ML20236L725

Integrated Matl Performance Evaluation Program Review of New York Agreement State Program,980126-0424, Draft Rept

ML20236L725
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Issue date:	01/26/1998
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{{#Wiki_filter:_ - - _ . _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ i INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF NEW YORK AGREEMENT STATE PROGRAM 1 January 26 - April 24,1998 l l 1 h i DRAFT REPORT U.S. Nuclear Regulatory Commission 9807130148 900624 PDR STPRQ ESON

New York Draft Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the New York radiation control program. The New York program is divided into four independent programs which were reviewed separately with the results of those reviews integrated into this report. The reviews were conducted during the period January 26 - April 24,1998, by four separate review teams comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement States of Alabama, Florida, North Carolina, and Tennessee. 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 a Final General Statement of Policy," published in the Federal Reoister on October 16,1997, and the November 25,1997, revised NRC Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period March 31,1995 to April 24,1998, were discussed with New York management on May 12,1998. [A paragraph on the results of the MRB meeting will be included here in the final report.) The New York Agreement State program is administered by: (1) the New York City Department of Health, Bureau of Radiological Health (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 m nerial 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. Organization charts for the four programs are included as Appendix B. At the time of the review, the combined New York programs regulated approximately 1500 specific licenses, including all types of major licensees except for uranium mill tailings. The 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. In preparation for the review, a questionnaire addressing the common and non-common performance indicators was sent to: (1) NYCH, November 21,1997; (2) NYDL, December 15, 1997; (3) NYSH, February 6,1998; and (4) NYDEC, February 12,1998. Each New York program provided a response to the questionnaire on: (1) NYCH, January 14,1998; (2) NYDL, January 27,1998; (3) NYSH, March 13,1998; and (4) NYDEC, March 27,1998. During the review, discussions with each program's staff resulted in the responses being further developed. A copy of these final responses are included in Appendix C to this report. The teams' general approach for conduct of these reviews consisted of: (1) examination of New York programs' responses to the questionnaire; (2) review of applicable New York State and City statutes and regulations; (3) analysis of quantitative information from the radiation control programs' licensing and inspection data bases; (4) technical review of selected licensing

I New York Draft Report Page 2 i and inspection actions; (5) field accompaniments of at least one inspector from each program; and (6) interviews with staff and management to answer questions or clarify issues. The teams evaluated the information that they gathered against the IMPEP performance criteria for each common and non common performance indicator as applicable to each program and made a preliminary assessment of each radiation control program's performance for each indicator. Section 2 below discusses each programs's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common performance indicators, and Section 5 summarizes the review team's findings and recommendations. Recommendations made by the team are comments that ) relate directly to each program's performance. A response is requested from each program to all recommendations in the final report. Suggestions are comments that the team believes

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could enhance each of the individual programs. Each program is requested to consider suggestions, but no response is requested. 2.0 - STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS During the previous routine review, which concluded on March 30,1995, ten recommendations were made and the results were transmitted to the respective Secretaries / Commissioners of the thre New York State agencies and the New York City agency on March 18,1996. The team's rNw of the current status of these recommendations is as follows: J NEW YORK CITY DEPARTMENT OF HEALTH (NYCH) (1) Status and Compatibility of Regulations. NYCH needed to revise its OM rule definitions by December 6,1996 in order to maintain compatibility with the NRC. Current Status: The NRC reinitiated an evaluation of whether the OM rule should be l used as a basis for the determination of an Agreement State program's compatibility. It l was decided that pending the completion of the re-evaluation, the absence of a compatible OM rule would not be used as a basis for withholding of a finding for compatibility. The compatibility category of the OM rule under the new Commission policy on Adequacy and Compatibility, which became effective on September 6,1997, has been set as "D" with paragraphs (a), (b), and (c) of the rule identified as having provisions important to Health and Safety. Based on the above, and because Part 35 is [ being amended in its entirety, the team determined that this recommendation should be closed. L (2) Inspection Procedures. It was recommended that NYCH develop a formal written policy on conducting unannounced inspections. , l Current Status: As part of the review of the indicator " Technical Quality of Inspections" l (see Section 3.2.1), the team examined NYCH's inspection procedures manual. In Section 5.C.3.a. of the manual, there is a discussion regarding NYCH's policy regarding announced versus unannounced inspections. This section of the manual clearly states it is the general policy of NYCH to perform routine inspections on an unannounced

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New York Draft Report Page 3 basis. The review team also determined that NYCH inspectors were following the City's policy regarding the conduct of routine inspections on an unannounced basis. Based on these findings, the team determined that this recommendation should be closed. NEW YORK STATE DEPARTMENT OF LABOR (NYDL) (1) Status and Compatibility of Regulations, it was recommended during the last review  ; that NYDL reconsider its decision not to adopt the amendments to 10 CFR Part 36,

                                  " Licenses and Radiation Safety Requirements for Irradiators" that became effective on July 1,1993.

Current Status: During this review, the team determined that NYDL has prepared a package of agulations, including those for Part 36, which is currently in legal review (see Section 4.1.2.2). As part of the team's review of the indicators " Technical Quality of Licensing" and " Technical Quality of Inspections," the team noted that NYDL was implementing the requirements of Part 36 through the use of checklists during the licensing and inspection of the only commercial irradiator facility under NYDL's jurisdiction. Use of the checklist ensures that the licensee has committed to all the , requirements in 10 CFR Part 36 even though not required to by regulation. The 'l licensee's commitments are incorporated into the licenses. Based on the team's finding j

                                 - that NYDL is implementing Part 36 through licensing and inspection until the adoption of      i the rule, the team determined that this recommendation should be closed.                       '

i NEW YORK STATE DEPARTMENT OF HEALTH (NYSH)

               -(1)                Status and Compatibility of Regulations.
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a. It was recommended that NYSH adopt the Decommissioning Rule as soon as ,

possible to maintain compatibility with the NRC. j Current Status: The NYSH has implemented the rule through license conditions. The team reviewed the list of licensees that are subject to the financial assurance requirements and reviewed the application of these license conditions. The team found that the licensees requiring financial assurance either had license conditions in place or 4 had been issued letters requesting additional information prior to issuance of license conditions. .The NYSH also implements other decommissioning provisions through regulations and other decommissioning license conditions (see Section 4.1.2.2). The team considers this approach to implementing the financial assurance and decommissioning requirements to be acceptable, and determined that this recommendation should be closed.

b. . The NYSH needed to revise its OM rule definitions by December 6,1996 in order to maintain compatibility with the NRC.

Current Status: The NRC reinitiated an evaluation of whether the QM rule should be used as a basis for the determination of an Agreement State program's compatibility. It was decided that, pending the completion of the re evaluation, the absence of a compatible QM rule would not be used as a basis for withholding of a finding for - l

I O New' York Draft Report . . Page 4 compatibility. The compatibility category of the OM rule under the new Commission policy on Adequacy and Compatibility, which became effective on September 6,1997, has been set as "D" with paragraphs (a), (b), and (c) of the rule identified as having provisions important to Health and Safety. Based on the above, and because Part 35 is being amended in its entirety, the team determined that this recommendation should be closed.

c. The NYSH should perform a review of its licensees based on the requirements of the emergency planning (EP) rule, document the review, and if any licensees meet the requirements of the rule, incorporate applicable section of the rule into

                                                 ' licenses until the rule can be promulgated.                                       1 Current Status: The team reviewed NYSH's evaluation of its licensees against the requirements of the EP rule and concurred with NYSH's conclusion that the possession limits of alllicensees were below that requiring an EP plan. The team determined that this recommendation should be closed.

o (2) Responses to incidents and Allegations, it was recommended that NYSH perform timely and on site investigations to independently assess allegations based on haalth i and safety considerations; develop criteria to determine which allegations can be referred to licensees; assess licensee's evaluation of allegations; and maintain complete files. Current Status: During the review of the common indicator" Response to Incidents and Allegations" (see Section 3.5.3), the team evaluated NYSH's response to these recommendations . Based on the findings detailed in Section 3.5.3 of this report, the team determined that this recommendation should be closed. NEW YORK STATE DEPARTMENT OF ENVIRONMENTAL CONSERVATION (NYDEC) (1) Technical Quality of Licensing Actons. It was recommended that NYDEC expeditiously

                                        . complete the inspection of NYCH licensees to determine if any where subject to NYDEC permitting requirements.

Current Status: The team evaluated NYDEC's response to this recommendation during its review of the common indicators " Technical Quality of Licensing" and " Technical Quality of Inspections". The team concluded that NYDEC staff took prompt action to identify those NYCH licensees requiring NYDEC permits. Periodic memoranda to NYDEC management documenting the progress of this evaluation were prepared by staff. Based on the team's findings during this review, the team determined that this j recommendation should be closed. 3.0 COMMON PERFORMANCE INDICATORS The IMPEP identifies five common performance indicators to be used in reviewing both NRC l Regional and Agreement State programs. These indicators are: (1) Status of Materials inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; l

L New York Draft Report Page 5 ,. (4) Technical Quality of Licensing Actions; and (5) Responso to incidents and Allegations. l: 3.1 Status of Materials insoection Proararn The team focused on four factors in reviewing this indicator: inspection frequency, overdue inspections, initial inspection of new licanses, and timely dispatch of inspection findings to licensees. This evaluation is based on the individual programs' questionnaire responses relative to this indicator, data gathered independently from each program's licensing and inspection data tracking system, the examination of completed licensing and inspection casework, and interviews with managers and staff.

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3.1.1 New York City Department of Health (NYCH)- Status of Materials inspection Program NYCH's inspection priority system closely matches NRC's system. The team's assessment of the current inspection priorities verified that inspection frequencies for various types or groups of licensees are equivalent to or more frequent than those listed in NRC Inspection Manual - l Chapter 2800 (IMC 2800) frequency schedule. In reviewing NYCH's priority schedule, the team noted that NYCH continues to have priority categories which are inspected more frequently I than those of the NRC. The NYCH has only five categories of licensees, with a total of three priorities. The NYCH priorities are either Priority 1 for once every 12 months, Priority 2 for once. every 24 months, or Priority 3 for once every 36 months. In their response to the questionnaire, NYCH indicated that as of January 1998, six licenses identified as core inspections in IMC 2800 were overdue by more than 25 percent of NRC's

        . frequency. The NYCH's current inspection schedule identified 21 Priority 1 licenses; however, the team discovered that the software-based system did not identify approximately 19 additional                                                                 ;

Priority 1 licenses for inspection purposes. Tracking of those, five were overdue at the time of j the review and were not scheduled for inspection. Overall, NYCH's inspection scheduling system tracked only 243 of the 440 active licenses. The team estimates that NYCH would need to perform approximately 220 inspections each year in order to keep pace with its due inspections (the estimate assumes that all Priority 1 licenses, one-half of all Priority 2 licenses, and one third of all Priority 3 licenses were inspected each year). Each year of the review period, NYCH budgeted approximately 266 inspections for completion. In fiscal years (July to June) 1995,1996 and 1997, NYCH completed 127,263, and 154 inspections, respectively. Due to difficulties in obtaining information from NYCH's inspection tracking system, tito true status of the materials inspection program could not be accurately assessed. Since there was not an adequate database to evaluate the status of inspections, the team did a sampling by examining the inspection histories of 25 out of the 40 total NYCH Priority 1 licenses. Since the last review,33 inspections of those licenses have been completed. Of those inspections (33 percent),19 inspections (58 percent) were overdue based on NYCH's priority at the time that the NYCH conducted them; however, only 11 inspections were overdue (33 percent) based on IMC 2800 priorities (8 of the 19 were teletherap,; N raview team recommends that the NYCH correct the software anomalies that limit NYCH's abmty to effectively track licenses for inspection, set and adhere to yearly inspection goals, and communicate'NYCH management's enectations with regard to inspection goals, such that NYCH is able to eliminate all overdue inspections.

L New York Draft Report Page 6 With respect to initial inspections of new licenses, the team reviewed the inspection tracking ,

system and found that initialinspections were usually entered into the system together with l existing licenses. The NYCH's inspection supervisor assigns all inspections, and is able to

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identify new licenses by the license number. NYCH currently has a six month inspection frequency for all initial inspections, which is consistent with NRC's initial inspection requirement  ! in IMC 2800. l From the review of the inspection database end examination of license files, NYCH was not L consistently implementing its six month initial inspection policy. The team examined 22 new l' licenses issued since February 1995. Of those new licenses, NYCH conducted initial ! inspections within six months of issuance for nine licenses (41%). The inspections that did not L meet the six month inspection goal ranged from 8 to 22 months after the licenses were issued. l 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.

i !  ; The timeliness of the issuance of inspection findings was also evaluated during the' inspection file review. Of the 15 files examined, in 11 cases the inspection correspondence was sent to the licensee within 30 days of the inspection date. Correspondence from three of the remaining l inspections was sent between 32 and 39 days. In the fourth case, Brooklyn Hospital Center, l License No. 91-2924-01, NYCH completed its inspection on June 21,1996, but did not transmit the inspection findings until November 1,1996 (134 days). Based on the sampling done by the team, it appears that NYCH is not conducting its inspection program for core licensees in accordance with IMC 2800. The lack of an adequate tracking system significantly contributed to this finding which was presented at the exit meeting with NYCH on January 30,1998. In response to the teams's findings presented at the exit meeting on January 30,1998, Mr. Kenneth R. Daniel, Jr., Deputy Director, Bureau of Radiological Health, Department of Health, submitted a letter dated February 17,1998, providing additional information regarding this indicator. The letter indicated that the software anomaly had been corrected and that NYCH was able to effectively track all of its licenses for inspection. The team's review of the inspection due list for the following 12 months ending in February 1999 j appeared to indicate that all licenses were now captured in the scheduling system. However,  ! the team could not reconcile the inspection dates in the updated list with the last known inspection dates identified during the review. Through further discussions with NYCH, some of these discrepancies have been cleared up; however, the database needs additional quality control that will occur over time with the use of the database. The NYCH's February 17,1998, i letter did not address the team's findings with regard to the conduct of initial inspections. The NYCH will need to continue to address the tracking, the timely scheduling and completion of inspections for all current licenses, and initial inspections for new licenses.  ; Based on the IMPEP evaluation criteria, the review team recommends that NYCH's  ! performance with respect to the indicator, Status of the Materials Inspection Program, be found unsatisfactory. i

New York Draft Report Page 7 3.1.2 New York State Department of Labor (NYDL) - Status Materials of Inspection Program i The team's review verified that NYDL's inspection priorities are at least as frequent as similar license types or groups listed in NRC IMC 2800. Of particular note is the greater number of inspections completed by NYDL choosing to designate its 110 Moisture / Density Gauge licenses as inspection Priority 2, while the NRC frequency for a similar licensee is Priority 5. Designating such a large number of licensees under such a high priority requires NYDL.to perform more frequent inspections of such licensees, while allowing some flexibility in .) inspection frequency in comparison to IMC 2800. Similar to IMC 2800, NYDL management has the ability to extend the interval between  ! inspections for licensees on the basis of good licensee performance. In 1997, NYDL extended i 37 license inspections by approximately one year due to good compliance histories. i As noted in their response to the questionnaire, no routine inspections completed by NYDL

           . during the review period were overdue by more than 25% of the scheduled frequency set out in                     l' lMC 2800. This level of completion, however, does not apply to NYDL's performance conducting reciprocity inspections.

l Fifty four companies requested reciprocity during 1997 and 10 were inspected while performing

           ' licensed activities in the State. The NYDL does not keep records of the types or the priorities of reciprocity licensees. Thus, NYDL does not schedule reciprocity inspections consistent with                      i any priority schedule. It is the decision of NYDL management to focus resources on NYDL licensee inspections, and thus complete reciprocity inspection = e.!y es resources allow.

Reciprocity licensees should be inspected to assure t% health and safety of both radiation workers as well as the public. The review team suggests that NYDL determine and document the appropriate inspection frequencies of all reciprocity licensees, and complete reciprocity inspections following NYDL inspection priorities, which should be based on the inspection priorities documented in IMC 1200. The team also examined NYDL's performance in completing initialinspections of new licensees, and noted that in general, initial inspections are not always completed within six months of the commencement of licensed activities. The team sampled 10 newly issued licenses during the review period, and found that three received an initial inspection within the six month guideline. Of the remaining seven, five of them received an initialinspection within seven months of the commencement of licensed activities. The two remaining initial inspections were performed 56 days and 314 days beyond the six month guideline.- The review team recommends that NYDL perform initial inspections of licensees witnin six months of the licensees' receipt of licensed material, or commencement of licensed activities. Contrary to IMC 2800, NYDL does not complete an initial inspection of a licensee within one

           . year of the issuance of the license if the licensee does not receive licensed material. If no material is received by a licensee within six months of license issuance, NYDL begins correspondence with the licensee to ensure knowledge of the receipt of licensed material. At

, the same time, NYDL attempts to persuade the licensee to cancel their license if the licensee believes no radioactive material will be received. The team recognizes this policy as an acceptable alternative to the guidelines established in IMC 2800.

New York Draft Report Page 8 The timely dispatch of inspection findings was also evaluated during the inspection file review. Of 20 inspection findings examined, the correspondence for 17 inspections was sent to the licensee within 30 days of the inspection date. For the other two inspections, the correspondence was sent to the licensee from 1 and 35 days beyond the 30 day guideline. The team does not believe that the issuance of inspection findings is a problem for this program. Based on the IMPEP evaluation criteria, the review team recommends that NYDL's performance with respect to the indicator, Status of Materials inspection Program, be found satisfactory. 3.1.3 New York State Department of Health (NYSH)- Status of Materials inspection Program

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The team's review of NYSH's inspection priorities verified that NYSH's inspection frequencies for various types or groups of licenses are at least as frequent as similar license types or groups listed in the NRC IMC 2800 frequency schedule. Fourteen program codes are scheduled for more frequent inspections by NYSH than similar NRC licensees. With respect to initial inspections of new licenses, the team evaluated the inspection tracking data system and verified that initial inspections were entered into the computerized tracking system together with existing licenses. A review of the inspection tracking system showed that initialinspections are differentiated from routine inspections by including the issuance date of the license in bold in the column listing the last inspection. Although new licenses are clearly marked in the tracking system and scheduled within six months of issuance, more than half of the initialinspections were not completed within six months as suggested by IMC 2800. A review of the database identified 67 new licenses issued since the 1995 review of NYSH. The team selected 34 of these licenses in which the initialinspection was due. Of these 34,10 licenses were inspected within the six month window, six were inspected one month late, nine were inspected two to six months late, and nine were inspected over six months late. The team determined that NYSH policy is that initialinspections are to be scheduled for inspection within six months of issuance. The NYSH management assigns inspection to inspectors twice a year and monitors the progress of inspections completed on a monthly basis. However, inspectors are not required by management to complete new inspections within six months. The review team recommends that NYSH modify its inspection program to ensure that initial inspections are performed within six months of the licensee's receipt of licensed material, within six months after commencement of licensed activities, or within one year of license issuance, whichever comes first, consistent with IMC 2800. In their response to the questionnaire, NYSH indicated that three inspections were overdue by more than 25% of the scheduled frequency. At the time of the on-site review, these inspections had been performed. The timeliness of inspection of core licensees at regular intervals in accordance with IMC 2800 was evaluated during the inspection file review. The team selected 31 inspections for review and determined that three of the inspections were performed at intervals that exceeded IMC 2800 inspection frequencies by more than 25% These three inspections were overdue by one, two and three months when next inspected. The timeliness of the issuance of inspection findings was also evaluated during the inspection file review. Of 16 inspection findings examined, the correspondence for all of these inspections

New York Draft Report Page 9 was sent to the licensee within 30 days of the inspection date. This totalincluded five escalated enforcement actions that required more documentation to be prepared and reviewed by NYSH staff and management. 4 Based on the IMPEP evaluation criteria, the review team recommends that NYSH's performance with respect to the indicator, Status of the Materials inspection Program, be found satisfactory with recommendations for improvement. l 3.1.4 New York State Department of Conservation (NYDEC)- Status of Materials inspection Program i The team's review of NYDEC's inspection priorities showed that inspection frequencies are based primarily on the magnitude of the permitted discharge of radioactive material to the environment (i.e., the maximum average annual concentration of the effluent that may be discharged to the environment) instead of IMC 2800. The inspection priorities range from one to four years. Based on the limited scope of NYDEC's regulatory oversight for facilities (i.e., discharges to environment only) and the priorities of the inspections, the team concluded that these frequencies were adequate to protect public health and safety and to assure permittee (licensee) compliance. in their response to the questionnaire, NYDEC indicated that it had no overdue inspections. The team confirmed this by reviewing the current permittee list which indicates the last inspection of the permittee and by file review. Since the NYDEC only regulates environmental discharges, reciprocity does not apply to this portion of the New York program. It was noticed by the team that the procedures for inspection priorities utilized by NYDEC states that "new permittees will continue to receive pre-permit inspection whenever possible, and will always receive an initial inspection within the first year of operation." The IMC 2800 states that the initialinspection be done within six months. The NYDEC has been inspecting almost all initial permittees within six months and performs a pre permit inspection of the facilities, in order to make NYDEC's initial inspection policy consistent with NRC policy and practice, the Program Director stated that the wording of the inspection priority memo would be revised to require an initial inspection within six months instead of within one year. For initial inspection of new licensees, the team reviewed the inspection schedules for the review period. For the seven new permits that were issued, inspections were conducted at six facilities within six months, and the other was done .at eight months. In addition to the initial inspection, the permittees also receive a pre-permitting inspection. During inspection file reviews, the team evaluated NYDEC's timeliness in issuing inspection findings. The team found that inspection findings were generally sent well within the 30 day time frame with two of ten inspections exceeding the 30 day guideline (one at 49 days and one at 335 days). Based on the IMPEP evaluation criteria, the review team recommends that NYDEC's performance with respect to the indicator, Status of the Material Inspection Program, be found satisfactory. (.

New York Draft Report

         .                                                                                        Page 10 3.2     Technical Quality of insoect:ons l  '3.2.1    New York City Department of Health (NYCH) - Technical Quality of Inspections
   -The team reviewed the inspection reports, enforcement documentation, and inspection field notes and interviewed inspectors for 15 materials inspections conducted during the review period. The 15 inspections selected for review included at least one inspection for each of the NYCH's inspectors and two team inspections of major broad scope licenses. The inspections included four medical broad scope licenses, two academic broad scope licenses, two l

teletherapy licenses, five limited medical use licenses, and two private practice physicians. L Appendix C-1 lists the inspection files reviewed in depth with case specific comments. l Of the 15 inspections reviewed, seven resulted in no violations being identified. For the l: remaining eight, violations were identified in transmittal letters to licensees. Of those l violations,13 were not described in the field notes documenting the results of the inspections. l' ' in a majority of the cases reviewed, the inspections identified technically valid violations;

• however, neither the techniques employed nor the manner in which inspections were documented provided many insights into the performance of NYCH's licensees, other than the status of the licensees' compliance with NYCH regulations. The review team recommends that NYCH inspectors follow the guidance in the NYCH inspection procedure manual which includes l the information necessary for properly documenting violations. In NYCH's letter dated February 1 17,1998, the NYCH responded to this recommendation by stating that a copy of the student l manual for the inspecting for Performance course has been obtained and they plan to conduct l an in house training course in the near future for their rnaterials inspectors.

For 14 of the violations issued in the inspections reviewed, the licensees provided information in their responses that appeared to dispute the violation. When a licensee disputes a Notice of Violation (NOV), the licensee must take the dispute to the Tribunal, if the licensee does not appear, the NOV stands and the fine must be paid In none of these cases, did NYCH's files it indicate whether the violations were upheld or retracted. The team could not determine the ( status of these violations and their final disposition. The review team suggests that NYCH establish a policy that the results of all Tribunal's be placed in the appropriate inspection files. The NYCH has a policy of performing annual supervisory accompaniments of inspectors. In response to the questionnaire, NYCH reported that each inspector was accompanied by the i supervisor at least once a year during the review period. Interviews of NYCH inspectors determined that the supervisor accompanies the inspectors more frequently, but in those other i occasions, the supervisor acted as the lead inspector. Following those inspections, the I _ supervisor provided feedback to the inspector. Four inspection accompaniments identified in Appendix C were performed by two team i members. During the week of October 28 - 31,1997, a team member performed 1 accompaniments of three inspectors on an inspection of an academic broad scope licensee. A second team member performed accompaniments of four inspectors during an inspection of a l medical broad scope licensee that included the source loading of a gamma knife unit, during i the week of December 1 - 5,1997. Two additional inspection accompaniments were performed 1 on January 20 and 21,1998 with each of newest inspectors in the program. These  ! accompaniments were performed at licensees that these inspectors were qualified to L independently inspect. I l l l l

l New York Draft Report Page 11 The team determined that the performances of the inspectors during team inspections were compliance, rather than performance, oriented. For example, during the December 1997 i inspection exit meeting attended by the team member, the reviewer was not able to determine whether the inspection findings discussed were violations, concerns, or recommendations. The NYCH's exit did not reference specific regulatory requirements that were violated, or distinguish poor practices from violations, in a few cases, the inspectors appeared to impose their personal preference in the conduct of some operations rather than limit themselves to the enforcement of NYCH's regulations. 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. During the inspection accompaniments performed in January 1998, the two inspectors demonstrated appropriate inspection skills and knowledge of the regulations. The inspectors l were thorough in their review of the licensee's radiation safety program. Inspection techniques were observed to be generally performance oriented. These inspections were adequate to , assess the licensee's radiological health and safety performance. l L The team noted that the NYCH has an adequate number of portable radiation detection l instruments for use during routine inspections and response to incidents and emergencies.  ; The NYCH uses an outside vendor for instrument service'and calibration. The portable l instruments used during the inspector accompaniments were operational and calibrated. l^

Based on the IMPEP evaluation criteria, the review team recommends that the NYCH's l

performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory with recommendations for improvement. 1 3.2.2 ~ New York State Department of Labor (NYDL) - Technical Quality of Inspections The team reviewed the inspection reports, enforcement documentation, and the data base information for 21 materials inspections conducted during the review period. The casework included NYDL's three materials inspectors and covered a sampling of different license types as follows: two broad scope commercial; one research and development; three portable gauges; two fixed gauges; three industrial radiography; three nuclear pharmacies; two service; one manufacturer; one waste broker; one gas chromatograph; one storage; and one commercial irradiator. Appendix C-2 provides a list of the inspection cases reviewed in-depth with case-specific comments. l The inspection procedures and techniques utilized by NYDL were reviewed and determined to be generally consistent with the inspection guidance provided in IMC 2800. Specific guidance j for certain classes of licensees or facilities are also included in the procedures manual E maintained in the Manhattan office where all inspectors are based. The team reviewed inspection reports and found them to be comparable with the types of information and data

                                                               - collected under NRC Inspection Procedure 87100. Inspections are generally performed on an announced basis.

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New York Draft Report Page 12 The inspection field notes provided excellent, consistent documentation of inspection findings. The NYDL uses supplementary field notes for different types of inspections covering the areas of manufacturing (quality assurance), industrial radiography, fixed gauge, and gas chromatograph licenses. Inspection reports were reviewed to determine if the reports adequately documented the scope ! of the licensed program, licensee organization, personnel protection, posting and labeling, control of materials, equipment, use of materials, transfer, and disposal. The reports were also checked to determine if the reports adequately documented operations observed, interview of workers, independent measurements, status of previous noncompliance items, substantiation of all items of noncompliance, and the cubstance of discussions during exit interviews with management. The reviewer completes an inspection review form which becomes part of the i inspection file. Overall, the team found that peer review of the inspection documentation and correspondence resulted in their consistent excellent quality. The review team noted a good practice in that NYDL's inspection field notes and inspection correspondence are peer reviewed by one of the senior inspectors to ensure consistency, thoroughness, and quality of reports. Routine enforcement letters were drafted and issued to licensees by the inspector. When the licensee responds to a NOV, the inspector evaluates the licensee's submittal and prepares a response. Once the inspector determines that the licensee has satisfactorily responded to the NOV and has acknowledged their response, the inspection field notes and correspondence is given to another senior inspector for review. The inspectors told the team that they discuss any 3 atypical issues regarding the inspection findings with the program manager prior to issuing the ] inspection findings to the licensee. When significant commitments are made in response to - NOVs, NYDL staff performed a follow-up inspection to confirm that the commitments made in the licensee's correspondence were implemented. For the casework reviewed, documented inspection findings led to proper regulatory actions 3

                 . and appropriate enforcement. The program manager stated that escalated enforcement action        ]

beyond the issuance of NOVs was limited to the issuance of orders. The NYDL held four l enforcement conferences which resulted in the issuance c.f orders. The team discussed with  ! NYDL management at the exit meeting that the incorporation of a wider range of enforcement tools into the enforcement policy such as severity levels and civil penalties would provide NYDL with alternative methods to emphasize the importance of prompt, comprehensive identification and correction of conditions important to safety. One inspector accompaniment identified in Appendix C-2 was performed by a team member on December 11 and 12,1997 at an industrial radiography storage location and a temporary job site of the licensee. The remaining two inspectors were accompanied during the previous

                 . review. During the accompaniment, the inspector demonstrated appropriate inspection skills and knowledge of the regulations. The inspector was well prepared and thorough in the review of the licensee's radiation safety program and performance of licensed activities in the public
                 . domain. ' Inspection techniques were observed to be performance oriented, and the technical performance of the inspector was at a high level. The inspection was adequate to assess the licensee's radiological health and safety performance.

The NYDL program manager performs annual supervisory accompaniments of all inspectors and documents each evaluation on an inspection accompaniment form. l I i

New York Draft Report Page 13 The team noted that NYDL has an ample number of portable radiation detection instruments for use during routine inspections and response to incidents and emergencies. Instrument calibration is performed by NYDL inspectors at the Manhattan office using NIST traceable alpha, beta, and gamma sources. The NYDL procedures also include laboratory and instrument calibration procedures. The NYDL uses an outside vendor for instrument service. t The portable instruments used during the inspector accompaniment was observed to be

  . operational and calibrated. The instrument storage area is co-located with the radiation counting laboratory and storage area for emergency response kits. A sampling of portable instruments maintained were found to be within calibration. The NYDL's radiation counting laboratory includes a low background alpha and beta proportional counter, liquid scintillation counter, and a sodium iodide detector coupled to a multichannel analyzer. The program's germanium lithium detector is no longer functional and has not yet been replaced. The inspection staff is responsible for analyzing their own samples and maintaining the laboratory counting equipment.

Based on the IMPEP evaluation criteria, the review team recommends that NYDL's l performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory. f 3.2.3 New York State Department of Health (NYSH) - Technical Quality of Inspections 1 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 casework included 11 of the NYSH's materials license inspectors, and covered inspections of various types including medical, academic, teletherapy and pharmacy. Appendix C-3 lists the inspection files reviewed in depth with case specific comments. During the week of February 23,1998, a team member performed accompaniments of four NYSH inspectors on separate inspections of licensed facilities.

  ' During the 1995 review of NYSH, there was a preliminary recommendation to modify the inspection report format to include sections to identify how previous items of noncompliance were addressed by the licensee and to deoment findings presented to licensee management during exit meetings. The NYSH has modified its field note format to include both of these topics. The NYSH now documents whether or not previous items of noncompliance were resolved and there is now an area to document the exit meeting and subsequent discussions.        1 During this review, the team noted that there was a lack of documentation of the substance of     I discussions at the exit meetings. The review team suggests that the NYSH's inspection documentation of exit meetings should contain substantive discussions of issues with the Radiation Safety Officer (RSO) and/or licensee management.

The inspection procedures and techniques utilized by NYSH were reviewed and determined to be generally consistent with the inspection guidance provided in IMC 2800. The team reviewed inspection reports and found them to be comparable with the types of information and data collected under NRC Inspection Procedure 87100 and NYSH procedures. Thirteen of the 16 inspections reviewed were performed on an unannounced basis. The inspection field notes provided good, consistent documentation of inspection findings. The NYSH uses the same field note format ' Inspection of Radionuclides Installations" for different

I i

    ' New York Draft Report                                                                      Page 14 types of inspections covering the areas of academic, research and development, medical, and teletherapy licenses.                                                                              ;

Inspection reports were reviewed to determine if the reports adequately documented the scope' , of the licensed program, licensee organization, personnel protection, posting and labeling, ' control of materials, equipment, use of materials, transfer, and disposal. The reports were also checked to determine if the reports adequately documented operations observed, interview of workers, independent measurements, status of previous noncompliance items, substantiation of ) allitems of noncompliance, and the substance of discussions during exit interviews with  ! management. Although it is evident that some workers were interviewed, it is rarely { documented that ancillary personnel, authorized users, or the RSO were involved in this process. Of the 16 inspections reviewed, not one documented interviewing ancillary personnel.

                                                                                                         )'

The review team suggests that iuYSH incorporate a field for documentation of interviewing ancillary personnel, authorized users, technicians, and RSOs into their field notes. To assure consistency and quality of reports, it was evident the Radioactive Material Section Field Supervisor and Section Chief provided thorough reviews but until recently did not document this review. Six out of the 16 inspections reviewed did not have documented supervisor review. Also, the inspection correspondence and field notes are not signed by supervision. Only the inspector's signature is available on this paperwork. The NYSH has initiated a new process to have the field supervisor and/or the section chief sign a separate memo sized paper documenting their review. This piece of paper is maintained in the j inspection file folder. Overall, the team found that the inspection reports showed excellent ' quality and attention to detail. Reports contained no major discrepancies from standard practices or established NYSH procedures. When the licensee responded to a NOV, the response was given to the inspector to evaluate the licensee's response and, in each case, a response was sent to the licensee within 30 days  ! of receipt. The team, as noted previously, identified a concern related to the documentation of ) supervisory review of enforcement letters and licensee responses.  ! For the casework reviewed, documented inspection findings led to proper regulatory actions and appropriate enforcement. Inspection results showed licensee compliance was acceptable during the review period and that escalated enforcement action in the process of Administrative Tribunals (Hearing Board) occurred only five times. A thorough review of all Administrative Tribunals revealed that this process is very effective in obtaining eventual compliance whether the end result is a fine, an American College of Radiology audit commitment, or other compliance commitment Four of the five cases reviewed were dealt with expeditiously through negotiation with NYSH which is a preliminary step in the Tribunal process. All five cases have been inspected or have been scheduled to be inspected within the next 6 to 12 months. Four inspector accompaniments identified in Appendix C-3 were performed by a team member. During the accompaniments, inspectors demonstrated appropriate inspection skills and knowledge of the regulations. The inspectors were well prepared and thorough in the review of licensee radiation safety programs. The technical performance of the inspectors was at a high level. During these accompaniments, the reviewer observed that the inspectors focused on records reviews and checking off the field notes instead of observing the licensees operations;

i. therefore, the reviewer identified that the inspectors would benefit from more training in inspecting for performance. The inspections were adequate to assess radiological health and l:

h l l

l New York Draft Report Page 15 safety at the licensed facilities. The review team suggests that the NYSH inspectors attend additional training in inspecting for performance techniques. The NYSH has a policy of performing annual supervisory accompaniments of inspectors. In response to the questionnaire, NYSH reported that 10 out of the 12 inspectors had accompaniments in 1997. The two inspectors that did not have accompaniments were a field supervisor and another inspector not assigned inspections for 1997. The team noted that NYSH has an ample number of portable radiation detection instruments for use during routine inspections and response to incidents and emergencies. The NYSH has a dedicated person in the Department for assuring and performing all instrument calibrations. The portable instruments used during the inspector accompaniments were observed to be operational and calibrated. *f he instrument storage area is located within the Department and at each field office. A sampling of portable instruments maintained at each location was available and found to be within calibration. Based on the IMPEP evaluation criteria, the review team recommends that NYSH's performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory. 3.2.4 New York State Department of Conservation (NYDEC) - Technical Quality of Inspections The team reviewed the inspection reports, enforcement documentation, and interviewed inspectors for 10 materials inspections conducted during the review period. The casework included seven of the NYDEC's materials license inspectors, and covered inspections of various types including air, water, and incinerator permits. Appendix C-4 lists the inspection files reviewed in depth with case-specific comments, A representative cross-section of completed inspection reports was reviewed and found to be very thorough with inspection findings well documented. Inspec, tion findings were consistently compared to the permit and regulatory requirements. Prior to the inspection, a full briefing is held among the inspector, their supervisor, and the Radiation Section Superviscr to discuss the inspection. Unresolved issues, recent changes to the permit, and specific concerns of the inspector are well documented in the inspection reports. The completed reports were reviewed by supervisory personnelin a very prompt time frame. Escalated enforcement procedures are in place and followed, as needed. The escalated actions include referral to the General Counsel in preparation for an enforcement conference which may result in a fine and/or a Consent Order. This process is used approximately once a year. The team reviewed the latest version of Part 380 Permit inspection Procedures, revised September 1996, Enforcement Guidance Memorandum Radiation dated May 17,1995, and all current inspection forms, in general, all procedures and forms appear to be consistent with the opplicable guidance found in IMC 2800 and IP 87100. Supervisory accompaniments of inspectors are conducted on a routine basis. All of the inspectors have been accompanied at least once a year and most of the supervisors have been accompanied during the review period.

   ,             c New York Draft Report                                                                          Page 16

i. Two inspector accompaniments identified in Appendix C-4 were performed by a team member on April 7,1998. Of the remaining three inspectors, two were accompanied during previous reviews and the other was re-assigned to other work within NYDEC. During the ,

accompaniments, the inspectors demonstrated appropriate inspection skills and knowledge of the regulations. The inspectors were well prepared and thorough in the review of licensee radiation safety programs. . Inspection techniques were observed to be performance oriented, and the technical performance of the inspectors was at a high level. The inspections were adequate to assess radiological health and safety of the licensee's effluent monitoring program. The team found that NYDEC has a variety of survey instruments. The instruments include a good mix of microroentgen meters, GM meters, ion chambers, velometers, and other portable survey meters. The meters are calibrated annually using an outside vendor. The NYDEC also has available a high purity germanium detector, tritium monitor, TLD reader /irradiator, and a

l. neutron detector. Samples are also sent to an outside laboratory for analysis.

Based on the IMPEP evaluation criteria, the review team recommends that NYDEC's performance with respect to the indicator, Technical Quality of Inspection, be found i satisfactory. ' i 3.3 Technical Staffina and Trainino i Issues central to the evaluation of this ino,cator include the radioactive materials program l staffing level, technical qualifications of the staff, training, and staff turnover. To evaluate these L issues, the team examined each program's questionnaire responses relative to this indicator, interviewed program management and staff, and considered any possible workload backlogs in

                    . licensing or compliance actions as well as the status of regulation development and other             1 program activities.                                                                                    I 3.3.1        New York City Department of Health - Technical Staffing and Training At the time of the review. NYCH's radioactive materials program was staffed by the Deputy Bureau Chief, licensing section with a supervisor and four staff, and compliance section with a I                     supervisor, senior scientist, and five staff. The Bureau Chief position had been vacant for 18 months, filled for four months, and then vacant again as of the week after the review. In general, the team found that the current staffing level is adequate except the team noted that the vacancy at the Bureau Chief position was affecting several aspects of the program as identified in this report. The review team suggests that the NYCH Bureau Chief position be filled as soon as possible so that attention can be applied to management oversight of the l program shortfalls identified in this review.

At the time of the review, all staff had been with the program for the majority of the review I period.' Two staff members joined the program shortly after the last review in 1995. Both

                   - performed well on their inspection accompaniments. The Bureau Chief resigned in July 1996
                   . with a successor hired in October 1997. The new Bureau Chief resigned in January 1998, effective February 6,1998. In addition, the Assistant Commissioner that oversees the Bureau was dismissed in mid-January 1998 with the Deputy Commissioner being dismissed in February 1998. In an additional organizational change, the Departments of Health and Mental Health are being combined into one department. The final organizational chart for this new Department I

l New York Draft Report Page 17 will not be available until the City Council approves the reorganization. At the time of the review, it appears that the NYCH will remain intact. From supervisor interviews'and a review of the position descriptions, the team determined that ~l successful candidates for technical positions are required to have a Bachelor's degree in

               . science and at least one year of experience.~ From the review of the technical qualifications of the current staff, the review team concluded that the NYCH has been able to hire qualified individuals. The NYCH has one Certified Health Physicist (CHP) and one individual that has passed Part 1 of the CHP examination.

In interviews with the staff and a review of documents, the team determined that there was no

               . written training policy or qualifications criteria. 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. In NYCH's letter dated February 17,1998, the NYCH responded to this recommendation by indicating that although their Policy and Procedures Manual contains a written policy for staff training, the manual is currently being updated and will include these recommendations.

The team's review of NYCH's training records and interviews with the staff identified that i several staff members should attend at least one course to '"!!y address their training needs. In discussions with senior management, they pointed out that getting approval for out-of-city travel was difficult and that they would seek as much training as they could from institutions within s New York City. They have been utilizing several one day seminars in the appropriate training 4 areas. The review team recommends that NYCH review the staff's training against their i training requirements, clearly document how the training was achieved, and acquire the i necessary training,' as appropriate. I

                                         ~

Based on the IMPEP evaluation criteria, the review team recommends that NYCH's L performance with respect to the indicator, Ts::hnical Staffing and Training, be found satisfactory j with recommendations for improvement.  ! 3.3.2 New York State Department of Labor - Technical Staffing and Training i

                ' At the time of the review, NYDL's radioactive materials program was staffed by the principle radiophysicist and seven associate radiophysicists, in general, the team found that the current staffing level is adequate, except that the team noted that the inspection staff has a very heavy                       i workload attributed to the fact that one of the four inspectors was restricted te office duties only.                  ;

The principle radiophysicist also carries a very heavy licensing caseload that may have affected the status of regulatory development.~ The staffing and training will be impacted by the recommendations in the SS&D section (4.2) with the recommendation for significant additional training for both of the SS&D staff. The review team suggests that NYDL management consider whether additional staffing is warranted when considering the impacts of the licensing and inspection workloads, the regulation development needs, and the SS&D program improvement needs. l The licensing and inspections functions of the program are segregated with all the licensing conducted in Albany and inspections conducted out of the Manhattan office. Licensing duties are performed by the principle radiophysicist and three associate radiophysicists. Inspection

l l New York Draft Report Page 18 duties are performed by four associate radiophysicists. All staff perform duties in incident and emergency response. At the time of the review, all staff had been with the program for the entire review period. From supervisor interviews and a review of the position descriptions, the team determined that { successful candidates for technical positions are required to have a Bachelor's degree in science and at least one year of experience. To be considered for a position, an individual must successfully complete a technical examination to be placed on the registry from which individuals are selected. From the review of the technical qualifications of the current staff, the team concluded that the State has been able to hire qualified individuals. The NYDL program has one CHP with one other person working on their certification. In intenriews with the staff and review of documents, the team determined that there was no

         ' written training policy. The' principle radiophysicist committed in a memo to upper management to follow the recommendations in the NRC/OAS Training Working Group report. The review of their training records and interviews with the staff identified that one staff member should attend the industrial radiography course and that most staff desired additional training in internal dosimetry and decommissioning. The review team recommends that NYDL document its training program to include overall policy and minimum training requirements for both the licensing and compliance staff.

Based on the IMPEP evaluation criteria, the review team recommends that NYDL's performance with respect to the indicator, Technical . Staffing and Training, be found  ! satisfactory. 3.3.3 l New York State Department of Health (NYSH)- Technical Staffing and Training At the time of the review, the NYSH radioactive materials program was staffed by the Director, two supervisors, and eleven staff. The team found that the current staffing level appeared adeouate, The staff of the materials program is segregated into five field offices and the main office in Albany.. Compliance duties are performed by both supervisors and the eleven staff. The field staff perform only compliance activities including compliance work for the x ray and other radiation programs. The Albany staff conduct all the licensing and a portion of the compliance activities. Licensing duties are performed by the supervisor and four staff. All Albany staff perform duties in incident and emergency response. l- ~. At the time of the review, all staff, except one, had been with the program for the entire review period." The new individual was transferred from the laboratory to the licensing / compliance staff in Albany. The individual has attended several training courses and is a senior staff member based on his 20 plus years working as a radiochemist in the laboratory. All work, by this individual both inspections and licensing actions, is reviewed by qualified staff prior to issuance.

          ' From supervisor interviews and a review of the position descriptions, the team determined that successful candidates for technical positions are required to have a Bachelor's degree in science and at least one year of experience. To be considered for a position, an individual must successfully complete a technical examination to be placed on the registry from which

New York Draft Report - Page 19 individuals are selected. From the review of the technical qualifications of the current staff, the review team concluded that the State has been able to hire qualified individuals. There are five certified health physicists in the NYSH program although not all of them are working in the

           - radioactive materials program.

In interviews with the staff and a review of documents, the team determined that there was no

           - written training policy. The review team recommends that NYSH document its training program to include overall policy and minimum training requirements for medical, academic, and research uses of radioactive materials for both the licensing and compliance staff.                   l The NYSH has a training matrix where they enter the courses that have been completed. The L

review of this matrix identified several courses which are needed for individual staff. These

           'were: two for inspection procedures, one for licensing practices and procedures, most of the staff for teletherapy / brachytherapy, three for transportation of radioactive materials, and, as recommended in Section 3.2.3, additional training in inspecting for performance for the inspection staff. Although these individuals have not attended specific courses, they have had        ,

some on the-job training and short seminars to cover these areas. The team considered that in  ! every training area the program had multiple qualified individuals that have provided the  ! on-the-job training, therefore, from a programmatic standpoint, the program has sufficiently ) trained staff. Through management review, all staff, except for the recent transfers, have been qualified to perform independent work. NYSH's program conducts monthly TeleVideo conferences with its regional and Albany staff. These sessions cover current health physics topics and other programmatic matters, as needed. The review team considers the TeleVideo conferences to be a good practice to bring and keep their staff current on health physics and program issues..

• Based on the IMPEP evaluation criteria, the review team recommends that NYSH's .

performance with respect to the indicator, Technical Staffing and Training, be found l satisfactory.- l , 3.3.4 New York State Department of Environmental Conservation (NYDEC) - Technical Staffing and Training . At the time of the review, NYDEC's radioactive materials program was staffed by the Bureau Chief, Radiation Section Leader,~and ten staff. There are currently two vacancies in the p radiation section. Both positions are for contaminated sites and environmental analysis to l support contaminated site evaluations. About half of the staff time is spent on contaminated

            . sites and events that are not directly covered under the agreement with NRC. The permitting
           . (licensing) and compliance functions of the program'are integrated with six staff perfor' both functions part of the time. All staff perform duties in incident and emergency res w a.

At the time of the review, all staff had been with the program for the entire review period. Two l- staff left the program in 1997,'and one staff member was assigned work outside the Bureau L which amounted to half of his time. From supervisor interviews and a review of the position descriptions, the team determined that successful candidates for technical positions are required to have a Bachelor's degree in science or engineering and at least two years of experience in the environmental radiation field.

  ~

1 l l New York Draft Report . Page 20 From the review of the technical qualifications of the current staff, the team concluded that the State has been able to hire qualified individuals. In interviews with the staff and a review of documents, the team determined that there was no  ! written training policy. Because of the small number of inspectors and permit reviewers, NYDEC does not have a formal qualification program. New staff have been trained in . ! pedorming inspections and reviewing permit applications individually by the permit unit supervisor, inspectors in training move through the following stages: (1) accompanying experienced inspectors as observers; (2) assisting experienced inspectors; (3) taking the lead in inspections, assisted by experienced inspectors; and (4) performing inspections independently. Inspectors move through these stages based on the assessment of the unit i

supervisor. The same staff are trained to review permit applications by reviewing first minor -  !

amendments and routine renewals, then applications of increasing complexity. All permitting  ! decisions are reviewed by the permit unit supervisor and the radiation section supervisor. The i review team recommends that NYDEC document its training program to include overall policy i and minimum training requirements for both the permitting and compliance staff. Based on the IMPEP evaluation criteria, the review team recommends that NYDEC's l pedormance with respect to the indicator, Technical Staffing and Training, be found , satisfactory. i 3.4 Technical Quality of Licensina Actions The teams examined completed licensing casework and interviewed the reviewers for specific licenses as specified for each of the four New York programs. Licensing actions were evaluated for completeness, consistency, proper isotopes and quantities used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for accuracy, . ! appropriateness of the license and of its conditions and tie-down conditions, and overall technical quality. Casework was evaluated for timeliness, adherence to good health physics practices, reference to appropriate regulations, documentation of safety evaluation reports, ! product certifications or other supporting documents, consideration of enforcement history on ! renewals, pre-licensing visits, peer or supervisory review as indicated, and proper signature l - authorities. The files were checked for retention of necessary documents and supporting data. 3.4.1 New York City Department of Health (NYCH) - Technical Quality of Licensing Actions The licensing casework was selected to provide a representative sample of licensing actions which had been completed in the review period and to include work by all reviewers. The cross-section sampling included all of NYCH's major licenses as defined by NYCH in the questionnaire, and included the following types: broad scope medical; broad scope academic; gamma knife; hospital nuclear medicine; private practice physicians nuc! ear medicine; teletherapy; high dose remote afterloaders; blood irradiators; bone mineral analyzers; and in vitro laboratories. Nineteen license files were reviewed. Licensing actions included three new licenses, nine renewals,28 amendments, two terminations, and one license rescinded. A list of these licenses with case-specific comments can be found in Appendix D-1. In discussions with NYCH management, it was noted that there are no major decommissioning efforts underway 1

New York Draft Report Page 21 with regard to agreement material in New York City. Also, there are no identified sites with potential decommissioning difficulties equivalent to those sites in NRC's Site Decommissioning Management Plan. The only exemptions issued were to physicians requesting the carbon 14 urea breath test recently approved by NRC. The team found that the licensing actions were thorough, complete, consistent, of high quality, and with health and safety issues properly addressed. The licensee's compliance history . appeared to be taken into account when reviewing renewal applications as determined from documentation in the license files or discussion with license reviewers. The review of the two . gamma knife licenses indicates license reviewers should pay close attention to the conditions of use listed in the SS&D registry for these type of devices. The team discussed with NYCH staff how they addressed these conditions since there was limited documentation in the file. Several of the conditions were individually considered by NYCH staff and others were not because NYCH staff considered them as being covered through the manufacturer operating procedures

       . and/or training program. The review team suggests that NYCH consider documenting how the SS&D conditions of use were addressed for the two gamma knife licenses and will be -

addressed in future SS&D licensee's actions. In NYCH's letter dated February 17,1998, the NYCH responded to this suggestion by adding a memo to the license reviewer's handbook that instructs reviewers to include as license conditions the specific language from the SS&D Registry dealing with the restrictions of use or recommendations concerning safety matters as appropriate. The team found that terminated licensing actions and the license rescinded were well documented, showing appropriate transfer records and survey records. For the case that the license was rescinded, NYCH took possession of licensed material for proper disposal. I Licenses are renewed on a 5-year frequency. Licenses that are under timely renewal are amended as necessary to assure public health and safety issues are addressed during the period that the license is in the renewal process. Each licensing action receives management review before the action is finalized and issued. Intenriews with the licensing staff indicate that there is discussion between reviewers and management on complex licensing actions completed by management. The license reviewers submit all deficiency letter replies and a date stamped final licensing action to management for review and management signature. If approved, management signs the action, then the license is held for license fee payment. The date of payment is the issuance date of the license action. The difference between these two dates may cause initialinspection scheduling difficulties. The review team suggests that NYCH list the date the licensing action is issued (date of fee payment) on the license and in their ! database, instead of the date of management signature. In NYCH's letter dated February 17, l 1998, the NYCH responded to this suggestion by upgrading their radiation database to trigger l an inspection due date based on the actual date of issuance of the new license rather than the j g date the license was signed. j l The casework'was reviewed for adequacy and consistency with the NYCH procedures. The casework review also indicated that the NYCH reviewers follow their licensing guides during the review process to ensure that licensees submit the information necessary to support the license. The licensing guides are similar to NRC guides.

 ^

i New York Draft Report Page 22 i l l l Based on the IMPEP evaluation criteria, the review team recommends that NYCH's

                                                                                                                                                      ]

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

3.'4.2 New York State Department of Labor (NYDL)- Technical Quality of Licensing Actions The team examined completed licenses and casework for 16 license actions, representing the work of four license reviewers. The license reviewers and program manager were interviewed to supply additional information regarding licensing decisions or file contents.

The license casework was selected to provide a representative sample of licensing actions which had been completed in the review period, and to include work by all reviewers. The ( sampling included the following types: research and development; manufacturing and L

                                              . distribution; industrial radiography; portable gauges; fixed gauges; gas chromatograph; commercial broad scope, and nuclear pharmacy. Licensing actions reviewed included two new licenses, six renewals, six amendments, and two terminations. A list of these 16 licenses with case specific comments can be found in Appendix D-2. In discussions with NYDL staff, the team noted that NYDL is currently performing confirmatory measurements at the

decommissioning of the Cintichem facility with regard to agreement materialin New York.

1 The team found that the licensing actions were very thorough, complete, consistent, of high quality, and with health and safety issues properly addressed. The licensee's compliance history is taken into account when reviewing renewal applications as determined from documentation in the license files and/or discussions with the license reviewers. Generic .

                                               - notices were issued to specific classes of licensees to address particular safety concerns, such as, a notice on bumpers for Amersham 660 radiography cameras.

One of the licensing actions examined by the team required the licensee to submit financial assurance. The originals of financial documents could not be located. Based on discussions with the program manager and a review of the original financial assurance documents ! maintained in NYDL's Manhattan office, the team determined that some licensees: (1) are no longer required to have financial assurance; (2) were inconsistent in designating the obligee; and (3) did not have a trust agreement with each financial mechanism. Prior to this review, NYDL sent a letter to its licensees requesting them to review their financial assurance and update their financial mechanism. The review team recommends that NYDL continue to audit their financial assurance files to ensure that they contain all required information and are current with NYDL requirements. The team found that terminated licensing actions were well documented, showing appropriate transfer records and survey records. A review of the licensing actions over the period showed that most terminations were for licensees possessing reated sources. These files showed that documentation'of proper disposal or transfer was available. Licenses are renewed on a 3-year frequency. The NYDL performs a complete review during

                                              . every other 3-year cycle to ensure that the license's radiation safety program is adequate and        ]

meets current NYDL requirements. Licenses that are under timely renewal are amended as ) necessary to assure that public health and safety issues are addressed during the period that i J l I

                . New York Draft Report                                                                       Page 23 the license is in the renewal process. Unless reviewed by the two individuals with signature authority, each licensing action receives a supervisory chain review.

1 At the time of the review, there were 57 renewals greater than a year old, and 27 amendments l and two new applications greater than 6 months old. Based on discussions with NYDL program manager, the program receives approximately 300 licensing actions a year and the total number of pending actions is approximately 200 actions. The total number of pending actions ' has been reduced in half compared to the last review period. The team found that the current staff is well trained and experienced in a broad range of licensing activities. The casework was reviewed for adequacy and consistency with NYDL procedures. The casework review indicated that NYDL staff follows their licensing guides ~ during the review process to ensure that licensees submit the information necessary to support

                  .the license. The licensing guides are similar to NRC guides. The NYDL has developed simplified licenses for fixed gauges and gas chromatograph licenses that do not require a license tie-down condition. The NYDL also issues notices to its licensees to alert them to changes in regulatory requirements or to emphasize a particular area of concern identified by NYDL or another agency.

Based on the IMPEP evaluation criteria, the review team recommends that NYDL's performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory. , j 3.4.3 New York State Department of Health (NYSH) - Technical Quality of Licensing l Actions l The team examined completed licensing casework and interviewed the reviewers for 21 specific 1 l ~

                 . licenses. The licensing casework was selected to provide a representative sample of licensing actions which had been completed in the review period and to include work by all reviewers.

The cross-section sampling included all of NYSH's major licenses as defined by NYSH in the questionnaire and included the following types: ' academic-broad; research and development- ' specific; research and development-broad; irradiator; medical (broad with high dose remote afterloader, private practice, hospital, nuclear cardiology, mobile nuclear medicine site, brachytherapy, teletherapy, and high dose remote afterloader); and clinical laboratory. Licensing actions included six new licenses, seven renewals, one amendment, and seven terminations. A list of these licenses with case-specific comments can be found in Appendix D-3. The team found that the licensing actions were very thorough, complete, consistent, of h;gh quality, and with health and safety issues properly addressed. The licensee's compliance history is taken into account when reviewing renewal applications as determined from documentation in the license files and/or discussions with the license reviewers. Generic notices were issued to specific classes of licensees to address particular safety concerns, such as, a notice on HDR issues. l in discussions with NYSH management, it was noted that there were no major decommissioning efforts underway with regard to agreement material in the NYSH program.

                ' Also there were no identified sites with potential decommissioning difficulties equivalent to l

l

New York Draft Report ' Page 24 those sites in NRC's Site Decommissioning Management Plan. The team found that terminated licensing actions were well documented,' showing appropriate transfer records and survey records. Certain standard license conditions were noted in some licenses and not in other licenses of the same class.' A license reviewer informed the team that this standard license condition should be put on all licenses. As this issue was pursued, the team was then informed that this standard license condition is now in the regulations. When NYSH standard license conditions are superseded by the regulations, are obsolete, or new standard license conditions are added, the list of standard license conditions is not revised. The review team suggests that NYSH's standard license conditions be revised periodically to ensure consistency with the updated

         -regulations and that old and superseded standard license conditions be deleted.                     l Based on the IMPEP evaluation criteria, the review team recommends that NYSH's performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.

3.4.4 New York State Department of Environmental Conservation (NYDEC) - Technical Quality of Licensing Actions The team examined completed licenses and casework for 14 license actions in 14 specific license files, representing the work of six license reviewers. The license reviewers and the Section Chief were interviewed when needed to supply additional information regarding

         - licensing decisions or file contents.

The license casework was selected to provide a representative sample of licensing actions which had been completed in the review period and to include work by all reviewers. The sampling included the following types of permits issued under Part 380 of the New York State Code of Regulations: air effluents, incinerators, water discharge, and environmental study. Licensing actions reviewed included three new licenses, three renewals, two amendments, three terminations, and three inquiries. Inquiries are permit applications or facility evaluations initiated by the radiation staff to determine if licensees discharging radioactive materials to the environment in their effluent exceed the 10% exemption threshold. A licensee is required to have a permit if the annual average effluent concentration of the licensee's discharge exceeds 10% of the NYDEC's regulatory limit in Table 11 of Part 380. If the licensee's discharge is less than 10% of NYDEC limits, then a permit is not needed; however, the licensee is still required to survey and maintain appropriate records to demonstrate compliance with Part 380. A list of the 14 permits and inquiries reviewed with case specific comments can be found in Appendix D-4. The team found that the licensing actions were very thorough, complete, consistent, of high quality, and with health and safety issues properly addressed. The licensee's compliance history appeared to be taken into account when reviewing renewal applications as determined from documentation in the license files and/or discussions with the license reviewers. No exemptions were issued by NYDEC during this review period.

         . The team found that terminated licensing actions were well documented, showing either appropriate survey records or documentation that the licensee's effluents did not exceed the 10% exemption limit.' A review of the licensing actions over the period showed that a majority

New York Draft Report Page 25 of terminations were for permittees whose effluents were reduced to less than the 10% exemption limit. Permits are issued or renewed with a 5-year expiration period. The radiation staff occasionally issues a permit for a shorter period, but this is done to coincide expiration dates with other NYDEC permits issued to the facility. Permits that are under renewal are amended as necessary to assure that public health and safety issues are addressed during the period that the permit is undergoing the renewal process. Each licensing action receives a supervisory chain review.

                                        ~

The team found that the current staff is well trained and experienced in licensing activities related to discharge of radioactive material into the environment. The casework was reviewed for adequacy and consistency with the NYDEC procedures. The casework review indicated F that the radiation staff follow their licensing guides during the review process to ensure that licensees submit the information necessary to support the license. The team found the checklists and the worksheets for each type of permit to be comprehensive and incorporated excellent notes to reviewers to assist in the review of applications. Based on the IMPEP evaluation criteria, the review team recommends that NYDEC's performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory. 3.5 Resoonse to incidents and Allegations 3.5.1 New York City Department of Health (NYCH) - Response to incidents and Allegations in evaluating the effectiveness of NYCH's actions in responding to incidents and allegations, the team examined NYCH's response to the questionnaire relative to this indicator, reviewed the incidents reported for NYCH in the " Nuclear Material Events Database (NMED)", and those contained in the City's casework and license files, and supporting documentation, as  ; appropriate for eight incidents. A list of the incident casework with comments is included in i Appendix E-1. The team reviewed NYCH's response to six allegations received during the review period. The eight incidents selected for review included two misadministration, one lost package of radioactive material, two loss of control of radioactive material, two overexposure, and one procedural failure. Of the six allegations reviewed in detail, the NRC Region I office referred one to NYCH and the others came directly from allegers. During the review period, NRC referred 10 allegations to NYCH. All of these allegations have been closed out.

   - Responsibility for initial response and follow up actions to material incidents and allegations rests with NYCH staff. When NYCH is notified of either an incident or an allegation (also referred to as " complaints") during working hours, an inspector takes the incoming notification and briefs the materials inspection supervisor or the Director of NYCH to determine the approach to be taken. Incoming complaints are considered either immediate or non immediate based on their apparent safety significance. The supervisor assigns the complaint to one of the g    inspectors who will respond the same day or next if the complaint is immediate, or a longer

                                                           ^

l (New York Draft Report Page 26 period if non-immediate. The NYCH provides a 24-hour emergency number for anyone to report emergencies involving hazardous materials. The NYCH can also receive notification

                                           ' through the State Warning Point (State operated emergency line). When a radiological incident is reported after work hours, NYCH staff is contacted at home.

The review of incident casework, licensing casework, and interviews with staff revealed that incidents are promptly evaluated for the need for on site investigations. For those incidents not requiring on-site investigations, copies of letters to licensees were in the incident and licensing -

                                           ' files indicating that the incident would be investigated during the next scheduled inspection, in response to incidents, NYCH took prompt, appropriate action. The review of casework
                                           - indicated that incident reports were thorough and well-documented. The team found that i
                                            ~ NYCH's complaint file is maintained manually with a copy in the appropriate specific license file.

Documentation on incidents or allegations involving non-licensees are maintained solely in the complaint file. These reports included sections on the background, findings, conclusions / recommendations, instruments used, and signatures. The team noted that some of the non immediate complaints were documented on a preprinted two sided " complaint control record" form. The incident reports were reviewed and signed by the inspection supervisor. The' team did note that follow up to incidents at the next inspection was not always documented in the field notes.- The review team suggests that NYCH investigated incidents be clearly . documented in the field notes at the next inspection. The team reviewed NYCH's process for reporting significant events immediately or 24 hour notification. The team determined that NYCH was inconsistent in reporting significant events to l the NRC Operations Center. The team also queried the incident information reported on the NMED system for NYCH which identified 11 reported materialincidents. These incidents were not based on reports submitted by NYCH, but through other notification mechanisms such as preliminary notification or calls to the NRC Operations Center. Although NYCH staff has been provided training on the NMED system, they have not been providing periodic reports on reportable events. During the exit meeting on January 30,1998, and their letter dated

                                            ' February 17,1998, NYCH and Department management committed to providing information on reportable events to NMED including those reportable events that occurred during fiscal years 1996 and 1997. The review team recommends that NYCH notify the NRC Operations Center within 24 hours for all significant events and provide complete follow-up documentation to NMED on reportable events.

The review of the allegation files indicated that NYCH took prompt and appropriate action in response to allegers' concerns. These action included detailed interviews with the allegers, prompt investigation and routine follow up at the next inspection, when warranted. The NYCH < protects the identity of the alleger if requested. The review of the casework and interviews of staff determined, however, that NYCH staff did not document any feedback to the alleger on NYCH's investigation into the allegation and NYCH's findings. The review team suggests that NYCH include written documentation that the alleger has been contacted regarding the results of NYCH's findings into the alleger's concerns. In NYCH's letter dated February 17,1998, the NYCH responded to this suggestion by confirming that documentation to file will indicate that allegers were notified of the results of investigations. Based on the IMPEP evaluation criteria, the review team recommends that NYCH's performance with respect to the indicator, Response to incidents and Allegations, be found satisfactory. l l

New York Draft Report Page 27 3.5.2 New York State Department of Labor (NYDL)- Response to incidents and Allegations in evaluating the effectiveness of NYDL's actions in responding to incidents, the team examined NYDL's response to the questionnaire relative to this indicator, NYDL's written procedures for incident response, and the incidents reported for NYDL in the " Nuclear Material Events Database (NMED)." The team examined NYDL's incident and license files and supporting documentation for 13 incidents, in all cases reviewed, once notification was received, NYDL promptly responded and adequately protected public health and safety, incidents were adequately documented in the files and when they involved a licensee of NYDL, the incident i was also reviewed at the next routine inspection. Issues and concerns arriving out of these incidents that involved other regulatory agencies were referred to the appropriate agency by NYDL. A list of the incident casework with comments is included in Appendix E-2. The team reviewed NYDL's process for reporting significant NYDt ovents (immediate or 24-hour notification). The team determined that NYDL was inconsistent in reporting significant events to the NRC Operations Center. During the review period, NYDL had made only one summary report of incidents for inclusion in the NMED system. For the NMED system to effectively identify in a timely manner any generic problems with equipment or procedures, NYDL must routinely submit the vital information on the incidents that occur in their jurisdiction to the NMED system. The review team recommends that NYDL notify the NRC Operations Center within 24 hours for all significant events, and provide complete follow-up documentation to NMED on all reportable events. In evaluating the effectiveness of NYDL's actions in responding to allegations, the team examined NYDL's response to the questionnaire relative to this indicator and NYDL's written procedures for response to allegations. The team reviewed NYDL's response to seven allegations, including the allegation referred to NYDL by NRC. NRC referred a total of three allegations to NYDL. All of them have been closed out. A!! possible allegations are evaluated by NYDL's Director to determine the level of investigation they may merit. Not all allegations referred to NYDL by the NRC were considered allegations by NYDL. Two of the NRC referred allegations selected for review were not in NYDL's allegation files but had been answered by letters to NRC from the Director, because in her evaluation they should not be included as NYDL investigated allegations. Based on the information provided by NYDL, NRC closed these allegations. The NYDL responded promptly with on-site investigations to the four allegations reviewed with potential ongoing conditions that could lead to excessive exposures. The NYOL's response to allegations was timely and appropriate for the significance of the allegation. NYDL protects the identify of the alleger, when requested. In two of the seven files reviewed, NYDL's allegation tracking system did not document that a closed investigation had in fact been closed out. The NYDL's tracking system does not indicate if the alleger was informed of the results of the investigation nor is this required by the NYDL's allegation procedures. The review team suggests that attention be given to NYDL's tracking system for allegations to ensure that the system accurately indicates when the response to each allegation has been completed and the , matter is considered closed out. Based on the IMPEP evaluation criteria, the review team recommends that NYDL's performance with respect to the indicator, Response to incidents and Allegations, be found satisfactory.

I New York Draft Report Page 28 3.5.3 New York State Department of Health (NYSH)- Response to incidents and

                  . Allegations In evaluating the effectiveness of NYSH's actions in responding to incidents and allegations, the
    . team examined NYSH's response to the questionnaire relative to this indicator, the incidents t

reported for New York in the " Nuclear Material Events Database (NMED)," those incidents contained in NYSH's casework and license files, and supporting documentation,- as appropriate for 12 incidents. A list of the incident casework with comments is included in Appendix E-3. The team reviewed NYSH's response to five allegations received during the review period. The 12 incidents selected for review included three misadministration, one leaking source, two loss of control of radioactive material, one overexposure, two equipment failures, two releases of radioactive material, and one contamination event. Of the five allegations reviewed, the NRC Region I office referred one to NYSH and the others came directly from allegers. The NYSH _use the same process for handling incidents and allegations. Responsibility for initial response and follow up actions to material incidents and allegations rests with the staff. When NYSH is notified of either an incident or an allegation during working hours, an inspector takes the incoming notification and briefs the Section Chief in Albany or the field supervisor in Syracuse to determine the approach to be taken. Either supervisor will evaluate the potential

    - safety significance of the incident / allegation to determine the type of response that NYSH will take.- Although staff and supervisors are located in five different offices around the State, the team noted effective use of NYSH's e-mail system to communicate and document actions taken for any of the events. The NYSH has a 24-hour number to report radiological                                                    i emergencies through the State Warning Point. The notification list includes after work hours phone numbers for NYSH staff.

The review of incident and licensing casework, and interviews with staff revealed that incidents are promptly evaluated for the need for on site investigations. For those incidents not requiring on-site investigations, copies of letters to licensees were in the incident and licensing files indicating that the incident would be investigated during the next scheduled inspection. In i response to incidents, NYSH had taken prompt, appropriate action. The review of casework l indicated that incident reports were thorough and well-documented. The team found that incident and allegations events are tracked on a computerized system and filed on monthly basis. Each event is classified by the type of accident / incident (including a category for allegations) and includes a summary sheet with an event description, contact person, site name and responsible party, follow up, outcome, and if the event has been closed out. Detailed l: information on each event such as telephone conversations and close out memorandums are l maintained in the incident file and, if a specific licensee is involved, in the appropriate docket

    - file. Documentation on incidents or allegations involving non-licensees are maintained solely in the incident file. The event reports are reviewed and signed by the Bureau Chief on a monthly basis. The team did note that incidents were generally followed up at the next inspection.

The team reviewed NYSH's process for reporting significant (immediate or 24-hour notification) events. The team determined that NYSH was inconsistent in reporting significant events to the NRC Operations Center. The team also queried the incident information reported on the NMED j system for NYSH which identified six reported material incidents plus one abnormal occurrence. I Although NYCH staff has been provided training on the NMED system, they have not been providing periodic reports on reportable events. The team determined that NYSH last reported 4

New York Draft Report Page 29 incidents to the NMED system in April 1997. The NMED system does not include NYSH reports since that time. During the exit meeting on April 3,1998, NYSH staff and management indicated that a new tracking system was under development to track incidents and allegations, and that NYSH would explore interfacing their software to allow transfer of reportable events to NMED. The review team recommends that NYSH notify the NRC Operations Center within 24 hours for all significant events, and provide complete follow-up documentation to NMED on all reportable events. The review of the allegation files indicated that NYSH has taken prompt and appropriate action in response to the allegers' concerns. The review of casework and interviews of staff determined staff provided feedback on the follow-up findings to the alleger. The identity of the alleger is protected by NYSH. Based on the IMPEP evaluation criteria, the review team recommends that NYSH's performance with respect to the indicator, Response to incidents and Allegations, be found satisfactory. 3.5.4 New York State Department of Conservation (NYDEC) - Response to incidents and Allegations in evaluating the effectiveness of NYDEC's actions in responding to incidents and allegations, the team examined NYDEC's response to the questionnaire regarding this indicator, the incidents reported for State of New York in the NMED against those contained in the NYDEC files, and the casework and supporting documentation for four material incidents and five allegations. The four incidents selected for review included two releases of radioactive material, one damage to equipment and one release of equipment resulting from equipment and procedural failure'and are listed in Appendix E-4. Of the five allegations reviewed, NRC Region I office referred four to NYDEC and the other one came directly to NYDEC from an alleger. The team noted during file reviews and confirmed during discussions with staff that a majority of the incidents received by the Radiation Section are radiation alarms at solid waste and regulated medical waste facilities involving patient excreta, exempt material, or NARM material. Responsibility for initial response and follow-up actions to material incidents and allegations rests with Radiation Section staff. When the NYDEC is notified of an incident during working hours, either the Section Chief or the Program Director is consulted to evaluate the safety significance of the event and determine the course of action to be taken. For incidents during non work hours, NYDEC's radiation management can be contacted through the New York's State Warning Point. Radiation Section management also indicated that NYDEC sometimes coordinates the response to an incident with one of the State licensing agencies (NYCH, NYSH, and NYDL) which have staff in regional offices in the vicinity of the incident. The review of incident and licensing casework, and interviews with staff revealed that incidents are promptly evaluated for the need for on-site investigations. For those incidents not requiring on-site investigations, copies of letters to licensees were in the licensing files indicating that the incident would be investigated during the next scheduled inspection. The team noted that the Radiation Section is currently evaluating the radiation detection systems at solid waste and I regulated medical waste facilities in an effort to prepare guidance for setting a radiation level for

Ne' "ork Draft Report Page 30 rejecting a shipment of waste containing radioactive material. Solid waste and regulated medical waste facilities are required by permit to monitor incoming waste for radioactivity, store the radioactive material in shielded areas, and report an alarm to NYDEC. In responding to incidents and allegations, NYDEC took prompt, appropriate actions. The review of casework indicated that incident reports are thorough and well-documented. The incident reports were reviewed and signed by the section supervisor. The team noted that documentation relating to the follow up to allegations pertaining to licensed material or operations is maintained in the licensing files. The other allegations are in the incident / allegation file. It was also noted that the Radiation Section's procedural manual does not address the handling of incidents and allegations. The review team recommends that 1 NYDEC incorporate the handling of incidents and allegations into their inspection procedures. ) l The team reviewed NYDEC's process for reporting significant (immediate or 24-hour i notification) events. The team determined that NYDEC was inconsistent in reporting significant events to the NRC Operations Center. The NYDEC's response to the questionnaire indicated that reporting of events to NMED is not their responsibility. During the team's discussions with l NYDEC management, they indicated that the licensing agency (NYDEC issues permits) would ' be responsible for reporting events to NMED and to NRC. A review of the information reported on an NMED system printout for the State of New York indicated one event reported to NMED by NYDL that NYDEC also treated as an incident. The review team recommends that NYDEC l coordinate with the appropriate New York licensing agency, the notification to the NRC l Operations Center within 24 hours for all significant events, and to NMED for all reportable  ! events involving permitted activities. NYDEC maintains a chronological file of radiation alarms at solid waste and regulated medical l waste facilities. Other incidents reported to the Radiation Section are maintained in the I appropriate licensing file, but there is no corresponding incident file for these events. The review team suggests that NYDEC maintain one file for all types of incidents involving radioactive material. Based on the IMPEP evaluation criteria, the review team recommends that NYDEC's performance with respect to the indicator, Response to Incidents and Allegations, be found satisfactory. 4.0 NON-COMMON PERFORMANCE INDICATORS The IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal i Program; and (4) Uranium Recovery Program. The New York agreement does not cover the uranium recovery program, so only the first three non-common performance indicators were applicable to this review.

New York Draft Report Page 31 4.1 Lealslation and Proaram Elements Reauired for Compatibility 4.1.1 New York City Department of Health (NYCH)- Legislation and Program Elements Required for Compatibility l' 4.1.1.1 Legislation - > Along with their response to the questionnaire, NYCH provided the team with the opportunity to review copies of legislation that affect the radiation control program. Legislative authority for i NYCH's portion of the Agreement State program is granted in Chapter 22 of the New York City Charter (specifically Section 556(s)). NYCH's radiation program is delegated from the NYSH program under Part 16 of the New York State Health Code which provides for delegation to l- local governments when covering greater than two million individuals. The team noted that the legislation and delegation has not changed since being found adequate during the previous

     . review, and found that the City Charter is adequate.

4.1.1.2 Proaram Elements Reauired for Compatibility The NYCH Regulations for Control of Radiation, found in Article 175 of the New York City ( Health Code - Radiation Control, apply to all ionizing radiation, whether emitted from i radionuclides or devices. New York City requires a license for possession, and use, of all L radioactive material including naturally occurring materials, such as radium, and accelerator-l produced radionuclides. New York City also requires registration of all equipment designed to produce x-rays or other ionizing radiations. [ The team examined the procedures used in NYCH's regulatory process and found that it is a six step process that takes between six months to a year to complete depending on the I complexity of the rule change. L The team evaluated NYCH's responses to the questionnaire and reviewed the regulations

adopted by NYCH since the 1995 review to determine the status of the NYCH regulations unde'r  ;

the Commission's new adequacy and compatibility policy. The team found that the NYCH did i not promulgate any new regulations since the last review. h l NYCH has not adopted the following regulations within the 3-year time frame: e " Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and 70 amendments (59 FR 36026) that became effective August 15,1994. The rule is being - l evaluated by NYCH's Office of General Counsel with an expected date for adoption of

         - September 1998.

l

      * " Frequency of Medical Examinations for Use of Respiratory Protection Equipment," 10 CFR
          - Part 20 amendment (60 FR 7900) that became effective March 13,1995. The NYCH has H           decided to not proceed with a rulemaking and will retain the more stringent requirement of annual medical examinations. At this time, NYCH does not have any licensees that use respiratory protection equipment.

o " Low Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 , amendments (60 FR 15649 and 25983) that became effective March 1,1998. The l-l'

New York Draft Report Page 32 Agreement States are to promulgate their regulations no later than March 1,1998 so that NRC and the State would require this national system to be effective at the same time. NYCH has this rule under review with their General Counsel to determine whether any additional rulemaking is needed, since NYDEC has this rule in place and it applies to all NYCH licensees. NYCH has not yet adopted the following regulations that are applicable to the NYCH program, but intends to address them in timely rulemakings or by adopting alternate generic legally binding requirements: e " Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective August 14,1995. 1

                     -*   " Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40 and 70 amendments (60 FR 38235) that became effective November 24,1995.

e "10 CFR Part 71: Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248 and 61 FR 28724) that became effective April 1,1996. e " Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20 and 35 amendments (60 FR 48623) that became effective October 20,1995. e " Termination or Transfer of Licensed Activities: Recordkeeping Requirements," 10 CFR Parts 20,30,40,61, and 70 amendments (61 FR 24669) that became effective May 16, 1996. e " Recognition of Agreement State Licensees in Areas Under Exclusive Federal Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective January 13,1997. 4 e " Criteria for the Release of Individuals Administered Radioactive Materials," 10 CFR Parts 20 and 35 amendments (62 FR 1662) that became effective May 29,1997. e " Radiological Criteria for License Termination," 10 CFR Part 20,30,40, and 70 amendments (62 FR 39058) that became effective August 20,1997. 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. Based on the IMPEP evaluation criteria, the review team recommends that NYCH's ' performance with respect to the indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory.

New York Draft Report Page 33 4.1.2 New York State Department of Labor (NYDL) - Legislation and Program Elements i Required for Compatibility 4.1.2.1 Legislation Along with their response to the questionnaire, NYDL provided the team with the opportunity to review copies of legislation that affect the radiation control program. Legislative authority for NYDL to administer its portion of the Agreement State program is granted in Section 27 of the Labor Law and Article 28-D of the General Business Law. The NYDL is designated as the radiation control agency for industrial and commercial uses of radioactive materials. The team noted that the legislation has not changed since being found adequate during the previous review and found that the State legislation is adequate. 4.1.2.2 Proaram Elements Reauired for Compatibility The NYDL Regulations for Control of Radiation, found in Part 38 of Title 12 c.f the Official Compilation of Codes, Rules and Regulations of the State of New York (12 NYCRR Part 38) apply to all commercial and industrial uses of radioactive materials. The NYDL requires a license for possession and use of all radioactive material for commercial and industrial I purposes including naturally occurring materials, such as radium, and accelerator-produced I radionuclides. I The team examined the procedures used in NYDL's regulatory process and found that it is a 6-step process that takes between six to 12 months to complete. The team evaluated NYDL's responses to the questionnaire and reviewed the regulations .l adopted by the State since the 1995 review to determine the status of the NYDL regulations  ! under the Commission's new adequacy and compatibility policy. The team found that the NYDL addressed the following NRC regulation amendments; however, they have not been finalized i and, therefore, they have not been cdopted within the 3-year time frame: e " Licensing and Radiation Safety Requirements for irradiators," 10 CFR Part 36 (58 FR 7715) that became effective July 1,1993. e " Decommissioning Recordkeeping: Documentation Additions," 10 CFR Parts 30,40, and 70 amendments (58 FR 39628) that became effective October 25,1993, e "Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40, and 70 amendments (59 FR 1618) that became effective January 28,1994. 7 - e ." Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and 70 amendments (59 FR 36026) that became effective August 15,1994.

    * " Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32, and 35 amendments (59 FR 61767 and 65243) that became effective January 1,1995.
     * " Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61             ;

amendments (60 FR 15649 and 25983) that became effective March 1,1998. Note: The

l New-York Draft Report Page 34 Commission delayed the effective date to March 1,1998 so that the Agreement States could oromulgate and implement these requirements at the same time. These rule changes, as well as others, are in a package that has been under review by NYDL's General Counsel's office for approximately a year. The review team recommends that NYDL management take appropriate action to move the rule package through the rule promulgation process. At the State exit meeting on May 12,1998, the team was informed that this rule package was released from the General Counsel's office and should be final by the end of 1998. The NYDL has not yet adopted the following regulations, but intends to address them in timely rulemakings or by adopting alternate generic legally binding requirements: e " Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective August 14,1995. e " Clarification of Decommissioning Funding Requirements,"10 CFR Parts 30,40 and 70 amendments (60 FR 38235) that became effective November 24,1995. e " Termination or Transfer of Licensed Activities: Recordkeeping Requirements," 10 CFR l Parts 20,30,40,61 and 70 amendments (61 FR 24669) that became effective May 16, 1996.

e " Recognition of Agreement State Licensees in Areas Under Exclusive Federal Jurisdiction I Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became effective January 13,1997.

j e " Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial Radiography Operations," 10 CFR Parts 30,34,71 and 150 amendments (62 FR 28947 that became effective June 27,1997. l * " Radiological Criteria for License Termination," 10 CFR Part 20,30,40 and 70 amendments l (62 FR 39058) that became effective August 20,1997. ! l Based on the IMPEP evaluation criteria, the review team recommends that NYDL's i

performance with respect to the indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory with recommendations for improvements.

, 4.1.3 New York State Department of Health (NYSH)- Legislation and Program Elements ! Required for Compatibility 4.1.3.1 Legislation l Along with their response to the questionnaire, the NYSH provided the team with the 1 opportunity to review copies of legislation that affect the radiation control program. Legislative j authority for NYSH's portion of the agreement with the NRC is granted in New York Public , Health Law, Article 2, Title ll, Sections 201 and 225. NYSH is responsible for regulating the l medical, academic and research uses of radioactive materials. The review team noted that the j 1 1

I New York Draft Report Page 35  ! legislation has not changed since being found adequate during the previous review, and found that the State legislation is adequate. 1 4.1.3.2 Program Elements Required for Compatibility L The NYSH Regulations for Control of Radiation, found in 10 NYCRR Chapter 1, Part 16 l

       -(lonizing Radiation), Part 76 (Public Health Administrative Tribunal), and Part 405 (Hospitals -

Minimum Standards) of the New York State Public Health Code apply to ionizing radiation, whether emitted from radionuclides or devices used for medical, academic, or research and development. NYSH requires a license for possession and use of all radioactive material, including naturally occurring radioactive materials, such as radium, and accelerator-produced radionuclides for medical, academic, or research and development. NYSH also requires

registration of all equipment designed to produce x-rays or other ionizing radiations.

The team examined the procedures used in NYSH's regulatory process and found that it is a ten step process that takes approximately 12 to 18 months, depending on the complexity of the action. The team evaluated NYSH's responses to the questionnaire and reviewed the regulations l adopted by the State since the 1995 review to determine the status of the NYSH regulations under the Commission's new adequacy and compatibility policy. The team noted that NYSH addressed the following NRC regulation amendments e . " Termination or Transfer of Licensed Activities: Recordkeeping Requirements," 10 CFR l Parts 20,30,40,61 and 70 amendments (61 FR 24669) that became effective on May 16, 1996. The NYSH has decided to address the above decommissioning and financial assurance regulations with the use of license conditions. The NYSH identified nine licensees that are subject to the financial assurance requirements. NYSH has imposed license conditions on five of these licensees and has requested information from the others so that appropriate conditions can be developed. The team reviewed the license conditions and verified that they are being used. Additional license conditions addressed the timeliness and records retention requirements in that the licensees must submit a decontamination plan to NYSH for approval 90 days prior.to ceasing operations and must keep all records of spills and incidents until the license is terminated. The team considers these license conditions adequate implementation of the intent of the decommissioning and financial assurance t rules. !' e " Emergency Preparedness for Fuel Cycle and Other Radioactive Materials Licensees," 10 CFR Parts 30,40 and 70 amendments (54 FR 14051) that became effective April 7,1990. The team reviewed the assessment done by NYSH and agree that they do not have any licensees that are subject to this requirement. Therefore, they have not adopted this rule.

            " Licensing and Radiation Safety Requirements for irradiators," 10 CFR Part 36 (58 FR 7715) that became effective July 1,1993. The NYSH authority in this area would only apply to large research irradiators not commercial operations. Therefore, NYSH has not adopted 10 CFR Part 36 equivalent regulations, but has licensed a facility using the safety requirements in their Part 16.12(f), which are equivalent to the requirements moved from 10 CFR Part 20 to Part 36 when it was promulgated. In addition to these safety requirements, l

L

l New York Draft Report Page 36 NYSH has imposed the other Part 36 requirements through license conditions. The team found this approach acceptable. e . " Notification of Incidents," 10 CFR Parts 20,30,31,34,39,40 and 70 amendments (56 FR 64980) that became effective October 15,1991. The team reviewed the requirements in Part 16.15 and identified that they do not fully address the notification requirements in this , rulemaking. The NYSH indicated that they would review this icsue further. l e " Frequency of Medical Examinations for Use of Respiratory Protection Equipment," 10 CFR Part 20 amendment (60 FR 7900) that became effective March 13,1995. At this time, the j NYSH does not have any licensees that use respiratory protection equipment. They are _ l l considering this rule in the next rule amendment package.  ! !- t l The NYSH has not yet adopted the following regulations, but intends to address them in timely rulemakings or by adopting alternate generic legally binding requirements: ) e " Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts 19 I l and 20 amendments (60 FR 36038) that became effective August 14,1995. 1

                                                                                                  -* " Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20 and 35 amendments (60 FR 48623) that became effective October 20,1995.
                                                                                                ' e . " Recognition of Agreement State Licensees in Areas Under Exclusive Federal Jurisdiction Within an Agreement State," 10 CFR Part 150 amendment (62 FR 1662) that became l'                                                                                                            effective January 13,1997.

e " Criteria for the Release of Individuals Administered Radioactive Materials," 10 CFR Parts 20 and 35 amendments (62 FR 1662) that became effective May 29,1997. e - " Radiological Criteria for License Termination," 10 CFR Part 20,30,40, and 70 amendments (62 FR 39058) that became effective August 20,1997. Based on the IMPEP evaluation criteria, the review team recommends that NYSH's performance with respect to the indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory. 4.1.4 New York State Department of Conservation (NYDEC)- Legislation and Program l Elements Required for Compatibility 4.' 1.4.1 Legislation Along with their response to the questionnaire, the NYDEC provided the review team with the l opportunity to review copies of legislation that affect the radiation control program. Legislative authority to create an agency and implernent a portion of the agreement with the NRC is granted in New York State Environmental Conservation Law Articles 1,3,17,19,27, and 29. The NYDEC is designated as the agency responsible for effluents from licensed facilities and environmental contamination as its portion of the State's radiation control program. The review

                                                                                                 - team noted that the legislation has not changed since being found adequate during the previous' review, and found that the State legislation is adequate.

l

New York Draft Report Page 37 4.1.4.2 Proaram Elements Reauired for Compatibility l- The NYDEC Regulations for Control of Radiation, found in Title 6, Parts 380,381,382, and 383 of the New York Codes, Rule, and Regulations (NYCRR) apply to environmental releases and the disposal of radioactive materials. The NYDEC requires a permit for release of radioactive materials to the environment including the disposal of radioactive materials, including naturally occurring materials, such as radium, and accelerator-produced radionuclides. . The team examined the procedures used in NYDEC's regulatory process and found that it is a l ' eight step process that takes approximately 12 to.18 months. The team evaluated NYDEC's

    ' responses to the questionnaire and reviewed the regulations adopted by the State since the i           1995 review to determine the status of the NYDEC regulations under the Commission's new

! adequacy and compatibility policy. The team found that the State addressed the following NRC regulation amendments: , i e " Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649 and 25983) that became effective March 1,1998. The NYDEC adopted this rule by reference on July 9,1997. The team noted that the reference listed in Section 381.18 was as of January 1,1996. Subsequent changes were made to the ' regulation that are not incorporated by refercnce. The NYDEC will adopt the more recent regulation by reference at the next opportunity to change the rule. e "10 CFR Part 71: Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendments (60 FR 50248 and 61 FR 28724) that became effective April 1,'1996. The NYDEC has adopted the DOT and NRC transportation regulations by reference on July 9, 1997; therefore, no further action is required to make this regulation effective on NYDEC permittees. The team noted that the incorporation by reference was as of January 1,1996 which does not include the corrected tables which were pubhshed in 1996. In addition, NYDEC reference includes those items that are limited to NRC implementation. The NYDEC is reviewing these issues and will address them in a future rulemaking, if necessary. The NYDEC has not yet adopted the following regulations, but intends to address them in timely rulemakings or by adopting alternate generic legally binding requirements: e " Radiation Protection Requirements: Amended Definitions and Criteria," 10 CFR Parts 19 -l and 20 amendments (60 FR 36038) that became effective August 14,1995.

           * " Termination or Transfer of Licensed Activities: Recordkeeping Requirements," 10 CFR Parts 20,30,40,61 and 70 amendments (61 FR 24669) that became effective May 16, 1996.

e " Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act," 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9,1997. e " Criteria for the Release of Individuals Administered Radioactive Materials," 10 CFR Parts

                            . 20 and 35 amendments (62 FR 1662) that became effective May 29,1997.

New York Draft Report Page 38 e = " Radiological Criteria for, License Termination," 10 CFR Parts 20,30,40 and 70 4 amendments (62 FR 39058) that became on effective August 20,1997. I Based on the IMPEP evaluation criteria, the review team recommends that NYDEC's . performance with respect to the indicator, Legislation and Program Elements Required for -{ Compatibility, be found satisfactory. I 4.2 Sealed Source and Device (SS&D) Evaluation Proaram l 1

    . The NYDL has the responsibility for commercial and industrial use of radioactive materials; therefore,-NYDL is the only New York program that has responsibility for the SS&D evaluation program and is the only program reviewed under this indicator. In assessing NYDL's SS&D evaluation program, the team examined information provided by the NYDL in response to the IMPEP questionnaire on this indicator. A review of all completed SS&D evaluations and supporting documents covering the review period was conducted. The team interviewed the staff and supervisor responsible for SS&D evaluations, and examined the staff's use of new l      guidance documents and procedures.

l Since the last review, NYDL has performed one SS&D review which was completed in 1997 involving a static eliminator. Historically, NYDL has performed few SS&D reviews due to the limited number of manufacturers (currently 2 licensees) in New York. Prior to 1997, the last l SS&D review was performed over six years ago by a former employee prior to his retirement. l Due to the infrequent number of SS&D reviews and limited scope and complexity of 1

    - manufactured SS&Ds in the State, NYDL management has not put forth the effort to bring the SS&D program in line with the specific guidelines in Management Directive (MD) 5.6. The .

NYDL management does not feel it is an efficient use of its resources to qualify and maintain j qualification for staff in a discipline that is infrequently needed. The.NYDL has adopted or issued a number of guidance documents to assist in the review of l' SS&Ds, and to help to ensure that all pertinent issues are addressed. These include NRC's

                                                                                                              )

l J NUREG-1550," Standard Review Plan for Applications for Sealed Source and Device .j Evaluations and Registrations"; Regulatory Guide 6.9," Establishing Quality Assurance l Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material"; Policy & Guidance Directive 84-22, Revision 1, "What Source and Device l Designs Require an Evaluation"; and a memorandum as standard reviewer guidance issued February 2,1996, containing draft regulations covering the licensing of manufacturers or initial transferrers of products containing sealed sources to persons generally licensed. Staff uses the checklist from NUREG-1550 to assist in the review of SS&Ds, and help to ensure that all pertinent issues are addressed. In addition, the NYDL has at its disposal a number of additional guidance documents including national and intemational standards, various

regulatory guides, and SS&D workshop materials ('95 and '97 manuals). The supervisor also l

Indicated that they have recently received NUREG-1556, Volume 3, " Applications for Sealed l- Source and Device Evaluation and Registration," and will incorporate it into their review procedures. This document was received after the one SS&D action was reviewed.

l l-l I l l _ _ _ _ o

New York Draft Report Page 39 4.2.1 Technical Quality of the Product Evaluation Prooram The team examined the one new SS&D registration certificate action and a " custom" product

evaluation and their supporting documentation. The evaluations reviewed covered the period l since NYDL's last review. The one SS&D registration certificate issued by the NYDL and  ;

l evaluated by the team is listed with case-specific comments in Appendix F. The review team l suggests that NYDL consider the comments identified in Appendix F, and take action as NYDL deems appropriate. Interviews with the two staff responsible for SS&D evaluations indicated that not all staff were

                  . aware of, or did not consult, the current NYDL SS&D policies and procedures during the SS&D review. The team believes that in order to have a sound program and ensure that reviews are performed consistently, it is important that SS&D reviewers be aware of, and follow, the standard policies and procedures established by NYDL's management.

The team noted three items in particular. Interviews with staff indicated that: !

• No't all reviewers were aware of, nor followed, the memorandum directing the staff to use, as guidance, the draft NYDL regulations concerning the requirements for licensing persons t

to manufacture or initially distribute products to persons generally licensed. The SS&D , l . reviewers were generally aware of the types of requirements placed on persons wishing to ] L manufacture or initially transfer products to persons generally licensed and were aware of ) l the February 2,1996, memorandum containing the draft regulations. However, the SS&D ' L reviewers were not aware of the specific requirements contained in the draft regulations and L did not consult them during their review.

                      -

• Not all staff were aware of, or completely understood, the policy for reviewing Quality ,

Assurance and Quality Control (OA/QC) programs for manufacturers and distributors of SS&Ds. The first reviewer indicated that the review of QA/QC programs was accomplished L during the licensing review rather than the SS&D review and, therefore, did not perform a l' review of the OA/QC program. The concurrence reviewer indicated that he was not aware l of the policy to review QA/OC programs during the licensing review, and assumed that the l- first reviewer adequately reviewed the QA/QC program during the first review and, L therefore, did not perform a review of the OA/QC program.

• Both reviewers relied heavily on the checklist in NUREG-1550 to identify specific items that should be reviewed during their evaluation rather than using it as a guide to help identify l- areas that should be evaluated. The SS&D reviewer should have then consulted additional guidance documents and regulations, as necessary, to identify specific items that must be evaluated or that must be addressed by the applicant.

The review team recommends NYDL establish and use additional procedures for conducting L L SS&D reviews based on the guidelines presented in the SS&D Workshop and tailored to NYDL's specific policies, requirements, and regulations.

                   . There was no clear NYDL established policy on what constitutes a concurrence review. During the interviews, neither the reviewers nor the supervisor indicated that a concurrence review should involve an. independent technical evaluation of the file such that the concurrence reviewer may determine if all areas were adequately addressed and all applicable regulations 1 j

l New York Draft Report : Page 40 were met. The concurrence review performed for the registration certificate completed during the review period relied heavily on the ability of the first reviewer and the completeness of his review (as indicated by the checklist) and little independent review of the file was performed. Furthermore, under the NYDL program, there is no formal process for granting signature authority, nor for determining if a reviewer is qualified to perform all areas of an evaluation prior to obtaining signature authority. The purpose of these guidelines is to ensure that each area of the evaluation is addressed by two qualified individuals. Full signature authority should be given only to those reviewers that have demonstrated that they are qualified to perform all ~ areas of the evaluation. The review team recommends that NYDL establish a clear policy for what constitutes a concurrence review in accordance with guidelines in Management Directive 4 5.6. l 4.2.2 Technical Staffino and Trainino The NYDL reported that two staff members currently have authority to sign SS&D evaluations,. with a combined staff effort equaling approximately 0.02 FTE dedicated to performing safety evaluations. The remainder of their time is spent in licensing actions and inspections. The supervisor has a Bachelor of Science in Physics, and a Masters in Chemistry and is responsible for oversight of the SS&D evaluation program. The supervisor does not perform technical evaluations of SS&D actions. However, interviews with the SS&D reviewers and the supervisor indicate that it is standard practice for the supervisor to review all documents (including SS&D certificates) prior to issuance. There are two staff members who have signature authority.' The first staff member has an Masters Degree in Physics and a Bachelors of Arts degree in Psychology. The second staff member has a Bachelors of Science degree in Biology. Neither staff member has any previous experience performing safety evaluations of products or similar types of evaluations, nor has worked in a related field. Both reviewers have attended NRC's SS&D Workshop.~ Since joining the State, the majority of the reviewers' i experience has been performing licensing actions. In general, SS&D staff are well trained in Health Physics principles. Due to the fact that only one action was processed by the State during the review period, the basis for assessing the adequacy of the engineering design analysis skills of the staff was limited. In addition, the complexity of the design of the one action process and the level of potential radiation hazard from the product was low. However, based on the interviews with the staff, it appears that i neither staff has a strong background, through formal training and prior experience, in the area l of engineering design analysis. To address this issue, the Supervisor indicated that the use of qualified engineering staff in another division has been proposed and was under consideration. l This option was attempted during the " custom" review, but resulted in limited success. The supervisor indicated that this request may have met with limited success due to a lack of understanding of what was expected of the engineering staff and a lack of emphasis placed on the importance of the engineering review by the engineering staff's management. However, the supervisor indicated that the process for requesting additional engineering help was also under review and possible revision, so that the next request would be more successful.

                         . The team identified that NYDL's policy for granting signature authority is to assign signature                                 ;

authority to persons who both meet the minimum criteria for a licensing reviewer and have also l l.

            ~

New York Draft Report Page 41

                                                             ~

attended an'NRC SS&D Workshop. No further evaluation of the reviewers qualifications is performed to ensure they meet the criteria in MD 5.6. The team discussed the importance of a qualification program in the SS&D area. Such a program would ensure that reviewers given SS&D signature authority would first be evaluated to ensure that the reviewer meets established minimum standards, through experience, training, and/or formal education, to enable the reviewer to fully address all issues in the areas for which they are being granted signature authority. A qualification program would also ensure that reviewers complete a sufficient number of cases which are critiqued by a qualified SS&D

reviewer to determine whether the reviewer adequately identified and addressed all pertinent issues. The review team recommends that NYDL develop a formal qualification program for l granting signature authority which would ensure that reviewers meet both the qualifications l listed in Management Directive 5.6 and are able to apply these qualifications appropriately during an SS&D evaluation.

The training should include the following subject areas:

        - engineering materials and their properties and uses
        -- reading and understanding engineering drawings and blueprints
        -- understanding the interrelationship of conditions of use and prototype testing, and
        - interpreting test results (e.g., prototype and performance testing)

Prior to performing another SS&D review, on-the-job training should be provided to the reviewers to gain additional experience in performing reviews that includes being critiqued by qualified SS&D reviewers. The team indicated that this training would be offered by the section l l within NRC responsible for performing SS&D reviews and would require a minimum of two weeks per reviewer. This type training could provide the reviewers additional understanding and experience in applying SS&D procedures and applicable regulations, and understanding and application of basic engineering principles as they apply to SS&D reviews. The NYDL receives a very limited number of SS&D evaluation requests and does not currently have any SS&D reviewers that meet the MD 5.6 criteria. Therefore, NYDL does not have the l casework, nor a qualified SS&D reviewer to conduct a qualification program for the existing ( staff. 'in addition, NYDL indicated that hiring additional reviewers who already have l demonstrated qualifications to perform SS&D reviews would not be cost effective given NYDL's l current budget and workload. The review team recommends that NYDL explore one of the following options to meet the qualifications for an SS&D program for New York:

a. Prior to performing another review, provide additional structured training for the SS&D reviewers in the area of engineering principles and materials and their application. This training must provide the reviewers with sufficient knowledge and understanding in the p areas listed in Management Directive 5.6 to perform adequate SS&D safety reviews l commensurate with the types, complexity, and radiation hazards anticipated for an SS&D l safety review.

p

  ~ b. If NYDL determines that maintaining SS&D evaluation authority with a staff that has sufficient qualifications and training to conduct adequate reviews is not viable, return the SS&D program to NRC.

i-I (

New York Draft Report Page 42

                                 '4.2.3                         Evaluation of Defects and incidents Reaardina SS&Ds The NYDL reported one incident involving a product failure. This incident involved a Troxler portable moisture density gauge. A user reported that the tip of the source rod fell off following a measurement. The manufacturer was made aware of the incident and followed up with an investigation. A determination was made by the manufacturer that the failure was caused by abuse and_ lack of maintenance and was not a generic issue. The incident file did not indicate whether the NYDL agreed with this determination, but the NYDL took actions against the licensee in an attempt to assure that the user would follow appropriate use and maintenance instructions. .in addition, the NYDL sent a notice to all of its portable moisture density gauge licensees concerning the importance of proper maintenance and use of these devices and modified f4YDL's inspection procedures to add a review of maintenance records to all                 ,

inspections of portable moisture density gauge licensees. The team examined the'NYDL's l evaluation of this incident, and determined that relevant issues were addressed.

                                 ' The IMPEP team members were unable to reach consensus on the rating for this indicator.               1 Based on the IMPEP evaluation criteria in MD 5.6, the reviewer of this indicator recommended         I
                                 - NYDL's performance be found unsatisfactory and the team leader recommended the performance rating be found satisfactory with recommendations for improvement. When
                                                                     ~

IMPEP team consensus on an indicator rating is not achievable, the team leader recommendation is used as the rating of record. 4.3 Low-Levei Radioactive Waste (LLRW) Disoosal Proaram The New York State Department of Labor (NYDL) and the New York State Department of

                                  . Environmental Conservation (NYDEC) split responsibilities for the low-level radioactive waste program in the State of New York. NYDL is responsible for the occupational exposure of individuals and control of radioactive material up to the point of placement in the disposal unit or release from the site. This includes the on-site radiation control program and management (including temporary storage) of wastes prior to disposal. NYDEC is responsible for all environmental releases and the permitting of the disposal units.

The State of New York has stopped activities for siting a commercial low level waste disposal

                                 - site. Therefore, the programs are not staffed nor prepared to process a new license i                                    application. The team finds this acceptable given the status of the LLRW siting process. The State does have two former LLRW sites (West Valley State disposal area (WVDA) site and the l

Cornell University disposal site).

                                  . The WVDA is a portion of the West Valley site and was operated as a commercial LLRW
                                  - disposal site. The site ceased operations in 1975, and has been under State ownership and control. The New York State Energy, Research, and Development Authority (NYSERDA)is the State agency responsible for the site and is permitted by NYDEC and licensed by NYDL.
                                 - NYDEC has issued three permits to NYSERDA for this site. One air emissions permit, one Research and Development (R&D) permit for the cover design study, and the LLRW disposal permit that limits the discharges from the disposal area itself. Now that the testing phase of the cover study is completed, the R&D permit will soon be combined with the disposal permit.
                                  ' NYDEC inspects the site on an annual basis with NYDEC staff and visits the site on a much more frequent basis. The team reviewed the latest inspection report (June 4,1997, see D 4) and found the inspection thorough and timely. The disposal area has been covered with the

i l l l New York Draft Report Page 43 R&D cover or a synthetic membrane cover. The State is monitoring the water levels in the trenches to determine the effect of the covers. The NYDL is responsible for the occupational activities at the site due to a storage building with a small amount of LLRW being stored. The NYDL inspects the site on an annual basis to determine if the materials are properly stored and if the licensee has maintained an acceptable radiation protection program. The NYDL has , conducted these inspections during the review period. The Cornell disposal site dates back to the early radiation programs through the mid-1970's. The NYDL has no responsibility at this site since there is no ongoing operations or disposal activities at this site. The site is being remediated through a consent order with a sister Bureau i within the NYDEC other than the Bureau of Pesticides and Radiation (BPR). The consent order includes the requirements that would be imposed by a permit from BPR. Upon completion of all i activities under the consent order, BPR will issue a permit for the ongoing monitoring activities I for this site. The site has been partially remediated by covering the waste disposal area with a synthetic cover and a layer of soil to protect the synthetic cover. There is still ground water remediation needed for non-radiological contamination at the site. The Cornell site is inspected on an annual basis. The team reviewed the last inspection and determined that the scope and quality of inspection was appropriate. Based on the IMPEP evaluation criteria, the review team recommends that NYDL's and NYDEC's performances with respect to the indicator, Low-level Radioactive Waste Disposal Program, both be found satisfactory. 5.0

SUMMARY

As noted in Sections 3 and 4 above, the revhw team found that the performance of the four New York agreement programs with respect to each of the performance indicators to be mixed with 21 satisfactory,4 satisfactory with recommendations for improvement, and 1 unsatisfactory. The most significant concerns were associated with the NYCH program. Accordingly, the team recommends the Management Review Board find the New York program to be adequate, but needs improvement, and compatible with NRC's program. The review team recommends that a follow-up review be scheduled for the Ni CH program to assess the progress of the program in implementing their responses to the recommendations in this report. Below is a summary list of suggestions and recommendations, as mentioned in earlier sections of the report, for evaluation and implementation, as appropriate, by the individual programs. NEW YORK CITY DEPARTMENT OF HEALTH (NYCH) RECOMMENDATIONS:

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)

I

New York Draft Report Page 44

2. The review team recommends that allinitialinspections 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)

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)

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) .

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)

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)

7. The review team recommends that NYCH notify the NRC Oporations Center with'n 24 hours for all significant events, and provide complete follow up documentation to NMEr, on all reportable events. (Section 3.5.1)

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)

SUGGESTIONS:

1. The review team suggests that NYCH establish a policy that the results of all Tribunals for their licensees be placed in the appropriate inspection files. (Section 3.2.1)

2. The review team suggests that the NYCH Bureau Chief position be filled as soon as possible so that attention can be applied to management oversight of the program shortfalls identified in this review. (Section 3.3.1)

3. The review team suggasts that NYCH consider documenting how the SS&D conditions of use were addressed for the two gamma knife licenses and will be addressed in future licensing action. (Section 3.4.1)

4. The review team suggests that NYCH list the date the licensing action is issued (date of fee payment) on the license and in their database, instead of the date of management signature. (Section 3.4.1)

5. The review team suggests that NYCH investigated incidents be clearly documented in the field notes at the next inspection. (Section 3.5.1)

__.__________-s

New York Draft Report - Page 45

6. The review team suggests that NYCH include written documentation that the alleger has been contacted regarding the results of NYCH's findings into the alleger's concerns.

_( Section 3.5.1) NEW YORK STATE DEPARTMENT OF LABOR (NYDL) RECOMMENDATIONS:

1. The review team recommends that NYDL perform initial inspections of licensees within six

l. . months of the licensees' receipt of licensed material, or commencement of licensed activities. (Section 3.1.2)

L 2. The review team recommends that NYDL document its training program to include overall policy and minimum training requirements for both the licensing and compliance staff. (3.3.2)

3. The review team recommends that N VDL continue to audit their financial assurance files to

                                                 ' ensure that they contain all required information and are current with NYDL requirements.

(Section 3.4.2) 1 l

4. The review team recommends that NYDL notify the NRC Operations Center within 24 hours for all significant events and provide complete follow-up documentation to NMED on all reportable events. (Section 3.5.2)

                                            - 5. The review team recommends that NYDL management take appropriate action to move the               ]

rule package through the rule promulgation process. (Section 4.1.2.2) -

6. The review team recommends NYDL establish and use additional procedures for conducting SS&D reviews based on the' guidelines presented in the SS&D Workshop and tailored to NYDL's specific policies, requirements, and regulations. (Section 4.2.1)

7. The review team recommends that NYDL establish a clear policy for what constitutes a concurrence review in accordance with guidelines in Management Directive 5.6. (Section i 4.2.1)

8. ~ The review team recommends that the NYDL develop a formal qualification program for granting signature authority which would ensure that reviewers both meet the qualifications listed in Management Directive 5.6 and are able to apply these qualifications appropriately

                                                ' during an SS&D evaluation. (Section 4.2.2)

9. The review team recommends that NYDL explore one of the following options to meet the qualifications for an SS&D program for New York:

                                                                                                                                                   )

a. Prior to performing another review, provide additional structured training for the

                                                            -SS&D reviewers in the area of engineering principles and materials and their application. This training must provide the reviewers with sufficient knowledge and understanding in the areas listed in Management Directive 5.6 to perform adequate l'

l New York Draft Report Page 46 SS&D safety reviews commensurate with the types, complexity, and radiation hazards anticipated for an SS&D safety review.

b. ' If NYDL determines that maintaining SS&D evaluation authority with a staff that has sufficient qualifications and training to conduct adequate reviews is not viable, return the SS&D program to NRC. (Section 4.2.2)

SUGGESTIONS: l: 1. The review team suggests that NYDL determine and document the appropriate inspection - frequencies of all reciprocity licensees, and complete reciprocity inspections following NYDL inspection priorities, which should be based on the inspection priorities documented in IMC 1200. (Section 3.1.2)

2. The review team suggests that the NYDL management consider whether additional staffing is warranted when considering the impacts of the licensing and inspection workloads, the regulation development needs, and the SS&D program improvement needs. (Section 3.3.2)

3. The review team suggests that attention be given to the NYDL's tracking system for allegations to ensure that the system accurately indicates when the response to each '

allegation has been completed and the matter is considered closed out. (Section 3.5.2)

4. The review team suggests that NYDL consider the comments identified in Appendix F, and take action as NYDL deems appropriate. (Section 4.2.1)

     ' GOOD PRACTICES:
                                                                                                              )

1. The review team noted a good practice in that NYDL's inspection field notes and inspection )

i correspondence are peer reviewed by one of the senior inspectors to assure consistency, i thoroughness, and quality of reports. (Section 3.2.2) l l NEW YORK STATE DEPARTMENT OF HEALTH (NYSH) RECOMMENDATIONS:

1. The review team recommends that NYSH modify to its inspection program to ensure that initial inspections are performed within six months of the licensee's receipt of I licensed material, within six months after commencement of licensed activities, or within one year of license issuance, whichever comes first, consistent with IMC 2800. (Section ,

3.1.3) l L 2. The review team recommends that NYSH document its training program to inclube  ; L overall policy and minimum training requirements for medical, academic, and research uses of radioactive materials for both the licensing and compliance staff. (Section 3.3.3)

New York Draft Report Page 47

3. The review team recommends that NYSH notify the NRC Operations Center within 24 I hours for all significant events, and provide complete follow up documentation to NMED j on all reportable events. (Section 3.5.3) l SUGGESTIONS:

1. The review team suggests that NYSH's inspection documentation of exit meetings ,

should contain substantive discussions of issues with the Radiation Safety Officer I (RSO) and/or licensee management. (Section 3.2.3) l

2. The review team suggests that NYSH incorporate a field for documentation of interviewing ancillary personnel, authorized users, technicians, and RSOs into their field notes. (Section 3.2.3)

3. The review team suggests that the NYSH inspectors attend additional training in inspecting for performance techniques. (Section 3.2.3)

4. The review team suggests that NYSH's standard license conditions be revised periodically to ensure consistency with the updated regulations and that old and superseded standard license conditions be deleted. (Section 3.4.3)

GOOD PRACTICES:

1. The review team considers monthly TeleVideo conferences to be a good practice to bring and keep their staff current on health physics and program issues. (Section 3.3.3)

NEW YORK STATE DEPARTMENT OF ENVIRONMENTAL CONSERVATION (NYDEC) RECOMMENDATIONS:

1. The review team recommends that NYDEC document its training program to include ,

overall policy and minimum training requirements for both the permitting and compliance l staff. (Section 3.3.4)

2. The review team recommends that NYDEC incorporate the handling of incidents and allegations into their inspection procedures. (Section 3.5.4) l l

3. The review team recommends that NYDEC coordinate with the appropriate New York licensing agency the notification to the NRC Operations Center within 24 hours for all  !

significant events, and to NMED for all reportable events involving permitted activities. l (Section 3.5.4) SUGGESTIONS:

1. The review team suggests that NYDEC maintain one file for all types of incidents involving radioactive material. (Section 3.5.4) l

i i I l LIST OF APPENDICES AND ATTACHMENTS 1 i Appendix A IMPEP Review Team Members Appendix B B-1 NYCH's Organization Charts B-2 NYDL's Organizational Charts B-3 NYSH's Organizational Charts

B-4 NYDEC's Organizational Charts Appendix C C-1 NYCH Inspection File Reviews C2 NYDL Inspection File Reviews C-3 NYSH inspection File Reviews C-4 NYDEC Inspection File Reviews .

l Appendix D D1 NYCH License File Reviews D-2 NYDL License File Reviews D3 NYSH License File Reviews D N(DEC License File Reviews l Appendix E E-1 NYCH Incident File Reviews E2 NYDL Incident File Reviews E-3 NYSH Incident File Reviews  ! E-4 NYDEC incident File Reviews Appendix F NYDL Sealed Source and Device Reviews Appendix G G-1 NYCH's Questionnaire Rescanse G2 NYDL's Questionnaire Response G-3 .NYSH's Questionnaire 3esponse G4 NYDEC's Questionnr. ire Response Attachment 1 February 17,1998 le%r from Mr. K. Daniel, Jr., NYCH ; l l

APPENDIX A IMPEP REVIEW TEAM MEMBERS New York City Department of Health. Bureau of Radioloalcal Health (NYCH) Name Area of Responsibility Dennis Sollenberger, OSP Team Leader Technical Staffing and Training Legislation and Program Elements Required for Compatibility Duncan White, RSAO, Region l Response to incidents and Allegations Technical Quality of Inspections Michael Stephens, Florida Technical Quality of Licensing Actions Jamnes Cameron, Region 111 Status of Materials inspection Program Technical Quality of Inspections New York State Department of Labor. Radioloalcal Health Unit (NYDL) Name Asea of Responsibility Dennis Sollenberger, OSP Team Leader Technical Staffing and Training Legislation and Program Elements Required for Compatibility Low-Level Radioactive Waste Disposal Program Duncan White, RSAO, Region i Technical Quality of Licensing Actions Technical Quality of Inspections James McNees, Alabama Response to incidents and Allegations Technical Quality of Inspections Douglas Broaddus, NMSS Sealed Source and Device Evaluation Program Lance Rakovan, OSP Status of Materials inspection Program

New York Draft Report Page A.2 IMPEP Review Team Members New York State Department of Health. Bureau of Environmental Radiation Protection (NYSH) Name Area of Responsibility Dennis Sollenberger, OSP Team Leader Technical Staffing and Training Legislation and Program Elements Required for Compatibility Duncan White, RSAO, Region l Status of Materials inspection Program Response to incidents and Allegations Lee Cox, North Carolina Technical Quality of Inspections Jacqueline Cook, Region IV Technical Quality of Licensing Actions

 ,New York State Department of Environmental Conservation. Bureau of Pesticides and Radiation (NYDEC)

Name Area of Responsibility Dennis Sollenberger, OSP Team Leader Technical Staffing and Training Legislation and Program Elements Required for Compatibility Low-Level Radioactive Waste Disposal Program Duncan White, RSAO, Region I Technical Quality of Licensing Actions Response to incidents arid Allegations inspector Accompaniments Allen Grewe, Tennessee Status of Materials inspection Program Technical Quality of Inspections

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ls i j l APPENDIX B-3 New York State Department of Health, Bureau of Environmental Radiation Protection (NYSH) ORGANIZATION CHARTS I

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i ) i APPENDIX C-1 NYCH INSPECTION FILE REVIEWS NOTE: ALL INSPECTION FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM Ts0 BE ACCEPTABLE. File No.: 1 Licensee: NY University Medical Center License No.: 75-2955-01 Location: New York City, NY Inspection Type: Unknown License Type: Medical Broad Scope Priority: 1 Inspection Date: 3/19/96 Inspector: TK Comments: a) No description of inspection history or indication of follow up on previous findings (previous inspection 3/2/94, identified 5 violations). b) No description of licensed program scope. c) Licensee did not appear on inspection due listing. d) Inspection overdue. File No.: 2 Licensee: Montefiore Medical Center License No.: 75-2885-01 Location: New York City, NY inspection Type: Unknown License Type: Medical Broad Scope Priority: 1 Inspection Date: 2/3/97 Inspector: TK l Comments: a) Field notes include personal privacy information (patient name and social security number). b) Licensee did not appear on inspection due listing.  ; File No.: 3 I Licensee: NY University Medical Center License No.: 74-2955-02 Location: New York City, NY Inspection Type: Unknown License Type: Non-Human use Broad Scope Priority: 2 Inspection Date: Unknown Inspector: Unknown Comment: a) License file did not include field notes or NOV from last inspection, only licensee's response.

l l l New York Draft Report Page C 1.2 l NYCH Inspection File Reviews File No.: 4 Licensee: Lenox Hill Hospital License No.: 92 2926-01 Location: New York City, NY inspection Type: Unannounced, Routine License Type: Teletherapy Priority: 1 inspection Date: 4/26/96 Inspector: TK l l Comments- l a) 2 of 3 violations not supported by information in field notes. b) Third violation cited against regulation that had been superseded two years prior and no longer in force. c) Licensee did not appear on inspection due listing. 1 File No.: 5 l Licensee: Lenox Hill Hospital License No.: 91-2926-01 l Location: New York City, NY Inspection Type: Announced, Routine License Type: Limited Medical Priority: 2 Inspection Date: 1/16/97;9/11/95 Inspectors: EC; TK l l Comments: I a) Transmittalletter includes four violations, none described in field notes. One violation ' contradicts information contained in field notes (1997). b) Field notes do not include follow up on previous inspection findings (one violation previously identified) (1997). c) Field notes for 1995 inspection include description of three violations, none include any supporting information. d) Supervisor overruled two of the violations for lack of information, only issued one violation (1995). File No.: 6 Licensee: Mt. Sinai Medical Center License No.: 91-2909-01 Location: New York City, NY Inspection Type: Unannounced, Routine License Type: Limited Medical Priority: 2 Inspection Date: 3/7/96 Inspector: BK Comment: a) Field notes include personal privacy information. __.___-_m_m-._m.-__ - _ _ .

New York Draft Report . Page C-1.3 NYCH Inspection File Reviews File No.: 7 Licensee: NYCHHC/ Lincoln Medical License No.: 91-2915-01 l Location: New York City, NY Inspection Type: Announced, Routine License Type: Limited Medical Priority: 2 Inspection Date: 4/28/95 Inspector: TK

             ' Comments:

a) Transmittal letter includes two violations, one not discussed at all in field notes, b) Licensee response provides information to dispute one violation, no response from NYCH providing analysis of licensee's response indicating whether violation upheld or retracted. c) Licensee did not appear on inspection due listing. File No.: 8 Licensee: -Young F. Eng, M.D; License No.: 91-3025-01 Location: New York City, NY . Inspection Type: Unknown License Type: Limited Medical - Priority: 2 Inspection Date: 7/9/96 Inspector: EC Comments:

             - a)                                              No discussion of inspection history in field notes or follow up on previous violations.

Previous inspection identified five violations. b) Licensee did not appear on inspection due listing. File No.: 9 l

              ~ Licensee: Joseph Greenberg, M.D.                                                                                  License No.: 91-2998-01 Location: New York City, NY                                                                               Inspection Type: Unknown License Type:- Limited Medical                                                                                               Priority: . 2 Inspection Date: 12/12/96                                                                                               Inspector: CS .    ;

Comments: , a)- No discussion of inspection history in field notes or follow up on previous violations. l

                                                             ' Previous inspection identified five violations.

b) Licensee did not appear on inspection due listing. E File No.: 10 i Licensee: St. Vincent's Hospital and Med Ctr of NY License No.: 75 3009-01 Location: New York City, NY Inspection Type: Unknown License Type: Medical Broad Priority: 1

 ,                   Inspection Date: 3/4/97                                                                                                  Inspector: EC Comments:
              - a)                                            Field notes include personal privacy and proprietary information, b)'                                      Licensee did not appear on inspection due listing.

New York Draft Report Page C-1.4 NYCH inspection File Reviews File No.: 11 Licensee: Brooklyn Hospital Center License No.: 92-2924-02 l Location: New York City, NY Inspection Type: Announced, Routino l License Type: Teletherapy Priority: 1 Inspection Date: 1/29/97 Inspector: AA 1 Comment: ' a) Licensee did not appear on inspection due listing.  ! l File No.: 12 Licensee: Brooklyn Hospital Center License No.: 91-2924-01 Location: New York City, NY Inspection Type: Unknown License Type: Limited Medical Priority: 2 Inspection Date: 6/21/96 Inspector: AA i Comments: a) Two of three violations not fully supported in field notes; one violation not described at all. b) Licensee did not appear on inspection due listing, c) Licensee response appears to dispute two of the violations. NYCH's response does not indicate whether violations were upheld or retracted. File No.: 13 Licensee: Columbia Presbyterian Med Ctr License No.: 75-2878-01 Location: New York City, NY Inspection Type: Unannounced, Routine License Type: Medical Broad Scope Priority: 1 Inspection Date: 12/5/97 Inspectors: RB, Team Comments: a) Nine violations cited. Description of several does not address whether violation was isolated (as observed by inspector on a specific date) or programmatic. b) One violation described in field notes, but not cited. c) Not all violations fully supported through documentation in field notes. File No.: 14 Licensee: Columbia Presbyterian Med Ctr License No.: 74-2878-03 Location: New York City, NY Inspection Type: Unknown License Type: Non Human Use Broad Scope Priority: 2 Inspection Date: 8/28/97 Inspectors: RB, Team Comment: a) Five of the nine violations cited are not supported through documentation in field notes. 1 I I l f 1

l 1 New York Draft Report Page C-1.5  ! NYCH Inspection File Reviews File No.: 15 Licensee: Columbia University License No.: 74 3030-01 ' Location: New York City, NY Inspection Type: Routine License Type: Broad Scope R&D Priority: 2 l Inspection Date: 10/28-31/97 Inspectors: BK,CS,VC l Comments: a) Two separate violations cited for same generic issue. b) Five out of 10 violations cited were questioned by licensee; licensee provided documentation in reply letter to support that information was available during inspection, c) One of two significant violations cited in letter was a repeat violation from previous inspection, but was not noted as a repeat violation in the cover letter. Field notes did note the previous violation, but the violation was closed out. d) Basis for one violation cited in cover letter was not supported by documentation in field notes. e) Cover letter specifically requested full RSC review of reply letter and specific attention to significant violations. In addition, a team member made the following inspection accompaniments as part of the l on-site IMPEP review: Accompaniment No.: 1 Licensee: Columbia University License No.: 74-3030-01 Location: New York City, NY Inspection Type: Routine License Type: Broad Scope R&D Priority: 2 Inspection Date: 10/28 31/97 Inspector: DK,CS,VG Comments: a) RSO not present during inspection. b) RSC meeting minutes not reviewed during on-site inspection. c) Inspection was checklist driven, not performance based. d) Although inspectors identified numerous violations, including two significant safety violations (one of which was a repeat violation from the previous inspection), lead inspector failed to address these programmatic issues during the exit meetings with licensee's management, e) RSC members not contacted during inspection nor were present at exit meetings.

New York Draft Report Page C-1.6 NYCH Inspection File Reviews l Accompaniment No.: 2 { Licensee: NYC DOH - Bureau of Lead Poisoning License No.: 52 2624-01 i Location: New York City, NY Inspection Type: Routine License Type: AnalyticalInstruments Priority: 3 Inspection Date: 1/20/98 Inspector: CS Comments: a) Inspector requested location of authorized users in field to conduct field inspection, but licensee could not locate any users during the inspection. b) Management representative not available for exit meeting. Accompaniment No.: 3 Licensee: Harvey Stern, MD License No.: 91 2969-01 Location: Brooklyn, NY Inspection Type: Routine License Type: Nuclear Medicine Priority: 2 Inspection Date: 1/21/98 Inspector: VG Accompaniment No.: 4 Licensee: Columbia Presbyterian Medical Center License No.: 75-2878-01 Location: New York City, NY Inspection Type: Routine License Type: Medical Broad Scope Priority: 1 Inspection Date: 12/5/97 Inspector: RB, Team Comment: b) The team inspection did not have a focus for the individual team members. c) The inspectors did not clearly indicate what were violations or poor practices. d) In some cases inspectors presented their opinion on a practice not the licensees commitment or the regulatory requirement. e) The field notes were not completed for all areas inspection. l

APPENDIX C 2 NYDL INSPECTION FILE REVIEWS I NOTE: ALL INSPECTION FILES LISTED WITHOUT COMMENT WERE DETERMINED BY , THE IMPEP TEAM TO BE ACCEPTABLE. File No.: 1 Licensee: Empire isotopes License No.: 2770-4012,2771-4012MD Location: Albany, NY Inspection Type: Announced, initial License Type: Nuclear Pharmacy Priority: 1 Inspection Date: 1/7 9/98 Inspector: JM Comment: a) Initla! Inspection performed 7 months after license issued. File No.: 2 Licensee: CoPhysics Corp. License No.: 2691-3949 Location: Middletown, NY inspection Type: Announced, initial License Type: Gas Chromatograph Priority: 5 , inspection Date: 11/29/95 Inspector: RP  ! File No.: 3 Licensee: Buffalo X Ray Company License No.: 0286-0511 Location: Buffalo, NY Inspection Type: Unannounced, Routine, Field  ; License Type: Iridustrial Radiography Priority: 1 ' inspection Date: 7/19-20/95 and 8/7/95 Inspector: AA Comment: a) Location of temporary job site not indicated in field notes. File No.: 4 Licensee: Atlantic Testing Labs License No.: 2125-2253 Location: Endicott, NY Inspection Type: Unannounced, Routine License Type: Portable Gauge Priority: 2 inspection Date: 10/8 - 9/97 Inspector: BK Comment: a) Licensee had seven locations authorized under license; only main office inspected. File No.: 5 Licensee: Bausch and Lomb License No.: 0771-3533 Location: Rochester, NY Inspection Type: Announced, Routine License Type: Research and Development Priority: 2 Inspection Date: 5/1/96 Inspector: RP

New York Draft Report Page C-2.2 NYDL Inspection File Reviews File No.: 6 Licensee: Isomedix Operations License No.: 2583 3814 Location: Chester, NY Inspection Type: Announced, Routine

                                . License Type: CommercialIrradiator                                                     Priority: 1 l                                 Inspection Date: 4/29 - 30/97                                                       Inspector: RP Comment:                                                                                             l a)      Inspection overdue; last inspection performed 2/95.

l File No.: 7 l Licensee: MOSInspection Location: Flushing, NY License No.: 1349-0452 Inspection Type: Unannounced, Routine, Field I ! License Type:' Industrial Radiography Priority: 1 l l ' Inspection Date: 12/11.-12/97 Inspector: RP l l Fi!e No.: 8 Licensee: Wyeth- Aye,st Research License No.: 0716-0007 Location: Bedford Inspection Type: Unannounced, Routine License Type: Broad Scope - Commercial Priority: 1

Inspection Date: 4/25 - 27/95 and 5/2/95 Inspector: JM File No.: 9 I Licensee: Mick's Radio-Nuclear Instruments, Inc. License No.: 2252 3034 Location: Bronx, NY Inspection Type: Announcer., Routine License Type: Medical Distribution Priority: 1 Inspection Date: 6/19/97 Inspector: JM

! Comments: I a) No field activities at time of inspection. File No.: 10 Licensee:' Finch, Pruyn and Company License No.: 0358-0260 Location: Glen Falls, NY Inspection Type: Announced, Routine License Type: Fixed Gauge Priority: 3 Inspection Date: 9/19/96 Inspector: JM File No.: .11 Licensee: NDL Organization License No.: 1226 1422 Location: Peekskill, NY Inspection Type: Unannounced, Routine License. Type: Waste Broker Priority: 1-Inspection Date: 6/14/95 Inspector: RP File No.: .12 Licensee: Syncorinternational License No.: 2364 3250,2365-329 A 2366-3250MD ! Location: Troy, NY - Inspection Type: Mregreed, Routine License Type: Nuclear Pharmacy Prio ity: 1 Inspection Date: 4/9 - 11/96 inspector: BK

New York Draft Report Page C-2.3 l NYDL Inspection File Reviews l File Nc.: 13 Licensee: Bethlehem Steel Corporation License No.: 0742-0119 Location: Lackawanna, NY Inspection Type: Unannounced, Routine License Type: Fixed Gauge Priority: 3 Inspection Date: 4/17/95 Inspector: RK Comment: a) Supervisory review of inspection documentation identified safety issues that were not addressed by the inspector, but were subsequently addressed in later correspondence with licensee. File No.: 14 Licensee: Carlin Simpson Associates NRC License No.: 29-19641-01 Location: North Castle, NY Inspection Type: Unannounced, Routine, Reciprocity License Type: Portable Gauge Priority: NA Inspection Date: 7/11/96 Inspector: JM File No.: 15 Licensee: Self Powered Lighting License No.: 1308-1611 Location: West Nyack, NY Inspection Type: Announced, Routine License Type: Manufacturing and Distribution Priority: 1 Inspection Date: 5/13-15/97 Inspector: BK File No.: 16 Licensee: Design Plumbing and Heating License No.: 2479-3583 Location: Staten Island, NY inspection Type: Routine, Announced License Type: Portable Gauge Prior lty: 5 Inspection Date: 10/22/96 Inspector: RP File No.: 17 Licensee: Medi-Ray,Inc. License No.: 2077-2157 Location: Tuckahoe, NY Inspection Type: Routine, Announced License Type: Storage & Transport Priority: 5 Inspection Date: 1/28/98 Inspector: BK File No.: 18 Licensee: Municipal Testing License No.: 2072-1988 Location: Hicksville, NY Inspection Type: Routine, Announced License Type: Radiography Priority: 1 inspection Date: 6/20/97 Inspector: HP File No.: 19 Licensee: Syncor International License No.: 2613-3868 Location: Buffalo, NY Inspection Type: Routine, Announced

                .6,.se Type: Nuclear Pharmacy                                                         Priority: 1 Inspection Date: 2/11-13/97                                                          Inspector: JM

l New York Draft Report Page C-2.4 NYDL Inspection File Reviews File No.: 20 Licensee: Wyeth-Ayerst License No.: 0716-0007 Location: Pearl River, NY Incpection Type: Routine, Announced ' License Type: Broad Research & Development Priority: 2 { inspection Date: 6/13/97 inspector: BK l l Comments: a) Inspection report lists releases to the sewer in total curies of activity. Calculations should have been made of concentrations released to verify compliance with sewer release ! section of the regulations. File No.: 21 Licencee: Nucletron Inc. License No.: 2674-3822 Location: Mt. Sinal Hospital, NY Inspection Type: Routine, Announced License Type: Service Priority: 3 l Inspection Date: 1/15/98 inspector: BK in addition, a team member made the following inspection accompaniment as part of the IMPEP review: Accompaniment No.1 Licensee: MOS Inspection License No.: 1349-0452 i Location: Flushing and Manhattan, NY inspection Type: Unannounced, Routine , License Type: Industrial Radiography Priority: 1 '

                                                                                                        ' inspection Date: 12/11-12/97                                                                                 Inspector: RP

l I APPENDlX C-3 NYSH INSPECTION FILE REVIEWS , NOTE: ALL INSPECTION FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE. File No.: 1 Licensee: Cani.slus College License No.: 500 Location: Buffalo, NY Inspection Type: Announced, Routine License Type: Academic Priority: 4 Inspection Date: 12/8/94 Inspector: Bl Comment: a) No documentation of supervisory review.

                 . File No.: 2 Licensee: Cardiology Associates of Schenectady                                             License No.: a107 Location: Schenectady, NY                                           _ inspection Type: Unannounced, Routine License Type: Nuclear Cardiology                                                                   Priority: 4 Inspection Date: 2/25/98                                                                       inspector: CC Comments:

a) - No documentation of substantive discussions during the exit meeting. b) No documentation of interviewing ancillary personnel or the authorized user. File No.: 3 Licensee: Ellenville Community Hospital License No.: 1162 Location: Ellenville, NY Inspection Type: Unannounced, Routine , License Type: Hospital Priority: 3 Inspection Date: 8/11/95 Inspector: AB Comment: a) No documentation of supervisory review. File No.: 4 Licensee: Ellis Hospital License No.: 484 Location: Schenectady, NY Inspection Type: Unannounced, Routine License Type: Hospital Priority: 3 Inspection Date: 2/26-3/4/98 Inspector: CB Comments: a) No documentation of supervisory review.

b) No documentation of interviewing ancillary personnel.

L__________________._________.________ _ _ _ _ _

New York Draft Report . Page C-3.2 NYSH Inspection File Reviews L File No.: 5 l Licensee: Genesee Hospital ~ License No.: 26 l - Location: . Rochester, NY Inspection Type: Announced, Routine License Type: Hospital _ Priority: 3-

j. Inspection Date: 3/20/96 Inspector: EC Comment:

                                        - a)~                    No documentation of interviewing ancillary personnel or the AU.
                                        - File No.: 6-Licensee: Geneva General Hospital                                                                                                                     License No.: 1766

,. Location: Geneva, NY Inspection Type: Unannounced, Routine L License Type: Medical Hospital Priority: 3 Inspection Date: 2/23/98 Inspector: RS - Comments: a) No documentation of interviewing ancillary personnel. b) : No documentation of substantive discussions during the exit meeting. c) No documentation of possible ingestion of material as a repeat item of violation. File No.: 7-

                                        . Licensee: Newark-Wayne Community Hospital                                                                                                             License No.: 1777 Location: Newark, NY                                                                                                          Inspection Type: Unannounced, Routine License Type: Medical / Hospital                                                                                                                                  Priority: 3 inspection Date: 2/24/98                                                                                                                                  Inspector: WK File No.: 8 Licensee: NYS Div. Of Military and Naval Affairs                                                                                                         License No.: 29 Location: ' Albany, NY                                                                                                        Inspection Type: Unannounced, Routine License Type: Civil Defense                                                                                                                                       Priority: 5 Inspection Date: 7/3/96                                                                                                                                    Inspector: RD
                                         ' Comments:

a) 3 years overdue in inspection frequency. b). No documentation of supervisory review. !. . c) _ No documentation that previous violations had been reviewed and no indication that repeat violations had been addressed. File No.: 9

                                        - Licensee: Oswego Hospital                                                                                                                             License No.: 1175 Location: Oswego, NY                                                                                                          Inspection Type: Unannounced, Routine LicenseType: Medical / Hospital                                                                                                                                   Priority: 3 L                                         - Inspection Date: 5/7/96                                                                                                                                   Inspector: VG

Comment

_ a) No documentation of interviewing ancillary personnel.

_ _ _ ___-__-_m ___u__m___ _ ______________m. _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ - _ . _ _ _ _ _ . . _ _ - _ . _ _ . _ . _ _ . _ _ _ _ . _ _ __ - . - _ ____________.___.m._.._-_a__-___

New York Draft Report Page C- 3.3 l- NYSH Inspection File Reviews l File No.: 10 l Licensee: Vassar College . License No.: 410 t Location: Poughkeepsie, NY Inspection Type: Announced, Routine License Type: Academic Priority: 4 Inspection Date: 10/8/97 Inspector: MV Comments: a) ..No documentation of supervisory review, b) No documentation of interviewing ancillary personnel. File No.: 11 Licensee: Adirondack Medical Center License No.: 1130 , Location: Saranac Lake, NY Inspection. Type: Announced, Routine License Type: Medical / Hospital Priority: 3 inspection Date: 7/17/96 Inspector: AD Comments: a) No documentation of supervisory review. b) No documentation of interviewing ancillary personnel. c) LNo documentation of substantive discussions during the exit meeting. Note: There were five other inspection files reviewed associated with the Administrative

            . Tribunals.-

File No.: 12 Licensee: Alfred Univ. License No.: 402 j Location: Alfred, NY inspection Type: Unannounced, Routine 1 License Type: Academic, specific Priority: 4 ! Inspection Date: 11/7/96 Inspector: AD File No.: 13 Licensee: Samaritan Hospital License No.: 498-2 Location: Troy, NY inspection Type: Unannounced, Routine License Type: Teletherapy - Priority: 1 Inspection Date: 11/30-12/4/95 Inspector: BD

            - File No.: 14                                                                                                                   i Licensee: Good Samaritan Hospital                                                                        License No.: 490 Location: Suffren, NY .                                  It.spection Type: Unannounced, Routine License Type: Medical / Hospital /HDR                                                                             Priority: 1 Inspection Date: 7/9/96                                                                               Inspectors: BD SG File No.: 15 Licensee: Good Samaritan Hospital                                                                        License No.: 575

Location: West is;!p, NY .

Inspection Type: Unannounced, Routine

            . License Type: Medical / Hospital /HDR                                                                             Priority: 1 inspection Date:~ 5/21/97                                                                                    Inspector: AB l

L___-_-______-____-__. -- . - - _ - - _ _ _ . _ - _ _ .

l l 1 l New York Draft Report Page C-3.4 NYSH Inspection File Reviews File No.: 16 Licensee: Immunosciences, Inc. License No.: 2991 Location: New Hyde Park, NY inspection Type: Reactive l License Type: Possession only Priority: 1 Inspection Date: 6/20/97 Inspector: SG In addition, a team member made the following inspection accompaniment as part of the IMPEP review: Accompaniment No.: 1 j Licensee: Geneva General Hospital License No.: 1766 Location: Geneva, New York Inspection Type: Unannounced, Routine License Type: Medical / Hospital Priority: 3 Inspection Date: 2/23/98 Inspector: RS l Comments: Inspector looked at OA records with no performance purpose. a) b) Inspector should have asked about injection areas outside the restricted area such as , patient rooms, and the ensuing procedures for surveys, transport of material to the l rooms, etc. c) Inspector should have done a more involved physical survey of the hot lab and adjoining areas. Accompaniment No.: 2 Licensee: Wayne Community Hospital License No.: 1777 Location: Newark, New York inspection Type: Unannounced, Routine l License Type: Medical / Hospital Priority: 3 i Inspection Date: 2/24/98 Inspector: BK l i I Comments: j a) Inspector should have asked about injection areas outside the restricted area such as , patient rooms, and the ensuing procedures for surveys, transport of material to the l rooms, etc. ' b) Inspector should have done a more involved physical survey of the hot lab and adjoining areas. There was a waste can in the imaging room in a cabinet labeled " Caution Rad. l Materials" that went unnoticed. c) Inspector during record review should have questioned emergency scans on the weekend and holidays, and looked for quality assurance testing on those days. d) Inspector should have questioned how unused unit doses are shipped back to the pharmacy and the compliance with the pertinent DOT regulations.

1 i I I l New York Draft Report Page C-3.5 NYSH Inspection File Reviews ! - Accompaniment No.: 3 j Licensee: Cardiology Associates of Schenectady License No.: 3107 l Location: Schenectady, New York inspection Type: Unannounced, Routine License Type: Imaging / Cardiologist Priority: 3 l Inspection Date: 2/25/98 Inspector: CC ' Comments: a) Inspector should have done a more involved physical survey of the hot lab and adjoining areas, b) Inspector during record review should have questioned emergency scans on the weekend and holidays, and looked for quality assurance testing on those days, j c) Inspector should have questioned how unused unit doses are shipped back to the i pharmacy and the compliance with the pertinent DOT regulations. d) Inspector should have checked " clean trash cans" for contamination. Accompaniment No.: 4 Licensee: Ellis Hospital License No.: 484 Location: Schenectady, NY Inspection Type: Unannounced, Routine License Type: Medical / Hospital Priority: 3 inspection Date: 2/26/98 Inspector: CB { Comment: e a) Inspector should have done a more involved physical survey of the hot lab and adjoining ) areas, b) Inspector during record review should have questioned emergency scans on the weekend and holidays, and looked for quality assurance testing on those days, c) Inspector should have questioned how unused unit doses are shipped back to the pharmacy and the compliance with the pertinent DOT regulations. d) Inspector should have checked " clean trash cans" for contamination. .a 1 i i i i i i I l I 1 l \ !- ) i l'

APPENDIX C-4 NYDEC INSPECTION FILE REVIEWS NOTE: ALL INSPECTION FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE. File No.: 1 Licensee: Wyeth Ayerst Research License No.: 168-2 Location: Chazy, NY Inspection Type: Unannounced, initial License Type: Water Priority: 4 Inspection Date: 7/29/97 Inspector: RR, AG \ File No.: 2 Licensee: University of Rochester License No.: 129-1 Location: Rochester, NY Inspection Type: Unannounced License Type: Incinerator Priority: 2 Inspection Date: 5/20-21/97 Inspector: MS, AG File No.: 3 Licensee: Trudeau institute, Inc. License Number: 96-1 Location: Saranac Lake, NY Inspection Type: Unannounced License Type: Incinerator Priority: 2 Inspection Date: 7/30/97 Inspector: AG,RR File No.: 4 Licensee: Syncor International Corp. License No.: 150-3 Location: Cheektowaga, NY Inspection Type: Unannounced

           ' License Type: Air                                                                    Priority: 3 Inspection Date: 8/28/96                                                   Inspector: RR, JA File No.: 5 Licensee: United Biomedical, Inc.                                       License No.: 156-3 Location: Hauppauge, NY                               Inspection Type: Announced, Special License Type: Air                                                                    Priority: 4 Inspection Date: 8/28/95                                                       Inspector: JA File No.: 6 Licensee: Syncor international Corp.                                    License No.: 140-3 Location: Franklin Square, NY                               inspection Type: Unannounced License Type: Air                                                                     Priority: 3 inspection Date: 12/12/96                                                 Inspector: AG,RR File No.: 7 Licensee: Progenics Pharmaceuticals, Inc.                                License No.: 168-3 Location: Terrytown, NY                               Inspection Type: Unannounced, initial License Type: Air                                                                                                              l Priority: 4 inspection Date: 6/19/96                                                 Inspector: JA, WG

i New York Draft Report Page C-4.2 l NYDEC Inspection File Reviews i File No.: 8 Licensee: NRD License No.: 53-3 . Location: Grand Island, NY Inspection Type: Unannounced License Type: Air Priority: 2 Inspection Date: 9/9/97 Inspector: BY Comment: a) Inspection letter not sent out within 30 days File No.: 9 Licensee: Mt. Sinal Medical Center License No.: None issued Location: New York City, NY Inspection Type: Announced, Special License Type: Air Priority: N/A Inspection Date: 2/13/97 Inspector: MS File No.: 10 Licensee: New York University Medical Center License No.: None issued Location: New York, NY Inspection Type: Announced, Special License Type: Air ~ Priority: N/A Inspection Date: 7/9/97 Inspectors: SH, AG File No.: 11 Licensee: NYSERDA License Nos.: 137-5,137-6,137-3 Location: West Valley, NY Inspection Type: Announced, Routine License Type: Bio-Engineering, Land Burial, Air Priority: 1 Inspection Date: 6/4/97 Inspectors: WT, JK in addition, a team member made the following inspection accompaniment as part of the IMPEP review: Accompaniment No.1 Licensee: University of Rochester Laboratory for Laser Energetics License No.: 170-3 Location: Brighton, NY Inspection Typa: Unannounced, Initial License Type: Academic Broad Scope Priority: 2 Inspection Date: '4/7/98 Inspectors: MS, SH l

APPENDIX D-1 NYCH LICENSE FILE REVIEWS NOTE: ALL LICENSE FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE. File No.: 1 Licensee: Montefiore Medical Center License No.: 75-2885-01 Location: Bronx, NY Amendment No.: 7,8 License Type: Broad Scope-Medical Type of Action: 2 Amendments Date issued: 7/25/97,10/23/97 License Reviewer: JB, RH File No.: 2 Licensee: Albert Einstein College of Medicine of Yeshiva University License No.: 75-2919-01 Location: Bronx, NY Amendment No.: 2,3 License Type: Broad Scope-Medical Type of Action: 2 Amendments Date issued: 3/15/96, 7/8/97 License Reviewer. DH, DH File No.: 3 Licensee: Columbia-Presbyterian Medical Center License No.: 74-2878-03 Location: New York City, NY Amendment No.: 4, 5 License Type: Broad Scope-Academic Type of Action: Renewal, Amendment Date issued: 2/8/97, 4/9/97 License Reviewer: GM, RH File No.: 4 Licensee: Columbia-Presbyterian License No.: 75-2878-01 Location: New York City, NY Amendment No.: C,7,8,9,10,11 License Type: Broad Scope-Medical Type of Action: Renewal,5 Amendments Date issued: 4/10/96,8/15/96,10/8/96 License Reviewer: GM, DH, RH 12/4/96,7/10/97,9/25/97 RH, GM, RF File No.: 5 Licensee: St. Lukes-Roosevelt Hospital Center License No.: 75-2898-01 Location: New York City, NY Amendment No.: 0,1,2,3,4,5 License Type: Broad Scope-Medical Type of Action: Renewal,5 Amendments Date issued: 7/20/95,6/4/96,10/7/96 License Reviewer: DH, GM, RH 11/19/96, See comment,11/19/97 RH, unknown, RH Comment: a) Amendment 4 not found in the file l l t

1: New York Draft Report Page D-1.2 NYCH License File Reviews  ; File No.: 6 Licensee: New York University Medical Center License No.: 93-2955-05 Location: New York City, NY Amendment No.: 0,1 License Type: Gamma Knife Type of Action: New, Amendment Date issued: 3/4/97, 6/20/97 License Reviewer: GM, GM Comment: a) SS&D registry sheet strongly recommends nine license conditions that address potential health and safety issues. Six of these conditions were not fully addressed in the tie-down condition or other license conditions. File No.: 7 Licensee: Columbia-Presbyterian License No.: 93-2878-05 Location:' New York City, NY License Type: Gamma Knife Type of Action: New Date issued: 10/31/97 License Reviewer: GM Comment: a) Same comment as file number 6 above. j File No.: 8. Licensee: NYCHHC-Lincoln Medical & Mental Health Center License No.: 91-2951-01 Location: Bronx, NY Amendment No.: 2,3  ! License Type: Hospital Type of Action: 2 amendments Date issued: 6/21/95,11/18/97 License Reviewer: RH,DH File No.: 9 Licensee: NYCHHC - Metropolitan Hospital Medical Center License No.: 91-2802-01 i Location: New York City, NY Amendment No.: 3,4,5,6,7 License Type: Hospital Type of Action: amendment, renewal,3 amendments Date issued: 6/19/95,8/14/96,6/12/97 License Reviewer: JB, JB, RF 10/23/97,1/9/98 JB,RF File No.: 10 Licensee: Steven W. Prufer, MD License No.: 91-2836-01 l Location: New York City, NY Amendment No.: 1 License Type: Human Use-Out Patient Type of Action: Termination Date issued: 8/12/97 License Reviewer: DH l File No.: 11 Licensee: Maimonides Medical Center License No.: 91-2844-01 Location: Brooklyn, NY Amendment No.: 2 License Type: Hospital Type of Action: Renewal Date issued: 6/26/96 License Reviewer: RH l l

l New York Draft Report Page D-1.3 NYCH License File Reviews File No.: 12 Licensee: Lenox Hill Hospital License No.: 91-2926-01 Location: New York City, NY Amendment No.: 2,3,4,5 License Type: Hospital Type of Action: 4 Amendments i Date issued: 12/12/95, 7/10/96,10/23/97,11/2/97 License Reviewer: RH, RH, RF, JB l File No.: 13 ' Licensee: Amiel Rodavsky, MD License No.: 91-3053-01 Location: New York City, NY License Type: Human Use-Out Patient Type of Action: Renewal Date Amendment issued: 6/14/96 License Reviewer: DH File No.: 14 Licensee: Mittal Brij, MD License No.: 91-2895-01 Location: New York City, NY Amendment No.: 0,1, Other License Type: Human Use-Out Patient Type of Action: New, Amendment, Rescind Date issued: 4/18/95,12/11/95,1/24/96 License Reviewer: RF, GM, Commission Order Comments: a) License rescinded b) NYCH confiscated radioactive material l File No.: 15 Licensee: Richard A. Herrmann, MD License No.: 16611-1 l Location: New York City, NY Amendment No.: 4 , License Type: In vitro Use Type of Action: Termination  ! Date issued: 12/5/95 License Reviewer: GM File No.: 16 Licensee: Modern Medical Laboratories, Inc. License No.: 52-2660-01 , Location: Brooklyn, NY Amendment No.: 6 License Type: Hospital Type of Action: Renewal Date issued: 5/22/96 License Reviewer: RF l File No.: 17 Licensee: Brooklyn Hospital Center License No.: 92 2924-02 Location: Brooklyn, NY Amendment No.: 0,1, 2 License Type: Teletherapy Type of Action: Renewal,2 Amendments Date issued: 6/14/96, 6/18/96, 8/8/96 License Reviewer: JB File No.: 18 Licensee: The Brookdale Hospital License No.: 92-2841-02 Location: Brooklyn, NY Amendment No.: 3 License Type: Teletherapy Type of Action: Amendment Date issued: 4/30/97 License Reviewer: DH

1 l New York Draft Report Page D-1.4 NYCH License File Reviews File No.: 19 Licensee: Kings County Hospital License No.: 92-0148-04 Location: Brooklyn, NY l License Type: Teletherapy Type of Action: Renewal Date issued: Pending License Reviewer: RF, JB ' Comments:

 . a)    Reviews failed to timely follow up on lack of licensee response.
                                                                                                   )

i l t l

l APPENDIX D-2 NYDL LICENSE FILE REVIEWS NOTE: ALL LICENSE FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE. i File No.: 1 Licensee: SyncorInternational License Nos.: 2328-3174, 2329-3174G L, 2330-3174 M D Location: Cheektowago, NY Amendment No.: 2 License Type: Nuclear Pharmacy Type of Action: Renewal Date issued: 1/6/98 License Reviewer: RA File No.: 2 Licensee: Entec Consultants, Inc. License No.: 2630-3897 Location: Albany, NY Amendment No.: 2 License Type: Industrial Radiography Type of Action: Amendment. Date Issued: 2/10/98 License Reviewer: CB File No.: 3 Licensee: Glynn Geotechnical Engineering License No.: 2458-3528 Location: Lockport, NY Amendment No.: 3 License Type: Portable Gauge Type of Action: Renewal Date issued: 11/9/97 License Reviewer: RK Comment: a) Deficiency letter sent to licensee prior to supervisory review, i File No.: 4 Licensee: Eastman Kodak Company License No.: 1347-0255 Location: . Rochester, NY Amendment No.: 3 License Type: Broad Scope - Commercial Type of Action: Renewal Date issued: 9/18/97 License Reviewer: RA l Comment: a) Correspondence incorporated into license dates back to 1983. File No.: 5 Licensee: Auburn Steel Company License No.: 2079-2159 Location: Auburn, NY Amendment No.: 2 License Type: Fixed Gauge and Contaminated Waste Type of Action: Termination Date issued: 11/18/97 License Reviewer: RA File No.: 6 Licensee: Orentreich Foundation for the Advancement of Science License No.: 2448-3499 } Location: Cold Spring-on-Hudson, NY Amendment No.: 2 License Type: Research and Development Type of Action: Renewal Date issued: 9/10/97 License Reviewer: DG l

New York Draft Report Page D-2.2 NYDL License File Reviews File No.: 7 l ' Licensee: Self Powered Lighting License No.: 1308-1611 Location: West Nyack, NY Amendment No.: 36 License Type: Manufacturing Type of Action: Amendment Date issued: 9/24/96 License Reviewer: CB Comments: a) Original standby trust agreement and financial mechanism not in NYDL files. File No.: 8 Licensee: Certified Testing Laboratories License No.: .1920-1896 Location: Bronx, NY Amendmeent No.: .1 License Type: Industrial Radiography Type of Action: Amendment Date issued: 10/31/97 License Reviewer: DG Comment:

                  - a)     . One facsimile not included in license tie-down condition.
                  . Fi!e No.: 9 Licensee: Northeast Technology Corporation                                               License No.: 2684-3943 Location: Kingston, NY                                                                                   Amendment No.: 1 License Type: Research and Development                                               -Type of Action: Amendment Date issued: 10/16/96                                                                      License Reviewer: CB
                  ' Comments:

a) Special condition authorizing a location of use in a non-Agreement State pending reciprocity approval by the NRC. b) . Device incorporating a Cf 252 source not reviewed using sealed source and device criteria since licensee's use was only for research and development at one location.

                  ' File No.: 10
                  - Licensee: PVS Chemicals Inc.                                                             License No.: 2646-3915 Location: . Buffalo, NY .                                                                                Amendment No.: 2 License Type: Fixed Gaugo                                                                Type of Action: Renewal Date issued: 9/30/97                                                                       License Reviewer: RK Comment:

a) License is written using NYDL's generic fixed gauge license format which does not contain tie-downs. File No.: 11 Licensee: Occidental Chemical Corp. License No.: 0297-0685 Location: Niagara Falls, NY Amendment No.: 3 License Type: Fixed Gauge and Gas Chromatograph Type of Action: Amendment Date issued: 8/21/97 License Reviewer: CB

l New York Draft Report Page D-2.3 NYDL License File Reviews l l- File No.: 12 l Licensee: Pharmaceutical Discovery Corp. License No.: 2637-3909 Location: Elmsford, NY Amendment No.: 2 l License Type: Research and Development Type of Action: Amendment Date issued: 5/30/97 License Reviewer: CB File W.: 13 Licensee: Acenced Environmental Services, Inc. License No.: 2275-3076 Location: Niagarh Falls, NY Amendment No.: 3 License Type: Gas Chromatograph Type of Action: Renewal Date Issued: 11/25/96 License Reviewer: RK j Comment: a) License is written using NYDL's generic gas chromatograph license format which does not contain tie-downs. 1 I File No.: 14 Licensee: Pall Corporation License No.: 2198-2951 l Location: Glen Cove, NY Amendment No.: 2  ! License Type: Research and Development Type of Action: Termination ; Date issued: 9/5/96 License Reviewer: CB l 1 File No.: 15

                                        - Licensee: Empire Isotopes                                  License No.: 2770-4012,2771-4012MD Location: Albany, NY License Type: Nuclear Pharmacy                                            Type of Action: New Date issued: 6/20/97                                                    License Reviewer: DG File No.: 16 Licensee: Conam Inspection                                            Licence No.: 2713-3965 Location: Itasca, IL Liceryse Type: Industrial Radiography                                     Type of Action: New Date issued: 6/10/96                                                    License Reviewer: CB Comment:

a) Licensee request to perform source exchanges not addressed.

APPENDIX D-3 NYSH LICENSE FILE REVIEWS NOTE: ALL LICENSE FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE. File No.: 1 l l Licensee: University at Albany State University of New York (SUNY) License No.: 459-1 I Location: Albany, NY Amendment No.: 45 License Type: Academic-Broad Type of Action: Renewal Date issued: 9/26/96 License Reviewer: CC l File No.: 2 i Licensee: North Shore University Hospital License No.: 1016 l Location: Manhasset, NY Amendment No.: 16 License Type: Medical-Broad with HDR Type of Action: Renewal Date issued: 1/26/96 License Reviewer: CC File No.: 3 Licensee: Upstate Open MRl/ Diagnostic Imaging License No.: 3152 Location: East Syracuse, NY Amendment No.: 4 License Type: Medical-Private Practice Type of Action: Amendment Date issued: 3/20/98 License Reviewer: RD File No.: 4 Licensee: Forest Laboratories, Inc. License No.: 3185 Location: Farmingdale, NY Amendment No.: N/A License Type: Research & Development-Specific Type of Action: New Date issued: 10/9/96 License Reviewer: CC File No.: 5 Licensee: Immunosciences, Inc. License No.: 2991 Location: New Hyde Park, NY Amendment No.: 4 Licenso Type: Research & Development Specific ~ Type of Action: Renewal Date issued: 11/5/96 License Reviewer: CC ! Comments: a) Renewal frequency for this licensee has been increased to yearly to allow for re-l evaluation of whether the unit will be used in the future or disposed of. l i File No.: 6 l Licensee: Cold Spring Harbor Laboratory License No.: 574 i Location: Cold Spring Harbor, NY Amendment No.: 26 License Type: Research & Development Broad Type of Action: Renewal l Date issued: 7/30/96 License Reviewer: CC l l l t

New York Draft Report Page D-3.2 NYSH License File Reviews File No.: 7 Licensee: Capital Cardiology Associates, P.C. License No.: 3186 Location: Albany, NY License Type: Medical-Private Practice l Type of Action: New i Date issued: 10/17/96 License Reviewer: CB File No.: 8 Licensee: Lakeshore Health Care Center License No.: 3201 Location: Irving, NY License Type: Medical-Hospital Type of Action: New Date issued: 6/12/97 License Reviewer: CC File No.: 9. Licensee: Skyline Oncology Associates, P.C. License No.: 3216 Location: Newburgh, NY License Type: Teletherapy (Storage only) Type of Action: New Date issued: 3/12/98 License Reviewer: BD File No.: 10 Licensee: Guthrie Medical Group, P.C. License No.: 3175 Location: Horseheads, NY License Type: Medical-Nuclear Cardiology Type of Action: New Date issued: 3/12/96 License Reviewer: CC File No.: 11 ' Licensee: Heart and Lung Center License No.: 3199 Location: Liverpool, NY License Type: Medical-Nuclear Cardiology Type of Action: New Date issued: 7/14/97 License Reviewer: CC File No.: 12 Licensee: Nassau County Police Department License No.: 2887 Location: Mineola, NY Amendment No.: 4 License Type: Research & Develop' ment-Specific Type of Action: Termination Date issued: 1/22/98 License Reviewer: MV File No.: 13 Licensee: Great Neck Public Schools License No.: 1164 l Location: Great Neck, NY Amendment No.: 7 License Type: Self Shielded Irradiator Type of Action: Termination Date issued: 10/23/96 License Reviewer: CC l

New York Draft Repor1. Page D-3.3 NYSH License File Reviews File No.: 14 I Licensee: ' Pomona Scanning License No.: 3085 Location: Pomona, NY Amendment No.:

• License Type: Mobile Nuclear Medicine Site Type of Action: Termination Date issued: 10/9/97 License Reviewer: CB ,

Comment: a) License was terminated when new license was issued for srae location. b). Authorized for diagnostic procedures and calibration of ins'.rur sentation. No storage authorized. Radioactive materials must be received through Nuclear Imaging Systems,  ; inc. File No.: 15 Licensee: State University of New York (SUNY) Health Science Center License No.: 47-2 Location: Syracuse, NY Amendment No.: 7 License Type: Medical-Brachytherapy Type of Action: Termination Date issued: 11/19/97 License Reviewer: CB File No.: ~16 Licensee: Samaritan Hospital License No.: 498 2 Location: Troy, NY Amendment No.: 18 License Type: Teletherapy Type of Action: Termination Date issued: 2/4/98 License Reviewer: BD File No.: 17 Licensee: Leonard Hospital License No.: 1757 Location: Troy, NY Amendment No.: 16 License Type: Medical Hospital with Brachytherapy Type of Action: Termination Date issued: 11/30/95 License Reviewer: CC

     .. File No.: : 18 Licensee: Bender Hygienic Laboratory                                                 License No.: 511 Location: Albany, NY                                                              Amendment No.: 15 License Type: Clinical Laboratory                                       Type of Action: Termination Date issued: 1/22/98                                                          License Reviewer: CB File No.: 19 Licensee: Rensselaer Polytechnic Institute                                          License No.: 1035 Location: Troy, NY Amendment No.: 30 License Type: Academic Broad                                                Type of Action: Renewal Date issued: 3/24/97                                                          License Reviewer: BD i

File No.: 20 -

    . Licensee: Our Lady of Victory Hospital                                                    License No.: 1170 Location:- Lackawanna, NY                                                         Amendment No.: 32 License Type: Medical Hospital                                              Type of Action: Renewal Date issued: 3/26/98                                                          License Reviewer: MV l

t i- ,

New York Draft Report Page D-3.4 NYSH License File Reviews File No.: 21 Licensee: Institute of Ecosystem Studies, Inc. License No.: 2826 Location: Millbrook, NY Amendment No.: 8 i License Type: Research & Development-Specific Type of Action: Renewal Date issued: 7/11/97 License Reviewer: CB h

APPENDIX D-4 NYDEC LICENSE FILE REVIEWS NOTE: ALL LICENSE FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE. i File No.: 1 Licensee: Syncor Intemational License No.: 159-3 Location: Bronx, NY License Type: Nuclear Pharmacy, Air Permit Type of Action: New Date issued: 11/27/97 License Reviewer: JA Comment: a) Permit issued 22 months after radiation review completed due to delay in completing another Department permit and public hearings. File No.: 2 Licensee: Wyeth-Ayerst Research License No.: 147-3 Location: Pearl River, NY License Type: Research and Development Broad Scope, Air Permit Type of Action: Renew Date issued: 9/5/97 License Reviewer: RR Comment: a) Permit for 2 of the 3 release points based on off site dose calculaticas to a member of the public, not stack effluent concentration. I File No.: 3 . Licensee: Cornell University License No.: 155-3 Location: Ithaca, NY License Type: Academic Broad Scope, Air Permit Type of Action: Amendment Date issued: 1/21/98- License Reviewers: AG and SH File No.: 4. ! Licensee: New York Medical College License No.: NA Location: Valhalla, NY License Type: Research and Development, Air Permit Type of Action: Inquiry i Date issued: 5/1/96 License Reviewer: JA l l l Comment.  ! a) Permit not required after review of application. Facility's effluents met 10% exemption limit. t L

New York Draft Report Page D-4.2 NYDEC License File Reviews File No.: 5 Licensee: St Luke's/ Roosevelt Hospital Center License No.: NA Location: New York, NY License Type: Research and Development, Air Permit Type of Action: Inquiry Date issued: 10/24/96 License Reviewer: MS Comment: a) Permit not required after review of application. Facility's effluents met 10% exemption limit. File No.: 6 Licensee: New York State Department of Health-Wadsworth Lab License No.: NA Location: Albany, NY License Type: Research and Development, Air Permit Type of Action: Inquiry Date issued: 5/1/96 License Reviewer: AG Comment: a) Permit not required after review of application. Facility's effluents met 10% exempt;on limit. File No.: 7 Licensee: University of Rochester-Laboratory for Laser Energetics License No.: 170-3 Location: Brighton, NY License Type: Academic Broad Scope, Air Permit Type of Action: New Date issued: 2/2/98 License Reviewer: MS Comment; a) Permit issued to existing facility where activities and use of licensed materials increased requiring a permit. File No.: 8 Licensee: Rensselaer Polytechnic Institute License No.: 70-1 Location: Troy, NY License Type: Academic Broad Scope, incinerator Permit Type of Action: Renewal Date issued: 7/25/96 License Reviewer: JA File No.: 9 Licensee: Wyeth Ayerst Research License No.: 168-2 Location: Moultonboro, NH License Type: Research and Development, Water Permit Type of Action: New Date issued: 5/21/97 License Reviewers: WT and SH

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I New York Draft Report Page D-4.3 l NYDEC License File Reviews File No.: 10 Licensee: NYS Energy Research and Development Authority License No.: 137-5 Location: West Valley, NY Amendment No.: Reissued in entirety ) 4 License Type: LLRW Disposal, Waste Burial Permit Type of Action: Amendment i Date issuod: 5/28/97 License Reviewer: WT I I File No.: 11 Licensee: New York State Department of Health-Griffin Laboratory License No.: 111-1 . Location: Albany, NY i License Type: Research and Development, incinerator Permit Type of Action: Termination Date issued: 4/1/98 License Reviewer: AG

              - File No.: 12 Licensee: Bristol-Myers Squibb                                                    License No.: 15 3 Location: Syracuse, NY License Type: Research and Development Broad Scope, Air PermitType of Action: Termination Date issued: 5/15/97                                                         License Reviewer: MS Comment:

a) Permit terminated since a permit is not required after review of application. Facility's effluents met 10% exemption limit. File No.: 13 Licensee: Self-Powered Lighting License No.: 108-3 Location: Elmsford, NY License Type: Manufacturing / Distribution, Air Permit Type of Action: Termination Date issued: 8/21/97 License Reviewer: RR , Comment: a) Termination application and licensee's closecut survey not in file. File No.: 14 Licensee: Medi-Physics License No.: 133-3 Location: Port Washington, NY License Type: Nuclear Pharmacy, Air Permit Type of Action: Renewal Date issued: 6/4/97 License Reviewer: AG l

APPENDIX E-2 NYDL INCIDENT FILES REVIEWED NOTE: ALL INCIDENT FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE. File No.: 1 Licensee: Trans World Airlines License No.: General License -Common Carrier i incident ID No: 95-43 I Location: New York City, NY Date of Event:11/4/95 Type of Event: Contamination event / transportation . Investigation Date: 11/7/95 l Investigation Type: Response to site  ! Summary of incident and Final Disposition: One of eight spent Tc-99m generators was  ! damaged during package handling at JFK Airport. Three days later the damaged package was I repackaged and the State notified. The NYDL responded and surveyed the repackaged item for contamination and external radiation. The radioactive package was damaged at approximately j 5:00pm on 11/4/95 yet the ground carrier that delivered the packages to the airport, Medical Delivery Systems, was not contacted by airport authorities until approximately 10:00 a.m. on 11/6/95. Medical Delivery Systems, also a general licensee, sent a representative to the site on 11/6/95, however, this individual took no action except to return the next day with a representative of the nuclear pharmacy from whom they had accepted the packages for transport. The personnel at JFK failed to call the emergency telephone number on the damaged package when they noticed the damage. The NYDL requested NRC to review the SSD registry sheets for the generator whose shielding failed. File No.: 2 Licensee: Del Med License No.: General Licensee -Contract Carrier incident ID No: 96 10 Location: Bronx, NY Date of Event: 4/23/96 Type of Event: Loss of control Investigation Date: 4/23/96 Investigation Type: Response to site Summary of incident and Final Disposition: A package containing a spent Tc 99m generator was stolen from a contract carrier's vehicle and subsequently disassembled by unauthorized I individuals. The package was'in interstate transport from an NRC licensee in Massachusetts to a location in New Jersey. The carrier, Del Med, allows the driver to stop at his residence in Bronx, NY to rest. The package was stolen from the transportation vehicle while it was parked at the driver's residence. The NYDL responded and supervised retrieval and packaging of the waste. The shipper, an NRC licensee located in Massachusetts, apparently does not provide any shipping papers to the carrier. NRC Region I, was notified of this problem, but no information was in the file of any follow up action that may have been taken by NRC on this matter. The U.S. DOT was contacted by NYDL concerning the problem. l _ _ - - - ____ _ ___- _ -

f New York Draft Report Page E 2.2 NYDL Incident File Reviews ! I File No.: 3 Licensee: Unknown i l License No.: None Incident ID No: 96-21 Location: Westbury, NY , Date of Event: Unknown -first identified 6/19/96 i Type of Event: Abandon Radioactive Material Investigation Date: 6/20/96

                 ' Investigation Type: Response to site Summary of incident and Final Disposition: A 75 mci Cs-137 source was found in a load of trash. Source was recovered by NYDL. An extensive effort was made by NYDL to identify the licensee that had last possessed this source.

File No.: 4 Licensee: Design Plumbing & Heating License No.: 2479-3583 Incident ID No: 97-21 Location: Staten Island, NY Date of Event: 4/20/97 Type of Event: Equipment Failure investigation Date: 5/12/97 investigation Type: Reactive Inspection Summary of Incident and Final Disposition: The source rod on a moistura density gauge failed causing the source to become detached. The failure was due to an improper abusive method of use cot in accordance with training or procedures. The licensee replaced the source in the shield and shipped the unit to the manufacturer who notified the NYDL. NYDL restricted the licensee to storage only due to deliberate abuse of the device. Comment: a) No indication was given in the report as to if the other of the two devices possessed by the licensee had been examined by the inspector to determine if it had also been improperly used. File No.: 5 Licensee: Mt. Sinal Hospital License No.: NYCH Licensee Incident ID No: 97-27 Location: New York City, NY Date of Event: 6/3/97 Type of Event: Loss of Control RAM Investigation Date: 6/3/97 Investigation Type: Response to Site

Summary of incident and Final Disposition

The NYCH licensee lost 176 mci of I-125 seeds which were presumed to have been carried out with trash. NYDL responded and assisted NYCH by surveying the waste transfer facility. Sources were never found.

i l

New York Draft Report Page E-2.3 NYDL incident File Reviews File No.: 6 Licensee: Wyeth-Ayerst Research License No.: 0716-60C7 incident ID No: 97-28 Location: Pearl River, NY Date of Event: 5/21/97 Type of Event: Procedure failure resulting in release of RAM

      ' investigation Date: 6/13/97 investigation Type: Reactive Inspection Summary of Incident and Final Disposition: 724 mci of H 3 was accidentally released via a fume hood. The cause of the H-3 leakage was presumed to be the use of a stopcock type grease on the fittings of the reaction vessel. Procedures were revised by the licensee to warn against this practice. Incident reviewed during the 6/13/97 inspection. N"OEC also investigated this incident.

File No.: 7 Licensee: Unknown License No.: none incident ID No: 97-36 Location: Bronx, NY Date of Event: 8/25/97 Type of Event: Release of RAM Investigation Date: 8/26/97 investigation Type: Telephone, Follow-up site visit. Summary of Incident and Final Disposition: Contaminated trash (diaper) rejected by a landfill. Materialis exempt from regulation and was stored by holder for decay. NYDL staff re-surveyed the trash after decay-in-storage and approved disposal. File No.: 8 Licensee: Syncor international License No.: Incident ID No: 97-37 Location: Saw Mill River Road, Westchester County, NY Date of Event: 8/28/97 Type of Event: Transportation Investigation Date: 8/28/97 investigation Type: Telephone Summary of incident and Final Disposition: A nuclear pharmacy delivery vehicle was involved in a traffic accident. The licensee responded to the scene, surveyed and recovered the packages. No contamination was found at the accident site. 1

New York Draft Aeport Page E-2.4 NYDL incident File Paviews File No.: 9 Licensee: Nucletron License No.: 2674-3822 Incident ID No: 97-38 Location: Poughkeepsie, NY Date of Event: 8/28/97 Type of Event: Equipment Failure Investigation Date: 8/28/97 Investigation Type: Telephone Interview Summary of Incident and Final Disposition: A 8.6 Ci source of Ir-192 became immobile in an HDR source exchanger during a source exchange by Nucletron at Vassar Brothers Hospital. The technician had to manually push the source back into the shipping pig. Source exchanger was returned to Holland for analysis and repair. The State of Maryland was adviscd on the incident by NYDL. File No.: 10 Licensee: Municipal Testing License No.: 2066-1988 Incident ID No: 97-44 Location: Brookhaven, NY Date of Event: 10/12/97 Type of Event: Equipment Failure Investigation Date: 10/14/97 investigation Type: Field Inspection Summary of incident and Final Disposition: A 21 Ci radiography source failed to retract into the camera. The licensee's RSO manipulated the source into another camera. The malfunctioning camera was sent to the manufacturer for evaluation. Licensee was cited for failure to notify the State within 24 hours and for performing an unlicensed activity. The State of California, which has jurisdiction over the camera manufacturer, was promptly notified. File No.: 11 Licensee: Universal Testing & Inspection Services, Inc. License No.: 2570-3788 incident ID No: 97-40 Location: North Valley Stream Court Shopping Center, Valley Stream, NY Date of Event: 9/8/97 Type of Event: Damage to Equipment investigation Date: 9/8/97 investigation Type: Site Summary of incident and Final Disposition: A moisture / density gauge was crushed by an asphalt roller bending the source rod and cracking the body of the gauge. The NYDL responded and assisted in securing the device for shipment and surveying the device for external radiation ar.d contamination. i

New York Draft Report Page E-2.5 NYDL incident File Reviews File No.: 12 Licensee: Geocore & Environmental Services License No.: NRC Licensee (Reciprocity) Incident ID No: 97-48 Location: Commac, NY Date of Event: 10/17/97 Type of Evont: Stolen RAM Investigation Date: 10/18/97 investigation Type: Telephone Summary of incident and Final Disposition: A vehicle containing a Troxler model 3430 gauge was stolen on 10/17/97. Vehicle was recovered but gauge was not in it. Gauge was found on road side on 11/12/97. The licensee was cited for bringing a gauge into New York without filing for reciprocity. File No.: 13 Licensee: Mallinkrodt Medical,Inc. License No.: 2312-3141 Incident ID No: 97-56 Location: Queens, NY Date of Event: 12/2/97 Type of Event: Transportation Investigation Date: 12/2/97 Investigation Type: Site Summary of incident and Final Disposition: A package containing a Mo/Tc generator was damaged at Laguardia Airport. NYDL staff surveyed and wiped the package at the airport. There was no release of radioactive materials and no removable contamination. l

New York Draft Report Page E-3.4 NYSH Incident File Reviews File No.: 10 Licensee: St. Mary Hospital License No.: 35 Location: Rochester, NY Date of Event: 1/26/98 Type of Event: Release of RAM Investigation Date: 1/27/98 - 2/4/98 investigation Type: Phone Summary of incident and Final Disposition: Medical waste rejected in South Carolina due to elevated radiation levels, returned to point of origin. Waste originated from nursing home patient treated with l-131 for ablation as an out-patient. Waste returned to hospital for decay-in-storage. In a letter to the licensee, NYSH stated that they would be inspecting the licensee to ensure compliance with State guidelines and to review the licensee's corrective actions. File No.: 11 Licensee: Herbert Ross, M.D. License No.: 1186 Location: White Plains, NY Date of Event: 12/96 Type of Event: Lost RAM Investigation Date: 12/27/96 investigation Type: Site Inspection ' Summary of incident and Final Disposition: Two Cs-137 sources discovered lost during termination of license. Extensive search by license and NYSH did not turn up sources. License terminated. File No.: 12 Licensee: Good Samaritan Hospital 4 License No.: 575 i Location: West Islip, NY  ! Date of Event: 10/96 Type of Event: Lost RAM i Investigation Date: 5/21/97 j Investigation Type: Site inspection Summary of incident and Final Disposition: During a routine inspection, the staff identified that the licensee failed to locate and report a missing Pd-103 seed during patient implant. Licensee cited for failure to report lost material and poor investigation of incident. NYSH reviewed licensee's corrective action for follow up at next inspection. l l t l

APPENDIX E-4 NYDEC INCIDENT FILES REVIEWED NOTE: ALL INCIDENT FILES LISTED WITHOUT COMMENT WERE DETERMINED BY THE IMPEP TEAM TO BE ACCEPTABLE. File No.: 1 l Licensee: Syncor international License No.: 152-3 Location: Troy, NY Date of Event: 4/23/96 Type of Event: Damage to Equipment and Facility investigation Date: 4/23/96 Investigation Type: Phone Summary of incident and Final Disposition: High winds destroyed roof mounted blower which caused the failure of the licensee's fume hood. Licensee suspended work in hood until repairs i made. The incident was reported to NMED by NYDL. Comments: a) No specific follow up of the incident at the next inspection. File No.: 2 Licensee: Buffalo General Hospital License No.: NA Location: Buffalo, NY Date of Event: 1/29/96 Type of Event: Release of RAM Date: 2/1/96 Investigation Type: Site Inspection Summary of incident and Final Disposition: A disgruntled employee placed approximated 3.6 mci of P-32 in medical waste stream which was incinerated at the facility's incinerator. NYDEC conducted on-site inspection to evaluate potential off site doses. File No.: 3 Licensee: Wyeth Ayerst Research License No.: 147-3 Location: Pearl River, NY Date of Event: 5/21/97 Type of Event: Release of RAM Date: 6/2-9/97 Investigation Type: Phone Summary of Incident and Final Disposition: Accidental release of approximately 724 mci of tritium during a labeling procedure. NYDEC evaluated licensee's event report and amended the permit to allow testing of the system. Release did not exceed dose threshold. Event occurred during renewal of permit. Permit issued with licensee's corrective actions. The incident was also investigated by NYDL.

i New York Draft Report Page E-4.2 ] NYDEC Incident File Reviews File No.: 4 Licensee: ICN East i License No.: 5-3 ' Location: Orangeburg, NY j Date of Event: April and May 1996 ' Type of Event: Equipment Failure and Release of RAM Date: 6/3/96,7/11/96 Investigation Type: Phone, Site inspection Summary of incident and Final Disposition: Accelerated filter aging resulted in release of 1.3 mCl of I-125 in excess of permit's 0.2 mci limit. Probable causes of the release were lack of l filter maintenance, inadequate HP oversight and audits, and changes in labeling protocol of j RAM prior to filter deterioration. Enforcement conference conducted as a result of NYDEC's

                                                                       ' inspection. Licensee's corrective actions where incorporated into a consent order.

I l i i e

APPENDIX F NYDL SEALED SOURCE AND DEVICE REVIEWS File No.: 1 . Registry No.: NY-0502-D-110-G

                                                          . Manufacture: NRD, Inc.

SS&D Type: Static Eliminator Date issued: 12/31/97 Comments: a) The determination of what is considered tamper resistant screws was left to the applicant. b) Applicant was not requested to identify the conditions of use under which the device would be used. c) Certificate limits the condition of use to an undefined " extreme conditions" and not on a known set of conditions, such as the ANSI classification. d) The materials of construction and methods of attachment for several components of the device were not specified. e) The visibility and durability of the labels were not reviewed. l f) The applicant did not provide justification for a leak test frequency greater than 6 months. g) The applicant did not provide dose scenarios and mounting instructions for the general licensees installing the device. h) The quality assurance and quality control procedures submitted by the applicant were not reviewed.  ! i) . The licensee's response to a deficiency request regarding the most vulnerable surface of ' the device was not adequate. j) Applicant did not provide historical use data to support claim regarding the lack of injury or significant radiological failures. k) Information contained in two letters were not referenced in the certificate but were listed in the tie-down condition of the license, was not accurately reflected in the certificate.

1) The wording of the leak testing requirement in the certificate could lead to misinterpretation.

m) The drawings of the device components did not contain tolerances for all components. I 1 l l (

1 I l l I l 1 l I APPENDIX G 1 New York City l Department of Health, Bureau of Radiological Health (NYCH) i i INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) QUESTIONNAIRE i l l l l-l

Approved by OMB' No. 3150-0183 l Expires 4/30/98 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Name of State / Regional Program: City of New York, Department of Health, Bureau of Radiological Health Reporting Period: April 01,1995, to January 1998. A. COMMON PERFORMANCE INDICATORS

1. Status _of_ Materials in=aadian Plogram i

l 1. Please prepare a table identifying the licenses with inspections that are overdue I by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800. The list should include initial inspections that are overdue. Insp. Frequency l Licensee.Name (Years) Due. Data Months O/D t l See attached list oflicenses. We have discovered 3 Priority 2 licenses and 1 Priority 3 license that are overdue and these will be inspected within the week. 1

2. Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this

! questionnaire. l l See above. l 3. Please identify individuallicensees or groups oflicensees the State / Region is inspecting more or less frequently than called forin NRC Inspection Manual l Chapter 2800 and state the reason for the change. None. i 2 Estimated burden per response to comply with this voluntary collection request: 60 hours. Forward comments regarding burden estimate to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0052), Office of Management and Budget, Washington, DC 20503. NRC may not conduct or sponsor, and a person is not required to i respond to, a collection of information unless it displays a currently valid OMB control number.

   . 4. Please complete the following table for licensees granted reciprocity during the reporting period.

Numberof Licensees Granted Reciprocity Number of Licensees Priority Permits Each Year inspected Each Year Service Licensees performing YR YH I teletherapy and irradiator source YR YR l installations or changes YR YR YR YR l M M i 1 YR YR I YR YR l YR YR YR YR 2 YR YR l YR YR YR YR YR YR ( 3 YR YR YR YR YR YR l 4 l l All Other i l

Seven out of state or city licensees were granted reciprocity by this Bureau betwen April,1995 and the present. These were Neutron Products, Therstronics, Alpha-Omega Services, Elekta, Quality Assurance Services, Ultra Company,Inc.,

and the State University of New York @ Stony Brook. A total of 223 reciprocity notices were RIed with this Bureau during the reporting period. Of this total,195 were HDR source exchanges and 23 involved teletherapylicenses. A total of 13 teletherapyinstallations, source exchanges, and source removals were inspected. t j 5. . Other than recipmcity licensees, how many Reid inspections of radiographer were performed? None. Industrialradiographyis under the purview of the New York State Department of Labor, not the Bureau.

6. For NRC Regions, did you establish numerical goals for the number of inspections to be peribrmed during this review period? If so, please describe your goals, the number ofinspections actually performed, and the reasons for 2

any differences between the goals and the actual number ofinspections performed. N/A. II. Inchnical Qualifv ofInsonetians

7. What, if any, changes were made to your wntten Inspection procedures during .

the reporting period? j We adopted the NRC inspection ibrms. No other substantive changes. l

8. Prepare a table showing the number and types of supervisory accompanimems made during the reviewperiod. Include:

, inspector Supsivisor License Cat. Date Ahmed Arafa Richard Borri Nuclear Medicine 9/2'5/97

! Terry Kirschenbaum Richard Borri Teletherapy 9/25/97 , Victor Goretsky Richard Borri Nuclear Medicine 9/18/97 l Chris Saganich Richard Borri Nuclear Medicine 9/16/97 l Edward Cutler Richard Borri Nuclear Medicine 8/26/97 l Ahmed Arafa Richard Borri Nuclear Medicine 8/21/97 Victor Goretsky Richard Borri Academic 7/15/7 Chris Saganich Richard Borri Medical (Broad) 7/11/97 Edward Cutler Richard Borri Academic 7/9/97 Chris Saganich Richard Borri Teletherapy 6/29/97 Ahmed Arafa Richard Borri Pvt. Office Med. 11/26/96 Terry Kirschenbaum Richard Borri Medical (Broad) 11/20/96 Edward Cutler Richard Borri Medical (Broad) 11/13/96 Ahmed Arafa Richard Borri Pvt. Office Med. 8/28/96 Victor Goretsky Richard Borri Teletherapy 6/25/96 Chris Saganich Richard Borri Medical (Broad) 6/21/96 TerryKirschenbaum RichardBorri Medical (Broad) 4/3/96 l Ahmed Arafa Richard Borri Medical (Broad) 3/26/96 Terry Kirschenbaum Richard Borri Nuclear Medicine 3/5/96 Edward Cutler Richard Borri Academic 1/23/96 Edward Cutler Richard Borri Nuclear Medicine 12/28/95 Victor Goretsky Richard Borri Academic 12/12/95 Chris Saganich Richard Borri Academic 11/21/95 Ahmed Arafa Richard Borri Nuclear Medicine 10/21/95 TerryKirschenbaum RichardBorri Nuclear Medicine 9/9/95 Teny Kirschenbaum B. Kamble Medical (Broad) 5!29/96 Edward Cutler B. Kamble Teletherapy 6!6/97 Chris Saganich B. Kamble Btved(Non-Human) 10/1/96 3

Edward Cuder B. Kamble Broad (Non-Human) 10/1/96 Chris Saganich B. Kamble S'vad(Non-Human) 12/21/96 Broad (Human Use) 12/21/96 AhmedArafa Edward Cuder Victor Goretsky Edward Cutter B. Kamble NuclearMedicine 7/1996 Edward Cutter B. Kamble Nuclear M3dicine 12/28/95 Chris Saganich B. Kamble Nuclear Medicine 12/2 &95 Edward Cutler B. Kamble Broad (Human Use) 11/1286 AhmedArafa &(Non-Human) Victor Goretsky , B.Kamble Richard Borri Broad (Human Use) 10'31.97 1 B.Kamble Richard Borri Broad (Human Use) 9/2997 B.Kamble Richard Borri Broad (Human Use) 7/3/96 Richard Borri L. Friedman Broad (Human Use) 11/12/97

9. Describe intemalprocedures kr conducting supervisory accompaniments ofinspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation kr each accompaniment.

Supervisory accompaniments consist of a supervisor}oining one or more inspectors during the course of an inspection to conRrm that all violations of Article 175 NYCHC are identiSed, documented and reported, using procedures as statedin the inspection procedure manual, as applicable. Results of the accompaniments are discussed with the inspector as soon as possible after the accompaniments end. Supervisory accompaniments also provide a setting forinformal, on the spot training. Written documentation nf accompaniments is not made unless formal, written charges will be Bled against the inspector; then documentation will be made sufficient to support the charges. During the reporting period no such actions were taken. i

10. Describe orprovide ait update on yt.srinstrumentation and methods of calibration. Are allinstruments properly calibrated at the present time?

The Bureau kr Radiological Health establishes a blanket order for the calibration of Roldinstrumentation with Ludlum Measurements of Sweetwater, Texas. Ludlum is authorized by the State of Texas Radiological Health Bureau to operate an instrument calibration facility. The Bureau calibrates all Reidinstrumentation used by the Radioactive Materials (RM) Division on either an annual basis or after any instrument repair. Ludlum calibrates the kilowing Instruments for the Bureau: Model 14C GM Counter with Model44-7 GMprobe & Model44-9 Scintillation Probe 4

Model 19 Micro-R Scintillation Meters Model 6112B Automins Stretch GM Probe Model ESP-1 Ebetiine Neutron Probe with Model NRD Probe Each inspectoris issued a copy of the calibration kr the Held instrument assigned to him. AII Bureau instruments are property calibrated at the present time. In those situations requiring more sophisticatedlaboratory analyses, the Bureau has access to the resources of Brookhaven National Laboratory. lli. Technient Rtamng and Training

11. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, kr Agreement States, the fraction of time spentin the ibliowing areas:

administration, materials licensing & compliance, emergency response, LLW, U-mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor work ofJunior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be: NAME POSITION AREA OF EFFORT FTE% Gene Miskin Head- Licensing Administration 70 Ucensing 30 Jane Bragg Scientist Licensing 90 Linac registration 10 Raymond Ford Scientist Licensing 90 Unac registration 10 i Richard Harmon Scientist Licensing 90 I Unac registration 10 l Daniel P. Hayes, Ph.D.,CHPScientist Licensing 90 l Unac registration 10 l l 5 l l 1

BLAME POSITION AREA OF EFFORT FTE% I Richard Borrl Sr. Scientist Materialslicensing & Compliance 80 Ememency Responses 20 BapuKamble Scientist Materials licensing & Compliance 85 Emergency Resp.nses 15 Ahmed Arafa Asst. Scientist Materialslicensing & Compliance 85 Emergency Responses 15 Edward CutlerAsst. Scientist Materialslicensing & Compliance 85 Emergency Responses 15 Victor Goretsky Asst. Scientist Materials licensing & Compliance 90 Emergency Responses 10 T. Kirschenbaum Asst. Scientist Materials licensing & Compliance 90 Emergency Responses 10 Chris Saganich Asst. Scientist Materials licensing & Compliance 85 Emergency Responses 15

12. Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.

Laurence F. Fn' edman, Ph.D., CHP, started as Director on 10/6/97. Dr. Friedman has over thirty-Rve years experience, including over thitteen years with NRC-Region I. No othernew hires since last review.

13. Please list allprofessional staW who have notyet met the quali6 cation requirements oflicense reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

Allof the staffis trained. The licensing statihave allattended core courses provided by NRC, attended an in-house licensing class and have been reviewed in all the types oflicensing done by this Bureau. The materials inspection staff have attended core courses provided by NRC and perform unsupervised and supervisedinspections of each of the types oflicenses 6

 .                                                                                                                                   1 l

issued by this Bureau, in addition to having had training and experience in Emergency Response, i

14. Please identify the technical staff who left the RCP/ Regional DNMS program dudng this period.

Robert R. Kulikowski, Ph.D., Director, resigned his position effective 7/19196. Laurence F. Friedman, Ph.D., ChP, Director, resigned his position effective 2/G98.

15. List the vacant positions in each prograta, the length of time each position has been vacant, and a brief summary of efforts to Sli the vacancy.

The Bureau Director position was vacant for 15 months from July of 1996 untii October of 1997. This position is now vacant again with the resignation of Dr. Friedman and this vacancy has been reposted. 1 IV. .TachnicaLQualitv of Licensing Actions.

16. Please identify any major, unusual, or complex iicenses which were issued, received a major amendment, terminated, decommissioned, bankruptcy notiRcation or renewed in this period. Also identify any new or amended licenses that now require emergency plans.

Two Gamma Knife licenses were issued- one to New York University Medical Center and one to Columbia Presbyterian Medical Center. A consolidated non-human use license was issued to New York Hospital-Comell Medical Center which eliminated about 100 individuallicenses for this Institution.

17. Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

Any physician wishing to use the "C-Urea capsules may request a variance from the Bureau and will receive a letter from us granting such variance for  ; ordering purposes.

18. What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

Thefollowing License Guides have been updated during the reportingperiod: License Guide 10.2, Revision 2, April,1997 License Guide 10.3 Revision 2.1, April,1997 License Guide 10.6, Revision 2, January,1996 l l 7

License Guide 10.7, Revision 2, April,1997 License Guide 10.8, Revision 2, December,1997 1g. For NRC Regions, Identify by licensee name, license number and type, any renewal applications that have been pending for one year or more. N/A V. Responses to Incidents and Allegations

20. Please provide a list of the reportable incidents (i.e., medical misadministration, I overexposure, lost and abandoned sources, incidents requiring 24 hour or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States ibr additionalguidance.) that occurredin the Region / State during the review period. For Agreement States, Information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB 3150 0178). Thelist should be in the following format:

M TYPE OF INCIDENT LICENSEE NAME LLCENSEM j,0;, supont Columbia- 9/97 A serious deficiencyin management and Presbyterian Medical proceduralcontrols in a majorarea; Center wrongdoing. The center failed to effectively monitorits regular waste stream for radioactive contamination . Though the \ Center installed fixed portal monitor j systems, when one broke down it was not l promptly repaired, and the Assistant RSO r ordered a te chnichian to make up false records showing the system to be coerational. When waste from the center was found to have radioactive contamination, these false records were displayed to Bureau representatives. l Mt. SinaiMedical &97 Theft or diversion oflicensed material. Center When a shipment of about 200 mCiof lodine -125 seeds was received at the l Center, it was left unsecured in an open I office area. When it was needed the next  ! day, it was gone. A search of the Center by the radiation safety staff and i representatives of the Bureau failed to l locate the shipment and it remains missing i l l 8 i i l

New York University MedicalCenter 11/97 Improper shipment and loss oflicensed material The Center attempted to transport 3 MCI of Yttrium-90 between its two campuses via a technician using a taxicab. The wtrium-90 was bost when the taxidrove off with the material still in the trunk. It was retumed to the Center the next day by the taxi company when another driver nobceditin the trunk. For allof these hcidents, a Nobce of Violation was issued and civilpenalties were imposed.

21. During this review period, did any incdonts occur that invotnd equipment or source failure or approved operating procedures that were deMcient? If so, how and when more other State /NRC licensees who might be aMected notified? For Stater, was timely notincetion made to NRC? For Regions, was an appropriate and timely PN generated?

No. \

22. Forincidents involving failure of equipment or sources, was information on the incident provided to the agency responsible & evaluation of the device for en assessment of possible generic design de&ciency? Please provide details foreach case.

There weren't any.

23. In the period covered by this review, were there any cases involving possible wrongdoing thet were reviewed or are presently undergoing review? If so, please describe the circumstances & each case.

During June 1997 we determined that en Assistant RSO at Mt. Sinal Hospital was ordering a technician to make out and sign false records of radiation monitoring equipinent, showing them as operating property when in fact they were not. In December of 1995, this Bureau revoked the license of a nuclear cardiologist when it was teamed that preceptor statements that had been submitted as proof of experience W this individual did not rneet the requirements ofAtticle 175 of the New York CMy Health Code. The originallicense was nest amended to read ' storage only untilproof of disposition of all radioactive materialsand then was canceIIed after a conRrmatory inspection by this Bureau.

24. Identify any changes to your procedures & handling allegations that occuned during the period of this review.

a. For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed. .

None. VI. General 9

( l i

25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.

In a letter dated W29N5 to Richere L. Bangert, Benjamin Mojica, M.D., M.P.M., Acting Commissioner of Health responsed to the comments andrecommendations made by NRC tbliowing the last program review.

26. Provide a brief descr> tion of your program's strengths and weaknesses. These strengths and weaknesses shoukt be supported by examples of successes, problems or difficulties which occurred during this reviewperiod.

? One obvious neskness is the tinct tne this Bureau has been without a director for most of the reporting period. Despite this, Bureau personnel have managed to maintain an effective radiation safety program 1 in New York City. B. NON COMMON PERFORMANCEINDICATORS

1. LanielnNon and Proaram Elements Ranuired ibr Comn=Nhildv

27. Please list all cunently effective legislation that aMiects the radiation controlprogram (RCP).

Article 175 of the New York City Health Code- Radiation Control Part 16 of the New York Sanitary Code 6 NYCRR Part 380 and Part 381, New York State Department of Environmental Conservation.

28. Are your regulations subject to a " Sunset' or equivalent law? If so, explain and include the next expiration date foryour regulations.

No.

20. Please complete the enclosed table based on NRC chronology of amendments. Identify those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.

Please see table. The Bureau is currently reviewing with our Office of General Counsel the Timeliness in Decommissioning Rule and the LowLevel Waste Shipment Manittst Rule. The Bureau has decided l to retain our more stringent Frequency of Medical Examinations for Use of Respiratory Protection Equipment.

30. If you have not adopted all amendments within three years kom the date of NRC rule promulgation, briery describe pour State's procedures ibr amending regulations in order to maintain compatibility with the NRC, showing the rxwmalbength of time anticipated to complete each step.

I Rule making language is done by Bureau personnel and this is then sent out ibr comment to NRC, State Health, and an advisory committee of the New York Academy of Medicine. A draft of the rule after comments is the sent to our Otnce of General Counsel, which prepares the proposed rule for approval i 10

_ _ _ - _ _ _ _ - _ _ _ _ - _ - - _ _ _ _ - _ _ _ = _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___ by the Board of Health for publication in The Citv Record. There is a thirty day period for comment and a public meeting is held on the last day of the commentperiod. Assessment of comments received is then done and the Snal rule is prepared for Board of Health approval. With approval, the rule is then published in The Citv Record and then becomes final within thirty days. Complexity of the proposed rule making is the determining factor for length of time to adoption. On average, the rule makhg process takes about six months to complete. I II. Sealed Source and Device Prooram j

31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the tuview period. The table heading should be: 1 SS&D Manufacturer, Type of  !

Registry Distributoror Device Date Number _ CutM m User or Source issued None. Approvals performed by State.

32. What guides, standards and procedures are used to evaluate registry applications?

N/A

33. Pieese include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:

N/A Ill. Low.LevelMaste Procram

34. Please include information on the following questions in Section A, as they apply to the Low-level Weste Program:

N/A IV. Uranium MillProcram

35. Please include information on the following questions in Section A, as they apply to the Uranium Mill Program:

N/A l 11 l l 1

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License inspectons Due By Priortty and By Deb Due . Ucense s License Type Priority Date Duo - Data Overtive Name Borough 2909 75 1 12/13/97 03/13/98 Rockefolier University MN 2924 92 1 01/2M8 04/29/98 Brooklyn Hospital Center BK 2885 75 1 02/04/98 05/05/98 Monternore Med Ctr BX 3009 75 1 03/0598 06C3/96 St. Vlnoonrs Hospital and Medical Center MN 2843 92 1 03/0&98 08/0M8 Long Island College Hospital BK 181 92 1 03/2598 08/23/98 Memorial Sloan-Kettering MN 185 75 1 03/25/98 08/23/98 Memorial Sloan- Kettering MN 2847 92 1 04/04/98 07/03/98 Peninsula Hospital Center GN 2894 91 1 04/11/98 07/10/98 New York Hospital Medical Center of Queena QN 131 92 1 04/24/98 07/23/98 Staten latand University Hospital SI 126 92 1 04/24/98 07/23/96 Staten Island UnN. Hoop Si 2830 92 1 05/09/98 08/07/98 Manfredi, Orlando L. . M.D. Si 2909 91 1 06/21/98 08/10/98 Mt Sinal Schod of Medidne MN 2841 92 1 05/24/98 OW22/98 Brookdale Hospital Medical Center BK 2919 75 1 08/05/98 09/03/98 Albert Einstein Conoge of Medidne BX 2889 92 1 08/06/98 09/04/98 AnirnalMedicalCenter MN 2899 92 1 0&V6/98 09/04/98 AntrnalMedicalCenter MN 188 , 92 1 06/22/98 09/20/98 Mornorial Sloan-Kettering Concer Ctr MN 2955 92 1 07/08/98 10/0M8 NYU Medical Center MN 78 92 1 07/29/98 10/27/98 Lenox Hill Hospital MN 269803 92 1 08/07/98 11/0598 Memorial Sloan-Kettertng MN 2957 91 1 09/17/98 12/18/98 NY Hosp..Comell Med Ctr MN 2897 92 1 09/24/98 12/23/98 Beth Israel Medical Ctr MN 86 75 1 10/12/98 01/10/99 NYU Med Center MN 2986 75 1 10/18/98 01/14/99 Long Island Jewish Med. Ctr. QN 2950 93 1 10/17/98 01/15/99 NYU Medical Center MN 2955 75 1 10/17/98 01/15/99 NYU Medical Center MN 2878 92 1 10/27/98 01!25@9 Columble Presbyterian Medica! Center MN 2922 92 1 10/28/98 01/2M9 Cabrin! Medical Center MN 2898 75 1 10/3148 01/29/99 St Luke's\Roosevett Hospital Ctr MN 3028 92 1 11/07/98 02/05/99 SUNY Health & Sdence Center Brooktp BK 82 92 1 11/07/98 02/05/99 SUNY Health & Sdences Center Brooklyn BK 44 92 1 11/07/98 02/05/99 SUNY Health & Sdence Brooklyn BK 148 92 1 11/28/98 02/26/99 NYCHHC . Kings County Hospital BK 2878 52 1 12/05/98 03/05/99 Columbia Presbyterian Medical Center MN 2878 75 1 12/05/9? 03/05/99 Columbia Presbyterian Medical Center MN 2848 92 1 12/24/98 03/24/99 Calvary Hospital BX 2934 75 1 01/1& 99 04/18/99 SUNY-Health & Sdence Ctr of Brooklyn BK 2883 92 1 02/13/99 05/14/99 Montenore Med. Center BX Tout 39 Priority Date Due Date Overdue Name Borough 2909 74 2 07/22/96 01/18/97 Mt Sinal School of Medidne MN 2881 91 2 02/08/97 08/07/97 Nestadt, Louis MD. MN 2915 91 2 04/28/97 10/25/97 NYCHHC Uncoln Medical and Mental Health Ctr BX 1518 91 2 09/21/97 03/20/98 Victory Memortal Hospital BK 2919 74 2 10/12/97 04/10/98 Albert Einstein Colle9e of Medidne BX 2903 91 2 01/0448 07/03/98 NYCHHC Harlem Hospital Center MN 3003 91 2 01/24/98 07/23/98 Annand, Azad K. MD ON 2731 91 2 01/24/98 07/23/98 Lugo Santiago, Erna MD QN 2932 91 2 01/2&S8- 07/27/98 Parkway Hospital QN 1515 91 2 01/30/98 07/29/98 North Shore University Hospital QN 2900 91 2 03/22 S 8 09/1&98 Our Lady Of Mercy BX 2844 91 2 03/2M8 09/22/98 Maimonides Med. Ctr. BK 3075 91 2 03/3048 09/2698 Haroid M. Tice ON 3069 91 2 03/30 S8 09/2M8 David Greenblatt, M.D. MN 2843 91 2 04/0348 09/30/98 Long Island College Hospital BK 1841 91 2 04/11/98 10/0M8 NYCHHC North Central Bronx Hospital BX 3070 91 2 04/11/98 10/0M8 Daniel Lortier QN 2882 91 2 04/16/98 10/13/98 St. Clare's Hospital & Health Center MN 2642 91 2 04/1998 10/16/98 Bloomne!d, Martin E. MD MN 2905 91 2 04/23/98 10/20/96 Caccavo, Nicholas MD BK 3002 91 2 05/05/98 11/01/98 Blake James MD MN 3020 91 2 05/0698 11/04/98 Thanawala, Shirtsh K. MD ON 185 91 2 05/0&S8 11/04/98 Weinstein,Victe MD . QN 2788 91 2 0509/98 11/05/98 Wolmer, tra MD. MN 2914 91 2 05/15/98 11/11/98 NYCHHC Coler Memorial Hospital MN 2680 91 2 05/15/98 11/11/98 Rosenthal, David, M.D. BK 03/1748

Ucense inspeceone Lue By PMortly and By Date Due

 ,         1540              91             ,  2   06/17/96       11/13/96 Doctor's Hospitsi of Staten leland                 St 2732               91              . 2   OW22/96        11/16/96 Paula M. Rotheus, M.D.                             MN 2796               91            ! 2    06/23/96       11/10/96 Sier, Steven MD                                    MN 3039               91               2   06/23/96       11/10/96 Jacobs, David R. MD                                MN 3053               91               2   06/24/96       11/20/96 Rudavsky, Amiel Zachary, M.D.                      MN 2761               91               2   06/29/96       11/28/96 Kaufman, D MD                                      BX 2955               74               2   OS/31/C8       11/27/96 NYU Medical Center                                 MN 295604                74               2   06/31/96       11/27/96 New York University                                MN 2795                91               2   06/06/96       12/02/96 Reismen, Steven MD                                 MN 2061                91               2   08/17/96       12/14/96 Potenze, Robert MD                                 BX 1672               91               2   08/16/96       12/15/96 SperpW.GabrielMD                                   BK 27:5               91               2   06/16/96       12/15/98 Preger, Marc MD                                    BX 2024               91               2   06/21/96       12/16/96 Brooldyn Hospital Center                           BK 2956               91               2   06/26/96       12/25/96 Nurti General Hospital                             MN 2642               91               2   07/03/96       12/30/96 Mottodist Hospital                                 BK 3025               91               2   07/10/96       01/06/99 Eng, Young F, . M.D.                               Si 2616               91               2   07/15/96       01/11/99 Sheinbrot,Stuart/ltwin, Sin 0er                    BK 3023               91               2   07/16/96       01/14/99 Novick, Mark MD                                    QN 3077               91               2   07/30/96       01/26/99 Joseph Hung Me, M.D.                               QN 3004               91               2   0691/96        01/26/99 Utile Neck Community Hosp.                         ON 2760               91               2   08/12/96       02/08/99 Sapienza, N MD                                     BK 3005                91              2   08/13/96       02/09/99 Usann, Neal, MD                                    MN 3036                91              2   06/14/96       02/10/99 DesN,1, mens MD                                    BK 2646                91               2  08/15/96       02/11/99 Uey, Jacob                                         MN 2630                91               2  06/17/96       02/13/99 Manfredi, Ortendo L M.D.                           Si 2651                91               2  08/20/96       02/16/99 St. John's Episcopal Hospital                      QN 3014                91               2  08/29/96       02/25/99 Rezzadeh, Rudy MD                                  MN 2797                91               2  09/04/96       03/03/99 Semefer, Kenneth MD                                Si 2798                91               2  09/10/96       03/09/99 Doohl, Leena M.D.                                  QN 2960                91               2  09/10/96       03/09/99 N.Y Flushino Hoso. Med. Ctr.                       QN 2638                91               2  09/11/96       03/10/99 Lottier, Daniel MD                                 ON 2771                91               2  09/16/96       03/15/99 Brendels,VincentT                                  MN 3022                91               2  09/24/96       03/23/99 Beth lereel . Kin 9s Highway Dnvision              BK 2944                91               2   09/26/96      03/25/99 Doshi, Leena M.D.                                  BK 3041                91               2   09/27/96      03/26/99 Rosenthal, David, M., MD                           BK 2821                 91              2   09/27/96      0',,/26/99 Ginde, Ravindre MD                               BK 2957                 91              2   10/01/96      03/30/99 Mang Henry M.D.                                     MN 3034                 91              2   10/01/96      03/30/99 Lefkowitz, Deved M.D.                               MN 3042                 74              2   10/01/96       03/30/99 CUNY City College                                  MN        i 2663                 91              2   10/01/96       03/30/99 Kampf, Jeffrey MD                                  MN 3056                91              2   10/03/96       04/01/99 Tartell, Jay MD                                   QN 2657                91              2   10/09/96       04/07/99 Lash, James MD                                     BK 2739                91              2   10/11/96       04/09/99 Schorr, P MD (Hikrest)                             QN 2666                91              2   10/18/96       04/16/99 Thanswels, SNrtsh K. MD                            BX 3051                91              2   10/22/96       04/20/99 Samil, Moheen MD                                   QN 2941                91              2   10/23/96       04/21/99 Hassan, Khalid MD                                  BK 1619                91              2   10/23/96       04/21/99 Westem Queens Comminity Hospital                   QN 2606                91              2   10/25/96       04/23/99 Feit, Sheldon, MD                                  ON 3050                91              2   10/30/96       04/26/99 Levine, Even MD                                    BX 2933                91              2   11/01/96         04/30/99 Parekh, Hershed MD                               SI 1640                 91             2   11/06/96         05/07/99 Schneider, Howard J                              MN 2635                 91             2   12/03/96         06/01/99 Grunther & Ston M.D.                             MN 2976                 91             2   12/05/96         06/03/99 A. Messina, MD & A. Ueberaldnd, MD               MN 2646                 91             2   12/05/96         06/03/99 Wyckoff Heights Medical Center                   BK 2929                 91              2   12/05/98        06/03/99 CMCBQ . 81 Mary's Hospital                       BK 2649                 91              2   12/06/96        06/04/99 St. Samabes Heepital            '

BX 2946 91 2 12/06/96 06/04/99 Bradley Moore, Pettck MD QN 2969 74 2 12/12/96 06/10/99 Rockefeller University MN 2996 91 2 12/13/96 06/11/99 Greenberg Joseph M.D. MN 3045 91 2 12/16/96 06/16/99 Munen, Edward E. MD QN 3054 91 2 12/21/96 06/19/99 Luthoren Med. Ctr. BK I 2917 91 2 12/23/96 06/21/99 Rosemen,8 MD MN ! 2616 91 2 12/26/96 06/24/99 Hospital for Joint t orthopaedic institute MN 2913 91 2 12/31/96 06/29/99 Jamaice Hosp. QN 2902 91 2 01/02/99 07/01/99 NYCHHC . Coney Island Hospital BK 696 91 2 01/07/99 07/06/99 Selverberg, Ameid I. MD BK 2950 91 2 01/07/99 07/06/99 Bronx-Lebanon Hospital Center BX 2658 91 2 01/06/99 07/07/99 Rabiner, Nort)ert, MD QN 2901 91 2 01/10/99 07/09/99 NYCHHC . Queens Hospital Ctr QN 02/17/96

o Lloones inspeadons Due By Priority and By Date Due

 .           2696            91         -

2 01/14/99 07/13/99 Heimes, Alison B. MD MN 2649 91, . W.' 2 01/1 "90 07/14/99 NYCHHC Woodhun Med Mnt Hith Ctr BK 3055 . . Si % 2 Ott; *.119 07/14/99 D'Alessandro, Thomas M.D. MN 2945 91 -

                                      -     2        *011:0/99        07/15/99 Interfelth Med. Ctr                                              BK 2926            91       ;     2         01/1b/99        07/15/99 Lenox HiH Hospital

• MN 2671 91 2 01/17/99 07/16/99 CMC 8Q . St Joeoph's Hoop DivisNm QN 2627 91 2 01/23/99 07/22/99 Novick, Mark MD BK 3021 91 2 01/23/99 07/22/99 Rentrop, Peter K MD QN 2979 91 2 01/23/99 07/22/99 Tobin, Keith M.D. MN 2926 91 2 01/29/99 07/26/99 CMC 8Q St. John's Hosp. Div QN 2910 91 2 02/06/99 06/05/99 New York Downtown Hospital MN 2907 91 2 02/07/99 06/06/99 NYCHHC Elmhurst Hospital QN 2670 91 2 02/07/90 06/06/99 Youn9, Iven S. MD MN 3059 91 2 02/13/99 06/12/99 McCarthy, Joseph M.D. BK Total 109 Priertty Date Due Date Overtive Name Sorough 3006 52 3 01/26/97 10/25/97 St. John's University QN 3066 52 3 03/30/96 12/25/96 Sleani, Merlo MD BK 3073 52 3 03/30/96 12/25/98 PalaenTeenologies,Inc. MN 2722 52 3 05/02/96 01/27/99 Dreamter,leanc MD MN 2662 52 3 05/05/96 01/30/99 Advanced Fertility Servloes MN 2660 52 3 05/11/96 02/05/99 Modem Medical Laborotory BK 3060 52 3 05/12/96 02/06/99 Professional Clinical Labs MN 1555 52 3 05/16/96 02/10/99 Quen6n Medical Lab BK 2939 52 3 05/19/96 02/13/99 Hoffman Center For Holiste Medicine MN 1666 52 3 05/23/96 02/17/99 Morris Park Test Lab BX 1614 52 3 05/23/96 02/17/99 Gilson, Saul B MN 1556 52 3 05/25/96 02/19/99 Bendiner & Schlesin9er inc MN 2942 52 3 06/07/96 03/04/99 Metropolitan Diagnostic Labs. lac. QN 2831 52 3 06/07/96 03/04/99 Bio Ted Labs Inc. BK 2851 52 3 06/06/96 03/05/99 Museum Of Modem Art MN 1566 52 3 06/15/96 03/12/99 NYC Medical Examiner's OfAce MN 1604 52 3 06/23/96 03/20/99 Orontrole Medical Group MN 296011 52 3 07/25/96 04/21/99 NY Hosp.- Comell Med Ctr MN 3076 52 3 06/30/96 05/27/99 GenQuest MN 2719 52 3 09/06/96 06/03/99 CUNY. Med9er Evers Colle9e BK 3015 52 3 09/06'96 06/03/99 NYC Housing Preservation and Development . Central Lead MN 1674 52 3 09/26/96 06/23/99 Singer, Joseph PC MN 2966 52 3 10/03/96 06/30/99 Univ Dis 96cate tab BK 2920 52 3 10/04/96 07/01/99 Bio Chem Technology Lab. Inc. MN 2911 52 3 10/25/96 07/22/99 CUNY. Brooklyn College BK 2975 52 3 11/21/96 06/16/99 CUNY. Queens College QN 128 52 3 11/23/96 06/20/99 Montenore Med. Center BX 122 52 3 11/27/96 06/24/99 Montenore Med. Center BX 131 52 3 11/27/96 06/24/99 Montenore Med. Center BX 120 52 3 11/27/96 06/24/99 Montenore Med Center BX 130 52 3 11/27/96 08/24/99 Montenore Med. Center BX 143 52 3 11/27/96 06/24/99 Montenore Med. Center BX 113 52 3 11/27/96 06/24/99 Montenore Med Center BX 110 52 3 11/27/96 06/24/99 Montenore Med. Center BX 104 52 3 11/27/96 06/24/99 Montenore Med. Ctr. BX 102 52 3 11!27/96- 06'24/99 Montenore Med. Center BX 114 52 3 11/27/96 06/'!4/99 Montenore Med. Center BX 3044 52 3 11/27/96 06/24/99 MonterSore Med. Ctr BX 115 52 3 11/27/96 06/24/99 Montenore Med. Center BX 266502 52 3 11/27/96 06/24/99 Montenore Med Ctr BX 116 52 3 11/27/96 06/24/99 Montenore Med. Center BX 103 52 3 11/27/96 06/24/99 Montenore Med. Ctr BX 140 52 3 11/27/96 06/24/99 Montenore Med. Center BX 132 52 3 11/27/96 06/24/99 Montenore Med. Center BX 109 52 3 11/27/96 06/24/99 Monte 8 ore Med. Center BX 123 52 3 11/27/96 06/24/99 Montenore Med. Center BX 106 52 3 11/27/96 06/24/99 Montenore Med. Ctr. BX l 111 52 3 11/27/96 06/24/99 Montellore Med. Center BX 105 52 3 11/27/96 06/24/99 Montenore Med. Ctr. BX 267605 93 3 12/05/96 09/01/99 Columbia Presbyterian Med Ctr MN 2667 52 3 12/20/96 09/16/99 Aeron Diamond DS Research Center MN 2906 52 3 01/03/99 09/30/99 Public Health Research Institute MN 147 52 3 01/05/99 10/02/99 CUNY-Hunter MN 02/17/96

Lkenee inspectior.s Dus By Priority and By dad Due 140 52 3 01/05/99 1GV2/99 CUNY-Hunter MN 148 52 3 01/05/99 10/02/99 CUNY-Hunter MN 123 .': 3 01/05/99 10/02/99 CUNY-Hunter MN 126 52 3 01/05/99 10/02/99 CUNY Hunter MN 156 52 3 01/05/99 10/02/99 CUNY . Hunter Colle90 MN 3031 52 3 01/05/99 1402/99 EMA Medicallabs QN 153 52 3 01/05/99 10/02/90 CUNY-Hueter MN 139 52 3 01/05/99 10/02/99 CUNY-Hunter MN 128 52 3 01/05/99 10/02/99 CUNY Hunter MN 136 52 3 01/05/99 10/02/99 CUNY Hunter MN 130 52 3 01/0499 10/02/99 CUNY Hunter MN 3049 52 3 01/05/99 10/02/99 NYC Dep. Health- Bur. of Labs MN 135 52 3 01/05/09 10/02/99 CUNY-Hunter MN 134 52 3 0145/99 10/02/99 CUNY-Hunter MN 127 52 3 01/0 % 9 10/02/99 CUNY-Hunter MN 124 52 3 01/05/99 10/02/99 CUNY Hunter MN 131 52 3 01/05/99 10/02M CUNY Hunter MN 133 M 3 01/05/99 10/0249 CUNY-Hunter MN 125 52 3 01/0599 10/02/99 CUN ( Hunter MN 142 52 3 01/06/99 10/03/99 NYCHHC Haf.stn Hospital Center MN 2958 52 3 02/01/99 10/29/99 Levin, AAan A.MD QN Total 74 02/17/98

APPENDIX G-2 New York State Department of Labor, Radiological Health Unit (NYDL) INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) QUESTIONNAIRE

Approved by OMB' No. 3150-0183 Expires 4/30/98 i l 1 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM l QUESTIONNAIRE New York State Department of Labor / Radiological Health Unit O Reporting Period: Month XX, [ YEAR], to Month XX, [ YEAR] $ l

                                                                                           -                                                                       G   a w
                                                                                                                                                                        .f)

A. COMMON PERFORMANCE INDICATORS 'J

                                                                                                                                                                  -]

I. Status of Materials Insrection Program $

1. Please prepare a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800. The list should include initial inspections that are overdue.

Insp. Frequency licensee Name (Years) Due Date Months O/D None

2. Do you currently have an action pisn for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire.

NA 2 Estimated burden per response to comply with this voluntary collection request: 60 hours. Forward comments regarding burden estimate to the information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 2055-0001, and to the Paperwork Reduction Project (3150-0052), Office of Management and Budget, Washington, CC 20503. NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

o l h

3. Please identify individual licensees or groups of licensees the State / Region is inspecting more or less frequently than called for in NRC Inspection Manual Chapter 2800 and state the reason for the change.

All of our licensees are inspected at intervals that are as frequent, or more frequent than NRC's inspection intervals. A list of license categories and 1 I inspection frequencies is attached.

4. Please complete the following table for licensees granted reciprocity during the reporting period.

Number of Ucensees i Granted Reciprocity Number of Ucensees

( Priority Permits Each Year Inspected Ese.h Year Service Licensees performing YR YR teletherapy and irradiator source YR YR YR YR installations or changes YR YR 1 YR YR YR YR YR YR YR YR 2 YR YR YR YR YR YR YR Yk 3 YR YR YR YR YR YR 4 All Other We do not keep records of the priorities of reciprocity applicants. Fifty-four companies requested reciprocity during 1997 and 10 were inspected while in the state.

5. Other than reciprocity licensees, how many field inspections of radiographer were performed? 8

6. For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe I

your goals, the number ofinspections actually performed, and the reasons for 2  ! l

I i any differences between the goals and the actual number ofinspections i performed. NA H. Technical Ouality of Inspections

7. What, if any, changes were made to your written inspection procedures during the reporting period?

l i We revised and updated three of our inspection forms: the general form, p.e industrial radiography supplemental form and the Exed gauge form.

8. Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:

Insoector Supervisor License Cat. Date Rose Marie Pratt Rita Aldrich Lg. Research (1) 9/9/97 Jim Mull Rita Aldrich Ind Rad (1) 4/16/97 Brajesh Kotharl Rita Aldrich Ind Rad (1) 9/16/97

9. Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.

Copies of evaluation forms for these accompaniments are attached.

10. Describe or provide an update on your instrumentation and methods of calibration. Are all instruments properly calibrated at the present time?

Instruments are still calibrated in our laboratory using a Tech / Ops Model 773 calibration device in accordance with accepted procedures. All instruments in use are properly calibrated at the present time. A list of typical instrument is attached. ] III. Technical Staffina and Training

11. Please provide a staffing plan, or complete a listing using the suggested format '

below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, 3

_ _ _7 LLW, U-mills, other. If these regulatory responsibilities are siividen between offices, the table should be consolidated to include all personn:2 con ributing to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor work ofjunior personnel. If consuhants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be: NAbg T_OSITION AREA OF EFFORT FTE% Rita Alrich Prin. Radiophysicist Program Director & licensing 95 % Clayton Bradt Assoc. Radiophysicist Licensing 95 % Desmond Gordon Licensing 100 %

                                            . Robert Kelly                                                                          Licenslag                            100 %

Andrew Awal* Inspection 80 % Brajesh Kothari* Inspection / licensing 80 % James Mull

• Inspection / licensing 80 %

Rose Marie Pratt* ' Inspection / licensing 80 %

• Manhattan omce staff rotate supervisory responsibilities for the field office and laboratory.

12. Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional j training and years of experience in health physics, or other disciplines, if '

appropriate. No new professional personnel were hired since the last review.

13. Please list all professional staff who have not yet met the qualification requirements oflicense reviewer / materials inspection staff (for NRC, Inspection Manual Chapters 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and

, . a tentative schedule for completion of these requirements. All staff meet basic training qualification requrlements for license review / materials inspection staff, as outlined in the NRC/OAS Training Worldng Group Recommendations (October,1997). l 14. Please identify the technical staff who left the RCP/ Regional DNMS program I during this period. No professional personnel have left the program since the last review. , l 4 l

15. List the vacant positions in each pregram, the length of time each position has been vacant, and a brief summary of effo;ts to fill the vacancy.

                         -NA IV.             Technical Ouality of Licensing Actions

16. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, terminated, decommissioned, bankruptcy notification or renewed in this period. Also identify any new or amended licenses that now require emergency plans.

Empire Isotopes Issued Syncor, Cheektowaga Renewed Self Powered Lighting Renewed

17. Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

No variances or exemptions were issued.

18. What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

We continuously review and try to improve our inspection and licensing procedures, documents and guides. During the review period we updated many of our guides and procedures and developed some new ones. This is an evolutionary process.

19. For NRC Regions, identify by licensee name, license number and type, any j renewal applications that have been pending for one year or more.

NA

   - V.             Responses to Incidents and Allegations

20. Please provide a list of the reportable incidents (i.e., medical misadministration, l overexposure, lost and abandoned sources, incidents requiring 24 hour or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB 3150-0178). The list should be in the following format:

5

LICENSEE NAME LICENSE # DATE OF INCIDENT / REPORT TYPE OF INCIDENT Incidents that occured up to May 16,1997 were sent to NRC on June 22,1997. A list and summary ofincidents occurring from that date through December, 1997 is attached. ,

21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified? For States, was I timely notification made to NRC? For Regions, was an appropriate and timely PN generated?

l During the review period we had an incident in which a Mallinkrodt generator's shielding faued. This was reported to NRC and copies of the reports are , I attached. I We also had in incident in which procedures used by MDS Nordion during an irradiator source change allowed a worker to fall into the storage pool Our correspondence with Nordion on procedures to prevent a recurrence was copied to the U.S. NRC since Nordion is also their licensee. Finally, there was an incident involving a theft of a troxler gauge that appeared to be due to NRC-approved operating procedures. An NRC licensee brought the

gauge into New York, where it was stolen, because the licensee had no secure

! storage location M lt and left k in his truck although it was not to be used in New York.

22. For incidents involving failure of equipment or sources, was information on the incidem provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each case.

Equipment manufactured / distributed by four companies was involved in incidents in New York State during the review period. In all cases the states that licensed the companies were given all available information for their follow up; including a report to NRC if equipment defects were found to be involved. To our knowledge the causes were all due to user error or abuse, and an information notice was sent to New York State licensees and the states that license the manufacturers, pointing out the need to properly train staff and maintain equipment so as to avoid accidents. (See incidents 97-2 and 97-21 in our 4/96-l 5/97 report to Pat Larkins, and incidents 97-38 and 97-44 on the enclosed list and summary). 6

i

23. In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.

1 No

24. Identify any changes to your procedures for handling allegations that occurred during the period of this review.

a. For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.

None. VI. General

25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.

NRC recommended that we formally adopt regulations compatible with Part 36. We have developed a detailed licensing guide incorporating all the rule's requirements, we use a 15 page checklist outline of these requirements for inspections, and have submitted a draft regulation adopting 10CFR Part 36 to our office of counsel and are awaiting action.

26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.

Our program's strengths are evident in the quality of our licensing, inspection and incident response actions which protect workers and the public while permitting the beneficial use of radiation sources in New York State. B. NON-COMMON PERFORMANCE INDICATORS I. Legislation and Procram Elements Reauired for Compatibility

27. Please list all currently effective legislation that affects the radiation control program (RCP).

The Department of Labor's radiation control program derives its authority from Section 27 of the Labor Law and Article 28-D of the General Business Law. 7

s

28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

No.

29. Please complete the enclosed table based on NRC chronology of amendments.' Identify

    ,                                                                         those that have not been adopted by the State, explain why they were not adopted, and                            i discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.

See attached table.

30. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.

NA I H. Scaled Source and Device Program

31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the review period.

I SS&D Manufacturer, Type of Registry Distributor or Device Date Number Custom User or Source Issued NY 0502 D 110 G NRD, Inc. Static Eliminator 12/31/97 4

32. What guides, standards and procedures are used to evaluate registry applications?

NRC Reg. Guides: 10.10, 10.11 ' NUREGS: 1550,1556 V.3 ISO 2919 " Sealed radioactive sources - classification" ANSI N542 - 1977 " Sealed Radioactive Sources, Classification" ANSI N540 " Classification of Radioactive Self-Luminous Light Sources" NRC SS&D Workshop reference materials 8

7 1

33. Please include information on the following questions in Section A, as they apply to the  ;

Scaled Source and Device Program: Technical Staffing and Training - A.III.ll-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to Incidents and Allegations - A.V.20-23 A.III. - Technical Staffine and Traininn (11-15)

11. . Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U-mills, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor work ofjunior personnel. If consultants were used to cany out the program's radioactive materials responsibilities, include their efforts.

NAME POSITION AREA OF EFFORT FTE% Clayton Bradt Assoc. Radiophysicist SS&D Review 1% Desmond Gordon Assoc. Radiophysicist SS&D Review 1%

12. Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.

No new professional personnel were hired since the last review.

13. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, Inspection Manual Chapters 1246; for Agreement States, please describe your qualifications requirtTnents for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

No training qualification requirements for SS&D review personnel have been established by NRC. 9

i i l i 33.(coat.) ,

14. Please identify the technical staff who left the RCP/ Regional DNMS program during

this period.

I No professional personnel have left the program since the last review.

15. List the vacant positions in each program, the length of time each position has been j vacant, and a brief summary of efforts to fill the vacancy.

NA l l A.IV. Technical Ouality of Licensing Actions (16-18) j l

16. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, terminated, decommissioned, bankruptcy notification or renewed in this period. Also identify any new or amended licenses that now require emergency plans.

1 Only one SS&D review was conducted during this period as listed in item 31, above.

17. Discuss any variances in licensing policies and procedures cr exemptions from the  !

regulations granted during the review period. No variances or exemptions were issued

18. What, if any, changes were made in your written licensing procedures (new '

procedures, updates, policy memoranda, etc.) during the reporting period? i No changes were made. 10

i l 33.(cont.) A.V. Responses to Incidents and Allegations (20-23) L 20. P case provide a list of the reportable incidents (i.e., medical misadministration, 1 overexposure, lost and abandoned sources, incidents requiring 24 hour or less ! notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review  ! period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB 3150-0178). The list should be i in the following format: Incidents that occured up to May 16,1997 were sent to NRC on June 22,1997. , A list and summary ofincidents occurring from that date through December, l 1997 is attached.

21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when l were other State /NRC licensees who might be affected notified? For States, was timely notification made to NRC? For Regions, was an appropriate and timely PN generated? '

None invoMag devices or sources reviewed by NYS DOL. l 22. For incidents involving failure of equipment or sources, was information on the l incident provided to the agency responsible for evaluation of the device for an l assessment of possible generic design deficiency? Please provide details for each case. NA l 23. In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing review? If so, please l describe the circumstances for each case. No. I l III. Low-Level Waste Program

34. Please include information on the following questions in Section A, as they apply to the Low-level Waste Pmgram:

Status of Materials Inspection Program - A.I.1-3, A.I.6 11

l t - i Technical Quality ofInspections - A.II.710 - Technical Staffing and Training - A.III.ll-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to Incidents and Allegations - A.V.20-23 NA IV. Uranium Mill Program

35. Please include information on the following questions in Section A, as they apply to the Uranium Mill Program-l Status of Materials Inspection Program - A.I.1-3, A.I.6 Technical Quality ofInspections - A.II.7-10 Technical Staffing and Training - A.III.ll-15 Technical Quality of Licensing Actions - A.IV.16-18 Res;ionses to Incidents and Allegations - A.V.20-23 NA l

i 12 i {. I \ _ _ _ _ _ . _ _ - _ - _ _ _ _ - _ _ _ - _ _ _ .

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d 1 I j APPENDlX G-3 l l New York State Department of Health, Bureau of Environmental Radiation Protection (NYSH) I INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) QUESTIONNAIRE

Approved by OMB' No. 3150-0183 F.xpires 4/30/98 . I l l INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE New York State Department of Health, Bureau of Environmental Radiation Protection i Reporting Period: April 1995, to March 1998 A. COMMON PERFORMANCE INDICATORS

1. Status of Materials inspection Proaram

1. Please prepare a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800. The list should include initial inspections that are overdue.

Insp. Frequency Licensee Name (Years) Due Date Months O/D New h Inso Frea. Date issued Months O/D Ramaiyer Narayan, M.D. 4 8/18/97 1 Northeast Radiology 4 12/19/96 8 Pomona Scanning 4 12/31/96 8 In addition, several other facilities were not inspected within 25% of the scheduled frequency, however this was due to program decision to not inspect within the regular schedule. A list of the se facilities and inspection schedule is available. 1 Estimated burden per response to comply with this voluntary collection requat: 45 hours. Forward comments regarding burden estimate to the Information and Records Management Branch /T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0183), Office of Management and Budget, Washington, DC 20503. If an information collection does not display a currently valid OMB control number, NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

2. Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this '

l questionnaire. I Yes. All overdue inspections have been assigned and will be completed by l the first quarter of this year. I

3. Please identify individual licensees or groups of licensees the State / Region is inspecting more or less frequently than called for in NRC Inspection Manual Chapter 2800 and state the reason for the change.

Teletherapy licenses are currently inspected over other year (more frequent than l NRC). All other categories are inspected on the same schedule as NRC l Inspection Manual Chapter 2800. j i

4. Please complete the following table for licensees granted reciprocity during the reporting period.

No licensees were granted reciprocity during the reporting period. Number of Licensees Granted Reciprocity Number of Licensees Priority Permits Each Year inspected Each Year l Service Ucensees performing YR YR tele'herapy and irradiator source YR YM installations or changes YR YR YR YR YR YR , i 1 YR YR i YR YR YR YR YR YR 2 YR YR YR YR YR YR l YR YR l 3 Yn YR l YR YR I YR YR 4 l All Other

5. Other than reciprocity licensees, how many field inspections of radiographer were performed? I 2

I

     .                                             None (Not Applic0le).                                                                        .

6. For NRC Regions, rild you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for

, any differences between the goals and the actual number of inspections performed. fl. Technical Quality of insometions

7. What, if any, changes were made to your written inspection procedures during the reporting period?

A section was added to include the review of previous items of non-compliance at the entrance interview in the section titled " BASIC INSPECTION PROCESS" and "3".

8. Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:

Insoector Suoervisor Ucense Cat. Daig See Attachment 1

9. Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.

As noted in the Bureau's inspection manual, inspectors are accompanied on inspections of radioactive materlats licenses annually. Inspection accompaniments are arranged by the field supervisor with each staff performing inspections. The field supervisor or other designated reviewer (senior inspector) utilizes the NRC inspector Field Work Evaluation Checklist. The reviewer's role is primarily ilmited to observation / evaluation only but may provide limited assistance, if felt necessary by the reviewer. The reviewer summarizes comments on various aspects of the inspectors performance with the inspector to help the inspector improve performance. The inspector's performance la reviewed with the inspector's supervisor, the Field Supervisor, and the Radioactive Materials Section Chief.

10. Describe or provide an update on your instrumentation and methods of calibration. Are allinstruments property calibrated at the present time?

The Bureau has numerous survey meters - Micro R, GM and Ionization chambers. In-house calibrations are performed for the GM and lonization chambers. The Micro R meters are sent out to a contractor for calibration. All instruments in use are calibrated. The Department laboratory support,

                        .                                                                     3

equipment and facilities remain the same as described during our last NRC review. - lll. Technical Staffino and Trainina

11. 'Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U-mills, other, if these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior i personnel assigned to monitor work of junior personnel. If consultants were l used to cany out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

NAME POSITION AREA OF EFFORT EIE'.a See Attachment 2

12. Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.

No additional hires. However, Mark Virgil has been assigned to the radioactive materials section. Mr. Virgil has over 20 years experience in health physics, B.S. Chemistry and a MBA.

13. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

Mark Virgil - needs additional training in inspection procedures as well as licensing policies and procedures. In house training is being provided. In addition, a request was submitted for Mr. Virgil to attend the NRC

                 " Inspecting for Performance course.

14. Please identify the technical staff who left the RCP/ Regional DNMS program during this period.

Christopher Parker, Associate Radiological Health Specialist Ferenc Tibold, Senior Radiological Health Specialist

15. List the vacant positions in each program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.

4

                                                                                          - - - _ _ _ . _ - - . - - - . _ _ _     --_-_____.__________a

No vacancies. . IV. Technical Quality of Licensing Actions ! 16. Please identify any major, unusual, or complex licenses which were issued, , received a major amendment, were terminated, decommissioned, submitted a I bankruptcy notification or renewed in th;s period. Also identify any new or amenced licenses that now require emergency plans. l See attachment 3 l

17. Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

Authorization was granted to dispose of an old Co-57 flood source via nc. mal trash; a license was issued to a physician (who did not meet the training requirements) for C-14 H-Pylori. . 18. What, if any, changes were made in your written licensing procedures (new l procedures, updates, policy memoranda, etc.) during the reporting period? Implemented new process for processing and evaluating license renewals; additional requirements for information necessary for renewals / amendments. ig. For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more. V. Resoonses to incidents and Allegations

20. Please provide a list of the reportable incidents (i.e., medical misadministration, overexposure, lost and abandoned sources, incidents requiring 24 hour or less notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB clearance number 3150-0178, Nuclear Material Events Database). The list should be in the following format:

LICENSEE NAME LICENSE # DATE OF INCIDENT / REPORT TYPE OF INCIDENT See attachment 4

21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified? For States, was timely notification made to NRC7 For Regions, was an appropriate and timely PN generated?

l l

3 Three incidents: 1.) A JL Shephard irradiator malfunctioned during a QA check. ' This incident was reported to the NRC. 2.) An Ir-192 HDR source became stuck in its transport cask wl' on trying to retrieve it during a source exchange procedure. This incident was reported to the responsible regulatory agency. 3.) A Nucletron HDR unit did not respond as programmed in the treatment plan. It automatically owitched dwell positions after a new source was installed it is not certain if this would be considered an equipment failure since the unit did indicated that the dwell positions were reset to their default values after the source exchange. All Nuclotron licensees were notified of this problem a few months earlier in a Nuclotron notification.

22. For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of <

possible generic design deficiency? Please provide details for each case. Nucletron equipment -The manufacturer issued notification to all of its customers (and MD?) JL Shepard - reported to NRC only. Stuck Ir 192 -reported to NYSDOL

23. In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.

There were two unusual cases that were previously reported to NRC: 1.) Two individuals arrested for conspiracy to commit murder (with Ra 226); 2.) Unauthorized use of a license (NRC Information notice 98 06).

24. Identify any changes to your procedures for handling allegations that occurred during the period of this review.

a. For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.

No cases referred by NRC that have not been closed. l t i e

9 General .

25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.

Our response was outlined in a letter dated Aprl! 29,1996 (Attachment 5). The items identified were the decommissioning funding rule and three definitions in Part i

35. Our position on the decommissioning funding rule remains the same. This is i further supported by the proposed NRC rulemaking to allow hospitals and universities to self guarantee funding for decommissioning (Federal Register notice, April 30,1997, vol. 62, number 83).

We do not believe that by adopting the three definitions as worded in Part 35 it would increase the effectiveness of our regulations. Nor is there any conflict, duplication or gaps by not adopting these definitions. However for the purposes of

                                                                              " compatibility" we will consider adopting this wording after Part 35 goes through its current amendment process.

26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses shoulo be supported by examples of successes, problems or difficulties which occurred during this review period.

I S. NON-COMMON PERFORMANCE INDICATORS

l. Legislation and Procram Elements Reauired for Comestibility

27. Please list all currently effective legislation that affects the radiation control program (RCP).

New York State Public Health Law; Article 2, Title il i 201 - Functions, Powers and Duties of the Department of Health 6 225 - Public Health Council; Powers and Duties; Sanitary Code 10 NYCRR Chapter 1 Part16 lonizing Radiation l Part 76 Public Health Administrative Tribunal l Part 405 Hospitals - Minimum Standards

28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations. No.

29. Please complete the enclosed table based on NRC chronology of amendments. Identify those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.

30. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in ordar to '

maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step. 1 See Attachment 6 ll. Sealed Scurce and Device Program

31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the review period. The table heading should be:

i SS&D Manufacturer, Type of Registry Distributor or Device Date Number Custom User or Source jaayed - l We do not have a Sealed Source and Device Program.

32. What guides, standards and procedures are used to evaluate registry applications?

33. Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:

Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 lli. Low-Level Waste Procram - N/A

34. Please include information on the following questions in Section A, as they apply to the Low level Waste Program:

Status of Materials inspection Program - A.I.13, A.I.6 Technical Quality of Inspections - A,II.7-10 Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 IV. Uranium Mill Procram - N/A

35. Please include information on the following questions in Section A, as they apply to the Uranium Mill Program:

Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Quality of Inspections - A.ll.7-10 Technical Staffing and Training - A.lli.11-15 8

Technical Qiulity of Licensing Actions - A.IV.16-10 , Responces !s incidents and Allegations - A.V.20-23 9 9

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Attachment 2 - Staffir;g

       '                                                                                                                                                           Central Office h                                                                                                                            Position                                        Ara of Effort          M      ,

K. Rimawi Bureau Director Administration 20 % S. Gavitt Prin. Rad. Health Spec. Adminstration 35 % Licensing / compliance 60 % Incident asponse 5% R. Dansereau Assoc. Rad. Health Spec. Licensing / compliance 95 % Incident response 5% . C. Costello Sr. Rad. Health Spec. Licensing / compliance 95 % Incident response 5% A. Damiani Sr. Rad. Health Spec. Compliance 30 % C. Burns Sr. Rad. Health Spec. Licensing / compliance 95 % Incident response 5% M. Virgil Assoc. Rad. Health Spec. Licensing / compliance 95 % Incident response 5% 1 12

i Recionni Office l Hame ' Position Area of Fend EIE , G. Baker Prin. Rad. Health Spec. Field Supervisor 50 % E. Carter Assoc. Rad. Health Spec. Compliance 30 % V. Goyal Assoc. Rad. Health Spec. Compliance 30 % B. Ignatz Assoc. Rad. Health Spec. Compliance 30 % W. Kelleher Sr. Rad. Health Spec. Compliance 30 % R. Snyder Sr. Rad. Health Spec. Compliance 30 % A. Bass Assoc. Rad. Health Spec. Compliance 80 % Total FTE for Radioactive Materials Program 8.3/546 licensees

     = 1.5 FTE/100 licensees 13

Attachment 3 r Unusuallcomplex Licensing Actions l Renewals License No. Hama Traa 574 Cold Spring Harbor R&D Broad 445 NYS WCL&R R&D Broad 1030 NYU Med. Ctr. Academic Broad 1016 NSUH Medical Broad 1035 RPl Academic Broad 469 SUNY ESF Academic Broad 47 SUNY HSC Medical Broad 459-1 SUNY Albany Academic Broad l Unusual 3185 Forest Laboratories R&D Spt i.ic 2991 Immunosciences irradiator(Type -1)  ; 3152 Upstate Open MRI Medical Private - Specific l l' l l 14

• e. 2 Radioactive Matenals IWe Accom_= - 1995-1997 .[]

Inspector Reviewer Facility Name License No Facility Type Date i Snyder Baker Geneva General Hospital Medical Specific - Hospital Kingston Diagnostic 1766 27 awe

 ,       Dansereau     Baker                                       3080          Medical Specific - Private Prac. 04 Mayl)5 Caner         Baker          University of Rochester      436           Therapy- HDR                    11 May 95 Snyder        Baker         Newark-Wayne Community Ho     1777          Medical Specific - Hospital       14 Jun 95 Samson        Dansereau     NYSDOH                        5000          XRF                             14 Aug 95 Damiani       Bass          Cold Sprina Harbor            574           R & D- Specific                 22 Aug-95 Phillips      Baker         Slocum D:-kann       ,        3122         ClinicalLein wiy                  05-Sep 95 Snyder        Baker         FFThompson Hospital           1874          Medical Specific- Hospital       19 Sep 95 Wormuth       Baksr         Sienna College               560           Academic                          Il-Oct 95 Ignatz        Baker          Roswell Park                  5082         Therapy                           26 Oct 95 Kelleher     Baker          Upstate Open MRI             5152           Medical Specific - Hospital     02 Nov-95 Bass        . Baker         Arden Hill Hospital          1171          Medical Specific- Hospital       13-Nov-95 Samson      IBaker          Steven Alexander             3146          Clinical i *=atory               20-Nov 95 Goyal       ; Baker         SUNY HSC                     44            Therapy                           13 Dec-95 Caner        ! Baker uJGenesee Hospital                   26         '

Medical- Hospital 20 Mar-96 Cestello !6setsid'" Albany Cardiology 2994 Medical- Private Practice 28 Mar 96 Samson IBaker Mount Vernon Hospital 1006 MedicalSpecific Hospital 14-May %

       .Phillips     iBaker         IBurke Rehabitation Center    1859          Research Institute               15 May-%

Burns IBaker  ! United Hospital 1005 Medical- Private Practice 16 May 96 Parker ' Baker ISUNY HSC 47 Broad - Medical 09 Jul-96 Damiani Dansereau Adirondack Medical Center 1130 Medical Specific -Hospital 17-Jul 96 Snyder iBaker Clifton Spring Hospital 1873 Medical Specific - Hospital 04-Oct 96 Igna:r  ; Baker Buffalo Cardio. and Puhn. 2880 Medical- Private Practice 09 Oct-96 Dansereau Baker Bassett Hospital 436 Medical Specific - Hospital w/ 17 Oct-96 IBass  : Baker iN. Dutchess Hospital 1195 Medical Specific- Hospital 07 Nov % lKelleher (Baker iSt. Joseph's Imaging 2881 16-Dec M

                                                                               . Medic _al- Private Practice

Wormuth  : Baker ' Nuclear Imaging Systems 3907  ; Mobile Nwlear Medicine Faci 20 Dec 96 Goyal  ! Baker ioneida City Hospital 1709 l Medical Specific - Hospital 27 Dec 96; iCBurns IBaker iSt. Joseph Hospital 1824 l Medical- Hospital 17 Mar 97:

lWKelleher ' Baker ;Watenown Cardiology 1974  ! Medical- Nuclear Cardiology I 05-Jun 97 IVGoyal  : Baker ' Rome Memorial Hospital 8 Medical- Hospital 26-Jun 97 iBIgnatz ' Baker , IMount St. Mary's Hospital 1018 Medical- Hospital 02 Jul-97

      'ADamiani Baker              iCommunity Memorial Hospital 2982            Medical- Hospital                  17 Jul 97 RSnyder     ' Baker         ' Lakeside Memorial Hospital   3090          Medical- Hospital                09-Oct 97 MVirgil       Baker           Masonic Medical Research Lab 492           Research A Development- Sp 05 Nov-97 IRDarsereau iBaker              University at Albany         459-1         Academic- Broad                  03 Dec 97
     'CCostello      Dansereau Albany Memorial Hospital           1151          Medical- Hospital                10 Dec 97 ABass         Baker          Good Samaritan Hospital       490           Medical- Hospital w/HDR          18 Dec.97 I

APPENDIX G-4 New York State Department of Environmental Conservation, Bureau of Pesticides and Radiation (NYDEC) INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGHAM (IMPEP) QUESTIONNAIRE f [ L

l Approved by OMB' No. 3150-0183 ' Expires 4/30/98 l INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE NEW YORK STATE DEPARTMENT OF ENVIRONMENTAL CONSERVATION Reporting Period: APRIL 1995 TO APRIL 1998 A. COMMON PERFORMANCE INDICATORS

1. Status of Materials intoection Proaram

1. Please prepare a table identifying the licenses with inspections that are overdue by rnore than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800. The list should include initial inspections that are overdue.

Insp. Frequency Licensee Name (Years) Due Date Months O/D There are no overdue ins: ctions at this time.

2. Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this questionnaire.

There are no overdue inspections at thic time. 1 Estimated burden per response to comply with this voluntary collection request: 45 hours. Forward comments regarding burden estimate to the Information and Records Management Branch (T-6 F33) U.S. Nuclear Regulatory Corrnission. Washingtor DC 20555 0001, and to the Paperwork Reduction Project (3150-0183). Offite of Management and Budget. Washington DC 20503. If an information collection does not display a currently valid OMB controi number. NRC may not conduct or sponsor, and a person is not required to respond to, the information cc11ection.

1

3. Please identify 'ndividual licensees or groups of licensees the State / Region is inspecting more or less frequently than called for in NRC Inspection Manual Chapter 2800 and state the reason for the change. -

Since our program concentrates on discharges and disposal of radioactive  ! material to the environment, our inspection frequencies are not based on NRC inspection Manual Chapter 2800.

4. Please complete the following table for licensees granted reciprocity during the reporting period. Not applicable.

Number of Licensees Granted Reciprocity Number of Licensees Priority Permits Each Year Inspected Each Year Service Licensees performing YR YR teletherapy and irradiator source YR YR installations or changes YR YR YR YR YR YR 1 YR YR YR YR YR YR YR YR 2 YR YR YR YR YR YR YR YR 3 YR YR YR YR YR YR 4 All Other

5. Other than reciprocity licensees, how many field inspections of radiographer were performed?

Not applicable.

6. For NRC Regione, did you estab!ish nume!ical goals for the number of

inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for any differences between the goals and the actual . number of inspections performed.

l 2 1 4

                           \ _i e

Not applicable.

11. Technical Quality of inspections

7. What, if any, changes were made to your written inspection procedures during the reporting period?

l Our Part 380 permit inspections procedures were revised in l September 1996. The revision provides more specific guidance to inspectors and clarifies the Department's purpose, policy and authority to conduct these inspections. S. Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include: Inspector Supervisor License Cat. Datt J. Abunaw S. Hinkel Air (Sy Bronx) 4/95 R. Rommel S. Hinkel Air (SPL) 5/95 W. Tetley P. Merges Land Burial (WV) 6/95 B. Youngberg P. Merges Air (NRD) 9/95 A. Gray B. Youngberg Air (Cornell) 10/95 M. Spivak S. Hinkel Conf (MSKCI) 5/93 J. Abunaw B. Youngberg A!r (Sy Bronx) 8/96 M. Spivak S. Hinkel Conf (St. Lukes) 8/96 W. Tetley P. Merges LB (WV) 10/96 A. Gray B. Youngberg incin & Air (BMS) 1/97  ! M. Spivak S. Hinkel Conf (Mt. Sinal) 2/97 W. Tetley S. Hinkel Air (ICN) 3/97 R. Rommel B. Youngberg Air (SPL) 3/97 M. Spivak S. Hinkel Air (Empire) 8/97 M. Spivak S. Hinkel Air (CPMC) 10/97 A. Gray B. Youngberg Conf (SUNY SB) 10/97 A. Gray B. Youngberg Air (MPI) 10/97 M. Spivak S. Hinkel Air (CPMC) 1/98

9. Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.

Part 380 permit inspectors are to be accompanied annually, if possible. During management accompaniments, supervisors evaluate the inspectors' performance. Supervisors provide feedback after the inspection, either verbally or via a written l 3

i

                                         ' ' cvaluation. Usually, any written evaluation is provided directly, and only, to the inspector.

10. Describe or provide an update on your instrumentation and methods of calibration. Are all instruments properly calibrated at the present time?

See attached list of instruments and calibration dates. Ill. Technical Staffino and Trainina

11. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U-mills, other if these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contribut ng to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

NAME POSITION AREA OF EFFORT FTE% i e

1 4 l N:me P0:ir Area of Effort FTE Paul J. Merges Chief, Gureau of administration 50 Pesticides & Radiation Jill A. Baille Secretary 1 administration 20 Barbara Environmental administration 50 i Ycungberg Radiation Specialist Permitting & compilance 20 (ERS) 3 contaminated sites 30 Marie Johnston Keyboard Specialist administration 100 S:ndra Hinkel ERS2 permitting and compliance 100 1 Markus Spivak ERS1 permitting and compliance 100 ) Ann Marie Gray ERS1 permitting and compliance 100 Robert Rommel ERS1 permitting and compliance 10 l contaminated sites 90 ! l Timothy Rir, e ERS 2 permitting and compilance 10 ; l former burials & contaminated sites 90 J:hn Kadlecex ERS2 contaminated sites 100 l William ERS1 contaminated sites 50 t Varcasio J2hn Mitchell ERS2 contaminated sites 100 j J:hn Abunaw ERS1 contaminated sites 5 RMW and SW facilities

• 35 l

Jchn Zeh - Environmental Analyst 2 transportation of LLRW 35 (to be hired) ERS1 contaminated sites 100 (to be hired) Environmental Analyst 1 to be determined 50

 ' radiation monitoring at solid waste and regulated medical waste facilities f

i l _ .

12. Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.

No new staff have been hired since the last review. l

13. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

The minimum qualifications for an environmental radiation specialist are a l bachelor's degree in science or engineering and at least two years of experience in the environmental radiation field. Because of our small number of inspectors and permit reviewers, we do not have a formal qualification program. New staff have been trained individually by the permit unit supervisor, in performing inspections and reviewing permit applications. Inspectors in training move through the following stages: (1) accompanying experienced inspectors, as observers; (2) assisting experienced inspectors; (3) taking the lead in Inspections, assisted by experienced inspectors, and (4) performing Inspections independently. Inspectors move through these stages based on th assessment of the unit supervisor. The same staff are trained to review permit applications by reviewing first minor amendments and routine renewals, then applications of increasing complexity. All permitting decisions are reviewed by the permit unit supervisor and the radiation section supervisor.

14. Please identify the technical staff who left the RCP/ Regional DNMS program during this period.

William Tetley, ERS 2, and William Gilday, EA 1, left the program in 1997. In addition, William Varcasio, ERS 1, was assigned to work part-time as the Department's emergency response coordinator, which was an initial commitment of 0.3FTE. Due to emergencies in New York State, he has actually spent about 0.5FTE working outside the radiation program.

15. List the vacant positions in each program, the length of time each position has been vacant, and a briaf summary of efforts to fill the vacancy.

6

4 ERS 1 - vacated in November 1997, when Timothy Rice was oromoted to fill the vacancy left by William Tetley. EA 1 - vacated in August 1997, when William Gilday left the Department. We recently received approval to fill these positions (an exemption from the current hiring freeze was required). The vacancies were posted from March 13, through March 24,1998. We plan to fill these positions by June 1,1998. 0.3 FTE ERS 1 -lost when W. Varcasio was assigned (by the Commissioner) to be the Department's SEMO Liaison and Emergency Response Coordinator. ! IV. Technical Quality of Licensino Actions

16. Please identify any major, unusual, or complex licenses which were issued, j received a major amendment, were terminated, decommissioned, submitted a j bankruptcy notification or renewed in this period. Also identify any new or 1 amended licenses that now require emergency plans.

Complex permitting actions that have occurred during the review period include the following facilities:

a. State Licensed Disposai Area at West Valley - permit modifications in 1996,1997, and 1998

b. Self-Powered Lighting -issued a new permit for its new location in 1996 and terminated its old permit at its former location in 1997 l l

c. ICN East, Inc. - permit modification in accordance with a consent l

i order in 1995 I

d. Cornell University - permit modification in accordance with a l l

consent order in 1995 l I

e. Columbia Presbyterian Medical Center Cyclotron - new permit  :

issued in 1996, permit modified in 1996,1997, and 1998 j i

f. University of Rochester Laboratory for Laser Energetics -issued a new permit in 1998 i

7

i 1

17. Discuss any variances in licensing policies nd procedures or exemptions from the regulations granted during the review Nied.

Since July 1995, we issued three separate variances to the Ginna Nuclear Power Plant for disposal of, coll, concrete, and rebar containing traces of radioactive material. The waste was added to the spoils pile on the Ginna Power Plant Site.

18. What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

We made minor revisions to our permit application review checklists and Part 380 permit guidance documents, as they were needed to ' more clearly explain the appilcation requirements.

19. For NRC Regions, identify by licensee name, license number and type, any l renewal applications that have been pending for one year or more. l l I l Not applicable l l

V. Resoonses to incidents and Allegations ' l l 20. Please provide a list of the reportable incidents (i.e., med:cel misadministration,  ! overexposure, lost and abandoned sources, incidents requiring 24 hour or less J notification, etc. See Handbook on Nuclear Material Event Reporting in l Agreement States for additional guidance.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated (i.e., those submitted under OMB clearance number 3150-0178, Nuclear Material Events Database). The list should be in the following format: t LICENSEE NAME LICENSE # DATE OF INCIDENT / REPORT TYPE OF  ; INCIDENT l l Not applicable. DEC is not the New York State agency responsible for rcporting to the Nuclear Materials Events Databau. We do respond to numerous reports of radiation alarms at solid waste and regulated medical waste facilities. During this repori!ng period, they all involved either patient excreta, exempt material, or non-AEA material (i.e., radium-226).

21. During this review period, did any incidents occur that involved equipment or source  ;

failure or approved operating procedures that were deficient? If so, how and when were i other State /NRC licensees who might be affected notified? For States, was timely l' notification made to NRC7 For Regions, was an appropriate and timely PN generated? j Not applicable f ' 8

r 22, For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide details f6r each case. I Not applicable

23. In the period covered by this review, were there any cases involving possible v/rongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.

One incident involving possible wrongdoing is under review. We will provide a description of the circumstances during the IMPEP team vhlt.

24. Identify any changes to your procedures for handling allegations that occurred during the period of this review.

l a. For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed. None VI. General

25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.

There was one recommendation following the last review: We recommend that the NYSDEC exped;tiously complete the inspection of New York City licensees and determine whether there are any licensees subject to its regulation. If licensees are determined to need NYSDEC permits, the agency should take steps to carry out its regulatory responsibilities with regard to these licensees' activities. 1 Since the last review, we have continued to implement our July 1994 action plan for implementing part 380 in New York City. We have inspected eight NYCDOH licensees, selected as the most likely to require a Part 380 permit. Columbia. Presbyterian Medical Center was identified as requiring a Part 380 permit. That permit was issued in 1997. We are working with one other facility, likely to require a permit for a new cyclotron. Complete reports of our activities for the calendar l years 1995,1996, and 1997 were written and will be available for review during the IMPEP team's visit.

26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.

9 1 l

f l Strengths We have an experienced staff. The nyerage length of tenure in tha pregram is nine years, the range is 3.5 to 15 years, and two thirds of the staff have been here for more than six years. We are well supplied with radiation survey and analytical equipment, velometers, and field sampling equipment. Much of our equipment is state of the art, particularly our Ultrasonic Ranging Data System, new TLD reader, and TLD l Irradiator. Weaknesses l There is no direct connection between the State's environmental radiation ! monitoring program, implemented by the State Health Department, and our l program. We receive the results of that program years after the data is collected. As is true for most programs, we could use more staff, particularly staff to work on contaminated sites. I ! The Radiation Program Control Director was named Chief of a new Pesticides & Radiation Bureau in 1995. As a result, his time is now divided laetween the radiation l control program and the DEC's pesticides program, with the pesticide program i requiring the larger portion of his time (it includes three separate regulatory

programs and a statewide staff fite times the size of the radiation staff). The RCP Director is far less available to the radiation staff. In addition, the radiation section supervisor is called upon to serve as acting Chief of the Bureau of Pesticides &

Radiation for about 20% of the work year, which decreases the time she can spend on the radiation program. ! B. NON-COMMON PERFORMANCE INDICATORS

1. Legislation and Procram Elements Reauired for Comontibility

27. Please list all currently effective legislation that affects the radiation control program l (RCP).

l l New York State Environmental Conservation Law Articles 1,3,'17,19,27, and 29 l

28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the

                - next expiration date for your regulations.

Our regulations are not subject to a " sunset" provision. l 1

           - 29. Please complete the enclosed table based on NRC chronology of amendments. Identify those that have not been adopted by the State, explain why they were not adopted, and 10 l

l

discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations. See attached table.

30. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to l maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.

These are the basic steps in our rulemaking process, with an estimate of the time needed in parentheses. Those times can vary considerably, depending on the nature of the rule.

1. A Rulemaking Initiation Memorandum is written, describing the proposed rulemaking. Once allinternal approvals are obtained, including those of the Commissioner and Counsel's Office, otsff can begin work on the rulomaking.

(2 months)

2. Input from the public is solicited before and during the drafting of the proposed rule. This may include mailings and workshops. (2 months)

3. The draft rule and cupporting documents ( including a draf t environmental impact statement, if required) are written. (2 months)

4. Once approved inside the Department, the draft rule is sent to the Governor's Office of Regulatory Reform (GORR) for review. ( 1- 6 months)

5. After GORR approves, notice of the draft rule and the text or a summary are published in the State Register. (1 month)

6. A public hearing must be held no sooner than 45 after notice of the rulemaking was published in the State Register. The comment period closes no less than 5 days after the last day of hearing. (2 months)

7. After the close of the comment period, staff responds to comments, and if no revised proposed rule is needsd, writes the final rule and supporting documents.

(3 months)

8. The final rule is submitted to State Environmental Board for approval. (2-3 months)

9. Once the Board approves the rule, it is submitted to the Commissioner for approval, then filed with the Department of State and published in the State Register. (2 months) 11

10. The rule becomes effective 30 days after the date of publication in the State Register. (1 month)

The entire process takes 18 months to 2 years. II. Sealed Source and Device Procram - Not applicable j

31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the review period. The table heading should be:

SS&D Manufacturer, Type of q Registry Distributor or Device Date Number Custom User or Source issued

32. What guides, standards and procedures are used to evaluate registry applications?

33. Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:

Technical Staffing and Training - A.lli.11-15 Technical Quality of Licensing Actions - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 111. Low-Level Waste Prooram - Our LLRW Program is in abeyance (although our regulations are still in effect), except for our Part 381, LLRW transportation manifest and permit program.

34. Please include information on the following questions in Section A, as they apply to the Low level Waste Program:

Status of Materials inspection Program - A.I.1-3, A.I.6 We have not had the staff needed to inspect LLRW transporters. Technical Quality of Inspections - A.ll.7-10 We have not had the staff needed to inspect LLRW transporters. Technical Staffing and Training - A.lli.11-15 , 1 See responses to A.lil.1115 Technical Quality of Licensing Actions - A.IV.16-18 l Not applicable q Responses to Incidents and Allegations - A.V.20-23 12 l t

l See re:ponza to A.V. 20 23 IV. Uranium Mill Program Not applicable j

35. Please include information on the following questions in Section A, as they apply to the Uranium Mill Program:

Status of Materials Inspection Program - A.I.1-3, A.I.6 1 i Technical Quality of Inspections - A.ll.7-10 i Technical Staffing and Training - A.Ill.11-15 Technical Quality of Licensing Actions - A.IV.16-18 l Responses to incidents and Allegations - A.V.20-23 i l l 1 l 13

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l i l l l I Attachment 1 February 17,1998 Letter from M. K. Daniel., Jr., NYCH l

f . CHE CITY OF NEW YORK

    @                               6EPARTMENT OF HEALTH udolph w. Giuhant Mayor Buruu of Radiological Hulth Benjamin Mojica M.D., M.P.H.

Acting Commissioner

                                .7 3.afayette Street .11th Floor, New York, N.Y.10007 1

Telephone: (212) 4741888, Fa'.: (212) 4741848 l l l February 17,1998 I i l l Dennis M. Sollenberger l l Office of State Programs l l U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001

Dear Mr.Sollenberger:

1 , The following responses are being made to the prelimmary fmdings db--A at the IMPEP closeout I meeting on January 30,1998. I

1. Status of Materials Inspection Program- Unsatisfactory 19 Priority 1 inspections were overdue by more than the 25% of the required 1 year intervals.

l

Response

i In reviewing our records of Priority 1 license inspections, for 1997, the Bureau came up with a total of 12 that had been overdue by more than 25 % of the inspection intervals during the reportmg period. Of this total,2 inspections were overdue by 12 days, I was overdue by 3 days, I was overdue by 25 days and one was overdue by 27 days. We have just completed a validation ! check of our new RAD Data base and have enclosed a printout of our inspections due during the next year. Please note that there are now no overdue Priority l inspections (Rockefeller University is being inspected at this time). Based on our actions to ensure that no Priority 1 inspections wi'l be overdue in the future, we request that you reconsider your finding of unsatisfactory for Common Performance Indicator 1. l 2. Technical Quality ofInspections- Satisfactory with recommendations for Improvement. , Inspections are compliance rather than performance driven. l Two inspectors should be sent to a Performance Inspection training course. l There was no documentation of follow-ups for results of hearings following issuance of NOVs

Response

l The Bureau has requested and received the Student Manual " Inspecting for Performance " from ! NRC and plans to conduct an in. house course for the materials inspectors in the near future. (uvv

Supervisors and staff have an reminded to document the findings of all hearings resulting from the issuance of NOVs. An Inspection checklist is being developed to include the follow up l report on hearings.

3. TechnicalStaffTraining Satisfactorywithrecommendations/ suggestions.

The Bureau needs a written policy for staff training needs. His should include checklists for on-the-job training for inspections and licensing. Out of State training should be part of budget proposals. Response-ne Bureau's Policy and Procedures Manual contains written policy for staff training needs. This manual is currently being updated The Bureau is exploring the possibility ofincluding the costs of out of state training in the current reevaluation of our fee- base schedule.

4. Technical Quality of Licensing- Satisfactory with suggestions.

Licensing actions which involve material from the Scaled Source and Device Registry should incorporate conditions, restrictions of use etc. as license conditions where appropriate. The dating of new licenses should more closely reflect the date the licenses are actually effective so that inspections of these facilities would be within the presenbed time frame. Response-A memo will be added to the License Reviewer's Handbook that instructs reviewers to include as license conditions specific language from the Scaled Source and Device Registry dealing with restrictions of use or recommendations conceming safe handling etc., as appropriate. The Rad Data Base has been upgraded to trigger an inspection due date based on the actual date ofissuance of the new license, rather than the date oflicense signing.

5. Responses to Incidents and Allegations Satisfactory with recommendations Files need to be documented that allegers were notified of results ofinvestigations.

He NMED System should be used for reportable incidents. Response-Documentation in the fonn of a memo to files will indicate that allegers were notified of the results ofinvestigations. Management and supervisory staff have received training in the use of NMED System from Mr. John Pettijohn of the NRC. The Bureau will enter all incidents back to September of 1996 into the NMED System

6. Non-Common Performance Indicator 1, Legislation. Satisfactory with recommendations.

he Bureau needs to act on the Uniform Manifest Rule which is due 3/1/98. He Bureau is overdue in incorporating the Timeliness in Decommissioning Rule which was due by 8/15/97

O Response- l The New York State Department of Emironn. ental Conservation has incorporated the Uniform Manifest Rule by reference (6 NYCRR Part 381, July 1997). We are working with our Office of General Counsel to determine whether the Bureau needs to incorporate this rule making into Article 175 of the New York City Health Code and if so, whether we may also incorporate it by reference. If we decide to incorporate this rule by reference, we will present the appropriate material to the Board of Health in the June,1997 meeting. ~ 1 We have also asked the Office of General Counsel to comment on the inclusion of the Timelmess  ! in Decommissioning Rule into our rerdations vs. handling these situations on a case by case basis through license conditions for the types oflicensees regulated by this Bureau. 1 l We hope this has addressed all the issues that were discussed during our closcout meeting. If you have any questions, please feel free to contact me or Gene Miskin. Sincerely, d N. w Kenneth R. Daniel Jr., Deputy Director l l 1 I 1

Uconee inspections Due By Priority :nd By Date Om Uconse# UcenseType Priority Date Due Date Overdue Name Borough 2989 75 1 12/13/97 03/13/98 Rodsefel:er UnNe$ty MN 2924 02 1 01/2948 04/29/98 Brooldyn Hospital Center BK 2885 75 1 02/0448 05/05/98 Monterflore Med Ctr BX 3009 75 1 03/05/98 06/03/98 St. Vincent's Hos,Ntal and Medical Center MN 2643 92 1 ,03/08/98 06/0M8 Long Island Cohoot Hospital BK 18: 92 1 03/25/98 06/23/98 Memorial Sloan-Kettering MN 185 75 1 03/25/98 06/23/98 Memorial Sloan.Kettering MN 2847 92 1 04/04/98 07/03/98 Peninsula Hospital Center QN 2894 91 1 04/11/98 07/10/98 New York Hospital Medical Center of Queens ON 131 92 1 04/24/98 07/23/96 Staten Island University Hospital SI 128 92 1 04/24/98 07/23/98 Staten Island Univ, Hosp SI 2830 92 1 05/09/98 08/07/98 Manfredt, Orlando L . M.D. Si 2909 91 1 05/21/98 08/19/98 Mt Sinal School of Medidne MN 2841 92 1 05/24/98 08/22/98 Brookdale Hospital Medical Center BK 2919 75 1 06/05S8 09/03/98 Albert Einstein College of Medidne BX 2889 92 1 06/0M8 09/04/98 AnimalMedicalCenter MN 2899 92 1 06/06/98 09/04/98 AnimalMedicalCenter MN 186 92 1 06/22/98 OE'20/98 Memorial SloerbKettstino Cancer Ctr MN 2955 92 1 07/08/98 10/08/98 NYU Medical Center MN 78 92 1 07/29/98 10/27/98 Lenox Hill Hospital MN 289803 92 1 08/07/98 11/05/98 Mornortal Sloan-Kettering MN 2957 91 1 09/17/98 12/16/98 NY Hosp.. Comell Med Ctr MN 2897 92 1 09/24/98 12/23/98 Beth Israel Medical Ctr MN 88 75 1 10/12/98 01/10/99 NYU Med Center MN 2988 75 1 10/10,98 01/14/99 Long Island Jewish Med. Ctr. ON 2950 93 1 10/17/93 01/15/99 NYU Medical Center MN 2955 75 1 10/17/96 01/15/99 NYU Medical Center MN 2878 92 1 10/27/98 01/25/99 Columbia Presbyterian Medical Center MN 2922 92 1 10/28/98 01/2H9 Cabrini Medical Center MN 2898 75 1 10/31/98 01/29/99 St Luke'sWoosevelt Hospital Ctr MN 3028 92 1 11/07/98 02/05/99 SUNY Health & Sdence Center Brooklyn BK 82 92 1 11/07/98 02/05/99 SUNY Hearth & Sdences Center Brooklyn BK 44 92 1 11/07/98 02/05/99 SUNY Health & Sdenca Brooklyn BK 148 92 1 11/28/98 02/26/99 NYCHHC . Kings County Hospital BK 2878 52 1 12/05/98 03/05/90 Columbia Presbyterian Medical Center MN 2878 75 1 12/05/98 03/05/99 Columbia Presbyterian Medical Center MN 2848 92 1 12/24/98 03/24/99 Calvary Hospital BX 2934 75 1 01/18/99 04/18/99 SUNY-Health & Sdence Ctr of Brooklyn BK 2883 92 1 02/13/99 05/14/99 Montenore Med. Center BX Total 39 Priority Date Due Date Overdue Name Borough 2909 74 2 07/22/98 01/18/97 Mt Sinal School of Medidne MN 2881 91 2 02/08/97 08/07/97 Nestadt, Louis MD. MN 2915 91 2 04/28/97 10/25/97 NYCHHC Uncoln Medical and Mental Health Ctr BX 1518 91 2 09/21/97 03/20/98 Victory Memottal Hospital BK 2919 74 2 10/12/97 04/10/98 Albert Einstein Colle9e of Medidne BX 2903 91 2 01/04/98 07/03/98 NYCHHC Hariem Hospital Center MN 3003 91 2 01/24/98 07/23/98 Annand, Azad K. MD ON 2731 91 2 01/2448 07/23/98 Lugo Santia90, Ema MD ON 2932 91 2 01/2H6 07/27/98 Parkway Hospital QN 1515 91 2 01/30/98 07/2&98 Narth Shore University Hospital ON 2900 91 2 03/22/98 09/18/98 Our Lady Of Mercy BX 2G44 91 2 03/26/98 09/22/98 Maimonides Med. Ctr. BK 3075 91 2 03/30/98 09/2M8 Harold M. Tice ON 3089 91 2 03/30/98 09/2&S8 David Greenblatt, M.D. MN 2843 91 2 04/03/98 09r30/98 Lon0 Island Colle9e Hospital BK 1641 91 2 04/11/98 10/0M8 NYCHHC Nor1h Centre' Bronx Hospital BX 3070 91 2 04/1158 10/0M8 Daniel Lorber ON 2882 91 2 04/18/98 10/13/98 St. Clare's Hospital & Health Center MN 2642 91 2 04/19/98 10/1H6 Bloomneld, Martin E. MD MN 2905 91 2 04/23/98 10/20/98 Caccavo, Nicholas K BK 3002 91 2 05/05/98 11/01/98 Blake James MD MN 3020 91 2 05/0M8 11/04/98 Thanawala, Shirtsh K. MD ON 185 91 2 05/08 S 8 11/04/98 Weinstein, Victor MD ON 2788 91 2 05/09/98 11/05/98 Wolmer, tra MD. MN 2914 91 2 05/1548 11/11/98 NYCHHC . Color Merr*31 Hospital MN 2880 91 2 05/15/98 11/11/98 Rosenthal, David, Mi. BK 02/17/98

l, usense inspections Due By Priority and By De's Due 1640 91 2 06/17/96 11/13/98 Ocelor's Hospitsf of Staten latend 81 i. 2732 91 2 06/22/96 11/18/98 Paula M. Rotheus, M.D. MN 2796 91 2 06G3/96 11/19/96 Bier, Steven MD MN 3039 91 2 06/23/96 11/19/06 Jeoobs, Dev6d R. MD MN 3053 91 2 06/24/98 11/20/98 Rudavsky, AmielZachary, M.D. MN 2761 91 2 06/29/98 11/2S/98 Kaufman. D MD . BX 2965 74 2 06/31/96 11/27/98 NYU Med6 cal Center MN 295504 74 2 06/31/98 11/27/98 New York University MN 2795 91 2 06/06/96 12/02/99 Reisman, Steven, MD MN 2981 91 2 06/17/98 12/14/96 Potenza, Robert MD BX 1672 91 2 08/18/96 12/15/96 Spor 9el, Gabriel MD BK 2785 91 2 08/18/98 12/1S/98 Prs 9er, Marc MD BX 2924 91 2 06/21/98 12/18/98 Brocidyn Hospital Center BK 2966 91 2 0676/96 12/26/96 North General Hospital MN 2842 91 2 07/03/98 12/30/98 Methodist Hospital BK 3025 91 2 07/10/96 01/06/09 En9, Youn0 F. . M.D. Si 2616 91 2 07/16/98 01/11/99 Sheinbrot,Stuart/ltwin, Sin 9er BK 3023 91 2 07/18/98 01/14/90 Novick, Mark MD ON 3077 91 2 07/30/96 01/26/90 Joseph Hun 9 Ma, M.D. QN 3004 91 2 08/01/96 01/26/09 Utus Neck Community Hosp. ON 2780 91 2 08/12/98 02/06/99 Sapienza. N MD BK 3005 91 2 08/13/96 02/09/99 Usann. Neal, MD MN-3036 91 2 06/14/98 02/10/99 DoeN, Leena MD BK 2646 91 2 08/15/98 02/11/09 Uchy, Jacob MN 2630 91 2 08/17/96 02/13/99 Manfredi, Ortendo L M.D. SI 2651 91 2 08/20/96 02/16/99 St John's Episcopal Hospital QN 3014 91 - 2 0849/96 02/25/99 Rezzadeh, Rudy MD MN 2797 91 2 09/04/96 03/03/99 Schaefer, Kenneth MD Si 2798 91 2 09/10/98 03/09/99 Doshi, Leena M.D. ON 2960 91 2 09/10/96 03/09/99 N.Y FlusNn0 Hosp. Med. Ctr. QN 2638 91 2 09/11/98 03/10/99 Lorber, Daniel MD QN 2771 91 2 09/16/98 03/15/99 Brendeis,VincentT MN 3022 91 2 09/24/96 03/23/99 Beth israel . Kin 9s Hghway DMsion BK 2944 91 2 09/26/96 03/25/99 DosN, Leena M.D. BK 3041 91 2 09/27/96 03/26/99 Rosenthal, Devid, M., MD BK 2821 91 2 09/27/96 03/26/99 Ginde, Ravindre MD BK 2957 91 2 10/01/96 03/30/99 Mang, Henry M.D. MN 3034 91 2 10/01/96 03/30/99 Lefkowitz, Devid M.D. MN ' 3042 74 2 10/01/96 03/30/99 CUNY City Come9e MN 2663 91 2 10/01/96 0#30/99 Kampf, Jeffrey MD MN 3056 91 2 10/03/96 04/01/99 Tartell. Jay MD QN 2657 91 2 10/09/96 04/07/99 Lash, James MD BK 2739 91 2 10/11/98 04/09/99 Schorr, P MD (Hilcrest) QN 2066 91 2 10/18/96 04/16/99 Thanswels, SNrtsh K. MD BX 3051 91 2' 10G2/98 04/20/99 Samil, Mohsen MD QN 2941 91 2 10/23/98 04/21/99 Hassan, Khalid MD BK 1619 91 2 10/23/98 04/21/99 Westem Queens Comminity Hospital QN I 2006 91 2 10GS/96 04/23/99 Felt, Sheldon, MD QN 3050 91 2 10/30/96 04/28/99 Levine, Even MD BX l 2933 91 2 11/01/98 04/30/99 Perekh, Hershed MD SI 1640 91 2 11/06/96 05/07/99 Schneider, Howard J MN 2635 91 2 12/03/98 06/01/09 Grunther & Stoll M.D. MN 2976 91 2 12/06/96 06/03/99 A. Messina, MD & A. Ueberskind, MD MN j 2646 91 2 12/05/98 06/03/99 Wyckoff Hel0 hts Medical Center BK 2929 91 2 12/05/96 06/03/99 CMCBQ St Mary's Hospital BK 2649 91 2 12/06/96 06/04/99 St. Bemebes Hospital BX 2946 91 2 12/06/96 08/04/99 Bradley-Moore, Petrick MD QN ' 2969 74 2 12/12/96 06/10/99 Rockefeuer University MN 2996 91 2 12/13/96 06/11/99 Greenberg, Joseph M.D. MN 304S 91 2 12/18/96 06/16/99 Munen. Edward E. MD QN 3054 91 2 12/21/98 06/19/99 Lut.aren Med. Ctr. BK 2917 91 2 12/23/98 06/21/90 Roseman,8 MD MN  ! 2616 91 2 12/26/96 06/24/99 Hospital for Joint Deesses/ Orthopaedic institute MN 2923 91 2 12/31/96 06/29/99 Jamaice Hosp. QN 2902 91 2 01/02/99 07/01/99 NYCHHC Coney leland Hospital BK 896 91 2 01/07/99 07/06/99 Silverber9, Amold 1. MD BK 2950 91 2 01/07/99 07/06/99 Bronx-Lebanon Hospital Center BX 2858 91 2 01/06/99 07/07/99 Rabiner, Herbert, MD QN 2901 .91 2 01/10/99 07/09/99 NYCHHC . Queens Hospital Ctr QN 02/17/96 f

e Ucense inspectons Due By Prot:y and By Date Due

 ,             '2898         91            2        01/14/99       07/13/99 Helmes, Aheca C. MD                                    MN 2649      . 91            2        01/15/99       07/14/99 NYCHHC . Woodhuh Me+1 M9tl Hith Ctr                    BK 3055         91            2        01/15/99       07/14/99 D'Alessandro, Thomas M.D.                              MN 2945         91            2        01/18/99       07/15/99 interfeith Med. Ctr                                    BK 2928         91            2        01/18/90       07/15/99 Lenox Hill Hospital                                    MN 2871         91            2        01/17/99       07/18/99 CMC 8Q . 8t Joesph's Hoop Division                     ON 2827         91            2        01/23/99       07/22/99 Novick, Mark MD                                        BK 3021         91            2        01/23/99       07/22/99 Rentrop, Peter K MD                                    QN 2979         91            2        01/23/99       07/22/99 Tobin, Keith M.D.                                      MN 2928         91            2        01/20fe9       07/28/99 CMCBQ- 8t John's Hosp. Div                             QN 2010         91            2        02/08/99       08/05/99 New York Downkun Hospital                              MN      ' l 2907         91            2        02/07/99       08/08/99 NYCHHC Elmhurst Hospital                               QN 2870         91            2        02/07/99       06/08/99 Young, tven 8. MD                                      MN 3059         91            2        02/13/99       06/12/99 McCarthy, Joeoph M.D.                                  BK Total             100 Priority     Dele Due        DeleOverdue Name                                                     Borough   1 3006        52            3        01/26/97       10/25/97 St. John's University                                  ON 3088         52            3        03/30/98       12/25/98 Sicheni, Merlo MD                                       BK 3073        52            3        03/30/98       12/25/98 Paleen Technologies,Inc.                                MN 2722        52            3        05/02/98       01/27/99 Dredter,laaec MD'                                       MN 2882         52            3        05/05/98       01/30/99 Advanced Fertility Services                             MN 288C         52            3        05/11/98       02/05/99 Modem Med6 cal Laboratory                               BK 3000        52            3        05/12/98       02/08/99 Professional Clinice! Labs                              MN 1555        52            3        05/16/98       02/10/90 Quentin Medical Lab                                     BK 2939         52            3        05/10/98       02/13/99 Hoffman Center For Holistic Medicine                    MN
       ,         1888        52            3        05/23/98       02/17/09 Morris Park Test Lab                                    BX 1814        52            3        05/23/98       02/17/99 Gason, Saul B                                           MN 1558        52            3        06/25/98       02/10/99 Bendiner & Schlesinger inc                              MN 2942        52            3        06/07/98       03/04/99 Metropolitan Diagnoste Labs. Inc.                       QN
               '2831         52            3        08/07/98       03/04/99 Bio Tech Labs Inc.                                      BK 2851        52            3        08/08/99       03/05/90 Museum Of Modem Art                                     MN 1588        52            3        06/15/98       03/12/99 NYC Medical Examiner's Of6ce                            MN 1804        52            3        08/23/98       03/20/99 Orontreich Medical Group                                MN 298011         52            3        07/25/98       04/21/99 NY Hosp.. Comet Med Ctr                                 MN 3078        52            3        06/30/98       05/27/99 GenQuest                                                MN 2719         52           3        09/06/98        06/03/99 CUNY

• Med9er Evers Colle9e BK 3015 52 3 09/08/98 08/03/99 NYC Housing Preservation and Development. Central Leed MN 1874 52 3 00G8/90 06/23/99 Singer, Joseph PC MN 2988 52 3 10/03/98 06/30/99 Univ Diagnosne Lab BK 2920 52 3 10/04/98 07/01/99 Bic> Chem Technology Lab. inc. MN 2911 52 3 10/25/98 07/22/99 CUNY. Brooklyn Colle9e BK 2975 52 3 11/21/98 08/18/99 CUNY. Queens Couege ON 128 52 3 11/23/98 08/20/90 Monte 6ere Med. Center BX 122 52 3 11/27/98 06/24/99 Montenore Med. Center BX 131 52 3 11/27/98 08/24/99 Monte 6 ore Med. Center BX 120 52 3 11/27/98 08/24/99 Monte 6ere Med Center BX 130 52 3 11/27/98 08/24/99 Montenore Med. Center BX 143 52 3 11/27/98 06/24/99 Montenore Med. Center BX 113 52 3 11/27/98 08G4/99 Montenore Med Center BX

, 110 52 3 11/27/98 06/24/99 MontefIore Med. Center BX 104 52 3 11/27/98 08/24/99 Montenore Med. Ctr. BX 102 52 3 11/27/98- OlV24/99 Montenore Med. Center BX 114 52 3- 11/27/98 08/24/99 Monteflore Med. Center BX 3044 52 3 11/27/98 08G4/99 Monterflore Med.Ctr BX 115 52 3 11/27/98 08/24/99 Montenore Med. Center BX 208502 52 3 11/27/98 08/24/99 Montenore Med Ctr BX 118 52 3 11/27/98 08/24/99 Montenore Med. Center BX 103 52 3 11/27/98 06/24/99 Monteflore Med. Ctr BX 140 52 3 11/27/98 06/24/99 Montenore Med. Center BX 132 52 3 11/27/98 08/24/9W Montenore Med. Center BX 109 52 3 11/27/98 08/24/99 Montenore Med. Center BX 123 52 3 11/27/98 08/24/99 Monto6cre Med. Center BX 108 52 3 11/27/98 08G4/99 Montoflore Med. Ctr. BX 111 52 3 11/27/98 06/24/99 Montenore Med. Center BX 105 52 3 11/27/98 06/24/99 Monteflore Med. Ctr. BX 287805 93 3 12/05/98 09/01/99 Columble Presbyterian Med Ctr MN 2887 52 3 12/20/98 09/18/99 Aaron Diamond AIDS Research Center MN 2908 52 3 01/03/99 09/30/99 Public HeaHh Research Inshtute MN 147 52 3 01/05/99 10/02/99 CUNY. Hunter MN 02/17/98 i

l Ucense Inspections Due By Priority end By D::to Due s 140 52 7 01/05/99 10/02/99 CUNY. Hunter MN 148 52 3 01/0599 10/02/99 CUNY44unter MN 123 52 3 01/05/99 10/02/99 CUNY44unter MN 126 52 3 01/0599 10/02/99 CUNY Hunter MN 156 52 3 01/0599 10/02/99 CUNY HunterCollege MN 3031 52 3 01/05/99 10/02/99 EMA Medice! Labe ON 153 52 3 01/05/99 10/02/99 CUNY Hunter MN 139 U2 3 01/05/99 10/02/99 CUNY Hunter MN 126 52 3 01/0599 10/02/99 CUNY-Hunter MN } 136 52 3 01/05/99 10/02/99 CUNY44unter MN i 130 52 3 Olar#w3 10/02/99 CUNY44unter MN l 3049 52 3 01/05/99 10/02/W t#C Deo. Heefth. Bur. of Laba MN 135 52 3 01/05/99 10/02/99 CUNY44unter MN 134 52 3 01/05/99 10/02/99 CUNY Hunter MN 127 52 3 01/05/99 10/02/99 CUNY-Hunter MN 124 52 3 01/05/99 10/02/99 CUNY44unter MN 131 52 3 01/0599 10/02/99 CUNY44unter MN 133 52 3 01/0509 10/02/99 CUNY44unter MN 125 52 3 01/05/99 10/02/99 CUNY-Hunter MN 142 52 3 01/06/99 10/0199 NYCHHC - Horiern Heapital Center MN 2958 52 3 02/01/99 10/29/99 Lavin, Allan A. MD QN Total 74 02/17/98 _ . . _}}