May 10, 2002

Ms. Ann Marie DeBiase, Director

Air and Radiation Management Administration

Maryland Department of the Environment

2500 Broening Highway

Baltimore, MD 21224

Dear Ms. DeBiase:

Enclosed is the final report of the follow-up Integrated Materials Performance Evaluation

Program (IMPEP) review of the Maryland radiation control program. The review was conducted

by an interoffice team on August 13-16 and November 13-16, 2001. The team reviewed, in

detail, the performance indicators of concern identified during the 1999 IMPEP review,

Technical Quality of Licensing Actions and Sealed Source and Device (SS&D) Evaluation

Program. Ms. Vivian Campbell, NRC Region IV, was the team leader for the follow-up

review. The review team’s preliminary findings were discussed with you and your staff on

November 16, 2001.

The follow-up review team concludes that the Maryland program has improved. The review

team recommended, and the Management Review Board (MRB) agreed, in changing the

performance rating from satisfactory with recommendations for improvement to satisfactory for

the common performance indicator, Technical Quality of Licensing. The performance rating for

the non-common performance indicator, SS&D Evaluation Program (satisfactory with

recommendations for improvement), will remain the same. Although the program has taken

significant steps to address the recommendations in the 1999 report, all SS&D activities have

not been fully completed due to the higher priority focus on improving the licensing program. 

The MRB continues to find the Maryland program to be adequate to protect public health and

safety and compatible with NRC’s program. Your letter faxed to NRC on March 20, 2002

described your staff’s actions taken in response to the recommendations in the draft report. 

We request no additional information at this time.

In your letter, you stated that you did not anticipate the addition of new recommendations and

questioned their appropriateness during a follow-up IMPEP review. The objective of any State

IMPEP review is to evaluate the adequacy and compatibility of an Agreement State program,

including evaluating the strengths and weaknesses of the nuclear material licensing and

inspection program. Regardless of whether an entire program or specific portions of a program

are reviewed, review teams have the responsibility to fully evaluate program performance,

including making or closing recommendations. 

Based on the results of the follow-up IMPEP review, the review team recommended, and the

MRB agreed, that the Maryland Agreement State program receive a full IMPEP review in fiscal

year 2003. The review team and the State agreed that the next periodic meeting could take

place in October 2002. 
Ann Marie DeBiase - 2 -

I appreciate the courtesy and cooperation extended to the IMPEP team during the follow-up

review and your support of the radiation control program. I look forward to our agencies

continuing to work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello

Deputy Executive Director

 for Materials, Research and 

 State Programs

Enclosure:

As stated

cc: Roland Fletcher, Manager

Radiological Health Program

Steve Collins, Assistant Manager

Office of Radiation Safety

OAS Liaison to MRB
Ann Marie DeBiase - 2 -

I appreciate the courtesy and cooperation extended to the IMPEP team during the follow-up

review and your support of the radiation control program. I look forward to our agencies

continuing to work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello

Deputy Executive Director

 for Materials, Research and 

 State Programs

Enclosure:

As stated

cc: Roland Fletcher, Manager

Radiological Health Program

Steve Collins, Assistant Manager

Office of Radiation Safety

OAS Liaison to MRB

bcc: Chairman Meserve

Commissioner Dicus

Commissioner Diaz

Commissioner McGaffigan

Commissioner Merrifield

Distribution:

DIR RF DCD (SP01)

SDroggitis PDR (YES)

KSchneider 

LRakovan MBurgess, NMSS

OSiurano, ASPO DWhite, RI

STreby, OGC KTraegde, MA

JLieberman, OGC

FCameron, OGC 

TCombs, OCA (2)

DCool, NMSS 

GDeegan, NMSS 

Maryland File

DOCUMENT NAME: C:\ORPCheckout\FileNET\ML021200418.wpd ML021200405

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 RIV STP:DD STP:D NMSS OGC DEDMRS

NAME VCampbell:gd JMPiccone PHLohaus MVirgilio KCyr STreby CPaperiello

DATE 4/3/02 *LJR for 4/9/02 4/10/02 *JMP for 4/18/02 4/24/02 05/10/02
INTEGRATED MATERIALS PERFORMANCE EVALUATION

PROGRAM (IMPEP) FOLLOW-UP REVIEW OF

THE MARYLAND RADIATION CONTROL PROGRAM

November 13-16, 2001

FINAL REPORT

U. S. Nuclear Regulatory Commission
Maryland Follow-Up Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the follow-up review of the Maryland Department of the

Environment (the Department), Radiological Health Program (the Program). This review was

directed by the Management Review Board (MRB) based on the results of the March 22-26,

1999 Integrated Materials Performance Evaluation Program (IMPEP) review. The MRB

directed that a follow-up review of the common performance indicator, Technical Quality of

Licensing Actions and the non-common performance indicator, Sealed Source and Device

(SS&D) Evaluation Program, be conducted in one year based on the finding of satisfactory with

recommendations for improvement for these indicators. The State, in a letter dated

May 4, 2000, requested that the follow-up review be delayed for one year due to a large

resource commitment involving escalated enforcement activities with a specific licensee. At the

May 31, 2000 meeting, the MRB directed the staff to report on the status of Maryland’s actions

to address the recommendations from the 1999 IMPEP review after the next periodic meeting. 

A periodic meeting was held with Maryland on June 29, 2000, and the summary of the meeting

was provided to the MRB by a memorandum dated August 4, 2000. The MRB approved the

State’s request to delay the follow-up IMPEP review at their October 24, 2000 meeting. 

The follow-up review began the week of August 13, 2001. However, the team was unable to

complete the review during that week due to an illness of one team member. The follow-up

review was completed the week of November 13-16, 2001. The follow-up review included

evaluation of actions taken by the State to address the five recommendations made during the

1999 IMPEP review involving the two indicators discussed above. 

The follow-up review was conducted by a review team consisting of technical staff members

from the Nuclear Regulatory Commission (NRC) and the Commonwealth of Massachusetts. 

Team members are identified in Appendix A. This review was conducted in accordance with

the "Implementation of the Integrated Materials Performance Evaluation Program and

Rescission of a Final General Statement of Policy," published in the Federal Register on

October 16, 1997, and the November 5, 1999, NRC Management Directive (MD) 5.6,

"Integrated Materials Performance Evaluation Program (IMPEP)." 

The Maryland Agreement State program is administered by the Secretary of the Department, 

who reports directly to the Governor. The Program is organized under the Air and Radiation

Management Administration. The organizational chart for the Program is presented in

Appendix B. The Radioactive Materials Licensing and Compliance Division consists of the

Inspection Section and the Licensing Section. The Licensing Section is responsible for

processing license applications for the use of radioactive material and for performing SS&D

evaluations. The Licensing Section consists of one supervisor and three staff. At the time of

the follow-up review, the Program regulated approximately 560 specific licenses, including all

types of major material licensees. 

A formal questionnaire addressing the specific common and non-common performance

indicators was not sent to the Program. However, the Program provided additional information

to supplement the information in questions 31 through 33 of the 1999 IMPEP questionnaire

response from Maryland. A copy of this supplemental information can be found on the NRC’s

Agencywide Documents Access and Management System (ADAMS) using the Accession

Number ML020170528.
Maryland Follow-Up Final Report Page 2

The team’s approach for conducting the follow-up review consisted of: (1) examination of the

Program’s supplemental information identified above; (2) in-depth review of the two program

indicators identified above; and (3) 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 the two performance indicators for activities conducted during the

period of March 26, 1999 - November 16, 2001. Preliminary results were discussed with

Maryland management on November 16, 2001.

Following the 1999 IMPEP review, the Program performed a self assessment of both program

areas and developed an action plan to address the recommendations from the 1999 review, as

well as any self-identified weaknesses. Based on the results of that assessment and resource

issues, Program management focused on improving the licensing program initially and

implemented that action plan in January 2000, which delayed actions to improve the SS&D

program until Spring, 2001. Prior to the team’s visit in August 2001, the Program took steps to

improve the SS&D program, including: hiring and training an additional staff member to review

SS&D casework in addition to materials licensing actions; designating one day a week to

completing SS&D casework review; establishing a formal memorandum of understanding

(MOU) with another Division within the Department that authorizes the use of a qualified

engineer for SS&D reviews; and including the resolution of safety concerns on some devices,

as appropriate. The Program focused resources on the SS&D program in the three months

following the review team’s initial visit in August 2001, and made significant improvements

within that time frame. 

Section 2 below discusses the results of the follow-up review of the Maryland program for the

common performance indicator, Technical Quality of Licensing Actions. Section 3 discusses

the results of the follow-up review for the non-common performance indicator, Sealed Source

and Device Evaluation Program. Section 4 summarizes the review team's findings and

recommendations resulting from the follow-up review. The Program’s progress in addressing

other recommendations from the 1999 review and general status of the program covered in a

periodic meeting can be found in Appendix C.

2.0 COMMON PERFORMANCE INDICATOR, TECHNICAL QUALITY OF LICENSING

ACTIONS

During the follow-up review, the team evaluated actions taken by the Program in response to

the finding of satisfactory with recommendations for improvement made during the 1999 IMPEP

review, as well as new licensing actions completed since that review. 

The review team examined completed licensing casework and interviewed the staff for 20

specific licensing actions. Licensing actions were evaluated 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. Licenses were evaluated for overall technical quality including accuracy,

appropriateness of the license, its conditions, and tie-down conditions. Casework was

evaluated 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 authority. The files were checked

for retention of necessary documents and supporting data. 
Maryland Follow-Up Final Report Page 3

The 20 license files selected for review included work by all reviewers. The cross-section

sampling included all of the Program’s major licenses, including the following types of licenses: 

academic (broad scope and limited specific), portable gauge, industrial radiography, medical

(institution and private practice), research and development, nuclear pharmacy, manufacturing

and distribution, and general license distribution. Licensing actions included new licenses,

renewals, amendments, financial assurance, and terminations. A list of the licenses reviewed

with case-specific comments can be found in Appendix D. 

The review team’s evaluation of the Program’s response to Recommendation 4 of the 1999

IMPEP report is presented below. 

Recommendation 4 

The review team recommends that Program management implement an action plan to

reduce the number of backlogged licensing actions and set goals to improve the

accuracy and overall technical quality of licenses. (Section 3.4 of the 1999 IMPEP

report)

Current Status

In response to this recommendation, Program management developed and implemented an

action plan in January 2000. Program management took several actions which have had a

positive impact on the accuracy and overall technical quality of the licensing actions. A

licensing section supervisor was assigned and an additional license reviewer was hired. 

License reviewers meet biweekly to discuss such items as outstanding problems in reviews and

implementation of new guidance. NRC’s NUREG-1556 series on consolidated license

guidance including the associated checklists are being utilized by staff. All licensing actions are

reviewed prior to issuance. Guidance documents are placed on the Department’s web site. 

Boilerplate language is used appropriately. Templates and current versions of licenses are

placed on the Program’s computer server, and all licensing actions are issued in their entirety. 

Licenses are converted into the new format as licensees amend or renew their licenses. 

Program management reports that approximately 40% of the 560 specific licenses have been

converted into the new format. The Program has set timeliness goals of seven months for

issuance of new licenses and renewals, and three months for amendments. Licensing actions

are assigned to individual reviewers by the Licensing Section Supervisor (the Supervisor).

The Program has also upgraded the software used to track licensing actions. A variety of

reports can be generated to track the status of licensing actions. The Program provides a

monthly report to senior Department management on the status of “extended licenses”

(renewals greater than seven months old). The team noted that there are currently 24 renewal

actions greater than one year old, the oldest action being seven years old. All of these

renewals are under active review by staff. This represents a reduction in the backlog of more

than 50% since the 1999 review. This backlog reduction was achieved during a period when

the Program focused resources on their licensing program. However, Program management

indicated that the backlog reduction rate has slowed recently due to the concentrated efforts to

address the concerns identified in the SS&D program during the 1999 review. 

The review team evaluated seven licenses from the 1999 IMPEP review identified as having

inconsistencies, being incomplete, or not properly authorizing licensed activities or materials. 

All these licenses had been reviewed and corrections were documented in the files. The review
Maryland Follow-Up Final Report Page 4

team also reviewed 13 additional licensing actions completed since the 1999 review. Overall,

the review team found the licensing actions thorough, complete, consistent and with health and

safety issues properly addressed. Deficiency letters clearly stated regulatory positions, were

used when appropriate, and identified deficiencies in the licensees’ documents. Appropriate

reviewer and supervisory checklists were maintained in the file. The review team did identify

three files where licensee documents identified in the tie-down conditions were not contained in

the correct file. Once identified to Program technical staff, the documents were located in

either another file or copies were obtained from the licensee. The licenses reviewed by the

team to observe the State’s progress with this recommendation are listed in Appendix D.

Based on the follow-up review, the team considers this recommendation closed.

The review team concludes that the technical quality of the licensing actions has shown

improvement since the 1999 IMPEP review and no performance issues were identified. 

Although the 1999 IMPEP report found the performance with respect to this indicator to be

satisfactory with recommendations for improvement, the review team is proposing a change in

the finding from the 1999 report. 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 changed to satisfactory.

3.0 NON-COMMON PERFORMANCE INDICATOR, SEALED SOURCE AND DEVICE

EVALUATION PROGRAM

In conducting this review, three sub-indicators were used to evaluate the Program’s

performance regarding their SS&D Evaluation Program. These sub-indicators include: 

(1) Technical Quality of the Product Evaluation; (2) Technical Staffing and Training; and

(3) Evaluation of Defects and Incidents Regarding SS&Ds.

In assessing the SS&D Evaluation Program, the review team examined the information

provided in the supplement to questions 31 through 33 of the 1999 IMPEP questionnaire

response from Maryland. The team also evaluated actions taken by the State in response to

the recommendations noted during the 1999 review, as well as new SS&D evaluations

completed since that review, deficiency letters, and supporting documents. The review team

noted the Program’s use of guidance documents and procedures, interviewed staff and the

Supervisor, who are involved in the SS&D evaluation, and verified the use of regulations and

license conditions to enforce commitments made in the applications.

As discussed in Section 1, Program management focused their resources on improving the

licensing program before addressing the SS&D program. The team noted several

improvements to the SS&D program had occurred in March 2001. Significant progress was

made in the three months following the review team’s initial visit in August 2001 because the

Program focused resources on the SS&D program.

3.1 Technical Quality of the Product Evaluation Program

The team reviewed a total of 15 certificates in the follow-up review which included: six

certificates identified from the 1999 IMPEP report, one new certificate, six amendments, and

two inactivations. The review of the six certificates from the 1999 IMPEP report was limited to

the Program’s actions in addressing previously identified comments. The SS&D registration

certificates evaluated by the review team are listed with case-specific comments in Appendix E. 
Maryland Follow-Up Final Report Page 5

As noted in Appendix E, the review team reviewed available ongoing casework, since the

Program has not completed the projected casework as anticipated in their response to the 1999

IMPEP review.

Program management determined that SS&D evaluations were not given a priority and were

performed on a time available basis. In response, Program management has instituted a policy

whereby one specific day each week is dedicated to SS&D casework review. In addition, the

Program has implemented a management database to track timely completion of actions and

provides management reports on the status of the current workload and backlogged casework. 

In addition, as discussed in Section 3.2, the Program has arranged for technical assistance

from an engineer from another division within the Department.

The State has modified its policy requiring management signatures on registration certificates in

addition to the initial and concurrence reviewers’ signatures. The two management signatures

have been eliminated from the registration certificate. However, the completion letter for the

certificates retains a management signature, thereby maintaining management oversight. 

Based on review of the work that has been completed since August 2001 under the Program’s

revised system, the team noted that Program staff generally followed the recommended

guidance from NRC’s SS&D training workshop, NUREG-1556, Vol. 3, and MD 5.6, with the

exception of the State’s concurrence process as discussed below. Pertinent American National

Standards Institute standards, Regulatory Guides, and applicable references were used when

performing SS&D reviews. Appropriate review checklists were used to assure that all relevant

materials were submitted and reviewed. The checklists were contained in the registration files. 

However, the team noted some discrepancies in documentation which did not allow verification

that the engineer and both reviewers had reviewed the casework. The review team discussed

the value of such documentation with the Supervisor. 

The review team noted that three files lacked documentation of deficiency questions and

information obtained through meetings or phone calls. The review team discussed this issue

with the Supervisor who indicated that staff would be reminded of the need to document

information obtained and used to make the safety analysis for registration. Despite the limited

sampling of reviews completed under the Program’s revised system, the team determined

through discussions with management and staff, that the product evaluations for these

certificates were thorough, complete, consistent, of acceptable technical quality, and

adequately addressed the integrity of the products during use and in the event of likely

accidents. 

The Program maintained a copy of SS&D guidance material accessible to all staff. The review

team noted that policy changes were communicated to staff verbally during the course of

business and during the bi-weekly meetings, due to the rapid changes currently being made in

the SS&D area. The review team discussed the value of documenting policy changes in writing

with an effective date and maintaining these documents with the standard guidance materials.

The review team’s evaluation of the State’s response to Recommendations 6, 7, and 9 of the

1999 IMPEP report is presented below. 
Maryland Follow-Up Final Report Page 6

Recommendation 6

The review team recommends that the State promptly review registration certificates

MD-1003-D-101-G and MD-1003-D-102-G, taking into consideration the deficiencies

listed in Appendix F (of the 1999 IMPEP report) for each registration certificate, and

amend the registration certificates accordingly. (Section 4.2.1 of the 1999 report)

Current Status

In August 2001, the Program was in the process of addressing the issues for registration

certificates referenced above, but the licensee had not been responsive. The Program

amended the license prohibiting distribution of the devices in question pending resolution of all

issues. Since August 2001, the licensee has submitted complete re-applications for the two

certificates and was granted permission, by license amendment, to continue distribution. At the

time of the follow-up review, the Program had not yet issued the amendments to these

certificates. The review team evaluated the licensee’s submissions within the scope of the

IMPEP review and agreed that safety issues had been resolved.

Based on the follow-up review, this recommendation remains open. 

Recommendation 7

The team recommends that the State, using NUREG-1556 guidance and following the

description of a “concurrence review” in MD 5.6, complete a secondary review of all

registration certificates issued by the State to identify any missing information and with

priority of the actions based on the risk associated with the device. (Section 4.2.1 of the

1999 report)

Current Status

In March 2001, the Program sent letters to all certificate holders requesting new information for

a re-review within 60 days to address this recommendation. The Program indicated that the

certificates and background information will be subjected to a full review. At the time of the

onsite review, approximately half of the licensees had responded to the request from the

Program, however none of the re-reviews had been completed. The Supervisor indicated that

the Program plans to complete the re-reviews by January 2003. 

The Program developed a concurrence review checklist that detailed the scope and magnitude

of the Program’s concurrence review. Discussions with staff and the Supervisor during the

team’s August 2001 visit indicated that the Program set a policy where the concurrence review

was an administrative review. The team noted that the administrative review did not fully

address the requirements for a concurrence review as described in MD 5.6. Based on the

August 2001 discussion, Program management modified their concurrence review to be a

limited technical review. A revised checklist was generated in order to ensure that the new

process was followed and documented. 

The concurrence reviewer uses the reviewer checklist in NUREG-1556, Vol 3, to ensure that all

areas have been addressed. The Supervisor indicated that this involves checking that the

licensee has addressed each area and briefly reviewing the information to determine whether it
Maryland Follow-Up Final Report Page 7

appears to adequately address the issue without performing a detailed review. The

concurrence reviewer ensures that the certificate follows the format in NUREG-1556, Vol. 3,

including cross-checking all diagrams references and ensuring all appropriate documents are

included in the Reference section. It was noted that this limited technical review is not currently

being performed by staff having qualifications in the engineering area, therefore the limited

technical review lacks an adequate double check in this area.

The review team noted that the Program’s policy of conducting the concurrence review as a

limited technical review is not in accordance with the current MD 5.6 for this sub-indicator. 

Program management indicated that questions and concerns have been raised by Agreement

States on the need for and definition of a concurrence review. Program management does not

agree with the team’s interpretation of the Directive’s definition of concurrence review and

believes that the Program’s current review is sufficient to protect public health and safety. This

issue is being addressed in proposed revisions to the criteria in MD 5.6 involving the SS&D

evaluation programs. Given that these revisions are still under review by the Agreement States

and NRC staff, the Program has chosen to maintain their current policy regarding concurrence

reviews. 

Based on the follow-up review, this recommendation remains open. 

Recommendation 9

The MRB recommends that the State respond to all of the review team’s comments in

Appendix F of the final report. (Section 4.2.4 of the 1999 IMPEP report)

Current Status

The State provided a response to the comments in the 1999 IMPEP review in a letter dated

October 18, 1999, addressed to Carl Paperiello, Deputy Executive Director for Materials,

Research and State Programs. The letter outlined Maryland’s plan of action for both licensing

and SS&D reviews. The follow-up review team examined the Program’s actions involving all six

certificates listed in the 1999 IMPEP report.

The status of two of the certificates was discussed in response to Recommendation 6. Of the

remaining four certificates, one was completed with one remaining comment to be resolved, two

were in the process of amendment approval but have yet to be completed, and one has not

been addressed. Thus, five of the six certificates are close to completion and the subsequent

review and approval of the amendment requests received from the respective licensees will

help to close these comments. The review team noted that although progress has been made

in addressing a majority of these comments, the State’s response to the specific file comments

from 1999 remains incomplete. 

Based on the follow-up review, this recommendation remains open. 

3.2 Technical Staffing and Training

The Program reported that four staff members currently have authority to sign SS&D

evaluations, in addition to their responsibilities for licensing casework. The Program’s

combined staff effort equates to approximately 1 full-time equivalent (FTE) dedicated to
Maryland Follow-Up Final Report Page 8

performing SS&D safety evaluations. The Program completed nine SS&D actions (excluding

the six re-assessments of the 1999 casework) and 18 evaluations of incidents or failures

involving Maryland products during the review period. The review team noted that the Program

had spent considerable resources resolving issues with three licensees, which decreased the

time staff could spend in both licensing and SS&D casework and program improvement. 

The review team noted in the review of the training program that there is no clear policy on how

signature authority is granted. Signature authority was granted on a case by case basis by the

Supervisor. The review team recommends that the Program establish a training policy that

prior to gaining signature authority, all reviewers must meet a set of standards through

experience, training, and/or formal education including, at a minimum, those listed in MD 5.6. 

Having only fully qualified reviewers (or qualified team reviewers) signing certificates is

particularly essential given the State’s decision not to perform a complete technical review for

the concurrence review. A copy of NRC’s draft SS&D reviewer qualification procedure was

provided to the Supervisor for consideration. The team also discussed the benefit of reviewing

SS&D training programs developed by other Agreement States.

The review team’s evaluation of the State’s response to Recommendation 8 of the 1999 IMPEP

report is presented below. 

Recommendation 8

The 1996 IMPEP team recommended that an additional senior staff member be trained

to perform the sealed source and device evaluations to supplement the program as it

matures. The State had assigned an additional individual to the program who has

completed one review to date and would also benefit from additional training and

experience. The review team recommends that the State provide the staff additional

training and experience in the review of sealed source and device applications and the

drafting of registration certificates (including the guidance contained in NUREG 1556,

Vol. 3). This should include training and experience which will meet the qualification

guidance found in MD 5.6. (Section 4.2.2 of the 1999 IMPEP report)

Current Status

In general, all the reviewers are trained in Health Physics principles and have attended NRC’s

SS&D workshop. However, based on the interviews with the staff, it appears that some of the

staff do not have a strong engineering background, either through formal training or casework

experience. In order to offset this weakness in engineering training and experience, the

Program has arranged for technical assistance from an engineer from another Division where

reviews are passed through the engineer for technical review. The engineer has attended

NRC’s SS&D workshop and has advanced engineering degrees which includes experience in

mechanical engineering and radiation. Starting approximately June/July 2000, the engineer

was available to the staff as a resource for specific questions. A formal MOU was established

in May 2001, authorizing up to 16 hours a week of the engineer’s time for SS&D review. 

At the time of the team’s August 2001 visit, actions were sent to the engineer at the discretion

of the licensing staff. The team discussed with Program management that this policy did not

fully address the qualifications concern raised in the 1999 IMPEP. The team indicated that all
Maryland Follow-Up Final Report Page 9

actions should be reviewed by an individual deemed qualified in engineering and design, which

could be accomplished through trained staff or the MOU. The Supervisor agreed to review the

issue with management. Effective August 20, 2001, the Program issued and implemented a

policy where all SS&Ds are required to undergo an engineering review by a qualified individual. 

The engineering review includes evaluation of the initial request, the licensee response(s), and

the final certificate, including a check of Nuclear Material Events Database (NMED) for each

sealed source or device in order to assist in identifying generic or repeating problems. 

In addition, the Program has developed a spreadsheet in order to track the status of actions

sent to the engineer, as well as the time spent by the engineer. This allows the Program to

monitor the hours spent by the engineer to ensure that the effort spent is reasonable given the

work performed, and identify any potential problems in the system. This approach addresses

the concerns raised in the 1999 IMPEP regarding qualifications for individuals performing

registration certificate reviews. 

Based on the follow-up review, this recommendation is closed.

3.3 Evaluation of Defects and Incidents Regarding SS&Ds

The review team queried NMED and identified 18 incidents reported nationally involving

registered products from two Maryland distributors, Shimadzu and Nucletron. The team

reviewed the Program’s evaluation of seven of these incidents and determined that relevant

issues were addressed. A list of incident casework examined with case-specific comments is

included in Appendix F.

Several of the Nucletron incidents involved software or mechanical failures. Even though

software is not typically included in the SS&D review process, the Program recognized the

frequency of occurrence and the potential for these failures to cause misadministrations or

worker doses. Nucletron is now required to report to the Program all failures of codes specified

by the State. This allows the Program to monitor and determine trends of failure frequencies

and types, assisting them in early identification of potential problem areas.

One mechanical failure involved a position simulator tool used with a MicroSelectron HDR

remote afterloader device. The Program did not investigate this portion of the report since the

position simulator tool was determined to be an associated device to the MicroSelectron HDR,

and not the device itself. Since the Program had not evaluated the associated device, the

review team discussed with staff whether the design of the simulator was of a similar design,

where failure could indicate potential failure of the MicroSelectron. During the IMPEP review,

the Program verified that the designs were different, and therefore the failure did not indicate

any potential of failure in the MicroSelectron HDR. The review team discussed the overall

incident evaluation process with the Program management who agreed to revise their incident

evaluation process to include an assessment of any particular incident or failure for generic

issues or applicability of the failure mode to other products. 
Maryland Follow-Up Final Report Page 10

In addition, the team discussed the involvement of the engineer in source and device incident

evaluations. The engineering aspect of the Program’s review for incidents or failures was not

performed on a consistent basis. The review team recommends that the Program establish a

policy that a qualified individual perform an engineering review for all incidents that may indicate

a source or device problem, and source and device product failures involving Maryland

vendors. 

The follow-up review team found that the SS&D program has shown improvement since the

August 2001 portion of the follow-up IMPEP review. However, due to the competing priority to

respond to the 1999 IMPEP recommendations regarding the licensing area, the Program has

not been able to fully address the recommendation made in the SS&D area, including re-review

of the specific cases listed in the 1999 IMPEP review. Of the four recommendations from the

1999 IMPEP report, the follow-up review team found that one had been adequately addressed

and should be closed, and three have not been completed and should remain open. In

addition, two new recommendations were made. Based on the IMPEP evaluation criteria, the

review team recommends that Maryland’s performance with respect to the indicator, Sealed

Source and Device Evaluation, continue to be found satisfactory with recommendations for

improvement.

4.0 SUMMARY

As noted in Section 2 above, the follow-up review team found Maryland’s performance in

responding to and resolving the recommendation involving the common performance indicator,

Technical Quality of Licensing Actions, to be acceptable. The review team recommends that

the Technical Quality of Licensing recommendation be closed and that Maryland’s performance

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

As noted in Section 3, the follow-up review team found that the SS&D evaluation program has

shown improvement since the 1999 IMPEP review. However, due to the competing priority to

implement 1999 IMPEP recommendations in the licensing area, the Program has not been able

to fully address the recommendation made in the SS&D area, including re-review of the specific

cases listed in the 1999 IMPEP review. The review team recommends that Maryland’s

performance with respect to the indicator, Sealed Source and Device Evaluation, continue to be

found satisfactory with recommendations for improvement. Based on the follow-up review, the

review team recommends that the Maryland program continue to be found adequate and

compatible with NRC’s program.

The follow-up review team recommends that the Maryland Agreement State program receive a

full IMPEP review in fiscal year 2003. The review team and the Program management agreed

that the next periodic meeting could take place in October 2002.

Below is a summary list of open recommendations from the 1999 report and the new

recommendations from this follow-up review.
Maryland Follow-Up Final Report Page 11

Open Recommendations from the 1999 IMPEP report:

Recommendation 6

The review team recommends that the State promptly review registration certificates

MD-1003-D-101-G and MD-1003-D-102-G, taking into consideration the deficiencies

listed in Appendix F (of the 1999 IMPEP report) for each registration certificate, and

amend the registration certificates accordingly. (Section 4.2.1 of the 1999 report;

Section 3.1 of follow-up review)

Recommendation 7

The team recommends that the State, using NUREG-1556 guidance and following the

description of a “concurrence review” in MD 5.6, complete a secondary review of all

registration certificates issued by the State to identify any missing information and with

priority of the actions based on the risk associated with the device. (Section 4.2.1 of the

1999 report; Section 3.1 of follow-up review)

Recommendation 9

The MRB recommends that the State respond to all of the review team’s comments in

Appendix F of the final report. (Section 4.2.4 of the 1999 report; Section 3.1 of follow-up

review)

New recommendations from the follow-up review:

Follow-up Recommendation 1

The review team recommends that the Program establish a training policy that prior to

gaining signature authority, all reviewers must meet a set of standards through

experience, training, and/or formal education including, at a minimum, those listed in MD

5.6. (Section 3.2)

Follow-up Recommendation 2

The review team recommends that the Program establish a policy that a qualified

individual perform an engineering review for all incidents that may indicate a source or

device problem, and source and device product failures involving Maryland vendors. 

(Section 3.3)
LIST OF APPENDICES

Appendix A IMPEP Review Team Members

Appendix B Radiological Health Program Organizational Chart

Appendix C Periodic Meeting Summary Including Status of Other

Recommendations from the Previous Review

Appendix D Licensing Casework Reviews

Appendix E Sealed Source and Device Casework Reviews

Appendix F Incident Casework Reviews (SS&D)

Attachment March 20, 2002 faxed letter from Ann Marie DeBiase

Maryland’s Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Vivian Campbell, RIV Team Leader

Duncan White, RI Technical Quality of Licensing Actions 

Periodic Meeting

Michele Burgess, NMSS Sealed Source and Device Evaluation Program

Kenath Traegde, Massachusetts Sealed Source and Device Evaluation Program
APPENDIX B

MARYLAND DEPARTMENT OF THE ENVIRONMENT

AIR AND RADIATION MANAGEMENT ADMINISTRATION

RADIOLOGICAL HEALTH PROGRAM

ORGANIZATION CHART 

ML020170337

Attachment

March 20, 2002 faxed letter from Ann Marie DeBiase

Maryland’s Response to Draft IMPEP Report

ML020940565