December 3, 2007 

Mr. George Aburn, Director 

Air and Radiation Management Administration 

Maryland Department of the Environment 

1800 Washington Boulevard, Suite 705 

Baltimore, MD 21230-1750 

Dear Mr. Aburn: 

On November 14, 2007, 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 Agreement State Program adequate 

to protect public health and safety and compatible with the U.S. Nuclear Regulatory 

Commission=s program. 

Section 5.0, page 14, of the enclosed final report contains a summary of the IMPEP review 

team=s findings. 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 2009. 

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/ 

Martin J. Virgilio 

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.: See next page 
LETTER TO GEORGE ABURN FROM MARTIN J. VIRGILIO DATED: DECEMBER 3, 2007 

cc w/encl.: Roland G. Fletcher, Program Manager 

Maryland Radiological Health Program 

 Raymond E. Manley, Chief 

 Radioactive Materials Licensing and Compliance Division 

 Maryland Radiological Health Program 

Karen Beckley, Nevada 

Organization of Agreement States 

 Liaison to the MRB 
December 3, 2007 

Mr. George Aburn, Director 

Air and Radiation Management Administration 

Maryland Department of the Environment 

1800 Washington Boulevard, Suite 705 

Baltimore, MD 21230-1750 

Dear Mr. Aburn: 

On November 14, 2007, 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 Agreement State Program adequate 

to protect public health and safety and compatible with the U.S. Nuclear Regulatory 

Commission=s program. 

Section 5.0, page 14, of the enclosed final report contains a summary of the IMPEP review 

team=s findings. 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 2009. 

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/ 

Martin J. Virgilio 

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.: See next page. 

Distribution: See next page. EDATS: FSME-2007-0033

 ML073190514 

OFFICE FSME/DMSSA FSME/DMSSA FSME/DMSSA Tech Editor 

NAME ATMcCraw:kk ADWhite RLewis CPoland 

DATE 11/15/07 11/16/07 11/20/07 11/20/07 

OFFICE FSME DEDMRT 

NAME CMiller (GPangburn for) MJVirgilio 

DATE 11/26/07 12/03/07 

OFFICIAL RECORD COPY
LETTER TO GEORGE ABURN FROM MARTIN J. VIRGILIO DATED: DECEMBER 3, 2007 

cc w/encl.: Roland G. Fletcher, Program Manager 

Maryland Radiological Health Program 

 Raymond E. Manley, Chief 

 Radioactive Materials Licensing and Compliance Division 

 Maryland Radiological Health Program 

Karen Beckley, Nevada 

Organization of Agreement States 

 Liaison to the MRB 

Distribution: 

DMSSA RF DCD (SP01) 

EDO RF 

RidsEDOMail Center 

RidsFsmeOd 

RidsSecyCorrespondenceMailCenter Chairman Klein 

KLukes, FSME/DMSSA Commissioner Jaczko 

KSchneider, FSME/DMSSA Commissioner Lyons 

Duncan White, FSME/DMSSA SECY 

JJankovich, FSME/DMSSA 

DJanda, Region I/RSAO 

JMullauer, Region III 

Shawn Seeley, ME 

DDiaz-Toro, OEDO 

KCry, OGC 

FCameron, OGC 

CMiller, FSME 

JSchlueter, FSME/DMSSA 
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE MARYLAND AGREEMENT STATE PROGRAM 

August 20-24, 2007 

FINAL REPORT

ENCLOSURE 
Maryland Final Report Page 1 

1.0 INTRODUCTION 

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

review was conducted during the period of August 20-24, 2007, by a review team comprised of 

technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of 

Maine. 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 the February 26, 2004, NRC Management Directive 5.6, “Integrated 

Materials Performance Evaluation Program (IMPEP).” Preliminary results of the review, which 

covered the period of July 26, 2003, to August 24, 2007, 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 19, 2007. The 

State responded by e-mail on October 3, 2007, from Ray Manley, Chief, Radioactive Materials 

Licensing and Compliance Division (the Division). A copy of the State’s response is included as 

the Attachment to this report. The Management Review Board (MRB) met on November 14, 

2007, to consider the proposed final report. The MRB found the Maryland Agreement State 

Program to be 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 environmental and radiological hazards 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 Division (as defined above) and the 

Radiation Machines Division. Organization charts for the Department, the Program, and the 

Division are presented in Appendix B. 

At the time of the review, the Maryland Agreement State Program regulated 633 specific 

licenses authorizing Agreement and non-AEA 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. 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Program on March 28, 2007. The Program 

provided its response to the questionnaire on July 20, 2007, and an updated response on 

September 4, 2007. A copy of the updated questionnaire response may be found in the NRC’s 

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

Number ML073190535. 

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

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

regulations; (3) analysis of quantitative information from the Program’s database; (4) technical 

review of selected regulatory actions; (5) field accompaniments of three of the Division’s 

inspectors; and (6) interviews with staff and management to answer questions or clarify issues. 

The review team evaluated the information gathered against the established criteria for each 
Maryland Final Report Page 2 

common and applicable non-common performance indicator and made a preliminary 

assessment of the Maryland Agreement State Program’s performance. 

Section 2.0 of this report covers the State’s actions in response to recommendations made 

during the previous review. Results of the current 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. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on July 25, 2003, the review team made 

three recommendations in regard to program performance by the State. The results of the 

review were transmitted to Mr. Thomas C. Snyder, Director, Air and Radiation Management 

Administration, on December 2, 2003. 

The review team’s evaluation of the current status of the recommendation is as follows: 

1. The review team recommends that the State fill the current vacancies in the Program as 

soon as possible. (Section 3.1 of the 2003 report) 

 Current Status: The Division was fully staffed at the time of the review. Details of the 

Division’s staffing level are discussed in Section 3.1 of this report. This recommendation 

is closed. 

2. The review team recommends that the Program implement an action plan to ensure that 

core inspections, including initial inspections, are performed in accordance with the 

NRC’s inspection priorities. (Section 3.2 of the 2003 report) 

 Current Status: The team determined that all core inspections were performed in 

accordance with the NRC’s inspection priorities listed in Inspection Manual Chapter 

(IMC) 2800, “Materials Inspection Program.” At the time of the review, the Division had 

no overdue radioactive materials inspections. Details of the status of inspections are 

discussed in Section 3.2 of this report. This recommendation is closed. 

3. The review team recommends that the Program conduct an appropriate evaluation of all 

licensing actions involving name changes and possible change in ownership/control. 

(Section 3.4 of the 2003 report) 

 Current Status: The review team verified that the Division took appropriate action in 

evaluating all licensing actions and developing and implementing new licensing 

guidance. Details of the Division’s actions are discussed in Section 3.4 of this report. 

This recommendation is closed. 

3.0 COMMON PERFORMANCE INDICATORS 

IMPEP identifies five common performance indicators to be used in reviewing NRC Regional 

and Agreement State radioactive materials programs. These indicators are: (1) Technical 
Maryland Final Report Page 3 

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; and reviewed job descriptions, training 

plans, 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 Licensing Section is responsible for processing license 

applications for the use of radioactive material and for performing sealed source and device 

(SS&D) evaluations. 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 and the Inspection Section each 

have authorization for one supervisor and three staff positions. At the time of the review, nine 

staff members, including managers and one contractor, worked full-time for the radioactive 

materials program. This staffing level does not include administrative support staff. 

Until May 2006, the Division used the services of an engineer from elsewhere in the Department 

to perform SS&D evaluations. Since April 2007, the Division has used a contractor to perform 

these evaluations. Details of staffing in the SS&D program are provided in Section 4.2.1 of this 

report. 

At the time of the review, the Division had no vacancies; however, during the review period, the 

Division experienced several periods of time in which the Inspection Section was not fully 

staffed. During most of the review period, the Inspection Section was down by one staff 

member. From July 2003 to September 2003 and from January 2007 to May 2007, the 

Inspection Section had only one inspector on staff. The Program addressed the staffing 

shortages by having Program supervisors and two license reviewers, who are also qualified 

radioactive materials inspectors, conduct inspections of Priority 1, 2, and 3 licensees. The 

staffing shortage resulted in a temporary backlog of inspections of Priority 5 licensees. This 

backlog is currently being addressed. 

The review team noted that, although the Division was fully staffed at the time of the review, the 

loss of one staff member could adversely impact performance. Program funding decreased 

during the review period (see Section 4.1.2 for more details), challenging the Program’s ability 

to fund training for new staff. 

The staff is well-trained and qualified from an education and experience standpoint. All have 

Bachelor’s degrees in the sciences. The Program has a documented training plan, the 

Radiological Health Inspection Manual, that is consistent with the guidance in the 

NRC/Organization of Agreement States Training Working Group Report and IMC 1246, “Formal 

Qualification Programs in the Nuclear Materials Safety and Safeguards Program Area.” The 
Maryland Final Report Page 4 

Radiological Health Inspection Manual has a chapter on training and qualification procedures, 

detailing training, inspection accompaniments, and evaluation by managers to qualify individual 

staff. Inspector requirements include NRC training courses, when available, or equivalents. 

The review team noted that Program management has exhibited a strong commitment to 

training. At the time of the review, the Program had five staff members that had attended the 

NRC’s Security Systems and Principles Course. The Program also takes advantage of on-thejob training opportunities. New staff members have also received training from other providers, 

including the Federal Emergency Management Agency, commercial vendors, and local 

educational institutions. 

The Radiation Control Advisory Board of the State of Maryland, as constituted under the law, 

acts in a purely advisory role to the Department. The Ethics Law addresses ownership 

interests, employment, receipt of gifts, misuse of confidential information, activities of formal 

officials, representational activities, and misuse of position. 

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, was 

satisfactory. 

3.2 Status of Materials Inspection Program

The review team focused on five factors in 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 responses relative to this indicator, data obtained from the 

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

managers and staff. 

The review team verified that the Division’s inspection priorities for various license types are at 

least as frequent as similar license types listed in IMC 2800. The Program utilizes inspection 

frequencies for various types of radioactive material licenses to conform with the priorities listed 

in NRC’s Temporary Instruction 2800/033, Revision 02, “Revised Materials Inspection 

Program.” The inspection priorities used during the review period were found to be generally 

the same as those listed in IMC 2800, although some categories of licenses were assigned 

inspection priority codes that prescribed a more frequent inspection schedule than those 

currently prescribed in IMC 2800. The review team identified 16 license categories that the 

Division inspects on a more aggressive schedule based on the Division’s evaluation of 

radiological hazard and complexity of licensees. 

During the review period, the Division conducted 302 routine inspections of Priority 1, 2, and 3 

licenses and 147 initial inspections of new licenses. No inspections were completed or are 

currently overdue by more than 25 percent of the respective inspection priority listed in IMC 

2800. 

The review team examined the timeliness of inspection findings issued by the Division during 

the review period. Inspection findings are generally communicated to licensees in a timely 

manner. The Division’s goal is to complete each inspection report and deliver the Notice of 

Violation, as appropriate, to the licensee within 30 days of the inspection’s completion date. Of 
Maryland Final Report Page 5 

the 17 inspection files reviewed, all licensees were given a record of inspection at the 

conclusion of the inspection; however, six Notices of Violation were issued to licensees beyond 

the Division’s goal. In all six cases, the violations were complicated or required extensive 

review before being sent to the licensee. In addition, two inspections that involved the 

assistance of the Maryland Attorney General’s Office before issuance of the inspection report to 

the licensee did not meet the 30-day goal. 

The review team determined that, during the review period, the Division granted reciprocity to 

64 licensees that were candidates for inspection based upon the criteria in IMC 1220, 

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

10 CFR 150.20.” The review team determined that the Division met and/or exceeded the NRC’s 

goal of inspecting 20 percent of candidate licensees operating under reciprocity in each of the 

four years covered by the review period. The Division conducted 28 total inspections of 

candidate reciprocity licensees during the review period. In addition, the Division inspected 14 

percent of non-candidate reciprocity licensees during the review period. 

The review team determined that the Division adequately planned for the initial set of Increased 

Controls inspections of affected licensees. The review team evaluated the Division’s 

prioritization methodology and found it acceptable. The Program currently has 27 licensees that 

are subject to the Increased Controls. The Division elected to perform all of its Increased 

Controls inspections by July 1, 2007. The review team determined that the Division had met its 

goal and completed all of its Increased Controls inspections. 

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, was satisfactory. 

3.3 Technical Quality of Inspections

The review team evaluated the inspection reports, enforcement documentation, and inspection 

field notes and interviewed inspectors for 17 radioactive materials inspections conducted during 

the review period. The casework examined included inspections performed by five of the 

Division’s radioactive materials inspectors, including an inspector who is a new hire and only 

partially qualified. The review team examined inspections of various license types, including: 

industrial radiography, medical broad scope, medical institutions requiring written directives, 

nuclear pharmacy, irradiators, sealed source production and distribution, and Increased 

Controls. Appendix C lists the inspection casework files reviewed, with case-specific 

comments, as well as the results of the inspector accompaniments. 

Based on the evaluation of casework, the review team found that routine inspections covered all 

aspects of the licensees’ radiation safety programs. The inspection reports were thorough, 

complete, consistent, and of high quality, with sufficient documentation to ensure that licensees’ 

performances with respect to health, safety, and security were acceptable. The documentation 

adequately supported the cited violations. Exit interviews were held with appropriate licensee 

personnel. Team inspections were performed when appropriate and for training purposes. 

The review team found that routine inspections included a written summary of the scope of the 

licensed activities and violations identified by the inspector. The review team also noted that, in 
Maryland Final Report Page 6 

cases that involved significant and/or ongoing violations, the Division had exercised escalated 

enforcement action through the issuance of orders, imposition of civil penalties, or suspension 

of licensed activities. The review team found that the Division had a good process for reviewing 

draft inspection documentation and enforcement actions, making any needed changes and 

providing the inspector with feedback regarding the quality of the draft document. 

The inspectors, including the supervisors, were accompanied at least once a year. All 

accompaniments were documented and kept on file. 

The Program maintains an adequate supply of survey meters to support the inspection program, 

as well as to respond to incidents and emergency conditions. The Program has contractors 

who calibrate their survey instruments on an annual basis. Appropriate documentation of 

calibrated survey instruments such as GM meters, scintillation detectors, ion chambers, and 

micro-R meters was provided. Air monitoring equipment, as well as prepared emergency field 

kits, is available for emergency use. Contamination wipes are primarily evaluated at the 

Maryland Laboratory Administration facility located in Baltimore. This facility is also capable of 

other analyses, including gamma spectroscopy of air, soil, and water samples. 

The review team accompanied three materials inspectors during the week of July 22, 2007, 

during health and safety inspections of a pool irradiator and two medical institutions licensed for 

diagnostic and therapeutic nuclear medicine. The accompaniments are identified in Appendix 

C. During the accompaniments, each of the inspectors demonstrated appropriate performancebased inspection techniques and knowledge of the regulations. The inspectors were wellprepared and thorough in their reviews of the licensees’ radiation safety programs. The 

inspections were adequate to assess radiological health and safety at the licensed facilities. 

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, was 

satisfactory. 

3.4 Technical Quality of Licensing Actions

The review team interviewed license reviewers, evaluated the licensing process, and examined 

licensing casework for 17 licensing actions for 16 specific licenses. Licensing actions were 

reviewed for completeness, consistency, proper radioisotopes and quantities, qualifications of 

authorized users, adequate facilities and equipment, adherence to good health physics 

practices, financial assurance, operating and emergency procedures, appropriateness of the 

license conditions, and overall technical quality. The casework was also reviewed for 

timeliness, use of appropriate deficiency letters and cover letters, reference to appropriate 

regulations, supporting documentation, consideration of enforcement history, pre-licensing 

visits, peer/supervisory review, and proper signature authority. The files were checked for 

retention of necessary documents and supporting data. 

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

that were completed during the review period. The sampling included the following license 

types: specific medical, research and development, broad scope medical, medical therapy, 

radiopharmacy, portable gauge, industrial radiography, broad scope research and development, 

medical gamma knife, and high dose-rate remote afterloader. Licensing actions reviewed 
Maryland Final Report Page 7 

included three new licenses, three renewals, nine amendments, two terminations, and one 

financial assurance instrument. A listing of the license casework evaluated, with case-specific 

comments, can be found in Appendix D. 

The review team found that the licensing actions were thorough, complete, consistent, and of 

high quality with health, safety, and security issues properly addressed. License tie-down 

conditions were stated clearly, backed by information contained in the file, and auditable. 

Deficiency letters clearly stated regulatory positions, are used at the appropriate time, and 

identified deficiencies in the licensees’ documents. 

Licensing actions are assigned to one of three license reviewers by the Licensing Section 

Supervisor, who also performs licensing reviews in order to reduce the backlog of pending 

actions. The status of all licensing actions is tracked on a database. The Licensing Section 

generates licenses and correspondence with standardized conditions and formats. The 

Licensing Section Supervisor reviews and initials all licenses before being sent to the Program 

Manager for signature. As of June 2003, the Licensing Section changed its license renewal 

frequency from a 5-year period to a 7-year period under a timely renewal system. The license 

reviewers utilize NRC licensing guides (NUREG-1556 series), as appropriate. The Program 

issues a complete license for each licensing action. 

No major decommissioning actions were completed over the review period; however, the review 

team evaluated two termination actions. The review team found that terminations were welldocumented, showing appropriate transfer records or appropriate disposal methods and 

records, confirmatory surveys, and survey records. 

At the time of the review, no licensing actions were overdue. The review team determined that 

the Division’s policy, whereby timeliness does not count against a particular licensing action 

when the licensee is responding to requests for additional information from the licensing staff, 

contributed to the timely dispatch of licensing actions. 

The review team found that the Division has a policy of listing the radiation oncologists 

(authorized users), the neurosurgeons, and the medical physicists (all part of the medical team 

that must be present during treatment) under the authorized user license condition for gamma 

knife licenses. The review team discussed with the Division the benefits of listing the 

neurosurgeons and the medical physicists under a separate license condition to avoid confusing 

them as authorized users of the gamma knife. 

During the 2003 IMPEP review, the team determined that three of four amendment actions 

containing requests for a name change and possible change in ownership/control of the license 

were not reviewed although the licensing staff was aware of the change in ownership/control 

guidance in NUREG-1556, Volume 15, “Guidance About Changes of Control and About 

Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses.” In response to 

the recommendation in the 2003 report, the Division implemented new licensing guidance to 

ensure these types of requests were adequately reviewed. During this review, the review team 

verified that the Division implemented the guidance and has been reviewing all actions involving 

a name change and possible change in ownership/control. 
Maryland Final Report Page 8 

The Division has a long-standing policy for conducting pre-licensing visits for all new 

applications for radioactive materials licenses. The visit covers all areas of an applicant’s 

proposed radiation safety program and confirms the legitimacy of the applicant’s need for 

radioactive materials. All pre-licensing visits are documented and signed by the inspector and 

the applicant’s management representative. 

The review team examined the list of licensees that the Division identified as meeting the criteria 

for the Increased Controls. The review team determined that the Division had correctly 

identified the licensees that required the Increased Controls based on the criteria. Each 

licensee was issued a license amendment requiring the Increased Controls. The Division has 

the means to issue the Increased Controls to any new or amended licenses meeting the criteria, 

as well. 

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, was satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities

To evaluate the effectiveness of the Division’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 Division’s files, and evaluated the casework 

for 10 radioactive materials incidents. A listing of the incident casework examined, with casespecific comments, can be found in Appendix E. The review team also evaluated the Program’s 

response to 13 allegations, 7 of which were referred to the State by the NRC during the review 

period. 

The review team discussed the Program’s incident and allegation processes, including 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 discuss the event and determine the level of initial response based on the 

health and safety risk associated with the event. The actions taken in response to an event are 

documented and filed, and the data are submitted to the NRC’s contractor responsible for 

maintaining NMED for inclusion in the database. 

The review team identified 35 events in NMED for Maryland during the review period, of which 

25 required reporting to the NRC Headquarters Operations Center. A review of the Division’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: damaged equipment, transportation, lost/stolen radioactive material, contamination, 

potential overexposure, and medical. The Division’s responses to the incidents were complete 

and comprehensive. Initial responses were prompt and well-coordinated, and the level of effort 

was commensurate with the health and safety significance. Inspectors were dispatched for onsite investigations when appropriate. Enforcement and/or other regulatory actions were taken 

as appropriate. 
Maryland Final Report Page 9 

The review team noted a majority of the incidents involved either damaged or lost/stolen 

portable gauges. In addition, the review team noted that the Division responded to two 

incidents involving Radium-226 that required a significant level of effort by the Division. These 

incidents involved contaminated railcars and instrumentation removed from older aircraft. 

In evaluating the effectiveness of the Division’s actions responding to allegations, the review 

team evaluated the casework for seven allegations referred to the State by the NRC and six 

received directly by the State. The casework review indicated that the Division took prompt and 

appropriate action in response to the concerns raised. The allegations were appropriately 

closed, and the appropriate parties were notified of the actions taken. 

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, was satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

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

State Programs: (1) Compatibility Requirements; (2) Sealed Source and Device Evaluation 

Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery 

Program. Maryland’s Agreement does not include the authority to regulate uranium recovery 

activities; therefore, only the first three non-common performance indicators were applicable to 

this review. 

4.1 Compatibility Requirements

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, “Radiation,” and Title 7, “Hazardous Materials and Hazardous Substances.” The 

Department is designated as the State’s radiation control agency. 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 statutes for the control of radiation are contained in COMAR 26.12.01.01, 

“Regulations for the Control of Ionizing Radiation.” COMAR 26.15, “Disposal of Controlled 

Hazardous Substances - Radioactive Hazardous Substances,” contains statutes specific to lowlevel radioactive waste issues. Maryland requires a license for the possession and use of all 

radioactive material, including naturally-occurring materials, such as radium, and acceleratorproduced radionuclides. Maryland also requires registration of all equipment designed to 

produce x-rays or other ionizing radiation. 

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

process takes 6 to 12 months from the development stage to the final approval by the Secretary 

of the Environment, after which the rule becomes effective in 10 days. 
Maryland Final Report Page 10 

The review team noted that the State’s rules and regulations are not subject to “sunset” laws. 

The State may adopt other agency’s regulations by reference and has the authority to issue 

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

regulations become effective. 

The review team evaluated the Program’s response to the questionnaire relative to this 

indicator, reviewed the status of regulations required to be adopted by the State under the 

Commission’s adequacy and compatibility policy, and verified the adoption of regulations with 

data obtained from the Office of Federal and State Materials and Environmental Management 

Programs’ (FSME) State Regulation Status Sheet. 

On June 28, 2007, the NRC provided comments to the State on a package of proposed 

regulations that addresses the following amendments: 

• “Medical Use of Byproduct Material,” 10 CFR Part 20, 32, and 35 amendments (67 FR 

20249) that became effective on October 24, 2002, and was due for Agreement State 

adoption by October 24, 2005. 

• "Medical Use of Byproduct Materials - Recognition of Specialty Boards," 10 CFR Part 35 

amendment (70 FR 16336, 71 FR 1926) that became effective on April 29, 2005, and is 

due for Agreement State adoption by April 29, 2008. 

• “Security Requirements for Portable Gauges Containing Byproduct Material,” 10 CFR 

Part 30 amendment (70 FR 2001) that became effective on July 11, 2005, and is due for 

Agreement State adoption by July 11, 2008. 

The State amended the above listed regulations based on the NRC’s comments and expects 

the amendments to be adopted in final by December 2007. 

The review team identified the following two NRC amendments that need to be addressed: 

• “Compatibility with IAEA Transportation Safety Standards and Other Transportation 

Safety Amendments,” 10 CFR Part 71 amendment (69 FR 3697) that became effective 

on October 1, 2004, and was due for Agreement State adoption by October 1, 2007. 

• “Minor Amendments,” 10 CFR Part 20, 30, 32, 35, 40 and 70 amendments 

(71 FR 15005) that became effective March 27, 2006, and is due for Agreement State 

adoption by March 27, 2009 

The review team discussed the Program’s funding status with Program managers. Since the 

last review in 2003, the Program has seen an overall decrease in funding for the program. In 

2003, the Program received approximately 65 percent of its funding from fees and 35 percent 

from the general fund. Currently, all funding for the Program is through fees. Since there has 

been no increase in fees since 2002, the Program’s budget has effectively decreased by 35 

percent. Program managers indicated that they have sufficient funds for the current fiscal year 

that ends on June 30, 2008. The Program has drafted their fee regulations to include a 
Maryland Final Report Page 11 

substantial increase in fees to go into effect in July 2008. During the on-site exit meeting, the 

review team discussed this matter with Department managers. Department managers were 

aware of the funding situation and were supportive of increasing fees. 

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, was 

satisfactory. 

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

In conducting this review, the review team used three sub-elements to evaluate the Division’s 

performance regarding the SS&D Evaluation Program. The three 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 SS&D Evaluation Program, the review team examined information provided in 

the Program’s response to the IMPEP questionnaire on this indicator; reviewed a sample of 

new, amended, and inactivated SS&D evaluations and supporting documents completed during 

the review period; verified the Division’s use of guidance documents and procedures; and 

interviewed managers and staff. 

4.2.1 Technical Staffing and Training

The Division has four staff members who are fully qualified to conduct SS&D safety evaluations 

and have signature authority to sign SS&D registration certificates. The review team identified 

no changes in the Division’s staffing or the staff’s qualifications since the previous review 

regarding those staff members who conduct SS&D evaluations. Consequently, the review team 

did not examine the Division’s training procedures or the training records of the four qualified 

individuals. 

The review team noted that the Division’s staff did not have the opportunity during the review 

period to address the traditionally broad spectrum of SS&D cases. Specifically, due to the 

limited product lines of the SS&D vendors who submitted applications to the Division during the 

review period, the Division’s staff could only review two types of devices (high-dose remote 

afterloader and gamma gauge). As a consequence of a limited scope of SS&D activities, the 

staff’s skills were not fully utilized or adequately challenged. The review team noted that in its 

evaluation of the two inactivation cases, some administrative issues had not been addressed in 

accordance with nationwide practices. The review team concluded that the Division’s SS&D 

reviews adequately addressed all safety issues. The review team discussed the potential 

benefit of Division staff working with NRC or other Agreement State SS&D groups to perform a 

variety of SS&D tasks in order to enhance their skill levels. 

The Division currently utilizes outside resources to conduct engineering analyses. Engineering 

staff was available from elsewhere within the Department until October 2005 and then again 

between December 2005 and May 2006. In April 2007, the Division contracted for engineering 

support with SAIC, Inc. To determine the qualifications of the engineering support, the review 

team reviewed the contract files and conducted a telephone interview with contract personnel 

assigned by the contractor to perform SS&D safety evaluations on behalf of the State. The 
Maryland Final Report Page 12 

review team also reviewed the technical quality of engineering analyses provided by SAIC, Inc. 

The review team found that the contracting process, the qualification and relevant professional 

experience of the SAIC, Inc., personnel, and the quality of the engineering analyses that were 

performed were adequate to supplement the skill level of the Division’s staff. 

At the time of the review, the Division did not have a backlog of SS&D cases. One case was 

open and under timely review. The review team concluded that the SS&D staffing level was 

adequate. 

4.2.2 Technical Quality of the Product Evaluation Program

During the review period, the Program processed 18 SS&D actions, including new device 

reviews, amendments, and inactivations. The review team selected eight SS&D case files for 

review including work performed by all qualified staff members. The SS&D actions were 

selected to represent a variety of actions which included two new certificates, four amendments, 

one inactivation, and one correction. The selected actions included a variety of the Program’s 

SS&D manufacturers and distributors. A listing of the SS&D certificates evaluated, with casespecific comments, can be found in Appendix F. 

The review team evaluated the conduct of safety evaluations and the use of deficiency 

correspondence and checklists for SS&D actions. Casework was evaluated for timeliness, 

adherence to good radiation safety practices and acceptable engineering practices, references 

to appropriate regulations, documentation of safety evaluation reports, review of manufacturing 

Quality Assurance/Quality Control (QA/QC), and use of peer or supervisory review and 

signature authority. The files were checked for retention of necessary documents and other 

supporting data. The SS&D certificates were reviewed for accuracy, appropriateness of 

authorizations, tie-down statements, and overall technical quality. 

The review team found that the evaluations were of high quality with health and safety issues 

properly addressed. Analysis of the casework and interviews with the staff confirmed that the 

Division followed the recommended guidance from the NRC SS&D training workshops and the 

relevant guidance document, NUREG-1556, Volume 3, Revision 1, “Applications for Sealed 

Source and Device Evaluation and Registration.” All applicable and pertinent regulations, 

industry standards, and applicable references were available and used appropriately in 

performing SS&D reviews. The registration files contained all correspondence, photographs, 

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

quality control program. Appropriate review checklists, which were retained in the case files, 

were used to assure that all relevant materials were submitted and reviewed. Deficiency letters 

were used when appropriate and clearly stated regulatory positions. The registration certificates 

summarized the product evaluation and provided license reviewers with adequate information 

on areas requiring additional attention in licensing the possession, use, and distribution of the 

products. 

The review team found that the SS&D files were maintained in an orderly manner and 

correspondence was filed chronologically, facilitating the accessibility of the records. Each 

SS&D case file contained a Table of Contents, which further facilitated access to relevant 

documents. The review team noted the Division established additional quality assurance 

measures. Specifically, the Division completed each SS&D case using two checklists unique to 

the Division’s SS&D program, in addition to the universally-used technical checklist in NUREG-
Maryland Final Report Page 13 

1556, Volume 3, Revision 1. The review team noted the Division’s use of a ‘completeness 

review checklist,’ which delineates in great detail the specific issues that must be addressed in 

the registration certificate, and a ‘concurrence review checklist,’ which assures that the 

concurring SS&D reviewer would not miss the significant issues in completing the casework. 

The review team recommended, and the MRB agreed, that the Division’s use of the two 

checklists be identified as a good practice. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Utilizing NMED and the Program’s response to the questionnaire, the review team selected and 

evaluated a sample of 10 incidents and/or equipment failures reported during the review period 

that occurred in Maryland or that occurred nationally involving SS&D products registered in 

Maryland. The review team also evaluated the Division’s response to one allegation received 

by the Division that was related to the SS&D evaluation program. 

The Division maintains multiple tracking systems to identify and resolve issues that involve 

SS&D failures: (1) a list of emergency responses/incidents, (2) a list of allegations, and (3) a list 

of Nucletron device events. In addition, Division staff conducts periodic searches of NMED 

several times a year to identify issues that may be related to SS&D products registered in 

Maryland. 

The review team determined that the Division analyzed the events, reviewed the issues, and 

followed up on the incidents adequately and in accordance with applicable guidance. None of 

the events involving equipment or source failures within the period appeared to be generic 

issues. A listing of the incident casework examined, with case-specific comments, is included in 

Appendix E. The Program’s handling of SS&D related incidents is consistent with the review 

team’s conclusions for the Division’s handling of other radioactive material incidents discussed 

in Section 3.5. 

The Program developed an “Event Flow Chart,” which leads to decision points to identify major 

issues involved in the event evaluation through a series of yes/no questions. The major issues 

that are addressed by the flow chart include such issues as human errors, the manufacturer’s 

root cause analysis, and the need for engineering analysis. The review team noted that the 

Division applied the Event Flow Chart retroactively to incident reviews that had already been 

closed out in order to determine the validity of the earlier resolutions. In four instances the 

Event Flow Chart identified the need for engineering analyses. The Division utilized its 

engineering contractor to perform the analyses. The results of the analyses confirmed Division 

staff’s earlier conclusions. The review team recommended, and the MRB agreed, that the 

Division’s development and use of the Event Flow Chart be identified as a good practice. 

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

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

satisfactory. 

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

In 1981, the NRC amended its Policy Statement “Criteria for Guidance of States and NRC in 

Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through 
Maryland Final Report Page 14 

Agreement” to allow a State to seek an amendment for the regulation of LLRW as a separate 

category. Those States with Agreements prior to 1981 were determined to have continued 

LLRW disposal authority without the need of an amendment. Although the Maryland Agreement 

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

for licensing a LLRW disposal facility until such time as the State has been designated as a host 

State for a LLRW disposal facility. When an Agreement State has been notified or becomes 

aware of the need to regulate a LLRW disposal facility, they are expected to put in place a 

regulatory program which will meet the criteria for an adequate and compatible LLRW disposal 

program. There are no plans for a LLRW disposal facility in Maryland. Accordingly, the review 

team did not review this indicator. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0, Maryland’s performance was found satisfactory for all 

performance indicators reviewed. The review team made no recommendations regarding 

program performance and identified two good practices. Accordingly, the review team 

recommended, and the MRB agreed, that the Maryland Agreement State Program was 

adequate to protect public health and safety and compatible with NRC's program. Based on the 

results of the current IMPEP review, the review team recommended, and the MRB agreed, that 

the next full IMPEP review take place in approximately 4 years. 
LIST OF APPENDIXES AND ATTACHMENT 

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 Review 

Attachment October 3, 2007, E-mail from Ray Manley 

 Maryland’s Response to Draft IMPEP Report 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Duncan White, FSME Team Leader 

 Technical Quality of Incident and Allegation 

 Activities 

Donna Janda, Region I Technical Staffing and Training 

 Compatibility Requirements 

Shawn Seeley, Maine Status of Materials Inspection Program 

 Technical Quality of Inspections 

 Inspector Accompaniments 

James Mullauer, Region III Technical Quality of Licensing Actions 

John Jankovich, FSME Sealed Source and Device Evaluation Program 
APPENDIX B 

MARYLAND ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML073190535 

PAGES 2-4 
APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Howard County General Hospital License No.: 27-016-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 7/25/07 Inspector: CW 

Comment: 

Inspector’s confirmatory surveys were not documented. 

File No.: 2 

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

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/26/07 Inspector: DA 

File No.: 3 

Licensee: Advanced Radiology License No.: 27-047-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 7/24/07 Inspector: FA 

File No.: 4 

Licensee: Memorial Hospital at Easton License No.: 41-001-03 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/6/07 Inspector: DA 

Comment: 

Notice of Violation (NOV) was not sent within 30 days from date of inspection. 

File No.: 5 

Licensee: Team Industrial Services License No.: 03-079-01 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 6/29/06 Inspector: RN 

Comment: 

The serial number for the inspector’s survey instrument used during inspection was not 

recorded in the field notes. 

File No.: 6 

Licensee: Team Industrial Services License No.: 03-079-01 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 6/29/06 Inspector: RN 

Comment: 

The serial number for the inspector’s survey instrument used during inspection was not 

recorded in the field notes. 
Maryland Final Report Page C.2 

Inspection Casework Reviews

File No.: 7 

Licensee: MQC License No.: 25-022-01 

Inspection Type: Special, Announced Priority: 1 

Inspection Dates: 11/27/06, 2/28/07 Inspectors: AJ, DA 

Comment: 

Inspections results were sent to licensee 71 days after the inspection. 

File No.: 8 

Licensee: Cardinal Health License No.: 05-148-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/17/07 Inspector: DA 

Comment: 

Notice of violation was sent to licensee 69 days after the inspection. 

File No.: 9 

Licensee: University of Maryland-Baltimore License No.: 07-014-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 2/2-3/06 Inspectors: DA, RN, FA 

Comment: 

 Notice of violation was sent to licensee 122 days after the inspection. 

File No.: 10 

Licensee: Neutron Products, Inc. License No.: 31-025-04/05 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Dates: 7/26-28/06 Inspectors: AJ, RN, DA 

Comment: 

 Notice of violation was sent to licensee 59 days after the inspection. 

File No.: 11 

Licensee: Neutron Products, Inc. License No.: 31-025-01 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Dates: 6/30/05, 7/1/05 Inspector: RN 

Comment: 

 Notice of violation was sent to licensee 52 days after the inspection. 

File No.: 12 

Licensee: University of Maryland-College Park License No.: 33-004-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 2/15-16/07 Inspector: DA 

Comment: 

Notice of violation was sent to licensee 52 days after the inspection. 
Maryland Final Report Page C.3 

Inspection Casework Reviews

File No.: 13 

Licensee: Radiation Service Organization, Inc. License No.: 33-021-02 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/10/06 Inspector: RN 

File No.: 14 

Licensee: Holy Cross Hospital License No.: 31-001-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 7/24/06 Inspector: DA 

File No.: 15 

Licensee: Advanced Radiology License No.: 25-024-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/3/05 Inspector: DA 

File No.: 16 

Licensee: American Cardiovascular Imaging, LLC License No.: 33-195-01 

Inspection Type: Initial, Unannounced Priority: 3 

Inspection Date: 7/12/07 Inspectors: FA, DA 

File No.: 17 

Licensee: Testing Technologies, Inc. License No.: NRC 45-25007-01 

Inspection Type: Reciprocity, Unannounced Priority: 1 

Inspection Date: 8/29/06 Inspector: RN 

INSPECTOR ACCOMPANIMENTS 

The following inspection accompaniments were made as part of the on-site IMPEP review: 

Accompaniment No.: 1 

Licensee: Advanced Radiology License No.: 27-047-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 7/24/07 Inspector: FA 

Accompaniment No.: 2 

Licensee: Howard County General Hospital License No.: 27-016-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 7/25/07 Inspector: CW 

Accompaniment No.: 3 

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

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/26/07 Inspector: DA 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Union Hospital of Cecil County License No.: 15-001-01 

Type of Action: Renewal Amendment No.: 45 

Date Issued: 2/27/07 License Reviewers: DM, CW 

Comments: 

a) Wrong date for letter used in tie down license condition. 

b) Radiation Safety Officer (RSO) signed renewal request, not licensee management. 

c) Checklist used by the license reviewers was not completed. 

File No.: 2 

Licensee: Union Hospital of Cecil County License No.: 15-001-01 

Type of Action: Amendment Amendment No.: 46 

Date Issued: 2/28/07 License Reviewer: RM 

File No.: 3 

Licensee: Nutramax Labs, Inc. License No.: 25-037-01 

Type of Action: Renewal Amendment No.: 06 

Date Issued: 4/13/07 License Reviewer: DM 

Comments: 

a) Licensee did not commit to a specific calibration frequency. 

b) Response letter dated 1/29/07 containing commitments for package receipt, monitoring 

logs, disposal logs and radiation safety survey logs not referenced in tie down condition. 

File No.: 4 

Licensee: Sinai Hospital of Baltimore License No.: 07-011-01 

Type of Action: Amendment Amendment No.: 126 

Date Issued: 4/27/07 License Reviewer: NO 

File No.: 5 

Licensee: John R. McLean, M.D. & Associates, P.A. License No.: 45-016-01 

Type of Action: Termination Amendment No.: 12 

Date Issued: 5/23/07 License Reviewer: BP 

File No.: 6 

Licensee: Frederick Memorial Health Care System License No.: 21-001-03 

Type of Action: New Amendment No.: N/A 

Date Issued: 3/29/07 License Reviewer: DM 

Comment: 

 File contained no record of deficiency phone call that requested additional information. 
Maryland Final Report Page D.2 

License Casework Reviews

File No.: 7 

Licensee: John R. Marsh License No.: 43-001-02 

Type of Action: Amendment Amendment No.: 30 

Date Issued: 6/5/07 License Reviewer: CW 

File No.: 8 

Licensee: Washington County Hospital Association License No.: 43-001-03 

Type of Action: Amendment Amendment No.: 19 

Date Issued: 6/5/07 License Reviewer: CW 

File No.: 9 

Licensee: Stanley Medical Research Institution License No.: 31-365-01 

Type of Action: New Amendment No.: N/A 

Date Issued: 7/3/07 License Reviewer: CW 

File No.: 10 

Licensee: Petnet Pharmaceuticals, Inc. License No.: 07-213-01 

Type of Action: Amendment Amendment No.: 02 

Date Issued: 7/20/05 License Reviewer: DM 

File No.: 11 

Licensee: Doctors Community Hospital License No.: 33-029-01 

Type of Action: Renewal Amendment No.: 65 

Date Issued: 8/21/06 License Reviewer: DM 

File No.: 12 

Licensee: Schnabel Engineering North, LLC License No.: 05-174-01 

Type of Action: Amendment Amendment No.: 27 

Date Issued: 12/28/06 License Reviewer: NO 

File No.: 13 

Licensee: Bowie PET Scan, LLC License No.: 33-165-01 

Type of Action: Termination Amendment No.: 02 

Date Issued: 12/28/05 License Reviewer: NO 

File No.: 14 

Licensee: Maryland QC Laboratories, Inc. License No.: 25-022-01 

Type of Action: Amendment Amendment No.: 46 

Date Issued: 6/21/07 License Reviewer: CW 

File No.: 15 

Licensee: University of Maryland License No.: 33-004-01 

Type of Action: Amendment Amendment No.: 136 

Date Issued: 7/23/07 License Reviewer: NO 
Maryland Final Report Page D.3 

License Casework Reviews

File No.: 16 

Licensee: John Hopkins Medical Institution License No.: 07-005-13 

Type of Action: Amendment Amendment No.: 12 

Date Issued: Not Recorded License Reviewer: NO 

File No.: 17 

Licensee: St. Joseph Radiation Oncology Center License No.: 05-211-01 

Type of Action: New Amendment No.: N/A 

Date Issued: 2/8/07 License Reviewer: BP 

Comments: 

a) Duties of the Radiation Safety Officer and frequency of calibration of survey instruments 

were not found in the file. 

b) Licensee did not address Deficiency No. 1, which requested a commitment to include 

dry runs during the training of authorized users. 

c) Fax and e-mail dated 2/8/07 were not signed by the licensee. 

d) Tie down condition indicates a letter dated January 17, 2007; it should be January 15, 

2007. 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: MAFI Associates Consultants Engineering License No.: 31-270-01 

Date of Incident: 12/22/04 Incident Log No.: NMED 050007 

Investigation Date: 12/22/04 Type of Incident: Damage to Equipment 

 Type of Investigation: Site 

File No.: 2 

Licensee: Northwest Hospital License No.: 05-034-03 

Date of Incident: 10/26/04 Incident Log No.: NMED 040777 

Investigation Date: 10/29/04 Type of Incident: Transportation 

 Type of Investigation: Site 

File No.: 3 

Licensee: Carroll County General Hospital License No.: 13-001-02 

Date of Incident: 3/16/04 Incident Log No.: NMED 040540 

Investigation Date: 3/19/04 Type of Incident: Lost Radioactive Material 

 Type of Investigation: Site 

File No.: 4 

Licensee: Cardinal Health License No.: 31-270-01 

Date of Incident: 1/1/05 Incident Log No.: NMED 050021 

Investigation Date: 1/1-4/05 Type of Incident: Transportation 

 Type of Investigation: Site 

File No.: 5 

Licensee: Joseph Smith License No.: N/A 

Date of Incident: 9/2/04 Incident Log No.: NMED 040726/040728 

Investigation Date: 9/24/04 Type of Incident: Contamination 

 Type of Investigation: Site 

File No.: 6 

Licensee: CTI Core Drilling Services License No.: NRC 45-25383-01 

Date of Incident: 6/30/05 Incident Log No.: N/A 

Investigation Date: 7/11/05 Type of Incident: Potential Overexposure 

 Type of Investigation: Site 

File No.: 7 

Licensee: Mallinckrodt License No.: 33-088-01 

Date of Incident: 11/8/05 Incident Log No.: NMED 050748 

Investigation Date: 11/9/05 Type of Incident: Lost Radioactive Material 

 Type of Investigation: Phone/Next Inspection 
Maryland Final Report Page E.2 

Incident Casework Reviews 

File No.: 8 

Licensee: John Hopkins Medical Institute License No.: 07-005-03 

Date of Incident: 3/2/06 Incident Log No.: NMED 060187 

Investigation Date: 3/14/06 Type of Incident: Stolen Radioactive Material 

 Type of Investigation: Site 

File No.: 9 

Licensee: Diageo License No.: General License 

Date of Incident: 7/1/06 Incident Log No.: NMED 070134 

Investigation Date: 2/16/07 Type of Incident: Lost Radioactive Material 

 Type of Investigation: Site 

Comment: 

 Licensee did not report loss of material to the State until January 2007. 

File No.: 10 

Licensee: Mount Sinai Hospital License No.: 07-011-01 

Date of Incident: 9/29/03 Incident Log No.: NMED 030798 

Investigation Date: 10/7/03 Type of Incident: Medical Event 

 Type of Investigation: Site 

SEALED SOURCE AND DEVICE INCIDENT CASEWORK REVIEWS 

File No.: 11 

Licensee: Nucletron Corp. License No.: 27-035-01 

Date of Incident: 1/23/07 Incident Log No.: NMED 070012 

Investigation Date: 3/23/07 Type of Incident: Maintenance Test Failure 

 Type of Investigation: Root Cause/Generic Application 

File No.: 12 

Licensee: Nucletron Corp. License No.: 27-035-01 

Date of Incident: 12/22/06 Incident Log No.: N/A 

Investigation Date: 6/19/07 Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No.: 13 

Licensee: Nucletron Corp. License No.: 27-035-01 

Date of Incident: 3/22/06 Incident Log No.: N/A 

Investigation Date: 6/16/06 Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No.: 14 

Licensee: Nucletron Corp. License No.: 27-035-01 

Date of Incident: 1/06/05 Incident Log No.: NMED 050471 

Investigation Date: 1/06/06 Type of Incident: Equipment Malfunction 

 Type of Investigation: Manufacturer’s Site 
Maryland Final Report Page E.3 

Incident Casework Reviews 

File No.: 15 

Licensee: Nucletron Corp. License No.: 27-035-01 

Date of Incident: 4/6/05 Incident Log No.: NMED 050222 

Investigation Date: 6/28/05 Type of Incident: Maintenance Test Failure 

 Type of Investigation: Root Cause/Generic Application 

File No.: 16 

Licensee: Nucletron Corp. License No.: 27-035-01 

Date of Incident: 9/8/03 Incident Log No.: NMED 030724 

Investigation Date: 1/21/04 Type of Incident: Equipment Malfunction 

 Type of Investigation: Root Cause/Generic Application 

File No.: 17 

Licensee: Nucletron Corp. License No.: 27-035-01 

Date of Incident: 7/12/04 Incident Log No.: NMED 050179 

Investigation Date: NMED Review/2004 Type of Incident: Maintenance Test Failure 

 Type of Investigation: Root Cause/Generic Application 

File No.: 18 

Licensee: Nucletron Corp. License No.: 27-035-01 

Date of Incident: 3/8/06 Incident Log No.: NMED 060643 

Investigation Date: 5/17/07 Type of Incident: Software Failure 

 Type of Investigation: Root Cause/Generic Application 

File No.: 19 

Licensee: Data Measurement Corp. License No.: 088-01/02 

Date of Incident: 7/13/04 Incident Log No.: NMED 050179 

Investigation Date: N/A Type of Incident: Equipment Damage 

 Type of Investigation: None 

Comment: 

The Program did not identify the event in NMED since codes did not reference Maryland. 

File No.: 20 

Licensee: Adaptive Technologies, Inc. License No.: 31-076-02 

Date of Incident: 2/4/04 Incident Log No.: NMED 040199 

Investigation Date: NMED Review/2004 Type of Incident: Failed Leak Test 

 Type of Investigation: Root Cause/Generic Application 
APPENDIX F 

SEALED SOURCE AND DEVICE CASEWORK REVIEW 

File No.: 1 

Registry No.: MD-1239-D-101-B SS&D Type: (D) Gamma Gauge 

Applicant Name: Carter Holt Harvey Ltd. Type of Action: New 

Date Issued: 4/26/05 Reviewers: DM, NO 

File No.: 2 

Registry No.: MD-1239-D-101-B SS&D Type: (D) Gamma Gauge 

Applicant Name: IsoScan Ltd. Type of Action: Amendment 

Date Issued: 10/19/06 Reviewers: DM, NO 

File No.: 3 

Registry No.: MD-1239-D-101-B SS&D Type: (D) Gamma Gauge 

Applicant Name: IsoScan Ltd. Type of Action: Correction 

Date Issued: 11/30/06 Reviewers: DM, NO 

File No.: 4 

Registry No.: MD-0497-D-111-S SS&D Type: (V) General Medical Use 

Applicant Name: Nucletron Corp. Type of Action: New 

Date Issued: 3/22/05 Reviewers: BP, RM 

File No.: 5 

Registry No.: MD-0497-D-111-S SS&D Type: (V) General Medical Use 

Applicant Name: Nucletron Corp. Type of Action: Amendment 

Date Issued: 8/12/05 Reviewers: BP, RM 

File No.: 6 

Registry No.: MD-0497-D-114-S SS&D Type: (V) General Medical Use 

Applicant Name: Nucletron Corp. Type of Action: New 

Date Issued: 6/12/07 Reviewers: BP, RM 

File No.: 7 

Registry No.: MD-0113-D-801-G SS&D Type: (E) Beta Gauge 

Applicant Name: Adaptive Technologies, Inc. Type of Action: Inactivation 

Date Issued: 5/18/06 Reviewers: BP, RM 

File No.: 8 

Registry No.: MD-1003-D-801-G SS&D Type: (D) Gamma Gauge 

Applicant Name: Pettit Applied Technologies, Inc. Type of Action: Inactivation 

Date Issued: 8/2/06 Reviewers: DM, RM 

Comment: 

The registration certificate was amended to show that the vendor’s license was 

terminated, but the vendor number (i.e. 1003) was not changed to an inactive vendor 

number (i.e. 8000 series). 
ATTACHMENT 

October 3, 2007, E-mail from Ray Manley 

Maryland’s Response to Draft IMPEP Report 

ADAMS: ML072841084