March 3, 2010 

John Hanger, Secretary 

Pennsylvania Department of Environmental Protection 

Rachel Carson State Office Building 

P.O. Box 2063 

Harrisburg, PA 17105-2063 

Dear Mr. Secretary: 

On January 26, 2010, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the Pennsylvania 

Agreement State Program. The MRB found the Pennsylvania Agreement State Program 

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

Commission=s (NRC) program. 

Section 4.0, page 9, of the enclosed final report contains a summary of the IMPEP review 

team=s findings and recommendations. Mr. Kenneth R. Reisinger’s letter dated January 11, 

2010, adequately discusses the Commonwealth’s proposed actions for resolving the review 

team’s recommendations. No further response is requested at this time. 

Based on the results of the current IMPEP review, the next full review of the Pennsylvania 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for November 2011. During the periodic meeting and at the next IMPEP 

review, NRC will evaluate the effectiveness of the Commonwealth’s response to the review 

team’s recommendations, as well as the overall implementation of your Agreement State 

program. 

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: 

Pennsylvania Final IMPEP Report 

cc w/encl.: David Allard, Director, Pennsylvania Bureau of Radiation Protection 

 Steve Collins, Illinois, Organization of Agreement States Liaison to the MRB 
March 3, 2010 

John Hanger, Secretary 

Pennsylvania Department of Environmental Protection 

Rachel Carson State Office Building 

P.O. Box 2063 

Harrisburg, PA 17105-2063 

Dear Mr. Secretary: 

On January 26, 2010, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the Pennsylvania 

Agreement State Program. The MRB found the Pennsylvania Agreement State Program 

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

Commission=s (NRC) program. 

Section 4.0, page 9, of the enclosed final report contains a summary of the IMPEP review 

team=s findings and recommendations. Mr. Kenneth R. Reisinger’s letter dated January 11, 

2010, adequately discusses the Commonwealth’s proposed actions for resolving the review 

team’s recommendations. No further response is requested at this time. 

Based on the results of the current IMPEP review, the next full review of the Pennsylvania 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for November 2011. During the periodic meeting and at the next IMPEP 

review, NRC will evaluate the effectiveness of the Commonwealth’s response to the review 

team’s recommendations, as well as the overall implementation of your Agreement State 

program. 

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: 

Pennsylvania Final IMPEP Report 

cc w/encl.: David Allard, Director, Pennsylvania Bureau of Radiation Protection 

 Steve Collins, Illinois, Organization of Agreement States Liaison to the MRB 

Distribution: See next page.

 ML100290181 EDATS: FSME-2010-0034 

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

NAME ATMcCraw:knm1 ADWhite TReis RJLewis 

DATE 01/29/10 02/16/10 02/23/10 02/24/10 

OFFICE Tech Editor FSME DEDMRT 

NAME CPoland CLMiller MJVirgilio 

DATE 2/25/10 2/25/10 3/3/10 

OFFICIAL RECORD COPY
Letter to J. Hanger from Martin J. Virgilio dated: March 3, 2010 

Distribution: EDATS: FSME-2010-0034 

MSSA RF 

EDO RF 

RidsEdoMailCenter 

RidsFsmeOd 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

JLynch, RIII Commissioner Klein 

DJanda, RI/RSAO Commissioner Svinicki 

SSahle, FSME/DILR SECY 

RBrowder, RIV 

Chuck McCracken, Ohio 

MBeardsley, FSME/MSSA 

TReis, FSME/MSSA 

MFranovich, OEDO 

CCarpenter, FSME 

BJones, OGC 

AHowell, RIV 

APowell, OCA (2 copies) 

DCD (SPO1) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE PENNSYLVANIA AGREEMENT STATE PROGRAM 

NOVEMBER 16-20, 2009 

FINAL REPORT
Pennsylvania Final Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the Pennsylvania Agreement State Program. 

The review was conducted during the period of November 16-20, 2009, by a review team 

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

the State of Ohio. This was the initial review of the program since the Agreement was signed in 

March 2008. 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 March 31, 2008, to November 20, 2009, were discussed 

with Pennsylvania managers on the last day of the review. 

A draft of this report was issued to Pennsylvania for factual comment on December 16, 2009. 

The Commonwealth responded by letter on January 11, 2010, from Kenneth R. Reisinger, 

Acting Director, Department of Environmental Protection (the Department). A copy of the 

Commonwealth’s response is included as the Attachment to this report. The Management 

Review Board (MRB) met on January 26, 2010, to consider the proposed final report. The MRB 

found the Pennsylvania Agreement State Program adequate to protect public health and safety 

and compatible with NRC’s program. 

The Pennsylvania Agreement State Program is administered by the Bureau of Radiation 

Protection (the Bureau). The Bureau is part of the Department. The compliance portion of the 

Agreement State Program resides in three Regional Offices. Organization charts for the 

Commonwealth, the Department, the Bureau, and the Regional Offices are included as 

Appendix B. 

At the time of the review, the Pennsylvania Agreement State Program regulated 790 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 Commonwealth 

of Pennsylvania. 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Bureau on August 7, 2009. The Bureau 

provided its response to the questionnaire on November 3, 2009. 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 ML093370717. 

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

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

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

review of selected regulatory actions; (5) field accompaniments of ten 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 Pennsylvania Agreement State Program’s 

performance. 
Pennsylvania Final Report Page 2 

Results of the review for the common performance indicators are presented in Section 2.0. 

Section 3.0 details the results of the review of the applicable non-common performance 

indicators, and Section 4.0 summarizes the review team's findings and recommendations. The 

review team’s recommendations are comments that relate directly to program performance by 

the Commonwealth. A response is requested from the Commonwealth to all recommendations 

in the final report. Mr. Kenneth R. Reisinger’s letter dated January 11, 2010, (Attachment) 

adequately discussed the Commonwealth’s proposed actions for resolving the review team’s 

recommendations; therefore, no further response was requested from the Commonwealth. 

2.0 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. 

2.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Bureau’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 Bureau’s questionnaire response relative to this 

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

considered any workload backlogs. 

The Bureau is managed by the Bureau Director from the Central Office located in Harrisburg. 

The Bureau consists of four Divisions, three of which have responsibilities for radioactive 

materials under the Agreement: the Radiation Control Division, the Decommissioning and 

Surveillance Division, and the Nuclear Safety Division. Within the Radiation Control Division, 

the Radioactive Materials Program Supervisor directly supervises radioactive materials licensing 

activities. Inspection activities are conducted out of three Regional Offices which are housed in 

the Deputate for Field Operations. Each Regional Office has a Radiation Protection Program 

Manager and Supervisor who directly supervise inspection and compliance activities in the 

Commonwealth. 

At the time of the review, there were 45 individuals with various degrees of involvement in the 

radioactive materials program. The Regional Offices devote approximately 16 full-time 

equivalents (FTE) to inspection, compliance, and emergency response activities, including 

supervisory duties. The Bureau devotes approximately 5.5 FTE to radioactive materials 

licensing activities, including supervisory duties. 

During the review period, 8 individuals left the program, including 4 supervisors, and 

13 individuals were hired, including 2 supervisors. At the time of the review, the radioactive 

materials program had eight vacancies for technical positions and one vacancy for a Radiation 

Protection Manager position. In October 2008, a Department hiring freeze was enacted. Later 

that year, the fee-based radioactive materials program was exempted from the freeze, but due 

to Commonwealth budget issues since then, hiring has been very limited in the Department. All 

of the vacant technical positions were newly created positions that cannot be filled until the 

Commonwealth’s budget issues are resolved. The manager position has been vacant since 
Pennsylvania Final Report Page 3 

June 2009 and was being filled by an Acting Manager at the time of the review and was 

expected to continue until the hiring climate improves. 

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

guidance 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 Bureau uses on-the-job training to 

supplement formal, classroom training. New licensing and inspection staff members are 

assigned increasingly complex duties under the direction of the licensing or inspection 

Radioactive Materials Program Supervisors or Managers, respectively. New inspectors 

accompany more experienced inspectors during increasingly complex inspections and are 

assigned independent inspections after demonstrating competence during accompaniment 

evaluations by their supervisor. The review team confirmed the qualifications of all staff through 

review of qualification journals, training records, and documentation of supervisory 

accompaniments. 

The review team noted that Bureau managers encourage and support training opportunities, 

based on program needs and funding. The Bureau has sponsored NRC training courses in the 

past and anticipates sponsoring additional courses in the future. In addition, because of high 

demand for attendance at NRC qualification courses and in order to meet the demands of staff 

training and qualification, the Bureau has sponsored courses that were equivalent in scope to 

NRC courses. The review team concluded that the Bureau’s staffing and training is adequate to 

carry out its regulatory duties. 

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

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

was satisfactory. 

2.2 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 Bureau’s questionnaire response relative to this indicator, data gathered from the 

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

managers and staff members. 

The review team verified that Pennsylvania’s inspection frequencies for all types of radioactive 

material licenses are at the same frequency as NRC’s inspection frequencies, listed in IMC 

2800, “Materials Inspection Program.” 

The Bureau conducted a total of 256 inspections of high priority (Priority 1, 2, and 3) licensees 

and 24 initial inspections during the review period. Of the 256 high priority inspections, the 

review team determined that 8 inspections were completed overdue by more than 25 percent of 

the inspection frequency prescribed by IMC 2800. The review team identified one high priority 

inspection that was overdue by more than 25 percent of the inspection frequency prescribed by 

IMC 2800, at the time of the review. Of the 24 initial inspections, the review team identified 

5 inspections that were conducted overdue. As required by IMC 2800, initial inspections should 
Pennsylvania Final Report Page 4 

be conducted within 12 months of license issuance. The review team verified that there were 

four overdue initial inspections at the time of the review. Overall, the review team calculated 

that the Bureau performed 6.3 percent of its inspections overdue during the review period. 

The review team evaluated the Bureau’s timeliness of issuance of inspection findings. The 

Bureau has a goal of completing inspection reports within 30 days of the final date of the 

inspection. The review team determined that inspection findings are consistently issued within 

the 30-day goal. 

During the review period, the Bureau received requests for reciprocity from 75 candidate 

licensees, and performed inspections of 39 percent of those licensees. The Bureau exceeded 

the criterion in IMC 1220 “Processing of NRC Form 241 and Inspection of Agreement State 

Licensees Operating Under 10 CFR 150.20,” that requires on-site inspection of 20 percent of 

candidate licensees operating under reciprocity. 

The Bureau had 67 licensees that were subject to the Increased Controls at the time of the 

review. Most initial Increased Control inspections were completed by the NRC prior to this 

review period. The review team noted that subsequent Increased Controls inspections were not 

being conducted consistently in all of the Regions in conjunction with routine safety inspections 

as recommended in the NRC Interim Guidance dated September 21, 2007. Bureau managers 

indicated that they were awaiting NRC’s final guidance with respect to this issue. 

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

that Pennsylvania’s performance with respect to the indicator, Status of Materials Inspection 

Program, was satisfactory. 

2.3 Technical Quality of Inspections

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

notes and interviewed a number of the responsible inspectors for 20 radioactive materials 

inspections conducted during the review period. The casework examined included a crosssection of inspections conducted by 16 current and former inspectors and covered a wide 

variety of inspection types involving initial, routine, and special inspections. The casework 

included inspection of various types of programs including: medical private practice, medical 

institution, mobile nuclear medicine service, gamma stereotactic radiosurgery, high dose-rate 

remote afterloaders, nuclear pharmacies, leak test services, industrial radiography, 

manufacturing and distribution, and portable gauges. Appendix C lists the inspection casework 

files reviewed. 

Inspections are performed by the three Regional Offices, Southeast (Norristown), Southcentral 

(Harrisburg) and Southwest (Pittsburgh). Inspection files are maintained in the Regional 

Offices, with copies sent to the Central Office. Inspection results are transmitted to licensees 

via inspection letters generated by the Regional Offices. 

Based on the evaluation of casework, the review team determined that 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. 
Pennsylvania Final Report Page 5 

Inspection report documentation supported violations, recommendations made to licensees, 

unresolved safety issues, and discussions held with licensees during exit interviews. 

The Bureau has a policy to accompany all staff performing radioactive materials inspections on 

an annual basis. The review team verified that Regional Supervisors performed staff 

accompaniments of all 18 staff performing materials inspections in 2009, the first full year of the 

Agreement. 

The review team noted that the Bureau maintains an adequate supply of appropriately 

calibrated survey instruments to support the inspection program, as well as to respond to 

radioactive materials incidents and emergency conditions. The Bureau’s instruments are sent 

to an authorized entity for calibration. The Department has a well-equipped radiochemistry 

laboratory to support the Agreement program. The Bureau also contracted with Oak Ridge 

Institute for Science and Education for technical assistance with complex decommissioning 

sites. 

The review team accompanied 10 of the Bureau’s inspectors in September and October 2009. 

The inspectors conducted inspections at medical facilities, industrial radiographers, a well 

logger, a service provider, a nuclear pharmacy, and a facility undergoing decommissioning. 

Three of the inspections included a review of the licensee’s implementation of the Increased 

Controls. Appendix C lists the inspector accompaniments. The inspectors demonstrated 

performance-based inspection techniques and knowledge of the regulations. The inspectors 

were well trained, prepared for the inspections, and thorough in their audits of the licensees’ 

radiation safety programs. The inspectors conducted interviews with appropriate personnel, 

observed licensed operations, conducted confirmatory measurements, and utilized good health 

physics practices. During two of the accompaniments, the inspectors did not hold exit meetings 

with the appropriate level of licensee management. Overall, the review team determined that 

the inspections were adequate to assess radiological health, safety, and security at the licensed 

facilities. 

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

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

was satisfactory. 

2.4 Technical Quality of Licensing Actions

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

26 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 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 signatures. 

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

completed during the initial review period. Licensing actions selected for evaluation included 

6 new licenses, 2 renewals, 3 decommissioning or termination actions, and 15 amendments. 

Files reviewed included a cross-section of license types, including: medical diagnostic and 
Pennsylvania Final Report Page 6 

therapy, brachytherapy, industrial radiography, research and development, nuclear pharmacy, 

gauges, and manufacturers. The casework sample represented work from each of the license 

reviewers. A listing of the licensing casework reviewed, with case-specific comments, is 

provided in Appendix D. 

On March 31, 2008, NRC transferred approximately 700 specific licenses to Pennsylvania’s 

jurisdiction. The Bureau merged the NRC licenses with existing Bureau licenses for naturally 

occurring and accelerator-produced radioactive materials. As a result, the Bureau had 

approximately 790 licenses at the time of the review. The majority of the license amendments 

completed by the Bureau during the review period consisted of merging NRC licenses into 

Pennsylvania licenses and reformatting all of the NRC licenses into the Bureau’s license 

template. The Bureau completed 12 license renewals, 47 new licenses and, 

64 decommissioning licensing actions during the review period. 

All licensing actions are initially entered into the Bureau’s computer tracking system called 

eFACTS (Environment, Facility, Application, Compliance Tracking System). The licensing 

actions are uploaded to the eFACTS system so that information is readily available to the 

Regional Offices for inspection purposes. In addition, a hard copy of the licensing action is 

mailed to the respective Regional Office. License reviewers use checklists and boilerplate 

licenses specific to the type of licensing actions to ensure consistency in licenses. The Bureau 

uses a License Review Tracking sheet to document each licensing action’s progress through 

the Bureau’s review process. A final quality assurance review of each licensing action is 

performed by the Radioactive Materials Program Supervisor, who signs the completed license. 

Based on the casework evaluated, the review team concluded that the licensing actions were of 

high quality and consistent with the NUREG-1556 guidance documents, the Commonwealth’s 

regulations, and good health physics practices. The review team attributed the consistent use 

of templates and quality assurance reviews to the overall quality noted in the casework reviews. 

The Bureau performs pre-licensing checks of all new applicants. The Bureau’s methods 

incorporate the essential elements of NRC’s revised pre-licensing guidance to verify that the 

applicant will use requested radioactive materials as intended. The Bureau checks applicants 

without a known radioactive materials license from another agency against records with the 

Pennsylvania Secretary of State’s Office for proper business registration. In addition, the 

Bureau uses various on-line search mechanisms and interagency communications to verify the 

identity of individuals. If a pre-licensing visit is necessary, the Central Office requests the visit 

through a Regional Office. The Bureau has a policy of hand-delivering all new licenses. 

Therefore, each applicant is subject to an on-site evaluation of their radiation safety and security 

programs prior to receipt of the initial license. 

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

and Fingerprinting Orders. The review team noted that the Bureau added legally binding 

license conditions to the licenses that met the criteria for implementing the Increased Controls, 

including fingerprinting, as appropriate. The review team analyzed the Bureau’s methodology for 

identifying those licenses and found the rationale was thorough and accurate. The review team 

confirmed that license reviewers evaluated new license applications and license amendments 

using the same criteria. The Bureau requires full implementation of the Increased Controls prior 

to issuance of a new license or license amendment that meets the established criteria. 
Pennsylvania Final Report Page 7 

The Commonwealth adopted NRC regulations required for compatibility by reference, including 

the regulations for implementation of the National Source Tracking System (NSTS). The 

Bureau is considering whether to impose a legally binding license condition on licensees that 

are required to report to NSTS to help ensure licensees are aware of the regulatory 

requirement. Since the NSTS is required by regulation, the license condition would be for 

awareness only. 

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

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

Actions, was satisfactory.

2.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Bureau’s actions in responding to incidents and 

allegations, the review team examined the Bureau’s response to the questionnaire relative to 

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

Events Database (NMED) against those contained in the Bureau’s files, and evaluated the 

casework for 16 of 32 reported radioactive materials incidents. A listing of the casework 

examined, with case-specific comments, can be found in Appendix E. The review team also 

evaluated the Bureau’s response to nine allegations involving radioactive materials. The NRC 

did not refer any allegations to the State during the review period. 

When notified of an incident or an allegation, the appropriate Regional manager and staff 

discuss the initial response and the need for an on-site investigation, based on the safety 

significance. If the incident meets the reportability thresholds, as established in FSME 

Procedure SA-300 “Reporting Material Events,” the Bureau notifies the NRC Headquarters 

Operations Center and enters the information into NMED, in a prompt manner. Early in the 

Agreement, State managers indicated that they thought entering an incident into NMED fulfilled 

the NRC Headquarters Operations Center reporting requirement. Of the incidents evaluated by 

the review team, all were properly entered into NMED, but 7 of the 16 incidents had been not 

reported to NRC within the required time frame, most because of the aforementioned 

misconception. 

The incidents selected for review included medical events, lost or stolen radioactive material, 

contamination events, a leaking source, a transportation event, and equipment failures. The 

review team determined that the Bureau’s responses to incidents were thorough, complete, and 

comprehensive in all but two instances. Those two incidents, both involving industrial 

radiography source retraction problems, were reported by licensees to the Central Office. The 

Central Office entered the information for both incidents into NMED, but did not send the 

information to the appropriate Regional Offices. Absent knowledge of the incidents, the 

Regional Offices could not perform the appropriate incident investigations. For the incident 

investigations conducted in the other 14 cases, the Bureau immediately dispatched inspectors 

to the site when the possibility of an immediate threat to public health and safety existed. The 

review team noted that at the conclusion of investigations, inspectors generated narrative 

reports that thoroughly documented the investigations. 

The failure to perform the two incident investigations cited above, and the failure to properly 

report numerous incidents to NRC were caused by insufficient communications within the 
Pennsylvania Final Report Page 8 

Bureau. The review team recommends that the Commonwealth strengthen its incident 

response program to ensure that incidents are appropriately investigated and are promptly 

reported to NRC, as appropriate. 

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

evaluated the casework for nine allegations. The review team concluded that the Bureau 

consistently took prompt and appropriate action in response to concerns raised. The review 

team noted that the Bureau thoroughly documented the investigations and retained all 

necessary documentation to appropriately close the allegations. The Bureau notified the 

allegers of the conclusion of the investigations. The review team determined that the Bureau 

adequately protected the identity of allegers. 

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

that Pennsylvania’s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, was satisfactory. 

3.0 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. NRC’s 

Agreement with the Commonwealth of Pennsylvania does not relinquish authority to regulate a 

sealed source and device evaluation program or a uranium recovery program, so only the first 

and the third non-common performance indicators were applicable to this review. 

3.1 Compatibility Requirements

3.1.1 Legislation

Pennsylvania became an Agreement State on March 31, 2008. Legislative authority to create a 

radiation control program and enter into an Agreement with NRC is granted in the Pennsylvania 

Statutes, Radiation Protection Act (Act 1984-147), as amended. The Bureau is designated the 

Commonwealth’s radiation control program and implements the Agreement State program. 

In addition to its response to the questionnaire, the Commonwealth provided the review team 

with a copy of the legislation that affects the radiation control program. There have been no 

changes since the effective date of the Agreement. Pennsylvania regulations are not subject to 

sunset laws. 

3.1.2 Program Elements Required for Compatibility 

The Commonwealth’s regulations for control of radiation are located in the Pennsylvania Code, 

Title 25, Article V, Chapters 215-240, and apply to all ionizing radiation, whether emitted from 

radioactive materials or produced by machines. Pennsylvania requires a license for the use, 

manufacture, production, transport, transfer, receipt, acquisition, possession, ownership and 

disposal of radiation sources. Pennsylvania also requires the registration of radiation-producing 

machines and radiation-producing machine service providers. 
Pennsylvania Final Report Page 9 

The review team evaluated the Bureau’s response to the questionnaire, reviewed the status of 

regulations required to be adopted by the Commonwealth under the Commission’s adequacy 

and compatibility policy, and verified the adoption of regulations with data obtained from the 

State Regulation Status Sheet that FSME maintains. 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. The Commonwealth adopts NRC 

regulations by reference and uses Orders or legally binding requirements such as license 

conditions as appropriate. Pennsylvania regulations “point” to NRC regulations so that if NRC 

modifies a regulation, the change is automatic for the Commonwealth’s regulations. If NRC 

develops a new regulation section, such as the upcoming 10 CFR Part 37 security requirements 

rule, Pennsylvania must create a new section in their regulations which points to the NRC Part. 

The Pennsylvania regulatory process typically takes approximately two years to complete, 

which includes two rounds of review and public comment. 

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

that Pennsylvania’s performance with respect to the indicator, Compatibility Requirements, was 

satisfactory. 

3.2 Low-level Radioactive Waste Disposal Program

Although NRC’s Agreement with the Commonwealth of Pennsylvania relinquishes the authority 

for a low-level radioactive waste (LLRW) program, the Commonwealth does not have any 

activities or plans for activities that fall under this authority. Accordingly, the review team did not 

review this indicator. 

4.0 SUMMARY 

As noted in Sections 2.0 and 3.0 above, Pennsylvania’s performance was found satisfactory for 

all performance indicators reviewed. The review team made one recommendation regarding 

the performance of the Commonwealth. Overall, the review team recommended, and the MRB 

agreed, that the Pennsylvania Agreement State Program is 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. 

Below is the review team’s recommendation, as mentioned in an earlier section of the report, for 

evaluation and implementation by the Commonwealth: 

The review team recommends that the Commonwealth strengthen its incident response 

program to ensure that incidents are appropriately investigated and are promptly 

reported to NRC, as appropriate. (Section 2.5)
LIST OF APPENDIXES AND ATTACHMENT 

Appendix A IMPEP Review Team Members 

Appendix B Pennsylvania Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Attachment January 11, 2010 Letter from Kenneth R. Reisinger 

 Pennsylvania’s Response to the Draft Report 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

James Lynch, Region III Team Leader 

 Technical Quality of Incident and 

 Allegation Activities 

 Inspector Accompaniments 

Donna Janda, Region I Technical Staffing and Training 

 Compatibility Requirements 

 Inspector Accompaniments 

Solomon Sahle, FSME Status of Materials Inspection Program 

Chuck McCracken, Ohio Technical Quality of Inspections 

Rachel Browder, Region IV Technical Quality of Licensing Actions 
APPENDIX B 

PENNSYLVANIA ORGANIZATION CHARTS 

ADAMS Accession No.: ML093350770
 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Advanced Imaging Specialists License No.: PA-0924 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 11/24/08 Inspector: RC 

File No.: 2 

Licensee: Delaware County Memorial Hospital License No.: PA-0065 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 10/30-31/08 Inspector: JK 

File No.: 3 

Licensee: Northeast Radiation Oncology Center License No.: PA-0953 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/1/09 Inspectors: RC, BR 

File No.: 4 

Licensee: UPMC Passavant License No.: PA-0310 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/8/09 Inspector: DM 

File No.: 5 

Licensee: St. Luke’s Hospital License No.: PA-0073 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 6/23/09 Inspectors: RC, BR 

File No.: 6 

Licensee: Professional Service Industries, Inc. License No.: PA-0281 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 9/9/09 Inspector: CR 

File No.: 7 

Licensee: Team Industrial License No.: PA-1176 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 2/24/09 Inspectors: SB, FC 

File No.: 8 

Licensee: Diamond Technical Services, Inc. License No.: PA-1077 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 1/22/09 Inspector: JH 
Pennsylvania Final Report Page C.2

Inspection Casework Reviews 

File No.: 9 

Licensee: Cardinal Health License No.: PA-0415 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/27/09 Inspector: GD 

File No.: 10 

Licensee: Professional Inspection & Testing Services License No.: PA-1038 

Inspection Type: Special, Announced Priority: 5 

Inspection Date: 5/9/08 Inspectors: RK, GD 

File No.: 11 

Licensee: Keystone Oncology, LLC License No.: PA-1111 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/22/08 Inspector: FP 

File No.: 12 

Licensee: Aqua Pennsylvania License No.: PA-0850 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 4/10/08 Inspector: MM 

File No.: 13 

Licensee: Abington Memorial Hospital License No.: PA-0055 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 10/20/09 Inspectors: EC, RC 

File No.: 14 

Licensee: Prime NDT Services, Inc. License No.: PA-1185 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/1/09 Inspector: FC 

File No.: 15 

Licensee: Lakeshore Isotopes, LLC License No.: PA-0843 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 8/8/08 Inspector: DM 

File No.: 16 

Licensee: Strube, Inc. License No.: PA-1004 

Inspection Type: Special/Decommissioning, Announced Priority: 5 

Inspection Date: 10/27/09 Inspector: JW 

File No.: 17 

Licensee: Holy Spirit Hospital License No.: PA-0249 

Inspection Type: Initial, Unannounced Priority: 2 

Inspection Date: 10/17/08 Inspector: GD 
Pennsylvania Final Report Page C.3

Inspection Casework Reviews 

File No.: 18 

Licensee: Acuren Inspection, Inc. License No.: PA-1063 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 10/21/09 Inspectors: DS, CS, DM 

File No.: 19 

Licensee: Neo-Pet, LLC License No.: PA-0905 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/30/09 Inspectors: BR, RC 

File No.: 20 

Licensee: Three Rivers Gamma Services License No.: PA-1164 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 1/14/09 Inspectors: JH, CR 

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: Pocono Medical Center License No.: PA-0034 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 9/3/09 Inspector: RC 

Accompaniment No.: 2 

Licensee: UPMC Passavant License No.: PA-0310 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/8/09 Inspector: DM 

Comments: 

a) The inspector reviewed only one patient therapy file. 

b) The inspector did not hold an inspection exit meeting with the appropriate level of 

licensee management. 

Accompaniment No.: 3 

Licensee: Professional Service Industries, Inc. License No.: PA-0281 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 9/9/09 Inspector: CR 

Comments: 

a) The inspector did not have a copy of the current license amendment. 

b) The inspector did not hold an inspection exit meeting with the appropriate level of 

licensee management. 
Pennsylvania Final Report Page C.4

Inspection Casework Reviews 

Accompaniment No.: 4 

Licensee: Superior Well Services License No.: PA-1168 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 9/10/09 Inspector: CR 

Accompaniment No.: 5 

Licensee: Philotechnics, Ltd. License Nos.: PA-0831 and PA-0831A 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 9/11/09 Inspector: DS 

Accompaniment No.: 6 

Licensee: Prime NDT Services License No.: PA-1185 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 10/1/09 Inspector: FC 

Accompaniment No.: 7 

Licensee: Mercy Fitzgerald Hospital License No.: PA-0082 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 10/6/09 Inspector: JK 

Accompaniment No.: 8 

Licensee: Strube, Inc. License No.: PA-1004 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 10/27/09 Inspector: JW 

Accompaniment No.: 9 

Licensee: Cardinal Health License No.: PA-0415 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/27/09 Inspector: GD 

Accompaniment No.: 10 

Licensee: Precision Custom Components, LLC License No.: PA-1042 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 10/28/09 Inspector: FP 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Commonwealth of Pennsylvania License No.: PA-1052 

Type of Action: Termination Amendment No.: 01 

Date Issued: 5/13/09 License Reviewer: JC 

File No.: 2 

Licensee: WeldSonix, Inc. License No.: PA-1320 

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

Date Issued: 12/18/08 License Reviewer: RH 

File No.: 3 

Licensee: Halliburton Energy Services, Inc. License No.: PA-1389 

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

Date Issued: 9/23/09 License Reviewer: GV 

Comment: 

The license reviewer did not specifically identify authorization for “neutron activation 

logging in oil, gas [and water] wells in downhole accelerator.” 

File No.: 4 

Licensee: Strube, Inc. License No.: PA-1004 

Type of Action: Amendments (Decommissioning) Amendment Nos.: 02, 03 

Dates Issued: 4/8/09, 10/6/09 License Reviewer: JC 

File No.: 5 

Licensee: Integrity Testlab, LLC License No.: PA-1181 

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

Date Issued: 10/28/08 License Reviewers: JC, RH 

Comment: 

The license reviewer did not authorize depleted uranium for the model of radiography 

cameras authorized under the license. 

File No.: 6 

Licensee: Lakeshore Isotopes, LLC License No.: PA-0843 

Type of Action: Amendment & pending action Amendment No.: 14 

Date Issued: 5/9/08 License Reviewers: RH, GV 
Pennsylvania Final Report Page D.2 

License Casework Reviews 

File No.: 7 

Licensee: Precision Calibration and Testing Corporation License No.: PA-1175 

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

Date Issued: 11/18/08 License Reviewer: RH 

File No.: 8 

Licensee: Cardinal Health License No.: PA-0895 

Type of Action: Amendment Amendment No.: 13 

Date Issued: 8/18/09 License Reviewer: JC 

File No.: 9 

Licensee: Weatherford International, Inc. License No.: PA-1030 

Types of Action: Amendment Amendment No.: 01 

Dates Issued: 5/9/08 License Reviewer: JC 

File No.: 10 

Licensee: Pennsylvania State University License No.: PA-0100 

Type of Action: Renewal, Amendment Amendment Nos.: 13, 14 

Dates Issued: 4/13/09, 8/31/09 License Reviewers: JC, RH 

Comments: 

a) The license reviewers did not obtain a description of the facilities and equipment 

provided, such as engineering controls and barriers to protect the health and safety of 

the public and its employees. 

b) The license reviewers did not request the criteria used by the Radiation Safety 

Committee to review and approve proposed facilities and laboratories, including the use 

of a classification scheme for radionuclide toxicity and quantity of radioactivity used in 

each laboratory. 

File No.: 11 

Licensee: H&H X-Ray Services, Inc. License No.: PA-1124 

Type of Action: New Amendment No.: New 

Dates Issued: 9/4/08 License Reviewer: RH 

Comments: 

a) The new license authorized a storage and use location in the State of Louisiana. 

b) The license reviewer did not include the appropriate 3-year leak test frequency for 

radiography sealed sources in storage. 

File No.: 12 

Licensee: Branch Radiographic Laboratories, Inc. License No.: PA-1132 

Type of Action: New Amendment No.: New 

Dates Issued: 9/5/08 License Reviewer: RH 
Pennsylvania Final Report Page D.3 

License Casework Reviews 

File No.: 13 

Licensee: Alliance Health Care Services, Inc. License No.: PA-0742 

Type of Action: Amendment Amendment No.: 17 

Date Issued: 9/8/09 License Reviewer: GV 

File No.: 14 

Licensee: Conemaugh Valley Memorial Hospital License No.: PA-0302 

Type of Action: Amendment Amendment No.: 16 

Date Issued: 10/6/09 License Reviewer: GV 

File No.: 15 

Licensee: St. Joseph’s University, Dept of Biology License No.: PA-1307 

Type of Action: Amendment Amendment No.: 01 

Date Issued: 7/29/09 License Reviewer: CS 

File No.: 16 

Licensee: Carnegie Mellon University License No.: PA-0203 

Type of Action: Amendment Amendment No.: 22 

Date Issued: 8/10/09 License Reviewer: GV 

Comment: 

 In Item 6 of the license, the license reviewer did not specify either: byproduct, source, or 

special nuclear material in lieu of “licensed material.” 

File No.: 17 

Licensee: Quality Engineering Solutions License No.: PA-1117 

Type of Action: Amendment Amendment No.: 01 

Date Issued: 10/27/09 License Reviewers: GV, DG 

File No.: 18 

Licensee: SmithKline Beecham Pharmaceuticals License No.: PA-0234 

Type of Action: Amendment Amendment No.: 23 

Date Issued: 11/4/08 License Reviewer: RH 

File No.: 19 

Licensee: Lancaster General Hospital License No.: PA-0233A 

Type of Action: Renewal Amendment No.: 01 

Date Issued: 11/5/09 License Reviewers: GV, JC 
Pennsylvania Final Report Page D.4 

License Casework Reviews 

File No.: 20 

Licensee: University of Pittsburgh License No.: PA-0190 

Type of Action: Amendment Amendment No.: 28 

Date Issued: 11/4/09 License Reviewers: GV, CS, JC 

Comment: 

The license reviewer did not obtain a drawing of a new facility for this Broad Scope 

license. 

File No.: 21 

Licensee: Cardinal Health Nuclear Pharmacy Services License No.: PA-0877 

Type of Action: Amendment (Termination of facility) Amendment No.: 07 

Date Issued: 10/14/08 License Reviewer: RH 

File No.: 22 

Licensee: Altoona Regional Health System License No.: PA-0016 

Type of Action: Amendments Amendment Nos.: 23, 25 

Dates Issued: 6/1/09, 11/5/09 License Reviewer: JC 

Comment: 

The license reviewer inappropriately authorized the licensee to approve training and 

experience for an Authorized Medical Physicist. 

File No.: 23 

Licensee: Alcoa, Inc. License No.: PA-1089 

Type of Action: Amendment Amendment No.: 01 

Date Issued: 9/28/09 License Reviewers: GV, JC 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Saint Luke’s Hospital License No.: PA-0073 

Date of Incident: 4/11/08 NMED Log No.: 080550 

Investigation Date: 6/10/08 Type of Incident: Overexposure 

 Type of Investigation: Site 

Comment: 

The Bureau did not report this incident to the NRC Headquarters Operations Center. 

File No.: 2 

Licensee: Weatherford International License No.: 42-29288-01 

Date of Incident: 4/18/08 NMED Log No.: 080362 

Investigation Date: 4/24/08 Type of Incident: Leaking Source 

 Type of Investigation: Site 

Comment: 

The Bureau did not report this incident to the NRC Headquarters Operations Center. 

File No.: 3 

Licensee: Weatherford International License No.: 42-29288-01 

Date of Incident: 7/29/08 NMED Log No.: 080554 

Investigation Date: 7/31/08 Type of Incident: Abandoned Source 

 Type of Investigation: Site 

Comment: 

The Bureau did not report this incident to the NRC Headquarters Operations Center. 

File No.: 4 

Licensee: Lehigh Valley Hospital License No.: PA-0232 

Date of Incident: 7/17/08 NMED Log No.: 080555 

Investigation Date: 8/21/08 Type of Incident: Medical Event 

 Type of Investigation: Site 

Comment: 

The Bureau did not report this incident to the NRC Headquarters Operations Center. 

File No.: 5 

Licensee: University of Pittsburgh Medical Center License No.: PA-0190 

Date of Incident: 12/4/08 NMED Log No.: 090076 

Investigation Date: 12/4/08 Type of Incident: Medical Event 

 Type of Investigation: Telephone 
Pennsylvania Final Report Page E.2 

Incident Casework Reviews 

File No.: 6 

Licensee: Westinghouse Electric Company License No.: PA-1053S 

Date of Incident: 10/29/08 NMED Log No.: 090377 

Investigation Date: 10/29/08 Type of Incident: Transportation 

 Type of Investigation: Site 

File No.: 7 

Licensee: The Western Pennsylvania Hospital License No.: PA-0121 

Date of Incident: 2/23/09 NMED Log No.: 090391 

Investigation Date: 3/18/09 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 8 

Licensee: TEI Analytical Services License No.: 37-38004-02 

Date of Incident: 9/23/08 NMED Log No.: N/A 

Investigation Date: 9/23/08 Type of Incident: Source Disconnect 

 Type of Investigation: Telephone 

Comment: 

The Bureau did not report this incident to the NRC Headquarters Operations Center. 

File No.: 9 

Licensee: Hahnemann University Hospital License No.: PA-0927 

Date of Incident: 12/22/08 NMED Log No.: 090465 

Investigation Date: 12/22/08 Type of Incident: Medical Event 

 Type of Investigation: Telephone 

File No.: 10 

Licensee: Acuren Inspection License No.: PA-1063 

Date of Incident: 2/19/09 NMED Log No.: 090477 

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

 Type of Investigation: None 

Comments: 

a) The Bureau did not investigate this incident. 

b) The Bureau did not report this incident to the NRC Headquarters Operations Center. 

File No.: 11 

Licensee: Geisinger Health Systems License No.: PA-0006 

Date of Incident: 2/26/09 NMED Log No.: 090485 

Investigation Date: 4/14/09 Type of Incident: Lost Source 

 Type of Investigation: Site 
Pennsylvania Final Report Page E.3 

Incident Casework Reviews 

File No.: 12 

Licensee: Mercy Fitzgerald Hospital License No.: PA-0082 

Date of Incident: 3/26/09 NMED Log No.: 090540 

Investigation Date: 5/7/09 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 13 

Licensee: Chester County Hospital License No.: PA-0071 

Date of Incident: 3/30/09 NMED Log No.: 090579 

Investigation Date: 3/30/09 Type of Incident: Embryo/Fetus Exposure 

 Type of Investigation: Telephone 

File No.: 14 

Licensee: Drexel University License No.: PA-1329 

Date of Incident: 4/1/09 NMED Log No.: 090593 

Investigation Date: 4/1/09 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

File No.: 15 

Licensee: Integrity Testlab License No.: PA-1181 

Date of Incident: 5/18/09 NMED Log No.: 090594 

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

 Type of Investigation: None 

Comments: 

a) The Bureau did not investigate this incident. 

b) The Bureau did not report this incident to the NRC Headquarters Operations Center. 

File No.: 16 

Licensee: Lehigh Valley Hospital License No.: PA-0264 

Date of Incident: 7/29/09 NMED Log No.: 090653 

Investigation Date: 8/11/09 Type of Incident: Medical Event (Retracted) 

 Type of Investigation: Site 
ATTACHMENT 

January 11, 2010 Letter from Kenneth R. Reisinger 

Pennsylvania’s Response to the Draft Report 

ADAMS Accession No.: ML10019018