December 8, 2011 

Robert M. Summers, Ph.D., Secretary 

Maryland Department of the Environment 

1800 Washington Blvd., Suite 750 

Baltimore, MD 21230-1718 

Dear Dr. Summers: 

On November 3, 2011, 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 found the Maryland program adequate to protect public 

health and safety and compatible with the U.S. Nuclear Regulatory Commission=s (NRC) 

program. 

Section 5.0, page 19, of the enclosed final report contains a summary of the IMPEP team’s 

findings and recommendations. We request your evaluation and response to the 

recommendations in the report within 30 days from receipt of this letter. Based on the results of 

the current IMPEP review, the next full review of the Maryland Agreement State Program will 

take place in approximately 4 years, with a periodic meeting tentatively scheduled for August 

2013. 

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

I also wish to acknowledge your continued support for the Agreement State program. I look 

forward to our agencies continuing to work cooperatively in the future. 

 Sincerely, 

/RA/ 

 Michael F. Weber

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Maryland Final IMPEP Report 

cc w/ encl: Roland G. Fletcher, Manager 

 Radiological Health Program 

 Raymond Manley, Chief 

 Radioactive Material Licensing & Compliance Division 

 Tom Levering 

 Emergency Response Director 

 State Liaison Officer 
December 8, 2011 

Robert M. Summers, Ph.D., Secretary 

Maryland Department of the Environment 

1800 Washington Blvd., Suite 750 

Baltimore, MD 21230-1718 

Dear Dr. Summers: 

On November 3, 2011, 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 found the Maryland program adequate to protect public 

health and safety and compatible with the U.S. Nuclear Regulatory Commission=s (NRC) 

program. 

Section 5.0, page 19, of the enclosed final report contains a summary of the IMPEP team’s 

findings and recommendations. We request your evaluation and response to the 

recommendations in the report within 30 days from receipt of this letter. Based on the results of 

the current IMPEP review, the next full review of the Maryland Agreement State Program will 

take place in approximately 4 years, with a periodic meeting tentatively scheduled for August 

2013. 

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

I also wish to acknowledge your continued support for the Agreement State program. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

/RA/ 

 Michael F. Weber

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Maryland Final IMPEP Report 

cc w/ encl: Roland G. Fletcher, Manager 

 Radiological Health Program 

 Raymond Manley, Chief 

 Radioactive Material Licensing & Compliance Division 

 Tom Levering 

 Emergency Response Director 

 State Liaison Officer 

DISTRIBUTION: EDATS: FSME-2011-0097 

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ADAMS Accession Number: ML113180028 

OFFICE FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA 

NAME MBeardsley via email LDimmick (KSchneider for) DWhite BMcDermott 

DATE 11/15/11 11/26/11 11/17/11 11/25/11 

OFFICE Tech Editor FSME DEDMRT 

NAME CPoland MSatorius MWeber 

DATE 11/28/11 12/01/11 12/08/11 

OFFICIAL RECORD COPY 
Letter to R. Summers from Michael F. Weber dated: 

SUBJECT: MARYLAND 2011 FINAL IMPEP REPORT 

DISTRIBUTION: EDATS: FSME-2011-0097 

MSSA_Technical_Asst_Resource DCD (SP01) 

RidsEdoMailCenter 

RidsFsmeOd 

RidsOgcMailCenter 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

JKatanic, FSME Commissioner Svinicki 

DJanda, RI/RSAO Commissioner Apostolakis 

PLanzisera, RI Commissioner Magwood 

SSahle, FSME Commissioner Ostendorff 

JDaehler, MA SECY 

MStephens, FL 

JUhle, RIII 

DMerzke, OEDO 

CCarpenter, FSME 

BJones, OGC 

TRothschild, OGC 

JBiggins, OGC 

JWeil, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE MARYLAND AGREEMENT STATE PROGRAM 

AUGUST 8-12, 2011 

FINAL REPORT 
EXECUTIVE SUMMARY 

This report presents the results of the Integrated Materials Performance Evaluation Program 

(IMPEP) review of the Maryland Agreement State Program. The review was conducted during 

the period of August 8-12, 2011, by a review team composed of technical staff members from 

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

The Management Review Board (MRB) met on November 3, 2011, to consider the proposed 

final report. Based on the results of the review, the review team recommended, and the MRB 

agreed, that Maryland’s performance be found satisfactory, but needs improvement, for the 

performance indicator Technical Quality of Licensing Actions, and satisfactory for the six other 

performance indicators reviewed. 

The review team recommended, and the MRB agreed, that the Maryland Agreement State 

Program be found adequate to protect public health and safety, and compatible with NRC’s 

program. 

The review team made four recommendations regarding the performance of the Maryland 

Agreement State Program. These recommendations, which are briefly described below, 

included areas for improvement to correct identified performance deficiencies and weaknesses 

in Maryland’s Agreement State Program. The review team recommends that the State: (1) take 

measures to ensure that sufficient information pertaining to the inspection review of items of 

non-compliance and effectiveness of licensee corrective actions is adequately documented in 

inspection records; (2) perform a self-assessment of selected licensing actions issued during 

the review period, and on a routine basis in the future, to ensure that the Program’s review of 

licensing actions are adequately documented and that licensing actions are thorough and 

consistent with the regulations and appropriate licensing guidance; (3) regarding financial 

assurance: take measures to ensure that financial assurance requirements are reviewed as part 

of significant licensing actions and during licensing renewals, evaluate the need for financial 

assurance related to the radionuclide production (cyclotron) licensees, and perform a review of 

the adequacy and validity of financial assurance mechanisms already on file; and (4) for the 25 

obsolete sealed source & device registrations identified in Appendix G, take actions to submit 

the status of those registrations for inclusion in the national Sealed Source and Device Registry, 

to include transfer of each registration to inactive status as recommended in Section 13.4 of 

NUREG 1556, Volume 3, Revision 1, “Applications for Sealed Source and Device Evaluation 

and Registration,” and to take measures to ensure that future registrations that become 

obsolete are inactivated in a timely manner. 

Based on the results of the current IMPEP review, and in accordance with the criteria in NRC 

Management Directive 5.6, the review team recommended, and the MRB agreed, that the next 

full IMPEP review take place in approximately 4 years. 
Maryland Final IMPEP Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the Maryland Agreement State Program. The 

onsite portion of the review was conducted during the period of August 8-12, 2011, by a review 

team composed of technical staff members from the U.S. Nuclear Regulatory Commission 

(NRC) and the Commonwealth of Massachusetts. Review team members are identified in 

Appendix A. The review was conducted in accordance with the “Implementation of the 

Integrated Materials Performance Evaluation Program and Rescission of Final General 

Statement of Policy,” published in the Federal Register on October 16, 1997, and NRC 

Management Directive 5.6, “Integrated Materials Performance Evaluation Program (IMPEP),” 

dated February 26, 2004. Preliminary results of the review, which covered the period of 

August 25, 2007, to August 8, 2011, were discussed with Maryland managers on the last day of 

the review. 

A draft of this report was issued to Maryland for factual comment on September 7, 2011. The 

State responded by electronic mail dated October 12, 2011. Copies of the State’s responses 

are included as an Attachment to this report. The Management Review Board (MRB) met on 

November 3, 2011, to consider the proposed final report. The MRB found the Maryland 

Agreement State Program adequate to protect public health and safety and compatible with 

NRC’s program. 

The Maryland Department of the Environment (the Department) is the responsible agency for 

regulating the possession and use of radioactive materials in the State of Maryland. The 

Maryland Agreement State Program is administered by the Secretary of the Department, who 

reports directly to the Governor. The Radiological Health Program (the Program), under the Air 

and Radiation Management Administration, has been delegated the responsibility to implement 

the Agreement State program. The Program is divided into the Radioactive Materials Licensing 

and Compliance Division (the Division), the Radiation Machines Division, and a group 

responsible for Regulations and Radiation Exposure Strategies. Organizational charts for the 

Department, the Program, and the Division are presented in Appendix B. 

The State has a Radiation Control Advisory Board (RCAB), which was established pursuant to 

the Annotated Code of Maryland, § 8-201 et seq. The statute provides that there is a RCAB in 

the Department. The RCAB periodically reviews the programs and policies of the Department 

that relate to radiation, and consults with and advises the Secretary of the Department on 

matters that relate to radiation including: advice on proposed legislation; emerging radiation 

issues; and proposed regulations. The RCAB consists of 12 members, ten of which are 

individuals recognized as knowledgeable about the subject of radiation and two of which are 

members of the public who represent the community at large. Members of the RCAB are 

appointed by the Secretary of the Department. 

At the time of the review, the Maryland Agreement State Program reported that they regulated 

598 specific licenses authorizing byproduct, source, and certain special nuclear materials. The 

review focused on the radioactive 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. 
Maryland Final IMPEP Report Page 2 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Program on March 29, 2011. The Program 

provided its response to the questionnaire via email on July 12, 2011. A publicly available 

version of the questionnaire response can be found in NRC’s Agencywide Documents Access 

and Management System (ADAMS) using the Accession Number ML112010075. 

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

the Program’s response to the questionnaire; (2) review of applicable Maryland statutes and 

regulations; (3) analysis of quantitative information from the Division’s databases; (4) technical 

review of selected regulatory actions; (5) field accompaniments of three qualified inspectors; 

and (6) interviews with staff and managers. The review team evaluated the information 

gathered against the established criteria for each common and the applicable non-common 

performance indicator and made a preliminary assessment of the Maryland Agreement State 

Program’s performance. 

Results of the review for the common performance indicators are presented in Section 3.0. 

Section 4.0 details the results of the review of the applicable non-common performance 

indicators, and Section 5.0 summarizes the review team's findings and recommendations. The 

review team’s recommendations are comments that relate directly to the Program’s 

performance. A response is requested from the State to all recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which was conducted during August 20-24, 2007, no 

recommendations were made in regard to program performance. 

3.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review NRC Regional and Agreement State 

radioactive materials programs. These indicators are: (1) Technical Staffing and Training, 

(2) Status of Materials Inspection Program, (3) Technical Quality of Inspections, (4) Technical 

Quality of Licensing Actions, and (5) Technical Quality of Incident and Allegation Activities. 

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Program’s staffing level and staff 

turnover, as well as the technical qualifications and training histories of the staff. To evaluate 

these issues, the review team examined the Program’s questionnaire response relative to this 

indicator, interviewed Program managers and staff, reviewed job descriptions and training 

records. The review team also considered any possible workload backlogs in evaluating this 

indicator. 

The Division implements the radioactive materials program and consists of the Inspection 

Section and the Licensing Section. The Division is supervised by a Chief, who is responsible for 

the oversight of both the Inspection and Licensing sections. The Inspection Section is 

responsible for performing radiation safety inspections, responding to incidents and allegations, 

and monitoring decontamination and decommissioning of licensed facilities. The Licensing 

Section is responsible for processing license applications and amendments for the use of 
Maryland Final IMPEP Report Page 3 

radioactive material and for performing sealed source and device (SS&D) evaluations. The 

Inspection and Licensing Sections each have authorization for one supervisor and three 

technical staff positions. 

At the time of the review, eight staff members, including three managers, worked full-time and 

two technical staff members worked part-time for the radioactive materials program. This 

staffing level does not include administrative support staff. During the review period, two 

technical staff members were hired into the Program and three technical staff members left the 

Program. One individual that was hired during the review period also left the Program during 

the review period, after having worked for the Program for less than a year and a half. The 

position vacated by this individual is a contractor position that is located in the Licensing 

Section. This position has been vacant since September 2010. At the time of the review, it was 

noted that the Program had initiated the process of posting this position. A staff member of the 

Inspection Section has been on a military duty assignment since November 2010 and is not 

expected to return to the Program until March 2012. Details of staffing in the SS&D program 

are provided in Section 4.2.1 of this report. 

The Program has a documented training plan for technical staff that is consistent with the 

requirements in the NRC/Organization of Agreement States Training Working Group Report and 

NRC’s Inspection Manual Chapter (IMC) 1246, “Formal Qualification Programs in the Nuclear 

Material Safety and Safeguards Program Area.” The License Reviewer Qualification Plan 

includes documentation of on-the-job training and formal course work for license reviewers, in 

addition to licensing policies, procedures, and checklists. A qualification log is maintained for 

each license reviewer which clearly documents the individual’s progress throughout the 

qualification process. The Radiological Health Inspection Manual has a chapter on inspector 

training and qualification procedures, including detailed training logs, documentation of 

inspection accompaniments, and evaluation by managers to qualify individual staff. Staff 

members are assigned increasingly complex duties as they progress through the licensing 

and/or inspection qualification process. The review team noted that Program management had 

a strong commitment to training. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Maryland’s performance with respect to the indicator, Technical Staffing and Training, be 

found satisfactory. 

3.2 Status of Materials Inspection Program

The review team focused on five factors while reviewing this indicator: inspection frequency, 

overdue inspections, initial inspections of new licenses, timely dispatch of inspection findings to 

licensees, and performance of reciprocity inspections. The review team’s evaluation was based 

on the Program’s questionnaire response relative to this indicator, data gathered from the 

Program’s database, examination of completed inspection casework, and interviews with 

Program managers and technical staff members. 

The review team compared the Program’s inspection frequencies for various license types to 

the inspection frequencies found in NRC’s IMC 2800, “Materials Inspection Program.” The 

inspection priorities used by the Program during the review period were found to be either the 

same or more frequent than those provided in IMC 2800. For those license types inspected 
Maryland Final IMPEP Report Page 4 

more frequently than provided in IMC 2800, the Program believes that these represent higher 

safety and risk significant activities and warrant more frequent inspection. The review team 

discussed with the Program the NRC’s recent revision to IMC 2800, which was issued on 

November 15, 2010. Regarding inspection frequencies, the revision to IMC 2800 added a few 

new license program codes and associated priority codes that the Program may find useful in 

implementing its licensing and inspection programs. 

The Program’s database had limited capabilities for retrieval of inspection data from the entire 

review period. As a result, the review team verified the Program’s inspection timeliness based 

on the information contained in the Program’s questionnaire response, information that could be 

obtained from the database, interviews with Program managers, and review of the inspection 

casework for determination of Priority 1, 2, 3, and initial inspections. As could be determined 

based on the above sources of information, during the review period, the Program performed 

254 Priority 1, 2, and 3 inspections. This number of inspections is based on the Program’s 

determination of inspection priority and not those of IMC 2800, and therefore includes some 

inspections conducted by the Program more frequently than provided in IMC 2800. The 

Program’s questionnaire response reported that using their priority codes for Priority 1, 2, 3 

licenses, out of 254 inspections, two inspections were performed overdue (i.e. greater than 

25 percent of the assigned inspection frequency) and no inspections were overdue at the time 

of the review. On November 2, 2011, the Inspection supervisor provided an email to the review 

team wherein the State reexamined the information that had previously been provided to the 

team and determined that no inspections were performed overdue during the review period. 

The review team identified a few typographical errors in the Program’s database wherein the 

indicated license program code did not match with the assigned inspection priority. Although in 

these few cases the priorities were less frequent than those of IMC 2800, the review team 

determined that none of the typographical errors resulted in any inspections being overdue at 

the time of the review. The inspection supervisor committed to review the discrepant entries 

and make corrections to either the license program code or inspection priority as appropriate. 

During the review period, the version of IMC 2800 that was in effect was issued on 

September 28, 2005. This version describes, in part, that an initial inspection of a new licensee 

shall be completed within 12 months of license issuance. Data regarding the performance of 

initial inspections had to be manually verified by the Inspection Section supervisor. Based on 

the data obtained from the manual search, 67 initial inspections were conducted during the 

review period, three of which were conducted overdue. Additionally, there were six pending 

initial inspections, none of which were overdue at the time of the review. On November 2, 2011, 

the Inspection supervisor provided an email to the review team wherein the State reexamined 

the information that had previously been provided to the team and determined that only one 

initial inspection had been performed overdue during the review period. On May 4, 2011, the 

Program revised its “Radiological Health Program Inspection Manual.” This revision addressed 

the changes regarding the circumstances under which an initial inspection is necessary that 

were described in NRC’s recent revision to IMC 2800, which was issued on November 15, 

2010. 

Based on the revised inspection data provided by the State regarding the Program’s Priority 1, 

2, and 3 licensees as well as the initial inspection data, the review team calculated that the 

Program performed less than 1 percent of its inspections overdue during the review period. 
Maryland Final IMPEP Report Page 5 

The review team verified the Program’s performance of inspections of licensees subject to the 

Increased Controls. At the time of the review, the Program had 25 licensees subject to the 

Increased Controls. Inspections of licensees subject to the Increased Controls were tracked by 

the Program separately from the routine inspections in order to ensure that inspections were 

performed in a timely manner. 

The review team evaluated the Program’s timeliness in issuing inspection findings. For each 

inspection, the inspector issues a “Form E-1, Radioactive Material Inspection Findings and 

Licensee Acknowledgement” to the licensee, and the licensee representative signs the form to 

acknowledge receipt. This form documents that an inspection was performed and 

communicates to the licensee that either: (1) licensed activities have not commenced under the 

license; (2) no non-compliances were identified; (3) non-compliances were identified but were of 

minor significance and documented at the conclusion of the inspection for licensee corrective 

action; or (4) non-compliances were identified and will be transmitted to the licensee via letter at 

a later date. The data regarding issuance of inspection findings to licensees was not able to be 

retrieved from the Program’s database. The review team found that, based on a review of 

selected inspection casework, “E-1” forms were routinely provided to licensees at the conclusion 

of the onsite inspection. For inspections where non-compliances were identified and the 

decision was made to issue them to the licensee in a letter, the Program typically issued the 

letters to licensees within 30 days of the date of the inspection. A few cases were identified 

where letters documenting non-compliances were issued to licensees greater than 30 days from 

the date of the onsite inspection, but none of the cases reviewed exceeded 45 days. It was 

noted by the inspection supervisor that significant enforcement actions may take longer to be 

issued due, in part, to the level of management review necessary. 

The Program grants reciprocity requests for many categories of licensees and considers all 

reciprocity licensees as candidates for inspection but focuses on accomplishing reciprocity 

inspections of Priority 1, 2, and 3 licensees. The review team found that the Program’s 

selection of candidates for inspection differed somewhat from that described in NRC’s IMC 1220 

“Processing of NRC Form 241 and Inspection of Agreement State Licensees Operating under 

10 CFR 150.20” but was still effective in meeting the intent of the criteria. Based on the 

Program’s questionnaire response and a review of the Program’s reciprocity files, the review 

team found that the Program was able to consistently perform inspections of 20 percent or more 

of the Priority 1, 2, and 3 reciprocity licensees annually. During each of the years of the review 

period, beginning with 2007, the Program performed inspections of: 33 percent, 30 percent, 

41 percent, and 38 percent, respectively, of Priority 1, 2, and 3 reciprocity licensees. For 2011, 

at the time of the review, the Program had granted 18 reciprocity requests to Priority 1, 2, and 3 

reciprocity licensees, and had already performed 5 inspections of Priority 1, 2, and 3 reciprocity 

licensees (28 percent). 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Maryland's performance with respect to the indicator, Status of Materials Inspection 

Program, be found satisfactory. 

3.3 Technical Quality of Inspections

The review team evaluated 13 inspection case files that included inspection records, 

enforcement documentation and letters to licensees, and interviewed the inspection section 
Maryland Final IMPEP Report Page 6 

supervisor and technical staff members who were responsible for some of the radioactive 

materials inspections conducted during the review period. The casework reviewed covered a 

wide variety of inspection types, including panoramic wet-source storage irradiator, nuclear 

pharmacy, radionuclide production (cyclotron), industrial radiography, self-shielded irradiators, 

veterinary non-human use, and medical-written directives required. The casework reviewed 

represented inspections conducted by the inspection section supervisor, three qualified 

inspectors from the inspection section, and two qualified inspectors from the licensing section. 

A listing of the inspection casework files reviewed, with case-specific comments, is provided in 

Appendix C. 

Based on the review of casework, the review team noted that with a few exceptions, inspection 

records were thorough, complete, consistent, and of high quality. When items of noncompliance were identified, inspection records and communications to licensees were of high 

quality and contained sufficient information to support the inspectors’ findings. The review team 

found that inspection documentation did not always address a review by the current inspector of 

items of non-compliance that were identified during previous inspections. In some cases, the 

previous inspection was the result of an incident or event and had resulted in the issuance of 

non-compliances to the licensee regarding matters of health and safety significance. In these 

cases, the inspectors that performed the next routine inspection did not document their review 

of the licensee’s immediate and long-term corrective actions and whether those corrective 

actions were sufficient and effective to correct the non-compliances and prevent recurrence of 

the non-compliances. The review team recommends that the State take measures to ensure 

that sufficient information pertaining to inspection review of items of non-compliance as well as 

the effectiveness of licensee corrective actions is adequately documented in inspection records. 

The review team found that during the review period, the Inspection Section supervisor had 

accompanied all qualified inspectors performing radioactive materials inspections at least once 

a year. The Division Chief performed accompaniments of both the Inspection Section 

supervisor and the Licensing Section supervisor during the conduct of complex event 

investigations and pre-licensing visits, respectively. Supervisory accompaniments were 

documented by the accompanying manager and the supervisor’s observations were discussed 

with the individual being accompanied. 

The review team found that the Program maintained an adequate supply of appropriately 

calibrated survey instruments to support the inspection program and to respond to incidents and 

emergency conditions. The instrumentation was calibrated by an outside vendor according to 

the manufacturer’s recommendations. Appropriate documentation of calibrated survey 

instruments such as Geiger-Mueller detectors, scintillation detectors, ion chambers, and microR meters was provided for review. Air monitoring equipment and emergency field kits were 

available for emergency use. Laboratory analyses of contamination wipes, as well as air, soil, 

and water samples, were primarily performed under contract by Maryland’s Department of 

Health and Mental Hygiene Radiation Laboratory, which is located in Baltimore. 

A review team member accompanied two qualified inspectors during inspections conducted on 

June 13-15, 2011 and July 28, 2011. A listing of the inspector accompaniments performed, with 

specific comments, is provided in Appendix C. During June 13-15, 2011, the license types 

inspected as part of the accompaniments included: manual brachytherapy-written directives 

required; nuclear medicine-written directives required; and self-shielded irradiator. Both 
Maryland Final IMPEP Report Page 7 

inspectors were well-prepared for the inspections, knowledgeable of the types of licensed 

activities, focused on risk-significant activities during inspections, and demonstrated appropriate 

performance-based inspection techniques related to radiation safety issues. During the 

accompaniment inspection that included the inspector’s review of licensee compliance with the 

Increased Controls, the inspector did not adequately review some areas related to the 

licensee’s compliance with the Increased Controls requirements. For one requirement, the 

inspector accepted the licensee’s explanation of compliance without verifying the information. 

The review team member discussed this with the inspector, but the inspector did not perform 

any additional review, develop supporting information, review relevant records, or engage in 

additional inspection activities to verify the licensee’s assertion. 

At the conclusion of the accompaniment inspections, the review team member discussed the 

observations from the accompaniments with Program managers. With regards to the Increased 

Controls inspection, the review team member was informed that this was the inspector’s first 

independent inspection of the Increased Controls requirements. Based on this discussion, it 

was mutually agreed to that the review team member would observe another Increased 

Controls inspection with a different qualified staff member. 

The additional accompaniment inspection was performed on July 28, 2011, at an industrial 

radiography licensee. The inspector was well-prepared for the inspection and demonstrated 

appropriate performance-based inspection techniques. The inspector also utilized an inspection 

guide to aid in the review of the licensee’s compliance with the Increased Controls. The 

thoroughness and quality of this inspection was higher than the earlier observed Increased 

Controls inspection. These observations were shared with Program managers. Program 

management stated that, based on the accompaniment observations, the inspectors would be 

provided with some additional guidance related to inspections of licensee compliance with the 

Increased Controls and would also be encouraged to more closely follow the inspection guide 

during the conduct of inspections. Program management also indicated that, as appropriate, 

they would perform inspection follow up related to the earlier Increased Controls licensee. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Maryland’s performance with respect to the indicator, Technical Quality of Inspections, be 

found satisfactory. 

3.4 Technical Quality of Licensing Actions

The review team examined completed licensing casework and interviewed license reviewers for 

21 specific licensing actions. Licensing actions were reviewed for completeness, consistency, 

proper radioisotopes and quantities, qualifications of authorized users, adequacy of facilities and 

equipment, adherence to good health physics practices, financial assurance, operating and 

emergency procedures, appropriateness of license conditions, and overall technical quality. 

The casework was also reviewed for use of appropriate deficiency letters and cover letters, 

reference to appropriate regulations, supporting documentation, consideration of enforcement 

history, pre-licensing visits, peer/supervisory review, proper signatures, and marking/control of 

documents that contain sensitive information. 

The licensing casework was selected to provide a representative sample of licensing actions 

completed during the review period. Licensing actions selected for evaluation included 
Maryland Final IMPEP Report Page 8 

two new licenses, nine renewals, three decommissioning or termination actions, and seven 

amendments. Casework reviewed included a cross-section of license types, including: medical 

broad scope, academic broad scope, medical diagnostic and therapy (including gamma 

stereotactic and high dose rate remote afterloader), industrial radiography, research and 

development, nuclear pharmacy, radionuclide production (cyclotron), portable gauge, fixed 

gauge, mobile nuclear medicine, panoramic and self-shielded irradiators. The casework sample 

represented work from three current license reviewers and two former license reviewers. A 

listing of the licensing casework evaluated is provided in Appendix D. 

The review team confirmed that all license reviewers had signature authority for licensing 

actions reviewed, or were reviewed by a second reviewer while under training. The Program 

Manager or the Division Chief performs a technical and supervisory review on all licensing 

actions before issuance to the licensee. Licenses are issued for a 7-year period under a timely 

renewal system. 

Based on the licensing casework files examined, the review team found that license tie-down 

conditions were stated clearly and were supported by information contained in the file. 

Deficiency letters clearly stated regulatory positions and often identified substantive deficiencies 

in the licensees’ documents. The review team also identified that license reviewers are 

equipped with both the Program’s and the NRC’s licensing guides, policies, checklists, and 

standard license conditions specific to the type of licensing actions to ensure consistency in 

licenses. 

Licensing actions were found to be generally complete, and with health, safety, and security 

issues properly addressed. For some casework files reviewed, all health and safety items as 

described in the NUREG-1556 “Consolidated Guidance About Materials Licenses” series of 

documents and the Program’s licensing guidance were not adequately addressed. For 

example, broad scope applications often did not include acceptance criteria used by the 

Radiation Safety Committee for approval of new uses, users, or facilities; broad scope 

applications often did not identify significant activities and facilities (e.g., iodination facilities, 

alpha use labs) or describe approval criteria for non-research activities (e.g., portable gauge 

uses). In one case, a licensee’s prior enforcement history was reviewed to ensure that 

violations were closed; however, health and safety issues identified during inspections were not 

specifically addressed during the licensing process. One license was terminated without 

submission of sealed source leak test results. The review team recommends that the State 

perform a self-assessment of selected licensing actions issued during the review period, and on 

a routine basis in the future, to ensure that the Program’s review of licensing actions are 

adequately documented and that licensing actions are thorough and consistent with State 

regulations and appropriate licensing guidance. 

One of the casework files reviewed was for a licensee that was only authorized by its license to 

perform service-related activities. However, this particular licensee is identified in several 

Maryland Sealed Source & Device registrations as a distributor of various sealed sources and 

devices that are used for medical applications (e.g. iridium-192 high dose-rate remote 

afterloaders, iodine-125 brachytherapy sources). Another consideration in this case is that 

some of the sources and all of the devices are manufactured outside the United States. It 

appears to the review team that there is no license that authorizes the distribution or oversees 

the manufacturing quality assurance of these sources and devices. 10 CFR 35.49 requires, in 
Maryland Final IMPEP Report Page 9 

part, that for medical use, a licensee may only use (a) sealed sources or devices manufactured, 

labeled, packaged, and distributed in accordance with a license issued under 10 CFR Part 30 

and 10 CFR 32.74 of this chapter or equivalent requirements of an Agreement State; or (b) 

sealed sources or devices non-commercially transferred from a 10 CFR Part 35 licensee or an 

Agreement state medical use licensee. Option (b) does not apply in this case because the 

subject Maryland licensee is not a medical use licensee. Therefore, in accordance with (a), the 

review team concluded that the Maryland license should authorize distribution and oversee 

manufacturing quality assurance of sealed sources and devices for medical use within the 

United States. The State’s equivalent of 10 CFR 35.49 is contained in the Code of Maryland 

Regulations (COMAR) 26.12.01.01 Section G.49, and its equivalent of 10 CFR 32.74, is 

contained in COMAR 26.12.01.01 Section C.28(l). Because licensees throughout the United 

States utilize these sources and devices for medical use, it is imperative that these sources and 

devices are provided by suppliers that are properly licensed and meet the applicable regulatory 

requirements to perform these activities. In its October 12, 2011, response to the draft IMPEP 

report, the State noted that on August 18, 2011, the subject license was appropriately amended 

to authorize the manufacture/distribution of sealed sources or devices for medical use. During 

the November 3, 2011, MRB, the State furthermore noted that it had reviewed its other 

licensees and found that this was the only license that did not have the appropriate language 

authorizing distribution. 

Based on the licensing casework reviewed, the review team identified a few issues related to 

financial assurance. The review team found that for two radionuclide production (cyclotron) 

facilities, financial assurance was not submitted by the applicant/licensee or requested by the 

license reviewer. In addition, the review team identified that financial assurance mechanisms, 

including financial instruments and decommissioning funding plans, have not been reviewed 

and updated since their original submissions. Some of these licenses have been amended 

many times with the addition of facilities and activities that would increase decommissioning 

costs; however, the financial instruments and decommissioning funding plans have not been 

updated accordingly. In one case, a licensee’s letter of credit had not been amended or reissued to reflect a new bank name and a new account number. Regarding financial assurance, 

the review team recommends that the State: (1) take measures to ensure that financial 

assurance requirements are reviewed as part of significant licensing actions and during 

licensing renewals; (2) evaluate the need for financial assurance related to the radionuclide 

production (cyclotron) licensees; and (3) perform a review of the adequacy and validity of 

financial assurance mechanisms already on file with the Program. 

The review team assessed the Program’s implementation of NRC’s pre-licensing guidance 

issued on September 22, 2008, and transmitted to the Agreement States via NRC’s Office of 

Federal and State Materials and Environmental Management Programs (FSME) Letter RCPD08-020, “Requesting Implementation of the Checklist to Provide a Basis for Confidence That 

Radioactive Material Will Be Used as Specified on a License and the Checklist for RiskSignificant Radioactive Material.” Following receipt of RCPD-08-020 regarding pre-licensing 

guidance, the Program reviewed the pre-licensing process they already had in place and 

determined that no changes were required. The Program performs pre-licensing checks of all 

new applicants. Current licensees who undergo a change of ownership are considered new 

applicants if their name changes and significant additional changes, such as authorized users 

and Radiation Safety Officer, occur; and are issued a new license concurrent with the 

termination of the current license. The NRC’s pre-licensing guidance for conducting 
Maryland Final IMPEP Report Page 10 

pre-licensing reviews provides standard questions for business operations, facility, radiation 

safety operations, and personnel. The Program’s pre-licensing review methods were found to 

be adequate to address the essential elements of NRC’s pre-licensing guidance to verify that 

the applicant will use requested radioactive materials as intended. The review team also shared 

with the Program some of the methods used and questions asked by NRC related to verification 

of the legitimacy of applicant personnel. 

The review team examined the Program’s licensing practices regarding the Increased Controls 

and Fingerprinting requirements. The review team noted that the Program uses legally binding 

license conditions that meet the criteria for implementing the Increased Controls requirements, 

including Fingerprinting, as appropriate. The review team evaluated the Program’s 

methodology for identifying those licenses requiring Increased Controls and Fingerprinting 

requirements and found the rationale to be sound; with the exception of broad scope licenses. 

For broad scope licenses, the license reviewers calculated the quantities of concern, and 

sometimes documented that the quantities of concern were exceeded, but made an assumption 

that the quantities would not be collocated; and therefore, did not impose the Increased Control 

or Fingerprinting requirements on the licensee. This assumption that sources would not be 

collocated was made based on information gathered during the conduct of inspections at the 

facilities. The review team noted that inspections are only a snapshot in time and that there 

were no provisions that would prohibit the licensees from co-locating the subject materials. The 

review team expressed that because the licenses authorized radioactive material quantities of 

concern that exceeded the unity rule, it would be prudent to impose the applicable license 

conditions on the licenses. If this were done, the responsibility would be placed on the licensee 

to assure that they either do not co-locate the materials and if they did they would need to 

implement the requirements. The Program agreed to review their practices in this area. The 

review team confirmed that license reviewers evaluated full implementation of the Increased 

Controls prior to issuance of a new license or license amendment adding radioactive materials 

in quantities of concern. 

Regarding the Program’s control of sensitive information, on May 5, 2011, the Program 

implemented “Increased Control-Sensitive Information Protection Procedure.” This procedure 

addresses the identification, marking, control, handling, preparation, transportation, 

transmission, and destruction of documents that contain sensitive information related to the 

Increased Controls. Following receipt of FSME letter RCPD-11-005, “Additional Guidance and 

Clarification regarding the review of the Control of Sensitive Information During IMPEP 

Reviews,” dated May 11, 2011, the Program reviewed the referenced guidance in RIS 2005-

031, “Control of Security-Related Sensitive Unclassified Non-Safeguards Information Handled 

by Individuals, Firms, and Entities Subject to NRC Regulation of the Use of Source, Byproduct, 

and Special Nuclear Materials.” Based on its review of the subject guidance documents, the 

program determined that only Increased Controls information related to Category 1 and 

Category 2 licensees must be controlled as sensitive information and that their procedure was 

appropriate and consistent with the guidance. The review team noted that the Program controls 

access to all their licensing and inspection files via password protection and key-card entry. 

Files that contained sensitive information were further secured in locked file cabinets. 

Following receipt of FSME letter RCPD-10-007, “Requesting Implementation of a Policy on 

Maximum Possession Limits for Radioactive Material Licenses,” dated June 21, 2010, the 

Program began a review of its portable gauge licenses and amended the licenses to include 
Maryland Final IMPEP Report Page 11 

total possession limits. The Program noted that at the time of the review, all but one portable 

gauge license had been amended to include a total possession limit. Other categories of 

licenses were under review by the Program and it was expected that the process would be 

completed by the end of 2011. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Maryland’s performance with respect to the indicator, Technical Quality of Licensing 

Actions, be found satisfactory, but needs improvement. 

3.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Program=s actions in responding to incidents and 

allegations, the review team examined the Program=s response to the questionnaire relative to 

this indicator, evaluated selected incidents reported for Maryland in the Nuclear Material Events 

Database (NMED) against those contained in the Program=s files, and evaluated the casework 

for 10 radioactive materials incidents. A listing of the incident casework examined, with casespecific comments, is provided in Appendix E. The review team also evaluated the Program=s 

response to six allegations involving radioactive materials, including five allegations referred to 

the State by the NRC during the review period. 

The review team examined the Program’s incident and allegation processes, including written 

procedures for handling allegations and incident response, file documentation, notification of 

incidents to the NRC Headquarters Operations Center, and the use of NMED software. When a 

notification of an incident or allegation is received, Program managers and staff determine the 

level of initial response based on the potential health and safety significance associated with the 

incident or allegation. 

The review team identified 24 events in NMED for Maryland during the review period, of which 

11 required reporting to the NRC Headquarters Operations Center. A review of the Program’s 

incident files did not reveal any additional reportable events. The review team selected 10 

radioactive material incidents for evaluation. These incidents included the following types of 

events: lost/stolen radioactive material; potential overexposure; medical event; damaged 

equipment; and leaking source. The Program’s responses to the incidents were found to be 

complete and comprehensive. Initial responses were prompt and well-coordinated, and the 

level of effort was commensurate with the potential health and safety significance of the event. 

Inspectors were dispatched for onsite investigations when appropriate. Enforcement and/or 

other regulatory actions were taken as appropriate. With the exception of one incident 

reviewed, the Program reported events to the NRC in a prompt manner. The actions taken in 

response to incidents were documented and filed, and the data were submitted to the NRC’s 

contractor responsible for maintaining NMED for inclusion in the database. 

In evaluating the effectiveness of the Program's response to allegations, the review team 

evaluated the completed casework for six allegations, including five that NRC referred to the 

State during the review period. The review team concluded that the Program consistently took 

prompt and appropriate actions in response to concerns raised. The review team noted that the 

Program documented the investigations of concerns and retained all necessary documentation 

to appropriately close the allegations. The Program notified the concerned individuals of the 
Maryland Final IMPEP Report Page 12 

conclusion of their investigations. The review team determined that the Program adequately 

protected the identity of concerned individuals. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Maryland=s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

Four non-common performance indicators are used to review Agreement State Programs: 

(1) Compatibility Requirements, (2) Sealed Source and Device Evaluation Program, (3) Lowlevel Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. The NRC’s 

Agreement with the State of Maryland does not relinquish authority to regulate a uranium 

recovery program, therefore only the first three non-common performance indicators were 

applicable to this review. 

4.1 Compatibility Requirements

To assess Maryland’s status with respect to this performance indicator, the review team 

examined the Program’s questionnaire response relative to this indicator; reviewed Maryland’s 

State Regulation Status Data Sheet (SRS), as maintained by FSME, and conducted interviews 

with managers and staff responsible for this program area. 

4.1.1 Legislation

Maryland became an Agreement State on January 1, 1971. The current effective statutory 

authority for control of radiation is contained in the Annotated Code of Maryland, Environmental 

Article, Title 8, ARadiation,@ and Title 7, AHazardous Materials and Hazardous Substances.@ The 

Department is designated as the State=s radiation control agency. Maryland’s statutory authority 

is sufficiently broad to provide authority for the regulation byproduct, source, special nuclear 

materials, and other radioactive materials. 

The Program provided the review team with a copy of the legislation that affects the radiation 

control program. The review team noted that no legislation affecting the radiation control 

program was passed during the review period. 

4.1.2 Program Elements Required for Compatibility 

Maryland=s regulations for the control of radiation are contained in COMAR 26.12.01.01, 

ARegulations for the Control of Ionizing Radiation@ and apply to all persons who receive, 

possess, use, transfer, own, or acquire any source of radiation. COMAR 26.15, ADisposal of 

Controlled Hazardous Substances - Radioactive Hazardous Substances,@ contains statutes that 

govern the management of radioactive hazardous substances and addresses low-level 

radioactive waste issues. Maryland requires a license for the receipt, possession, use, 

ownership, or transfer of all radioactive material, including byproduct, source, certain quantities 

of special nuclear material, accelerator-produced radionuclides, and naturally-occurring 

materials, such as radium. Maryland also requires registration of all equipment designed to 

produce x-rays or other ionizing radiation. 
Maryland Final IMPEP Report Page 13 

The review team examined the State’s administrative rulemaking process and found that the 

process takes six months to a year from the development stage to the final approval by the 

Secretary of the Environment, after which the rule becomes effective in 10 days. The public, 

NRC, other agencies, and potentially impacted licensees and registrants are offered an 

opportunity to comment during the process. Comments are considered and incorporated, as 

appropriate, before the regulations are finalized and approved by the Secretary of the 

Environment. 

The review team noted that the State=s rules and regulations are not subject to Asunset@ laws. 

The State may adopt the regulations of another agency by reference and also has the authority 

to issue legally binding requirements (e.g., license conditions) in lieu of regulations until 

compatible regulations become effective. Changes or revisions to regulations are incorporated 

into COMAR by means of supplements. During the review period, four supplements to COMAR 

were issued that addressed regulatory changes related to the radioactive materials program 

Current NRC policy requires that Agreement States adopt certain equivalent regulations or 

legally binding requirements no later than 3 years after the effective date of NRC’s regulations. 

At the time of this review, the following two amendments had been previously reviewed by NRC 

as proposed regulations, but had not been submitted by the Program to NRC as final 

regulations. The review team discussed this matter with the Program, at which time it was 

apparent that the regulation amendments had been previously finalized but due to an oversight 

had not been submitted to NRC as final for review. One regulatory amendment was due for 

State adoption by January 31, 2009, and was made effective on June 15, 2009 with the 

publication of Supplement 17 to the COMAR. This regulatory amendment is not considered 

overdue because the State had legally binding license conditions in place prior to the adoption 

due date. The other regulatory amendment was due for State adoption by November 30, 2010, 

and was made effective on November 15, 2010, with the publication of Supplement 19 to the 

COMAR. During the conduct of the review, on August 10, 2011, the Program submitted the two 

regulatory amendments to NRC: 

 

• “National Source Tracking System,” 10 CFR Part 20 (71 FR 65685, 72 FR 59162), which 

was due for Agreement State adoption by January 31, 2009. 

• “Exemptions From Licensing, General Licenses, and Distribution of Byproduct Material: 

Licensing and Reporting Requirements,” 10 CFR Parts 30, 31, 32 and 150 (72 FR 

58473), which was due for Agreement State adoption by November 30, 2010. 

At the time of the review, the following two amendments had been reviewed by NRC as 

proposed regulations, but had not been submitted to NRC as final for review. The NRC’s review 

of the proposed regulations resulted in comments being provided to the State on March 2, 2011. 

At the time of the review, the State had reviewed and addressed the comments and expected 

that both amendments will be finalized in the next Supplement to the COMAR, which was 

expected to become effective in October 2011. The two regulatory amendments are: 

• ARequirements for Expanded Definition of Byproduct Material,@ 10 CFR Part 20, 30, 31, 

32, 33, 35, 61, and 150 (72 FR 55864), which was due for State adoption by November 

30, 2010. 
Maryland Final IMPEP Report Page 14 

• AOccupational Dose Records, Labeling Containers, and Total Effective Dose 

Equivalent,” 10 CFR Parts 19 and 20 (72 FR 68043), which was due for State adoption 

by February 15, 2011. 

During the November 3, 2011, MRB, the State reported that the above two regulatory 

amendments were finalized with an effective date of September 19, 2011. The State expected 

that the regulatory amendments would be submitted to NRC as final for review in the near 

future. 

The Program will need to address the following two regulatory amendments in upcoming 

rulemaking: 

• “Medical Use of Byproduct Material – Authorized User Clarification,” 10 CFR Part 35 

(74 FR 33901), which is due for Agreement State adoption by September 28, 2012. 

• “Decommissioning Planning,” 10 CFR Parts 20, 30, 40, and 70 (76 FR 35512), which is 

due for Agreement State adoption by December 17, 2015. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Maryland=s performance with respect to the indicator, Compatibility Requirements, be found 

satisfactory. 

4.2 Sealed Source and Device (SS&D) Evaluation Program

In reviewing this indicator, the review team used three sub-elements to evaluate the Program’s 

performance regarding the SS&D Evaluation Program. These sub-elements were: (1) Technical 

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

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

In assessing the Program’s SS&D evaluation activities, the review team examined information 

provided by the Program in response to the IMPEP questionnaire for this indicator, performed a 

search of the national Sealed Source and Device Registry for registrations issued by Maryland, 

and performed NMED searches of manufacturers and distributors identified on SS&D 

registrations issued by Maryland. A review of new, amended, and inactivated SS&D 

evaluations and supporting documents covering the review period was conducted. The review 

team reviewed the Program’s use of guidance documents and procedures, interviewed Program 

managers and staff, and verified the use of regulations, license conditions, and inspections to 

enforce commitments made in the applications. 

4.2.1 Technical Staffing and Training

At the time of the review, the Program had four qualified SS&D reviewers with full signature 

authority to sign SS&D registration certificates. There were no newly qualified SS&D reviewers 

nor did any qualified SS&D reviewer leave the Program during the review period. The 

Program’s SS&D evaluation program received support from a contractor, SAIC, Inc., during the 

review period. The contractor provided the Program with engineering analyses of SS&D 

applications received by the Program and of incidents related to products identified on SS&D 

registrations issued by Maryland. 
Maryland Final IMPEP Report Page 15 

The Program’s four qualified reviewers with full signature authority each have a BS degree in 

physical and/or life sciences and have each attended the NRC SS&D workshop. The State’s 

contractor, SAIC, Inc., provides additional support to the Program, was led by a licensed 

Professional Engineer who, on occasion, received additional support of another licensed 

Professional Engineer. The two licensed Professional Engineers were determined by the 

Program to have possessed, in combination, greater than 70 years experience in mechanical 

and nuclear engineering. 

Qualification criteria for reviewers were established, implemented, and documented by the 

Program. The Program maintained written procedures for evaluating when engineering analysis 

support from its contractor was necessary. The Program had one pending new SS&D 

evaluation for a new registration and one pending SS&D evaluation for inactivation of a 

registration at the time of the on-site review. 

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

performance with respect to the sub-element, Technical Staffing and Training, be found 

satisfactory. 

4.2.2 Technical Quality of the Product Evaluation Program

Information provided by the Program in response to the IMPEP questionnaire identified 

14 SS&D registrations issued during the review period. The review team identified an additional 

three SS&D registrations that were issued during the review period. During the review period, 

the Program performed 17 SS&D actions: two new; 12 amended; and three inactivated SS&D 

registrations. The review team reviewed casework related to 12 of the 17 SS&D actions that 

were performed during the review period. The casework review included all supporting 

documentation, licenses, and inspections associated with the distributors of the sealed sources 

and devices. A list of the SS&D casework examined by the review team, with case-specific 

comments, is provided in Appendix F. 

The review team’s evaluation of the casework and interviews with the management and staff 

confirmed that the Program’s policy is to follow the recommended guidance from the NRC 

SS&D training workshops and NUREG-1556, Volume 3, Revision 1, “Applications for Sealed 

Source and Device Evaluation and Registration.” The review team found that appropriate 

review checklists were used to assure all relevant materials had been submitted and reviewed. 

The checklists were retained in the SS&D files along with other documents that identified the 

assigned reviewers. Pertinent American National Standards Institute standards, regulatory 

guides, and applicable references were confirmed to be available and were used when 

performing the SS&D reviews. 

The Program’s registration files contained all correspondence, engineering drawings, 

photographs, radiation profiles, and details of the applicant’s quality assurance and quality 

control program. The registrations clearly summarized the product evaluation to provide license 

reviewers with adequate information to license the possession and use of the products. 

Deficiency letters clearly stated regulatory positions and all health and safety issues were 

properly addressed. The review team found that the evaluations were of high quality with health 

and safety issues properly addressed. The Program enforces the requirements of SS&D 

registrations through regulation, COMAR 26.12.01.01 Section C.37. 
Maryland Final IMPEP Report Page 16 

Information provided by the Program in response to the IMPEP questionnaire identified that 

there were 28 SS&D registrations active in Maryland. The review team discovered that 61 

active Maryland registrations are identified in the national Sealed Source and Device Registry 

(SSDR). The review team provided the Program with a list of the 61 registrations. A 

discrepancy of 33 registrations was identified by the review team and confirmed by the 

Program. Of the 33 registrations, the Program determined that 25 registrations were obsolete 

and that 8 registrations were not obsolete. For two of the 25 obsolete registrations, the products 

identified on each registration were made part of two other Maryland SS&D registrations, prior 

to the review period, and the obsolete registrations had not been inactivated by the Program. 

For one of the 25 obsolete registrations, the products identified on the registration were last 

distributed in 2002. At that time, the Program staff had made note in their file to inactivate the 

registration, however, the Program did not inactivate the obsolete registration. For 22 of the 25 

obsolete registrations, the specific licenses authorizing manufacturing and/or distribution of 

products identified on the SS&D registrations had each been terminated by the Program, prior 

to the review period, and the obsolete registrations had not been inactivated by the Program. 

Of these 22 obsolete registrations, nine were related to a Maryland license that was terminated 

in 2003 when the company relocated to another Agreement State. At that time, the Program 

made an effort to resolve the registration issue with the licensee and the other Agreement State 

but the issue was not resolved. The Program followed up with the licensee and the other 

Agreement State in 2006 but the issue of the obsolete sheets was still not resolved. At the time 

of the review, the issue related to the 9 obsolete registrations still had not been resolved. 

Based on the review team’s examination, and in coordination with the Program, it was found 

that the 25 obsolete registrations initially became obsolete prior to the review period. 

Specifically, the range of known dates where the registrations became obsolete spanned 

between January 1986 and July 2007. The range is represented by MD-0357-D-101-U when 

the specific license authorizing manufacturing and/or distribution of products identified on the 

SS&D registration had been terminated by the Program in January 1986 and by MD-0590-D112-G when the products identified on the registration were made part of another Maryland 

SS&D registration, MD-0105-D-101-G in July 2007. The review team examined three 

registrations that had become obsolete where the three obsolete registrations were inactivated 

by the Program during the review period. The review team found that for the three registrations, 

each had been promptly transmitted for inclusion into the SSDR as inactive registrations. 

Although the 25 obsolete registrations became obsolete prior to the review period, the review 

team discussed with the Program the need to provide the status of the 25 obsolete SS&D 

registrations to SSDR. It is important that the SSDR contain accurate information because NRC 

and Agreement State personnel have access to SSDR and use the information contained in the 

SSDR to make licensing decisions regarding sealed source and device products. The review 

team recommends that, for the 25 obsolete SS&D registrations identified in Appendix G, the 

Program take actions to submit the status of those registrations for inclusion in the national 

Sealed Source and Device Registry, to include transfer of each registration to inactive status as 

recommended in Section 13.4 of NUREG 1556, Volume 3, Revision 1, “Applications for Sealed 

Source and Device Evaluation and Registration,” and to take measures to ensure that future 

registrations that become obsolete are inactivated in a timely manner. During the November 3, 

2011, MRB, the State indicated that they are making progress toward inactivating the 25 

obsolete SS&D registrations and had identified an additional 8 registrations that also warranted 

inactiviation. 
Maryland Final IMPEP Report Page 17 

During the on-site review, the review team provided the Program with a list of the 25 obsolete 

SS&D registrations. To aid in addressing the recommendation and to facilitate review of this 

recommendation at a later date, a list of the 25 obsolete SS&D registrations identified by the 

review team is provided in Appendix G. 

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

performance with respect to the sub-element, Technical Quality of the Product Evaluation 

Program, be found satisfactory. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Based upon the Program’s response to the questionnaire, interviews with the Program’s 

management and staff, and the review team’s searches of NMED, the review team determined 

that the Program received and evaluated 25 incident cases during the review period. All 

25 cases were related to products from a single sealed source and device vendor that held 

10 active SS&D registrations and a specific license issued by the Program. 

The review team selected and reviewed all 25 incident cases. Of the 25 cases evaluated by the 

Program, nine cases were identified by the Program to include generic defects. Of the nine 

cases identified by the Program to include generic defects, four cases included products 

identified on one SS&D registration, four cases included products identified on another SS&D 

registration and one case included products identified on a third SS&D registration. Of the nine 

cases determined by the Program to include generic defects, eight were related to software 

issues and one was related to mechanical issues. The listing of the casework examined, with 

case specific comments, is provided in Appendix E. 

The review team noted that the Program routinely monitors incidents reported to NMED and 

identified incidents or defects associated with SS&D products registered in Maryland for further 

investigation and review. Incident procedures established by the Program involving SS&Ds 

included use of an SS&D event flow chart developed by the Program. The flow chart includes 

generic fault considerations when evaluating SS&D incidents. 

Based upon review of the 25 incident cases, the review team concluded that the Program is 

routinely evaluating the root causes of defects and incidents involving SS&D evaluations and is 

taking appropriate actions. The review team determined that the Program analyzed each 

incident, reviewed the issues, and followed up on each incident adequately and in accordance 

with procedures established by the Program with one exception. The one exception is that, for 

the single case related to a generic defect involving mechanical issues, the Program identified 

on the Program’s SS&D event flow chart that a modification was being done to the device. 

However, the Program was not aware of what specific modification was being done. The 

incident case file did not contain any engineering drawings nor specific descriptions of what 

modification was being done in order to adequately evaluate generic fault considerations for this 

case, including a determination of whether a change or amended to the SS&D registration was 

warranted. The distributor of the device made a report to the Program that similar issues, 

related to the incident, have been discovered and resolved in other countries. The review team 

discussed with the Program the benefit of obtaining specific information about what modification 

was/is being done to the device and the need to determine whether a change or amendment of 

the SS&D registration is warranted. During the onsite review, the Program agreed to obtain 
Maryland Final IMPEP Report Page 18 

specific information regarding what modification was/is being done to the device and determine 

whether a change or amendment of the SS&D registration is warranted. 

In addition to the 25 incident cases received and evaluated by the Program, the Program 

received three incident cases that, prior to the time of the on-site review, had not been 

evaluated by the Program. Each incident was related to leaking or contaminated sealed 

sources discovered in countries other than the United States. One of the incidents occurred in 

Poland on January 6, 2010. The second incident occurred in the United Kingdom on May 20, 

2010. The third incident occurred in Poland on May 31, 2010. For each incident, the Program’s 

licensee notified the Program that each problem is being reported because several facilities in 

the United States receive these sources from the same manufacturer and this posed an 

increased risk of contamination for these sites. For each incident, the licensee identified the 

related SS&D registration issued by Maryland which was, for the two Poland incidents, MD0497-S-107-S and for the United Kingdom incident, MD-0497-D-115-S and also the same 

foreign sealed source manufacturer made part of each of the Maryland issued registrations. 

The review team asked Program staff whether the Program had any follow up information 

related to the three incidents and their potential implications for licensees in the United States. 

Based on these questions, during the on-site review, the Program staff requested for and 

received, from its licensee, additional information related to all three incidents. The licensee 

submitted to the Program that problems were identified at the sealed source manufacturing 

facility and also that device product technical manuals were changed to include additional leak 

testing procedures. The review team discussed with the Program the benefit of evaluating each 

of the three incidents, including use of the SS&D event flow chart developed by the Program, to 

include evaluation of generic fault considerations and determination of whether a change or 

amendment of any Maryland issued SS&D registration is warranted. The Program contended 

that these incidents occurred outside of the United States and, therefore, the Program is not 

required to investigate nor evaluate the incidents. The Program continued that, although the 

Program does not believe they are required to do so, it is prudent for the Program to evaluate 

each of the three incidents. The Program agreed to evaluate each of the three incidents, 

including use of the SS&D event flow chart developed by the Program, to include evaluation of 

generic fault considerations and determination of whether a change or amendment of any 

Maryland issued SS&D registration is warranted. 

The review team did not identify any allegations received by the Program related to defects or 

failures of SS&D products registered in Maryland during the review period. 

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

performance with respect to the sub-element, Evaluation of Defects and Incidents Regarding 

SS&Ds, be found satisfactory. 

4.2.4 SS&D Evaluation Program Summary

Based on the IMPEP evaluation criteria, for a non-common performance indicator that contains 

sub-elements, a single finding for the overall performance will be made by the review team. 

Because the review team is recommending that Maryland’s performance is satisfactory for all 

sub-elements evaluated, based on the IMPEP evaluation criteria, the review team recommends 

that Maryland’s overall performance with respect to the indicator, SS&D Evaluation Program, be 

found satisfactory. 
Maryland Final IMPEP Report Page 19 

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

In 1981, 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 such authority to 

regulate a LLRW disposal facility, NRC has not required States to have a program for licensing 

a 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, it is expected to put in place a regulatory program that will 

meet the criteria for an adequate and compatibility LLRW program. There are no plans for a 

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

indicator. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0 above, the review team recommended, and the MRB agreed, 

that Maryland’s performance be found satisfactory, but needs improvement for the performance 

indicator Technical Quality of Licensing Actions, and satisfactory for the other six performance 

indicators. The review team made four recommendations regarding the performance of the 

State. 

Overall, the review team recommended, and the MRB agreed, that the Maryland Agreement 

State Program be found adequate to protect public health and safety and compatible with 

NRC's program. Based on the results of the current IMPEP review, and in accordance with the 

criteria in NRC Management Directive 5.6, the review team recommended, and the MRB 

agreed, that the next full IMPEP review take place in approximately 4 years. 

Below are the review team’s recommendations, as mentioned in the report, for evaluation and 

implementation by the State: 

1. The review team recommends that the State take measures to ensure that sufficient 

information pertaining to the inspection review of items of non-compliance as well as the 

effectiveness of licensee corrective actions is adequately documented in inspection 

records. (Section 3.3) 

2. The review team recommends that the State perform a self-assessment of selected 

licensing actions issued during the review period, and on a routine basis in the future, to 

ensure that the Program’s review of licensing actions are adequately documented and 

that licensing actions are thorough and consistent with the regulations and appropriate 

licensing guidance. (Section 3.4) 

3. The review team recommends that the State: (1) take measures to ensure that financial 

assurance requirements are reviewed as part of significant licensing actions and during 

licensing renewals; (2) evaluate the need for financial assurance related to the 

radionuclide production (cyclotron) licensees; and (3) perform a review of the adequacy 
Maryland Final IMPEP Report Page 20 

and validity of financial assurance mechanisms already on file with the Program. 

(Section 3.4) 

4. The review team recommends that, for the 25 obsolete SS&D registrations identified in 

Appendix G, the Program take actions to submit the status of those registrations for 

inclusion in the national Sealed Source and Device Registry, to include transfer of each 

registration to inactive status as recommended in Section 13.4 of NUREG 1556, 

Volume 3, Revision 1, “Applications for Sealed Source and Device Evaluation and 

Registration,” and to take measures to ensure that future registrations that become 

obsolete are inactivated in a timely manner. (Section 4.2.2) 
 

LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Maryland Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Appendix F Sealed Source and Device Casework Reviews 

Appendix G List of Obsolete SS&D Registrations 

 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Janine Katanic, FSME Team Leader 

 Status of Materials Inspection Program 

Technical Quality of Inspections 

 Inspector Accompaniments 

 

Donna Janda, Region I Technical Staffing and Training 

Technical Quality of Incident and 

 Allegation Activities 

Penny Lanzisera, Region I Technical Quality of Licensing Actions 

Solomon Sahle, FSME Compatibility Requirements 

 

Joshua Daehler, Massachusetts Sealed Source and Device Evaluation Program 
APPENDIX B 

MARYLAND ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML112010077
 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Radiocat License No.: MD-05-145-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 11/6/09 Inspector: AG 

Comment: 

The inspector’s documented independent radiation surveys indicated that 

8.41 millirem/hr was measured outside of a waste storage room door (located inside the 

facility). There was no documentation that an evaluation was made (or an inquiry was 

made to the licensee) to determine whether or not dose limits for members of the public 

were exceeded. 

File No.: 2 

Licensee: Cardinal Health License No.: MD-33-198-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 8/25/10 Inspectors: RN, AG, FA 

Comments: 

1) The inspection record did not document a review of the licensee’s corrective actions 

related to non-compliances from the previous inspection. These non-compliances 

were previously issued to the licensee as a result of the Program’s 

inspection/investigation regarding a potential occupational dose in excess of the 

regulatory limits. 

2) The inspection record documented the inspectors’ review of the radiopharmacy 

portion of the inspection but did not adequately document a review of the cyclotron 

operations portion of the inspection. 

File No.: 3 

Licensee: Holy Cross Hospital Radiation Treatment Center License No.: MD-31-303-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 1/27-28/11 Inspector: RN 

File No.: 4 

Licensee: Maryland Q.C. Laboratories, Inc. License No.: MD-25-022-01 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 11/17/10 Inspector: RN 

 
Maryland Final IMPEP Report Page C.2 

Inspection Casework Reviews 

File No.: 5 

Licensee: H & H X-ray Services, Inc. License No.: LA2970-L01 

Inspection Type: Reciprocity, Unannounced Priority: 2 

Inspection Date: 7/23/10 Inspector: RN 

Comment: 

The inspection record did not document a review of special security requirements. 

File No.: 6 

Licensee: GBMC HealthCare, Inc. License No.: MD-05-002-03 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 6/14/11 Inspector: FA 

Comment: 

The inspection record did not document a review of the licensee’s corrective actions 

related to non-compliances from the previous inspection. These non-compliances were 

previously issued to the licensee as a result of the Program’s inspection/investigation 

regarding a lost source/medical event. The inspector did not document which corrective 

actions were reviewed during the current inspection and which corrective actions were 

not reviewed and therefore warranted review during a future inspection. 

File No.: 7 

Licensee: Washington Adventist Hospital License No.: MD-31-003-04 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 1/25/11 Inspector: FA 

File No.: 8 

Licensee: Terumo Medical Corporation License No.: MD-15-007-02 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 8/30/10 Inspectors: AJ, FA, AG 

File No.: 9 

Licensee: Berlin Radiation Therapy Treatment Center, LLC License No.: MD-47-005-01 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 7/31/09 Inspector: AJ 

Comment: 

The inspection record did not undergo management review since the inspector was a 

supervisor and there were no items of non-compliances identified. 

 
Maryland Final IMPEP Report Page C.3 

Inspection Casework Reviews 

File No.: 10 

Licensee: Johns Hopkins University License No.: MD-27-014-01 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 4/1/09 Inspectors: NO, DM 

Comment: 

The supervisory review of the inspection record identified missing or incomplete data but 

the inspection record was not corrected. 

 

File No.: 11 

Licensee: University of Maryland College Park License No.: MD-33-004-03 

Inspection Type: Routine, Announced Priority: 2 

Inspection Dates: 3/25 + 4/8/10 Inspectors: RN, AG 

Comment: 

The inspection identified several safety-significant items of non-compliance that should 

have warranted timely follow up. Although the Program has visited the facility several 

times since the inspection, these visits were not documented in a manner that would 

indicate the inspector’s follow up on the licensee’s corrective actions related to the 

identified non-compliances. The Program also held a meeting with the licensee and 

discussed corrective actions, but this does not substitute for verification of licensee 

corrective actions. On 7/26/11, the Program performed other activities at the facility and 

also reviewed the previously identified non-compliances. Documentation of this visit was 

expected to be performed in the near term. 

File No.: 12 

Licensee: GBMC HealthCare License No.: MD-05-002-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/13/11 Inspector: FA 

Comment: 

The inspection record did not document a review of the licensee’s corrective actions 

related to non-compliances from the previous inspection. 

File No.: 13 

Licensee: Anne Arundel Medical Center License No.: MD-03-001-05 

Inspection Type: Special, Announced Priority: 5 

Inspection Date: 6/15/11 Inspector: AG 

 
Maryland Final IMPEP Report Page C.4 

Inspection Casework Reviews 

INSPECTOR ACCOMPANIMENTS 

The following inspector accompaniments were performed prior to the on-site IMPEP review: 

Accompaniment No.: 1 

Licensee: GBMC HealthCare License No.: MD-05-002-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 6/13/11 Inspector: FA 

Accompaniment No.: 2 

Licensee: GBMC HealthCare, Inc. License No.: MD-05-002-03 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 6/14/11 Inspector: FA 

Accompaniment No.: 3 

Licensee: Anne Arundel Medical Center License No.: MD-03-001-05 

Inspection Type: Special and Routine, Announced Priority: 5 

Inspection Date: 6/15/11 Inspector: AG 

Comment: 

The inspector did not adequately review some issues related to licensee compliance 

with special security requirements. 

Accompaniment No.: 4 

Licensee: Maryland Q.C. Laboratories, Inc. License No.: MD-25-022-01 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 7/28/11 Inspectors: AJ, AG 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Type of Action: Renewal Amendment No.: 52 

Date Issued: 7/11/07 License Reviewer: BP 

Comment: 

The Authorized Use is listed on the license as “install, service, repair and decommission 

Nucletron remote afterloading brachytherapy devices at Maryland customers’ facilities.” 

The license does not authorize manufacturing or distribution, which appear to be 

activities conducted under this license. 

File No.: 2 

Licensee: Johns Hopkins Medical Institutions License No.: MD-07-005-03 

Type of Action: Renewal Amendment No.: 53 

Date Issued: 7/8/08 License Reviewer: NO 

Comments: 

1) The licensing assessment performed by the license reviewer to determine the need 

for security requirements did not include all radionuclides subject to the security 

requirements. 

2) A total possession limit was not provided for item 6.A.; however the Program plans to 

address this by the end of the year. 

3) The review team noted that the broad scope licensee did not submit criteria for the 

licensee’s Radiation Safety Committee approval of new users, new uses, and 

facilities. 

4) The financial assurance document (letter of credit from 1996) was not amended or 

re-issued for a new bank name and a new account number. 

5) The licensee’s Decommissioning Funding Plan was not re-reviewed during the 

renewal and does not include costs for disposing of sources or updated costs for 

decommissioning since 2000. 

File No.: 3 

Licensee: Johns Hopkins Medical Institutions License No.: MD-07-005-03 

Type of Action: Amendment Amendment No.: 58 

Date Issued: 3/7/11 License Reviewer: NO 

Comment: 

The licensing action added contaminated facilities associated with a cyclotron 

(PETNET), including activated foils, targets, and parts; however, financial assurance 

considerations were not addressed by the license reviewer. 
Maryland Final IMPEP Report Page D.2 

License Casework Reviews 

File No.: 4 

Licensee: Johns Hopkins Medical Institutions License No.: MD-07-005-03 

Type of Action: Amendment Amendment No.: 56 

Date Issued: 7/13/10 License Reviewer: NO 

Comments: 

1) The licensing action added radium-223 and americium-241; however, safety 

considerations for the use of alpha emitters were not addressed. 

2) A total possession limit for americium-241 was not included in the license. 

3) The radionuclides and quantities authorized by the license exceed the unity rule for 

consideration of security requirements license conditions; however, the security 

requirements license condition was not included on the license. 

File No.: 5 

Licensee: Johns Hopkins Medical Institutions License No.: MD-07-005-03 

Type of Action: Amendment Amendment No.: 57 

Date Issued: 8/30/10 License Reviewer: DM 

Comment: 

The licensing action added astatine-211; however safety considerations for use of alpha 

emitters were not addressed. 

File No.: 6 

Licensee: Maryland Transportation Authority License No.: MD-05-086-01 

Type of Action: Renewal Amendment No.: 10 

Date Issued: 9/10/09 License Reviewer: DM 

Comment: 

The license authorizes leak test analysis by the licensee; however, the licensee did not 

submit sufficient information to support this request and appears to have requested for 

an outside company to analyze leak tests. 

File No.: 7 

Licensee: University of Maryland at Baltimore License No.: MD-07-014-01 

Type of Action: Renewal Amendment No.: 82 

Date Issued: 6/22/10 License Reviewers: NO, AF 

Comments: 

1) The review team noted that the broad scope licensee did not submit criteria for the 

licensee’s Radiation Safety Committee approval of new users, new uses, and 

facilities. 

2) The license authorizes quantities that require an emergency plan (e.g., 8 curies of 

iodine-125 and 8 curies of iodine-131); however neither an emergency plan nor a 

commitment to restrict collocation of quantities was submitted. 

 
Maryland Final IMPEP Report Page D.3 

License Casework Reviews 

File No.: 8 

Licensee: University of Maryland Medical Center License No.: MD-07-014-07 

Type of Action: New Amendment No.:00 

Date Issued: 3/10/11 License Reviewer: NO 

Comment: 

The license application was signed by an individual (Chair of the Department of 

Radiation Oncology). It is unclear whether the Department Chair had sufficient authority 

to sign this application for a new license. 

File No.: 9 

Licensee: University of Maryland Medical Center License No.: MD-07-014-07 

Type of Action: Amendment Amendment No.:01 

Date Issued: 3/24/11 License Reviewer: NO 

File No.: 10 

Licensee: University of Maryland Medical Systems Group License No.: MD-07-014-06 

Type of Action: Renewal Amendment No.: 36 

Date Issued: 5/19/09 License Reviewer: NO 

Comment: 

The high dose-rate remote afterloader spot-check procedures were limited to a checklist 

that did not include detailed step-by-step procedures for conducting spot-checks and did 

not include criteria for acceptance for all checks (e.g., timer accuracy). 

File No.: 11 

Licensee: University of Maryland College Park License No.: MD-33-0004-01 

Type of Action: Renewal Amendment No.: 143 

Date Issued: 4/30/09 License Reviewer: DM 

Comments: 

1) The radionuclides and quantities authorized by the license exceed the unity rule for 

consideration of security requirements license conditions; however, the security 

requirements license condition was not included on the license. 

2) A total possession limit not provided for item 6.B. and radionuclides, type, or total 

possession limit was not provided for item 6.FF. However, the Program plans to 

address this by the end of the year. 

3) The license authorizes fixed and portable gauges, however, standard license 

conditions were not included for these uses and the licensing guidance for these 

activities does not appear to have been used. 

4) The Decommissioning Funding Plan accepted from licensee dated January 9, 2007, 

does not include all radionuclides with half lives greater than 120 days listed on the 

license. Additionally, the statement of intent prepared by the licensee does not 

include supporting documentation. 

5) The review team noted that the broad scope licensee did not submit criteria for the 

licensee’s Radiation Safety Committee approval of new users, new uses, and 

facilities. 
Maryland Final IMPEP Report Page D.4 

License Casework Reviews 

File No.: 12 

Licensee: University of Maryland College Park License No.: MD-33-004-03 

Type of Action: Renewal Amendment No.: 29 

Date Issued: 3/25/09 License Reviewer: NO 

Comments: 

1) Standard license condition 87 (regarding repairs), from NUREG-1556, Volume 20, 

“Consolidated Guidance About Materials Licenses: Guidance About Administrative 

Licensing Procedures” was not included in the license. 

2) Previous violations for detectors and alarm testing were not addressed specifically in 

the review of the renewal application. For example, the submitted procedures did 

not include a source re-positioning procedure. During a 2010 inspection, the 

previous violations were found to be repetitive from an earlier inspection and the 

inspector determined that re-positioning procedures were not submitted as part of 

the renewal application. Following the inspection, a license amendment was 

submitted to provide the source re-positioning procedure. 

File No.: 13 

Licensee: Cardinal Health License No.: MD-33-198-01 

Type of Action: Amendment Amendment No.:101 

Date Issued: 8/27/09 License Reviewer: DM 

Comments: 

1) The license amendment was to terminate the cyclotron license and add all activities 

and license commitments from MD-33-177-01 to this license. However, no re-review 

of commitments in accordance with NUREG-1556, Volume 21, “Consolidated 

Guidance About Materials Licenses: Program-Specific Guidance About Possession 

Licenses for Production of Radioactive Material Using an Accelerator” appears to 

have been conducted. 

2) Financial assurance was not taken into consideration or requested when the 

cyclotron was added to the license. 

File No.: 14 

Licensee: Alliance Health Care License No.: MD-33-206-01 

Type of Action: New Amendment No.: 00 

Date Issued: 8/25/08 License Reviewer: BP 

Comment: 

The license provided to document the Radiation Safety Officer’s training and 

experience does not include all pages and it is unclear whether it is a full medical 

license or just a calibration license. 

 
Maryland Final IMPEP Report Page D.5 

License Casework Reviews 

File No.: 15 

Licensee: Functional Genetics License No.: MD-31-331-01 

Type of Action: Termination Amendment No.: 05 

Date Issued: 7/20/11 License Reviewer: DM 

Comment: 

The license was terminated, however Condition 10 was retained that lists a location of 

use. No licensed material is included on the license. 

File No.: 16 

Licensee: Functional Genetics License No.: MD-31-331-01 

Type of Action: Renewal Amendment No.: 04 

Date Issued: 8/4/10 License Reviewer: AF 

File No.: 17 

Licensee: TASR Company License No.: MD-07-032-01 

Type of Action: Termination Amendment No.: 25 

Date Issued: 10/27/09 License Reviewer: NO 

Comments: 

1) The license was terminated with a notation on the top of the license and the 

termination request included in the license tie-down. However, all other items remain 

on the license including the listing of licensed material, authorized uses, and 

locations of use. 

2) Leak test records were not provided for sealed sources prior to license termination. 

File No.: 18 

Licensee: Tidewater Inc. License No.: MD-27-087-01 

Type of Action: Termination Amendment No.: 04 

Date Issued: 9/27/10 License Reviewer: NO 

Comment: 

License terminated with a notation on the top of the license and the termination request 

included in the license tie-down. However, all other items remain on the license 

including the listing of licensed material, authorized uses, and locations of use. 

 

File No.: 19 

Licensee: Tidewater Inc. License No.: MD-27-087-01 

Type of Action: Amendment Amendment No.: 02 

Date Issued: 7/8/08 License Reviewer: CW 
Maryland Final IMPEP Report Page D.6 

License Casework Reviews 

File No.: 20 

Licensee: Johns Hopkins Medical Institutions License No.: MD-07-005-05 

Type of Action: Renewal Amendment No.: 26 

Date Issued: 1/14/10 License Reviewer: NO 

Comments: 

1) Total possession limits were not included for all devices; however the Program plans 

to address this by the end of the year. 

2) No response specific to “Maintenance” was included in the licensee’s application. A 

general license condition limiting maintenance to authorized individuals is included 

on the license; however, it is unclear whether “authorized individuals” are limited to 

the manufacturer’s representatives or other persons specifically authorized by NRC 

or an Agreement State to perform maintenance, as described in NUREG-1556, 

Volume 5. 

 

File No.: 21 

Licensee: Maryland QC Laboratories License No.: MD-25-022-01 

Type of Action: Amendment Amendment No.: 55 

Date Issued: 3/1/11 License Reviewer: DM 

Comments: 

1) Total possession limits were not included on the license; however the Program plans 

to address this by the end of the year. 

2) Non-standard license condition included on the license allowing possession of 

sources in excess of possession limit by 20% for Iridium-192 or 10% for Cobalt-60. 

Since most SSDR’s include a maximum quantity to include shipment decay; this 

condition appears unnecessary. 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Greater Baltimore Medical Center License No.: MD-05-002-03 

Date of Incident: 8/17/08 NMED No.: 080489 

Investigation Date: 8/22/08 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

File No.: 2 

Licensee: Stone Industrial License No.: General 

Date of Incident: 2/27/09 NMED No.: 090386 

Investigation Date: 3/10/09 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

File No.: 3 

Licensee: Cardinal Health License No.: MD-33-198-01 

Date of Incident: 7/21/09 NMED No.: 090733 

Investigation Date: 9/22 & 11/24/09 Type of Incident: Potential Overexposure 

 Type of Investigation: Site 

File No.: 4 

Licensee: University of Maryland at Baltimore License No.: MD-07-014-01 

Date of Incident: 3/9/10 NMED No.: 100430 

Investigation Date: 4/6/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 5 

Licensee: Greater Baltimore Medical Center License No.: MD-05-002-03 

Date of Incident: 7/9/10 NMED No.: 100397 

Investigation Date: 7/27 & 8/18/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

 

Comments: 

1) No documentation was provided by licensee related to post-implant dose to the 

organ that did not receive intended dose due to dislodged source. 

2) The State reported the event to NRC approximately 3 weeks late. 

File No.: 6 

Licensee: University of Maryland Medical Systems License No.: MD-07-014-05 

Date of Incident: 1/27/10 NMED No.: 100174 

Investigation Date: 3/21/10 & 8/6/10 Type of Incident: Medical Event 

 Type of Investigation: Site 
Maryland Final IMPEP Report Page E.2 

Incident Casework Reviews 

File No.: 7 

Licensee: Digirad Imaging Solutions License No.: MD-03-107-01 

Date of Incident: 11/1/07 NMED No.: 080008 

Investigation Date: 1/10/08 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

File No.: 8 

Licensee: Hillis Carnes License No.: MD-21-041-01 

Date of Incident: 3/28/08 NMED No.: 090432 

Investigation Date: 3/28/08 Type of Incident: Damaged Equipment 

 Type of Investigation: Site 

File No.: 9 

Licensee: Engineering Consulting Services License No.: MD-03-092-01 

Date of Incident: 11/28/08 NMED No.: 080843 

Investigation Date: 11/28/08 Type of Incident: Damaged Equipment 

 Type of Investigation: Site 

File No.: 10 

Licensee: Prince Georges Hospital Center License No.: MD-33-003-01 

Date of Incident: 8/13/09 NMED No.: 100172 

Investigation Date: 5/10/10 Type of Incident: Leaking Source 

 Type of Investigation: Site 

SEALED SOURCE AND DEVICE INCIDENT CASEWORKS REVIEWS 

File No. 1: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 7/14/08 Incident Log No.: NMED 080406 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 2: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 8/7/08 Incident Log No.: NMED 080460 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 3: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 6/25/09 Incident Log No.: NMED 090571 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

 
Maryland Final IMPEP Report Page E.3 

Incident Casework Reviews 

File No. 4: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 7/16/09 Incident Log No.: NMED 090614 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 5: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 2/10/10 Incident Log No.: NMED 100071 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 6: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 2/14/10 Incident Log No.: NMED 100074 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 7: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 1/18/10 Incident Log No.: NMED 100082 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 8: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 3/11/10 Incident Log No.: NMED 100118 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 9: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 6/3/10 Incident Log No.: NMED 100314 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 10: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 10/6/10 Incident Log No.: NMED 100506 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 11: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 12/22/10 Incident Log No.: NMED 110005 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 
Maryland Final IMPEP Report Page E.4 

Incident Casework Reviews 

File No. 12: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 9/1/09 Incident Log No.: NMED 110087 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 13: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 2/10/11 Incident Log No.: NMED 110104 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 14: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 2/8/11 Incident Log No.: Moses Cone Regional Cancer Center 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 15: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 12/2/10 Incident Log No.: Customer Site-HDR Knocked Over 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 16: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 8/14/09 Incident Log No.: Rush Univ. Hospital 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 17: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 7/29/09 Incident Log No.: 21st Century Oncology 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 18: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 7/5/09 Incident Log No.: MD Anderson 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 
Maryland Final IMPEP Report Page E.5 

Incident Casework Reviews 

File No. 19: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 1/20/09 Incident Log No.: Grant Riverside Methodist Hosp. 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

Comments: 

1) This incident is a 24 hour reportable event in accordance with 10 CFR 30.50(b)(2) or 

equivalent Agreement State regulations. The Program received a report of this 

incident from the licensee on February 13, 2009, but the Program did not report the 

incident to NRC. Based on discussions during the onsite review, on August 12, 

2011, the Program reported the event to NRC (NRC Event No. 47148). 

2) A generic issue was identified by Program. The device is identified in SS&D 

Registration No. MD-0497-D-108-S. The program determined that a modification 

was being done by the licensee. The case file did not contain any engineering 

drawings or specific descriptions of what modification was being done. 

File No. 20: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 3/4/09 Incident Log No.: Williams Beaumont Hosp. 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 21: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 11/12/08 Incident Log No.: Central Indiana Cancer Center 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 22: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 10/12/07 Incident Log No.: Florida Cancer Center Malfunction 

Investigation Date: Not Available Type of Incident: Equipment 

 Type of Investigation: Root Cause/Generic Application 

File No. 23: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 12/13/07 Incident Log No.: Gamma West Brachytherapy 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No. 24: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 2/7/08 Incident Log No.: Latrobe Area Hospital 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

 
Maryland Final IMPEP Report Page E.6 

Incident Casework Reviews 

File No. 25: 

Licensee: Nucletron Corporation License No.: MD-27-035-01 

Date of Incident: 2/13/08 Incident Log No.: Central Indiana Cancer Center 

Investigation Date: Not Available Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 
 APPENDIX F 

SEALED SOURCE AND DEVICE REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Registry No.: MD-0497-D-108-S SS&D Use Code: (AC) Photon-emitting Remote Afterloaders 

 Applicant=s Name: Nucletron Corporation Type of Action: Amended Registration 

Date Issued: 11/5/10 SS&D Reviewers: BP, RM 

Comment: 

The FDA Approval Summary was not included in the registration as recommended in 

Section 12.11 and Appendix D of NUREG-1556, Volume 3, Revision 1, “Applications for 

Sealed Source and Device Evaluation and Registration.” The device did receive FDA 

510k approval and the approval was maintained with the file. 

File No.: 2 

Registry No.: MD-0497-D-114-S SS&D Use Code: (AC) Photon-emitting Remote Afterloaders 

 Applicant=s Name: Nucletron Corporation Type of Action: Amended Registration 

Date Issued: 4/11/11 SS&D Reviewers: BP, RM 

Comment: 

The FDA Approval Summary was not included in the registration as recommended in 

Section 12.11 and Appendix D of NUREG-1556, Volume 3, Revision 1, “Applications for 

Sealed Source and Device Evaluation and Registration.” The device did receive FDA 

510k approval and the approval was maintained with the file. 

File No.: 3 

Registry No.: MD-0497-D-108-S SS&D Use Code: (V) General Medical Use 

Applicant=s Name: Nucletron Corporation Type of Action: New Registration 

Date Issued: 11/20/08 SS&D Reviewers: BP, RM 

Comments: 

1) The first page information section of the registration incorrectly indicated the use 

code as A(V) General Medical Use@. This use code was discontinued in 2002. 

2) The FDA Approval Summary was not included in the registration as recommended in 

Section 12.11 and Appendix D of the NUREG-1556, Volume 3, Revision 1, 

“Applications for Sealed Source and Device Evaluation and Registration.” The 

device did receive FDA 510k approval and the approval was maintained with the file. 

File No. 4: 

Registry No.: MD-0497-D-115-S SS&D Use Code: (AC) Photon-emitting Remote Afterloaders 

 Applicant=s Name: Nucletron Corporation Type of Action: Amended Registration 

Date Issued: 4/20/11 SS&D Reviewers: BP, RM 
Maryland Final IMPEP Report Page F.3 

SS&D Casework Reviews 

File No. 5: 

Registry No.: MD-0497-D-115-S SS&D Use Code: (AC) Photon-emitting Remote Afterloaders 

 Applicant=s Name: Nucletron Corporation Type of Action: New Registration 

Date Issued: 3/26/10 SS&D Reviewers: BP, RM 

File No. 6: 

Registry No.: MD-1299-D-801-S SS&D Use Code: (AC) Photon-emitting Remote Afterloaders 

 Applicant=s Name: Isodose Control, Inc. Type of Action: Inactivated Registration 

Date Issued: 3/26/10 SS&D Reviewers: BP, RM 

File No. 7: 

Registry No.: MD-1299-D-101-S SS&D Use Code: (AC) Photon-emitting Remote Afterloaders 

 Applicant=s Name: Isodose Control, Inc. Type of Action: New Registration 

Date Issued: 8/28/08 SS&D Reviewers: BP, RM 

File No. 8: 

Registry No.: MD-1239-D-101-B SS&D Use Code: (D) Gamma Gauges 

Applicant=s Name: Isoscan Limited Type of Action: New Registration 

Date Issued: 8/21/08 SS&D Reviewers: DM, NO 

File No. 9: 

Registry No.: MD-0497-D-110-S SS&D Use Code: (V) General Medical Use 

Applicant=s Name: Nucletron Corporation Type of Action: Amended Registration 

Date Issued: 11/5/10 SS&D Reviewers: BP, RM 

Comments: 

1) The first page information section of the registration incorrectly indicated the use 

code as A(V) General Medical Use@. This use code was discontinued in 2002. 

2) The FDA Approval Summary was not included in the registration as recommended in 

Section 12.11 and Appendix D of NUREG-1556, Volume 3, Revision 1, “Applications 

for Sealed Source and Device Evaluation and Registration.” The device did receive 

FDA 510k approval and the approval was maintained with the file. 

File No. 10: 

Registry No.: MD-1149-D-101-G SS&D Use Code: (E) Beta Gauges 

Applicant=s Name: Bahia 21 Corporation Type of Action: Amended Registration 

Date Issued: 12/8/10 SS&D Reviewers: DM, RM 

 
Maryland Draft Report Page F.2 

SS&D Casework Reviews 

File No. 11: 

Registry No.: MD-8191-D-801-G SS&D Use Code: (D) Gamma Gauges 

Applicant=s Name: Pettit Applied Technologies Type of Action: Inactivated Registration 

Date Issued: 8/31/07 SS&D Reviewers: DM, NO 

Comment: 

The “Limitation and/or Other Considerations of Use” section, for this inactivated 

registration, incorrectly identifies that the device may be distributed. Item 13.4 of 

NUREG-1556, Volume 3, Revision 1, “Applications for Sealed Source and Device 

Evaluation and Registration” recommends indication that the product will no longer be 

commercially distributed but may still be approved for licensing purposes. 

File No. 12: 

Registry No.: MD-8191-D-802-G SS&D Use Code: (E) Beta Gauges 

Applicant=s Name: Pettit Applied Technologies Type of Action: Inactivated Registration 

Date Issued: 8/31/07 SS&D Reviewers: DM, BP 

Comment: 

The “Limitation and/or Other Considerations of Use” section, for this inactivated 

registration, incorrectly identifies that the device may be distributed. Item 13.4 of 

NUREG-1556, Volume 3, Revision 1, “Applications for Sealed Source and Device 

Evaluation and Registration” recommends indication that the product will no longer be 

commercially distributed but may still be approved for licensing purposes. 
APPENDIX G 

LIST OF 25 OBSOLETE MARYLAND SS&D REGISTRATIONS 

(1) MD-0205-D-101-G 

(2) MD-0226-D-101-S 

(3) MD-0226-S-102-S 

(4) MD-0263-D-101-G 

(5) MD-0327-D-101-G 

(6) MD-0351-D-101-U 

(7) MD-0351-D-102-U 

(8) MD-0357-D-101-U 

(9) MD-0381-D-106-S 

(10) MD-0381-D-107-G 

(11) MD-0381-D-108-G 

(12) MD-0381-D-109-G 

(13) MD-0381-D-110-G 

(14) MD-0381-D-111-G 

(15) MD-0381-D-112-G 

(16) MD-0381-D-113-G 

(17) MD-0381-D-116-G 

(18) MD-0558-S-101-S 

(19) MD-0558-S-102-S 

(20) MD-0590-D-112-G 

(21) MD-0656-D-102-G 

(22) MD-0670-S-108-G 

(23) MD-0691-S-101-S 

(24) MD-0691-D-102-S 

(25) MD-0741-S-102-S 
ATTACHMENT(S) 

October 12, 2011 Letter from Roland Fletcher 

Maryland’s Response to the Draft Report 

ADAMS Accession No.: ML112910131 

NRC Comment Resolution to October 20, 2011 

ADAMS Accession No.: ML113000070