DATED: JULY 29, 1999 SIGNED BY: FRANK J. MIRAGLIA

Neal L. Cohen, M.D.

Commissioner

New York City Department of Health

125 Worth Street, Room 329

New York, NY 10013

Dear Dr. Cohen:

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

(IMPEP) review of the New York City Department of Health (NYCH) radiation control program. 

The review of the NYCH program was conducted by an interoffice team during the period April

26-28, 1999. The areas of concern (Status of Materials Inspection Program and Technical

Quality of Inspections) were reviewed in detail as well as response to, and resolution of, eight

recommendations made during the January 25-30, 1998 IMPEP review.

The review team found the City's performance in responding to and resolving the eight

recommendations to be satisfactory with the exception of Recommendations 3, 5 and 6. 

Recommendation 3 discussed the need for the documentation for violations presented to

licensees. Recommendations 5 and 6 discussed the need to develop training requirements and

evaluate current and future staff so they will have the necessary skills for their specific work

assignments. The team found that the database for the inspection and licensing program was

working well and management had the needed information to plan and schedule inspection

assignments. The follow-up team concluded that the program has improved and the significant

issue of the status of the materials inspection program has been resolved.

Based on the follow-up IMPEP review, the Management Review Board finds that there is no

change to the finding resulting from the January-May 1998 IMPEP review, that the New York

program is adequate to protect public health and safety, and compatible with NRC’s program.

Section 5 on page 8 of the enclosed final report presents the follow-up IMPEP team’s

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

in this section within 30 days from the receipt of this letter.

Based on the results of the follow-up IMPEP review, the next IMPEP review will be scheduled

in approximately 3 years to correspond with the IMPEP reviews of the other New York radiation

control agencies.
Neal L. Cohen, M.D. - 2 -

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

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

continuing to work cooperatively in the future.

Sincerely, /RA/

Frank J. Miraglia, Jr.

Deputy Executive Director 

 for Regulatory Programs

Enclosure: 

As stated

cc: Gene Miskin, Director

Bureau of Radiological Health, NYCH

John P. Spath, Director

Radioactive Waste Policy and Nuclear Coordination, NYSERDA

Rita Aldrich, Principal Radiophysicist

Radiological Health Unit, NYDL

Karim Rimawi, Ph.D., Director

Bureau of Environmental Radiation Protection, NYSH

Paul J. Merges, Ph.D., Director

Bureau of Radiation and Hazardous Site Management
Neal L. Cohen, M.D. - 2 -

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

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

continuing to work cooperatively in the future.

Sincerely,

Frank J. Miraglia, Jr.

Deputy Executive Director 

 for Regulatory Programs

Enclosure: 

As stated

cc: Gene Miskin, Director

Bureau of Radiological Health, NYCH

John P. Spath, Director

Radioactive Waste Policy and Nuclear Coordination, NYSERDA

Rita Aldrich, Principal Radiophysicist

Radiological Health Unit, NYDL

Karim Rimawi, Ph.D., Director

Bureau of Environmental Radiation Protection, NYSH

Paul J. Merges, Ph.D., Director

Bureau of Radiation and Hazardous Site Management

bcc: Chairman Dicus

Commissioner McGaffigan

Commissioner Diaz

Commissioner Merrifield

Distribution:

DIR RF

SDroggitis, DWhite, RI

KSchneider, ASPO JCameron, RIII

STreby, OGC GKim, OGC

RBores, RSLO, RI DCool, NMSS DCD (SP01)

GDeegan, NMSS LRakovan, OSP PDR (YEST)

New York City File TCombs, OCA (2)

 

DOCUMENT NAME: Z:\REVIEWS\NY99\99NYCF~1.FIN G:\IMPEP\Nychfu99.fin *See previous

concurrence.

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

OFFICE OSP OSP:DD NMSS OGC OSP:D DEDR

NAME DMSollenberger:gd FCCombs CJPaperiello KDCyr PHLohaus FJMiraglia

DATE 07/08/99* 07/09/99* 07/19/99*via Memo 07/22/99* 08/ /99 08/ /99

OSP CODE: SP-AG-20-1
INTEGRATED MATERIALS PERFORMANCE EVALUATION

PROGRAM (IMPEP) FOLLOW-UP REVIEW OF 

THE NEW YORK CITY RADIATION CONTROL PROGRAM

April 26-28, 1999

FINAL REPORT

U. S. Nuclear Regulatory Commission
New York City Follow-Up Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the follow-up review of the New York City Department of

Health, Bureau of Radiological Health (NYCH), radiation control program conducted April 26-28,

1999. The follow-up review was conducted by a review team comprised of technical staff

members from the Nuclear Regulatory Commission (NRC). Team members are identified in

Appendix A. The follow-up review was conducted in accordance with the “Policy Statement on

Adequacy and Compatibility of Agreement State Programs,” published in the Federal Register on

September 3, 1997 (62 FR 46517), and the November 25, 1998, NRC Management Directive

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

A draft of this report was issued to NYCH for factual comment on May 26, 1999. The NYCH

responded in a letter dated June 17, 1999, from Neal L. Cohen, M.D., Commissioner of Health

(Attachment 1). A copy of the final report was provided to the Management Review Board

(MRB). The MRB considered and concurred in the team’s overall recommendation and found

the New York radiation control program remains adequate to protect public health and safety and

compatible with NRC’s program.

The New York Agreement State program is administered by: (1) the NYCH, which has

jurisdiction over medical, academic, and research uses within the five boroughs of New York

City; (2) the New York State Department of Labor, Radiological Health Unit (NYDL), which has

jurisdiction over commercial and industrial uses of radioactive materials, including the

possession of radioactive material to be disposed of at a commercial disposal site; (3) the New

York State Department of Health (NYSH), which has jurisdiction over medical, academic, and

research uses of radioactive materials except in New York City; and (4) the New York State

Department of Environmental Conservation, Bureau of Pesticides and Radiation (NYDEC), which

has jurisdiction over discharges of radioactive material to the environment, including releases to

the air and water, and the disposal of radioactive wastes in the ground. At the time of the review,

the combined New York programs regulated approximately 1400 specific licenses, including all

types of major licensees except for uranium mill tailings. NYCH regulated approximately 440 of

these licenses.

The follow-up review focused on the materials program as it is carried out under the Section

274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the

State of New York and administered, in part, by the NYCH. The follow-up review covered the

NYCH’s response to, and resolution of, eight recommendations made during the January 26 - 30,

1998 IMPEP review. The team’s general approach for conduct of the follow-up review included:

(1) evaluation of NYCH’s implementation of their responses to the recommendations, (2) the

status of the program indicators, Status of Materials Inspection Program and Technical Quality of

Inspections, for the period of January 30, 1998 - April 28, 1999, (3) review of quantitative

information from the radiation control program inspection database, (4) technical review of

selected inspection program documentation for response to issues identified during the previous

review, (5) interviews with staff and management to answer questions or clarify issues and (6)

inspection accompaniments. The team evaluated the information that it gathered against the

IMPEP performance criteria for each of the common performance indicators reviewed and made

a preliminary assessment of the radiation control program’s performance for activities conducted

during the period of January 30, 1998 - April 28, 1999. Preliminary results were discussed with

New York City management on April 28, 1999.
New York City Follow-Up Final Report Page 2

Section 2 below discusses the results of the previous IMPEP review of the New York program. 

Results of the follow-up review of the NYCH program for the IMPEP common performance

indicators are presented in Section 3. Section 4 discusses the results of the applicable noncommon performance indicators. Section 5 summarizes the review team's findings and

recommendations during the follow-up review.

2.0 RESULTS OF THE PREVIOUS REVIEW

The previous routine IMPEP review for the New York programs was conducted between January

and May 1998, with the New York City program portion conducted on January 26-30, 1998. This

review resulted in an overall finding that the New York radiation control programs were “adequate

to protect public health and safety and compatible with NRC’s program.” Due to the significance

of the findings in the inspection portion of the New York City program, which included findings of

satisfactory with recommendations for improvement in two performance indicators, the review

team recommended, and the Management Review Board agreed, a follow-up review should be

performed after a year of operation with identified corrective actions being taken. 

During the follow-up review, the team discussed the five suggestions from the previous review

which included: (1) policy on placement of Tribunal results in the inspection files, (2)

documentation on how SS&D conditions are addressed in licensing, (3) dating of the issuance of

new licenses, (4) investigated incidents to be documented in the notes at the next inspection,

and (5) documentation that the alleger has been contacted regarding the results of NYCH’s

findings into the alleger’s concerns. All suggestions were considered and actions taken by

NYCH except the fourth one. NYCH staff indicated that they would consider this issue in the

future. The actions taken on the four suggestions were acceptable to the team. 

3.0 COMMON PERFORMANCE INDICATORS

The IMPEP process uses five common performance indicators in reviewing both NRC Regional

and Agreement State programs. These indicators are: (1) Status of Materials Inspection

Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; 

(4) Technical Quality of Licensing Actions; and (5) Response to Incidents and Allegations. The

1998 review team’s recommendation was that the follow-up review focus on the two indicators

that were found satisfactory with recommendations for improvement (i.e., Status of Materials

Inspection Program and Technical Quality of Inspections). The discussion of the

recommendations for the other indicators are presented in the respective indicator sections.

3.1 Status of Materials Inspection Program

During the April 1999 follow-up review, the team focused on NYCH’s database for inspection

information and its impact on overdue inspections, initial inspections of new licenses, and the

timely management of the inspection program. To evaluate these issues, the team interviewed

program management and staff, reviewed automated data, and examined the State’s responses

to the recommendations in the final report of the 1998 IMPEP review, which resulted in a finding

of satisfactory with recommendations for improvement. The final report contained two

recommendations for this indicator. The team’s evaluation of the NYCH’s response to the two

recommendations are presented below:
New York City Follow-Up Final Report Page 3

Recommendation 1

The review team recommends that the NYCH correct the software anomalies that limit

NYCH’s ability to effectively track licenses for inspection, set and adhere to yearly

inspection goals, and communicate NYCH management’s expectations with regard to

inspection goals, such that NYCH is able to eliminate all overdue inspections. (Section

3.1.1 of the 1998 report)

Current Status

NYCH responded to this recommendation stating that they had corrected the database and could

accurately plan and implement their inspection priorities. During the follow-up review, the team

evaluated the computer tracking system and found that the system had been corrected and

greatly improved the oversight capabilities of the inspection process. The team evaluated how

NYCH uses the database and discussed clarifying issues with the Bureau Director. The team

found that the Bureau Director and Inspection Supervisor can now identify overdue and past due

inspections, and take the necessary actions to address the needs of the inspection program in a

timely manner. The team found that NYCH had completed 170 inspections in 1998. Following

the review of the database and list of inspections completed since January 1998, the team

examined the inspection histories of 18 licenses. Sixteen licenses were inspected on schedule

and two inspections were overdue at the time of the follow-up review. One broadscope licensee

(one month overdue) was scheduled for inspection the week following the review. One Gamma

Stereotactic Radiosurgery licensee was identified as being entered into the database under the

incorrect license type code, and, therefore, was not identified as due. The Inspection Supervisor

assigned this overdue inspection for the week following the follow-up review. These were the

only two inspections that were identified as overdue at the time of the review. The Inspection

Supervisor files a monthly report with the Deputy Director who tracks the inspections completed. 

The team identified a few errors in the database which will be corrected by NYCH staff. The

team found the database system in NYCH to be acceptable and that it provides the information

needed to effectively manage the materials inspection program.

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

Recommendation 2

The review team recommends that all initial inspections of licensees be performed within

six months of license issuance or within six months of the licensee’s receipt of material

and commencement of operations, consistent with IMC 2800 and NYCH policy. (Section

3.1.1 of the 1998 report)

Current Status

During 1998, NYCH issued 12 new licenses. Initial inspections were completed for nine of these

licenses, two were overdue about one month, and one is due in May 1999. The Bureau Chief

demonstrated how the database was changed upon issuance of a new license and the automatic

assignment of the initial inspection due date in the database. The team found the performance

of the database in providing information on initial inspections and the subsequent conduct of

initial inspections to be acceptable.
New York City Follow-Up Final Report Page 4

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

The timeliness of the issuance of inspection findings was also evaluated during the inspection file

review. Of the 16 inspections files examined, NYCH issued compliance letters within 30 days for

all but two. One letter (51 days late) was delayed due to negotiations with the Food and Drug

Administration on the experimental use of the labeled compound. The other letter (22 days late)

had no specific reason for its being late. 

Based on the team’s review of the Status of Materials Inspection Program, the issues identified

during the 1998 review regarding tracking of inspections, conduct of initial and routine

inspections, and timeliness of issuance of inspection findings have been addressed by NYCH

and the team considers this recommendation to be closed.

3.2 Technical Quality of Inspections

During the April 1999 follow-up review, the team focused on the quality of inspections as

reflected in the performance during inspection accompaniments and documentation in inspection

files. To evaluate these issues, the team interviewed program management and staff, reviewed

inspection files, performed inspection accompaniments, and examined the State’s responses to

the recommendations in the final report of the 1998 IMPEP review, which resulted in a finding of

satisfactory with recommendations for improvement. The final report contained two

recommendations for this indicator. 

The team reviewed the inspection reports, enforcement documentation, and inspection field

notes and interviewed inspectors for 16 materials inspections conducted during the review

period. The inspection files selected for review included at least one inspection for each of the

NYCH’s inspectors. The inspections included four medical broad scope licenses, three

academic broad scope licenses, two teletherapy licenses, two limited medical use licenses, and

five private practice physicians. One of the limited medical use license inspections included a

review of a high-dose-rate afterloader program. Appendix B lists the inspection files reviewed in

depth with case-specific comments.

The team’s evaluation of the State’s response to the two recommendations are presented below:

Recommendation 3

The review team recommends that NYCH inspectors follow the guidance in the NYCH

inspection procedure manual which includes the information necessary for properly

documenting violations. (Section 3.2.1 of the 1998 report)

Current Status

Of the 16 inspections reviewed, six resulted in no violations being identified. For the remaining

ten, a majority of the violations identified in the transmittal letters to the licensees were not

sufficiently described in the field notes documenting the inspection. The team continues to

recommend that NYCH inspectors follow the guidance in the NYCH inspection procedure manual

which specifies that supporting information documenting the basis for violations be in the file. 

During discussions with management, they stated that the requirement for documentation in

support of violations as stated in their procedures manual referred to the violation citations that
New York City Follow-Up Final Report Page 5

result in civil penalties. The team indicated that supporting documentation for all cited violations,

whether it results in a civil penalty or not, should be available in the inspection file. 

Based on the follow-up review, the team considers this recommendation to be open, in part, until

management addresses the issue of interpretation/revision of the inspection procedure manual to

clarify the policy on supporting documentation needs prior to issuing letters identifying violations

of the regulations. 

Recommendation 4

The review team recommends that NYCH inspectors follow the guidance in NYCH

inspection procedure manual which emphasizes the use of performance-based inspection

techniques rather than compliance-based techniques and provide training to its

inspectors through NRC’s Inspecting for Performance Materials Course or similar course. 

(Section 3.2.1 of the 1998 report)

Current Status

In response to this recommendation, NYCH used the NRC training manual for the “Inspecting for

Performance” course and presented an in-house course. The instructor emphasized the need to

do performance based inspections. During the week of April 12, 1999, a team member

performed accompaniments of two NYCH inspectors on separate inspections of two medical

private practice physician licensees. Appendix B lists the accompaniments performed with

specific comments. 

During the accompaniments, inspectors demonstrated appropriate inspection skills and

knowledge of the regulations. The inspectors were prepared and thorough in their reviews of

licensee programs. Inspection techniques were observed to be performance-oriented and the

technical performance of both inspectors was good. The inspections were adequate to assess

the radiological health and safety of the licensed activities.

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

Based on the team’s review of the Technical Quality of Inspection indicator, the issues identified

in the 1998 IMPEP review have not been fully addressed. The team continues to recommend

that NYCH inspectors follow the guidance in the NYCH inspection procedure manual which

includes the information necessary for properly documenting violations or that NYCH clarify the

policy in their inspection manual for supporting documentation of violations noted during an

inspection. 

3.3 Technical Staffing and Training

During this follow-up review, the team reviewed the response to the two recommendations for

this indicator presented in the revised final report for the 1998 IMPEP review. The results of the

discussions with management on the two recommendations are presented below:
New York City Follow-Up Final Report Page 6

Recommendation 5

The review team recommends that NYCH document its training program to include

overall policy and minimum training requirements to be qualified to conduct the

responsibilities of the program for both the licensing and compliance staff. (Section 3.3.1

of the 1998 report) 

Current Status

The discussions with the Bureau Director and Deputy Director clarified the recommendation. 

They stated that they had collected documentation for the training of the materials staff and that

they considered them adequately trained. The least experienced person has been with the

program for at least five years. The documentation of the training requirements for materials

inspectors and licensing staff will be assigned to the person hired to fill the Chief of the materials

section position (formerly the Licensing Supervisor). As program documentation is revised, the

training requirements may be incorporated prior to filling the position. 

The team considers this recommendation to be open until the training requirements are

documented in the NYCH procedures manual. The above approach discussed during this review

was acceptable to the team.

Recommendation 6

The review team recommends that NYCH review the staff’s training against their training

requirements, clearly document how the training was achieved, and acquire the

necessary training, as appropriate. (Section 3.3.1 of the 1998 report)

Current Status

As discussed above, the documentation for the training requirements has not been completed. 

The Bureau Director stated that he considers the current staff adequately trained. Since the

1998 IMPEP review, one assistant scientist left the program and the licensing supervisor was

selected for the Bureau Director position. NYCH has posted an assistant scientist position and

modified the licensing supervisor position description to be the Chief of the materials section

which includes the responsibility for the duties of the Licensing Supervisor. Given the new

potential staff for the program, the need for training requirement documentation is emphasized. 

The team considers this recommendation to remain open until the training requirements are

documented and the evaluation completed. 

3.4 Technical Quality of Licensing Actions

During the 1998 IMPEP review, the NYCH was found to be satisfactory for this indicator with no

recommendations. This indicator was not reviewed during this follow-up review and no issues

were identified during discussions to warrant additional review. 
New York City Follow-Up Final Report Page 7

3.5 Response to Incidents and Allegations

During the 1998 IMPEP review, the NYCH program was found to be satisfactory for this indicator. 

The final report contained one recommendation for this indicator. The team reviewed NYCH’s

response to the recommendation the current status is presented below:

Recommendation 7

The review team recommends that NYCH notify NRC of significant reportable events and

provide documentation for all reportable events both in accordance with SA-300. 

(Section 3.5.1 of the 1998 report)

Current Status

The team found that the Inspection Supervisor attended the recent Nuclear Materials Event

Database (NMED) training course in Region I and is prepared to begin using the NMED system

to manage their events including reporting to NRC. They identified that they did report one event

and that they were not aware of any other reportable events. 

The team considers this recommendation to be closed. 

4.0 NON-COMMON PERFORMANCE INDICATORS

The team reviewed one non-common performance indicator that applied to the New York City

program, Legislation and Program Elements Required for Compatibility.

4.1 Legislation and Program Elements Required for Compatibility

During the April 1999 follow-up review, the team discussed the status of NYCH’s adoption of 

regulations needed for compatibility. The final report had one recommendation.

Recommendation 8

The review team recommends that NYCH place the regulatory changes agenda and

establish specific schedules to address the regulatory changes in Section 4.1.1.2 within

three years of the regulations becoming effective NRC rules. (Section 4.1.1.2 of the 1998

report)

Current Status

NYCH has promulgated the transportation regulation which was the major regulation in need of

adoption. They are reviewing the list of regulations needed for compatibility and will add them to

their regulatory agenda. The team discussed the need to continue promulgation of amendments

to maintain a compatible regulatory basis for the program. The team demonstrated the use of

the OSP Home Page, how the NYCH can access NRC’s list of regulations, and the process for

NRC review of draft and final regulations (OSP Procedures SA-200 and SA-201). 

The team considers this recommendation to be closed based on the action taken and future

actions discussed. 
New York City Follow-Up Final Report Page 8

5.0 SUMMARY

The team found the NYCH’s performance in responding to and resolving the eight

recommendations to be satisfactory with the exception of Recommendations 3, 5 and 6. 

Recommendation 3 discussed the need for the documentation for violations presented to

licensees. Recommendations 5 and 6 discussed the need to develop training requirements and

evaluate current and future staff so that they will have the necessary skills for their specific work. 

The team found that the database for the inspection and licensing programs was working well

and management had the needed information to plan and schedule the inspection work. 

The team concluded that the program has improved and the significant issue of status of the

inspection program has been resolved. The team recommended, and the MRB concurred, that

the New York program remains adequate to protect public health and safety, and compatible with

NRC’s program. The team recommended that the NYCH portion of the New York agreement

program be reviewed along with the other three implementing programs at the next scheduled

IMPEP review. The MRB considered and concurred with the review team’s recommendation.

Below is a summary list of open and modified recommendations from the 1998 report.

Recommendations:

1. The review team continues to recommend that NYCH inspectors follow the guidance in

the NYCH inspection procedure manual which includes the information necessary for

properly documenting violations (Recommendation 3, Section 3.2.1 of the 1998 report), or

that NYCH clarify the policy in their inspection manual for supporting documentation of

violations noted during an inspection (Section 3.2). 

2. The review team recommends that NYCH document its training program to include

overall policy and minimum training requirements to be qualified to conduct the

responsibilities of the program for both the licensing and compliance staff. 

(Recommendation 5, Section 3.3.1 of the 1998 report, Section 3.3) 

3. The review team recommends that NYCH review the staff’s training against their training

requirements, clearly document how the training was achieved, and acquire the

necessary training, as appropriate. (Recommendation 6, Section 3.3.1 of the 1998

report, Section 3.3)
LIST OF APPENDICES

Appendix A IMPEP Follow-up Review Team Members

Appendix B Inspection File Reviews

Attachment 1 New York City’s Response to Draft Report 

Dated June 17, 1999
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Dennis M. Sollenberger, OSP Team Leader

Status of Materials Inspection Program

Duncan White, RI Technical Quality of Inspections

Inspection Accompaniments

Jamnes Cameron, RIII Status of Materials Inspection Program

Technical Quality of Inspections