waste                         - W. des 9qtl y                                                                                     . S. tmery
. Astecuns a InJussrial                                                                 -Ilasmams klasesials 'Isansportation                                                 - Regnisim C..eJenske 113 gicuc                                                                                                                     . tilal/N.=-Iklal Wcelands                                                                          - linJJeng Operatunes
                                                                                        -lindesgsimnd la L RcmcJiatsni                                                       -I ses4=n at tal.=make Ast
- Air kl unscriang & infarrmation                                                                                                  WAes Argmegwi.sekes                                                                              -I eleasy Asdes
                                                                                        - lindesgionmJ Imik i u. ens                                                           ( n uilmannen Spions                                                                                 - 0 8 Comsud
                                                                                                                                 - ILIming Gs.qJ.es s Lgq=wt
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- klainte Snaces                                                                                                                 -I ngeneesmg/Cosishacehm                                                                              Cannamaessinues Divistaan
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                                                                                                                                                                                                                                     . I mg.soyec Sasay ita.Indagk al licahh                                                                                                           - N:* ere leM*ewas                           - klI nec*    ren9 'cv='.esw
                                                                                        - Su ese lhes blanagemens                                                                   ttshi. S.nas.es                                  -(16,nesws & C. nag.aigns
                                                                                                                                 - Sc lenacus I s. esse C.unuJ                - kl.Junw&a Isslenesal Seqq==t
                                                                                        - I caJ l'ing e.mo                       - Sa. nema Ace klassagenwas
                                                                                        - Supcilmul I cJesaldame
                                                                                                                                 - W-lh Scgdes s
                                                                                        . I edesai I .esilisws Assh stics
                                                                                                                                 - I as irinamemal lla.nJ3
                                                                                        - Seaage SinJcc

AIR AND RADIATION MANAGEMENT ADMINISTRATION REORGANIZAITON OF THE RADIOLOGICAL HEALTH PROGRAM RADI0toGICAL MEALTN PROGRAll 7 It0LAIS C. FLETCKE, PNE-VI, PIN 018242 Envi.orimmtal Program Manager-II ADMIN. SPECIALIST ADMINISTRATIVE AIDE i Det6Ie Keep Diane Netscre 4 PIN 018369 - PIN 018171 l

                                                                                                                                                                                                                                                                                                                                              - E. Goines, CC-IV, PIIP 0581M6 PROGRAM ASSISTANT                                                                                                                                                                                                                                                                                          -

09-II [C] FOR ltEEJLATORT & - J. Witt, O'3-II TC) CIBFLIANE ACTIIrtS

• Wittiem Santa PIN 018398 l

RADIATION MACHIIIFT DIVISION RADI0 ACTIVE MATERIALS LIENSING, CEBFLIANE AIS SAFEN DIVISION Thrras Fergusere EPM-l' PIN 019488 .......-.= - - - --- Carl Trimp, EPM-I, PIN 015732 I I MMOODGRAPWY, I I INS 8TCTION & ERTIFICAft0N, & LIE NSIIIG & ENFORG ENT SECTION REGISTRATION SECTIDIl INSPECTION AIB ElfVlROINENTAL RADIATION EN"GRCEENT SECT 1016 SECTION - 9.Cill, IF-L, [C] - W. VanAntiserp, HP-L, PIN 060582

                                                                                                                                                                                                                                                                                                                                        - R. Manley, IIP-L, PIII 058884                                        - N. Oncrutsky, IIP-L

- A.Bhatti, IIP-I [C] - C. Hughes, PP-II, PIN 018236 PIN 018239

                                                                                                                                                                                                                                                                                                                                        - A. Jacobson, IIP-L, PIN 018194                                       - L. Rectnes, IIP-L

- 3. Martin, IIP-II, PIN 066367 - F. Rustad, HP-II, Pilt 069W- PIN 058880 I

                                                                                                                                                                                                                                                                                                                                        - R. IIetson, IIP-II, PIN 05M                                          - D. McAbee, IF-II L 6.Arer, IIP-II, PIN 066366                                                                                         - I. IItsedije, IF-II, PIN 06940                                                                                                                                                                                                                                                                                                                                '

PIN 066368

                                                                                                                                                                                                                                                                                                                                        - F. Kasper, IIP-I, PIN 066365

- N. Perry, HP-II, PIII 069693 - R. Neock, IIP-II, PIN 018241 M ~ Roland G. Fletcher, Program Manager April 4, 1996

4 AnAm.-- - 4 - J *e __ 4 ea 2 - 4 #4__ m b 4 .G du,. # ..m.se.~- O e l APPENDIX C INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) QUESTIONNAIRE 1

l l j INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM l j QUESTIONNAIRE l ( Maryland Department of the Environment Radiological Health Program i Reporting Periodi April 8,1994, to September 20,1996 I A. COMMON PERFORMANCE INDICATORS i l l. Status of Materials insoection Proaram - 1 1

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 1 l Inspection Manual Chapter 2800 (issued 4/17/95). The list should I include initial inspections that are overdue. I Insp. Frequency l Licensee Name (Years) _Due Date Months O/D_ I l

answer: There are no inspections that are overdue by more than 25% as outlined in , NRC incpection manual 2800.

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

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

3. Please identify individual licensces or groups of licensees the State / Region is inspecting less frequently than called for in i4RC Inspection Manual Chapter 2800 (issued 4/17/95) and state the reason for the change.

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

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

! a. Of these, how many were industrial radiography, well-logging or other users with inspection frequencies of three years or less? (- ! answer: 708 licensees filed reciprocity notices in the reporting period. 498 of i those requests were for types of licensees which have inspection frequencies of 3 l- years or less.

1 l MD IMPEP Questionnaire ' Page C. 2 j i

b. For those identified in 4a, how many reciprocity inspections were conducted? I answer: 56 reciprocity inspections within the reporting period.

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

answer: 4 field inspections of radiographers were performed.

6. For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for any differences between the goals and the actual number of inspections performed.

answer: N/A

11. Technical Staffino and Trainina

7. Please provide a staffing plan, or complete a listing using the I suggested format below, of the professional (technical) persen-years l of effort applied to the agreement or radioactive material program by 1 individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U-mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program, include all vacancies and identify all senior personnel assigned to monitor work of junior personnel, if consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

NAME POSITION AREA OF EFFORT Carl E.' Trump, Jr. Program Administration,25% Materials Manager Licensing & Compliance,65%; Emergency Response,5%; *LLRW, 5% Raymond E. Health Physicist Administration,15%; Materials Manley Lead Licensing & Compliance,70%; Emergency Response,10%; LLRW, 5%

r MD IMPEP Questionnaire Page C.' 3 4

                                                                                                                        ~

l Alan D. Jacobsori Health Physicist Administration,10%; Materials ' Lead Licensing & Compliance,80%; Emergency Response,8%; LLRW, 2% Robert K. Nelson Health Physicist Administration, 5%; Materials , 11 Licensing & Compliance,85%; Emergency Response,8%; LLRW, l 2% Frank A. Kasper Health Physicist Administration 0%, Materials , Licensing & Compliance 95%, I Emergency Response 5% Leon J. Rachuba Health Physicist Administration 0%, Materials Lead Licensing & Compliance 98%, l Emergency Response 2% Douglas K. Health Physicist Administration 10 %, Materials. McAbee il Licensing & Compliance 88%, l Emergency Response 2% i i Nathanial A. Health Physicist Administration 5%, Materials -  ; Owrutsky Lead Licensing & Compliance 93%, l Emergency Response 2% l LLRW responsibilities are shared between RHP and Mr. Alvin Bowles l (Hazardous & Solid Waste Management Administration) who spends 5% of  ! , his time on LLRW.

8. Please provide a listing of all new professional personnel hired since I

the last review, indicate the degree (s) they received, if applicable, and  ;

i additional training and years of experience in health physics, or other  ! disciplines, if appropriate. l answer: No new professional personnel have been hired since the last review. 4

9. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1245 and 1246; for Agreement States, please describe your qualifications requirements for materials license ,

I reviewers and inspectors). For each, list the courses or equivalent  ! l training / experience they need to attend and a tentative schedule for j completion of these requirements. I l I

I . j MD IMPEP Questionnaire Page C. 4 l answer: Frank Kasper needs to attend the Licensing Practices and Procedures. He will attend course provided funding is available or NRC sponsorship continues. Leon Rachuba needs to attend Safety Aspects of Industrial Radiography. He will attend course provided funding is available or NRC sponsorship continues. INSPECTOR TRAINING Inspectors must attend all NRC core courses. A. Inspections l B. Diagnostic and Therapeutic Nuclear Medicino C. Five Week Health Physics 1 D. Safety Aspects of Industrial Radiography i

            ' E.      Licensing Practices and Procedures                                        I 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 C. Five Week Health Physics 1 D. Safety Aspects of Industrial Radiography E. Licensing Practices and Procedures License reviewers must be trained and aware of relevant NRC licensing guidance and pertinent technical documents.

10. Please identify the technical staff who left the RCP/ Regional DNMS program during this period, answer: Retirement of Charles R. Flynn as Licensing Program Manager on 6/95.

Transfer of Thomas Ferguson to X-Ray Program Manager on 12/95. Ill. Technical Quality of Licensina Actions

11. Please identify any major, unusual, or complex licenses which were

[ issued, received a major amendment, terminated or renewed in this period.

MD IMPEP Questionnaire Page C. 5 I muu4Wtus LICENSEE NAME LICENSE LICENSE TYPE ACTION NUMBER I Neutron Products MD-31 025-01 . Manufacturer Renewal Neutron Products MD-31-025-03 Teletherapy Renewal Service Neutron Products MD-31-025-04 Irradiator Renewal Neutron Products MD-31-025-05 Irradiator Renewal Eastern isotopes MD-03-068-01 Nuclear Pharmacy New Mallinckrodt MD 05-105-01 Nuclear Pharmacy Renewal Medical Terumo Medical MD-15-007-01 Irradiator Renewal Corp Adaptive MD-21-026-01 Sealed Source Renewal Technologier inc Design H&H X-ray MD-03-047-01 Industrial Terminated Services Radiography Law Engineering MD-27-060-01 Industrial Terminated inc. Radiography Measurex-DMC MD-31-088-01 Sealed Source Renewal Design Measurex-DMC MD-31-088 02 Service Renewal Mid Atlantic MD-05-148-01 Nuclear Pharmacy New Isotopes Oncology Center MD-25-026-01 HDR New at Riverside Montgomery M D-31-217-01 HDR New General Hospital Cancer Treatment Center Chesapeake MD-37-010-01 HDR New l Regional Cancer Center GTS Duratek M D-27-059-01 Industrial Terminated Radiography

. 1 MD IMPEP Questionnaire Page C. 6 1 Veterinary Imaging MD-05-145-01 Therapy New Veterinary Referral MD-31-242-01 Therapy New i Service North American MD-43-019-01 Industrial Terminated Inspections Radiography Maryland General MD--07-177-01 HDR New l Cancer Center TABLE OF MAJOR LICENSEES l licensee Name License Number License Tvoe 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 l Veterinary Imaging MD-05-145-01 Therapy l l Mid-Atlantic Isotopes MD-05-148-01 Nuclear Pharmacy 1 Johns Hopkins Medical MD-07-005-03 Broad Scope Institute University of Maryland at MD-07-014-01 Broad Scope Baltimore University of Maryland at MD-07-014-04 Incinerator Baltimore Maryland General Cancer MD-07-177 01 HDR l Center Union Memorial MD-07-181-01 HDR Oncology Center Terumo Medical Corp MD-15-007-02 Irradiator Therapy Services MD-21-007-01 Therapy Source Service and Distribution Adaptive Technologies MD-21-026-01 Service and Distribution Inc.

I . MD IMPEP Questionnaire Page C. 7 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 Irradiator Neutron Products MD-31-025-05 Irradiator Nucletron Inc. MD-27-035-01 Therapy Source Service . 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 j Treatment Center Mediphysics MD-31-222-01 Nuclear Pharmacy Veterinary Referral MD-31-242-01 Therapy Associates l 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-31025-01 Manufacturer of teletherapy sealed

sources.

1 ! 13. Discuss any variances ir. iicensing policies and procedures or } exemptions from the regulations granted during the review period. answer: There were none.

MD IMPEP Questionnaire Page C. 8

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

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

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. Includa:

Supervisor insoector License Cat. (code) Date l Carl E. Trump, Jr. Randall Haack 03121 6/20/94 Carl E. Trump, Jr. Alan J'acobson 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 Carl E. Trump, Jr. Ray Manley 03320 Incident 1/25/95 Alan Jacobson Reenactment Bob Nelson Frank Kasper Tom Ferguson Carl E. Trump, Jr. Alan Jacobson 02120 1/31/95

     . Thomas Ferguson     Leon Rachuba         03121               11/14/95

1 l l MD IMPEP Questionnaire Page C. 9 l l l l 18. Describe internal procedures for conducting supervisory i accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the { I documentation for each accompaniment. 1 answer: Accompaniment involves on site evaluation by senior supervisor for competency and knowledge of a selective license category. Each inspector was l 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 ) 2 Bicron mrem 1 Eberline E-120 9 Eberline Prm-7 4 Ludlum 12S 1 Ludlum 14A 1 Ludlum 19 4 Eberline MS2 3 Eberline Pac 4G 3 Eberline Plc 6a 12 Eberline Pic 6B 1 Victoreen 470 A Meters are calibrated at Radiation Services Organization or by BGE (Calvert i Cliffs Nuclear Facility). Allinstruments used by personnel for compliance or investigatory purposes are calibrated. p i l

_ ~ . _ _ _ 1 MD IMPEP Questionnaire Page C.10 l V. Resoonses to Incidents 'and Alleoations l p { ~20. Please provide a list of the most sionificant incidents (i.e., medical .i misadministration, overexposures, lost and abandoned sources, l incidents requiring 24 hour 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: f L LICENSEE NAME LICENSE # DATE OF - TYPE OF I INCIDENT \ REPORT INCIDENT  ! Private Paint Shop GL Device 7/11/94\\7/20/94 Stolen Device ! Material Testing NRC-45-17151- 10/6/94\\12/12/94 Industrial Laboratories 01 12/14/94 Radiography 12/23/94 (loss of control) Atec 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. 1 Mallinckrodt Inc. MD-33-088 01 1/10- Unrestricted 11/95\\2/1/95 Area & DOT l Contamination Maryland State MD-05-049-01 1/23/95\\1/24/95 Stolen Gauge Highway i Soil Safe Inc. MD-07-172-01 5/26/95\\7/10/95 Lost Gauge Nucletron MD 27-035 01 1/9/96\\2/22/96 System Failure Corporation . Aerosol Monitoring MD 03-056-01 5/30/96\\6/10/96 Stolen Paint Analyzer Johns Hopkins MD-05 007-03 6/5/96\\Pending Brachytherapy Medical Institutions (loss of control)

21. During this review period, did any incidents occur that involved

[ equipment or source failure or approved operating procedures that ,; were deficient? If so, how and when were other State /NRC licensees l who might be affected notified? f r

l . MD IMPEP Questionnaire Page C.11

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

! generated? i answer: a. Notification to RHP by NRC regarding failure of Nucletron HDR's door interlock system to always retract the source when the treatment room door is opened. NRC notified other states that might be affected by an abnormal occurrence report. US, Canadian and Mexican users also notified via safety alert issued by the manufacturer. ! b. Multiple dose vial breakage during pharmaceutical preparation at Mallinckrodt pharmacy causing contamination of pharmacy, surrounding unrestricted areas and DOT transport packaging. l 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 l evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each case.

! answer: For 21a. NRC and tite manufacturer supp!!ed appropriate information to Maryland. For 21b. a manufa~cturing 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 ccses involving possible wrongdoing that were reviewed or are presently undergoing y review? If so, please describe the circumstances for each case.

! answer: No.

24. Identify any changes to your procedures for handling c!:egations that occurred during the period of this rev'iew.

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

l l answer: Draft allegation procedure is under review.

a. None VI. General

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

1 l MD IMPEP Questionnaire Page C.12 1 answer: Of the 30 program indicators that were evaluated during the 1993 program review,19 were found satisfactory. NRC recommendations and RHP's l current status is indicated below: i

1. Status and Comoatibility of Reaulations (Category l}

NRC RECOMMENDATION: The RHP should continue their efforts to amend State regulations that are needed for compatibility including revision to the definition of " person" set out in the Maryland low level radioactive waste regulations, and obtain the necessary support needed to adopt the regulations in an expeditious manner. The RHP should develop and submit to NRC a management plan for eliminating the current rulemaking backlog  ; and a schedule for adoption of revisions to the regulations. I i RHP STATUS: On September 21,1996 RHP. submitted to NRC a regulations adoption management plan indicating Mary land's commitment to expeditiously evaluate and update pertinent radiation regulations falling under the NRC compatibility designation. This mandates the actions of a regulation committee ! whose mission is to coordinate, evaluate and implement the expedient adoption of required regulations. An extensive update of the Code of Maryland Regulations , (COMA.R) 26.12.01.01 titled, " Regulations for Control of lonizing Radiation,"

adopted September 9,1995 and effective October 9,1995, incorporated the i thirteen (13) compatibility regulations which had exceeded the three (3) year incorporation deadline. The definition of " person" as given in COMAR 26.12.01.01 Section A.2 meets the compatibility standard. Currently the regulation committee is near completion regarding the adoption of regulations governing the licensing and l l radiation safety requirements for irradiators and anticipates adoption in November, 1996.

2. Budaet (Category 11)

NRC RECOMMENDATION: The RHP should assess programmatic needs and, if determined to be necessary, a supplemental budget increase requested to provide sufficient operating funds for the program. , l RHP STATUS: The RHP has been assessing program needs annually during the l budget preparation process. Specific considerations that impact available l resources during the year are being addressed as they occur. Program needs have t been impacted by: , a. the requirement to allocate staff in order to keep the Maryland program l 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, l

i . l

                                                                                                    \

MD IMPEP Questionnaire Page C.13

c. the importance of responding appropriately to implement the NRC's

, recommendations resulting from the audit of Maryland's program. I 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. 1 Programmatic reassessment will continue as requirements change.

3. Administrative Procedures (Category 11) 2 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 rative procedures in the areas of licensing, reporting of events, and misad ons. Inspection procedures were revised and implemented in i November of .

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

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

b. explaining segments of licensing procedures to all personnel.

5. Adeauacy of Product Evaluations (Category I)

NRC RECOMMENDATION:

a. The RHP and vendors should replace missing information and review outdated registration sheets in accordance with the standard format and

l. .

MD IMPEP Questionnaire Page C.14 1

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

b. The RHP should re-evaluate the Nucletron Microselectron HDR considering the deficiencies and questions identified in Appendix B.

c. The RHP should discontinue the practice of performing a sealed source and de.vice acceptance evaluation that authorizes a manufacturer, located in another State, to routinely distribute that source or device.

i (See Registration sheets MD-327-D-101-G, MD-0691-S-101-S, MD-i 0691-D-102-S). The RHP would have no basis to inspect the i 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 j

                               . affected State, this practice should be discontinued.                                 1 RHP STATUS:

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

b. The NRC's25 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 licensees. Two registry sheets (MD 0691-S-101-S, and MD 0691-S-102-S) were written for a licensee who immediately moved out of the State. A third registry sheet (MD-327D-101-G) was written for a Maryland licensee acting as the East Coast distributor. The sheet has been rewritten, thereby deleting >

the West Coast distr;butor.

6. Licensino Procedures (Category ll)

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 i changes or related information. ( 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 i 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 compliance.

t MD IMPEP Questionnaire Page C.15

7. Technical Quality of Licensina Actions (Category l} ~

NRC RECOMMENDATION: The RHP should continue its efforts to renew the NPI license to include a clear set of license requirements against which the l 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 i of NPIlicense 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 l for the molybdenum-99 breakthrough licensed activity, and reflect the other  ! comments in future licensing actions. l i

                - RHP STATUS: NPl'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-31025-03 (teletherapy service) was renewed on 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, i

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

                'Specifically, the standard condition for molybdenum-99 breakthrough has been                   !
 .               modified tr. O.15 microcuries of molybdenum-99 per one millicurie of technetium-               ;

l 99m and will be used en all nuclear medicine and pharmacy licenses when issued ! or renewed. li l l 8. Insoection Freauency (Category I) NRC RECOMMENDATION: The RHP should revise the inspection frequency for all afterloader licensees to a one-year inspection frequency. RHP STATUS: This NRC recommendation was misdirected and should not have i been included as a Category Iindicator. The RHP revised the inspection frequency i for afterloader licensees from a three (3) year frequency to an annual frequency during the NRC's September 1993 review, because NRC guidelines regarding this inspection frequency change had not b'een received by the RHP prior to the NRC's review. As emphasized during the March 4,1994 outbriefing with MDE Secretary

Robert Perciasepe, MDE would certainly have implemented this policy sooner, had l

the NRC provided this information. Please note, however, that all afterloader devices in Maryland were inspected within six (6) months of the issuance of the license and all were within one year of that inspection at the time of the review.

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

l a .. l MD IMPEP Questionnaire Page.C.16

9. Enforcement Procedures (Category l}

! I NRC RECOMMENDATION: The RHP should continue with implementation of 1 the April 4,1994 strategic plan for NPIinspection and compliance activities. l The RHP should revise and implement enforcement procedures to: (1)

                                                                                                                                       )

address the routine enforcement policy, the use of the Notice of Violations 1 and the MDER-E-1 form; and (2) include use of acknowledgement letter in routine enforcement actions. RHP STATUS: -The RHP has continued with the implementation of'the April 4, t 1994 strategic plan for NPI inspection'and compliance activities. The RHP has l revised enforcement proced. ires to address routine enforcement policy, the use of l l the Notice of Violations, aw the MDE E-1 form. The RHP began issuing l acknowledgement letters ior routine enforcement actions in March 1994. l l 10. Insoection Procedures (Category 11) i NRC RECOMMENDATION: The RHP should update inspection procedures to reflect current program operations. RHP STATUS: RHP has reviewed existing inspection procedures and revised them accordingly. The review includes evaluation of NRC guidance regarding inspection procedures and guidelines. The updated procedures were implemented by November,1995.

11. Insoection Reoorts (Category ll)

NRC RECOMMENDATION: The RHP should consider the comments I identified in Appendix C relating to inspection reports and should ensure that inspection reports receive timely review by the Compliance Supervisor for l uniformity and quality control purposes, i.e., soon after the inspection and i prior to any enforcement actions. l l 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) l that all inspection reports are received for timely review by the Compliance i -Supervisor. The Compliance Supervisor will review these for uniformity, accuracy,

and completeness within ten (10) working days of receipt. Routine inspections will require each inspector to complete the report within twenty (20) working days after completion of the inspection. For team inspections, the lead inspector will be

;                 required to complete the report within thirty (30) working days after completion of i                 the inspection.

i

MD IMPEP Questionnaire Page C.17 l in November,1995 NRC conducted a follow up inspection to the 1993 audit. NRC l recommendations and RHP's current status is indicated below: ' l Item 1. Status and Comoatibility of Reoulations (Category l} I l 1 NRC RECOMMENDATIONS: I (1) NRC recommends that the RHP staff address rulemaking for the irradiator rule as soon as possible in order to meet the July 31, l 1996 deadline. (2) NRC recommends that the State revise the " Regulation  ! Adoption Management Plan" to address the points in the letter , I specifically to begin rule development sooner and, if the SSRCR has not been developed in parallel with the NRC rule, the State i should proceed without the SSRCR. I (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 Federallaw. I RHP STATUS: (1) Maryland regulations specific to NRC's irradiator rule are on track for adoption in November of 1996 l l (2) RHP is in agreement with NRC's recommended revisions to the " Regulation

Adoption Mariagement Plan."

(3) It is RHP's opinion that this issue has been resolved. It is RHP's understanding that the definitica 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 l corporation and any agency, bureau, department, or instrumentality of state l or local government and, to the extent authorized by federallaw, federal ( government. 5 I

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

l L - i. MD IMPEP Questionnaire Page C.18 Item 4. - Technical Quality of Licensino Actions (Category l} l NRC RECOMMENDATION: NRC recommends that the RHP continue to work with Montgomery l County in evaluating and approval of the NPI proposal for construction activities which should reduce the unnecessary radiation levels in and arcund the facility. RHP STATUS: On March 18,1996 a management meeting was held between RHP, NPI and l . Montgomery County. As a direct result of this meeting, on April 8,1996, RHP approval (with specific conditions) was given to NPI for the construction of a courtyard enclosure. NPIis currently working on detailed engineering plans for submittal tc Montgomery County. RHP feels that the construction of this enclosure l should significantly reduce radiation levels in and around the facility. j 26. Provide a brief description of your program's strengths and weaknesses. i These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review l j period.  ! l 1 answer: The program has the full support of the Program Administrator. RHP's i feels confident that it has fulfilled the MDE mission to insure the safety and l protection of occupational workers, members of the general public and the environment. Furthermore, RHP has established an aggressive and effective  ; compliance program. Examples of the above can be seen in enforcement actions ! specific to NPI, Mallinckrodt Pharmacy and Material Testing Laboratories. The program is currently conducting ongoing evaluations in procedures used for inspections, licensing and investigatory actions. RHP staff time is still being significantly impacted by compliance and licensing overview associated with Neutron Products Inc.

B. NON COMMON PERFORMANCE INDICATORS Reaulations and Leaal Authority

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

! control program (RCP). l l answer: l i l l 1

1 I l MD IMPEP Questionnaire Page C.19 l l 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 waste issues). l l l Comar 26.12.01.01 titled " Regulations for Control of lonizing Regulations" j Comar 26.15 titled " Disposal of Controlled Hazardous Substances-Radioactive Hazardous Substances" l

28. Are your re0ulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

                                                                                                      .l answer: Regulations have no expiration date. Our procedure is to review the regulations for compatibility and revise the appropriate part of COMAR within the 3

! year deadline, { i I

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

(- to adopt them. I l 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 I step. j L

answer: Regulations for the licensing and radiation safety requirements of l irradiators are in the final stages of promulgation and are scheduled to be published l 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 1 1 l

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

MD IMPEP Questionnaire Page C.20 1 II. Sealed Source and Device Prooram l l

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

l SS&D Manufacturer, Type of Registry Distributor or Device Number Custom User or Source MD 0113-D-104-G AdaptiveTechnologies Thickness / density i MD 0113 D-107-G Adaptive Technologies Thickness / density l MD-0113 D-108-G Adaptive Technologies Gamma MD-0113 D-109-G Adaptive Technologies Beta l 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 Cr j Fill Gauge MD 1003-D 101-G Pettit Applied Thickness / density l MD-0541-S-101-G Wallac LSC sources l l

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

answer: USNRC Reg Guide 10.10 USNRC Reg Guide 10.11

USNRC Reg Guide 6.9 Policy and Guidance Directive 84-22 l ANSI Standards

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 they apply to the Sealed Source and Device Program:

I Technical Staffing and Training - A.ll.7-10 l Technical Quality of Licensing Actions - A.lli.11, A.lli.13-14 Responses to incidents and Allegations - A.V.20-23 answer: 1 Technical Staffing & Training:

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

8. N/A

9. N/A

   . 10. Charles R. Flynn

? _ .

1 l - l l MD IMPEP Questionnaire Page C.21 l Technical Quality of Licensing Actions: I

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

13. Nucletron was allowed to upgrade HDR safety systems prior to amendment l of HDRs.

l

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

l Responses to incidents and Allegations: l 20. Nucletron Corporation (see above) i

21. Nucletron Corporation (see above) i

22. Nucletron Corporation (see above) I l

23. NONE 1' l

Ill. Low-Level Waste Proaram l l 34. Please include information on the following questions in Section A, as they apply to the Low-level Waste Prt> gram: 1 Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.lli.11, A.lli.13-14 Technical Quality of Inspections - A.IV.16-19 Responses to incidents and Allegations - A.V.20-23 answer: RHP does not have a Low level Waste Program. Overview of such areas i I as decommissioning, NPI radioactive waste storage, licensig of decay in storage, l 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 i they apply to the Uranium Mill Program: Status of Materials Inspection Program - A.I.1-3, A.I.6 } Technical Staffing and Training - A.ll.7-10 4 Technical Quality of Licensing Actions - A.lll.11, 1 A.lli.13-14 Technical Quality of Inspections - A.IV.16-19 Responses to incidents and Allegations - A.V.20-23 answer: N/A

MD IMPEP Outationnaire Pcg3 C. .22 , TABLE FOR QUESTION 29. ' f OR  ! DATE DATE 10 CFR RULE DUE A00PTED CURRENT EXPECTED , STATUS ADOPTION l Any amendment due prior to 1991. Idertify each regulation (refer to the  ! Chronology of Amendments) , IAEA Compatibikty 10 CFR Part 71 9/6/86 9/9/95 Addressed in Section T, of Regulations for Control of lonsring  ! Radiation (1994) Glass Enamel and Glass Frit 9/11/87 9/9/95 .l Addressed in Section C.3(c)(2)(iii) I industrial Radsography Surveys 7/16/89 9/9/95 Addressed in Section E.201 Bankruptcy Filing Notification 2/11/90 9/9/95 Addressed in Section C.31(el i Notifications, Reports, and Record of 4/1/90 9/9/95 Addressed in Section D.1209 Misadmwustration Well Loggmg 7/14/90 9/9/95 Addressed in Sectica W Dosametry Processing 2/12/91 9/9/95 Addressed in Section D.501(c)(ii) , Decommissioning: 7/27/91 9/9/95 Addressed in Section C.29 l Parts 30,40,70 j LT.e v-ncy Plannmg, 4/7/93 9/9/95 Addressed in Section C.23 Parts 30,40,70 , Standards for Protection Against Radiation: 1/1/94 9/9/95 Addressed in Section D & Section A.2 Part 20 Safety Reg.:.e.a.as for Radiographic 1/10/94 9/9/95 Addressed in Section E.308 ' Equepment: Part 34  ! Notification of Incidents: 10/15/94 9/9/95 Addressed in Section D.1202 Parts 20,30,31,34,39,40,70 [ Quality Management Program and 1/27/95 9/9/95 Addressed in Section G.76 Misadministrations: Part 35 i i Licensing and Radiation Safety 7/1/96 proposed Section X 11/96 Requirements for Irradiators: Part 36

                                                                                                                                                                                                                                                                                                                                       +

_______m . _ . _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ r-

                                                                                                                                                                                                                          .i MD IMPEP Quszti::nnrira                                                                                                                         Pcga C.                                                     23 i

I

                                                                                                                                                                     . OR -

l DATE DATE , 10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION i Defininon of Land Desposal 7/22/96 N/A and Weste Site OA Program: Part 61 Decommesssonmg Recodeepeng: Docu- 10/25/96 9/9/95 Addressed in Section C.29ffM3) mentation Additions: Parts 30,40,70 [ i Self-Guarantee as an Additional Financial 1/28/97 Not consistent with concluseons reached by Maryland's Legislative N/A t Mechanism; Parts 30,40,70 Auditors ' i Uransum Mill Tailings: Conformeng to EPA 7/1/97 N/A i Standards: Part 40 l i Timeliness in Decommissioneng 8/15/97 No action taken 8/97 Parts 30,40,70 #

                                                                                                                                                                                                                          .i Preparatson, Transfer for Commercial Dis-    1/1/98                                             No action taken                                                                                       12/97                 :

tribution, and Use of 8yproduct Material for ' Medical Use: Parts 30,32,35 - Frequency of Medical Examsnations for Use 3/13/98 No action taken 12/97 of Respiratory Protection E , ' .2 ^ i Low-Level Weste T'  : t Manifest 3/1/98 No action taken 12/97 t Information and Reporting i Performance E:g' ....; .:s for Radiography 6/30/98 No action taken 12/97 l Equipment Radiation Protection E: ' ....: ^s: 8/14/98 No action taken - 12/97 Amended Definitions and Criteria i Clarification of Decomnussionsng Funding 11/24/98 No action taken - 12/97 E;Cx.;..ts f 10 CFR Part 71: Competitsty with the 4/1/99 No action taken 12/97 l International Atomic Energy Agency ,

                                                                                                                                                                                                                           +

Medical Adrmnestration of Radiation and 10/20/98 No action taken 12/97 Radioactive Materials. I Termmation or Transfer of Licensed 5/16/99 No action taken 12/97 - Activities: Recordeeping Requirements. ,

                      . _ _ . ~                                    . _ _ _

__~.-_,--__c____ -_-_____ - __ - ___ -________ - _ .-

4 APPENDIX D LICENSE FILE REVIEWS l File No: 1 Licensee: Eastern isotopes, Inc. l Location: Hanover, MD License No. 03-068-01 Amendment No. 0 l License Type: Nuclear Pharmacy Type of Action: NEW i Date Amendment issued: 4/7/95 License Reviewers: CRF/NAO Comments: a) Checklist not in docket file b) Ownership verified, not the same name as operator l c) Applicant stated use of certified packages, submitted acceptable response, reviewer asked for more information l d) Application stated use of independent audits by RSO, approved; because another company committed to outside audits, an inspector asked company and reviewer to amend licensee to do the same File No. 2 ' Licensee: G.T.T. Incorporated l Location: Bethesda, MD License No. 31-246-01 Amendment No. O License Type: Portable Gauces Type of Action: NEW Date Amendment issued: 4/26/95 License Reviewers: CRF/NAO l File No. 3

Licensee

K.M.Lindgren, M.D. et al License No. 31-120-01 l Location: Rockville, MD Amendment No.4 l License Type: Nuclear Medicine Type of Action: Renewal l

Date Amendment issued: 11/27/95 License Reviewers: NAO/CET File No. 4 l Licensee: PSI, Inc. License No. 03-036-01 l Location: Linthicum, MD Amendment No.18 License Type: Portable Gauges Type of Action: Amendment Date Amendment Issued: 3/7/96 License Reviewers: NAO/ REM Comment: a) Licensee requested extension of renewal preparation time for business reasons. Extension granted, renewal submitted within time extension. File N o. 5 Licensee: Schnabel Engineering Assoc. License No. 047-141-01 Location: Baltimore, MD Amendment No. 20 License Type: Portable Gauges Type of Action: Renewal Date Amendment issued: 6/26/96 License Reviewers: NAO/CET

Maryland Proposed Final Report Page D. 2 License File Reviews

File No. - 6 I Licensee: Oncormed, Inc. License No. 31-237-01 Location: Gaithersburg MD_ , Amendment No. 2 License Type: R & D Laboratory Type of Action: Amendment Date Amendment issued: 6/26/96 License Reviewers: NAO/CET '

Comment: l a) Action requested increases, provided sufficient information to make safety determination File No. 7 Licensee: Biomedical Research Inst. License No. 31 102-01 Location: Rockville, MD Amendment No.16 & 17

        . License Type: R&D Lab                                        .

Type of Action: Renew & Amend Date Amendment issued: 8/30/94 & 9/23/94 License Reviewers: NAO/CRF NAO/CRF Comment: a) 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 i 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. I b) ~ COMAR D.401 allows change of leak test, State does not use option. l I File No. 9 Licensee: Campbell & Nolan Assoc. License No. 25-030-01 Location: Amendment No. 5 License Type: Portable Gauges Type of Action: Amendment-Date Amendment issued: 9/12/96 License Reviewers: NAO/CRF l File No.10 l Licensee: Patriot Mining Co., Inc. License No. 23-007-01 i Location: Star City, WV Amendment No. 2 l License Type: Fixed Gauges Type of Action: Amendment Date Amendment Issued: 6/14/95 License Reviewers: NAO/TDF Comment: l a) Mine in MD, home office in WV l ?

1

  .                                                                                                         l Maryland Propo: sed Final Report                                                        Page D. 3 1

j l License File Reviews 1 l , File No.11 l Licenseo: Chesapeake Reg. Cancer Ctr. License No. 37-010-01 Location: Mechanicsville, Mr) Amendment No. O i License Type: HDR Afterloadu Type of Action NEW l Date Amendment issued: 5/31/94 License Reviewers: NAO/CRF l File No.12 Licensee: AMVAX, Inc. License No. 33 108-01 Location: Beltsville, MD Amendment No. 6 License Type: R&D Lab Type of Action: Renewal Date Amendment issued: 2/21/95 License Reviewers: NAO/CRF Comments: l a) Deficiency phone call only documented in licensee response b) Liquid scintillation analyzer doesn't show MDA for wipe results File No.13 Licensee: American Red Cross License No. 07-177-01 Location: Baltimore, MD Amendment No. 7 License Type: Blood Irradiator Type of Action: Renewal Date Amendment issued: 6/19/95 License Reviewers: NAO/CET File No.14 Licensee: Gene Logic, Inc. License No. 27-066-01 i Location: Columbia, MD Amendment No. O i License Type: R&D Laboratory Type of Action NEW Date Amendment issued: 8/12/96 License Reviewers:NAO/RKN File No.15 l Licensee: Wallac License No. 31-071-01 Location: Gaithersburg, MD Amendment No. 38 License Type: Demonstration of devices Type of Action: Renewal Date Amenoment issued: 8/14/96 License Reviewers: NAO/RKN Comments: a) Distribution, manufacturer's service representative b) No material possessed. File No.16 Licensee: GTS Duratek License No. 27-059-01 Location: Beltsville MD Amendment No. 3 License Type: Radiography Type of Action: Terminate Date Amendment issued: 9/14/94 License Reviewers: NAO/CRF j Comments: l a) Material transferred to corp. operation in Florida l b) Inspector verified sources moved j c) No records related to personnel or possible public exposure discussed i

i' Maryland Proposed Final Report Page D. 4 License File Reviews l File No. ' 17 , Licensee: BG&E (Calvert Cliffs) License No. 030-027-01 i Location: Lusby MD Amendment No.16 License Type: Radiography j Type of Action: Terminate ;

             'Date Amendment issued: 1/5/95                                                                License Reviewers: CRF/NAO   '

i Comme as: l a) Licensee's close-out survey not complete l 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 l License Type: Service / Leak Test Type of Action: Terminate i Date Amendment issued: 11/3/95 License Reviewers: NAO/TDF Comments: al Letter states no materials, no sction on letter for 1 year b) No closeout action by Program to verify File No.19 Licensee: Engineering Technologies Assoc. l.icense 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 Amersdment No.16 License. Type: Service License Type of Action. Terminate Date Amendment issued: 6/10/96 License Reviewers: NOA/CET Comments: a) All materials transferred properly b) Inspected and documented adequately File No. 21 l Licensee: Washington Radiology Assoc. License No. 31-227-01 l Location: Bethesda MD Amendment No.1 License Type: Nuclear Medicine Type of Action: Terminate Date Amendment issued: 5/17/96 License Reviewers: NAO/CET l

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t . Maryland Proposed Final Report Page D. 5 License File Reviews Comments: a) Materials decayed-in-storage, transferred to another licensee b) Licensee's closeout survey adequate c) Program's survey and termination adequate File No. 22 Licensee: SAIC License No. 31-076-01 Location: Rockville & Gaithersburg MD Amendment No.31 License Type: Analytic samples Type of Action : Terminate Date Amendment issued: 2/8/93 License Reviewers:CRF/NAO I Comments: a) . Continuous monitoring through weekly reports from licensee b) Cloceout survey 1/6,21,28/93 summary documented adequately File No. 23 Licensee: Oboler, Kaufman et al Location: Silver Spring MD License No. 31-121-01 License Type: Nuclear Medicine Amendment No.18 Type of Action

• Renewal Date Amendment issued: 10/20/96 License Reviewers: CRF/NAO Comment: 't c) Deficiency phone call not documented l File No'. 24 Licensee: St. Agnes Hospital License No. 07-010-01 I Location: Baltimore MD License Type: Nuclear Medicine Amendment No. 38  ;

Type of Action: Amendment Date Amendment issued: 6/29/95 License Reviewers: TDF/NAO Comment: a)  !

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

Amendment No. 1 License Type: Portable Gauge Type of Action: Renewal Date Amendment issued: 4/25/95 License Reviewers: CRF/NAO File No. 26  ! l Licensee: Nuclear Imaging Systems, Inc. License No. 33-130-01 Location: Riverdale MD Amendment No. 3 l License Type: Nuclear Medicine Type of Action: Renew i ! Date Amendment issued: 7/12/94 License Reviewers: CRF/NAO ' I l

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l Maryland Proposed Final Report Page D. 6 License File Reviews File No. 27 Licensee: Chektec Corporation License No. 07-171-01 l

Location

Baltimore Amendment No. 7 l

License Type

Type of Action: Terminate l

Date Amendment Issued: 4/3/95 License Reviewers: CRF/NAO l l Comments: a) Licensee survey adequate . j

b) Program'r inspection timely, no calibration listed on survey document for survey ,

meter

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l 1 File N o. 2 8 Licensee: Potomac Engineering & Surveying License No. 23-004-01 i Location: Amendment No.1 l License Type: Portable Gauge Type of Action: Terminate Date Amendment issued: 2/23/95 License Reviewers: NAO/CRF Comments: l l a) No record of action to verify transfer of gauges l b) No closeout survey

     ,.,        File No. 29 Licensee: Isorad Limited                                                License No. 31 209-01 Location: Bethesda MD                                                             Amendm3nt No. 2 License Type:                                                        Type of Action: Terminate                  l Date Amendment issued: 2/5/96                                     License Reviewers: NAO/CET 5

Comments: a) No materials possessed b) Verified by visit File No. 30 Licensee: Louisiana Pacific Corp. License No. 27-049-01 Location: Savage MD Amendment No. 4 License Type: Fixed Gauge Type of Action: Terminate Date Amendment issued: 7/23/96 License Reviewers: NAO/CET Comments: a) Licensee states returned to manufacturer b) No record of verification File No. 31 Licensee: Dames & Moore License No. 03-039-01 Location: Annapolis MD Amendment No. 8 License Type: Portable Gauges Type of Action: Terminate l Date Amendment issued: 6/5/96 License Reviewers: NAO/CET

B 1) i Maryland Proposed Final Report Page D. 7 l License File Reviews . l l Comments: i a) Transferred to another corporate cifice, not authorized to possess portable gauges i on submitted copy. b) Licerse at recipient office amended prior to actual transfer. File No. 32 Licensee: Engineering Technologies License No. 027-065-01 I Location: Ellicott City MD Amendment No. 0 l License Type: Portable Gauge Type of Action: NEW Date Amendment issued: 3/4/96 License Reviewers: NAO/CET Comments: 1 a) No standard locking condition when not in use, and no locking instruction in , Operating & Emergency instructions  ! File No. 33 Licensee: Engineering Technologies Licensa No. 27-065-01 Location: Ellicott City MD Amendment No.1 License Type: Portable Gauges Type of Action: Terminate , Date Amendment issued: 5/7/96 License Reviewers: NAO/CET l l Comments: a) No materials received, no work done, no verification in record File No. 34 Licensee: H&H X-ray Servicec, Inc. License No. 03-047-01 Location: Baltimore MD Amendment No. License Type: Radiography Type of Action: Terminate Date Amendment issued: 10/2/05 License Reviewers: NAO/TDF Comments: a) Letter request, discussion with Co. President, transfer to NRC license. b) No closecut, no verification File No. 35 Licensee: Laurel Regional Hospital License No. 33-37-01 Location: Laurel MD Amendment No. 29 License Type: Nuclear Medicine Type of Action: Amend Date Amendment issued: 6/25/96 License Reviewers: NAO/CET File No. 36 Licensee: kcl Technologies License No. 05 150-01 Location: Hunt Valley MD Amendment No. License Type: Portable Gauge Type of Action: Amend

Date Amendment issued

7/11/96 License Reviewers: DKM/CET i

i I l Maryland Proposed Final Report Page D. 8 i License File Reviews t l File No. 37 Licensee: Dames & Moore License No. 31-245-01 Location: Annapolis MD Amendment No. 4 l License Type: Portable Gauge Type of Action: Amend l Date Amendment issued: 9/13/96 License Reviewers: DKM/CET File No. 38 Licensee: Oncology Center at Riverside License No. 25-026-01 Location: Belcamp MD Amendment No. 0; 1; 2 License Type: HDR Afterloader Type of Action: NEW, Amend Date Amendment issued: 5/3/94, License Reviewers: CRF/NAO, NAO/TDF, NAO/CET 11/15/95, and 1/3/96. Comments: a) Conterit 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 i Location: Baltimore MD Amendment No. O License Type: Nuclear Pharmacy Type of Action: NEW Date Amendment issued: 10/12/95 - License Reviewers: NAO/TDF Comments:  ! a) Licensee submitted full re application after deficiency letters b) License condition requires submission of proposed changes, does not require approvol prior to implementation  ; c) Person to do internal audits not specified, no frequency specified, see Standard ) l Review Plan. l l File No. 40 Licensee: Univ, of MD (Environmental Safety) License No. 33-004-01 Location: College Park MD Amendment No.100 License Type: Broad Scope Type of Action: Amend I Date Amendment Issued: 8/29/96 License Reviewers: NAO/CET l l L a l l

d k a APPENDIX E INSPECTION FILE REVIEWS File No.: 1 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 inspection Date: 06/11/96 Inspector: RN E Comment: a) Report doesn't identify what was reviewed to correct previous item of non-compliance b) Radiation Safety Committee meeting minutes not reviewed File No.: 2 Licensee: Terumo Medical Corporat:on 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/AJ Comment: a) Separate interviews not held with management to determine program involvement. File No.: 3 Licensee: NW Radiation Oncology Center License No. 05-034-02 Location: Randalistown, MD inspection Type: Routine, unannounced, follow up License Type: HDR Priority: Annual Inspection Date: 06/27/96 and 07/03/96 Inspector: FK Comment: a) Field note descriptions not indicative of a performance based inspection in that the 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 violation issued. 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. File No.: 4 . Licensoe: 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 inspection Date: 06/23/95 inspector: RM Comment: a) Unable to determine from report involvement of Radiation Safety Committee. J

l ! Maryland Proposed Final Report Page E2 Inspection File Review File No.: 5 Licensee: MKM Engineers License No. 27 064-01 l Location: Columbia, MD Inspection Type: Initial, unannounced l License Type: Gauge (portable) Priority: 4

Inspection Date: 05/16 17/96 Inspector: LR Comment:

i a) Cannot determine whether employee interviews were conducted. b) Licensee response to NOVs - enclosures of leak test results, survey meter l procurement, and security measures not in file. I c) ltem of non-compliance for not maintaining usage logs identified during inspection ) but not included in enforcement letter. I 1 File No.: 6 Licensee: Syncor International Corporation License No. 33 061-01 Location: Lanham, MD inspection Type: Routine, unannounced License Type: Pharmacy Priority: A l Inspection Date: 04/12-13/95 Inspector: RN l Comment: l 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 j Location: Greenbelt, MD inspection Type: Routine, announced, follow-up i License Type: Priority: 4 Inspection Date: 04/11/96 Inspector: FK l Comment: a) Independent measurements inc. only one smear sample. Fi!e No.: 8 Licensee: Nucletron Corporation License No. 27-035-01 Location: Columbia, MD inspection Type: Announced, follow-up License Type: Service / Mfg Priority: A Inspection Date: 02/07/96 Inspector: RM Comment: None File No.: 9 Licensee: Calvert Memorial Hospital License No. 09-003-01 Location: Prince Frederick, MD inspection Type: Unannounced, follow-up License Type: Nuclear Medicine Priority: 3 Inspection Date: 03/21/96 Inspector: RN i Comment: None i

l~ \- l ! Maryland Proposed Final Report Inspection File Review Page E.3 t File No.: 10 Licensee: Bon Secours Hospital l Location: Baltimore, MD License No. 07 002-01 inspection Type: Routine, unannounced l License Type: Muclear Medicine Inspection Date: Priority: 3 02/28/96 and 03/05/96 Inspector: FK Comment: None i File No.: 11 Licensee: Washington County Hospital Assn. Location: Hagerstown, MD License No. 43-001-03 } Inspection Type: Routine, unannounced, follow-up License Type: Nuclear Medicine - HDR Inspection Date: Priority: 1 02/06-07/96 Inspector: FK Comment: None File No.: 12 Licensee: Greater Baltimore Medical Center Location: License No. 05-002-03 Baltimore, MD inspection Type: Routine, unannounced, follow-up License Type: Brachytherapy inspection Date: Priority: 3 01/23-24/96 Inspector: RM Comment: a) Complete, thorough inspection I File No.: 13 Licensee: Eastern isotopes, Inc. License No. 03-068-01 Location: Hanover, MD inspection Type: Initial, unannounced follow-up License Type: Pharmacy  ; Priority: 1  ; Inspection Date: 10/03/95 Inspector: RN  ! Comment: a) No indication in report whether independent measurements included smear samples. File No.: 14 Licensee: Duebriss Hospital of PG County License No. 33-029-01 Location: Lanham, MD inspection Type: Routine, unannounced follow-up License Type: Hospital Priority: 3 Inspection Date: 07/18-19/95 Inspector: FK Comment: a) Report indicates previous non-compliance items " corrected" but does not indicato information or operations reviewed. t b) No ecknowledgement letter in response to licensee's enforcement letter from previous inspection. c) Lab results report only one wipe sample taken. l

4 Maryland Proposed Final Report , Page E.4 Inspection File Review l File No.: 15 Licensee: ATEC Assoc License No. 27-005-01 Location: Columbia, MD inspection Type: Routine, unannounced follow-up License Type: Portable Gauges Priority: 4 Inspection Date: 06/19/95 Inspector: AJ Comment: None File No.: 16 Licensee: Guilford Pharmaceuticals, Inc. License No. 07-186-01 Location: Baltimore, MD inspection Type: Initial, unannounced, follow-up  ; License Type: Research and Development Priority: 4 Inspection Date: 04/30/96 l Inspector: AJ Comment: a) License terminated and survey performed after April 96 inspection but license not amended. I In addition, the following inspection accompaniments were made as part of the on site l IMPEP review: Insoection Accomoaniments l Accompaniment No.1 Licensee: Terumo Medical Corporation License No. 15-007-02 Location: Elkton, MD inspection Type: Routine, unannounced l License Type: Irradiator Priority: Annual inspection Date: 06/25 26/96 inspectors: RN(lead)/AJ l Good, complete performance-oriented inspection of licensee operations, inspection consisted of licensee walkthroughs of scheduled (daily, weekly, monthly, quarterly, and l 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 l Inspection Date: 07/16-17/96 Inspectors: FK l 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. l l

l Maryland Proposed Final Report Page E5 Inspection File Review Radiation surveys and wipe samples not taken in waste holding or material storage (loading dock) areas. Interviews with nursing staff treating therapy patients not performed. Last inspection conducted 1993 but personnel dosimetry records, dose calibrator records, waste shipments, and leak test records reviewed only for previous year. Field notes used as reference to identify inspection areas. Accompaniment No. 3 Licensee: Medi-Physics, Inc. License No. 31-222-01 Location: Cheverly, MD inspection Type: Routine, unannounced License Type: Nuclear Pharmacy Priority: 1 Inspection Date: 08/07/96 Inspectors: AJ Inspector demonstrated thorough control over inspection activities. Preparation and inspection plan complete. Licensee requested to demonstrate acceptability of various procedures including equipment reliability and engineering controls. Wipe samples not taken in all areas where radioactive materials used. Information clearly communicated to licensee during inspection and at exit interview. Accompaniment No. 4 Licensee: North American inr.pection Co. NRC License No 37-23370-01 Location: Cheverly, MD inspection Type: Routine, unannounced, License Type: Nuclear Pharmacy under reciprocity 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 radiatiori 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 (site foreman) not consulted or interviewed to determine knowledge of site operations. { l

l APPENDIX F MARYLAND INCIDENT FILES REVIEWED File No.1 Licensee: Nucletron Oldelft Corp. (Mallincrodt Medical) Location: BWI Airport License #: MD27-035-01 Date of Event: 05/28/96 Type of Event: Transportation Summary of Ircident: Package containing a 9.74 Ci tr-192 sealed source, shipped from Mallinckrodt Medicalin Holland with Nucletron as shipper of record, was received at BWI Airport in damaged condition with survey readings of 45 mR/hr. MD RAM and HAZMAT team responded and performed cleanup and recovery. File No. 2 Licensee: Nucletron Oldefit Corp. Location: Memorial Medical Center, Springfield, IL License #: MD27-035-01 Date of Event: 02/01/96 Type of Event: Equipment failure Summary of incident: Nucletron HDR console malfunctioned during patient treatment. Computer froze and source failed to return to shielded position. Attending physician entered room and started emergency hand crank which retracted source. Generic problem identified and State requested Nucletron to modify design with hardware change to hardwire unit to console and revise software program. Nucletron is currently making the changes to all service customers. File No. 3 Licensee: ATEC Associates, Inc. Location: Baltimore Washington International airport light rail jobsite License #: MD31-189-01 Date of Event: 07/18/96 Type of Event: Lost / Stolen RAM Summary of incident: Trox!er gauge stolen from BWIlight rait jobsight. Persons broke into house next door to jobsight where gauge kept in a case in locked basement. Gauge recovered as a result of State issued Press Release. File No. 4 Licensee: N/A Location: Bresco Solid Waste Plant, Baltimore, MD License #: N/A Date of Event: 07/19/96 l Type of Event: Release of RAM Summary of incident: Trash truck and driver set off radiation alarm at entrance to solid l waste plant. Investigation concluded there was no contamination or loss of RAM; the l Bresco plant's radiation monitors malfunctioned. Monitors sent for repair.

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l l Maryland Proposed Final Report Page F. 2 {

l incident File Reviews i I File N o. 5 l l Licensee: John Hopkins Hospital Location: Baltimore, MD License #: MD07-005-03 i Date of Event: 07/23/96 l Type of Event: Medical Event i Summary of incident: A brachytherapy interstitialimplant catheter containing 30 mci of l ten Ir-92 seeds,0.3 mci ea., 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 Location: Baltimore, MD License #: MD05-051-01 1 Date of Event: 08/96 I Type of Event: Equipment or Procedure Failure I Summary of Event: -A teletherapy machine malfunctioned by sticking "on," at end of I 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 l nurse attendant manually closed the source by turning hand crank, and received l approximately 200 mR to hand (less than 1.5 rem). , 1 File No. 7 Licensee: LaurelBeltsville Hospital l Location: Montgomery Co. Solid Waste Transfer, Rockville, MD License #: MD33-037-01 Date of Event: 08/05/95 l Type of Event: Release of RAM Summary of incident: " Hot trash" set off radiation monitor at waste transfer station. County office building trash had been contaminated by county employee who had recently l received 8-12 millicuries of I-131 during thyroid therapy treatment at Laurel-Beltsville  ! Hospital. File No. 8 Licensee: Sacred Heart Hospital Location: Cumberland, MD  ! License #: MD01-002-02 l Date of Event: 04/13/94 Type of Event: Lost / abandoned RAM j l Summary of incident: Discarded lead pig and vial containing radioactive label found on  ! j local street in Cumberland, MD by Columbia Gas Co. representative. Through investigation l l State found that the hospital failed to follow standard disposal procedures. l l l i

D l l 1 l Maryland Proposed Final Report Page F. 3 Incident File Reviews 1 File No. 9 t Licensee: MD State Highway Administration License #: MD05-049 01 Date of Event: 01/25/95 Type of event: Lost stolen RAM { i Summary of incident: Troxler moisture / density gauge stolen overnight from locked field site trailer. Press release issued by State. File No.10 Licensee: MD Dept. of Transportation License #: N/A Date of Event: .07/31/95 Type of Event: Damaged to Equipment l Summary of incident: During road work Troxler thin layer asphalt gauge containing 8 mci I 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. l

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1 1 l l , l

APPENDIX G SEALED SOURCE AND DEVICE EVALUATION REVIEWS File No.: 1 Registry No.: MD-0263-D 101-G SS&D Type: lon Mobility Manufacturer.: Environmental Technologiac Spectrometry Cell Group, Inc. Date issued: 12/16/94 Comments: a) First page of registry sheet was amended dated 12/16/94. b) No information in file as to the reason the registry sheet was amended. On comparison to previous sheet, a different company was identified as the distributor. Manufacturer is now listed as distributor. c) Last sheet of registration not reissued to indicate a change in references. d) .No supervisor or reviewer signature supporting the amendment. e) Single reviewer. , 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 a low risk device, no safety product evaluation or discussion of quality assurance program was requested during this reissuance of the registry sheet. l' d) Single reviewer. I i File No.: 3 Registry No.: MD-1003-D 101-G SS&D Type: Thickness / density gauge Manufacturer: Pettit Applied Techn' ologies Date issued: 7/11/96 , i l 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  ! was previously employed. For this new license, the licensee is should be required to submit more comprehensive manufacturing QA/QC program. The licensee was required to manufacture and distribute devices according the approved certificate through commitment made and the tie down license condition. c) Although only the manufacture can perform source changes per information in the backup documentation, information regarding limitations of use on the registry sheet L

i a I l Maryland Proposed Final Report Page G.2 SS&D Evaluation Reviews l should be revised to indicate the radiation source will be installed or removed by the manufacturer. File No.: 4 Registry No.: MD-0113-D-107 G SS&D Type: Thickness / density gauge Manufacturer: Adaptive Technologies, Inc. { Date issued: 6/3/94 l l Comments: ! 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 little information on the~ OA/QC program. File No.: 5 Registry No.: MD-0113-D 108 G SS&D Type: Gamma gauge Manufacturer: Adapaw Technologies, Inc. -Date issued: 7/12/94 l Comments: 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 l been treated as new device. Older devices manufactured by this company have  ! little information on the QA/QC program. File No.: 6 Registry No.: MD-0113-D-110-G SS&D Type: Beta gauge Manufacturer: Adaptive Technologies Date issued: 7/1/96 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 brachetherapy unit Manufacturer: Nucletron Corporation Date issued: under review. Comments:

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

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

a, NEFW Fe . :410-631-31M Feb T 'W 14:42 F.02 i

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             ~ J'. h .           MARYLAND DEPARTMENT OF THE ENVIRONMENT MQ          ,

2500 Broening Highway e Baltimore, Maryland 21224 (410) 631-3000 Parris N. Glendening

Governor Jane T. Nishida i Secretary FEB 81997 .

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

Dear Mr. Bangan:

This correspondence remonds to your letter of December 16,1996 which forwarded your draft " Integrated Materials Performance Evaluation Prognun" (IMPEP) repon for Maty!and. Enclosed are the Maryland Department of the Envirofunent's (MDE) comments and explanations regarding the IMPEP team's observations and findings as contained in the draft repon. MDE appaciate.s this opponunity to provide comments to you. In general, we fuUy support the Nuclear Regulatog Commission's (NRC) revised Agreement State periodic review process. It is a significant improvement over the previous process. However. we think that the two week time period initially provided to the State for response was not adcquate. Though your office granted the requested exten.< ions without hesitatian. MDE recommends that additional time to respond to IMPEP conunents teven a draft report) should be incorporated in the initial correspondence to the State. i Regarding the IMPEP team's general concerns over staffing, please be assured that l Radiological Health Program (RHP) staffing wiU be maintained at a level sufficient to ensure that Maryland's program contbmes to be adequate to protect the public health and safety. as required l by the NRC. As with other govenunent agencies in an era of re-engineering and downsizing, the Air and Radiation Management Administration (ARMA) has made diffi: ult stafflug decisions to ' conform to budgetary limitations. Staffing of the RHP has been impacted by titis phenomenon as has virtually every other MDE progmm. Under no circumstances, however. has public health and safety suffered because of needed fiscal constraints, nor will it be in the future. An additional concern raised by the team relates to the current status of adoption of compatibuity regulations. The regulation, " Licensing and Radiation Safety Requi.tements of Irradiators", covered in 10 CFR Pan 36 of NRC regulations has become Part X in MarylandN

• Regulations for the Control ofIonizing taadjation." Your office was provided with a timetable for the promulgation of this regulation, which forecasted adoption by November II,1996.

The regulations were actually adopted on November 19,1997 with an effective date of December 16.1906. A copy of the final adoption verification is enclosed. The Regulation > Adoption Management Plan is being implemented and even effort will be made to publish ! compatibihty regulations within the required three year time frame. l l l Too roR THE DEAF H10> 013009 "Together We can Clean Up.- ATTACHMENT 2 g

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KEFW F6.:410-631-319": Feb 7

                                                                                                                iC   14:42 F.03 Mr. Richard L. Bangart -

Page2 On behalf of the Department. please extend our app.Teiation for the way the IMPEP was conducted. All participants have stated that the IMPEP experience was a very poritive one and Ms. Patricia I. arkin and her team are to be con 1 mended for their courtesy, professionalism and l ' consideration. It is also very satisfying to have a repre,sentative from another state radiation

             . program as a member of the team. Mr. Terry Frazee of Washington did a great job.

Specific responses to concerns, findings and observations are enclosed. If you should have l any questions, please feel free to contact me at (410) 631-3255, or Mr. Roland G. Fictcher, l Manager, Radiological Health Program at (410) 631-3300. You may also reach our offices l toll free by dialing 1-800-633 6101 and requesting the appropdate four-digit extension. Sincerely. bu- ' .S ' t N Merrylin Zaw-Mot, Dircetor Air and Radiation Management Administration l MZM:dpn l l Endosure I l l l i I I l l

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MARYLAND DEPARTMENT OF THE ENTIRONMENT COhGiENTS ON APPROPRIATE PORTIONS l OF THE

SUMMARY

LIST OF SUGGESTIONS AND RECOMMENDATIO l i 1. NRC RECOMMENDNIlON: The State should take action to have the Waste Management Administration revise the definition of "Petwn" in the low-level radioactive waste 0.1RW) regu,'ations COMAR 26.14.01.02B(28)(c) that was identified in both follow up review. thereview and the 1995 1993-94 RHP RESPONSE: Maryland questions the need for a change in the defutition of " person" in the LLRW regulations. Ahhough the definition in the LLRW regulations does not e.tplicitly exempt l federal facilities, if federal law does not allow application of the LLRW requirements to federal facilities, they would. in fact, be exempt. l with the Waste Management Administration, as a clarification.However, MDE w '

2. NRC RECOMMENDATION:

The State should take prompt action to ensure that Sacred Heart Hospital (SIGI) comp with the recommendations of the joint review te:un report dated March 5,1996, that was transmitted to the State April 15. 1996. HHP RESPONSE: A letter (enclosed) was sent to SHH. dated November 25,1996, that included the NRC ' recommendations resulting from their review of the 1987-88 misadministrations. SHH responded with a letter dated December 17,1996 (also enclosedl which requested a meeting between SHH and MDE for a discussion of those recommendations. During a telephone conversation on Januar.s 10,1997 between Mr. Carl Tnimp of the RHP and Mr. George Tyler, legal counsel for SHH, Mr. Tyler stated that SHH will follow through by seeking all the physicians

• input to those patients that were inisadministered. The physicians will repon back to the hospital administration, in writing, the status of the reponing requirements of those patients' families or next of k.in. After receising all physicians' reports, SHH will send a draft report to MDE for review, possibly followed by a meeting to discuss the report. Mr. Tyler has also requested a complete copy of the NRC's report from Dr. Griem.

3. NRC RECONBIENDATION:

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

o KE FIF Fa :41M31-il9i: Feb ? 7' 14:4I PM 1 1 !' l ! Enclosure l Page 2 r ! RHP RESPONSE: MDE has received a copy of the April 1995 revisions to IMC 2800. Although NRC has reduced their frequency of inspection of cenain programs, medical facilities requiring a Quality Management Program (QMP) were increased from a 4 year frequency to a 3 year frequency. MDE has implemented this change effective Jamlary 1997 under the code 02200. Those private medical programs no: requiring a QMP will remain at the 4 year inspection frequency and have been coded as 02201.

4. NRC RECOMMENDATION:

l l l The State should consider the development of a fonnal professiona] training plan through i the use of university and industry educational programs for training new staff and retrai.ning or refresh for long term staff. RHP RESPONSE: MDE will review and evaluate current trahting needs for existing staff and any additional staff that may be hired. The NRC's decision to discontinue full trairdng suppon will severely limit panicipation in all NRC courses. However. MDE wil] continue to investigate all options, including private industry and university training, to maintain the perfonnance proficiency of radioactive materials staff members. MDE strongly recommends that the NRC recognize the negative impact its . suspension of tmining sponsorsitip will have, and that it expeditiously reverse this decision. l

5. I NRC RECONBfENDATION: l Management should provide a corrective action plan to address the issue of qualifying staff.

The team also recommends that management provide a training and qualification plan for 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-tenn staff. I RHP RESPONSE: a l Training priorities and procedures are understood and followed by all radioactive materials health physicists. Fonnal training such as the five week Health Physics and other core courses are documented and kept in a binder Radioactive Materials Licensing and Compliance Division (RAMLCD) staff will document all training activities into a (comprehensive plan by June 1997, incorporating the following components: { a. Staff assigned to the RAMLCD will read peninent parts of state and federal l regulations, regulatory guides, ANSI standards and other relevant documents and venfy understanding with a signature. l

b. Existing training log will be expanded to include formal and informal training. l l

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MiC FW Fa < :dlW31-T.1'.^4 Feb i W' 14:44 P.iX. Enclosure Page 3

c. Senior inspector accompaniments of lower level inspectors will be documented on pre approved forms completed by the senior inspector.

d. A protocol outlining the purpose, frequency and resolution of supervisory accompaniments by the RAMLCD Cldef will be established,

d. NRC RECOhBiENDATION:

Maryland should assess whether a reinspection or revision to move-up the next inspection date should be considered for any higher priority licensees, i.e.. HDPa. .minographers, previously inspected by the HP 1 inspector whose accompaniment was unsatisfactory. i RHP RESPONSE: i The two inspections for.which NRC accompaniments were performed and for which the inspected performance was deemed unsatisfactory will be reinspected by another RHP staff member no later than April 1,1997. Other previous inspections of priority In or higher that were done by the inspector who performeo below cxpectation during the t accompaniment are being evaluated to determine the :ged for a reinspection sooner than the l prescribed frequency. Tids evaluation will be completed by April 1,1997. Upon i L completion, any licensee requiring reinspection will be completed by August 1.1997. l 7. NRC RECOMMENDATION: The State should asse.ss the adequacy of the program staff to ensure the long-tenu ability of the proFram to maintain an adequate program to protect publ.ic health and safety and complete the pending rules and amendments for adoption to remain compatible.

         ,               RHP RESPONSE:

1 1

j. ARMA believes that the current allocation of staff positions to the RHP is sufficient to i

maintain an effective program. In addition. the RHP is currently conducting a strategic 1 planning exercise aimed at identifying the key functions and responsibilities of each program in order to ensu e that adequale resources are available to satisfy program obligations. It should also be pointed out that the staffing description on page 11 of the draft repon is only panially accurate. Total staff positions in the RHP, which includes the Radiation Machines Division ard the RAMLCD is twenty seven, with a current fill of twenty five. The number of positions directly applied to Agreement State staff activities, including the RHP Program Manager and the RAMLCD Chief, is nine. This is a decrease of two positions from the prior tuview, but ARMA believes the restnscturing of the i RAMLCD has minimized the impact of these losses. Also, in addition to assigned staff, the RAMLCD receives support from five administrative and/or clerical positions and a Program Assistant responsible for regulatory assistance. l l l I e .- . -_. - _ . _ - . _ _ . . _ - .. -... .- , , . - ,

MIE F W Fa, :410431-3MG reb 3 ST 14:/ F. 07 l Enclosure Page 4

8. NRC RECOMMENDATION:

The RHP could benefit from a guidance document on termination oflicenses. REP RESPONSE: l ' MDE will obtain draft NUREG/CR 5846. " Manual for Conducting Radiological Surveys in Suppon of License Tennination" and develop a guidance document. The document will be available within 120 days of manual receipt.

9. NRC RECOMMENDATION:

l The State should adhere to tne policy of annual supervisory accompaniment > of aU inspectors. RHP RESPONSE: ! I MDE will adhere to the annual supervisory accompaniments of all inspection staff. Subsequent to the September 1996 NRC audit and prior to March 31.1997, all radioactive materials inspectors will have been accompanied by the RAMLCD Chief. ' 10 NRC RECOMMENDATION: The State should develop a program outlining the necessary steps to be followed by compliance staff for fuU inspector qualification, l RHP RESPONSE: 1 MDE will review current inspectors' qualifications and will develop a program by June 1.1997 that will reDeet the inspectors' competence and progression in the different skill levels of inspection. II. NRC RECO:GiENDATION: The State should begin voluntary reporting of all reportable events to the NRC Operations l Center and begin participating in the NMED data base of material events. RIIP RESPONSE: MDE will attempt to supply this voluntary infonnation to maintain this database in i accordance with the guidance contained in the " Handbook on Nuclear Material Event Reporting in the Agreement States." Draft Report, March 1995. l

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 .       MIC F F                           Fa :410-631-3193:        Feb ? 'W l

14:45 F.(6 I l l l Enclosure l ' i Page 5 l l

12. NRC RECOKvirNDATION:

             *Ihe State should provide event information for three events identified by the State in j             response to the IMPEP Questionnaire.

l RHP RESPONSE:

                                                                                                              )

MDE will supply investigation repons for these events under separate cover.  ! J

13. NRC RECOMMENDATION:

The State should provide close-out infonnation to NRC on allegations referred to the State by NRC. RHP RESPONSE: To our knowledge information has been provided to the NRC on all allegations through NRC Region L The RAMLCD is mviewing this area and will institute procedures that ensure more efficient tmcking of all allegatious to closure.

14. NRC RECOhnENDATION:

1 The State should improve the effectiveness of the Regulation Adoption Plan by providine a realistie schedule of milestones for deselopment and adoption of 10 mies currently identified in the pian for adoption by the end of 1997. RHP RESPONSE: The schedule as previously submitted to the NRC is being myiewed to incmporate additional milestones. A revised version will be provided by April 1.1997.

15. NRC RECOhBfENDATION:

The State should address the process for multiple rulemakings to ensure that they are completed within three years of the effective date. l RHP RESPONSE: l The RHP has already committed to the time frame for multiple rulemaking and has j enablished a process (copy enclosed).

16. NRC RECOhBIENDATION:

The State should implement a plan to review all registration sheets, based on the risk associated with the device, especially detailed QA!QC program infonnation. t l

i KEFW Fei. :410-631-31sti: Feb ' V 14:45

                                                                             .                   F . O.4 Enclosure Page 6 RHP RESPONSE:

MDE wb] evaluate Maryland's SS&D sheets for safety, adequacy and QA in accordance ! with associated risk. Those found deficient will be further evaluated for amendment i their entirety. The implementation date will be August 1,1997

17. NRC RECOhbiENDATION:

L The State should adopt regulations compatible with 10 CFR 30.32(g) and 10 CFR 32.210. REP RESPONSE: The RHP is committed to the adoption of these regulations. The adoption of these regulations is on the Regulations Committee agenda and has an implementation deadline of December 1997 for 10 CFR 30.32(g) and July 1998 for 10 CFR 32.210.

18. NRC RECONNENDATION:

An additional senior staff should be trained to perfonn the SS&D evaluations to supplement the program as it matures. RHP RESPONSE: An additional staff member wiU be trained in SS&D reviews. J I l

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itE FW Fe, :410-631-315G Feb 3 '97 14:4? F,10 1 l . i 4 t 1 i j i b = 1 i Enclosures i I 1

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MIE FtF Fb :41H.31-319':: Feb ? *W 14:46 P.13

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GEPPERT, McMULLEN. PAYE & GETTY l a enorcssio, SAL compomatione I as phosprev sovAnc { cvMacnANo. wAnytAno riso:

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                                                                                                   . . .      DEC I 91996 !J-                .

! Roland G. Fletcher, Environmental Manager II, - ' Radiological Health Program, l 'a l

                                                                                                    . c :0'. COE HEA'U. ??SP. F !

Maryland Department of the Environment, -~'~~~~ ~ ) 2500 Broenig Highway, Baltimore, Maryland. 21224. Re: Radioactive Material License No.: MD 01-002-02 1 NRC Review of Misadministrations at Sacred Heart Hospital (1987-88) j i

Dear Mr. Fletcher:

I am general counsel for Sacred Heart Hospital and a new parent organization, Western Maryland Health System, as a result of t i a hospital affiliation concluded in the spring of 1996. On behalf l of the Hospital and the System, I acknowledge your letter dated November 25, 1996 (received by the Hospital on or about December 11, 1996). 1 and 'your I am staffconfirming that the Hospital desires to confer with you in detail to review the existing compliance information and to reach clear, mutual resolution in regard to any further compliance measures. In f act, we had asked Attorney George l Tyler (who continues to represent the Hospital as special counsel I in this matter) to contact you, discuss any preliminary issues { involved in the past actions of the parties, and to arrange a conference. l We understood that he had contacted Mr. Trump several months ago. We desire to work ef fectively with you to resolve any lingering problems, and ask that you contact Attorney Tyler so that we can get started. Although we are anxious to retiolve matters, we do have a short-term scheduling problem. Mrs. Candace Geatz, the Hospital Quality Assurance Manager, is on medical leave and will not return until January 6. She is the primary custodian with knowledge of documentation regarding past compliance activity. We would like to l have several weeks following her return to assemble l the ' documentation for review with you. t ! Under the circumstances, we would like an extension until the end of January to respond with the agreed documentation. l l i l

MIE FF Fa :410-631-3193 Feb ? *W 14:47 F 12

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l Roland G. Fletcher, Environmental Manager II December 17, 1996 , Page No. Two l Then, your staff. we would like to have a detailed conf erence with you and At that time, we could review together the agreed documentation and any further compliance requirements. ! We ask that yoJ contact George Tyler with any comments or suggestions, and to arrange a conference. Also, please let me have a copy of future correspondence regarding this matter. Very truly yours, GEPPERT, M B y__ l/,fc. LLEij,',PAYE

                                                                   .    ((way,
                                                                               ,q & GETTY w

7-RSP:st cc: George T. Tyler, Esq. Edward M. Dinan, President Dorothy Winner, Vice President fi 0 id 3 , ~ri;;

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                                                                          .                           . L;    .-

l , DEC l 91996 jij l .__- -- i

                                                                         ..//. EEAi. HEALTH PROGRM.!

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, MIE F w Fe :41 H 31-iliG Feb 7 '97 14:47 F.I? QQ MARYLAND n DEPARTMENT OF THE ENVIRONMENT Highway e Baltimore, Maryland 21224 Parris N. Glendening Governor Jane T. Nishida Secretary November 25,1996 R CE[p Ofc g CERTIFIED MAft  % g 4 Dorothy Winner, Vice President CAL Patient and Administrative Services ray Sacred Heart Hospital (SHH) l P.O. Box 539, 900 Seton Drive , Cumberland MD 21502 t ret Radioactive Material License Number: MD-01-002 02 Questions in 19871988Remaining from NRC Review of Misadministrations at Sacred Heart Hos

Dear Ms. Winner:

This letter refers to the Nuclear Regulatory Commission's (NRC) Executive Summary of their review of the SHH misadministrations that occurred 19871988 in and whether the required actions, notifications and follow up activities have been taken or are scheduled to occur as recommended by the NRC. Copies of this report were sent to your hospital and Mr. George Tyler, Attorney representing the hospital. As part of the report, the NRC specifically identified five (5) topics included under 1 Enclosure 1 that have not been answered sufficiently by SHH staff. As a follow up to this observation. the Maryland Department of the Environment's (MDE) Radiological Health Program (RHP) is committed to obtain the necessary information. Therefore, MDE requests that the SHH staff carefully review each of the topics and address all issues and concerns listed under each topic. Specifically, MDE requires the assurance itom SHH that all of the 33 patients whoincurred misadministrations at SHH during the 1987*1988 { period were notified in accordance with the requirements of COMAR 26.12.01.01. Section D.1209 titled, " Notifications. i Records and Reports of 1 Misadministrations." E,ach referring physician should have notified each patient, the f amily the next of kin. However, the referring physicians were required to inform SHH that they notified their patients, or that, based on medical judgement, informing their patients would have been harmful.

                                                                                                                          \

Each attending physician is required to provide the appropriate documentation for such patient and submit their reports to SHH. In turn, MDE requires that copies of these reports be submitted to the Department within thirty (30) days upon receipt of this letter. l I Tco poa THE DEAF (4101631.W/ "Together We Can Clean Up" anne * *er

o MIE F W Fai :410-631-31% Feb ? 'W 14:C P.14 l 6 l l Ms. Dorothy Winner page two Should you have any questions concerning this letter please contact Mr. Carl Trump. Jr. or me at (410) 6313302. You may also reach our office by calling toll free i 1 800 633 6101 and requesting ext. 3302. l l Sincerely, Roland G. Fletcher, knvironmental Manager il Radiological Health Program d.[ RGF/CET/edjg cc: George Tyler. Esquire Christine Buesch, Assistant, Attorney General's Office Each referring physician should have notified each patient who incurred the

misadministration.

i l l 1 l 1 1 l 4

i MIC F W Fa t410-631-?l95 Feb ? '97 14:41 F.15 { i J a RNAL ACTION ON REGULATIONS 1787  ! eoc to 300 animal unita has been added to aprec more com. I pletely wlth iederallanguage. casar a darharre and breause teater cuality violation: or

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f& Regulation .09Nt2irchiiir: Languare has been repeated for the hkelihini to ducharge have prevsousiv been accio. i

     'T                                                                      'mented.

clarity

• Site conditions including slope. lack of vegetatiw cover and proximity tn surface waters have been included .091 Fees for General Discharge Fermits.

to match the federal language more closely and for more A. - G. (text unchanged) W'5'I'1 11. Fee fur Discharges from Suimming Ponts and Spos Regulation .091H: Language has treen added to clnrify

• Notke ofintent (NOI) Fee. Persons seekona coe.:rup; unace, that ND1 fees need not be paid for the repstration of mu. this general permst shall submit on NO! together neith a fee sucipa). State. or county owned 'paolo and spa s. of $100(ur cach faciliev. Afee ss not requirral with the Not Segulation .0911: In place cia $500 fee for each marm.a, submnsion for the reiistratuon n! pocin owned bv munsci-a allding fee scale has been adopted. reducing fees (or all marinas with fewer than 200 shps. Tbv phrase *the lesser of pohties, eng mdmdual counties.

ressdencesur arethe not State. require Owners ofbo<sts or sp submu an N01 the above fee or $350" was added to *Facihties already reg. f

  ;     , latered under 92.GP-0001 shall psy,,.                              # fT, j,,#'Discharyn f            from Mo ri
  -                                                                                                                    noa. N OI fa.

Regulation .091J: The title has been changed from "Atu* . 1! Persons oceking coverage under this general permst mal Waste FacilJties'to

• Concentrated Animal Feeding op. shal submit an NOI rosether with ((a fee of $500 for each orations for consistency mth federal regulations and dcfi. farsisty)) the followsnr fee depending upon the number of

                                                                             ,y,,,, nuortaN4 at the monna:

nitions Permittees with 300 or fetver animal units have been exempted from paying dischstge permit fees. Number o/Shos Fer

          .09 General Discharge Permu.ts                                                        200 or more shps                           $~Go A. -M. tproposed text unchsnged1                                    100 ne more and feu er than 200 slim                     M N. General Dinharge fermst (vr (Vm.mni %te l'scth.                   pr w rnere and fewer than 100 shns                      M tirs)) Concentrated Anwel Tecdine Operotion-                              yo ,, mo,e an,g g,we, gy,, y, ,j,9                     y (1) Exce                                                                       y,,, g, j 9 ,y                              y diehnescs' ptv>ns Tha permtt aocs not evver the follou o_ng m paejugw as,rady regisiered under 92 GrBTshell ta* Posnt source dwcharges of wastewater to eurface       pay tic lesser nf the above fre or a fee of 5350 before Septer -

water eserpt in the case of a storm water svent groater than y,,.199b to regater for thn per trut the 25., scar. N hour stver% lland)) o":  ; y,, (n, pug;,,,ge, f,.vra \Vrurnal %'nete Faniitm)) tb] Duchotgu from fecdlots Tr duckr Cortcentrated Arumal Tending Operctions. (2) Eheble Ducharges Thus permtt costra ground wa. (1) (propot.ed text unthun ter dhchargn licomposed.)) tqa application of houa_J waste. t2 Ducharge Permet Tec. gedt t watre in the sont surface. The followsnt fauhtees shool hor,e u ducharge permit' to) The Departrnent shall calculcts the dsscharge per-Mt fee und shall bill l\the permstice}} permittee s wsth rnurc to) llEntsrely of animul wastewater from concen. than 300 u nimal units. This fee shall he paid h' July 1 of the trated animcl ferannt operorsons}} Operatirme with more

• p ear.

than 1,000 animal untt.sll, ib te> (proposwd text unchanged tb> Of animal wastescater from faelittnes wtth. (3s (proposed text unchanged > (J More than)) ne 35,000 turkeys [(]). JANE T. NISHIDA th Occratsons wsTIs 30.000 or more c'hickens wHeh bMhWAkN*NM produce a hourd waste stream ,M t>ercent or mnot haundi

                     \\'un 100.000 laying hen.t nr broHers and a contor;w ous overflow watering, c' i

(iiii 30,000laysng heta or broilers and c liquid me. Subtitle 12 RADIATION MANAGEMENT

   '      nure system)). and

_ (c) llOf wastewater from animal)) .Snimal(ceding fa. 26.12.01 Radiation Protection ethtues whnh have been or uss u threat to.turloce water euul. _ . y , ,,,,,,,, , ,7w;,, ;,,, , , ,,,, _, ,e ,, nty because. An.vuwe cs et Marv)srai tD Cmlined animals come into direct contact wnth surfart' noters. Notice of Fknal Action ( Win There us a potentini to discharge into curface gw.y i waters of th,s State through a mon made conveyorat. or on November 10,1996, the Secretarv of the Environmust

  ;                 tiin, Previous surface water ducharge. have been        adopted amendments to Regulation'.01 under COMAR 1      d8'""###d'3I                                                     28.12.01 Radiation Protection Theer amendments.

(sil The Department determs.nes. ofter o ss.te insocc. which were pmposed for adoption in 23:20 Md. R 1s35 jt oyp t the animal feedtnr focsiutses are hhch to dischare' (Stptember 27.19961. hsve been sdopted as proposed sntc wers vi thn State throuen, c man made cons erance Effectivc date: December 16,1996, hnciuling sprov irr<gatsont because the arte of the ansmal fredsnioperunan exceeds 300 annmal units and sucsterrater 3,WE T. NISMA is hhelv to te dsscharged. or Svutetary of Envirnnment 6iit The Departmer:t determtnes. cfter a site snspeg tion. that the ansmal feeding facshtnes are hkely to discharge into uwsters of thn State thrvuph a man.mnde convevance h (sneludum spra_v srreratton

• because the means of wastewc.

ter consnante and site condstsons unclwtune slope. Lock of sorectatsce cos.r*. nnet proxtmots to surface waterr are bhclv in MARYt.AND REGtSTER, VOL 23. lSSUE 25 FRIDAY. DECEMBER 6.1996 A e

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TABLE FOR QUESTION 29. OR DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED , STATUS ADOPTION Any amendment due prior to 1991. Identify each seg-dation trefee to the Chronology of Amendments) IAEA Compatibility 10 CFR Part 71 916/8 6 91919 5 Addressed in Sectic, T, of Raguis:lons for Control of lontring Radiation (19941 Gfess Enemet and Glass Frit 9/11187 9/9#95 Addressed in Settlon CJfcH2xiirl y Indtsstrial Radiography Surveys 711 618 9 98919 5 Addressed in Section E.201 k l Banneruptcy Filing Notification 2i11190 9/919 5 Addressed in Section C.31te) f' Os Notifications, Reports, and Record of 4i1/90 9/9195 Addressed in Section D.1209 Y Mishstration '.s Welt Lagging 7114/90 9/9/95 Addressed in Section W S Dosimetry Processing 2/12/91 9/9/95 Addressed in Section D.501(cNiil Decommissioning: 7/27191 91919 5 Addressed in Section C.29 Parts 30. 40. 70 Emergency Planning: 4/719 3 9/9/95 Addressed in Section C.23 Parts 30,40. 70 y tr - Starxfards for Protection Against Radiation; 1/1/94 9/9/95 Addressed in Section D & Section A.2 *-*8 Part 20 - Safety Requisements for Radiographic

                                                                                                                                                                                                                                                                                                                                  'b
                                                                                       'i                                                 1110194    919/95    Addressed in Section E.308 Equ'pment; Part 34 5

Notifice:lon of incidents: 10/15/94 9/9/95 Addressed in Section D.1202 E Parts 20,30,31,34,39 40. 70

• Quality Monsgement Program and 1127/95 9/9/95 Addressed in Section G.76 Misadminrstrations: Part 35 m Licensing and IIndlation Safety 7/1/96 proposed Section X 11196 '

Requirements for Irradiators; Part 36 20

                                                                                                                                                                   .                                                      =     a r

DR DATE DATE , 10 CFR RULE DUE ADOPTED _ CURRENT EXPECTED

                                                                                                                                       $TATUS                                 ADOPTION                                          d Definition of Land Disposal                      7/22/96                                                                                                                                                     m and Waste Site QA Program: Part 61                                                                                                                        Mla                                                y Decomrnissioning Recordlieeping Docu-            10/25196               9/9195         Adttressed in Section C.29tfl[3]

mentation Additions; Parts 30,40,70 Self-Guarantee as an Additional Financial 1!28197 Not consistent with conchesions reached by Marytend's Legislative Mechanism; Ports 30,40,70 N/A Auditors Uranium Mitt Toilings: Conforming to EPA 7/1/97 Standards; Part 40 NfA Timeliness in Decommissioning 8115/97 No action taken 8f97 Ports 30. 40,70 y Preparation Transfer for Commercial Dis- 111/9 9 No action taken 12/97 tribution, and Use of Byproduct Material for , Medical Use: Parts 30,32,35 M, i Frequency of Medical Eneminations for Use 3f13/98 No action taken U of Respiratory Protection Equipment 12fS7 '8 Low-Level Weste Shipment Manifest 311/9 8 No action taken Informatiori and Reporting 12157 Performance Requirements for Radiography 6130/98 No action taken Equipn ent 12r$ 7 Radiation Protection Requirements: 8/14198 No acti.in talien e 12/97 Amended Definitions and Critoria v8 Clarifiestion of Decommissioning Funding 11(24f99 Nn action taken Requirements 12!97 j 10 CFR Part 71: Compatibility with the 411/99 No action taken 12f97

              ' International Atomic Energy Agency                                                                                                                                                                           h
                                                                                                                                                                                                                             .t, t.

Medical Administration of Radiation and 10/20/98 No action taken 12f97 Radioactive Meterials. Termination or Transfer of Licensed 5/16199 No acticci taken Activities: Recordkeeping Requirements. 12/97 L

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1 ( [ UNffE0 STATES ,

  '      I                              NUCLEAR RECULATORY COMMISSION WAaMINeToN, D.C. MMMGM

[ k..... February 28, 1997 Mr. Roland G. Fletcher, Administrator Radiological Health Program Maryland Department of the Environment 2500 Broening Highway Baltimore, MD 21224

Dear Mr. Fletcher:

We have completed a review and evaluation of the Final Maryland Rules, COMAR 26.12.01.01, for compatibility with equivalent NRC regulations contained in the Code of Federal Raoulations, Title 10, " Energy," Chapter I, " Nuclear Regulatory Commission, Parts 0199. We indicated, in the Draft IMPEP Report, dated December 12,1996, that NRC ataff had reviewed the 13 amendments to the final COMAR regulations adopted by the State, that became effective October 9,1995, and, based on the review, found that our earlier comments had been addressed. However, as a resutt of our review for j i compatibility, several new comments having compatibility significance were found and have been identified in the enclosure. Therefore, we are unable to find the final Maryland regulations compatible. 1 As you are aware, Agreement States have flexibility to adopt rules required for compatibility in the form of legally binding requirements (LBR), as opposed to regulations. For example, since Maryland has no welllogging ikensees, comments in the enclosure > regarding the Maryland welllogging rule can be ado essid through a general LBR, such as a generic or standard license condition if an applicati0n for a welllogging license is received. If our comments need clarification, or you disegree with them, we recommend a meeting after you have completed your review. If you have any questions regarding the comments, please contact me at (301) 415 2326 or Mr. Craig Gordon at (610) 337 5216. ereiy,

                                                                                               .,    r k      w        D&jh4<Y Paul H. Lohaus, Deputy Director Office of State Programs Enclosurei As stated n,n   y
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i . Review of COMAR 26.12.01.01 Ansinst Comoatibility Division 1 and 2 Reauirements State NRC t DiL &dt Bult Subject and Comments 1 D.703 20.1703 Use of Individual Respiratory Protection Equipment. Section D.703 a.vi. uses the words "the licensee shall use equipment within the equipment manufacturer's expressed limitations for type and mode..." Reference only to the manufacturer's limitations may narrow the scope of the rule. This narrowing may inadvertently ' result in a licenses failing to comply with limitations established by NIOSH or MSHA, especially if those limitations are not included (for any reason) in the manufacturer's literature. This rule is a Division 1 i matter of compatibility. We suggest that Maryland use the more general wording set out in Section i 20.1703(a)(6), which would encompass both the manufacturer's and any NIOSH or MSHA limitations. 2 D.801 20.1801 Security of Stored Material. t Section D.801 does not include the entire phrase

                                          "...shall secure from unauthorized removal or access.'.."

as set out in Section 20.1801. The words "or access" have been deleted. This section, as written, may not require an equivalent level of security. For example, the rule may not cover a situation where an unauthorized individual gained access to a storage location and removed radioactive matorist from it's shielding / packaging, but did not physically remove the material from the storage location. This rule is a l Division 2 matter of compatibility. We suggest you  ! amend this section to include the additional wording, "or access". 1 D.1202 20.2202 Notification of incidents. In order to assure compatibility in subsections a.i.(3) and b.i.(3), the phrase "or a total organ dose equivalent" should be deleted. In subsection a.ii, the word " occupational" should be deleted. 2 None 30.50 Reporting Requirements. Staff was unable to find incident reporting requirements equivalent to those contained in i 30.50 in the

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 ,           DiL BH11    Bult           Subiect and Comments Maryfend regulations. This rule is designated as a Division 2 matter of compatibility and should be adopted to maintain compatibility.

2 None 39.49 Uranium Sinker Bars. Staff was unable to find an equivalent section in the Maryland reguistions. This rule is designated as a Division 2 matter of compatibility and should be I adopted to maintain compatibility. 2 None 39.51 Use of Scaled Source in Well Without Surface Casing.  !

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Staff was unable to find an equivalent section in the Maryland regulations, if Maryland has other a requirements that would preclude welllogging from being performed in an uncesed well, staff sees no need l for Maryland to adopt this requirement. However,  ! these provisions are designated as a Division 2 mettrsr I of compatibility. Therefore, if welllogging opereticas could be performed in walls without surface casing, the provisions of this section should be adopted to maintain compatibility. 1 l 2}}