Text

Provides Requests for Insp Work During Period Jan-Mar 1989 & Requests That Schedule Be Provided by Last Wk of Dec
	ML20057A280
Person / Time
Issue date:	12/21/1988
From:	Pasciak W; NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:	Keimig R, Shanbaky M; NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
Shared Package
ML20055C202	List: ML20055C201; ML20055C218; ML20055C219; ML20055C220; ML20055C221; ML20055C223; ML20055C242; ML20055C243; ML20055C268; ML20055C467; ML20056B907; ML20056B908; ML20056C036; ML20056C043; ML20056C046; ML20056C060; ML20056G749; ML20056G752; ML20057A123; ML20057A128; ML20057A200; ML20057A205; ML20057A218; ML20057A221; ML20057A232; ML20057A238; ML20057A243; ML20057A249; ML20057A251; ML20057A259; ML20057A263; ML20057A265; ML20057A267; ML20057A271; ML20057A280; ML20057A283; ML20057A287; ML20057A289; ML20057A295; ML20057A320; ML20057A322; ML20057A323; ML20057A327; ML20057A328; ML20057A330; ML20057A331; ML20057A332; ML20057A344; ML20057A349; ML20057A354; ... further results
References
	NUDOCS 9309130312
	Download: ML20057A280 (29)
	v • d • e

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I DEC 21 1988 HEMORANDUM FOR: Richard R. Keinig, Chief, Safeguards Section, FRSSB Mohamed M. Shanbaky, Chief, Facilities Radiation Protection Section, FRSSB THRU:

Ronald R. Bellamy, Chief. Facilities Radiation Safety &

i Safeguards Branch, DRSS j

FRON:

Walter J. Pisciak, Chief,'Efflu'eWRadiation protection Section, FRSSB

SUBJECT:

WISH-LIST FOR SPECIALIST INSPECTION EFFORT FOR FUEL FACILITIES 2ND QUARTER, FY-89

)

The following list provides requests for inspection work during the period January-March, 1989.

Please provide me with your schedule by the last week of I December.

A team inspection at Combustion Engineering will be held the week comencing January 30, 1989. Jerry Roth will be the team leader and inspectors should be directed to follow his instructions and guidance during I

this effort. An inspection plan will be provided shortly before the inspection.

Facility Area Responsible section Priority Combustion Rad protection FRPS high Engineering 2 inspections:

Team Jan. 30, 1989 Follow-up Mar 13, 1989 CE Security SS

~

high Penn State Rad. protection FRPS low MIT Rad. protection FRPS medium (2ndrequest)

MIT Security SS medium NIST(NBS)

Rad. protection FRPS high UNC Rad. protection FRPS high 9309130312 930830

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PDR STPRC ESGGEN PDR

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The following comments are in response to Question No. 4 ADMINISTRATIVE SUPPORT i

The NMS Branch depends on several administrative support units that are external to the Branch, but also has several internal functions which l

contribute to the overall operation.

The main internal support group unit is the Licensing Assistance Section.

This group was organized in April 1988 with Doris Foster as Chief.

Several functions are handled by the Licensing i

Assistance Section (LAS), including:

processing and docketing of incoming mail.

preparation of licensing actions for reviews by the technical staff.

i typing of certain high priority work, such as escalated enforcement actions, preliminary notifications, urgent inspection reports, and special projects.

filing, maintenance and retrieval of docket files.

clerical effort involved with the documentation of inspections, inquiries, etc.

implementation of the materials " returned mail" procedure.

preparation for signature of amendments not requiring technical reviews.

Administrative services provided by groups outside of the Branch include travel, typing of all licensing and routine inspection documentation, inspection tracking system support and computer data entry contract support.

The groups that provide administrative support typically perform their functions in a timely manner. However, timeliness is a function of workload and availability of personnel.

For example, in the processing of incoming mail received by NMSB, it has typically taken an average of three days for the mail to be available for Fees or for the reviewer to evaluate.

Recently, the average has gone up to four days because of illnesses to LAS staff members and because of the beginning of year concentration of holidays.

The Word Processing Center (WPC) types essentially all licenses and does the bulk of routine inspection documentation typing.

The WPC turnaround time is generally between two and three days, which is acceptable.

This is a sig-nificant improvement from past experience, which, at times, tended to run 10 or more days, particularly for routine inspection documentation.

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Question No. 4 2

Materials docket filing continues to be done in a meticulous and timely mant?r.

Documents generally are filed on a daily basis.

Untiled materials are kept in readily accessible areas so that they are always available.

The Computer Assistant in CRMA inputs inspection data for the RITS Inspection Tracking System for DRSS. We have experienced difficulty in the past with the accuracy of information in the system.

For example, reports that had been issued still showed as overdue and 'aspections that had been performed did not i

show up at all.

In addition, occasional data entry errors result in inaccurate summary data, such as average time to issue inspection documentation.

The Computer Assistant has instituted procedures that allow NMSB to review and correct the weekly report before it is published.

Lack of backup support for the Computer Assistant is an occasional prcblem, resulting in delays in data entry, but this problem impacts only the availability of current statistics or tracking information.

In the latter part of 1988 hMSB began utilizing a DRMA computer contractor for routine data entry to the Li$ and tr the Region I inspection tracking system.

For the first few months there was considerable turnover in that staff and they were of little help to the Branch. Within the last few months, however the contractor's staff has become more stable and they have become a great

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asset and have reduced the workload of the Branch.

While there have been a number of improvements in the administrative elements in ORMA and the Branch, a number of both direct and support activities presently are being performed by other than the appropriate staff member.

Since the reorganization that resulted in establishment of the LAS and selec-tion of Ms. Foster as the Section Chief, the Licensing Assistant position has remained vacant, pending demonstration to the Regional Administrctor that the position is needed.

In the meantime, the duties originally performed by the Licensing Assistant (such as implementation of the returned mail procedure, the purging of erroneous information from the computer data base, and the preparation of simple licensing actions) are being performed by other members of the staff, including the Processing Assistants, Reference Assistant, LAS Section Chief or l

members of the technical staff.

Similarly, some tasks normally done by members of the LAS, such as the preparation of inspection documentation for mailing, I

still must be done by a member of the technical staff because of the admin-istrative staff's involvement with other work.

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l The following comments are in response to Question No. 5.

INTERACTIONS WITH HEADQUATERS USEFULNESS OF CONFERENCE CALLS Monthly teleconferences between NMSS and the regional offices provide a forum for the sharing of information that is important to all of the participants. However, our current teleconferencing practices do not always result in the exchange of high quality information.

We believe that the calls too often involve region-specific problems and run too long. We suggest that the agenda be restricted to items that are generic, and be constrained to about one hour. NMSS should assure that topics which relate to a region-specific problem or concern are resolved separate from the teleconference.

Each topic that is discussed should be resolved or assigned for resolution, with a due date as necessary.

Following, a report of the teleconference should be prepared and distributed. Agreed upon assignments should be regarded as Action Items and handled accordingly.

LICENSING WORKSHOP The Licensing and Inspection Workshop held in Atlanta on January 10-11, 1989, was well done.

However, the real worth of the effort will only be realized when planned actions are completed.

Relative to this effort, we believe that it is not in the best interest of the agency to invite representatives from the Departments of the Air Force and Navy to attend the entire conference.

Rather, these licensees should be invited to make specific presentations and participate in selected discuss's J at directly concern their respective programs.

Their presence the i re duration of the conference may prevent open discussion and e rea y ax nange of information, some of which may be predecisional,

..al, or investigative in nature.

In the future, participation by such NRC licensees in affairs that are clearly internal to the NRC should be carefully considered.

One of the benefits commonly expressed relative to the workshop was the opportunity to compare approaches and problem solutions with other regions. We believe that such benefit could be further enhanced by selective and discrete exchanges of personnel (including inspection,

.l Question No. 5 2

l licensing and management personnel) among the regions and HQ. We believe that such exchanges should be of short duration and directed toward specific areas of interest or concern INSPECTION ACCOMPANIMENTS Recent interviews with several of our inspectors and license reviewers indicate inspection accompaniments may be useful in maintaining HQ personnel cognizant of regional techniques and protocols, and the scope and type of licensed programs that the regions regulate.

However, the inspection personnel usually view such accompaniments as a one way l

exchange, and are sometimes led to believe that their performance is being critically evaluated.

In such cases, the inspector tends to be uncomfortable with the accompanying HQ personnel.

Since accompaniments are not performed to critique the performance of the individual inspector, the actual purpose of the exercise should be explained by the accompanying personnel.

Several inspectors voiced the opinion, that, when interviewed by members of the National Program Review Team, the emphasis appeared to be too narrowly focused on the administrative, documentation, and production aspects of their job, as opposed to inquiries directed toward examples of how the inspector views and exercises responsibility for public health and safety. We recommend that the statistical and production aspects of National Program Review be reserved for management interface.

TELEPHONE CALLS ON CASE REVIEWS AND TECHNICAL ASSISTANCE PROVIDED ON A DAY-TO-DAY BASIS We are generally pleased with the. assistance provided by Steve Baggett, and recognize that the timeliness problems associated with Source and Device reviews is largely a function of resources available. He has, however, been very prompt in responding to questions from the staf f and usually handles specific information requests within 24 to 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />.

Similarly, emergency requests for guidance in the medical area have been handled promptly and the information provided has been useful.

Problem areas include the generally long delays by NMSS in responding to written TARS and the lack of feedback on the quality of licenses or inspection reports issued by the Region.

STANDARD REVIEW GUIDES / REGULATORY GUIDES / POLICY AND GUIDANCE DIRECTIVES /

SOURCE AND DEVICE CATALOG We are generally pleased with the quality of information published for 1

licensing and regulatory guidance, but note that certain Reg Guides

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should be considered for technical revision.

We often receive comments from licensees indicating that they have difficulty in understanding the applicable Reg Guide. While some of this

Question No. S 3

difficulty may be a function of the licensee's limited knowledge, the NRC should assure that published guidance documents exhibit clarity, conciseness and uniformity.

Utilization of the Source and Device Catalog could be enhanced by a better indexing system.

Currently, we file the material alphabetically according to manufacturer. However, such a system has limited usef ulness as the manufacturing concerns change in name and ownership.

The use and adherence to Policy and Guidance Directives could be enhanced significantly by better organization and document control. We recommend that alternatives to the existing system be consic? red, including:

(1) Reorganizing and promulgating the existing guidance documents in a NMSS Manual; and, (2)

Incorporating Policy and Guidance Directives in a database that is accessible by computer.

Use of a computer-accessible data file for this material would also permit timely revision of the documents.

INSPECTOR AND LICENSE REVIEWER TRAINING We continue to have difficulty in scheduling Nuclear Materials Training l

courses that are required for personnel qualification.

Too often the courses are not available or are offered sporadically.

For example, while teletherapy is now considered as a Priority 1 program, we have very few personnel with sufficient training and experience to perform critical reviews, and a training program has not yet been established to fulfill this need.

DISSEMINATION OF INFORMATION It has been observed that informatio, may be distributed to licensees I

before it is available in the regio 7al offices.

The latest example includes NUREG/BR-0133, Working Sately With Nuclear Gauges. Our inspectors had inquiries concerni g this document before they even knew l

it existed. We recognize that tiformation distribution is usually accomplished via contracted serv'ce<

If it is not possible to supply advance information to the regions, then including the regional offices on the contractor's mailing list would seem appropriate. We have noted a concerted effort to provide Information Notices to the regions prior to q

publication, an effort that is appreciated.

MULTI-REGIONAL INSPECTIONS Certain licensee types, principally large radiography companies, may maintain a corporate office in one NRC region and have several field offices and places of use in other NRC regions. Usually, the license is administered by the region in which the corporate office is located.

Examples include, U. S. Testing (Regiun V), Industrial NOT (Region II),

Question No. 5 4

Magnaflux (Region III), and PSI-Pittsburgh Testing Laboratory (Region I).

In these cases, the NRC regional offices may not be aware of the fact that a radiography field office is established in their jurisdiction.

Consequently, these licensed activities may not be inspected.

Region I was not aware of Industrial NDT field operation in Mexico, Maine until Region II requested our assistance in following up on a source disconnect.

We recommend that an ef fort be made to identify the location of such field offices, and that a system of regional assist inspections, similar to that employed for inspecting Navy and Air Force licensed activities, be established.

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The following' comments are in response to Question No. 6 REGIONAL INITIATIVES DURING FY88 AND FY89 THROUGH FEBRUARY 28, 1989 1.

Implemented the " Recommendations for Action" contained in Sections 2.5 and 5.6 of the " National Program Review Report" dated September 29, 1988, Region I routinely monitored the status of completion of inspections a.

of high priority licensees and began using the " official field note formats" in all inspections.

The region has been able to accomplish inspections, even in the lower priorities, in a timely manner and has not had to resort to the optional use of the telephone contact I

procedure.

b.

With one exception (an inspector who became pregnant and concentrated on licensing), all inspectors were accompanied on inspections at least once by their Section Chief during FY88.

That practice has continued during FY89 with each Section Chief accompanying at least two inspectors thus far (a total of 11).

It is our intent that each inspector will be accompanied during FY89.

2.

Aggressively pursued qualification (by an oral board) of all materials inspectors. The status of each technical member of the Branch is shown in the attachments.

Thus far in FY89, seven inspectors have met (and passed) oral boards, and nine more are expected to meet oral boards before the end of FY89.

The additional flexibility that will result from this progress is expected to enable the region to meet or exceed its inspection goals for the FY.

3.

Aggressively pursued qualification (in accordance with the attached program outline) of all materials license reviewers.

This two phase process is well underway, and nine reviewers have completed at least one of the steps and been authorized by the Regional Administrator to sign licenses. The training program associated with the qualification process

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has e.nabled the region to issue licenses (including renewals) well in j

excess of its budgeted goal at this time and the annual goal is also expected to be exceeded.

4.

Develooed and coordinated a national seminar for operators of NRC and Agreement State-licensed irradiators.

The seminar was held in Arlington, Texas on May 24-25, 1988, and was attended by approximately 100 repre-sentatives from the approximately 36 active irradiators in the U.S. and from NRC/ Agreement State regulatory authorities. The meeting was transcribed and a draft of a NUREG has been prepared by Region I.

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Question No. 6 2

5.

Developed several Information Notices for issuance by NMSS, including:

Criminal Prosecution of Licensee's Former President for I

Intentional Safety Violation (89-02)

Dose Calibrator Quality Control (89-12)

Unauthorized Transfer of Ownership or Control of Licensed Activities (89-25)

Loss and Theft of unsecured Licensed Material (submitted for review February 7,1989)

I 4

6.

Participated in a number of meetings and seminars'in support of NMSS in the medical area.

In addition, the region identified, during inspection of recently-licensed nuclear medicine and nuclear cardiology private practices, an apparent generic problem.

Inspection of six such facilities in late 1988 and early 1989 revealed that all six had initiated operations without satisfying all requirements of the license.

As described in a memorandum dated February 27, 1989, from S. Ebneter to R. Cunningham (copy attached), Region I has initiated a new procedure in an effort to assure safe operation of these facilities and to avoid repetition of the problem.

7.

In February 1989, the NMS Branch Chief initiated a monthly audit of inspection documentation issued during the preceding month as a quality control check.

Findings are then provided to the appropriate Section Chief.

Focus is on clarity of communication of problems to the licensee (in both the cover letter and in the Notice of Violation) and on consistency of the inspectors' techniques of inspection and documentation.

Format, grammar and spelling errors are also noted.

8.

Heightened awareness and aggressiveness with which we identify and pursue cases in which licenses have been transferred to new owners without informing NRC.

The Region I program was described in a memorandum dated December 30, 1988 from Bill Russell to Hugh Thompson and Jim Lieberman, (copy attached) and a draf t Information Notice was forwarded for NMSS consideration (being issued as IN 89-25).

9.

Purchased two cutaway radiography cameras and related equipment for use in training the inspection staff. A training session using.the new equipment-was held in February 1989.

Similar orientation sessions were held (prior to receipt of the training aids) for the Division of Reactor Safety (DRS) in November 1988 and for the Region I resident inspectors in December 1988 to familiarize them with the radiation safety requirements imposed on 4

radiographers. DRS and resident inspectors often encounter radiographers doing work under their byproduct material license at reactor sites.

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Question No. 6 3

10.

Developed a training program on the requirements of Part 35 to be presented to licensee nuclear medicine technologists and radiation safety 5

staff.

These training sessions, to be initiated March 10, 1989, will k

be presented at 12-14 Region I facilities.

1 11.

Coordinated, and scheduled for April 27, 1989, a seminar for all of the Harvard-af filiated institutions, on the NRC's expectations and requirements relative to radiation safety programs that are performed under contract by the Harvard radiation safety staff.

12.

Plan and present, as soon as the final direction of rulemaking for medical quality assurance is determined, a series of workshops explaining the rule.

The workshops will be held in several major metropolitan areas and will be directed at medical physicists and radiotherapists.

13.

Aggressively pursued appropriate enforcement for those licensees unable or unwilling to comply with NRC requirements.

This included the conduct of 21 enforcement conferences in FY88 and 10 thus far in FY89.

14.

Reduced the average time required for issuance of inspection documentation from over 100 days in the first quarter of 1988 to less than 50 days as of the first quarter of 1989.

15.

Made a significant contribution to the effort to develop performance evaluation factors.

The region has utilized the factors as described in its memorandum to Mr. Cunningham dated September 28, 1988.

16.

Planned and implemented a major reorganization of the Nuclear Materials Safety Branch to focus attention on the safety problems of types of facilities, rather than focustng on licensing versus inspection of all facilities.

17.

Aggressively recruited to fill all funded vacancies in the technical staff, including selection of a medical program specialist.

19.

Developed a book of guidance on inspection documentation, including model citations, which received widespread notice within the agency.

19.

Began the development of an organized book of detailed guidance on the formatting of license documents.

20.

Began reviewing licenses for which financial assurance is required. Most of the staff has attended formal workshops given by NMSS and specific procedures and guidance are in preparation by Region I.

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QUALIFICATION STATUS - MATERIALS SECTION A 07-MAR 89 REPORT TO INSPECTOR ORAL LIMITED FULL IDP NAME REGION I JOURNAL BOARD LICENSING LICENSING J.

PELCHAT IN ECD ECD ECD IN HEAL H PHYS MAY-87 PROCESS 05/31/89 03/31/89 05/31/89 PLACE L.

TRIPP IN ECD APPROVED ECD IN HEALTH PHYS JAN-88 PROCESS 03/31/89 01/11/89 04/30/89 PLACE

5. COL:TEMANCHE COMPLETED PASSED ECD ECD IN HEAL H PHYS JAN-86 02/15/89 03/31/89 07/31/89 PLACE T.

DARDEN IN ECD ECD ECD IN HEALTH PHYS MAY-82 PROCESS 04/30/89 03/31/89 07/31/89 PLACE C.

SCHULINGKAMP 1N ECD ECD ECD MATERNITY HEAL H PHYS Nov-87 PROCESS 04/30/90 10/31/89 04/30/90 LEAVE J.

G ESICK IN PASSED APPROVED ECD IN SEN OR HP JUL-88 PROCESS FRSS 01/11/89 04/30/89 PLACE J.

JCUSTRA COMPLETED PASSED APPROVED APPROVED IN HEALTH PHYS APR-84 05/01/88 02/17/87 01/11/89 PLACE i

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COSTELLO COMPLETED PASSED APPROVED SENIOR HP JAN 77 02/27/78 NA 04/04/86 NA L.

FPIEDMAN COMPLETED PASSED APPROVED SENIOR HP JAN-77 01/10/78 NA 10/22/87

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.' E N S E N COMPLETED PASSED ECD ECD IN HEALH PHYS AUG-85 02/14/89 03/31/89 09/01/89 PLACE T.

OBERG REG lil GRAND ECD TBD IN HEALTH PHYS AUG-84 03/05/76 FATHERED 08/01/89 PLACE R.

PROVENCHER IN ECD ECD ECD IN HEAL'4 PHYS SEP-88 PROCESS 10/01/89 01/01/90 07/01/90 PLACE 5.

RAJENDRAN IN ECD ECD ECD IN HEA._~H PHYS MAY-87 PROCESS 04/30/89 06/01/89 06/01/90 PLACE E. UL_ RICH COMPLETED PASSED ECD ECD IN HEALTH PHYS MAR-87 02/16/89 03/31/89 09/01/89 PLACE V.

W'cLACE IN ECD ECD ECD IN H[AL~H PHYS MAR-87 PROCESS 04/30/89 06/01/89 06/01/90 PLACE l

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OUALIFICATION STATUS - MATERIALS SECTION C 07-MAR-89 REPORT TO INSPECTOR ORAL LIMITED FULL IDP NAME REGION I JOURNAL BOARD LICENSING LICENSING J.

DAVIS COMPLETED PASSED APPROVED APPROVED SENIOR HP OCT-73 10/22/87 NA J.

PILLER COMPLETED PASSED APPROVED APPROVED IN HEAL H PHYS JUN-84 11/28/88 10/22/87 PLACE d

T.

T-OMPSON IN ECD APPROVED APPROVED IN HEAL H PHYS JAN-84 PROCESS 04/30/89 10/22/87 PLACE R.

LADUN IN ECD ECD TBD IN HEALTH PHYS OCT-82 PROCESS 05/31/89 06/30/89 PLACE I

D. CCLLINS IN EXCEPTED ECD TBD IN HEAL H PHYS SEP-81 PROCESS FRPS 12/31/89 PLACE j

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RKWOOD IN PASSED ECD TBD IN HEAL-d PHYS OCT-88 PROCESS FRPS 12/31/89 PLACE M.

%ARELA IN ECD ECD TBD IN HEAL H PHYS Nov-80 PROCESS 06/30/89 06/30/89 PLACE M.

TAYLOR COMPLETED PASSED ECD ECD IN HEAL H PHYS JAN-84 01/12/89 06/30/89 01/31/90 PLACE I

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UMTED STATES f

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LEGON i

,e 478 ALLENDALE ROAD KING OF PRUSSIA, PENNSYLVANIA 19406 JAll 191989 MEMORANDUM FOR:

Stewart D. Ebneter, Director Division of Radiation Safety and Safeguards FROM:

James H. Joyner, Branch Chief Nuclear Materials Safety Branch, DRSS

SUBJECT:

CRITERIA FOR DELEGATION OF AUTHORITY TO SIGN LICENSES TO HEALTH PHYSICISTS IN THE NUCLEAR MATERIALS SAFETY BRANCH Qualification and training for materials license signature authority is divided into two phases.

The first phase covers those types of licensed programs which-are implicitly simple or for which detailed, clear guidance has been provided by NMSS. The final phase covers more complex programs for which there are larger variations in activities, there is less specific guidance provided or tnere are unique technical issues.

The minimum criteria for demonstrating the competency to sign licenses are specified for each phase in the enclosure.

W ames H Joyner Chief Nuclear a* rials Safety Branch, ORSS

Enclosure:

As stated

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MINIMUM CRITERIA FOR SIGNATURE AUTHORITY Phase I Demonstrate adequate knowledge of the use of NMSS Standard Review Plans, the administrative procedures for materials licensing and the purpose and format of NRC Form 374, " Materials License," by competently completing three full application reviews in each of the following five categories:

1.

Nuclear medicine (02120, 02121, 02210, 02220) 2.

Small laboratory research and development (02400, 02419, 03620) 3.

Portable gauges or plutonium / beryllium neutron sources (03121, 21320,22120) 4 Fixed gauges or self-contained irradiators less than 100 curies (03120,03510) 5.

Gas chromatographs, leak test services, survey meter calibration services, or civil defense calibration sets (03122, 03123, 03124, 03220, 03221, 03222, 03223, 03224, 03710)

Phase 11 Demonstrate adequate knowledge of NRC regulations, complex materials programs, NMSS policy and guidance and safety issues by competently completing three full a; plication reviews in each of the following five categories:

1.

Teletherapy, in air i-radiators or general license distribution (02300, 03521, 03240, 03:41, 03242, 03243, 03244) 2.

Industrial radiography or well logging (03110, 03111, 03112, 03113, 03310,03320) 3.

Broad scope research (academic, medical, or industrial) (03610, 03611, 03612, 03613) 4.

Nuclear pharmacy, waste disposal service, or nuclear laundry (02500, 03231, 03231, 03232, 03233, 03234, 03218) 5.

Pacemaker, source material, or special nuclear material Ccmpetency will be determined by review of completed deficiency letters and licenses either by the Section Chief or appropriate Senior Health Physicist.

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%4 UNITED STATES NUCLEAR REGULATORY COMMISSION

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4M ALLEN 0 ALE ROAD KING OF PRUES4A,PENNEYLVANIA 19408 FEB. 271989 MEMORANDUM FOR:

Richard E. Cunningham, Director Division of Industrial & Medical Nuclear Safety, NMSS FROM:

Stewart D. Ebneter. Director Division of Radiation Safety and Safeguards, RI

SUBJECT:

REGION I INITIATIVES TO ADDRESS PROBLEMS AT MEDICAL FACILITIES During my brief tenure in this position, I have been surprised at the lack of importance medical licensees appear to attach to understanding and following NRC rules and regulations.

In particular, the failure of physicians to accept their responsibilities and perform their duties as Radiation Safety Officer (RS0) appears to be the rule rather than the exception.

The problems have most sharply been brought to my attention by several recent inspections of new nuclear medicine or nuclear cardiology private practices.

Our findings at five such facilities are summarized in the attached table.

Every private practice facility that we have recently inspected soon (within three weeks) after initiation of operations is on this list. We are forced to conclude that the majority of physicians starting up apparently highly lucrative imaging practices are willing to tolerate lack of equipment, lack of quality assurance testing, lack of an RSO's review of readiness and lack of-t training in order to start patient services as rapidly as possible, i

The RSO in each case was either a physician-user or a nuclear medicine i

pnysician who agreed to let his name be submitted so that a cardiologist-owner cou'd qualify for a license.

In no case, did the RSO attempt to establish the readiness of the facility to initiate operations nor did the RSO object to startup without required equipment or instrumentation calibration.

In an effort to better ensure that private medical practice. licensees are ready to begin licensed activities, Region I has initiated a trial program to verify that all necessary radiation safety requirements have been satisfied prior to allowing these licensees to treat patients.

The basic process will involve implementation of the following licensing procedures:

1.

Upon completion of the routine license application and review process, i

the licensee will be issued a license specifically authorizing only the possession of calibration and reference sources as described in 10 CFR 35.57. This will allow a licensee to obtain and use the reference sources r.acessary to ensure that dose calibrators and radiation survey equipment are perfonning adequately. A condition in the license will specifically prohibit the administration of licensed radioactive materials to patients.

(Sample license enclosed)

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The licensee's radiation safety officer will be required to telephone Region I and to certify that all radiation safety program requirements have been met and that the program is ready to possess and administer radioactive material to patients (see enclosure to be sent with the license). A questionnaire (enclosed) has been prepared for use in questioning the RSO regarding the program status.

3.

Upon receipt of the RSO's telephone certification that the program is ready to receive and use radioactive material, a materials health physicist will be dispatched to verify the program's readiness (and to validate the information contained in the questionnaire). A license amendment will be signed and issued at the end of the inspection authorizing the licensee's requested activities, if the program is found to be ready.

It is hoped that as confidence in the questionnaire (as a means of validating readiness) is established that the on-site visits can be reduced, or eliminated.

In an ef fort to ensure that RSO's are aware of their responsibilities, Region I has also initiated a policy of sending every medical license to the RSO and including a copy of the enclosed " Notice to Radiation Safety Officers" with this copy.

i Y ' U4 :s il tewart D. Ebneter Director Division of Radiation Safety and Safeguards, RI Enc 1csures:

1.

Table of Findings i

2.

Sample License 3.

Enclosure for Sample License (CAUTION) 4.

Checklist 5.

Notice to RSO's cc:

O. Collins, RII C. Norelius, RIII R. Bangart, RIV R. Scarano, RV J. Austin, NMSS a

1

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LICENSEE FIIIDINGS h

NAME h5urverMeter Failure to " ~ ; Failure of R50ifAilure to lFatIule to lFatture to Failure to k

icheck source

perform Dnme

to implement

possess l maintain leak ! maintain Dose ' train 1

LICENSE RO.

not possessed : Calibrator Radiation,,

required

test records : Calibrator

. employees ichech.not

teste prior

Safety Program:Su rvey

test recorde !

performed

to patient use l Instruments

10CFR35.51(c) : 10CFR35.50

10CFR35.21

10CFR35.220 : InCFR35.59

10CFR35.50

10CFR19.12 l

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James S. Chen.MD X

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e 29-28273-01

Dele Edlin. MD X

X X

X I

I 129-28041-01 l_

!Fertis.Lonnita lBlumberg.Lauer.MDe X

X I

29-28186-01 e

Jeffror Weisman.MD :

I X

I I

X I

137-28291-01 t

Christian Chinwuba.:

MD X

X X

X I

X 108-28277-01 k

Licensee was identified and agreed t o stap nettwittas before patienta dosed i

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License No. 29-28330-01 Docket No.

030-30943 Control No. 110056 North Jersey Nuclear Diagnostic, Inc.

ATTN: David E. Cohen, M.0.

Radiation Safety Officer 1031 McBride Avenue West Paterson, New Jersey 07424 Gentlemen:

Please find enclosed your NRC material license.

Please review the enclosed document carefully and be sure that you understand al'. concitions.

If there are any errors or cuestions, please notify the Region I Material Licensing Section, (215) 337-5239, so that we can provide appropriate corrections and answers.

Please be advised that you must conduct your program involving licensed racioactive materials in accordance with the conditions cf your NRC license, re:resentations made in your license application, and NRC regulations.

In particular, please note the items in the enclosed, " Requirements for Materials Licensees."

This license is being issued in two stages. Please note that this license autnerizes possession of reference standards identified in 10 CFR 35.57

)

only. You are not yet authorized for byproduct material to practice nuclear mecicine.

Refer to the colored enclosure for further details and instructions.

Sir:e serious consequences to employees and the public can result from failure to comply with NRC recuirements, the NRC expects licensees to pay meticulous at.ention to detail and to achieve the high standard of compliance which the NR ex;;:ts of its licensees.

Yee will be periodically inspected by NRC. A fee may be charged for inspections in accordance with 10 CFR Part 170.

Failure to conduct your i

program safely and in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in prompt and vigorous enforcement action against you.

This could include issuance of a notice of violation, or in case of serious i

viciations, an imposition of a civil penalty or an order suspending, modifying i

or revoking your license,as specified in the General Policy and Procedures for NRC Enforcement Actions,10 CFR Part 2, Appendix C.

~..

W Nsrth J2rsey Nuclear Diagnostic, Inc.

2 We wish you success in operating a safe and effective licensed program.

Sincerely, JohnLE. Glenn, Ph.D.,_ Chief Nuclear Materials Safety Section A Division of Radiation Safety and Safeguards Enc;osures:

1.

License No. 29-28330-01 2.

Requirements for Materials Licensees 3.

Notice for Medical Radiation Safety Officers 4.

NRC Forms 3 and 313 5.

10 CFR Parts 2, 19, 20, 35, and 170 6.

Regulatory Guides 10.8 7.

NRC Form 473 - Diagnostic Misadministration Report 8.

Caution - Limitations of Use i

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MATERIALS LICENSE Punuant to the Atomic Energy Act of 1954, as amended the Energy Recrganiz.ation Act of 1974 (Public Law 93 -438), and Title 10.

Code of Federal Regulations. Chapter 1. Parts 30,31. 30. 33,34. 35,40 and 70, and m rehance on sta heretcfore me.de by the bcensee. a heense is hereby tssued authonzing the beensee to receive, acquire, possess.and tr source. and special nuclear matenal designated below, to use such matenal for the purpose (s) and at the place (s) designate I

cehver or transfer such matenal to persons authonted to receive it m accordance with the regulations of the appheable Part(

l bcense shall be deemed to contam the co-ditions specified m Section 183 of the Atomic Energy Act of 1954, as amended, and is sub.iect to :D apshcable rules, regulations and orders of the Nuclear Regulatory Commisuon now o1 c:ndittorts specificd below 1

Lcensee l

1-North Jersey Nuclear Diagnostic, Inc.

3. Ucense number 29-28330-01 2-1031 McBride Avenue Scst Paterson, New Jersey 07424

4. Expiration date March 31,1994 l

l 5. Docket or 030-30943 i

Reference No p

e kprocu ".. source. and or

7. Chemical and/or physical B. Maximum amount that beensee M

specsal nu.:}eas matenal form P

may possess at any one ttrne i'

under this hcense A. Any byprcduct material A. Any byproduct material A. Total possession liinits authorized under paragraphs (including sealed sources) not to exceed individual 35.57(a), (b), (c) and (d) identified in paragraphs amounts as specified in fi of 10 CFR Part 35.

35.57(a), (b), (c) or (d) in paragraphs 35.57(a).

p of 10 CFR Part 35, that (b), (c) and (d) of t(p has been manufacturea, 10 CFR Part 35.

labelled, packaged and j

distributed in accordance E

with the requirements of

'f 10 CFR 35.49(a).

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Autnorized use G

A.

Non-human use.

For calibrations and checking of instruments.

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Location of use:

1031 McBride Avenue, best Paterson, New Jersey 07424 id 1

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Radiation Safety Officer: David E. Cohen, M.D.

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12.

Authorized User (s):

Material and Use(s):

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Davic E. Cohen, M.D.

Reference sources including sealed sources u

Laterence k' einstein, M.D.

F.eference sources including sealed sources b

Michael Green, M.D.

Reference sources including sealed sources h

Authur Siegel, M.D.

Reference sources including sealed sources j

Glenn Ross, M.D.

Reference sources including sealed sources

,a Surekha D. Khedekar Reference sources including sealed sources l'

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MATERIALS UCENSE 29-28330-01 j

SUPPLEMENTARY SHEET 030-30943 g

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I (Continued)

CONDITIONS f

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13.

Licensed material shall not be used in or on human beings.

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14 This license is based on the licensee's statements and representations listed below:

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A.

Application dated December 21, 1988 I

B.

Letter dated January 27, 1989 l

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For the U.S. Nuclear Regulatory Comission Cate By I

Nuclear Materials Safety Branch Region I p

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'IHIS LICDGE CHLY PERMTIS DE iwrMICH NO USE OF CALIBRATICH AND REFE SOURCES AS SPEuru.u IN 10 CFR 35.57. 10 N9CN CR USE OF DIM 20STIC OR

'DiERAPUJrIC RADICACTIVE MAIERIAL FM PAIIDC SIUDIIS CR 1REAIMDR IS NJDD IZED !!

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IN ORDER 'IO EE AUIHORIZED TO FNM AND USE DIAGiTTTIC OR DERAPHJrIC ACTIVE EM YCU MJSr FULFIII DE FCII.DiDC REU3RDOCS:

i 1.

TAKE DELIVDtY OF MO TEST ALL Fewsw SAFETY KUIINE2C, DiCIIJDDG DOSE CALIBRAIM(S) AND RADIATICN/CDiIAMINAIIGi SURVEY KUIINDE.

2.

CI:MPIETE AND DGITIVIE AIL REUJIRED RADIATICN SAFIIY PROCEDURES.

3.

CCHPIETE 'IPADiDC OF TECHNICAL AND MCIIIARY STAFT AS dm.aru.v TICN 19.12 OF 10 CFR PART 19 AND IN I3IX 8 OF YOUR APPLICATICN.

4.

HAVE YCUR RADIATIQi SAFETY OFTICER uxurY 'IU UUS OFTICE T CUIRDENIS HAVE.EEDI MET AND THAT YOUR NOCIEAR MEDICIN

'IO RECEIVE AND USE RADIQACTIVE MAIERIAL IN ACCCFOVCE WI MDiTS OF DIE NRC'S REDUIATICtG AND YOUR LICDGE.

UFCN lOTIFICATICN UfAT YOUR PPOGRAM IS READI IDR NOCI.DR M TO YCLH LICDGE MJIHORIZDG 'DE USE OF 1HE PADIOF FOR PATIDC SIUDIES CR TREAIMDE.

~~FE U!WJDORIZID USE OF RADIOACTIVE MAIDUAL CR DE FAIIL FADICACTIVE MATIRIAL IN ACCDRDUiCE WTIH NRC REGUI.ATICNS, DE CDOITICNS O YCUR LICDGE OR DE i<.t.ne;5tzfIATICtG IN YCUR APPLICATICN MAY RESULT Di T PDSITICH OF SANCTICtG, INCEL'DDG M2ETARY CIVIL PDE"'IIs AND DE ISSUANCE CRDERS SUSPENDDG OR RD/OKDG YOUR PRIVrTM 10 IOSSISS M VATERIAL.

l i

MEDICAL LICENSEE READINESS VERIFICATION CHECKLIST Licensee:

Docket Number:

License Number:

Describe licensee training of techs:

duration:

Describe licensee training of other staf f:

duration:

Has the radiation safety officer reviewed the program and procedures and concurrred that it is completely ready for the commencement of licensed activities?

Describe R50's role in program:

Cate dosimetry received:

Supplier:

Vn:le Body?

Extremity?

Exchange frequency?

Check source for measurement instrument?

Measured at calibration?

Che:k source for detection instrument?

Measured at calibration?

Describe equipment for wipe sample analysis:

Des: ribe available radiation safety equipment (gloves, lab coats, tongs, etc.)

Check sources for dose calibrator Isotope Activity Manufacturer Mocel Date dose calibrator delivered:

Cate of dose calibrator accuracy test:

Results:

Date of dose calibrator linearity test:

Results:

Date of dose calibrator geometry test:

Results:

Date of dose calibrator constancy test:

Results:

Reviewer Date h

m

NOTICE TO MEDICAL 4ADIATION SAFETY OFFICERS The duties of the Radiation Safety Officer are detailed in Section 35.21 of Part 35 of Title 10, Code of Federal Regulations.

These duties include responsibility for the establishment, collection and implementation of written policies and procedures, presenting yearly management briefings, reviewing records and personally signing specified records.

You should immediately assure that you are aware of the requirements in both the NRC regulations and in the procedures you have established and submitted to the NRC for review as part of the license application.

The NRC expects that you will be the primary person responsible for safe use of radioactive materials at your facility and will assure compliance with our regulations.

To aid you in the performance of your duties, we have highlighted some of the changes which occurred in Part 35 when it was totally revised on April 1,1987.

1.

The rules in Part 35 may conflict with a licensee's currently approved radiation safety program.

If the license was approved by the Commission before April 1,1987 and has not been renewed since April 1,1987, the license requirements may take preceoence, as provided in 10 CFR 35.999.

2.

Ministerial changes, that is, minor changes in radiation safety procedures that are not important to safety, are limited to the changes detailed in 10 CFR 35.31 and to the adoption, by your organization, of NRC Regulations or NRC Regulatory Guide model radiation safety procedures.

Changes other than these will require license amendment.

[35.31]

3.

All licensees, irrespective of license issue date, are authorized to make minor changes in their radiation safety procedures, provided the admin-istrative review and record keeping requirements of 10 CFR 35.31(b) are met.

All ministerial changes must comply with this section.

[35.31(b)]

4.

The diagnostic misadministration form has been iss~ued as NRC Form 473.

In the abstract section of this form, please include your calculated organ and/or whole body dose estimations.

[35.33(c)]

5.

In the event a diagnostic misadministration involves radiation to the wrong patient, the controlling factor for NRC notification is ".. an organ dose greater than 2 rem or a whole body dose greater than 500 millirem." [35.33(c))

6.

Regardless of whether a misadministration requires NRC notification, records must be prepared for all misadministrations and retained by the licensee for NRC review.

[35.33(d)]

7.

All medical uses involving imaging and localization, radiopharmaceuticals for therapy, and brachytherapy require possession of a detection survey instrument capable of detecting dose rates from 0.1 millirem per hour to 100 millirem per hour and a portable radiation measurement survey instrument capable of measuring dose rates from 1 millirem per hour to

2

'O 1000 millfrem per hour.

One instrument may satisfy both requirements if the instrument has scales from 0.1 to 1000 millirem per hour and the instrument can be shown to be energy independent over the entire range of energies encountered or if correction factors are available to compensate for the energy dependence.

[35.220,35.320,35.420]

8.

A dedicated check source must accompany survey instruments at the time of calibration and must be used to check the survey instrument for proper operation each day of use.

[35.51) 9.

The permissible molybdenum-99 concentration is 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m.

[35.204]

The Part 35 revisions have consolidated all the essential radiation safety recuirements that were previously contained in regulations, license conditions, regulatory guides and staf f positions. All new and renewal licenses issued af ter April 1,1987, require that licensed material activities be conducted in accordance with the revised Part 35 regulations.

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Remorandum For:

Hugh L. Thompson, Jr., Dfrector Office of Nuclear Material Safety and Safeguards James Liebermen. Director Office of Enforcement From:

William T. Aussell

.)

Regional Adminfstrator, Region I

Subject:

POLICY ISSUES RELATIVE TO TRANSFER OF LICENSO ACTIVITIES IN THE MATERIALS PROGRAM I

My staff has

\\

small users, perceived an increasing tendency of licensees, both large and to terminate or, more frequently, transfer their ifcensed activities without abiding by the regulatory requirements of 10 CFR 30.36, and 30.41.

Two particular types of problems are involved:

1.

A licensee terstaates licensed activities These situations are usually detected long, after the fact, andbut does noti and the material often are not easy to locate. consequently, are 2.

new owner without notif.1 cation of the NRC.A licensee's bus Itcensed facility and transfer of the licensed mater location, or the assumption of Itcensed activities by a corporation not previously reviewed by the NRC.

As before, this situation is usually detected after the fact, and activities involving the use of RRC regulate material are already in progress.

While both of these problems have been expertenced by the NRC (in ca as the Pesses Company and the Safety Light Corporation), the latter situa recently has been more prevalent in Region I and we believe the-issue d increased attention.

The frequency of mergers, buy-outs the present economic environment, are matters which and enjorf ty stock n

regulatory prestse, i.e., that:

The NRC knows those who possess and use radioactive materials, has evaluated their capability and competency to handle such materfals; an these individuals have been made aware of their responstbflf ty to per licensed activities in accordance with the regulatory requfrements L

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of radioactive material is severely eroded when thi Such is the case when we do not have current knowledge of the specific corporate entities involved in licensed activities, and their consituent trs carry out the radiological safety program in accordance with the applicable requirements.

of corporations owning, controlling, or otherwise involved w activities is necessar decommissioning rule, y in onkr to effect regulation in accordance with the narclear sites.

and provide financial assurance for the cleanup of Though it is the licensee's responsibility to abide by the regulatory constraints and obtain written consent from the NRC prior to formally requirement 6nd our failure in the past to hold licensees a for compliance in this regard may be contributcrs to the failure to cceply e_xample, previously when such situations were detected, we usually attempt For resolve the matter as a licensing issue by requiring the transfuee to discontinue use of the reterial until the actinity had been authorized by en ICtC license.

While we may cite the successor company for unauthorized possession and use, or the predecessor company for unlawful transfer, we have not usually instituted enforcerent action relative to 10 CFR 30.34(b) once the immediate concern of licensing has been addressed.

licensees may not understand what information the Cornissior reouf res forFurth evrluation prior to consent to the proposed transference.

Consequently, me propose the following for consideration:

1.

advising them of their regulatory responsibilities in the ev with 10 CFR 30.34(b);the transfer of ownership or control of licensed acti 2.

Consider revising 10 CFR 30.34(b) to indicate the expected timefrare of notification, and describe the type of information required to be submitted; 3.

Revise the existing guidance (POLICY AND GUIDANCE DIRfCTIVE FC 86-2 PROCESSING MATERIAL LICENSE APPLICATIONS INVOL relative to evaluation of licensees' submittals.The current guidance presupposes that the agency is provided with tirely notification and stresses an evaluation of the nature of the transfer.

address determination of outstanding regulatory, safety, enforcement, or It does not cleanup issues involving the currently licensed company, or the technical and financial ability of the successor company to adequately perform licensed activities.

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4 Establish the policy that regardless of the resolution of Itcenstag matters in these cases, en,forcement of 10 CFR 30.34(b) is requ addressed.

If it. is determined that health and safety ceW1d have been compromised by failure to give prior notice to the Cammission. such violation should be considered for evaluation as Severity Level III an appropriate enforcement action initiated.

2 It is our intent to take action as described in this partievlar recossendation, as appropriate.

Me believe that this issue is resoluble only if a very clear and consi message is p only worsen.rovided by the Commission.. If not addressed, this situation can offices and the NMSS technical staff.In an effort to assure that ou 4

be held in Atlanta, Georgia, Januarythis matter as an agend 10-11, 1989.

p to Safety Section C (346-5102).Our staff contact for this matter is John Orte' 23 si p s 37

" '1Tiam T. ushli WI Regional Adnfaistra' tir " ~ ".-:T~. y;: ' c. 6N. '

cc:

8egional Administrators (RII. RIII, RIV. RY)

V. Miller, GPA/SLITP W. Parler, OGC S

RM e

'JJoyner WJohnston 12

/88 12/jh88 12/M/88

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d The following comments are in response to Question No. 7 TRANSPORTATION INSPECTIONS Inspections against modules 86740 and 86740A by the materials staff are as follows:

Staff Hrs Inspections Hrs /Insp.

FY88 159 324 0.49 FY89 thru 2/15/89 24 51 0.47 We have been unable to.atain information from the 766 system to answer the question about the most typically observed violations in the transportation area.

However, the NMSB staff believe the most common violations to be lack of a certificate of compliance, lack of shipping papers and lack of documen-tation on the certification of Type A packages.

__ __

ML20057A280

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