DATED: MARCH 21, 1997 SIGNED BY: H. L. THOMPSON, JR.

Ms. Merrylin Zaw-Mon, Director

Air and Radiation Management Administration

Maryland Department of the Environment

2500 Broening Highway

Baltimore, MD 21224

Dear Ms. Zaw-Mon:

On March 6, 1997, the Management Review Board (MRB) met to consider the

proposed final Integrated Materials Performance Evaluation Program (IMPEP)

report on the Maryland Agreement State Program. The MRB considered and

concurred with the review team's recommendation that the Maryland program be

found adequate to protect public health and safety but needs improvement, and

not compatible with NRC's program. 

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 issues in the State's final equivalent rules, that

became effective October 9, 1995, for Parts 20.1703, 20.1801, 20,2202, 30.50,

39.49, and 39.51, that had not been previously identified by NRC during

previous reviews of the regulations in question. The State staff 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 final promulgation of the revisions of the

specific regulations that were identified by NRC as not compatible, in the

February 28, 1997, letter to the State. 

Due to less than satisfactory performance of a HP-inspector during two onsite

field inspections at a radiography site and a high dose rate brachytherapy

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 inspector who performed unsatisfactorily is no longer

with the program, and revised the team's recommendation to a Satisfactory for

this indicator. 

Section 5, page 26 of the enclosed final report presents the IMPEP team's

recommendations. Note that there are two additional suggestions and/or

recommendations that were identified at the MRB: (1) to inform NRC when the

referring physician/patient notification requirement has been completed by

Sacred Heart Hospital; and (2) to consider implementing an allegation tracking

system. We have received your letter dated February 3, 1997, and appreciate

the positive actions that you and your staff have taken and are continuing to

implement with regard to our comments. No response to this letter is

necessary.
Ms. Merrylin Zaw-Mon 2

Based on the results of the current IMPEP review, the next review will be

scheduled in three years, unless program concerns develop that require an

earlier evaluation.

I appreciate the courtesy and cooperation extended to the IMPEP team during

the review and your support of the Radiation Control Program. I look forward

to working with you in the future.

Sincerely,/RA/

Hugh L. Thompson, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosure:

As stated

cc: R. G. Fletcher, Manager

Radiological Health Program

Air and Radiation Management Administration
Ms. Merrylin Zaw-Mon 2

Based on the results of the current IMPEP review, the next review will be

scheduled in three years, unless program concerns develop that require an

earlier evaluation.

I appreciate the courtesy and cooperation extended to the IMPEP team during

the review and your support of the Radiation Control Program. I look forward

to working with you in the future.

Sincerely,

Hugh L. Thompson, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosure:

As stated

cc: R. G. Fletcher, Manager

Radiological Health Program

Air and Radiation Management Administration

bcc: Chairman Jackson

Commissioner Rogers

Commissioner Dicus

Commissioner McGaffigan

Commissioner Diaz

Distribution:

DIR RF DCD (SP01) PDR (YES _X__ NO ___)

SDroggitis

KSchneider

CZGordon, RSAO, RI TFrazee, WA

KCyr, OGC DCollins, RII

FCongel, AEOD CHaney, NMSS

CPaperiello, NMSS DCool, NMSS

TCombs, OCA

FCameron, OGC

Maryland File

DOCUMENT NAME: G:\PML\MDFNL.CVR 

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy

OFFICE OSP OSP:DD OSP:D EDO

NAME PMLarkins:kk PHLohaus RLBangart HLThompson

DATE 03/13/97 03/ /97 03/ /97 04/ /97

OSP FILE CODE: SP-AG-17
 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF MARYLAND AGREEMENT STATE PROGRAM

SEPTEMBER 23-27, 1996 

FINAL REPORT 

U.S. Nuclear Regulatory Commission

04/23/97
1.0 INTRODUCTION

This report presents the results of the review of the Maryland radiation

control program. The review was conducted during the period September

23-27, 1996, by a review team comprised of technical staff members from

the Nuclear Regulatory Commission (NRC) and the Agreement State of

Washington. Team members are identified in Appendix A. The review was

conducted in accordance with the "Interim Implementation of the

Integrated Materials Performance Evaluation Program Pending Final

Commission Approval of the Statement of Principles and Policy for the

Agreement State Program and the Policy Statement on Adequacy and

Compatibility of Agreement State Programs," published in the Federal

Register on October 25, 1995, and the September 12, 1995, NRC Management

Directive 5.6, "Integrated Materials Performance Evaluation Program

(IMPEP)." Preliminary results of the review, which covered the period

April 4, 1994 to September 20, 1996, were discussed with Maryland

management on September 27, 1996. 

A draft of this report was issued to Maryland for factual comment on

December 16, 1996. The State of Maryland responded in a letter dated

February 3, 1997 (attached). The 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 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, 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 improvement, and not compatible with NRC's program. 

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 issues in the States final

equivalent rules, that became effective October 9, 1995, for Parts

20.1703, 20.1801, 20.2202, 30.50, 39.49, and 39.51, that had not been

previously 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
Maryland Final Report Page 2

licenses, which include commercial irradiators, manufacturers, broad

academic, broad medical, radiopharmacy and radiographers. In addition

to its radioactive materials program, MDE is responsible for the control

of machine produced radiation, and 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 Appendix C to this report. 

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

of: 

(1) examination of Maryland's response to the questionnaire, (2) review

of applicable Maryland statutes and regulations, (3) analysis of

quantitative information from the radiation control program licensing

and inspection 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 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 IDENTIFIED IN PREVIOUS REVIEWS

The previous routine review was conducted August 30 -- September 4,

1993, with follow-up activities conducted at selected times through

April 7, 1994. The results of this review were transmitted to Ms. Jane

Nishida, Secretary Designee, Maryland Department of the Environment on

March 3, 1995. A follow up to this review was conducted November 7-8,

1995, and the results transmitted to Secretary Nishida on April 17,

1996. A special joint U.S. Nuclear Regulatory Commission (NRC) and

State of Maryland review of 33 misadministrations that occurred in 1987-

1988 at the Sacred Heart Hospital (SHH) located in Cumberland, Maryland,

(MD-01-002-02) was conducted in late 1993 and early 1994, in response to

issues raised during an August 1993 Congressional hearing that

questioned: (1) the adequacy of the State's 1988-1989 review; (2) why

NRC had not previously reviewed the event; (3) inconsistencies in the

records; and (4) the State's agreement to limit access to the records. 
Maryland Final Report Page 3

2.1 Status of Items Identified During the 1993-1994 Routine Review

A number of recommendations were identified as part of the 1993-1994

review. The 1993-1994 review resulted in the withholding of a finding

of compatibility due to 13 regulations not having been adopted within

the 3 year period required by NRC. The team noted that the definition

of "person" in Maryland's low-level radioactive waste (LLRW) regulations

included jurisdiction over Federal facilities which is not consistent

with 10 CFR 150.10. Section 274 contains no explicit waiver of the

sovereign immunity of the United States; therefore, the agreement does

not convey any authority for the State to regulate Federal agencies. 

Agencies of the Federal government are not exempted and continue to be

subject to NRC regulation, not State regulation. The 1993-94 report

stated that the definition of person in an Agreement State's regulations

should not include agencies of the Federal government. Therefore, the

State was requested to either remove or provide clarification to explain

that, in COMAR 26.14.01.02B(28)(e), which includes Federal agencies in

the definition of "person," with regard to Agreement materials, Federal

agencies are not subject to these regulations. In addition, it was

recommended that the State continue its efforts to renew the Neutron

Products, Inc. (NPI) license to establish a clear set of license

requirements against which the state can assess continued operations at

NPI and against which enforcement action can be taken, if required. 

Specific milestones and schedules for completion of actions were

requested. The State was notified of NRC's intention to conduct a

follow-up review. Some of the recommendations were closed at the time

of the 1995 follow-up review. The review team looked at each remaining

item to determine whether or not the Maryland program had taken

additional actions to close open recommendations.

(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 Ionizing Radiation (1994)" which became effective October 9,

1995. See the next section for a continued discussion. 

(2) Status of the State's definition of "person" in the LLRW

regulations to include Federal entities is as follows:

As of the 1993-1994 review this item was pending the result of

discussions between the State and NRC legal staff. See the next

section 2.2(1) for a continued discussion.

(3) Status of the effort to renew the NPI license.

In January 1994, a court settlement was reached which required

certain actions by the licensee (NPI). With regard to the NPI

license renewal, the State maintained discussions with NPI and, on

August 1, 1994, NPI submitted a renewal application. However, in

their preliminary screening, the State found the application to be

deficient in several procedural areas including some of the

requirements identified in the January 1994 court settlement. 
Maryland Final Report Page 4

Discussion between the State and NPI continued in an attempt to

resolve the issues. In the June 6, 1995 response letter to the

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

issuance or renewal of the four (4) 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 the State noted difficulties in resolving issues with NPI

management. See following section 2.2(3).

2.2 Status of Items Identified During the 1995 Follow-up 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 Ionizing 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 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 radioactive waste regulations that included jurisdiction

over Federal facilities is as follows:

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 action to revise the definition of "person" in Section 2.A of

COMAR 26.12.01.01, titled "Regulations for Control of Ionizing

Radiation." The definition now includes and "to the extent

authorized by federal law, federal government," which is

acceptable to NRC, as of May 1996.

The 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 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 (attached). These 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 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 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 NPI license is as

follows:

A specific concern, during the 1995 follow-up review, resulted in

a recommendation that the State work with Montgomery County in

evaluation and approval of the NPI proposal for construction
Maryland Final Report Page 6

activities which should reduce the unnecessary radiation levels in

and around the facility.

The 1995 follow-up review also commented on the prescriptiveness

of the draft license (MD-31-025-01) and the concern that

specifically tying the licensee's detailed procedures to the

license would preclude the necessary flexibility for the licensee

to satisfy and promptly address emergent conditions at the

facility. However, the State experienced difficulty in getting

NPI cooperation in resolving issues such as financial assurance,

the 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 from NRC to renew the

NPI license, 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 NPI.

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 has inspected the

facility three times in 1994, twice in 1995 and twice to date in

1996. While this does not meet the State's intended quarterly

unannounced inspection schedule, it does exceed the NRC inspection

frequency for this type license. The State also notes that

contact with this licensee is quite extensive and time consuming
Maryland Final Report Page 7

and that when these other contacts are taken into consideration

the State does interact with NPI on at least a quarterly basis. 

The State has performed an independent assessment of the internal

exposure potential (much less than the amount requiring monitoring

and summation of doses) and the dose to the nearest residents

(probably near 100 mrem per year). In April 1996, the State

approved the conceptual design for a courtyard enclosure to reduce

worker and public exposures and on and off-site contamination. In

August 1996, the State demanded the licensee submit the detailed

plans for the courtyard enclosure as required by court order. The

licensee, in accordance with the court order, submitted plans to

the County and State in September 1996. Subsequently, the team

found that upon technical review the plans were found incomplete.

The licensee has agreed to use concrete 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. Finally, the

State has succeeded in requiring the licensee to reduce the volume

of waste storage by sorting and shipping lightly contaminated

combustible material to SEG for incineration.

The team believes slow but steady progress has been made in

dealing with NPI despite the unwillingness of NPI management. 

Although the very prescriptive renewal license issued in January

1996 has been appealed and held in abeyance pending the outcome of

an administrative hearing, significant progress has been made for

the most serious health and safety issues. The Maryland program

continues to maintain a strong licensing and enforcement stance

with respect to NPI yet has indicated to the review team a

willingness to work with NPI to resolve issues and produce a less

prescriptive and more performance oriented licensing document. A

well thought out and documented strategic plan is in place to

implement a performance-based inspection plan at NPI which

emphasizes the achievement of quality in all facets of NPI's

operations. These inspections will emphasize direct observation

and surveillance of licensed activities and will stress 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. 

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
Maryland Final Report Page 8

1994, in response to issues raised during an August 1993

Congressional hearing that questioned: (1) the adequacy of the

State's 1988-1989 review; (2) why NRC had not previously reviewed

the event; (3) inconsistencies in the records; and (4) the State's

agreement to limit access to the records.

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

1996, to Ms. Merrylin Zaw-Mon, Director, Air and Radiation

Management Administration, Maryland Department of the Environment,

the review team concluded that the direct cause of the

misadministrations was the use of an incorrect computer file. 

There were a number of factors contributing to the

misadministrations including, for example, inadequate

communications and failure to verify procedures and calculations. 

The review concluded that the root cause was lack of management

oversight of the SHH radiation safety program. The special review

team found that SHH did not provide all the notifications to

referring physicians and patients as required by Maryland law. 

The special review team recommended that the State of Maryland

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

reviewed the report and agreed to implement those actions the

review team recommended the State take. The recommendations

included actions the State should take to ensure that SHH complies

with the referring physician/patient notification requirements of

Maryland law. The IMPEP review team was tasked to follow up on

the State's action. In discussions with the Director, RHP, the

team found that the State discussed the recommendations of the

joint NRC/MD review, including the referring physician/patient

notification requirement with the new SHH staff (NOTE: SHH has a

new CEO Administrator, who was not a member of the SHH staff

during the joint NRC Maryland team review). In a telephone

discussion in June 1996, the legal counsel for SHH expressed

concern that some of the joint report recommendations were overly

burdensome. The legal counsel was concerned that an upcoming

merger between SHH and Cumberland Memorial Hospital might be

jeopardized if the new affiliate had to adhere to the terms of the

recommendations placed on SHH. The SHH legal counsel requested

that the State delay action on the 4/15/96 letter through the

State 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. 

The IMPEP team recommended that the State take action to ensure

that SHH complies with the referring physician/patient

notification requirements of Maryland law as identified in a

report dated March 5, 1996, that was transmitted to the State

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 recommendations resulting from the 1987-88

misadministrations. SHH responded and will follow through with

physicians information regarding notification to misadministered

patients, families or next-of-kin. 

This recommendation is closed. 
Maryland Final Report Page 9

! The review team recommends that the State of Maryland inform NRC

when the referring physician/patient notification requirement has

been completed by SHH.

3.0 COMMON PERFORMANCE INDICATORS

IMPEP identifies five common performance indicators to be used in

reviewing both NRC Regional and Agreement State programs. These

indicators are: (1) Status of Materials Inspection Program, (2)

Technical Staffing and Training, (3) Technical Quality of Licensing

Actions, (4) Technical Quality of Inspections, and (5) Response to

Incidents and Allegations. 

3.1 Status of Materials Inspection Program

The team focused on four factors in reviewing this indicator: 

inspection frequency, overdue inspections, initial inspection 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 inspection data tracking system, the examination of licensing and

inspection casework files, and interviews with managers and staff. 

Review of the State's inspection priorities showed that, with the

exception of medical private practice licenses with a QMP, the State's

inspection frequencies for various types or groups of licensees are at

least as frequent, or more frequent than, similar license types or

groups listed in the frequency schedule in the NRC Inspection Manual

Chapter 2800 (IMC 2800). Inspection frequencies under the State's

system range from quarterly to 5-year intervals. More frequent

inspections are required by the State in the following license

categories: licensees manufacturing sealed sources for irradiator use

have a 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

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 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 QMP

is required. The team noted that the State was referencing a previous

version of IMC 2800 and had not incorporated the April 1995 revisions to

IMC 2800. Management indicated action would be taken to correct the

oversight. 

! The review team recommends that the State incorporate the April

1995 revisions to IMC 2800 into their Inspection Procedures

Manual.
Maryland Final Report Page 10

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 initial inspections

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

In reviewing twelve initial inspections from among the 81 new licenses

issued during the review period, none of the initial inspections were 

conducted within the first six months following issuance of the license. 

However, more than half (7 of 12) were completed from 6 to 8 months

following issuance and essentially all (11 of 12) were inspected from 6

to 12 months following issuance (that is, within 6 months of scheduling

the inspection). One new license was inspected approximately 32 months

following issuance due to an administrative error in assigning the first

due date.

While the initial inspection timing is a significant deviation from the

programmatic indicator, the State's program for new licenses contains

an element which, in total, makes it equally as effective as the IMPEP

program indicator would achieve. This element is completion of a

pre-licensing inspection which helps assure that licensees are equipped

and knowledgeable before receiving radioactive materials thus helping

licensees to achieve early success in complying with the requirements of

the license. The high percentage of initial inspections in which no

items of non-compliance are found appears to validate this methodology.

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 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

occurred because more information was known to be forthcoming from the

licensee or greater care, and thus more time, was needed to document

circumstances relative to a potential enforcement action.

The State reported that 136 license requests for reciprocity were

processed during the period of review. Approximately 50% of the

reciprocity requests included industrial radiography, others included

well-logging, mobile nuclear medicine, and other service licensees. The

State conducted 56 inspections of reciprocity licensees during the

review period, which met the inspection frequency for conducting

inspections of reciprocity licensees contained in IMC 1220, "Processing

of NRC Form 241, Report of Proposed Activities in Non-Agreement States,

and Inspection of Agreement State Licensees Operating Under 10 CFR Part

150.20." 

Based on the IMPEP evaluation criteria and the acceptability of the

State's equally effective method of handling new licensees, the review

team recommends that Maryland's performance with respect to the

indicator, Status of Materials Inspection Program, be found

Satisfactory.
Maryland Final Report Page 11

3.2 Technical Staffing and Training

A review of this indicator includes consideration of the adequacy of the

concept and balance of the radioactive materials program staffing

strategy which includes training, technical qualifications of the staff,

any staff turnover, and prompt management attention to any problem

areas. To evaluate these issues, the review team examined the State's

questionnaire responses relative to this indicator, interviewed program

management and staff, and considered any possible backlogs in licensing

or compliance actions. 

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 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 program is divided into two sections, the

Inspection and Enforcement Section comprised of four health physicists

responsible for all inspection and enforcement activities, and the

Licensing and Environmental Radiation Section comprised of three health

physicists, two are responsible for all licensing and environmental

activities, as well as, sealed source and device evaluations. A third

health physicist, recently transferred from Radon, is currently

performing less complex inspections, i.e. gauge manufacturers, and is in

training for licensing and environmental activities. The team noted

that the RAM program supervisor and two of the more senior personnel

appear to handle most of the inspections. Additionally, the RAM

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

involved in several Agreement State technical organizations and task

groups in support of Agreement State activities. In discussions with

the RAM program supervisor the team found that one of the health

physicists was recently 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
Maryland Final Report Page 12

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 primarily performing medical

license inspections could benefit from attending the 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. 

! 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. 

In discussions with the RAM supervisor, the team found that new staff

are assigned increasingly complex duties under the direction of senior

staff and accompany experienced inspectors during increasingly

complicated inspections. When time allows, the RAM supervisor

accompanies newly qualified staff. There is no formal program in place

for the supervisor to perform an annual inspection accompaniment with

each inspector. This issue is further addressed in Section 3.4.

The team found that during two accompaniments the inspections conducted

by a health physicist-I inspector, with 5 years of experience were not

satisfactory. During one accompaniment it was not identified that the

potential existed for radiation exposure to non-radiation workers in the

immediate area where field radiography was being performed, which posed

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

inspections was paperwork rather than a performance based inspection. 

Interviews were not conducted with management. This issue is discussed

in greater depth in Section 3.4, Technical Quality of Inspections. 

Through discussions with the RAM program supervisor the 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 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 management inattention or

inaction to deal with staffing problems. One to two years would be an

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

! 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
Maryland Final Report Page 13

another technical area, and continued training for long-term

staff.

! 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-I inspector 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 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 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 and compatible

program to protect health and safety. The team noted that the adequacy

of one FTE managing such an unusually large area of responsibility with

a technical staff of six (total 7 FTE) should be closely monitored by

Maryland due to the number and complexity of licensees in the Maryland

program. The team discussed increased use of automated systems to

provide increased control through tracking actions, wider access and

more efficient retrieval of information. The State has several complex

licensees, including NPI, which consumes an inordinate amount of staff

time, in the preparation of legal documents, and technical analysis of

corrective action plans; additionally there has 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 with the NRC regulatory program. The team questioned the

adequacy of program staff to ensure the long-term ability of the program

to maintain and complete pending rules and amendments for adoption to

remain compatible.

! Based on the teams findings, the team recommends that the State

assess the adequacy of the program staff to ensure the long-term

ability of the program to complete the pending rules and

amendments for adoption to remain compatible. 

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

review team recommends that Maryland's performance with respect to this

indicator, Technical Staffing and Training, be found Satisfactory with

Recommendations for Improvement.
Maryland Final Report Page 14

3.3 Technical Quality of Licensing 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,

and operating and emergency procedures sufficient to establish the basis

for licensing actions. Casework was reviewed for timeliness, adherence

to good health physics practices, reference to appropriate regulations,

documentation of safety evaluation reports, product certifications or

other supporting documents, consideration of enforcement history on

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

and proper signature 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 checked for

retention of necessary documents and supporting data.

The cases were selected to provide a representative sample of licensing

actions which had been completed in the review period and to include

work by all reviewers. The cross-section sampling included five of the

State's major licenses and the total included the following types: 

nuclear pharmacy, high dose rate afterloader, academic broad scope,

portable gauges, hospital nuclear medicine, private practice and

cardiology limited, research and development laboratory, fixed gauges,

blood irradiator, sales demonstration of devices, radiography,

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

eight new licenses, nine renewals, ten amendments, and fourteen

terminations. A list of these licenses with significant case-specific

comments can be found in Appendix D. 

The review team found that the licensing actions were generally

thorough, complete, consistent, and of acceptable quality with health

and safety issues properly addressed. Special license tie-down

conditions were almost always stated clearly, backed by 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 few

exceptions, reviewers appropriately used the new licensing guides and

accompanying check sheets, although the check sheets are not routinely

signed and dated. Licensing action authorship is indicated by initials

and date. At least one, but occasionally two peer reviews, are

documented by initials and dates. All licensing actions are signed by

the Radiological Health Program Manager. Pre-license-issue visits are

now routinely noted in the file. This visit enables the license

reviewer to ascertain the status of licensed facilities and use, as

applied for by the applicant. It also allows an explanation of the

licensing and inspection process prior to the start of licensed

activities. 

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
Maryland Final Report Page 15

Identified in Previous Reviews. NRC will continue to monitor the status

of NPI'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 closeout 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 termination, identified under the NRC Site

Decommissioning Management Plan (SDMP) as an SDMP site during the 1993

program review, was evaluated at the request of the NRC's Office of

State Programs and was found to have been surveyed appropriately to

verify licensee actions and terminated properly. 

! The team suggested that the Radiological Health Program could

benefit from a guidance document on termination of licenses.

The Radiological Health Program requires a full replacement application

for renewal. On occasion a new licensee has been requested to submit a

full replacement application when extensive deficiency discussions or

letters have been exchanged. This has the benefit that 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.

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

less complicated licensing reviews and will be brought into reviewing

the more complicated license actions in the near future. Both license

reviewers have an inspection background. 

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

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

of Licensing Actions, be found satisfactory.

3.4 Technical Quality of Inspections

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 material

inspectors and covered higher priority inspections of various types
Maryland Final Report Page 16

including hospitals, nuclear medicine facilities, academic institutions,

research and development facilities, industrial use, an instrument

calibration service, and a nuclear pharmacy. Attachment E lists the

inspection cases reviewed in depth with case-specific comments. Prior

to the review, a team member 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, commercial irradiators,

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 all inspection documents and field notes. 

Reports 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 inspection 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 prompt regulatory actions. Routine

enforcement letters were drafted by the inspector, signed off by the RAM

Supervisor, and issued to the licensee by the RHP Manager. With the

exception of NPI (currently under court order), the team determined the

State's enforcement policies to be effective in achieving licensee

compliance. Enforcement correspondence was timely for files reviewed by

the team. Licensee responses to items of noncompliance were also timely

and assigned by the RAM Supervisor to inspectors for review. In cases

where inspection results indicated a need for escalated enforcement
Maryland Final Report Page 17

action, enforcement conferences were held with licensees to discuss

inspection findings and possible enforcement action against them. 

From staff interviews and some inspection reports the team found that

inspectors were aware of the need to provide inspection information

affecting licensing to license reviewers, but the process for ensuring

inspector feedback to licensing staff was informal. Inspectors

discussed inspection findings with the RAM Supervisor, who served as the

intermediary between license and compliance staffs for information

sharing.

The State's practice calls for annual supervisory accompaniments of all

inspectors. 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 all inspectors 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 all inspectors. 

Four inspector accompaniments of three of the program's five inspectors

were performed by a review team member as follows: the first inspector

was reviewed on June 25-26, 1996, at a pool irradiator facility; the

second inspector was reviewed on July 16-17, 1996 at a hospital and

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

inspector was reviewed on August 7, 1996, at a nuclear pharmacy. These

accompaniments are also identified in Appendix E. The second inspector

(who had been performing inspections of high priority licensees) was

accompanied twice because a State supervisory accompaniment was not

performed during the review period (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

satisfactory technical performance. However, accompaniments did not

show a comparable level of performance by another State-qualified

inspector either to conduct a performance-based inspection or in

inspection thoroughness to address potentially important radiological

safety concerns. The team observed inspector performance issues related

to the areas of facility walk-throughs, conduct of licensee operations
Maryland Final Report Page 18

and licensee demonstrations, worker and management interviews, and

independent measurements. Areas not fully covered during inspections

included failure to take independent wipe samples at all hospital

material storage and waste locations, not conducting interviews with the

hospital radiation safety officer and nursing staff until prompted by

the team member, incomplete follow up of licensee corrective actions

resulting from a 1994 hospital contamination incident, inadequate walk

through and site observation at the beginning of the field radiography

inspection to verify storage and inventory of radiographic cameras, lack

of an independent radiation survey surrounding the site which confirmed

the licensee's posting of radiation boundaries, deficiencies in

recognizing the potential for radiation exposure to non-radiation

workers in the immediate area where field radiography was performed, and

inadequate check of radiation workers for proper dosimetry.

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 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 showed

staggered annual due dates for calibrations of instruments so that

meters were always available when needed for inspections. The State

laboratory was reviewed and found to include liquid scintillation

spectrometers, gas flow proportional counters, and gamma spectrometers

(multichannel analyzer) for full capability to analyze wipe, water, 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.
Maryland Final Report Page 19

3.5 Response to Incidents and Allegations

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 (IES) 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 found in the NMED database system. Events

reviewed included two equipment problems, one transportation event,

three lost or stolen radioactive material, three loss of control, and

one 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 State 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 been referred by NRC to the State, were reviewed. During the

MRB, a suggestion was made that the State consider implementing a

tracking system for allegations. 

! The review team suggests that the State consider implementing

a tracking system for allegations.
Maryland Final Report Page 20

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 unable to

provide a complete listing or complete events file, all of the events

found in the NMED database were either in the State events file or

licensee compliance files. The team noted that three of the events

identified by the State in response to the Questionnaire had not been

provided to NRC and were not found in the NMED database (1/23/95

Maryland State Highway, 5/26/95 Soil Safe Inc., 5/30/96 Aerosol

Monitoring). The team also noted that the State is notifying the

Regional State Agreements Officer of the occurrence of a significant

event (24 hour or less notification requirement) rather than the NRC

Operations Center, as identified in the "Handbook on Nuclear Material

Event Reporting in the Agreement States," Draft Report, March 1995.

! The team recommends that the State begin voluntary reporting of

all reportable events to the NRC Operations Center and begin

participating in the NMED database system collection of material

events by providing event information directly into the NMED

system electronically or providing compatible information in

written form 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 Maryland State Highway

event, (2) 5/26/95 Soil Safe Inc. event, and (3) 5/30/96 Aerosol

Monitoring event.

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 information. The team found

that the results of allegations received directly by the State were

promptly related to the alleger. But, the results of the investigations

of allegations referred by NRC to the State were not provided to NRC in

a timely manner. The team found that the State had not provided close

out information to NRC on allegations referred to the State by NRC. 

When NRC does not receive close out information from the State on

investigation results, NRC cannot provide a response to allegers who

request and receive anonymity. 

! 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. 
Maryland Final Report Page 21

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, §3-101-102) prohibiting intentional acts

of reprisal against any employee who has filed a complaint, grievance,

or other administrative or legal action involving State employment.

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

Maryland's performance with respect to the indicator, Response to

Incidents and Allegations, be found Satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS

IMPEP identifies four non-common performance indicators to be used in

reviewing Agreement State programs: (1) Legislation and Regulations,

(2) Sealed Source and Device Evaluation Program, (3) Low-Level

Radioactive Waste Disposal Program, and (4) Uranium Recovery. 

Maryland's agreement does not cover uranium recovery operations, so only

the first three non-common performance indicators were applicable to

this review.

4.1 Legislation and Regulations

4.1.1 Legislative and Legal Authority

In response to the questionnaire, the State reported the legislation

which authorizes the Maryland Radiological Health Program is identified

in the Annotated Code of Maryland, Environmental Article, Title 8,

"Radiation", and Title 7, "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 Compatibility of Regulations

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 

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:

! "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. 
Maryland Final Report Page 22

Current NRC policy on adequacy and compatibility requires that Agreement

States adopt certain equivalent regulations or legally binding

requirements no later than three years after they become effective. In

the November 1995 review NRC recommended the State address adoption as

soon as possible of the following rule needed for compatibility: 

! "Licensing and Radiation Safety Requirements for Irradiators," 10

CFR 36 amendments (58 FR 7715) that became effective July 1, 1993,

and due for adoption by the State by July 31, 1996.

The State of Maryland regulates irradiator facilities which would be

subject to the regulations in "Licenses and Radiation Safety

Requirements for Irradiators, 10 CFR Part 36. Equivalent rules were in

the final stages of promulgation and were scheduled to be adopted in

November 1996. The team found that the State had not established

legally binding requirements equivalent to NRC requirements in 10 CFR

Part 36 that are required for compatibility, at the time of review. 

Subsequent to the review, the State informed the team that Part X of the

Maryland Code covering, "Licenses and Radiation Safety Requirements of

Irradiators," was adopted on November 19, 1996, with an effective date

of December 16, 1996. 

From interviews with staff assigned to the RHP regulations development

committee, the team found the RAMP was in place, but its effectiveness

with respect to beginning rule development was incomplete. In response

to the questionnaire the State reported that no action has been taken on

the following compatibility rules, but expected adoption by the end of

1997:

! "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.

! "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.

! "Frequency of Medical Examinations for Use of Respiratory

Protection Equipment," 10 CFR Part 20 amendments (60 FR 7900) that

became effective March 13, 1995 and will need to be adopted by

March 13, 1998. 

! "Low-Level Waste Shipment Manifest Information and Reporting," 10

CFR Part 20 and 61 amendments (60 FR 15649 and 60 FR 25983) that

becomes effective March 1, 1998 and will need to be adopted by

March 1, 1998. The NRC delayed its effectiveness until the States

could adopt compatible requirements so that the national manifest

system will go into effect at one time.
Maryland Final Report Page 23

! "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.

! "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.

! "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.

! "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. 

! 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. 
Maryland Final Report Page 24

! The team recommends that the State address the process for

handling multiple rulemakings to ensure that they are completed

within the three years of the effective date.

! 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 with respect to this indicator, Legislation and

Regulations, be found Unsatisfactory due to issues identified by the

staff related to existing sections of Maryland's final COMAR regulations

that were not modified by the 13 amendatory actions 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 Radiation Safety Requirements for Irradiators," was

adopted effective December 16, 1996. 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.

4.2 Sealed Source and Device Evaluation Program

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 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 Staff's

use of guidance documents and procedures, and interviewed the staff and

Program Manager involved in SS&D evaluations. 

4.2.1 Technical Quality of the Product Evaluation Program

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 additional SS&D registry

certificate for a device involved in an incident. The certificates

reviewed covered the period since the last program review in April 1993

and 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. 

The State does have procedures in place to protect proprietary

information submitted in support of an evaluation. Policy and guidance

documents were on file and being utilized by the staff. The review team

observed that both SS&D reviewers will be signing each completed SS&D

registry certificate to verify the second reviewer's audit of the

application and the original reviewer's conclusions for future

certificates. This is a change in the previous policy of the State.
Maryland Final Report Page 25

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

had comments on detailed Quality Assurance/Quality Control (QA/QC)

programs. Specifically, the staff did not obtain detailed QA/QC program

commitments for devices previously approved (prior to 1995) or new

devices similar to previously approved devices. When

manufacturer/distributors are amending their certificate, they should be

required to submit detailed Quality Assurance/Quality Control (QA/QC)

programs regarding the SS&D product manufacturing process. The review

team noted that the staff had obtained detailed 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 comment. The

present staff was not aware of this commitment and management was not

able to produce documentation of actions taken by Maryland in response

to the 1993 review. 

! 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 Commission approval of minimum standards for

Agreement States desiring to maintain authority to evaluate SS&Ds. 

! In keeping with this guidance, the review team recommends that the

State adopt regulations compatible with 10 CFR 30.32 (g) and 10

CFR 32.210. 

These regulations require manufacturers/distributors to submit certain

key product information in support of an SS&D evaluation and permits the

State to enforce against those commitments. More specific guidance in

this area is contained in Regulatory Guide 6.9 dated February 1995

entitled, "Establishing Quality Assurance Programs for the Manufacture

and Distribution of Sealed Sources Containing Byproduct Material." It

should be noted that the two new SS&D evaluations and certificates

issued in 1996 had either a specific license condition on the

manufacturers/distributors addressing these requirements or the through

a tie down condition to documents submitted by the licensee. 
Maryland Final Report Page 26

4.2.2 Technical Staffing and Training

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

conducted by the program manager, who retired in June 1995. On the

retirement of the program manager, responsibility for SS&D reviews was

assigned to the new program manager and a lead health physicist, who is

a senior license reviewer. Both staff members had a Bachelor's degree

in physical or biological sciences. Both staff members had completed

the NRC recommended core training courses for materials licensing

personnel and more advanced training such as the SS&D evaluation

workshop. In December 1995, the program manager was reassigned as the

program manager for the X-ray program. Another lead health physicist

was assigned the program manager's responsibilities for SS&D reviews. 

This staff member has reviewed the course material from the SS&D

workshop, has become familiar with the processes and had demonstrated

the ability to understand and interpret the information submitted by

applicants as described in the performance criteria. Although the lead

health physicist is newly assigned to the SS&D reviews, he is an

experienced senior inspector with a Bachelor's degree in biological

sciences and has had all the NRC recommended core training courses for

materials licensing personnel. An offer was extended to the State for

this reviewer to work with the Sealed Source Safety Section at NRC

Headquarters, and his management is considering that option. 

The review team is aware that recent retirement and reassignment of the

program manager presents potential for weaknesses to develop. During

the 1993 review, NRC recommended that Maryland develop a program for

cross-training senior staff members in other areas, specifically SS&D

evaluations. 

! 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 Regarding SS&Ds

The State is following up on two SS&D-related incidents which occurred

in other jurisdictions concerning the Nucletron microselectron HDR and

its interlock system. The State's response to these incidents (with

regard to manufacture) was evaluated by the review team and is included

in the incidents reviewed in section 3.5 of this report. The staff is

working with the licensee to issue a revision to the 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.
Maryland Final Report Page 27

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

In 1981, the NRC amended its Policy Statement, "Criteria for Guidance of

States and NRC in Discontinuance of NRC Authority and Assumption Thereof

by States Through Agreement" to allow a State to seek an amendment for

the regulation of LLRW as a separate category. Those States with

existing Agreements prior to 1981 were determined to have continued LLRW

disposal authority without the need of an amendment. Although Maryland

has LLRW disposal authority, NRC has not required States to have a

program for licensing a LLRW disposal facility until such time as the

State has been designated as a host state for a LLRW disposal facility. 

When an Agreement State has been notified or becomes aware of the need

to regulate a LLRW disposal facility, they are expected to put in place

a regulatory program which will meet the criteria for an adequate and

compatible LLRW disposal program. There are no plans for a LLRW

disposal facility in Maryland. Accordingly, the review team did not

review this indicator.

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team found the State's

performance with respect to each of the performance indicators to be

Satisfactory with the exception of 3.2 Technical Staffing and Training

and 3.4 Technical Quality of Inspections, both of which were found

Satisfactory with Recommendations for Improvement, and the non-common

indicator, 4.1.2 Status and Compatibility of Regulations, which was

found Unsatisfactory. The MRB, after considering the unsatisfactory

performance of one HP-inspector during two on-site field inspection

accompaniments, and the overall satisfactory performance of three other

inspectors during accompaniments, revised the team's recommendation for

Section 3.4 Technical Quality of Inspections. The final MRB

recommendation for Section 3.4, Technical Quality of Inspections is

Satisfactory.

The team recommended, and the MRB concurred, to find the Maryland

program to be adequate to protect public health and safety but needs

improvement and not compatible.

Below is a summary list of suggestions and recommendations, as mentioned

in earlier sections of the report, for consideration by the State. As

previously indicated, the State 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 Management Administration revise the definition of "Person"

in the low-level radioactive waste regulations COMAR

26.14.01.02B(28)(e) that was identified in both the 1993-94 review

and the 1995 follow-up review. (Section 2.0)

2. The review team recommends that the State of Maryland inform NRC

when the referring physician/patient notification requirements has

been completed by SHH. (Section 2.0)

 
Maryland Final Report Page 28

3. The review team recommends that the State incorporate the April

1995 revisions to IMC 2800 into their Inspection Procedures

Manual. (Section 3.1)

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 plan for staff that do

not meet the initial qualifications, and staff who are reassigned

from another technical area, and continued training for long-term

staff. (Section 3.2)

6. The team suggests that 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-I 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 supervisory accompaniments of all inspectors. (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 full

inspector 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)
Maryland Final Report Page 29

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)

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)

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

review all registration sheets, based on the risk associated with

the device, especially detailed QA/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)

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)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Maryland Organization Charts

Appendix C Maryland's Questionnaire Response

Appendix D License File Reviews

Appendix E Inspection File Reviews

Appendix F Incident File Reviews

Appendix G Incident File Reviews

Attachment 1 Maryland's Response to Review Findings
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

Status of Materials Inspection 

Program

Dave Collins, RII Technical Quality of Licensing 

Actions

Craig Gordon, RI Technical Quality of Inspections

Legislation and Regulations 

Kathleen Schneider, OSP Sealed Source and Device 

Evaluations
APPENDIX B

MARYLAND DEPARTMENT OF THE ENVIRONMENT

AND

AIR AND RADIATION MANAGEMENT ADMINISTRATION,

RADIOLOGICAL HEALTH PROGRAM

ORGANIZATION CHARTS
APPENDIX C

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

(IMPEP) QUESTIONNAIRE