ML20153H660

Package of IE Insp Manual Procedures 83890,83822 & 92701 & Chapters 0330,2800 & 2820 & Outlines for Well Logging Insp Field Notes,Industrial & Academic Insp Rept & Limited Scope for Distribution to Specific Licenses Checklist

ML20153H660
Person / Time
Issue date:	04/10/1985
From:	NRC
To:
Shared Package
ML20153H361	List: IA-88-394, Package of IE Insp Manual Procedures 83890,83822 & 92701 & Chapters 0330,2800 & 2820 & Outlines for Well Logging Insp Field Notes,Industrial & Academic Insp Rept & Limited Scope for Distribution to Specific Licenses Checklist ML20153H358 ML20153H660
References
FOIA-88-394 NUDOCS 8809090282
Download: ML20153H660 (117)

Text

O j#' "8 4

• UNITED STATES

\  ; NUCLEAR REGULATORY COMMISSION 2

j WASHINGTON. D. C. 20%5

/

NRC INSPECTION MANUAL itp3 INSPECTION PROCEDURE 92701 FOLLOWUP h// W O PROGRAM APPLICABILITY: 2500, 2511, 2512, 2513, 2514. 2515 2525 2545, 2600, 2000 92701-01 INSPECTION OBJECTIVE To ensure that followup inspection is perfonned for the items listed below: R

a. Unresolved Items,

b. Open Items,

c. Information Notices and Bulletins. R

d. Headquarters and Regional requests,

e. Other Followups.

92701-02 INSPECT!0h REQUIREMENTS 02.01 Unresnived Item Followup. Evaluate the followup of Unresolved Items with respect to the following:

a. Status of resolution,

b. Quality of resolution,

c. If unresolved, the cause of delay, effort expended to resolve, and estimated resolution data.

02.02 Open Iten Followup. Evaluate the followup of open items with respect to the following:

a. Statu; of completion,

b. Expediency of completing the oper, item,

c. Effectiveness of completion, l

8909090202 000016 i PDR FOIA ,

KUROWSK00-394 PDR

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02.03 Followup of Information hotices and Bulletins Sent For Infomation. R

a. On a sanpling basis, verify the effectiveness of the licensees program R for responding to infomation Notices (ins) anc' Eulletins sent to the R licensee. Verify the licensee performance of the following actions: R

1. IN and Bulletin review for applicability. R

?. Proper IN and Bulletir distribution to the appropriate personnel R at the corporate and site levels.

3. If applicable, the scheduling or performance of appropriate '

corrective actions,

b. Suvmit proper feedback if the licensee's action or inaction appears R inappropriate, and the area of concern relates to matters not covered R by NRR requirements. R 02.04 Headquarters or Regional Requests Followup. Take actions es appropriate to followup and complete Headquarters or Regional requests.

92701-03 INSPECTION GUIDANCE 03.01 General Guidance

a. 1. This procedure encompasses the follovup of items applicable to all phases of the inspection program with the exception of those items already detemined to be a violation or deviatien (IP 92702), non-routine events, and those items whose performance is required by confimatory action letters (IP 9?703). R

2. Fcr items resulting from previous inspection effort, followup performed using this procedure shall be reported under the module number of the procedure in which the item was initially identified. Any other followup effort conducted utilizing this procedure shall be reported under module number 92701.

) b. The periodicity for the perfomance of these followup itens varies, depending upon the nature of the item. The followup periodicity shall be as follows:

1. The followup of INS and Bulletins sent for inforration should be performed within a year of the date f their issuance and annually thereaf ter, until the applicable followup actions are complete. The inspector shall follow up at least five Bulletins or ins on an ongoing , basis to ensure proper licensee .

attentiveness to the infomation presented. The dccuments l selected should consist of those which affect safety or safety-related systems. The inspector should ensure that all of the various stages of licensee response to the infomation (e.g., engineering disposition or corrective action provided schedulingardimplementation)areevaluatedannually.

Issue Date: 04/05/PP 9?7C1

2. Unresolved and open inspection items shall require followup soon af ter they are identified.

Effort should be made to minimize the time needed to closeout these items. It is recogni:ed that followup time for these items is dependent upon the cooperation and effort expended by the licensee.

3. The followup of all other items included in this procedure shall be performed strictly on a when required basis, at the discretion of the inspector.

03.02 Specific Guidance

a. Inspection Requirement 02.01

1. An unresolved item is a matter about which more infomation is required in order to ascertain whether it is an acceptable item, a deviation, or a violation. R

2. Although a problem ray not exist, the matter shall be resolved R to the extent that the inspector can determine that the facility R will not be operated in an unsafe manner before leaving the site. R .

3. Upon detemination of whether an item is a deviation or violation, followup shall be cnntinued through implementation of IP 92702.

b. Inspection Requirement 02.02. An open item is a matter that requires further review and evaluation by an inspector. It is used to document, track, and ensure adequate followup on matters of concern to the inspector.

Open itens dealing with Confimatory Action Letters shall be followed R in compliance with IP 92703. R

c. Inspection Requirement 02.03. Neither a Bulletin issued for information nor an Information Notice reouires a response from the licensee or construction permit holder. For these infomation documents received by the licensee, the inspectur should verify that an adequate review was conducted by the licensee in accordance with its procedures, to detemine applicability to the facility. P

When & licensee or construction permit holder finds that the infoma-tion is applicable to the facility, the inspector should review the actions taken or planned by the facility. These actions may be corrective or preventive in nature and may include such actions as infoming the plant operating staff, training, procedure revition, design review, safety evaluation, or change to the facility. The actions should be reasonable and appropriate to the substance of the <

infomation documents.

Due to the inforcational nature of these documents, a "no followup" action on the part of the licensee may be acceptable to the FRC. If the licensee's or pemit holder's action or inaction appears in-appropriate, the matter should be pursued ie accordance with the feedback process described in FC 2500.

92701 3 Istua Nte: 04/05/FF

90701-04 -

REFERENCES IE Nanual Chapter (MC) 0610. "Inspection Reports."

IE Panual Chapter (MC) 0720 "NRC Office of Inspection and Enforcement Bulletins and Information Notices."

., END Issue Date: 04/05/8F t- 92701

.1,,,

f. ~%An UNITED STATES f NUCLEAR REGULATORY COMMISSION 5  !

OFFICE OF INSPECTION AND ENFORCEMENT C

'g . . . . . j Washington, D.C. 20665 INSPECTION AND ENFORCEMENT MANUAL DI tutoreTinn onnrrnaar nupp RADIATION PROTECTION PROGRAM APPLICABILITY: 2600, 2800 83822-01 INSPECTION OBJECTIVE To determine whether the licensee is complying with regulatory requirements related to radiation protection, and to evaluate the adequacy of certain aspects of the licensee's radiation protection program.

83822-02 INSPECTION REQUIREMENTS 02.01 Radiation Protection Procedures. Verify that changes in the radiological protection procedures made since the last inspec-( 02.02 tion are consistent with regulations and license requirements.

Instruments and Equipment. Verify that radiation protection instruments and equipment are operable, have the proper alann settings (if applicable), and are calibrated in accordance with license requirements and licensee procedures.

~

02.03 Exposure Controls

a. External Exposure. Deterinine compliance with the following regulatory requirements:

1. 10 CFR 20.202(a) (personnel monitoring)

2. 10 CFR 20.101(a) (permissible doses)

3. 10 CFR 20.101(b) (extended pertnissible doses)

4. 10 CFR 20.104(a) (exposure of minors)

5. 10 CFR 20.102 (exposure history)

6. 10 CFR 20.401(a) (exposure records)

b. Internal Exposure. Determine compliance with the following regulations:

1. 10 CFR 20.103(a1(1) and (a)(2) (internal exposure limits) p Issue Date: 04/21/86

s

2. 10 CFR 20.103(a)(3) (air sappling and bioast my pro- I gram) l

3. 10 CFR 20.103(b)(1) (use of engineering controls)

4. 10 CFR 20.103(b)(2) (40-hour control measure and evaluations)

c. Respiratory Protection. For facilities with a respirator I protection program, in accordance with 10 CFR 20.103(c)y ,

i also determine compliance with the following:

1. 10 CFR 20.103(c) (certification by NIOSH/MSHA)

2. 10CFR20.103(c)(1)(selectionofequipment)

3. 10 CFR 20.103(c)(2) (maintenance, training, and fit-ting)

4. 10 CFR 20.103(c)(3) (policy statement re: routine, emergency,andrelief)

5. 10 CFR 20.103(c)(4) (special capabilities)

6. 10 CFR 20.103(d) (protection factors) 7, 10 CFR 20.103(e) (allowances of protection . a tors for unapproved equipment) -

02.04 Posting, Labeling, and Control

a. Posting and Labeling. Determine compliance with the fol-lowing regulations and license procedures:

1. 10CFR20.203(b)(radiationarea)

2. 10 CFR 20.203(c) (high radiation area)

3. 10CFR20.203(d)(airborneradioactivityarea) 4 10 CFR 20.203(e) (radioactive materials area)

5. 10 CFR 20.203(f) (container labeling)

6. Other posting and labeling requirements specified in the license nr licensee procedures

b. Control Deternine compliance with the following regulations, license requirements, and licensee procedures:

1. 10 CFR 20,203(c) (high radiation area access) s 83822

!ssue Date: 04/21/86 2

2. 10 CFR 20.207 (storage area)

3. Radiological Work Pemit system specified in license requirements or licensee procedures

4. Controls for radioactive, or contaminated areas and equipment specified in license requirements or licen-see procedures

c. Posting of Notices. Determine compliance with 10 CFR 19.11.

02.05 Surveys

a. Requirements. Determine compliance with the following regulations:

1. 10 CFR 20.201(b) (surveys)

2. 10 CFR 20.401(b) (survey records)

b. Leak Tests. Verify cornpliance with license requirements for leak testing of radioactive sealed sources.

4 02.06 Notifications and Reports

a. To the NRC. Deterinine compliance with the following regu-lations and license requirements:

1. 10 CFR 20.402 (loss or thef t of material)

2. 10CFR20.403(incidents)

3. 10CFR20.405(overexposure) 4 10 CFR 20.408 (terinination of work report)

5. Other radiation protection reports required by the license

b. To the Individual. Determine compliance with 10 CFR 19.13.

02.07 As low As is Reasonably Achievable (ALARA1 It should be clear R that the following does not establish icensee requirements, R unless the licensee has connitted to any such criteria in pre- R vious correspondence or unless imposed by license condition. R Paragraph 20.1(c) of 10 CFR 20 states in part that persons R engaged in NRC licensed activities should, in addition to com- R plying with regulatory requirements, make reasonable efforts to R maintain radiation exposures and releases of radioactive ma te - R

/

rials in effluents to unrestricted areas as low as is reasonably R

( achievable. During inspections: R 838?? 3 he+ h'e- o"'c'

o

a. Determine if high level management has made a comitment to R minimize exposure to workers and has clearly defined proce- R ,

dures and policies to implement the ALARA philosophy. R

b. Determine that licensee personnel are made aware of manage- R ment's comitment to keep occupational exposures ALARA. R

c. Ascertain that the radiation protection staff has been R given authority to make certain that ALARA policies are R carried out and that workers have been adequately trained R to understand the ALARA philosophy and how it should be R implemented at their work places. R

d. Determine that management and its designees perform peri .R odic audits to find out how exposures (both external and R internal)mightbelowered. Also determine that effluents R released are ALARA. R

e. Determine compliance with 10 CFR 19.12 with respect to R workers' understanding of radiation protection in their R work place, and how the training received includes an R understanding of ALARA as it pertains to the work place. R

f. Determine whether modifications to equipment and facili- R ties including procedures, have been made to significantly R '

reduce exposures at a reasonable cost. The benefits gained R should outweigh the cost of modifications. Also determine R if the licensee has considered the ALARA philisophy during R -

the engineering phase for changes in facilities, equipment, R or processes and whether an ALARA review was performed dur- R ing initial imp?ementation of changes. R

g. Determine if the R50 and radiation protection staff have: R

1. Identified the origins of radiation exposures by loca- R tion and job category and have noted trends in the R amounts of radiation at the locations. R

2. Considered ways to reduce exposures in those locations R where exposure to personnel are significant. R

3. Periodically reviewed operating procedures that affect R radiation safety and have made surveys of operations R to identify situations where radiation exposures can R be reduced. R

h. Determine if there exists a program in which workers can R make suggestions en radiation protection (feedback). R

i. Determine if adequate equipment and supplies are available R for radiation protection and procedures are available for R proper use of these supplies and equipment. R Issue Date: Oa/21/86 4 835??

e e

( 83822-03 INSPECTION GUIDANCE General Review of the licensee's HP log book or file on HP pro-blems may be useful to identify areas deserving special atten-tion. Particular attention should be directed towards identify-ing trends and ascertaining whether corrective actions were directed toward the cause end not merely the symptoms.

[ Regulatory Guides 8.8 and 8.10 may be discussed in terms of 1 providing useful guidance to the licensee regarding ALARA. If i the licensee has a documented comitment to ALARA, implementa-1 tion of the program should be discussed with management. With i respect to implementing ALARA comitments, citations will not be made for failure to achieve "limits" (or goals) that are more restrictive than regulatory requirements.

The licensee may have submitted certain of his radiation protec-tion procedures, or his radiation protection manual, along with the license application and, in some cases, those proced-ures or the manual may be incorporated into license require-ments. There are references to licensee procedures throughout this inspection procedure; however, this is not done for all inspection areas. The absence of a notation regarding licensee procedures is not intended to preclude the inspector from inspecting a given area against licensee procedures if there is an applicable license requirement.

03.01 Radiation Protection Procedures. Review all substantive changes to procedures which have been implemented since the last inspec-tion; verify that limits, precautions, controls, etc., specified in the procedures are consistent with regulations and license requirements.

03.0. Instrueents and Equipment

a. Randomly select instruments of each major type and examine them to verify operability and proper alarin settings, if alarm settings are applicable. These may include portable survey instruments, fixed monitoring equipment, constant air monitors, portable air samplers, film badges and TLDs, and pocket dosimeters,

b. Review the most recent calibration records of the instru-ment (s) selected for inspection to assure that the calibra-tion and surveillance program for these instruments are being accomplished in accordance with license requirenents or licensee procedures,

c. Yerify that the licensee has a system (a schedule, card file, etc.) which identifies all the instruments and iden-tifics when they are due for calibration or functional

( testing.

E38?? 5 !ssue Nte: 04/'1/U 1

d. Verify that the procedures used to calibrate the instW-ments selected above contain: review thd approval require- '

ments of the licensee's procedural system or lir,ense requirements, acceptance criteria including values for trip settings that conform to license requirements, if applic-able, and detailed stepwise instructions.

03.03 Exposure controls

a. External Exposure

1. Examine any changes made in procedures for control and use of personnel monitoring equipment; verify that limits, precautions, controls, etc., specified in the procedures are consistent with regulations and license requirements.

Examine the type of monitoring devices used, the period of use or exchange period, and the number used to determine if these aspects seem consistent with the monitoring program. Determine who the supplier is, and if the service has been changed since the last inspection, detennine the reasons for the change.

For pocket dosimeters or pocket chambers, determine when they are read and recharged, the number used, and ~

review the calibration procedure or leak test proce-dure. -

Evaluate the adequacy of the licensee's procedures or system for evaluating and using personnel monitoring data to control and minimize exposures.

2. Review reports of exposure sumaries generated since the last inspection to determine compliance.

3. Select all individuals who have current exposures in excess of 10 CFR 20.101(a) limits and verify that Form NRC 4 was completed prior to exceeding the 10 CFR 20.101(a) limit for each individual.

4. Determine, by discussion with supervision, if minors have been permitted to work in restricted areas and, if so, detemine compliance with 10 CFR 20.104(a) by review of exposure records.

5. Review all NRC Forms 5 to detennine compliance.

s issue Date: N/24/86 6 83822

o e O

b. Internal Exposure

1. During review of exposure evaluations in 03.03b4

.)

below, determine cog 11ance with the iMernal exposure limits.

i

2. Review randomly selected air sampling and utoassay records and independently verify airborne concentra-tions as appropriate.

3. By observation, discussion, and review of documenta-tion, verify that temporary engineering controls are considered and used to the er. tent practicable. Evalu-ation of fixed process and engineering controls will be performed by the Division of Licensing; the  ;

inspection program will evaluata the use of temporary engineering controls.

4. Review documentation of evaluations performed as the result of suspected overexposures or when the 40 MPC-hour control value was exceeded. Include verification of the following:

(a) Appropriateness of preventative measures institu-ted following an exposure greater than the 40 MPC-hour control value (b) Proper use of 25% and 5% MPC-hour exclusions

c. Respirator _y Protection

1. Determine tnat the equipment is certified by NIOSH/

MSHA

2. Determine proper selection of equipment.

3. Determine by review of records and discussions that a m&intenance and training program is conducted and that it is administered and conducted in accordance with written procLJures. Determine by review of records, discussions, and observations that respirator users are ir.dividually fitted for respirators and that respiratory equipment is operationally tested imediately prior to each use.

4. Randomly select several control requirements and deter.

mine compliance by review of records, discussions, or observation.

5. In the selection and use of respiratory protective

' equipment, the ALARA statement of 10 CFR 20.103(b)(2) is met by selection of equipment to provide a protec-

• \

tion factor greater than the multiple by which peak 83822 7 1ssue Date: 04/21/86

concentrations are expected to exceed the velues of Table 1, Appendix B,10 CFR Part 20.

03.04 posting. Labeling, and control

4. Posting and Labeling. Inspect representative areas to verify compliance; pay particular attention to "temporary" work areas that may be required for mairtenance activity.

4 etc.

Inspect a random sampling of containers in work or stor- .

age areas.

i b. Control

1. Randomly select high radiation areas to verify that access is controlled in accordance with regulations or license requirements.

2. Inspect areas where radioacti.- wtorial is located i or stored in an unrestricted arw.

3. Review a random selection of RWPs'on file and those currently in effect.

4. Review a random selection of records and inspect work -

areas to determir,* compliance with controls.

c. Posting of Notices. Ontaine, by questiMing of manage-ment, how the licensee complies with the requirements of 10 CFR 19.11; inspect bulletin boards or other places where

, notices are posted; question a few individuals to determine if they are aware of the posting of notices, l

03.05 Surveys

a. Requirements Verify that the licensee has established schedules for periodic surveys of work areas of the plant and facility site; verify that surveys are conducted using approved  :

procedures; review a random selection of survey records to .

see thet surveys are being performed according to sche- '

dules; and verify that the survey results are reviewed by appropriate supervision.  ;

i Verify specifically that schedule and procedural require- [

ments for surveys appear adequate to demonstrate compliance  :

with the following aspects of the regulations and with j pertinent license requirements.

s i

Issue Date: 04/21/86 8 838??

I

..- l l

1, 10 CFR 20.101 and 20.104 (permissible doses)

Determine whether due consideration is given to energy, beta exposure, and extremity exposure, and ,

whether neutron surveys are performed if appropriate.

2. 10 CFR 20.103 and 20.104 (exposure to airborne radio- i activity)

Determine whether both particulates and halogens are considered, if appropriate.

L

3. 10 CFR 20.203 (postedareas)

4. 10 CFR 20.105(b) (radiation in unrestricted areas)

b. Leak Tests. Inspect a random selection of records of leak i tests of radioactive sealed sources.

03.06 Notifications and Reports

a. To the NRC. The objective is to determine if the licensee L is reporting all the events and data required by the regu- i lations and the license. The inspector should have '

reviewed those reports submitted since the last inspection; I therefore, a determination should be made whether evtnts '

( have occurred which have not been reported. A discussion with management, operating pe rson.1el , maintenance, and health physics personnel, and review of RWPs, log books, and other data during the course of the inspection should aid in this determination.

For followup on the corrective actions taken by the licen-see as a result of reports, see Inspection Procedure 90826, Followup Nonroutine Events,

b. To the Individual. Determine by discussion with indivi-3uals selected at random (identified during the course of j

inspection of other requirements) whether they were noti-j fled in accordance with 10 CFR 19.13.

i 03.07 General. For fuel facilities. ALARA programs are part of the R license application. The programs are audited periodically and R the results reported to the Radiation Safety Comittee for R acticn. However, for materials licensees there may be very R active ALARA programs for the higher inspection priorities that R are identified in the license applications or license condi- R tions, for lower p iority licensees (V, VI. Vll), limited ALARA R programs may exist; for priorities VI and Vil, ALARA programs R may be nonexistent. R

! The depth of the ALARA programs will depend on the cuantities of R

i. radioactive t sterials possessed and used, a.'d whether the poten- R tial for radiation exposures can be significant. On the other R 838?? 9 Issue Date: 04/I1/C6 i

hand, licensees such as users of gas chromatographs my have no R ALARA program at all because radiation exposures are insignifi- R cant. The following guidance should be used as applicable or at R the inspector's discretion. R

a. Facility personnel should be u de aware of management's R comitment to keep exposures to workers ALARA. The cossnit- R ment should appear in policy statements, instructions to R pe rsor.nel , and similar documents. As a minimum, workers R should be familiar with the ALARA comitment so that they R can explain what the comitment is, what ALARA means, why R it is recomended, and how they have been advised to imple. R ment it on their jobs. Examine a selection of policy stan- R dards and instructions (if they exist) and interview R workers to determine if they understand the ALARA philo- R sophy and what it means at the work place. R

b. As a minimum, management should be abic to discuss which R operating procedures were reviewed, in which locations R most exposures are being received, what groups of workers R are receiving the highest exposures, what discussions they R have had with the radiation protection staff or outside R consultants, and what steps have been taken to reduce expo- R sures. Examine a random sample of records and interview R personnel to determine what has been done to redu:e expo- R sures. '

R

c. No guida9te.

d. No guidance,

e. Radiation workers should understand how radiation protec- R tion relates to their job and should be tested on this R understanding at least annually, or as otherwise stated in R the license application. Training should be sufficient to R .

ensure that workers can correctly answer questions on radi- R ation protection as it relates to their jobs. Interview R workers (consistent with the size of the program) to deter- R nine if the workers understand radiation protection as it R relates to their jobs and if they have an opportunity to R discuss radiation safety with the radiation protection R staff. R

f. Inquire if modifications have been mde to facilities and R equipment to reduce exposures. Randomly examine any proce- R dures or records that reflect modifications and att$mpt to R determine the extent of the benefits gained through Wdifi- R cations (forexample, modifications may have been benefi- R cial if exposures of 50 mrems/ hour were reduced by a factor R of 10 or 5 mrems/ hour, it may not be beneficial to reduce R 1 r. rem / hour to 0.1 mrems/ hour, considering cost and risk. R in both of the above exarrples, consideration nust be given R to costs of nodification and risk to the population). R -

Issue Date: 04/21/86 10 83822

g. Examine Radiation Cossiittee records or other records on R I

' (s A1. ARA policies to determine whether source ters surveys R have been conducted and actions taken to reduce significant R exposures. R

h. No guidance. R i

1. Examine equipment and supplies to determine if they ade- R quately protect personnel from unnecessary radiation. Such R

' equipment and supplies may include, but are not limited to. R decontamination supplies, survey meters, protective cloth- R ing, ventilation systems, air sagling equipment, and sup- R plies used for posting areas, such as radiation areas. R END i

t l

i l

i 83822 11 Issue Date: 04/21/85

, 1

. i Q am

\* UNITED STATES

NUCLEAR REGULATORY COMMISSION 5 0FFICE OF INSPECTION AND ENFORCEMENT Washington, D.C. 20066

• g

..... l INSPECTION AND ENFORCEMENT MANUAL DI J INSPECTION PROCEDURE 83890 CLOSE0VT INSPECTION AND SURVEY PROGRAM APPLICABILITY:

2600, 2800 83890-01 INSPECTION OBJECTIVE The objective of the procedure is to verify that a facility where licensed materials were used has been decontaminated to acceptable levels and to assure that the f acility will not present a radiation hazard to future occupar.ts.

83890-02 INSPECTION REQUIREMENTS Preliminary Review. Determine the scope of the licensee's pro-02.01 gram and the potential for site contamination.

02.02 Disposition of Materials

a. Confirm by inspection of records (inventory, transfer, dis-posal, etc.) and form NRC-314,"Certification of Disposition of Materials," that licensed material has been transferred to an authorized recipient, and/or

b. Verify by inspection of the licensee's facility that licensed material and radioactive / contaminated equipment, This materials, scrap, etc. are not being used or stored.reports should be done following receipt and evaluation of of the f acility's status as required by 10CFR 30.36, 40.42, and 70.38.

Surveys by Regional Offices. The NRC regional office will 02.03 ter-review each proposed retirement of expired, superseded, or minated license to determine the necessity of performing a closecut survey.

The review will be on a case by-case basis using the following criteria, following criteria do not

a. Those facilities that meet the requ re a confirmatory survey:

i has been conducted by th.

1. An adequate closeout survey licensee.

>\\

Issue Date: 04/10/E

43890:02.03a CLOSEOUT INSPECTION & SURVEY

2. Use has been limited to small quantities of radio R nuclides with half-lives of 60 days or less. R

3. The use of sealed sources only (if leak tests have R been <0.005 pCi). R

4. The use of limited materials that pose a very low risk R to public health and safety. R

b. Those facilities that meet the following criteria do R require a confirmatory survey: R

1. Use of unsealed radionuclides with half-lives in R excess of 60 days where significant residual contami- A nation is possible. R

2. A significant safety issue has occurred (for example R an enforcement conference and civil penalties durinj R the course of the license) other than licensees in R a.3. R

3. Politically sensitive issues, such as cases pending R before a hearing board, or other technical issues that R have been brought to the attention of the NRC by con- R cerned cit izens or elected public officials. ,

R

4. An adequate closeout survey has not been conducted by R the licensee. R 02.04 The Conduct of Confirmatory Surveys. Determine by performing a R survey that there is no residual radioactivity greater that the R criteria in Appendix A (attached) or that the contamination pre- R sent in the facility or in the environs does not pose a radia- R tion hazard to the public. This survey should include measure- R i ments for both fixed and removable contamination (as appropri- R t ate). If the potential for contamination exists outside the R facility, environmental samples should be taken. R l 02.05 Reports and Record <g

a. For licensees subject to the reporting requirements, verify by reviewing records and files that: ,

1. Personnel exposure and monitoring reports required by 10 CFR 20.407 have been submitted to the NRC for the calendar year in which the license has expired or is being terminated, and  !

2. Reports of personnel exposures for terminated employ-  ;

ees or employees no longer working with radioactive materials required by 10 CFR 20.408 and 19.13 have been submitted to both the NRC and the employee.

Issue Date: 04/10/85 2

O e <

CLOSE0VT INSPECTION & SURVEY 83890-02.05b

b. Determine what plans or arrangements have been made for preserving records required by 10 CFR 20.401(c).

02.06 Burial of Waste. Determine if waste has been buried on the site.

If burial has occurred, do the following:

a. Obtain information on the type and quantity of the mate-rials buried. Also identify the following: radionuclides, type of packaging, specific location of burial, depth and spacing used for bur al. Obtain iriformation on the planned d

use of the area after the license is terminated,

b. Conduct a surface survey to determine the radiation levels at the burial site,

c. Submit the information acquired under 02.06 a. and b. to R the HMSS licensing staff for final action. R 02.07 Final Inspection Report. Prepare a final inspection report in accordance with IE Manual Chapter 1005, which summarizes the actions taken under this inspection procr. dure and the findings and evaluations of the inspection staff. Submit the report to the licensing staff.

83890-03 INSPECTION GUL'1ANCE 03.01 No guidance 03.02 No guidance 03.03 No guidance 03.04 Conduct of Confirmatory Surveys R

a. Buildings, rooms, furniture, systems and equipment; venti-lation ducts, filters, sinks, drains, traps and sumps; overhead fixtures, walls and floors, etc. , should all be considered as areas to be surveyed. The number of the confirming measurements made by the inspector will vary with the magnitude of the potential for contamination and the thoroughness of the licensee's survey,

b. The number and type of samples collected for analysis will depend on the determination that a potential exists for facility and environmental contamination and on other find-ings; i.e., the material involved, extent of area affected, nature of media involved, etc.

c. "As appropriate" is determined on the basis of the poten-tial for environmental contamination and the inspector's professional judgment.

1 ',<~m., na /m /ct

r _ - - - - - - - - - - - - - - - _ . _ _ - - _ _ __

33890-03.04d CLOSE0VT INSPECTION & SURVEY

d. Radiation levels should be below those listed in the attached Appendix A, "Guidelines for Decontamination of Facilities and Equipment Prior to Release for Unrestricted Use or Termination of Licenses for Byproduct, Source or Special Nuclear Material." The guidelines in Appendix A should be made available and used by the licensee during decontamination and/or decommissioning. If levels exceed those listed in Appendix A, the licensee should demonstrate that reasonable efforts to decontaminate the facility do

- not result in an appreciable reduction in the radiation levels. If the radiation levels are greater than the accepted levels and the licensee had made a reasonable effort to decontaminate the facility, the licensing staf f should be consulted in determining an acceptable radiation level for release of the facility.

03.05 Reports and Records. Although certain licensees are not required to report personnel exposures, and the limitations of a license removes the legal obligation to maintain the records required by 10CFR 20.401(c), the licensee should be informed that retention of these records is highly recommended.

03.06 Burial of Waste. Information is required to determine whether long-tartn control of the area will be required. Radiation levels

- and geographical coordinates or other specific means of identi-ficatior, should be recorded on a map, diagram, photo, or other similar document.

03.07 Final Inspection Report. The final inspection report becomes the official certification of the disposal of licensed material.

The final inspection report forms the basis for retiring and eventually disposing of both the licensing and inspection files.

END t

.. . , , _ r..,r,u a

CLOSE00T INSPECTION & SURVEY APPENDIX A, 83890 APPENDIX A GUIDELINES FOR DECONTAMINATION OF FACILITIES AND EQUIPMENT PRIOR TO RELEASE FOR UNRESTRIC1ED USE OR TERMINATION OF LICENSES FOR BYPRODUCT, SOURCE, OR SPECIAL NUCLEAR MATERIAL July 1982 U. S. Nuclear Regulatory Commission Division of Fuel Cycle & Materials Safety Washington, D. C. 20555

-1 Itsua 0=te- Oa /lo / A5

83890, APPEN0lx A CLOSE0VT INSPECTION & SURVEY The instructions in this guide in conjunction with Table I specify the radionuclides and radiation expos are rate limits that should be used in decontamination and survey of surf aces or premises and equipment prior to abandonment or release for unrestricted use. The limits in Table 1 do not apply to premises, equipment, or scrap containing induced radioactivity for which the radiological considerations pertinent to their use may be differ-ent. The release of such facilities or items from regulatory control is considered on a case-by-case basis.

1. The licensee shall make a reasonable effort to eliminate residual con-tamination.

2. Radioactivity on equipment or surfaces shall not be covered by paint, plating, or other covering material unless contamination levels, as determined by a survey and documented, are below the limits specified in Table 1 prior to the application of the covering. A reasonable ef fort must be made to minimize the contamination prior to use of any covering.

3. The radioactivity on the interior surfaces of pipes, drain lines, or duct work shall be determined by making measurements at the traps, and other appropriate access points, provided that contamination at these locations is likely to be representative of contamination on the inter-ior of the pipes, drain lines, or duct work. Surfaces of premises, equipment, or scrap which are likely to be contaminated but are of such size, construction, or location as to make the surface inacces-sible for purpose of measurement shall be presumed to be contaminated in excess of the limits.

! 4. Upon request, the Commission may authorize a licensee to relinquish possession or control of premises, equipment, or scrap having surf aces i contaminated with materials in excess of the limits specified. This I may 'nclude, but would not be limited to, special circumstances such as rizing of buildings, transfer of premises to another organization contiauing work with radicactive materials, or conversion of facili-ties to a long-term storage or standby status. Such a request must:

a. Provide detailed, specific information describing the premises, eq.iipment or scrap, radioactive contaminants, and the nature, extent, and degree of residual surface contamination,

b. Provide a detailed health and safety analysis which reflect that the residual amounts of materials on surface areas, together with other considerations such as prospective use of the premises, equipment or scrap, are unlikely to result in an unreasonable risk to the health 6nd safety of the public.

I i

'L '

. (' b30 fa b /b hk k*

. l CLOSE0VT INSPECTION & SURVEY APPEN0!X A, 83890

5. Prior to release of premises for unrestricted use, the licensee shall make a comprehensive radiation survey which establishes that contami-nation i '. within the limits specified in Table 1. A copy of the survey report shall be filed with the Division of Fuel Cycle and Mate-rial Safety, USNRC, Washington, u.C. 20555, and also the Administrator of the NRC Regional Of fice, having jurisdiction. The report should be filed at least 30 days prior to the planned date of ahnndonment. The survey report shall:

a. Identify the premises,

b. Show that reasonable effort has been made to eliminate residual contamination,

c. Describe the scope of the survey and general procedures followed,

d. State the findings of the survey in units specified in the instruction.

Following review of the report, the NRC will consider visiting the facilities to confirm the survey.

i i

l 1

I i

l A-3 issue Oste: 04/10/85

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[**% '; UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON. D C 20%5

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\'.....'/ NRC INSPECTION MANUAL itRs CHAPTER 0330 GUIDANCE FOR NRC REVIElf Or LICENSEE DOClHENTS 0330-1 PURPOSE This chapter provides guidance for staff review and handling of itcensee draft dorunents which have been submitted to ilRC for review and comtrerit.

0330-2 OBJECTIVE The ebjective of this chapter is to ensure that a review or discussion of a licensee draf t document would not have a real or perceived appearance of impropriety.

0300-3 APPLICAh!LITY All NRC licersing and inspectiori staff reviewing licensee draf t documents during conduct of ar inspection er other review of documents subritted by the licensee to NkC officer sball corrply with the policy identified in this manual chapter.

0330-4 PJSIC RE0VIREMENTS 04.01 General. As a regulatory agency, the NRC staff has the obligation of overseeing licensee activities to ensure they are beirt; conducted safely ano in corpliarce with conditions cf e license and with the reculations and orders of the Comisticri. In the ccurse of cerducting regulatery activities, licensees roy request steff review are comet.t er draft licensee doeurnents before they are formally subritted to the agency. A review cr discussion of a dref t document by the NRC would be inapprepriate if the review wruld have the real cr perceived appearance of tr prepriety (such as where the staff member stept eut of the role of regulator and into the role of advisor) or of giving tvre of an aavantage to cre licensee than to another.

~

The decision whether it is , proper for the NRC to review a dratt of a particular licensee document sheuld be baseo solely _nn the re&d for the flRC to revieve the draf t ir carryino out its regulatory ebligatiens.

The policies containe;c in this chepter supersede all previous quidance on this subject.

04002 Specific Guidance

a. Any document obtained from a Itcensee which the licensee indicates is a draft, sheuld be clearly marked and handled as such,

b. It is the Cemission's policy to address all matters of safety in pub-lic.

Consequently, it is the Comission's policy generally that any document, including those labeled "drafts," considered by the staff in reachine a regulatory decision shculd generally be placed in the appro-priate docket file and the Public Document Room (PDR) unless the docu-ment labeled "drafts" falls within one of the exempt categories listed below.

c. Consistent with this chapter, NRC review of drafts of the follewing licensee, applicant, or vendor enforcement-related documents, would be impreper:

1. Licensee doeurents arguing that violations did not occur.

2. Licensee documents arguing the apprcpriateness of sanctions in-posed on iti e.g., civil penalties.

3. Licensee documents arguing whether or not an order should be im-posed.

4 Responses to 50.54(f) letters and similar requests for information specifically requested under cath or affirmation (excluding appro-priate technical licensing documents).

d. In other cases, an extrinatier of draft documents from a licensee, appiteant, or vendor which the NRC desires and which is in the interest of the hRC in carrying out its public health and safety responsibili-ties es contrasted to purely assisting the licensee, may be proper, included in this category are draft documents that:

1. Cculd assist 6n inspection er an assessment or corrective actions.

2. Could form the basis for a confirnatory order.

3. Could form the basis for a settlement agreement.

e. Labeled "draf ts" corsidered by the staff in reaching a regulatory de-cision shculd generally be placed in the appropriate docket file and the Public Oneument Room (PDR) unless the document falls within one cf the exempt categories listed in f belcw.

f. Categories exerpt from this general policy are:

1. Docueents or portions of decuments that fall within the exerpt categeries of 10 CFR 2.790 (e.g., propriatary information and in-vestigatory raterial). These should be placed in the appropriete docket file enly. If a proprietary document is involved, to the exttrt possible a non-proprietary version should be plbced in the PDR. However, if such a preprietary document is requested by the public. OGC shculd review the cetermination for proprietary treet-cent.

Issue Date: 10/21/E7 -I- 0330

2. Documents that resident insp;ctors ard others examine durino ensite inspection and oversight. In conducting an onsite inspection a substantial number of documents, including draf t documents, may have to be examined to provide background information regarding the facility. Placirg all such documents in the PDR would place an unnecessary burden on the agency, and might hamper the necessary flow of background information from the licensee to the inspectors.

For these reasons, the meterial need not be placed in the POR if the material does not leave the licensee's premises or is returned to the licensee upon completion of the inspection.

3. All draf t material relied upon by an inspector to prepare an ir-spection report or to make inspection findings must be retained by the inspector because a draft document by its nature may be changed or destroyed by the licentee., Draf t material retained for such purpose % must be placed in the appropriate docket end placed in the PDR if the material coes not fall within one of the exempt cate-geries of 10 CFR 2.790.

4 Draft proposals concerning a confirnatory order or settlement agreement if an Office Director determines that it is in the interest of the public health and safety to consider such proposals in preparing the final regulatory document.

04.03 Additional Guid6nce The essence cf the specific guidance discussed in 04.02 f.2 and f.3 above is that the review of background information relative to an area of irspection (f 2) would net necessarily recuire the inspector to retain draft documents of that category unless the draft document itself will be the basis of or will be needed to support a finding (f.3). Additional guidance in this regard is provided by the following examples.

1. Inspector reviews draft procedure change to assure comitted changes are included. l Need not retain; f ir.41 procedure will form basis for finding.

2. Inspector examines work ir progress on electrical redificatien and I reviews related rarked-up drawings and proposed procedure changes i to be sure appropriate modification and werk control procedures are beinn followed, heed not retain; work observation is inspection ob,iective.

3. Situation as in extrple 2 above. Inspector notes marked-up drawing (draft) violates electrical separation requirements.

Retein; may be basis for enforcement.

4 Inspector reviews electrical analyses in progress to ascertain cuality of licensee's corrective action plan.

Need not retain; inspection objective was observatien cf ;

analytical process.  ;

End 1

0330 -S- Issue Date: 10/21/87

o ,

1. j..*eegk UNITED STATES

[

G NUCLEAR REGULATORY COMMISSION

' / OFFICE OF INSPECTION AND ENFORCEMENT Washington, D.C. 20666

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INSPECTION AND ENFORCEMENT MANUAL DI CHAPTER 2800 MATERIALS INSPECTION PROGRAM 2800-01 PURPOSE To establish the inspection program for licensees authorized to possess and use licensed material for radiography, medical programs, academic and industrial uses, waste disposal operations, manufacturing and distribution of products, and leak testing, calibration, other types of services, and transportation related thereto.

2800-02 OBJECTIVES 02.01 To establish general policy for the materials inspection programs, including priorities for inspection.

02.02 To define specific requirements for inspection of materials licen-ses.

02.03 To aid in the achievement of a consistent process of inspection for materials licensees.

2800-03 DEFINITIONS 03.01 Inspection Prierities. The priority number assigned to a licensee R is based on the potential hazard of the licensee's programs. For example, R a license with an inspection Priority 1 is one in which there is the great- R est potential for hazards in health and safety; this priority requires the R most frequent inspections because of the nature of the operations. On the R other hand, an inspection Priority 7 involves little potential hazard to R health and safety and requires less frequent inspection. R 03.02 Telephonic Contacts. These are contacts done by telephone using a R questionnaire to determine the status of licensees' activities. These con- R tacts are only used for the low priority licenses, Priorities 6 and 7, and R under certain conditions, PrTority 5 licenses (see Enclosure 1 for instruc- R tions). R 03.03 Telephanic Inquiries. These are inquiries done by telephone to de- R termine (1) some facts about the licensed program such as reminding the R licensee that its license is near espiration, (2) if there is sufficient R activity to conduct an inspection (radioactive material may be in storage), R /

or (3) if the licensee actively possesses radioactive material under its R )

... . ... ..-..e,

license. These are only examples; there may be other reasons to make tele- R phonic inquiries of licenses regarding license expiration, decommissioning, R and so forth. Telephone inquiries generally do not involve direct inspec- R tion effort, whereas telephone contacts do (03.02 above). R 2800-04 INSPECTION PRIORITIES  ;

04.01 Routine, Periodic Inspections. (Also see 2800-05 and 2800-06.) In-spections of licenses in Pruorities 1 through 5 shall be conducted at in-tervalt in years corresponding to the inspection priority: Priority 1 =

each year; Priority 2 = each 2 years; Priority 3 = each 3 years; Prior-ity 4 = each 4 years; Priority 5 = each 5 years. Licenses in Priorities 6 and 7 are inspected initially (04.03, below) and thereaf ter only for reso-lution of complaints, allegations, or incidents, or in connection with an inspection of another specific license; Priority-W (as needed) is for walk-in or pool-type irradiators under construction (see IE 2815).

Because considerable travel is required, inspectors may telephone licensees R located in Puerto Rico, Guam, American Samoa or other island locations to R verify that a routine inspection can be performed before undertaking such R travel. We have experienced situations where inspectors, after arriving in R such locations, have found that licensees did not possess and use radio- A active material. R 04.02 Initial Assignment of Inspection Priority. When a new license is issued by the regional of fice, it shall be assigned an initial inspection priority and scheduled for an initial inspection. These actions should be i

taken as soon as possible. The initial inspection priority is assigned by comparing the types, quantities, and forms of material and authorized uses with the descriptions of the priority sy. tem in Table 1. If a license involves more than one type of use, the type associated with the highest priority (most frequent inspection) shall establish the initial inspection j priority.

04.03 Initial Inspections. These shall be conducted of licenses in In-spection Priorities 1 through 5 within 6 months af ter material is received and operations under the license have begun. Initial inspections of li-censes in Priorities 6 and 7 shall be conducted within 1 year. Initial inspections of new licenses may be announced.

04.04 Expired and Terminated Licenses. Notification that a license has expired or is being processed for termination will require prompt action to ensure that licensed material has been properly disposed of and areas wherein material was used can be safely released to unrestricted use.

Final action, including inspection and confirmatory survey, if necessary, should be conducted as soon as possible, but no later than 6 months af ter the notification is received (see Procedure No. 83895.)

04.05 Abandonment of Licensed Activities. Returned, undeliverable mail to R licensees should be included as a weekly routine follovup. The followup R -

l should include a telephone call to the licensee. If no response is R received, an inspector should be ser.t to the licensee' site. The returned R  !

I mail should be tracked by an entry into the LMS, indicating the status of R  ;

the license, such as shown in the example, Enclosure 5. R l

l 2800  !

Issue Date: 04/08/87

. . l 04.06 Inspection Activities and Licensee Inspection Fees. The following R l

guidance is being provided to assist in determining when activities con- R stitute an inspection and when fees applicable to those activities will be R charged to the licensee. R

a. Before scheduling an _ initial inunction, detersint if the licensee R possesses any radioactive material. An ' initial inspection should R not be attempted if it is determined that the licensee does not R possess licensed material. An inspection should not be considered R to have been performed if, after arriving on an announced initial R inspection, it is found that no radioactive material is possessed. R Before attempting an initial inspection, the licensee should be con- R tacted by telephone. R

b. An inspection should not be considered to have been performed (1) R if, af ter arriving on an unannounced inspection, it is found that no R radioactive material is possessed or used because of disposal or R storage of the material and no inspection activities are performed R or (2) if the licensee or licensee's representatives are not avail- R abla to assist with the inspection and the inspector is unable to R perform inspecticn activities. On the other hand, if it is possible R to inspect records or other items according to license conditions or R NRC regulations, such activities should be inspected and be recorded R as an inspection whether the radiation safety officer (R50) is pre- R sent or not, including those licenses that have been terminated. R

c. For any situation where an inspection was not perforsed as defined R above, the region should not prepare an NRC Torm notification to the R licensee or other type oT"Bocument that is sent to the licensee and R the region should ,n.ot record the attempted inspection in the Li- R cense Management System (LMS) as "an inspection." However, a note R should be placed in the docket file to record the reason an inspec- R tion could not be performed and giving a date when the next inspec- R tion should be performed. The "next inspection date" data element R in the LNS should be changed to reflect the new date. R

d. Te_1ephone contacts.are not inspections. Therefore, the results of R these activities should not be recorded on an NRC-591 form or in a R Notice of Violation. The fact that a telephone contact of a licen- R see was made should not be entered into the LMS as an inspection. R However, the Regulatory Information Tracking System (RITS) allows R the time spent in gathering factual material to be charged against R the time budgeted for performing routine inspections, R 04.07 Unannounced Inspections. With the exceptions provided in the above R sections of this manual chapter, all other materials inspections should be R performed on a strictly unannounced basis. R 2800 05 TELEPHONE CONTACTS As defined in 03.02, contacts by telephone are a useful means of maintain- R ing contact with licensees who are never inspected or are inspected infre- R quently, such contacts may be performed by an adequately trained person R 2800 Issue Cate: 04/08/87

who would not ordinarily conduct field inspections. Telephone contacts of R low priority licensees also say be done by a junior inspector. Other more R experienced inspectors may do telephonic contacts only if the region has R completed inspections of the higher priority licensees (Priorities 1 - 5), R allegations, and special inspections. Contacts shall be limited to general R licensees and Priority,1,and Priority 5 R

' licensees may be included if,]the programs are small the and,potential licensees with for R small p for health and safety liazards is remote. Procedures for using the tele- R phonic contacts are included as Enclosure 1. A telephone questionnaire R is attached as Enclosure 2 and standard responses back to licensees con- R tacted by telephone are included as Enclosures 3 and 4. R 2800-06 CHANGE IN PRIORITY BASED ON CHANGE IN TYPE OF PROGRAM A change to a lower or higher inspection priority shall be made when it is determined that the licensed activity being carried out is of a priority different from that initially assigned and is one which warrants a lower or higher inspection priority under the system in Table 1. T heo ram prior-ity codes sha11_,be3 hanged in the LM$ t Any changes from the usual'p lori-

' ' ties shaTfbe authorized by the Section Chiefs and a note placed in the docket file, but the program code shall not be changed.

A reduction to a Priority 6 may be done if: R

a. it is not likely that radiation workers will exceed 10% of the air- R borne radioactivity limits listed in 10 CFR 20, Appendix B. Table 1 R b, it is not likely that a radiation worker will exceed 25% of the R radiation dose limits listed in 10 CFR 20.101(a) or will not need to R use personnel monitoring devices R I

c. it is not likely that any work with radioactive material will result R in a spill causing spread of contamination R

d. complex surveys are not required R

e. waste disposal is not. required R 2,800-07 EXTENSION Of INSPECTION INTERVAL The interval between inspections may be extended (lengthened) beyond that specified by the priority system on the basis of exemplary perforsance on the part of the licensee, The governing consideration in extending the inspection interval should be evidence of a level of performance in safety and compliance on the part of the licensee that provides a greater-than-normal assurance of a well-managed, safe operation. The determination to extend the inspection interval shall be made on the basis of an inspection, considering current and prior findings. The extension shall be valid only until the next inspection, but may be renewed on the basis of repeated favorable findings. The extension shall be limited to a maxinum of 6 months for licensees in Priorities 1 and 2, and to a maximum of 2 years for licensees in other priorities. For computer entry, the letter E shall be used for licensees on an extended inspection interval.

Issue Date: 04/08/87 2800

The designated inspection priority for these licensees should not be changed in the uts. However, the "next inspection date" data element in R the uts should be changed to contain the extended date for the next inspec-tion. To support the extension in the interval between inspections, a R brief note should be written giving the basis for the extension, approved R R

by the Section Chief, and placed in the docket file.

2800-08 REDUCTION OF INSPECTION INTERVAL The interval between inspections say be reduced (shortened) and inspections conducteu more frequently than specified by the priority system on the basis of minimally satisfactory performance on the part of the licensee.

The governing consideration in reducing the inspection interval should be a lack of confluence in the level of performance in safety and coepit-ance on the part of the licensee that indicates continuing adequate pro-tection of worker and public safety will not be provided without increased attention by the licensee and the NRC. The determination to reduce the inspection interval shall be made on the basis of an inspection, consider-ing current and prior findings. For computer entry, the letter R shall be entered for licensees on a reduced inspection interval.

for these licensees should not be R l The changeddesignated inspection in the LMS, priority'next However, the inspection date" data element in R LMS should be changed to contain the date for the next inspection based on R a reduction of the interval between inspections. A brief note should be R written giving the basis for the reduction, approved by the Section Chief' Rg and placed in the docket file.

2800 09 SCHEDULING OF INSPECTIONS 09.01 Basis for Scheduling. The month in which an inspection is actually performed say be completed earlier or later than scheduled (by its place-ment in the priority system) for the purpose of the efficiency realized in inspector travel time. The efficiencies of travel time should be balanced  !

against the basic purpose of the inspection priorities, that is, effective use of an inspector's time versus the potential hazards in a licensee's operation. A low-priority licensee should not be over insper.ted just be-cause an NRC inspector is in the area of the facility. Inspection of a high-priority licensee should not be unduly delayed merely for scheduling purposes.

09.02 Radiography Inspections. For radiogrcphy licensees that are autho-rized to conduct radiography at temporary job sites, an inspection of a ,

temporary job site should be attempted for at least 24 of these licensees. l For a number of the inspecticns of temporary job sites, attempts should be t sade to accompany licensee auditors during a quarterly audit of those sites. The accompaniment of auditors may be on an announced basis.

09.03 Combinins inspections, if a licensee holds more than one kind of itcense (that < s, of dif ferent priorities), a single inspection say be scheduled whenever practicable to aid in more ef fective use of inspector's time spent in travel status. In the determination to combine inspections on a continuing basis, consideration should be given to "over inspecting" a lower priority license versus the need and desirability of inspecting a licensee's total activities for a em complete picture of its safety and 2m00 !ssue Date: 04/08/87

compliance performance. The priority designations of the lower priority licenses shall not be changed in these cases; the more frequent inspec-tions of lower priority licenses shall be handled only in the scheduling process.

09.04 Performance Indicators. These are defined in Inspection Procedure R 89100, that, when finalized shall be used by inspectors to determine if the R licensee is conducting its operation in a way, that may, if not corrected R or changed, lead to violations. There is no regulatory basis for most per- R formance indicators, but there is a basis for sound radiation protection by R the industry. Several of these practices are included in the inspection R procedure.

09.05 Permissible Frequency of Inspection. To achieve the goals of cost saving and ef ficient use of staff time as described in 09.01 and 09.03, inspections (other than initial inspections) may be performed at a frequen-cy other than that defined by the priority system. However, the frequency of inspection for a licensee should not f all outside the following points:

Type of Inspection Permissible Frequency Initial inspections of new licensees. See 04.03.

Inspection of licensees in Interval between inspections may Priorities 1, 2, 3. vary by 2 25%.

Inspection of licensees in Interval between inspections may Priorities 4 and 5. vary by 1 1 year.

If escalated enforcement action has taken place, an inspection should be conducted within 1 year following closeout of the escalated enforcement action.

09.06 Inspection Before License Renewal. Before renewing e license in R Priorities 1, 2 or 3, the compliance / inspection history of the licensee R should be checked to determine whether additional requirements should be R made a part of the license, particularly for those licensees that have a R history of marginal performance. In some cases, it may require an on-site R inspection to determine if the license should be renewed, based on prior R performance and up-to date information on the licensee. R 4 09.07 Notification to Non- Agreement States. Notify in a reasonably time- R ly manner by telephone or in writing non-Agreement State radiation control R progran personnel of planned NRC materials inspections and enforcement R cases in their own States. Inform the States of the type of materials in- R spections, enforcement cases applicable for participation, and the number R of such personnel that may participate in each case. For inspection accom- R paniments at Federal facilities, the non-Agreement State radiation control R progran director must seek permission from the Federal agency licensee. R Personnel interested in participation may do so as observers as long as R their presence does not impact en NRC's inspection program, The NRC R assumes no responsibility fo injuriM ct radiation exposures that may be R received by v dpatin;, nov Agreement State personnel. R lssue Date: 04A 2800

2000-10 REGIONAL RESPONSIBILITY FOR LICENSES General. When a license authorizes operations in more than one re-10.01 gion, the responsibility for inspection shall reside with the regional of-The mafr. office means fice in which the Itcensee's main office is located.

the corporate office, normally the address given on the license.

Assistance in Inspections. In the interest of ef ficiency in travel l 10.02 time and funds, the responsible regional office shall request another re-gional office to conduct inspections (assist inspections) of the activities of such licensees when the licensee is operating outside the geographical area of the responsible region. The inspecting region should provide com-I plate documentation (draft inspection report) and recommend enforcement action to the responsible region. The responsible region should distribute the documentation, initiate enforcement action, and take other followup actions, as appropriate to the case. These last two actions shall be completed by mutual agreement of the regional offices involved.

1 When ' requesting assist inspections, the regional offices shall take into consideration the sample size of inspections for which they are requesting

assistance. In this ef fort, the regions should dif ferentiate between large and small companies and establish different inspection programs for each Some companies have many field offices and general class of licensee.The strength of the licensee's internal inspection pro-others have few.

gram is another factor in determining the sample size of the licensee's field operations.

10.03 Transfer of Responsibility. Notwithstanding the above (10.01 and 10.02), when a license carries an address that places the inspection responsibility in one region and operations under the license occur princi-pally within another region, the inspection responsibility may be trans-This transfer ferred to the region in which the operations are performed.

The shall be done with mutual agreement of the regional of fices involved.

regional of fices should ensure that the appropriate changes are made to the i

LMS to show which office has the overall responsibility for inspection and l

enforcement.

1 2800-11 INSPECTION OF GENERAL LICENSEES 11.01 Routine Inspection Not Required. With the esceptions specified in 11.02, inspections of general licensees are not required on a routine ba-l

sis. However, inspections shall be made to resolve allegations, com-plaints, or other indications of an unsafe practice or a case of noncom-pliance, or when such an inspection is directly pertinent to an inspection I

involving a specific license. Any inspections conductedinunder the above areas of NRC provisions should be done during activities conducted jurisdiction, 11.02 Inspection of Activities Under Reciprocity. The NRC region in which i

i i an Agreement 5 tate is located is the recipient of the NRC-241 form report from a State licensee of its proposed activities in non-agreement States, The regional of fice receiving the NRC-241 form shall take action on the report, including prompt notification of the NRC regional office having i

jurisdiction in the area in which the Agreement State licensee's activities j take place. The responsible regional of fice shall make every reasonable

' ef fort to conduct inspections of Agreement State licensees at the same fre_-

quency as the NRC licensees.

Issue Date: 04/08/87

2800 1

. 2800 12 CONSTRUCTION AND PREOPERATIONAL INSPECTIONS 0F IRRADIATORS Construction and preoperational inspections of new walk-in or pool-type R irradiator facilities shall be a regular part of the inspection program. R The inspections will involve the use of engineering inspectors and will A require that the materials staff identify the parts of the facility that R are especially important to safe operations of irradiators. MC 2815 des- R cribes the inspection program for these facilities. A 2800-13 SPECIAL INSPECTIONS R i Special inspections are reactive in nature and cannot be scheduled on a R routine basis. Occasions for which a special inspection should be per- R formed include, but are not necessarily limited to, the following: R 13.01 Licensee report of an incident where onsite inspection is needed to R

'l determine the facts of the case, the cause of the incident, and adequacy of R the licensee actions to correct the cause of the incident, mitigate its R 1 consequences, and prevent recurrence. (Sce IE 2820 for criteria and R guidance.) R 13.02 Followup within 1 year of escalated enforcement to determine whether R the licensee has taken the actions to which it committed itself in its re- R sponse to the enforcement order. R 13.03 Obtain information as to the validity and significance of the al- R leged unsafe operations. R 2800-14 INSPECTION METHODS R I To the maximum extent practicable, inspectors should ascertain whether a R t

licensee is in compliance with specific provisions of the license and the R regulations by direct observation of work activities, demonstrations of how R i the licensee performs an NRC-required test or other activity, interviews R of licensee employees, and, in appropriate cases, by independent measure- R l ments of radiation and air concentrations. Less reliance should be placed R on determining compliance based solely on information in licensee records. R 2800-15 INPUT INTO THE LMS SYSTEM AND AS$1GNMENT OF INSPECTION PRIORITIES R 15.01 Table 1 provides a listing of license program codes with the assoct- R I ated inspection priorities. We have adopted these codes as the exclusivs R I system _ for determinie the inspection prioritv for each ifeente. However, R it may be necessary to continue using a "subpriority" code (inspection R category code) from the previous system to satisfy an edit in the LMS, R

While the IE staff has tried to eliminate all problems that have been R

! identified in the use of the license program code system for assigning R j inspection priorities, it is possible that other problems remain or may be R

encountered in the future. In any such case, the inspection staff should R i make a judgment about the proper inspection priority for the license based R l on past practice and should insert that priority into the LMS. R i

Issue Date: 04/08/87 2800

• 15.02 Data should be entered promptly into the LMS at the time a new li- R conse is issued or an inspection has been performed, including the dates R for initial inspections of new licensees, the last inspection date, and the R next inspection date for licensees already inspected. R R

2800-16 INSPECTION PROCEDURES FOR THE MATERIALS PROGRAM Table 2 lists the inspection procedures that should be used in the mate- R rials inspection program and the frequency for use of each procedure. R END

Enclosures:

1. Tables

2. Appendix i

j i

.i i

Issue Date: 04/08/87 2800

b

• Enclosure 1 Jep chone Contact Procedures for Priority 5, 6 and 7 Licenses Picur6m Objectives: In the past there have been times when manpower limita-tions have required exempting lower priority licensees from routine inspection by the NRC. As a result of this practice, the regions were lef t with a large number of licensees many of which had never been inspected. To improve general performance of these low priority licenses, this telephone contact l procedure was developed so each licensee would be interviewed at least once during the duration of the license and at some periodic frequency thereafter to be determined by the regional staf f.

1. Select license to interview at random (see 2800-05) f rom the computer listing of licenses never inspected. Af ter this is done, select li-censees that have had initial inspections (Priorities 6 and 7) and those inspected infrequently (Priority 5).

I 2. Pull the license file and review the file to determine the person to contact for information needed to complete interview questionnaire (Enclosure 2).

1 3. Telephone licensee and complete questionnaire. Note that not all licen-ses require each procedure mentioned in the questionnaire.

4. If the licensee reports any problems, namely:

a, personnel exposures in excess of 1.25 rems for a calendar quarter

b. lost licensed material

c. leak tests indicating source leakage or

d. any event the licensee considered unusual The person filling in the questionnaire should promptly notify the Ma-terials Section Chief. Provide the Section Chief with the appropriate draft letter (Enclosure 3).

l 5. If the licensee responses confirm no problems are present, prepare the appropriate draf t transmittal letter (Attachment 4) for signature by the Section Chief.

1 6. Send package to Section Chief for review.

l NOTE: The first priority on use of an inspector's time should be reduction of the backlog of overdue materials inspections in the higher priori-l ties (1, 2, 3, 4).

{

i El-1 Issue Date: 04/08/87 2800 i

. Enclosure 2 EVALUATION OF POSSESSIONS AND USE OF SYPRODUCT MATERIAL Name: License Number:

Address: Phone Number:

Name and Title of person responsible for radiation safety program:

Describe how this material is used:

Describe how you safeguard the byproduct material from use by unauthorized personnel:

Describe how you safeguard the material from loss or thef t:

a Describe controls which prevent individuals who work in the area around the material from becoming exposed to radiation:

Do you have a personal monitoring program for your esployees such as film badges, dosimeters, : Yes No If yes, were there any exposures to individuals in excess of 1.25 rems for any calendar quarter for the year (s) 7 Yes No 2800 E2-1 !ssue Date: 04/08/87

Do you perform s"rveys to C;tect external radiation in the area around the byproduct material? Yes No If yes, how often are the surveys performed?

What instrument is used to perform the surveys?

When was this instrument last calibrated?

On what date was the last physical inventory of all byproduct material in your possession performed?

Do you perfors leak tests on the sealed source? Yes No If yes, how often are these leak tests performed?

Who evaluates the leak test results?

If no, describe the provisions you have made to have the leak tests done:

Describe your provisions for repair and maintenance of .your device or source holder:

Describe any unusual events involving the byproduct material or device (s) in which it is used:

Name of person filling in questionnaire Title Date l

Issue Date: 04/08/87 E2-2 2800

Enclostre 3 License No.

'1 Gentlemen:

This refers to a telephone contact conducted on , , 19 _.

The contact was an examination of activities conducted under your license as  !

they relate to radiation safety and to compliance of the Commission's rules and regulations and wit.h the conditions of your license. The contact con-sisted of discussions with .

As a result of this examination of activities, regulatory concerns were noted and are specified below. These may be evaluated at an onsite inspection at your facility in the near future.  !

As you described on the telephone, the following apparent regulatory concerns ,

were identified.  !

(examples) c i

1. failure to leak test sealed sources at the required intervals

2. an exposure of rems to an individual during the third quarter of 1986*

• l 3. an apparently lost gauge containing curies of

• (!f apparently serious enough (such as overexposure), add the following) ,

! You should examine your license and NRC regulations to determine how you can .

correct the apparent regulatory concerns that you discussed on the telephone. l In addition, we would like to highlight the following items that Itcensees i should pay particular attention to as follows:

1 l l a. maintaining awareness and control of licensed material ,

b. proper transfers and disposal of radioactive sources i

c. promptly reporting losses or thefts of licensed materials If you have any questions regarding this contact, you may contact us at f i  !

Sincerely. l l

l

. Chief '

Nuclear Materials Safety and l

Safegu:rds (Branch or Section) l

! bec

, DCS/RSB (RIDS) l l

2800 E3-1 Issue Date: 04/08/87

Enc) cony,4 License No.

Gentlemen:

This refers to a telephone centact conducted on , 19 _,

The contact was an examination of activities conducted under your license as they relate to radiation safety and to compliance of the Commission's rules and regulations and with the conditions of your license. The contact consisted of discussions with __

No regulatory concerns were identified.

If you have any questions regarding this contact, you may contact us at 1

Sincerely,

, Loief 3 Nuclear Materials Safety and Safeguards (Branch or Section) bec DCS/RSS (RIDS)

]

l 2800 E4-1 ,.ue Date: 04/08/87

,. Table 1 Inspection Priarity by Program Codes Program Code Category Title Remarks Priority I 01100 Academic Type A Broad Committee approved users 2 01110 Academic Type B Broad RSO approved users 3 01120 Academic Type C Broad Named users 5 01200 Academic Other (Secondary Code) Classroom teaching-Physics, Biology, or Chemistry (see program code 03620) 02110 Medical Institution Broad Hospitals cnly 2 02120 Medical Institution Other - Group Hospitalt only 3 02121 Medical Institution Other -

Groups I, II (includes Diagnostic -

Limited Therapeutic) 5 02200 Medical Private Practice - Group 5 Clinics and diagnostic medical centers with one or more physicians 3 12201 Medical Private Practice - Lixiscopes by podia-Groups I, II (includes Limited trists, physicians Diagnostic, Limited Therapeutic) (bone mineral analysis)

Also iodine-131 for d.$2d9 ,$s YsVo "h/43 diagnostic / therapeutic 5 S

02210 Eye Applicators Strontium-90 Hospitals or physician's offices 5 3

02220 Nuclear Medical Vans 02300 Teletherapy Human use only 3 Veterinary Nonhuman 5 02400 02410 In Vitro Testing Laboratorles 5 2

02500 Nuclear Pharmacies -

R 02510 Medical Product Distribution 32.70 (No active licenses) 02511 Medical Product Distribution-32.72 Radiopharmaceuticals 3 R 02512 Medical Product Distribution-32.73 Reagent Kits 5 R Mo/Tc generators 3 R 02513 Medical Product Distribution-32.74 Group VI materials, calibration and references sources 3 R 03110 Well Logging Byproduct and/or SNM 3

Tracer and Sealed Sources 03111 Well logging Byproduct and/or SNM Scaled Sources Only 3 02112 Well Logging Byproduct Only-Tracers Only 3 Field Flooding Studies 3 03113 Heasuring Systems Fixed Gauges 7 03120 Measuring Systems Portable Gauges Industrial Lixiscope 5 03121 rioisture/ density gauges 4 R 2800 T1-1 Issue Date: 04/08/87

Program Code Category Title Remarks Priority 03122 Measaring Systems Analytical Instruments 6 03123 Measuring Systems Gas Chromatographs 7 03124 Measuring Syste.as Other 7 03211 Manufacturing and Distribution Type A Broad 1 03212 Manufacturing and DistHbution Type B Broad 3 03213 Manufacturing and Distribution Type C Broad 5 03214 Manufacturing and Distribution Other 6 03218 Nuclear Laundry 3 03220 Leak Test Services Only 7 03221 Instrument Calibration Services Only

<100 Curies 7 03222 Instrument Calibration Services Only

>100 Curies 3 03223 Leak Test and Instrument Calibration -

Services <100 Curies 7 03224 Leak Test and Instrument Calibration Services >100 Curies 3 03225 Other Services Soil and water analysis 7 Large Medical / Industrial Repairing tele-Source Applications therapy units, irradiators, and gauges 4 03232 Waste Disposal Service Prepackaged Only 2 03233 Waste Disposal Service Incineration 1 03234 Waste Disposal Service Processing and/

or Repackaging 1 03235 Incineration-Noncommercial (Secondary Licenses issued Code) for decontami-nation and con-taminated equip-ment storage -

03240

• General License Distribution - 32.51 Generally licensed gauges, other 4 03241

• General License Distribution - 32.53 H-3, PM-147 signs or markers 4 03242

• General License Distribution - 32.57 Am-241 calibra-tion sources 4 .

03243

• General License Distribution - 32.61 Sr-90 ice detec-tion 5 03?44

• General License Distribution - 32.71 In vitro kits 3 03250

• Exempt Distribution - 32.11 Ecludes broad, exempt concen-trations 6 If expedient, may be inspected at the same time that the manufacturing /

processing license is inspected.

Issue Date: 04/05/88 T1-2 2800

• 1 Program )

Category Title Remarks Priority Code l l

" 251

.

• Exempt Distribution Time l Pieces - 32.14 M-3, Pa-147, and I other isotopes in .

30.15 5 R l 03252

• Exempt Distribution - 32.17 Sc-46 resins 5 R 03253

• Exempt Distribution - 32.18 Byproduct saterial in processed chemical elements, compounds, mixtures, tissue samples, bio-assay samples, etc. 5 R 03254

• Exempt Distribution - 32.22 Self-luminous products 5 R 03255

• Exempt Distribution - 32.2G Smoke detectors 5 R 03310 Industrial :.n ;raphy Fixed 1 03320 Industrial Radiography Temporary 1 Job Sites 03510 Irradiators Self Shielded <10,000 Curies 3 03511 Irradiators Other <10,000 Curies Animal teletherapy 3

<1000 curies from which no beam can be extracted 6 R Irradiators Under Construction W 03511 03520 Irradiators Self Shielded >10,000 Curies 3 03521 Irradiators Other >10,000 Curies Pool type, other 1 gama cells 5 R l W 03521 Irradiators Under Construction i 03610 Research and Development Type A Broad Commit' n approved Users 2 l 03611 Research and Development Type B Broad R50-approved users 3 03612 Research and Development Type C Broad Named users 5 l

i and nonBroad Small Multisite-Multiregional Type A Broad -

I (Secondary Code) 03620 Research and Development Other Teaching, non-l I

routine in vitro,

' Program Code I 01200, and other 5 R l

7 03710 Civil Defense Source Material Other <150 Kilogram 3 l 11200 Source Material Shielding 7 R 11210 11220 Source Material Military Munition Indoors / 7 Testing outdoors 3 R 11230 Source Material General License R 5

Distribution - 40.34 T1-3 Issue Date: 04/08/87 2800 l

l

Program Code Category Title Re arks Priority 11300 Source Material Other >150 Kilograms Includes munition production subcriti-cal assembly, and other 3 11700 Rare Earth Extraction and Processing 3 21310 SNM Plutonium - Neutron Source PuBe Greater Than 200 Grams at Universities 5 21320 SNK Plutonium - Neutron Source Greater Than 200 Grams Other Than Universities 5 22110 SNM Plutonium - Unsealed, less Than 2 Critical <15 grams 3 R 22:11 SNM U-235 and/or U-333 Unsealed, 2 Less Than Critical <15 grams 3 R

, 22120 SNM Plutonium - Neutron Source PuBe, non-critical, Less than 200 Grams and others 6 22130 Power Sources Byproduct and/or $NM Snap Generators, 7 22140 SNM Plutonium - Sealed Sources in Gauges, but no PuBe Devices 6 22150 SNM Plutonium - Sealed Sources Not PuBe Less Than Critical 6 22151 SNM U-235 and/or U-233 Sealed Sources Less Than Critical Mass 6 22160 Pacemaker Byproduct and/or SNM Medical Institution 7 22161 Pacemaker Byproduct, SNM and/or' Individual 7 22162 Pacemaker Byproduct, SNM and/or Manufacturing and Distribution 1 22170 SNM General License Distribution-70.39 5 R Issue Date: 04/08/87 11-4 2800

Table 2 Inspection Procedures The procedures listed in this table comprise the inspection program for is divided into two parts, saterials licensees. The list of procedures programmatic and generic. The programmatic procedures specify the inspec-tion requirements for operational and radiological safety aspects of licen-see activities; the generic procedures cover instructions and requirements ,

J applicable to all licensees. )

Inspection .

Procedure Frequency

• Number Title PROGRA M TIC PROCEDURES I, P 83822 Radiation Protection Manufacturing and Distribution Prelicensing W R 87100 Manufacturing and Distribution Postlicensing I, P R 87100 I, P 87100 Multisite Broad License I, P R 87100 Radiography I, P R 87100 Radiography - Field Sites I, P R 87100 Waste Disposal 87100 All other Special Nuclear Material, Industrial, Academic, Environmental, R I, P and Other Specific Licenses Multisite/Multiregional Broad Licensees I, W MC 2810 MC 2815 Construction and Preoperational Inspection of Panaramic Wet Source Storage Gamma Irradiators W R I, P R 87100 Medical I, P R 87100 Medical Teletherapy I, P **

84850 Inspections of Waste Generator Requirements I,

• • d n 89100 Performance Indicators GENERIC PROCE0llRES W R 0517 Management of Allegations (proposed MC)

X 30703 Management Meeting--Entrance and Exit Interviews

• See footnotes at end of table.

12-1 Issue Date: 04/08/87 2800

,' Procedure Inspection

. Number Title Frequency 30800 Initial Management Meeting I 86740 Transportation Activities I,P**

MC 1330 Response to Transportation Accidents Involving Radioactive Materials W MC 2820 Followup Actions to Incidents Involving Fuel Facil;ty or Materials Licensees W R 83890 Closecut Inspection and Survey W 83895 Followup on Expired Licensees W 90712 In-Office Review of Event Reports W 92700 Licensee Event Followup W 92701 Followup on Inspector-Identified Problems W 92702 Followup on Noncompliance and Deviations W 92703 IE Bulletins /Information Notices /

Confirmatory Action Letter Followup W R 92715 Review of 10 CFR Part 21 Reports W 93710 Followup on Significant Event Occurring During an Inspection W Codes for inspection frequencies:

I = initial inspection W = when required P = by priority of license X = each inspection As applicable to the activities of the licensee being inspected.

• • • When procedure become ef fective.

Issue Date: 04/08/87 T2-2 2800

[g. o , *t UNITED STATES '

4 j NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT

%(

i, .., ,/

e Washington, D.C. 20565 INSPECTION AND ENFORCEMENT MANUAL ni PLI A DT r D 9A?n FOLLOWUP ACTIONS TO INCIDENTS INVOLVING FUEL FACILITY OR MATERIALS LICENSEES 2820-01 PURPOSF To provide a uniform method for followup actions to incidents that involve byproduct, source, or special nuclear material possessed by fuel facility or materials licensees. Neither emergency response to such incidents nor safeguards incidents involving special nuclear material are included in this chapter. (NPC Manual Chapter 050? addresses NRC's emergency response to events involving NRC licensed activities.)

2820-0? OBJECTIVE To ensure that followup action is taken as warranted by the nature and hazard associated with the incident, followup actions are documented, and the documents are placed in the docket file.

-- - ~ ~ - - --

2820-03 DEFINITIONS 03.01 Prompt Notifications. Telephone notifications may be followed by telegraph, mailgram, or facsimile transminions received by IE within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of an incident. Such notifications may be received by either the NRC Operations Center at headquarters (HQ) or an NRC regional office. Most prompt notifications are expected to be initiated in accordance with reuuirements of 10 CFR 20, 35, 70, and/or license conditions. However, the NRC licensees also ray make notifications not specifically reouired or specified by the NRC.

03.0? Written Reports. Refer to documentation of incidents subecitted by licensees or other cognizant parties to the NRC regional offices pursuant to applicable NRC regulatory requirements. Vritten repnrts of incidents are generally reovired to be submitted within S to 30 days after identifi-cation of the incident or condition, depending on the regulatory document that requires the report. The subject incident of the written report may or may not have been the subject of a prompt notification.

03.03 Incident. A situation involving byr oduct, cource, or special nuclear material that rey cause a radiologica? hazard .o licensee personnel or the public and that must be reported to the NRC .ns required by an NRC regulation or license condition, a

issue Date: 08/?0/86

', APPENDIX FOLLOWUP ACT10FS TO INCIDENTS INVOLVING FUEL FAtlllTY OP PATERIALS LICENSFES A. GENERAL These general admiristrative procedures should be used by an NPC regional office when it receives a report of a licensee incident. For each reported i t.ci dent , regior.a1 action should include one or more of the following:

1. Report the utter to NMSS, other regicinal offices, and other Federal and State agencies as provided for in the NRC Pesponse Plen for nuclear mattrial in unauthorized places.

2. Evaluate the need for a medical consultant if a laroe dose of radiation was received by anyone.

3. Determine whether or not the incident requires inspection atten-tion before the next routine inspection, based on an evaluation of its safety significance.

4. Dispatch a regional inspector to conduct a special inspection of the incident, if necessary.

5. Decide whether to notify H0 by telephone.

6. Documnt regional decisions, any followup actions, and place these records in the official regional files.

7. Issue a Preliminary Notification (PN) in appropriate cases and/

or place an item in the Daily Report B. OFFICE OF INSPECTION AND ENFORCEMENT

1. Followup Actions to Prompt Notifications Cognizant individuals from the Office of Inspection and Enforce-ment routinely review the NRC Operations Center Operations Officer's logs to assure appropriate followup actions have been taken to reported incidents.

?. Review of Written Reports The Safeguards and Materials Program Branch reviews and evalu-ates written reports of incidents in order to identify oeneric problems and to detennine whether an IE Infomation Notice or Bulletin sheuld be issued or other action should be taken. The review efforts should be coordinated with those of the NPC regional offices and other NRC offices.

u 7820 A-1 Issue Date: 08/20/86

I

, Co NRC REGIONAL OFFICES

1. Followup Actions to Prompt Notifications When a protrpt notification of an incident is received from the NRC Operations Officer, licensee, or other source, the NRC regional office should make telephone calls needed to obtain the necessary details about the incident so as to be able to decide what action to take. (See IE MC 1300, incident Response Actions, and IE MC 1330, Response to Transportation Accidents involving Radioactive Materials.) in each case, the regional office takes one or more of the steps listed under A above.

P. NRC Regional Review of Written Reports of Incidents Regional offices are responsible for the screening, evaluation, followup, and closeout of written reports of all types of inci-dents reported by licensees under their cognizance. The NRC regiont.1 offices should:

/ a. Establish a system to track, review, and follow up written reports of incidents,

b. Forward the report including details of the NRC regional office's reconsner.dations and support documentation to IE and/or other NRC offices for followup action if the review of the report resulted in such recomrendation by the NRC regional office.

c. Document closure of all types of written reports of inci- ,

dents in an inspection report or other type of record.

• Corrective actions sheuld be tracked to completion.

D. SPECIAL INSPECTIONS During a special inspection the regional office should make an initial detennination of the related harard, the need for further action, and should proceed as follows:

1. Discuss with the licensee the current status of the incident.

?. Collect details reoarding the cause of the incident and the incident chronology.

3. Review licensee actions for consistency with the regulations, license requiren nts, approved procedures, and the nature of the incident.

4. Evaluate the @tential radiological consequences and personnel exposure using all available infonnation at the time.

5. Fvaluate the need for 6 nedical consultant based on the poten-tial radiologicel consequences and personnel exposure.

Issue Date: 08/?0/86 A-? ?8?O

6. Determine if proposed licensee actions and plans will provide a .

safe recovery from the incid2nt and help prevent a recurrence.

7. Notify the State and local oovernments and the NRC H0, as neces-

. sery, of any new developments or significant changes.

8. Evaluate the need for continued onsite presence of the NPC and fer other NRC actions.

9. Discuss findings related to the incident with IE, NMSS, SP, and other Federal and State offices, as appropriate.

E. CRITERIA FOR EVALVATION OF INCIDENTS

1. Reofonal manaaenent should evaluate the necessity for the dis-patch of an inspector to the site for followup actionf and the issuance of a PN and/cr a daily report item, depending on the severity of the incident and the potential hazard to the health and safety of the public (see IE MC 11?0, Telephonic and Written Preliminary Notifications and IE MC 0230, Horning Report).

Examples that may deserve dispatch of an inspector for followup action and/or the preparation of a PN and/or a daily report item may include the following:

a. Single exposure of a worker in excess of 5 rems of radia-tion to the whole body, 30 rems to the skin of the whole body, or 75 rems to the feet, ankles, hands, or foreanns.

b. Whole-body exposure of a r+mber of the public in excess of 0.5 rem / year of radiation.

c. Release of radioactive r.aterial to an unrestricted area in

~ ~ - - excess of ~ ten ~tinies thelimitrof 70 CW20'~106..

d. Disposal of licensed material in quantities or concentra-tions in excess of ten times _ the limits of 10 CFR 20.303.

e. Exposure of a worker in restripted areas to ten times the limits of 10 CFR 20.103. ( # @

f. Lost or stolen radioactive material that could lead to an exposure equal to or greater than items 1 and ?, above, i.e., materials or sealed sources in shielded devices such as gauges and radiography sources,

g. Events that have or could lead to ma.ior safety or environ-rental significance, e.g., irradiator fire or large source, rupture._ -

?. Although not requiring dispatch of an inspector to the site, reported incidents r.ay merit performance of a special inspection within a reasonable time. Examples of these conditions may include:

v

?8?O A-3 !ssue Date: 08/20/86

a. Therap:utic and diagnostic medical Cisadministrations$ that resulted in patients receiving radiation d3ses that meet the abnonnal occurrances threshold (AO).*

b. Exposure of a worker in the range of 3.0-4.9 rees of radi-ation to the whole body, 7.5-29.9 rems to the skin of the whole body, and 18.75-74.9 rems to the feet, ankles, hands, or forearms.

c. Release of radioactive material to an unrestricted area in excess of five tiros the limits of 10 CFR 20.106.

d. Disposal of licensed material quantities or concentrations in excess of five times the limits of 10 CFR 20.303,

e. Exposure of a worker in restricted areas in excess of five times the limits of 10 CFR 20.103,

f. Lost or stolen radioactive material that could lead to an exposure equal to or greater than item 2b above.

F. DOCUMENTATION Followup actions taken by the regional office staff regarding a reported incident should be sumarized in writing and maintained in the docket file. A formal report of the results of each special inspection should be prepared and distributed in accordance with the standard distribution list (see IE HC 0610 Inspection Reports).

G. FOLLOWUP ACTIONS TO INCIDENTS OCCURRING IN AGREEMENT STATES ,

Followup actions to incidents at byproduct, source, or special nuclear material ' facilities licensed 'by AgrefrEnt '5tates will ~be provided by Ste.te officials. NRC inspectors may be dispatched to provide assistance if requested by State officials. In such cases, howeve.r. the NRC has no official ,1urisdiction, and the NPC personnel sent to the site will act in an advisory capacity if requested by cognizant State officials. Sore facilities may hold licenses from the NRC and the State. It is possible that State and NRC personnel may both take followup action to incidents at such facilities ur.til the regulatory jurisdiction of the incident has been established.

END

• See NRC MC 0?!?, Abnormal Occurrence Reporting Precedure.

l 1ssue Date: 08/70/86 A-4 20?0

1

.'.' PC20-04 \

RESPONSIBILITIES AND AUTHORITIES 04.01 Office of Inspection and Enforcement. Develops and administers the program for NRC followup actions to incidents involving byproduct, source, or special nuclear raterial neceived throuch the NRC Operations Center at I H0 or the NRC regional offices except for those covered by the NMSS '

response plan.*

04.0? NRC Regional Offices

a. Promptly evaluate reported incidents and decide, in accordance with the criteria of this chapter, what action to take, if any, corcern-

'ng the setter.

b. Ensure that the Director, Division of Fuel Cycle and Material Safety, hMS5, is notified concerning incidents falling within the response plan cited in the footnote.

c. Conduct special inspections as necessary.

d. Document regional evaluatinns and decisions regardino e.--h incident and any followup action that the NRC regional of fice took in response to the incident.

28?O-05 RASIC RCQUIREMENTS 05.01 Aoplicability. This chapter and its appendix apply to the Office of InspectTon and Enforcement and the NRC regional offices.

t.

05.0? Appendix. Guidance and procedures relating to the action the NPC regional of fices should_take_to . reported incidents are.given.in_the appen-dix.

END Appendix

• See "NRC Response Plan for incidents involving Nuclear Materidl in Unauthorized Places " June 28, 1985, sior+d by the Director, NMSS.

t

'\ .

Issue Date: 08/?0/86  ? 28?0

o .

WELL LOGGING INSPECTION FIELD NOTES Inspection Report No. License No.

Licensee (name and address) Docket No.

Temporary Site Inspect -

Approximate Location Licensee Contact Telephone No.

License No. . Date of Inspection Last Amendment No. Date of Amendment.

Priority III.

Programs Codes ( 03110 ) 03111 ( ) 03112 Type of Inspection: ( Announced Initial

( Unannounced Special Reinspection Next inspection Date. ( ) Normal ( ) Reduced ( ) Extended Sunnary af Findings and Action.

( ) No Noncompliance, Clear 591 issued ()ActiononPreviousN/C

( ) Noncernpliance. 591 issued ( ) Regional Action

( ) HQ Action Persons Contacted.

• Those present at exit interviews.

Inspector (5ignature) (Date signed)

Approved (Signature) (Date Signed)

)N Attachrent 87100 1 Issue Date: 05/20/86

b. Coments (responsibility of auditor or comittee, management control).

Refrarks.

5. TRAINING, ANNUAL REVIEWS, INSTRUCTIONS TO WORKERS 10 CFR 39.13(b)

a. Training program specified in L/C or application. ( ) Yes ( ) No (1) Verify records of test results, including field exams of supervisors.[39.13(b)and39.61]

b. Describe scope of training program.

c. Annual reviews examined. Records maintained. ( ) Yes ( ) No

[39.13(b)and39.61]

d. Period reviewed.

Remarks (percent completed, tests results, etc.).

I c. Training provided, but not covered above, such as on-the-job

( training.

Remarks.

i f. Instructions to workers in accordance with 10 CFR 19.12 and 39.61(a)(2). ( ) Yes ( ) No Remarks.

6. RADIOLOGICAL PROTECTION PROCEDURES

a. Operating and Emergency Procedures (10 CFR 39.63)

1) Required by L/C or application. ( ) Yes () No

2) Procedures reviewed. ( ) Yes () No

3) Appeared adequate. ( ) Yes ( ) No (4) Remarks (personnel understanding of procedures),

b. Equipment such as remote handling tools, gloves available and used. ( ) Yes ( ) No

(

c. Changes in procedures since last inspection. ( ) Yes ( ) No l

i Were changes authorized? () Yes ( ) No Remarks.

l l

l Attachment 87100 3 issue Date: 05/20/86 t

e

. b. Uranium sinker bars properly labeled or stamped [10 CFR 39.49)

( ) Yes ( ) No

c. Remarks.

11. RECEIPT AND TRANSFER OF MATERIAL

4. Proceduresforpickingupandreceivingpackages[10CFR20.205 (b)(c)] ( ) Yes ( ) No (1) Incoming shipments monitored. ( ) Yes ( ) No (2) Recordsofmonitoringmaintained[10CFR20.401(b)].

( ) Yes ( ) No (3) Records reviewed by NRC inspector. ( ) Yes ( ) No (4) Period reviewed. _

b. Proceduresforopeningpackages[10CFR20.205(d)].()Yes

( ) No

c. Remarks.

d. Records of receipt, transfer and inventory of material available (30.51(a);40.61(a);10,51(b)(1)]. ( ) Yes ( ) No (1) If "Yes," review of records by inspector.

(2) Period reviewed.

(3) Remarks.

e. Packanes on hand meet labeling requirements (49 CFR 173.399).

( )Yes ( ) No Remarks.

f. Reports to Commission iequired by L/C or regulation were submit-ted. ( ) Yes ( ) No Remarks.

g. Semiannaul physical inventory conducted. [10CFR39.37]

()Yes ( ) No Remarks.

Attachment 87100 5 !ssue Date: 05/20/86

. I 1

. j

. 1 (2) Remarks. l I

d. Bioassayprogramrequired[10CFR39.45) ()Yes ( ) No if "Yes," was bioassay program reviewed? ( ) Yes ( ) No Bioassayprogramappearsadequate()Yes ( ) No Remarks.

14 LEAK TESTS OF SEALED SOURCES [10CFR39.35)

a. Records of leak tests maintained. ( ) Yes ( ) No

b. Leak tests records reviewed. ( ) Yes ( ) No

c. Period reviewed.

d. Records of leak tests appear adequate. ( ) Yes ( ) No

e. Remarks.

15. UTILIZATION RECORDS [10CFR39.39]

a. Utilization records contain all pertinent information. ( ) Yes

()No

16. RADIOACTIVE LIQUID CONTROL

a. Radioactive material unintentionally released to groundwater or aquifersand[20.303). ( ) Yes () No

b. Exemption granted for unintentional releases. [39.45(b))

c. Records of releases or radioactive effluents maintained [20.401).

( ) Yes ( ) No

17. DESIGN AND PERFORMANCE CRITERIA FOR SEALED SOURCES [10 CFR 39.41]

a. Sources meet design criteria. ( ) Yes ( ) No

b. Remarks.

18. INSECT 10N, MAINTENANCE, AND OPENING OF SOURCES OR SOURCE HOLDERS

[10 CFR 39.43J

a. Licensee has program for inspection and maintenance of equip-rent. ( Yes ( ) No

b. Equipment inspected both daily and semiannually. ( ) Yes ( ) No

c. Records of inspection maintained. ( ) Yes ( ) No

d. Stuck sources in source holders or repair, opening, modification done only by persons specifically licensed. ( ) Yes ( ) No

e. Use of radioactive markers in wells only if individual markers contain quantities of licensed material not exceeding exempt quantities. () Yes ( ) No [39.47]

Remarks.

i Attachrent 87100 7 !ssue Date: 05/20/86

4 Yes Ng Vio,

c. Special Form Material performance test records availableforeachsourcedesign?[173.476(a)) () () ()

d. Packages Labeled as required? [172.403(a)) () () ()

( ) Excepted ( ) WI ( ) Yll ( ) YIII Surveys performed to select correct label category and compliance with rad. limits?

[173.475(i)]

e. Packages marked as required, i.e., proper shipping name,10No., Spec.No.,COCNo.,etc.[172.300]

f.

Shipping]paperspreparedforeachshipment?

() () ()

[172.200 Such papers contain required information? () () ()

[172.203(d)]

Such papers carried in vehicle and readily () () ()

available,

g. For licensee private carrier shi >ments:

Vehicles placarded as required? [172.500, 172.504 Table 1)

Cargo blocked, braced, tied down in vehicle?

() () ()

() () ()

[177.842(d)]

AnyincidentsreportedtoDOT?[171.15-16] () () ()

h. Does licensee ship any radwaste?

If yes, are shipments:

() () ()

tendered to comon carriers by licensee? () () ()

tendered through a Radwaste Broker? () () ()

If "Yes,' name of Broker is licensee aware of 10 CFR 61 waste generator

() ()

requirements? [10CFR61]

Has licensee classified and characterized waste? ())

( () ()

[20.311(d)]

i. Proper disposal reacords for decay-in-storage wastes,

() () ()

j. Remarks.

23. NOTIFICATIONS AND rep 0RTS

a. Licensee in compliance with 10 CFR 19.13 (reports to indivi-duals).()Yes ( ) No

b. Licensee in compliance with 10 CFR 20.405 (overexposure).

( ) Yes () No

c. Licensee in compliance with 10 CFR 20.403 (incidents).

( ) Yes ( ) No

d. Licensee in compliance with 10 CFR 20.402 (thef t or loss).

( ) Yes ( ) No

e. Remarks.

Attachrent 87100 9 !ssue Date: 05/20/86

m ,

31. CONTINUATION FROM PREVIOUS PARAGRAPHS-USE BACK 0F PAGC IF NECESSARY t i

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11 1ssue Date: 05/20/86 Attachment 87100

l '.

Attachment 3 PERFORMANCE EVALUATION FACTORS t

Licensee: _

License No.:

t Date of Inspection:

l Inspector (s): ,

r

1. Does the Radiation Safety Committee appear to be functioning adequately to >

successfully implement the licensee's radiation safety program? (e.g., Is membership and attendance at meetings adequate? Are adequate reviews of users and/or facilities being conducted? Are reaningful issues being 4

discussed at the meetings?)

( ) Yes ( ) No ( ) h/A

2. Is the Radiation Safety Officer (R50) able to perform his or her duties q adequately without being burdened by other duties?

e ( ) Yes ( ) No ( i N'A

3. Is sufficient staffing available to manage the licensed prograr workload? .

( ', Yes ( ) No ( ) h/A 4 Does licensee renagement provide support for the radiation safety aspects  !

of the licensed program?

l ( ) Yes ( ) No ( ) L'A

, 5. Does the licensee have the resourct, so operate the facility safely and support decontamination of the facility if necessary?

( )Yes ( ) No ( )N/A

6. Is it evident that the licensee is capable of res

:ndino to a radiological  !

event?

( ) Yes ( ) No ( ) h/A i

I i

h

Attachment 3

7. Are periodic audits conducted of the radiation safety program by the licensee and/or a contractor and do the audits appear adequate?

( )Yes ( ) No ( ) N/A

8. Are licensee's radiation exposures in accordance with ALARA?

( )Yes ( )No ( )N/A

9. Are reportable events (10 CFR 20.402, 20.403, 20.405) kept to a level commensurate with the licensee's workload?

( ) Yes ( ) No ( ) N/A

10. Are the number of repeat violations kept to a minimum and has the licensee successfully implemented corrective actions on previous violations?

( ) Yes ( ) No ( ) N/A

< 11. Are safety-related allegations kept to a minimum level? Doe; the licensee have an adequate system to follow up on complaints?

( ) Yes ( ) No ( ) N/A

12. Are licensee's reports and responses to violations complete, candid and tirely?

( )Yes ( ) No ( ) N/A

13. Are misadministrations (diagnostic or therapeutic) kept to a le'.el comensurate with the licensee's workload?

( )Yes ( ) No ( )N/A 14 Does the licensee have sufficient instrurentation to safely manage the program and are those instrunents properly maintained? (e.g., Is there a

,' preventive maintanance/ quality assurance progran?)

( ) Yes ( ) No ( ) N/A

15. Does the licensee have an adequate prograr in place to store radioactive waste safely? (e.g.. Are materials properly labeled and irventoriec? 15 j exposure to the elements controllet?)

]

( )Yes ( )No ( ) N/A

.I 2

_. . _ . . _ - _ = _

Attachment 3

-Inspector's' Comments: (Required for any factor given a negative response)

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. Action Recuired: (As deemed by Region !!! management, i.e., telephone i

contact. licensee management meeting, increased inspection effort, etc.) l 1

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Action Taken

.[

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l Section Chief Sigr.ature: Date:  !

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{

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ys

\* .

INDUSTRIAL - ACADEMIC INSPECTION REPORT Inspection Report No. License No.

Licensee (name and address) Docket No.

Licensee Contact Telephone No.

Last Amendment No. Date of Amendment Priority Category Program Code Date of Inspection Type of Inspection: ( ) Announ:ed ( ) Unannounced ( ) Normal

( ) Initial ( ) Special ( ) Reinspection Next Inspection Date

( ) Normal ( ) Reduced ( ) Extended Summary of Findings and Action:

( ) No Violation Clear 591 issued ( Action on Previous Violation

( ) Violation (s), 591 issued ( Regional Action i

( ) Violation (s), Appendix ( Headquarters Action f Inspector: 1 (Signature) (Date Signed)

Approved:

I51gnature) (Date Signed)  ;

b t

i

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r--- - - - - - - - - - - - , - , , - - - - - - - - - - . - - e - - ..-- - - -- - --. - - - , ,, , - - , - - - - - - - - - - - - - - - , , - , - - - - - - ,

1. INSPECTION HISTORY

a. Items of noncompliance or safety items noted during last inspection conducted on Yes No Corrected by letted dated

b. Requirement Corrected Not Corrected .

c. If any items of noncompliance or safety items noted during the last inspection were not c'orrected, explain:

.? .

2. Organization

a. Organizational structure as described in application or letter Dated , Or

b. List primary licensee contact: Telephone No.

c. Comments:

3.

SUMMARY

OF LICENSED PROGRAM (Kind of program, number of use or quantities on hand, places and frequency of use,type, people, rateand quantity of '

useasauthorized). .

1 2

4 1NTERNAL AUDITS OR INSPECTIONS 1

a. Required by L/C or application: Yes 1 By whom No , if "Yes": '

2 Frequency _ Announced:

3 Scope Unannounced:

i i

4 Records maintained: Yes  !

No 5 Records reviewed: Yes No 6 Period Reviewed:

b. ~

Comments (responsibility of auditor or committee, management control):

5. TRAINING, RETRAINING. AND INSTRUCTIONS TO WORKERS

a. Training program specified in L/C or application: Yes No

b. If training program is required, describe scope of program:

c. Retraining required: Yes No If "Yes" is retraining: Complete Incomplete 1 Are tests and/or examinations required: Yes ho 2 If "Yes" are records available: Yes no 2 Reviewed test results: Yes No  ?

4 Period reviewed: '~

5 Connents (per cent completed, test results, etc.):

d. Training provided, but not covered above:

• e.

Instructions to workers in accord with 10 CFR 19.12: Yes No 3 ,

. ' .. ;~~ -

6. RADIOLOGICAL PROTECTION PROCEDURES a.

Op)erating 1 and Emergency ProceduresRequired Yes No by L/C or application 2 )

Provided, but not required by L/C or application: Yes 3 No Procedures reviewed: Yes 4 )) Appeared adequate: Yes

5) Cont,ents (personnel's understanding of procedures):

No No

b. Changes in procedures since last inspection: Yes No 1 Were changes authorized: Yes _. ,_No 2 Comments:

7. INSTRUP.EKTATION

a. Type tion or(s)equivalent:

of radiation'Yes survey instruments on hand as per L/C, applica-No

1) If "No" list changes:

b. Capability of radiation survey instruments adequate for program:

Yes No -

e

c. Calibration of instruments required: Yes No

d. If "Yes", instruments calibrated in accord with requirements:

Yes No

e. Coenents:

l 1

)

4

3.. .

8. MATERIALS

a. Radioactive material secured to prevent unauthorized removal from:

1) Restricted area: Yes No

2) Unrestricted area (20.207): Yes_

l

b. Method of control appear adequate: Yes No a

c. Coments:

9. FACILITIES

a. Facilities described in letter or appplication: Yes No

b. Facilities inspected: Yes No ,

c. Coments:

10. POSTING AND L ABELING

a. Posting and labeling in accord with 20 CFR 20.203: Yes No

b. Coments:

l l 11. RECE1PT AND TRANSFER OF MATERIAL l

e. Procedures for picking up and receiving packages (10 CFR 20,205(b)[c)'

Yes No 11 Incoming shipments monitored: Yes No

' l Records of monitoring maintained (10 CFR 20.40llbj): Yes No~~

2l' 3 l Records reviewed by NRC inspector: Yes 4J Period reviewed:

No_

b. Procedures for opening packages (10 CFR 20.205(d]): Yes No ,

c. Connents:

_m-5

.=

i d.

Records;70.51[b[1]):

of receip)t andYes_ transfer ofNomaterial available (30.51[a);

40.61a)Yes",reviewofrecordswasmadebyinspector:

1 1 Yes No 2 Period reviewed:

3 Coments:

9 I

e. Packages on hand meet labeling requirements (49 CFR 173.399):

Yes No

. Coments:

f. Reports to comission required by L/C or regulation submitted:

Yes No' Coments: '

12. PERSONNEL RADI ATION PROTECTION - EXTERNAt.

, s. Film or TLD badge supplier

b. Badge exchange frequency

c. Reports reviewed by

d. Records reviewed for period to _

by NRC inspector

e. NRC forins or equivalent

1) NRC-4(20.102;b)): Yes No Complete: Yes No

2) HRC-5 (20.401,a)): Yes No Complete: Yes No Maxirvn whole body quarterly exposure- '

Maximum extremity quarterly exposure i

3) Coments:

.h

'f. Pocket dosimeters used: Yes No 1 Type used:

2 Frequency of recharging:

3 Frequency of reading:

4 Coments:

g. Direct radiation surveys of restricted and/or unrestricted areas being made: Yes No 1 Records of surveys being r.aintained: Yes No 2 Records of surveys reviewed: Yes NE ,

3 Period reviewed: ~

l 4 Coments:

6

13. PERSONNEL RADIATION PROTECTION - INTERNAL

a. Potential for exposure of individuals to airborne radioactive mate-rial exists: Yes No

1) If "Yes" does program for monitoring and control asist:

Yes No '

2) Program for sonttoring and exnt ol appears adequate:  :

Yes No

b. Coments:

c. Respiratory protection program required by L/C or application:

Yes No

1) If "Yes" wer2 respiratory protection procedures reviewed:

Yes No ,

2) Respiratory protection procedures appear adequate: )

Yes No ,

3) Coments: *

d. Bionssay program required: Yes No 1 If "Yes" was bioassay prsgram revieweT: fes No 2 Cicassey program appears adequate: Yes No 3 Coments:

e. Smears and air samples: '

1) Monitoring for airborne radioactivity is conductM (20.103): i Yes No

a. Records of monitoring reviewed: Yr No

b. Period reviewed: -

c. Records of monitoring appears adequate: Yes ho

2) Seear surveys being conducted (20.201.b): Yes Ro

a. Records of smear surveys reviewed: Yes. N o~

i

b. Period reviewed: ~

c. Records appeared adequate: Yes ho

3) Coments:

14. LEAK TESTS

a. Leak tests required: Ves No .,

b. If "Yes" leak tests conducted: Yes No .

c. Records of leak tests maintained: Yes No

d. Leak tests records reviewed: Yes No l

i ,.

f

=

e. Period reviewed:

f. Records of leak tests appear adequate; les- Mt.

' ~ '

g. Coments:

15. _ RADIOACTIVE EFFLUENT CONTROL AND WASTE DISPOSAL

a. Byproduct material released to atmosphere and/or sewer (20.'l06 and 20.303):

Yes No b.

Recores Yes ofNoreleases or radioactive effluents maintained (20.401): -

1) Period reviewed:

2) Records appear adequate: Yes No

c. Solid waste disposal method:

1 Records of disposal maintained (30.51): Yes ho t 2 Surveys of waste prior to disposal made (20.201): *

' Yes ho~~

3 Period reviewed: '

4 Records of surveys appear adequate (20.401): Yes No

d. Coments:

A \

j Y.

?

1

)

1 O g

8

4 INDUSTRIAt/ACADEM1C

16. TRANSPORTATION (10 CFR 71.5a and 49 CFR 171-178) _Ve s N/A g

a. Licensee makes shipments of RAM 7 Such shipment'. are: ( )( )( )

( l C ))transported deliveredinto common licensee's own carriers?

vehicle as private '

carrier? 8

( )both?

i If above is yes, complete items below:

b. Are authorized packages used? [173.415-416) package types used:

( )( )( ) ,

( ) 00T-7A. Type A [173.415(o)

I l ( ) performance DOT-55(173.416(a)) test records on file? ( )( )( ) -

l i

f licensee aware of 6/30/b5 cutoff on use?

Excepted. Instruments / articles (173.421-424)

( )( )( ) 3 i

I l L5A-strong tight (173.425(b)(1)) '

d NRC-Certified i

NRCC0C'sonfile?[71.123173.416(b)1[c)(1))  ; llj (3 )

l Registered Documented NRC-Approved with NRCQ/A asProgram?

user? [71.12(c]71.17(b))

l, h

I NRC Q/A Approval No.:

( )Other:

i l

c. Special Form Material performance test records available for each source design? [173.476(a))

( )( )( ) ,

I

) d.

Packages

( ) Excepted Labeled ( )WIas required? ( )Yll I'172.403Ca))!

( jYll

( )( )( ) ,

J Surveys performed to select correct label category and compliance with, Rad. Limits? {173.475(i))

( )( )( ) .-

e. packages Marked as regoired i.e., proper shippin

• i

! name. ID ho., 5pec. No.. C0C No.. etc. [172.300) g ,

f.

Shipping 2 ( ) (

Such paperspapers contain required prepared for each information? shipment?

[172.203(d (172.'003))

( ) (()) () )

4 g. For Licensee private carrier shi ments: -

. Vehicles placarded as required? 172.504 Table 1 1 1 Cargo blocked, braced, tied downl172.500* in vehic le? [177.842(d))) '

I

)

Any incidents reported to DOT 7 [171.15-16] h

! h. Does Licensee ship any radwestel h )i I l

Ifges,areshipments:

tendered to comon carriers by i ?:ensee?

i ( f 1f 1f p

! ( h tendered through a Radwaste Tf.uct? dhdhdJ I If yes, name of Broker i

i i

Is licensee aware of 10 CFR E6 'g~enerator requirements? [10CFR61)

( )( )( )

i l

I Has licensee classified and characterized waste?

[20.311(d))

( )( )( ) l l t 4

9 .

f i

e

17. .h01171 CAT 10NS AND REPORTS a.

Licensee inNocompliante with 10 CFR 19.13 (reports to individuals):

Yes _

b. Licensee in compliance with 10 CFR 20.405 (over exposure):

Yes No ,

c. Licenseeincompliancewith10CFR20.403(incidents):

Yes No

d. Licensee in compliance with 10 CFR 20.402 (theft or loss):

Yes No

e. Coments -

~

18. POSTING 0F NOTICES

a. Licenseeincompliancewith10CFR19.11(a)or(b): Yes No

b. Licenseeincomplian:ewith10CFR19.11(c): Yes No

c. Coments: ,.

19. thVIROW. ENTAL MONITORING PROGRAM ,

e

a. Environmental Monitoring Program required: Yes No

'a ,

If 'Yes" records reviewed: Yes No

c. Period reviewed:

d. Records appeared adequate: Yes No

e. If Environmental Program is not required, briefly describe any existing program:

a l

10 .

o* . .

20. CONFIRMATORY MEASUREMENTS

a. Independent measurements made by inspector: Yes Ilo

b. Connents (describe type, results, comparison with lictosee results):

~

4

21. INDEPENDENT INSPECTION EFFORT

a. Coment on type of independent inspection effort conducted:

\

e e

22. . CONTINUATION FROM rREVIOUS PARAGRAPHS - USE BACK 0F PAGE 1F NECESSARY 4

j .

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II ,

Trial Program for Materials Perfog ance Indicators l

1. Failure of Radiation Safety Comittee (or certain key. members of) to meet or discuss meaningful issues. ( )Yes ( )@ ( )N/A

2. RSO unable to perform his or her duties due to other unrelated tasks assigned to him or her. ( )Yes (

)& ( )N/A

3. Licensee does not have sufficient technologist / authorized user /raciation staffing for licensed program workload. ( ) Yes ( )M ( )N/A 4 Numerous customer cceplaints regarding manufacturers or distributors

( AMS, StmA SYNCOR, Mallinckrodt, etc.) ( )les, e ( )M ( ) N/A S. Numero"s safety related allegations which have been substantiated.

( ) 1p ( )M ( )N/A

6. Significant number of diagnostic misadministrations (greater than one per thousand procedures). ( )Yes ( )g ( )N/A l 7. Radiation exposures approaching 10 CFR Part 20 limits. ( )Yes ( ) ~No

( ) N/A

8. Frequent or excessive contamination within restricted areas (greater than 10 x hMS$ guidance for release to unrestricted areas). ( )Yes ( )@

( ) N/A

9. Excessive missed surveillances (leak testing, inventories, surveys, etc.,

greater than 50% per year). ( )Yes ( )M ( )@

10. Financial instability of licensee (shoe-string cperation, or.e or two-man operation such that cost of cleanp is significant to continued operations of the facility). ( )_Yes ( )@ ( ) N/A

11. Lack of senior management involvement in licensed activities. ( ) ~Yes

( )@ ( )N/A

12. Inadequate consulting services (consultant not findings problems but NRC does ). ( ) ,Y15 ( )M ( )N/A

13. Radiation Safety Comittee give 'rchber stamp approvals

• to users and/or uses of licensed meterials or issues permits for indefinite periods of time. ( )Yes ( )g ( )NfA

2-

14. Excessive number of repeat viciations (three or more). ( ) ~Yes

( )]!90 ( )!/h

15. Numerous 10 CFR 20.402, 20.403, and 20.405 reportable events. ( )Yes

( )EE ( )548 Inspector (s) Corrents/ Suggestions: '

d l

I Inspector (s) Signature: Date:

Action Required as deemed by Region !!! management (telephone contact, licensee managerent meeting, reduced inspection frequency):

1 l Action Taken:

Section Chief Signature: Date:

2

\

(

Violation Nh (Taken from NOV or 591 Form)

Xerox Additional Sheets For Each Violation The facts documented in the inspection report should address the following questions for each violation as applicable (MC 0400-05,02.a and b and MC 0610-05.03.e):

1. What was the regiurement'and, if the requirement was conditional, how were the conditions satisfied which made the requirement applicable ?

2. How the requirement was violated ?

3. When was the requirement violated and what was the duration of the violation ?

4 What was the apparent root cause and contributing casual factvrs for the violation ?

5. How and by whom (be specific if an NRC inspector) was the violation discovered ?

6. Was the violation required to be reported and, if so, what was the applicable reporting requirement ?

7. Was the violation reported and, if so, when and by whom was it reported ?

8. If the violation was reported, but the report was late, why was the report late ?

9. was the report complete and accurate ?

10. Were there multiple examples of the violation ?

11. What were the opportunities and when did they exist for licensee staff and management to be aware of the violation ?

12. What were the cirucumstances surrounding the violation which effect the significance of the violation ?

13,15 the violation indicative of programmatic problems or is it an isolated case ?

14. What short term corrective and remedial action was taken and when was it taken ?

15. Did NRC have to intervene to accomplish satisfactory short terin correction and remedial action ?

16. Were there previous similar NRC inspection or licensee- audit findings and, if so, should tha corrective actions from those findings have prevented this violation ?

The inspection report details .should include tiraes, dates, titles of persons types of equipment, and spectfic factual information responsive to the above listed questions, as 3

applicable. Potential severity level and enforcement options will not be discussed in the inspection report.

e

% 88

. ,(

~

Attachment 3 PERFORMANCE EVALUATION FACTORS Licensee:

License No.:

Date of Inspection:

Inspector (s):

1. Does the Radiation Safety Comittee appear to be functioning adequately to successfully implement the licensee's radiation safety program? (e.g., is membership and attendance at meetings adequate? Are adequate reviews of

, users and/or facilities being conducted? Are meaningful issues being discussed at the meetings?)

( ) Yes ( ) No ( ) N/A

2. Is the Radiation Safety Officer (R50) able to perform his or her duties adequately without being burdened by other duties?

( )Yes ( ) No ( ) N/A

3. Is sufficient staffing available to r.anage the licensed program workload?

( )Yes ( ) No ( ) N/A 4 Does licensee ranagerent provide support for the radiation s;fety aspects 1 of the licensed program?

( ) Yes ( ) No ( ) N/A I 5. Does the licensee have the resources to operate the facility safely and support decontamination of the facility if necessary?

( ) Yes ( ) No ( ) N/A

6. 15 it evident that the licensee is capable of respondir'o to a radiological event?

( ) Yes ( ) No ( ) h/A i

P O

Attachment 3

7. Are periodic audits conducted of the radiation safety program by the licensee and/or a contractor and do the audits appear adequate? '

( )Yes ( )No ( ) N/A

8. Are licensee's radiation exposures in accordance with ALArd?

( )Yes ( ) No ( )N/A

9. Are reportable events (10 CFR 20.402, 20.403, 20.405) kept to a level  !

commensurate with the licensee's workload?

l

( ) Yes ( ) No ( ) N/A J

10. Are the number of repeat violations kept to a minimum and has the licensee successfully implemented corrective actions on previous violations?

( )Yes ( )No ( )N/A

11. Are safety-related allegations kept to a minimum level? Does the licensee

• i

have an adequate system to follow up on complaints?

t t

( ) Yes ( ) No ( ) N/A t

12. Are licensee's reports and responses to violatiotis complete, candid and I timely? '

( )Yes ( ) No ( ) N/A

13. Are misadministrations (diagnostic or therapeutic) kept to a level ,

corrensJrate with the licensee's workload?  !

1  !

1

( )Yes ( )ho ( )N/A f 14 Does the licensee have sufficient instrurrentation to safely manage the .

l program and are those instrunents properly maintained? (e.g., Is there a i

preventive maintanance/ quality assurance program?)

( ) Yes ( ) No ( ) N/A I

15. Docs the licensee have an adequate program in place to store radioactive i waste safely? (e.g., Are materials properly labeled and irventoried? Is

exposure to the elements controllec'?)

4

! ( )Yes ( )No ( ) N/A l

l l

l 2

Attachment 3 o.

6 Inspector's Cossnents: (Required for any factor given a negative response) f i

i l

i.

t f

t i

h Action Required: (As deemed by Region !!! management, i.e. , telephone contact, licensee managemer.t meeting, increased inspection effort, etc.)  ;

i I

l i

I t

1 i

Action Taken:

t Section Chief Signature: Date:

3

3.

NUCLEAR MEDICAL INSPECTION FIELD NOTES Inspection Report No. License No.

Licensee (name and address) Docket No.

Licensee Contact _

Telephone No.

Last Arnendment No. Date of Arnendment Priority Category Program Codes: ()02110-Broad ( ) 02201. Private Practice - Lt.7.ite

) 02120 - Group Hospital ( ) 02220 - N.M. Van

) 02121 - Non-Group Hos.( ) 02209 - InVivo Testing

) 02200 - Private Prac- ( ) 02500 - Pharmacy tice - Group ( ) 02210 - Eye Application Date of Inspection

()Other Type of Inspection: ( ) Announced ( ) Unannounced ( ) Normal

( ) Initial ( ) Special ( ) Reinspection Next inspection Date

( ) hermal ( ) Reduced ( ) Extended Summary of Findings and Action:

{}NoViolation, Clear 591 issued ( ) Action on Previous Violation s ) Violation (s), 5C1 issued ( ) Regional Action

( ) Headquarters Action Persons contacted:

Those present at exit interview:

l l

Inspector (Signature) (Date Signed) 0 Approved 0

(Signature) (Date signed) ,

1. ORGANIZATION

a. Organizational structure meets license requirements. ( ) Yes

( ) No (L/C)

Remarks:

I

b. Use by authroized individuals. ( ) Yes ( ) No (t/C)

Remarks:

c. Radiation Safety Comnittee meets at reqJired intervals. ()Yes ( ) he (35.22 (a)(2))

Membership in accordance with 35.22 (a)(1) L/C ( ) Yes ( ) No ,

d, Record of Conmittee meetings. ( ) Yes

( ) No (L/C or 35.22 (a)(4))

i Remarks:

2. INSPECTION HISTORY i

a. Item (s) of violations or deviations noted during last inspection l conducted on ( ) Yes ( ) No.

Response letter dated b.

Corrective Actier. Taken Status Requirement Typt of Violation ( ) Yes ( ) ho Oper. Clost i

4 (continue b, paragraph 20, if needed)

c. If any item (s) of violations or deviations noted during last inspectier.

> were not corrected explain.

i

3. SCOPE OF PROGRAM 4 INTERNAL AUDITS OR INSEPCTIONS

a. Required by license condition. ( ) Yes ()No

b. Audits or inspections .:enducted ( ) Yes ( ) No (L/C)

c. Records maintained. ( ) Yes ( ) No (L/C)

Remarks :

5. TRAINING, RETRAINING. AND INSTRUCTION TO WORKEP.S

a. Training program required by license condition. ( ) Yes ( ) he f

b. Training program implemented. ( ) Yes ( ) No (L/C)

Remarks:

i

c. Retraining program required by license condition. ( ) Yes ( ) No

d. Retraining program implemented. ( ) Yes ( ) No (L/C)

Remarks:

l l

l t

e. Instruction to workers in accordance with 10 CFR 19.12 ( ) Yes

( ) No (19.12)  ;

Remarks.

r h

3

6. RADIOLOGICAL PROTECTION PROCEDURES

a. Procedure referenced in license condition. ( ) Yes ( ) No

b. Used in accordance with referenced procedure. ( ) Yes ( ) No Remarks:

c. Individuals understanding of procedures adequate. ( ) Yes ( ) No Remarks:

d. Examples of key procedures:

(1) ordering and accepting packages RAM ( ) Adequate ( ) Inadequate (2) general rules for safe use of RAM ( ) Adequate ( ) Inadequate (3) emergency procedures ( ) Adequate ( ) Inadequate (4) survey procedures ( ) Adequate ( ) Inadequate (5) handling of volatile RAM (e.g., Xe-133, I-131)

( ) Adequate ( ) Inadequate (E) precautions for use of RAM (sealed and unsealed) for therapy

( ) Adequate ( ) Inadequate

7. MATERIALS, FACILITIES AND INSTRUMENTS

a. Facilities as described in license application. ( ) Yes ( ) No (L/C)

Remarks:

b. Isotope, chemical form, quantity and use as authorized. ( ) Yes ( ) h: (L/C Remarks:

c. Tests required by license condition or regulations.

(1) molybdenum-99 breakthrough. ( ) Yes ( ) No (35.204(a))

(2) performed as required. ( ) Yes ( ) No (L/Cand/or 35.204(b))

(3) records maintained. ( ) Yes ( ) No (35.204(c))

Remarks:

(4) leak tests ( ) Yes ( ) No (5) leak tests performed as required. ( ) Yes ( ) No (L/C)

(35.59 (b)(1), 35.59 (b)(2), 35.59 (c)(1))

Remarks:

(6) other tests required (e.g., physical inventories; surveys to ensure that patients contain 30 millicuries of Au-198,1-131 before leaving hospital) (L/C or 35.75)

d. Inventory of sealed sources.

(1) Inventory of Group VI sources. ( ) Yes ( ) No (35,$g(g (2) Inventory of calibration sources. ( ) Yes ( ) No (35.59 (g))

e. Areas for storage and use of radioactive materials.

(1) Method used to prevent an unauthorized individual from entering a restricted area is adequate. ( ) Yes ( ) No (2) Radioactive material secured to prevent unauthroized removal from an unrestricted area. ( ) Yes ( ) No (20,207) Remarks:

f. Instrumentatien.

(1) Operable survey instruments are as described or equivalent to those decribed in license application. ( ) Yes ( ) No (L/C or 35.120 35.220, 35.330, or 35.420) < Remarks,: ' (2) Capability of radiation survey instruments is adequate for prograr ( ) Yes ( ) No Remarks: P (3) Calibration of survey instruments required. ( ) Yes ( ) No (4) Performed as required. ( ) Yes ( ) No (L/C or 35.51) Remarks:

(5) Dose calibrator checks required. ( ) Yes ( ) No (6) Performed as required. ( ) Yes ( ) ko (L/C or 35.50)

8. RECEIPT AND TRANSFER _OF RADIDACTIVE MATERIAL Receipt of incoming packages during "off-duty' hours by whom?

Where stored? Security?

a. Survey of incoming packages. ( ) Yes ( ) No (20,205(b)(1))-L/C)

Remarks:

b. Record of survey. ( ) Yes ( ) No (20.401(b))

Remarks: l l

c. Procedure for opening packages. ( ) Yes ( ) No (L/C;20,205(d))

Remarks: 1

d. BPM transferred in accordance with 10 CFR 30.41. ( ) Yes ( ) No (30.41)

Remarks: I

e. Records of receipt and transfer maintained. ( ) Yes ( ) No (30.51)

Remarks: 6-

9. PERSONNEL RADIATION PROTECTION - EXTERNAL (Obtain inforination regarding whole body and extremity monitors)

a. Film or TLD badge supplier ,_ Frequency

b. Reports reviewed by Frequency (Are badges assigned to personnel as per licensee's correspondence with NRC7)

c. MRC inspector reviewed personnel monitoring records for period to

d. NRC forms or equivalent.

(1) NRC-4: ( ) Yes () No Complete: ( ) Yes ()No (2) NRC-5: ( ) Yes () No Complete: ( ) Yes ( ) No (20.401 (a)) Remarks:

e. Maximum quarterly whole-body exposure,

f. Maximum quarterly extremity exposure,

g. Licensee has implemented an ALARA program. ( ) Yes ( ) No (35.20)

Remarks:

h. Radiation survey of uvestricted areas. ( ) Yes ( ) No (20.201(b) to show compliance with 20.105 (b), 35.415(a)(4), 35.315(a )(4 )

Re arks:

1. Record of surveys maintained. ( ) Yes ( ) No (20.401 (b) to show compliance with 20.105(b) 35.315(a)(t.) or 35.415(a)(4))

Remarks:

j. Radiation survey of use areas (hot lab, therapy treatment area, patient's room, etc.). ( ) Yes ( ) No (L/C or 35.70, 35.59(h),

35.315(a)(4)) Remarks:

   .       k. Rec ^rd of survey maintained.   (    )  Yes     (            ) No                                                                          (L/C,35.70(h),

35.415(a)(4))

10. PERSONNEL RADIATION PROTECTION - INTERNAL

a. Potential for exposure of individuals to airborne radioactive material exists.

Remarks: () Yes ( ) No

b. ( ) No Monitoring)for airborne (20.201(b) to show radioactivity compliance conducted.

with all sections of ( )20.103 Yes - (L/C,or 35.205 Remarks:

c. Records of monitoring maintained. ()Yes ( ) No (20.401(b) or L/C or

' 35.205(d)) Remarks:

d. Bloassay program implemented as described in correspondence with NRC

( ) Yes ( ) No (L/C or 35.315(a)(8))

11. RADI0 ACTIVE EFFLUENT AND WASTE DISPOSAL

a. Radioactivity in effluents to unrestricted areas. ( ) Yes ( ) ho i

b. Release in accordance with regulatory limits. ( ) Yes ( ) No  !

(20.106(a)) Remarks: ' t

c. State solid waste disposal method, t

(

d. State liquid waste disposal method,

e. Disposal of solid and liquid waste in accordance with regulatory i requirements (decay in storage). ( ) Yes ( ) No (L/C or 35.92)

Remarks: '

f. Recceds of disposal. ()Yes ( ) No (30.51 or 35.92(b))

Rentoks:

g. Surve y of waste prior to disposal. ( ) Yes ( ) No (20.201(b) to show compliance with 20.301 35.92(a)(2))

Remarks: I

h. Records of surveys maintained. ( ) Yes ()No (20.401(b) or 35.92(b)

Remarks:

12. NOTIFICATIONS AND REPORTS  ;

a. Licensee in compliance with 10 CFR 19.13 (reports to individuals).

( ) Yes ( ) No (19.13) Remarks:

b. Licensee in compliance with 10 CFR 20.405 (overexposures).

( ) Yes ( ) No (20.405(a)) Remarks: l i

c. Licensee in compliance with 10 CFR 20.403 (incidents).

( ) Yes ( ) No (20.403) , Remarks: , I

d. Licensee in compliance with 10 CFR 20.402 (theft or loss).

( ) Yes ( ) No (20.402(a) or 20.402(b))  ! Remarks: 1 i r 9

to Licensee in compliance Gith 10 CFR 35.33 and 35.44 (misedministration). ( ) Yes ()No(35.33a,b. cord) and 35.44) Remarks:

13. POSTING OF NOTICES Notices to workers posted. ( ) Yes ( ) No (19.11(a) or (b))

(19.11(c)) Remarks: 14 CONFIP.MATORY MEASUREMENTS / INDEPENDENT MEASUREMENTS

a. Measurements made by inspector. ()Yes ( ) No

b. Survey instrument NRC Serial No.

c. Describe type and results of measurements and compare with licensee's measurements.

15. POSTING AND LABELING Posting and labeling in accordance with 10 CFR 20,203. ( ) Yes ( ) No (20.203 or 35.60 or 35.66)

Remarks:

16. LICENSE CONDITIONS

a. All license conditions reviewed during inspection. ( ) Yes ( ) No

b. Activities were conducted in accordance with license conditions, except as noted elsewhere in this report ( ) Yes ( ) No I

17 BULLETINS AND INFORMATION NOTICES

a. Bulletins and In'/ormation Notices issued during current year,

b. Bulletins and Information Notices received by licnesee. ( ) Yes

( ) No. Remarks:

c. Licensee took appropriate action in response to Bulletins and Information Notices. ( ) Yes ( ) No Remarks: *

18. TRANSPORTATION ( 10 CFR 71.5a and 49 CFR 171-178)

Yes Violation

a. License makes shipments of RAM?

If "Yes", complete the following items. () ()

b. Such shipments consisted of:

( ) radwaste ( ) sources / products ( ) other i

c. For radwaste, shipments are:

' ( ) by licerisee. using common carrier ( ) through Radwaste Broker  ; name of Broker

d. Licensee is aware of 10 CFR 61:

() () Radmaste requirements for generators? l Licensee has classified and characterized itsradwaste?(20.311(d)) () () e i l

C

19. LIST OF VIOLATION (5)

20. CONTINUATION Of REPORT ITEMS - USE BACK Of PAGE If NECESSARy l

LIMITED SCOPE LICENSE FOR DISTRIBUTION TO SPECIFIC LICENSES CHECKLIST Reft Form 313. Guide for Distribution Group Medical Licenses Regulatory Guide 10.8, and Nuclear Pharmacy Guide. DEF ACC ITEM 2 Applicant's name and address

1. Full name of legal entity (e.g. , corporation, not division)

2. Mailing address

3. Telephone number ITEM 3 Locations from which items will *oe distributed

1. Name

2. Address

3. Correlate items with distribution sites 4 Lane as place of use ITEM 5 Radioactive material f\

s 2 DET ACC ITEM 6 Purpose for which material vill be used t

1. List of radionuclides /fors/ possession limit for items to be used or distributed r

(a) Por sealed sources and devices to be used or distributed: (1) Evidence of current registration with NRC or an Agreement State (2) Is currently under review by NRC or an , Agreement State (3) Request for longer leak test interval [ approved on registration sheet i 2 Intended use by licensee

3. Identification of typ . licensee will be distributing to and anticipated use ITEM 7 Individuals responsible for Radiation Safety Program I

1. Individual users trained with material they desire to [

use

2. Radiation Safety Of ficer i

a. Designated

b. Properly trained

c. Duties I

(Should be trained for basic training as in Appendix A 1 Medical Guide 10.8. authorise in categories-low beta's.  ! high beta's, samma's, and todine) I t I i I

3 DEF ACC i ITEM 8 Training for individuals working in areas Tor all individuals

1. Frequency

2. Subjects adequate (lab rules, 3ection 19.12)

ITEM 9 Tacilities and equipment (These items are only needed for R & D, redistribution or manufacturing portions)

1. For Research and Development, diagras/ description of all use areas including access control, shielding fort  ;

a. Adjacent areas l

t. Receipt areas

c. Waste  !

d. Ventilation systems, if airborne materials l

e. Tunehood, glove boxes, etc., if required  ;

' f. Storage areas L

2. List of R$ instruments I

a. Manufacturer's name, model number, number of each [

type, type radiation detected ... Proper window j k r l I i [

4 DEF ACC

b. Proper calibration (require same as in Regulatory Guide 10.8)

(1) Frequency - annually (2) two points on each scale (3) Action levels - 1101, 2201 (4) Daily check

c. If calibration by manufacturer or consultant. name.

location, procedures, frequency as in Appendix D. l Regulatory Guide 10.8 l l l

d. If calibration by licensee (1) Proper source - activity high enough l l l (2) Traceable to NBS (3) Manufacturer's name, model number and accuracy (4) Step-by-step procedures ITEM 10 Radiation Safety Program (For R & D redistribution and/or manufacturing portion)

1. Personnel monitoring

a. If required - name and frequency of service Appropriate badges - ring, whole body

b 5 DEF ACC

b. If pocket dosimetets (1) Manuf acturer's name and model number i

(2) Range  ! (3) Prequency and method of calibration (4) Prequency of recording or reading

c. Bioassays - proper, if not description of consideration i

2. Area survey program

a. Proper area survey (1) Wipe (2) CM [

, (3) Air saapi.ag  ; (4) Effluent sampling [ b. Area surveys of all areas (e.g.. vaste disposal. where air-borne, etc.) , i

c. Proper action levels for ster surveys I

d. Proper f requency of area surveys (Individual -RSO i should do.one specifically at least quarteriv)  ;

i

e. Proper records of area surveys maintained l'

f. Sealed source 1cak tests  !

(1) If by commercial leak test kit. is name of i supplier and model m:aber of kit supplied l [ e i f i c

6 l DEF _AC _ C_ , (2) If performing their own c (a) Name and qualifications of individual performing , (b) Type, name of manufacturer, and model number of measuring instrument used to analyse samples (c) Procedures for calibration of measuring instrument STDs listed. Method including semple calculation showing how results converted to activity units (e.g.,uC1) l 3. Proper ordering procedures (should only have one person ordering) Check possession limits l

4. Proper receipt procedures ,

1 l (a) During regular hours l l (b) During off-duty hours l l (c) If damaged notify R$0 (d) One receiving area I

5. Package opening; proper procedure  !

l ( l (a) Minimum should be equivalent to Appendix T of [ Regulatory Guide 10.3 (b) Leakage and/or contamination (c) Monitoring the an. ace. 3 feet  ! (d) Montior packing materials (e) Wear gloves (f) Transferring to users r i t i

^

7 DEF ACC 4

6. General lab safety instructions (a) Copy posted (b) Procedures for users obtaiaing and using materials (c) Supervision (d) Lab coets (e) !astructions wearing monitoring equipment (f) Surveys (3) Waste disposal (h) Mouth piping (i) Smoking, eating, drinking in areas of use or storage 7 Special instructions -high energy beta's/ synthesis etc.

i (a) Finger badge (b) Appropriate shielding; (10 sci) sye protection (c) Survey 8

• Product packaging and shielding For each radiopharmaceutical or sealed source to be distributed (a) Radionuclide; chemical / physical form (b) Packaging (c) Maximum activity per type of conceiner (d) Type and thickness of shfelding (e) Maximum radiation level at ourface of each shielded container when filled with maximum activity (see 10.d.(3))

         - ~ , , ,
                   ,av .,   - - . - -.    , _ . _ . . . . ,      -   .,   _-,_._._ - -..__,- , ,.___.- ,_ ,__ -_ _-

e 8 DEF ACC 9

• Product labelling For each radiopharmaceutical or sealed source to be distributed:

(a) Color samples of all labels; where each label is to be used; sufficient labels (i) Radiation symbol: yellow and magenta or purple (ii) Radionuclide, chemical / physical form (iii) Activity (iv) Assay time /date (time for sealed sources only if short half-life) (b) Leaflets, brochures (i) Radiation safety related instructions (ii) For handling and storage (iii) Optional, not required Waterproof gloves Shielding Extremity monitors Storage within auxiliary shisiding Use of tongs / devices to pick up sources Special care in handling, sterilizing "fragile" source (c) Extent of use of advance calthration date, if 3 eater than 201, justification

• NOTE: If licensee has too numerous sources / radionuclides to describe, obtain this information in general teres l

l i

i t 9 DEF ACC 10 Source return program (a) If not source return program is offered, it is acceptable to state that fact (b) If such a program is offered, need copies of detailed instructions (including labsis and shipping documents) provided to customers. As a minimum, these must: (1) Establish customer's responsibility / liability as shipper (ii) Step-by-step instructions to complete each form / label (iii) Discuss customer's responsibilities Survey / wipe test packages Security seal Dose rate limits for label Ac: ion levels for wipe test results ITEM 11 Waste management

1. Methods

a. Are name and license number of commercial vaste disposal service listed (not mandatory)

b. Liquid waste in accordance with 20.303

c. Air release in accordance with 20.106

d. If approved, proper incineration

e. Solid waste by decay, proper disposal

f. Transfer from users to di.posal

i. 10 D7 ACC

2. Certification

a. Signature of responsible individual

b. Date

c. Fee information i

          .                                         UNITED STATES

[pbanscoq# $ NUCLEAR REGULATORY COMMisslON [ : i S REGION 811

   ,   %          l                            7ss moostvatt moAo g                          cLEN ELLvN, tLuNoos s0:37 PEDICAL TELETHERAPY INSPFCTION FIELD NOTES Inspection Report No.                                         License No.

Licensee (NameandAddress) Licensee Contact Telephone No. License No. Last Amendment No. Date of Amendment Priority: 3 Program Code: 02300 Date of Inspection Type of Inspection: ( ) Announced ( ) Initial ( ) Unannounced ( ) Special ( ) Reinspection Next inspection Doce ( ) Nonnal ( ) Reduced ( ) Fxtended Summary of Findings and Action: ( ) No violations, Clear 591 issued ( ) Action on previous violations ( ) Violations, 591 issued ( ) Regional Action Letter with NOV ( ) Peinspection Persons Contacted

            *Atterded exit interview Inspector (Signature)                                      (Date Signed)

Approved (Signature) (Date S.,_ igned) hv L ' ed Date: 03/16/ES i {i

e

1. ORGANIZATION A. Material used by or under supervision of authorized users.

( ) Yes ( ) No Remarks B. "Visiting physician" condition on the license or 35.27. ( ) Yes ( ) No if so, has licensee complied with all requirements of license condition or regulation. ( ) Yes ( ) No C. Name of consulting physician if not listed under persons contacted. ( ) N/A

2. INSPECTION HISTORY A. Violations or deviations noted during last inspection conducted on . ( ) Yes ( ) No Corrective Action Taken Status B. Requirement Violation ( ) Yes ( ) No ( ) Open ( ) Closer Remarks C. If any violations or deviations noted during last inspection were not corrected, explain

                                                ?

S. l

3. SCOPE OF PROGRAM l l

4. TRAINING A. Status of individual designated as "teletherapy physicist".

Certification by Education & Experience ( ) Yes ( ) No (10 CFR 35.961 or 35.606(e)) B. Training program for personnel implemented ( ) Yes ( ) No ( ) 35.25(a)(1)(?)and(3) ,. C. Retraining program implemented. ( ) Yes ( ) No ( ) N/A Remarks e D. Training records maintained for 2 years (35.610(c)) ( ) Yes ( ) No

5. RADIOLOGICAL PROTECTION PROCEDURES A. Emergency procedures posted, ( ) Yes ( ) No j Remarks. (35.610(a))

E 3  ;

B. Individuals( understanding)of adequate. ) 'les ( No operating and (35.610(b)) emergency procedures Remarks

6. MATERIALS, FACILITIES, AND INSTRllMENTS A. Amount and use of material as authorized. ( ) Yes ( ) No B. Possession and use of depleted uranium as shielding as authorized, if needed.

( ) Yes ( ) No C. Facilities as described in License Application (35.606). ( ) Yes ( ) No Remarks D. Inspection and servicing perfomed during source replacement or at intervals not to exceed 5 years (35.647) ( ) Yes ( ) No Remarks E. Perfonned ( ) Yes by() persons No specifically authorized to do so (35.647(b)).

1. Any work (other than in D. above) done. ( ) Yes ( ) No If so, done by authorized personnel. ( ) Yes ( ) No Remarks F. Facility provided with system to pemit continuous observation of the patient (35.615(e)) ( ) Yes ( ) No Remarks G. Facility provided with interlock system to control access to treatment rocm (35.615(b)(1)(2) and (3)). ( ) Yes () No i

L l 4 I

9 H. Interlock ( ) Yes sy(stem) NotestedRemarks at 1-month intervals (35.634 (d)(1))

1. Recordsofinterlocktests(35.634(f)) ( ) Yes ( ) No Remarks J. Leak tests performed as required (35.59(a)) ( ) Yes ( ) No Remarks K. Leak test performed by authorized individual. ( ) Yes ( ) No Remarks L. Results of leak tests recorded (35.59(d)) ( ) Yes ( ) No Remarks M. Postino of area, rooms and teletherapy unit is adequate.

( ) Yes ( ) No Remarks N. when access to an area is required (35.636(b)).( Facility ) Yes maintained

                                                                                     ) No locked du

0. Survey Instruments calibrated as required (35.620).

( ) Yes ( ) No Remarks P. Dosimetry system calibrated by NBS or ar. credited lab within 2 years (35.630). ( ) Yes ( ) No Remarks Q. Permanent radiation monitor in accordance with 35.615(d). ( ) Yes ( ) No R. Records of daily monitor check (35.615(d)(4)). ( ) Yes ( ) No , 5

S. If radiation monitor nonfunctional, was survey meter used (35.615(d)(5)). ( ) Yes ( ) No Radiation monitor repaired promptly? (35.615(d)(6)) ( ) Yes ( ) No T. Facility equipped with functioning beam condition indicator light (35.615(c)). ( ) Yes ( ) No

7. RECEIPT OF MATERIAL A. Transte, vi iicensed material in accordance with Part 30.41.

( ) Yes ( ) No Remarks B. Record of transfer and receipt maintained (30.51(c)(3)). ( ) Yes ( ) No ( ) N/A Returks B. PERSONNEL RADIATION PROTECTION - EXTERNAL A. Film or TLD badge supplier Frequency B. Reports reviewed by Frequency C. NRC inspector reviewed personnel monitoring records for period to . D. NPC form or equivalent (1)NRC-4( ) Yes ( ) No Complete ( ) Yes ( ) No (2) NRC-5 ( ) Yes ( ) No Complete ( ) Yes ( ) No Remarks E. Maximum quarterly whole body exposure . F. Maximum quarterly extremity exposure . G. Licensee has implemented an ALARA Program (35.20). Remarks 6

9. SURVEYS A. Surveys have been conducted in accordance with 35.641. 3 (1) before first patient treatment ( ) Yes ( ) No (2) after new source installation ( ) Yes ( ) No (3) after any changes in room shielding ( ) Yes ( ) No Remarks B. Surveys of areas adjacent to treatment room were conducted (1) before first treatment ( ) Yes ( ) No Remarks (2) after new source installation ( ) Yes ( ) No Remarks (a) af ter any changes in roce shielding, location of the unit within the treatment room or use of the unit.

( ) Yes ( ) No Remarks (b) survey results of console area and entrance to treatment room with beam "on". (c) measurement of radiation levels in areas adjacent to teletherapy room with beam on. Remarks

10. NOTIFICATIONS AND rep 0RTS

{ A. Licensee in compliance with 10 CFR 19.13 (reports to individuals). ( ) Yes ( ) No Remarks 7

B. Licensee in compliance with 10 CFR 20.405 (overexposures). ( ) Yes ( ) No Remarks C. Licensee in compliance with 10 CFP 20.403 (incidents). ( ) Yes ( ) No Remarks D. Licensee in compliance with 10 CFR 35.33 (misadministration). ( ) Yes ( ) No Remarks

11. POSTING OF NOTICES Notices to workers posted (19.11). ( ) Yes ( ) No Remarks F

12. BULLETIN! AND INFORMATION NOTICE 2 A. Bulletins and information Notices issued during current year.

B. Bulletins and Information Notices received by licensee. ( ) Yes ( ) No Remarks i C. Licensee took appropriate action in response to Bulletins and , Information Notices. ' ( ) Yes ( ) No Remarks

13. TELETHERAPY CALIBRATION I

l l i 8

A. Full Calibration (35.632). (1) Performed: (a) priortofirstuseonhumans(35.632(a)(1)). ( ) Yes ( ) No Remarks (b) af ter source change, relocation, major repair 35.632(a)(2)(ii). ( ) Yes ( ) No Remarks (c) annually (35.632(a)(3). ( ) Yes ( ) No Remarks , 1 (d) whenever spotchecks indicate output change 45% (35.632(a)(?)(i)). Remarks (2) Full Calibration (35.632(q)(3)). (a) exposure rate or dose rate to an accuracy.A3% (35.632 (b)(1)). ( ) Yes ( ) No Remarks (b) for all field. sizes and treatment distances (35.632 (b)). ( ) Yes ( ) No Remarks (c) congruence ( ) Yes ( ) No Remarks (d) timer accuracy (35.632(b)(4)). (e) accuracy of all distance reasuring devices (35.632(b)(6)). 9

      .- ,    - .    .-    . _ _ _ _ _ -                                        ..       .    . - _ . = _ - - . , _ . _ .

(3) Proper procedure followed - American Association of Physics in Medicine (AAPM) (35.632(d)). ( ) Yes ( ) No Remarks (4) Performed with instrument calibrated by NBS or accredited lab within previous 2 years (35.630(a)). ( ) Yes ( ) No Pemarks (5) Records of full calibration (35.632(q)). ( ) Yes ( ) No Remarks (6) Performed by therapy physicist (35.632(f)). Remarks B. Monthly Spot Checks (35.634) (1) Performedmonthly(35.634(a)). ( ) Yes ( ) No Remarks (2) Performed by or in accordance with procedures established by the teletherapy physicist (35.634(b)). ( ) Yes ( ) No if teletherapy physicist does not perform spot checks, results checked by teletherapy physicist within 15 days (35.634(c)). ( ) Yes ( ) No~ (3) SpotChecksinclude(35.634(a)(1thru6)). (a) timer accuracy ( ) Yes ( ) No Remarks 10

(b) Coincidence ( ) Yes ( ) No Remarks (c) accuracy of distance measuring device ( ) Yes ( ) No Remarks (d) eutput ( ) Yes ( ) No Remarks (e) difference between measured and expected output ( ) Yes ( ) No Remarks (f) spot checks performed using NBS/ regional lab calibrated instrument or direct intercompairson with same (35.630). ( ) Yes ( ) No (g) records of monthly spot check (35.634(f)). ( ) Yes ( ) ho Remarks

14. PROTOCOL A. Does licensee participate?

( ) Yes - Complete Section 16 only ( ) No - Complete Sections 15 and 16 B. If "Yes", protocol is part of: ( NBS ( National Cancer Institute Center for Radiological Physics ( AAPM - Radiological Physics Center C. Date of last intercompairson . D. Were results with.iS% ? ( ) Yes ( ) No Remarks

15. OUTPUT VERIFICATION A. Type of Unit Co-60 Cs-137  ; Curies as of (date)

Machine make Model Shutter Type Type of machine mount: Vertical Isocentr.c Other(specify) B. Licensee's Data Taken froa ( ) monthly spot check ( ) full calibration 12

y _ 4

                                      ~

c - ( -

                                                                                      \                              s
                                                                                     /8e --                                -

i I

                                                                                                                             ~

8IDE FR0HT 2 s.R/hr average 2 mR/hr average ind 10 mR/hr maximum ind 10 mR/hr maximum at 1 meter at 1 meter ( ) Yes ( ) No ()Yes ( ) No

16. APPARENT VIOLATIONS FOUND

17. QC/QA PROGRAM A. Has the licensee implimented a QC/QA Program ( ) Yes ( ) No B. Description of quality assurance program to prevent misadministrations i for therapy patients.

(1) Havesecondary)checksofthedosecalculatinsbeendone? ( ) Yes ( No (2) Do the second party checks of the dose calculations provide assurance that the final treatJnent plan will provide the dose prescribed on the patient chart ? ( ) Yes ( ) No (3) Do technologist consult with the doctor if the prescription or other orders are unclear ? ( ) Yes ( ) No Remarks l 1 i 13 i

                      *C. Followup on therapy misadministration (1) 10 CFR 35.33 properly implemented ?           ( ) Yes        (    ) No (2) Was proper medical care given for the patient pursuant to the NRC medical consultant recommendations ? (       ) Yes ( ) No (3) Were appropriate actions implemnted to prevent recurrence ?

( ) Yes ( ) No (4) Were the technologist and dosimetrist made aware of these actions ? ( ) Yes ( ) No (5) Does the licensee's QA/QC procedures address these actions to prevent recurrence ? ( ) Yes ( ) No Remarks

• Inspect the QA Program and misadministrations when the rule becomes final.

I i 14

             ,                         Violation No.          (Taken from NOV or 591 Form)

Xerox Additional Sheets for Each Violation The facts docenented in the inspection report should address the following questions for each violation as applicable (MC 0400-05.02.a and b and MC 0610-05.03.e):

1. What was the regiurement and, if the requirement was conditional, how were the conditions satisfied which made the requirement applicable ?

2. How the requirement was violated ?

3. When was the requirement violated and what was the duration of the violation ?

4 What was the apparent root cause and contributing casual factors for the violation ?

5. How and by whom (be specific if an NRC inspector) was the violation discovered ?

6. Was the violation required to be reported and, if so, what was the applicable reporting requirement ?

7. Was the violation reported and, if so, when and by whom was it reported ?

8. If the violation was reported, but the report was late, why was the report late ?

9. was the report complete and accurate ?

10. Were there multiple examples of the violation ?

11. What were the opportunities and when did they exist for licensee staff and management to be aware of the violation ?

12. What were the cirucumstances surrounding the violation.which effect the significance of the violation ?

13. Is the violation indicative of programmatic problems or is it an isolated case ?

14. What short tenn corrective and remedial action was taken and when was it taken ?

15. Did NRC have to intervene to accomplish satisfactory short term correction and remedial action ?

16. Were there previous similar NRC inspection or licensee audit findings and, if so, should the corrective actions from those findings have prevented this violation ?

The inspection report details should incluoe times, dates, titles of persons types of equipment, and specific factual information responsive to the above listed questions, as applicable. Potential severity level and enforcement options will not be discussed in the inspection rerort.

1 Attachment 3 l l l PERFORMANCE EVALUATION FACTORS l Licensee: License No.: Date of Inspection: Inspector (s):

1. Does the Radiation Safety Comittee appear to be functioning adequately to successfully implement the licensee's radiation safety program? (e.g., is membership and attendance at meetings adequate? Are adequate reviews of users and/or facilities being conducted? Are meaningful issues being discussed at the meetings?)

( )Yes ( ) No ( ) N/A

2. Is the Radiation Safety Officer (R50) able to perform his or her duties adequately without being burdened by other duties?

( ) Yes ( ) No ( ) N/A

3. Is sufficient staffing available to manage the licensed program workload?

( ) Yes ( ) No ( ) N/A 4 Does licensee management provide support for the radiation safety aspects of the licensed program? ( )Yes ( ) No ( ) N/A

5. Does the licensee have the resources to operate the facility safely and support decontanination of the facilitf if necessary?

( )Yes ( ) No ( ) N/A

6. Is it evident that the licensee is capable of respondinc to a radiological event?

( )Yes ( ) No ( ) N/A

 .                                                                                                            \
   *

• Attachment 3 l

. l l

7. Are periodic audits conducted of the radiation safety program by j the lionsee and/or a contractor and do the audits appear adequate? l i

                   )Yes

( ( )No ( )N/A

8. Are licensee's radiation exposures in accordance with ALARA?

( )Yes ( )No ( )N/A

9. Are reportable events (10 CFR 20.402, 20.403, 20.405) kept .to a level commensurate with the licensee's worklaad?

( ) Yes ( ) No ( )N/A ,

10. Are the number of repeat violations kept to a minimum and has the licensee  !

successfully implemented corrective actions on previous violations? ( ) Yes ( ) No ( )N/A

11. Are safety-related allegations kept to a minimum level? Does the licensee have an adequate system to follow up on complaints?

( ) Yes ( ) No ( ) N/A

12. Are licensee's reports and responses to violations complete, candid and timely?

( )Yes ( ) No ( ) N/A

13. Are misadministrations (diagnostic or therapeutic) kept to a level corrensurate with the licensee's workload?

( )Yes ) No ( )N/A 14 Does the licensee have sufficient instrumentation to safely manage the program and are those instruments properly maintained? (e.g., Is there a l preventive maintanance/ quality assurance progran?) ( )Yes ( ) No ( ) N/A

15. Does the licensee have an adequate program in place to store radioactive  ;

waste safely? (e.g., Are materials properly labeled and inventoried? Is exposure to the elements controllet'?) ( )Yes ( ) No ( )N/A i 2 i

Attachment 3 Inspector's Connents: (Required for any factor given a negative response) e t-

                                                                                                                          <c Action Required: (As deemed by, Region !!! management, i.e., telephone contact, licensee management meeting, increased inspection effort, etc.)

l Action Taken: I i-Section Chief Signature: Date: 3

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