ML20217Q449
| ML20217Q449 | |
| Person / Time | |
|---|---|
| Issue date: | 04/24/1998 |
| From: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL, OHIO, STATE OF, OKLAHOMA, STATE OF, PENNSYLVANIA, COMMONWEALTH OF |
| References | |
| SP-98-034, SP-98-34, NUDOCS 9805080129 | |
| Download: ML20217Q449 (22) | |
Text
.\
ALL AGREEMENT STATES APR 2 41998 '
, TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-98-034) ,
Your attention is invited to the enclosed correspondence which contains:
INCIDENT AND EVENT INFORMATION.... ......
c .
l
' PROGRAM MANAGEMENT INFORMATION... l
- TRAINING CO RSE INFORMATION... ............
~ TECHNICAL INFORMATION...... .......... ..... .. .
- OTHER INFORMATION.... . . . ...... .. . . . .....:.XX REVISED INSPECTION .l PROCEDURE 87100, LICENSED MATERIALS PROGRAM Suoolementarv information: The enclosed revised NRC Inspection Procedure (IP) 87100 is being provided for your information only. NRC IP 87100 is being issued for use by NRC Regions.- It was revised to remove wording dealing with the inspection of industrial / academic licensees and industrial radiography licensees. Both of these inspection programs are covered - ;
in separate specific inspection procedures issued since or concurrent with the last revision of IP l 87100, issued February 3,1997 (IP 87100, Industrial / Academic /Research Programs, issued 1 February 3,1997, and IP 87120, industrial Radiography Programs, issued September 2,1997).
Whenever available, NRC uses specific inspection procedures in place of the general IP 87100.
If you have any questions or comments, please contact me or the individual named below.
POINT OF CONTACT: Ronald E. Zelac
. TELEPHONE: (301) 415-6316 FAX: (301) 415- 5369 INTERNET: REZ@NRC. GOV RICff L RT Richard L. Bangart, Director Office of State Programs [
Enclosure:
As stated Distribution: rz~~
DIR RF (8S120)
"24--. '~
. DCD (SP03)
SDroggitis -
p;M me
- M:'y 5 i" T "7 2
' RZetac, NMSS ru n L #~ """ h[ PDR (YES.4) (NO_)
DCool, NMSS
- A/S File DOCUMENT NAME: G:\ ROV \SP98034. ROV *See previous concurrence.
To receive a cop r of this docu,nent, indicate in the box: "C" = Copy without attachment / enclosure "E" s Cop t with attachment / enclosure "N"
- No copy OFFICE OSP- l OSP:DD . l OSP:D [L f l l NAME- RVirgilio:nb:kk PLohaus RBangart [44 DATE- 04/23/98* 04/23/98* 04/ d4 /98 OSP FILE CODE: SP-A-4 9805080129 980424 PDR '
STPRO ESOGEN PDR _
L . e ALL AGREEMENT STATES OHIO, OKLAHOMA, PENNSYLVANIA l.
TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFOR ATION (SP Your attention is invited to the following correspondence which ontains:
i INCIDENT AND EVENT INFORMATION.. . ......
PROGRAM MANAGEMENT INFORMATION....
]
l TRAINING COURSE INFORMATION.... . .. .. ..
1 TECHNICAL INFORMATION........ ... ...... .. ...
1 OTHER INFORMATION.. .. .. . .... ....... . . . ... REVISED INSPECTION l PROCEDURE 87100, LICENSED MATERIALS PROGRAM Supplementarv information: The enclosed revised NR Inspection Procedure (IP) 87100 is being provided for yourinformation only. NRC IP 871 is being issued for use by NRC regions.' It was revised to remove wording dealing wit the inspection of industrial / academic !
licensees and industrial radiography licensees. Both f these inspection programs are covered in separate specific inspection procedures issued sin e or concurrent with the last revision of IP 87100, issued February 3,1997 (IP 87100, Industria Academic /Research Programs, issued February 3,1997, and IP 87120, Industrial Radiogr hy Programs, issued September 2,1997).
Whenever available, specific inspection procedures are to be used in place of the general IP 87100 if you have any questions or comments, please c ntact me or the individual named below.
POINT OF CONTACT: Ronald . Zelac TELEPHONE: (301)4 5-6316 FAX: (301) 4 5- 5369 INTERNET: REZ RC. GOV ichard L. Bangart, Director ffice of State Programs
Enclosure:
As stated Distribution:
DIR RF (8S120) DCD (SP03)
SDroggitis PDR (YESj_.) (NO._.)
RZelac, NMSS DCool, NMSS A/S File DOCUMENT NAME: G:\ ROV \SP98lP. ROV Tt receive a copi of this document, Indicate in the box: "C" = Copy ' attachment / enclosure "E" = Copf with attachrnent/ enclosure "N" = No copy OFFICE OSP ;\ g) OSP/gN/l OSP:D l NAME RVirgilio:nb N PLohauM% RBangart DATE 04/ f.3 /98 04/W/98 04/ /98 OSP FILE CODE: SP-A-4
L 1 guarg l'
lp *n UNITED STATES - :
I.D-W " '[
t
~ NUCLEAR REGULATORY COMMISSION. r
- WASHINGTON, D.C. 30e86-0001 b
,k.gp / . April 24,=1998-i ALL' AGREEMENT STATES '
- l. .OHlO, OKLAHOMA, PENNSYLVANIA-..
f
? TRANSMITTAL ~ OF STATE AGREEMENTS PROGRAM INFORMATION (SP-98-034)i t
.Your attention is invited to the enclosed correspondence which contains:
INCIDENT AND EVENT INFORMATIO' N...........
1 PROGRAM MANAGEMENT INFORMATION.,..
~ TRAINING COURSE INFORMATION.. .............
.1-
. TECHNICAL INFORMATION.. ........ .................. <
p OTHER INFORMATION.............. ................. ...XX REVISED INSPECTION !
PROCEDURE 87100, LICENSED l MATERIALS PROGRAM ,
4
_ Suoolementary Information: The enclosed revised NRC Inspection Procedure (IP) 87100 is .
i being provided for your information only. NRC IP 87100 is being issued for use by NRC '
- Regions. It was revised to remove wording dealing with the inspection of industrial / academic .
licensees and industrial radiography licensees. Both of these inspection programs are covered -
. - in separate specific inspection procedures issued since or concurrent with the last revision of IP 87100, issued February 3,1997 (IP 87100, Industrial / Academic /Research Programs, issued 4
., February 3,1997, and IP 87120, Industrial Radiography Programs, issued September 2,1997).?
E Whenever available, NRC uses' specific inspection procedures in place of the generalIP 87100. > -
[lf you have any questions or comments, please contact me or the individual named below.
. 'M - _
~~
, .. POINT OF CONTACT: Ronald E. Zelac Q. 4i TELEPHONE: (301) 415-6316 i 1.*" . x: FAX: _ .
(301) 415- 5369 .,
o INTERNET: REZ@NRC. GOV -
l (c k At > <rdt
'- Richard L. Bangart, Director
. Office of Stata Programs
, 4
Enclosure:
As stated
l e
NRC INSPECTION MANUAL NMSS/IMNS INSPECTION PROCEDURE 87100 LICENSED MATERIALS PROGRAMS PROGRAM APPLICABILITY: 2800 87100-01 INSPECTION OBJECTIVES 01.01 To determine if licensed programs are being conducted in accordance with NRC requirements.
01.02 ~ To determine if licensed activities are being conducted in a manner that
~
will ensure the health and safety of workers and the general public.
87100-02 INSPECTION REQUIREMENTS-Review of the licensed activities should be~ commensurate with the scope of the licensee's program. To the extent possible, a determination regarding compliance with an NRC recuirement should be based on direct observation of a-work activity, interviews witn workers. a demonstration by a worker of how he/she performs a i task that is regulated by NRC, .or an independent measu'rement of radiation conditions at the facility (rather than exclusive reliance on a review of records). Specific inspection requirements follow:
02.01 Proaram Administration. Review th'e following elements in sufficient depth to verify that organization and administrative systems have been established to ensure safe conduct of the licensed activity.
- a. Oraanization. Reference- Applicable license conditions.
.The organizational structures will be found in license applications and
.may involve one or more individuals. Examine any changes in the organization with respect to changes that have occurred in personnel, functions, responsibilities and authorities since the previous inspection.
If individuals are named in the license application, an amendment must be provided whenever changes in personnel are made (except for some broad and radiography licenses, where only responsibilities are defined). If there have been no changes in the organization since the 3revious inspection.
there is no need to pursue that element in any dept 1 except to ask the licensee if there have been changes and to make inquiries of personnel to confirm (to the inspector's satisfaction) that no changes have taker <
place. l l
l Issue Date: XX/XX/XX 87100 1
(
> b. - - 0A Proaram and Licensee Audits.
References:
Medical QA program to mitigate therapeutic misadministrations (only if the program being inspected has QA requirements in the license). Applicable license L- conditions.
! The quality assurance program will be in the form of procedures specified I in the license and covering a variety of activities and methodologies.
, Generally, the procedures will specify limitations. "do's." and " don'ts." )
I and how to perform one or more tasks. In any event, the licensee is bound '
, to the procedures. The inspector should verify (preferably by direct l
observation) the implementation of a selection of procedural activities to the extent that the inspector is satisfied that procedures are being j followed.
The inspector also should verify that internal audits are performed, as ,
required. The results of audits of activities will be found in records I of audits. Examine those records with particular attention to deficien-cies found by the auditors and note corrective actions taken as a result of deficiencies found. If no corrective actions were indicated whenever deficiencies were found, ask the licensee's representatives what actions were taken and determine why they were not noted in the records.
Internal audits of licensees may involve such determinations as the use l of syringe shields (hospitals), whether technetium generators are properly shielded (hospitals), and whether established ALARA programs are being implemented (all licensees). These are only a few examples: the inspector should examine the licensee's commitments in the license to determine the kinds and extent of audits required.
As one part of assist inspections, the inspector should determine that the licensee's internal inspection program is actually being carried out in
' l that facility. For example, t1e date of the last internal inspection l findings and those corrective actions taken should be determined. The I above information should be included in the. inspection summary report sent ;
to the home region and, if negative, so stated.
- c. Medical Licensees. Radiation: safety quality assurance procedures for radioactive drug and device research programs may be found in the US Food and Drug Administration (FDA) accepted investigational new drug (IND) or investigational' device exemption (IDE) applications. These procedures should be audited by the RSO and/or the Radiation Safety Committee (RSC).
For nuclear medicine and teletherapy secondary checks of dose calculations should be done to provide assurance that the final treatment plan will provide the dose prescribed on the patient's chart, if required in the license,
- d. Trainina.
References:
10 CFR 19.12. Instructions to workers.
10 CFR 34.31. 35.900-972. 39.61. Training.
l Applicable license conditions.
Certain kinds of training and instruction are found in the regulations; how they are implemented will be found in the license. The inspector should verify that proper training and initial instructions are being accomplished as specified in the license or regulations. Discuss with 87100 Issue Date: XX/XX/XX
e licensee's representatives how and by whom the training is conducted and the. content.of the training (generally found in the license application).
Verify. pursuant to 10 CFR 19.12. that the initial instructions have been
.given to workers who. enter restricted areas. Under the basic instruc-tions. . it is management's responsibility to inform the workers of l
precautions to take when entering a restricted area, kinds and uses-of radioactive materials. in that area, exposure levels, and the types of protective equipment to be used. The workers should also be informed of the pertinent provisions of NRC regulations and the license and the
= requirement to notify management of- conditions observed that may, if not corrected, result in a violation of NRC requirements.
Of the training program elements in the license application, training given to authorized users is of primary importance. One or more users of radioactive materials should be interviewed to determine that they have received the required training, both in the basic instructions and that i specified in- the license ap)lication. For medical licensees, this l
- includes specific training neeced to perform infrequent medical procedures and prepare and use radioactive material in medical research studies. -)
Randomly examine records of training of personnel and attendant ' tests or l examinations (if applicable) to the extent that- the inspector is satisfied )
that the training program is being implemented as required. Where examinations are required, read a ' few of the examination questions to ascertain that they are indicative of what the worker should know to carry out his/her responsibilities. l
- e. Doeratina and Emeraency Procedures. Safety Comoonent Defects.
Reference:
10 CFR 39.63. Operating'and emergency procedures. -
l 10 CFR 21.21 Notification of failure to comply or existence-of a defect and its evaluation.
Applicable license conditions.
Operating and emergency # procedures will be found in license applications and may vary from step-by-step procedures to more generalized procedures l for lower inspection priority licenses. The procedures will be approved by the NRC and reviewed and updated by the licensee. Any revision requires an amendment to the license except for broad licenses.
Examine the emergency procedures to determine that the procedures are as approved by NRC. Discuss with.the licensee's representatives, or observe (for the higher priority licensees), the conduct of periodic tests and drills, especially for scenarios involving fires and large releases of
, radioactive material . Also verify that operational procedures are being followed by observation of personnel perf orming tasks at selected work stations 'and comparison of their activities with operational procedure !
requirements.
For uie larger licensees there may be agreements with other agencies to respond to emergencies. Such agreements may be in writing and include .
state regulatory commissions (or equivalent) and hospitals. Generally. l there will be no agreements in writing with fire departments. Discuss with licensee's representatives what has been done to ensure that agencies (for which agreements are in effect) understand their roles in emergency Is' sue Date: XX/XX/XX 87100
'S '
responses. Also' inquire if- fire departments are knowledgeable of fires involving'large quantities of radioactive materials and high radiation
, levels and whether they are equipped to fight such fires.
The inspector may, at his option, visit one or more agencies or departments to determine their understandings of their roles in responding
.to emergencies.
Inspectors should verify that licensees have procedures for reporting defects. The complexity of the procedures will vary. Manufacturers should have detailed procedures to evaluate the safety significance of
, identified defects. 0ther licensees need only to address identification and r'eporting requirements.
- f. Reoorts and Notifications.
References:
10 CFR 19.13 Notifications and reports to individuals.
10 CFR 20.2201 Reports of theft or loss of licensed material.
10 CFR 20.2202 Notifications of incidents.
10 CFR'20.2203 Reports of exposures, radiation levels, and concentratiors of radioactive material exceeding the constraints or -
limits. i 10 CFR 20.2206 Reports of individual monitoring.
10 CFR 31.5 Certain measuring, gauging, or controlling devices.
10 CFR 32.12 Records and material transfer reports.
10 CFR 32.16 Certain items containing byproduct material reports of transfer: Records and reports of transfer 10 CFR 32.20 Records and material transfer reports.
10 CFR 32.25 Conditions of licenses issued under S32.22: Quality control labeling, and reports of transfer.
10 CFR 32.29 Conditions of licenses issued under S32.26: Quality control.' labeling, and reports of transfer.
10 CFR 32.52 Material transfer reports and records.
10 CFR 35.21(a) and (b)(2)(xi) Internal audits or.' inspections and records of the audits.
10 CFR 35.33(a) Reports of therapy misadministrations.
10 CFR 35.33(c) Reports of_ diagnostic misadministrations.
10 CFR 150.20 Recognition'of Agreement State licenses.
Applicable license conditions.
- 1. 10 CFR 19.13 requires that licensees provide individuals with reports of external and internal exposures on an annual basis.
For those employees who worked under contract temporarily and for permanent employees who have left the company, the licensee must provide the report within 30 days. An exception is that when licensees file a report to the NRC, they must also provide reports (of excessive exposures) to the workers involved. The regional offices that receive the reports should examine them for accuracy and completeness.
Prompt follow-up of reports -of excessive exposures under certain conditions may be necessary: for example, reports filed under 10 CFR 20.2202(a) and (b) may require prompt follow-up to determine if adequate medical care is being provided. Other essential items (including medical care) that are missing from the reports (initially reported by telephone, telegraph, etc.) may be obtained by telephone 87100 Issue Date: XX/XX/XX
r or'by' dispatch' of an inspector to the site to determine the causes
'of overexposure'and adequacy of corrective actions.
In the case of high exposures to personnel, if the exposure is believed to be valid, an inspector must be dispatch'ed to the site to conduct an' inspection to support possible escalated enforcement :
action. In these cases, an inspection should be scheduled as.soon as practicable. However, this decision is best left to the judgment of the region. depending on the circumstances set forth -in. the reports and by telephone communications.
During routine inspections, inspectors need only inquire. if 10 CFR 20.2206 reports have been submitted without going into further depth, unless the Office of Resource Management has requested a follow-up l because no report was submitted. Those . reports should ' only be examined at random so that the inspector is satisfied that the g reports are being generated.
- 2. 10 CFR 20.2201 requires licensees to reports . losses or theft of licensed radioactive material when a substantial hazard may result to persons in unrestricted areas.
- 3. The remaining reports listed in 02.01f. deal with leak tests above limits (10 CFR 31.5. 34.25.)] materials transfer reports for manufacture or transfer of certain items (10 CFR 32.12, 32.16, 32.20, 32.25, 32.29 32.52): resorts of medical therapeutic and diagnostic misadministrations [10 C R 35.33(a)) and (c)] and Form 241 reports of. activities conducted in Agreement States (10 CFR 150.20).
- 4. Inspections should be done for therapy misadministrations that result in serious illness or death, etc; -Depending on the content of the reports, where'significant'cause appears to exist for follow-up, the
. ,~
follow-up shall be done promptly to gather additional details about the cause of the' event and the circumstances under which the event occurred. Reports that indicate moderate health and safety problems may be followed up during the next inspection unless there appears to be sufficient cause for possible escalated enforcement actions.
The occurrence of a misadministration is not, in and of itself, the basis for enforcement action unless there is'a' failure to timely and properly report the misadministration as required in 10 CFR 35.33 or there is a violation of other applicable requirements.
- g. ' Records.
References:
10 LtR 20-Subpart L -- Records 10 CFR 20.1101 Radiation Protection Programs.
- 10 CFR 30.41 Transfer of byproduct material.
^10 CFR 30.51 Records. l 10 CFR 35.33 Notification, reports, and records of misadministrations 10 CFR 35.59(e)- Leak testing sealed sources 10 CFR 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
10 CFR 35.632 F'ull calibration measurements 10 CFR 35.634 Pcriodic s)ot checks 10 CFR 35.630 Dosimetry Equipment 10 CFR 35.961 Teletherapy physicist 10 CFR 40.61 Records.
Issue Date: XX/XX/XX 87100
4
' ~
Applicable license conditions.
I During the ' course of an inspection, most items examined will have
!' attendant records to support each portion of the licensed activity. Some records should be only randomly examined: i .e. , spot-checked to the satisfaction of the inspector that the records are being maintained and are complete. Other records that are more closely related to health and -
safety (such as personnel exposure records) should all be examined.
However, examinations of records should not be construed as the primary part of the -inspection program. Rather, observations 'of areas where personnel work, equipment, usage, etc.. will give the inspector a better idea of what is going on than records review and may also support what the records reveal. During examinations of records, look for trends, such as trends in air sampling. . Records such as surveys, waste disposal, effluent release, receipt and transfer of radioactive materials, training, utilization . logs, and air sampling may be examined randomly until the
! inspector is satisfied that the records are being maintained and are complete.
Records that should be examined in their entirety include personnel monitoring; leak testing of sealed sources: instrument calibrations: and l for teletherapy units, full calibration, spot-check measurements and records of calibration of dose calibrators and checks of dose calibrators.
Other records to be examined may be found in license conditions such as
~ ALARA records, records of safety committee minutes, etc.
The extent to which records are to be examined,. either randomly or in their entirety, will depend on the category of the licensee as well as the history of noncompliance of the- licensee inspected. In each case.-
judgment will need to be exercised so that the inspector is satisfied that the licensed program.is being operated safely to protect the health and safety of the workers and general public. 3 i
As a general rule,' records should be examined for the preceding three-year period or back to the last inspection, whichever is less. Older records preceding the three-year period should be inspected if warranted by circumstances: such as a. history of non-compliance or high radiation
-exposures.
02.02 Authorized Materials. Uses. and Users. Determine from reviewing records, 1 observing the use of- radioactive-material.. and discussing the activities with !
licensee personnel, that the ty)e. cuantity, and use of material at ' the licensee's facility are authorizec by the license. Specific records and areas to be reviewed are as follows:
- a. Receiots. Transfers. and Packaae-handlina Procedures.
References:
10 CFR 20.1906 Procedures for receiving and opening packages.
-10 CFR 30.41 Transfer of byproduct material.
'.. 10 CFR 40.51 Transfer of source or byproduct material.
Applicable license conditions.
Depending on the size of the licensed program, the procedures (a few or many) will be found in the license application. The procedures should be carefully reviewed before an inspection is conducted. The reason for such
- a. review is to determine completeness repeated procedures that may be 1
87100 Issue Date: XX/XX/XX
contradictory, and procedures that should be in the application but are missing.
L The procedures for' picking up, receiving, and opening packages should l include how and when packages will be picked up, radiation surveys and wipe tests of. packages upon receipt, and procedures for opening packages, such as'where in the facility packages are received, surveyed, and opened.
The procedures also should include what actions are to be taken if L packages 'are contaminated in excess of specified limits and radiation
. levels are higher than limits (the latter would depend on the package index. i.e., the dose rate at 3 feet for each category). If packages have arrived during the course of an inspection, observe the person performing the surveys as an indication of training.
L The inspector should randomly examine records of surveys of packages received and also determine if inventories for each ' licensed nuclide .is within the license limits. In this regard, records of inventories following receipt and transfer should always show that the materials on hand at any one time are within the license limit. The records examined L should be compared with the physical-inventories of materials possessed.
l By discussions with the licensee, inquire if the procedures. have been l
changed or added to (requiring license amendment except for broad scope licenses and, in general, medical. licensees that can change minor i L procedures by regulation). Randomly examine procedures used by the ;
licensee to determine if they are in accordance with those in the license a) plication (if the licensee's procedures are supplementary to those in t1e license application. or if the changes in certain procedures were .
! minor.)
]
b, Authorized Users.
References:
.i. l 10 CFR 33.17 Conditions of specific . licenses of broad scope. l j Applicable license conditions.
Authorized users will normally,be named in the license application, or, if the license is a broad license, will be appointed as authorized users by the radiation safety committee or isotopes committee. )
The inspector should determine during an insaection that named authorized-users are doing the work authorized rather tlan someone else not named in I the license. This will depend on the wording.in the license with phrases l such as "used by or under the supervision of." Guidance on the phrase l J
.used by or under the supervision of" may be found in the "10 CFR" Section of the IE Manual under 10 CFR Part 30 issued on 10/1/79 entitled " License Condition '. .used by or under the supervision of....'" For some specific or broad licenses (Types A, B. and C) the phrase for users is "under the l direct supervision of' which implies the authorized user should be present at the facility for easy contact or to observe the individual (s) working
-under the authorized user. .
l L However, another phras' e not often seen in licenses is "under the direct ;
I- supervision and. physical presence of" which means the authorized user must l l .directly supervise and be present at the work station. Another phrase <
used for physicians doing patient therapy states "may only be used by."
(
Issue Date: .XX/XX/XX 87100 ;
a
^ '
The_ inspector must use more than the-usual amount of judgment during
. inspections to interpret the role of the authorized users, considering the many-license condition' phrases used above. First, -a determination of-
- p. qualifications should be made. Second for the : broad . licenses, the -
radiation safety committee appoints the authorized users based on
-qualifications.
For a determination of. required traini_ng, see " Training" under 502.01d of
- this - procedure. .In general. authorized users must' be specifically-licensed by the. Commission or otherwise listed in the license application i
l
.and'in a license condition for s ecific tasks that only the individual (s) named can perform. _ This inc udes. -leak testing ;of sealed sources, replacement of sealed sources, and modification and opening for purposes of. repairing or replacing sealed sources in teletherapy units. Such !
i
' authorized users may not be those of the licensee but of a separate firm specifically authorized by the Commission.
j l
L c. Authorized Uses.
References:
l l .10 CFR 33.13 Requirements for the issuance of a Type A specific license 1 '
of broad scope.
L 10 CFR 33.14 Requirements for the issuance of a Type B specific license l of broad scope. I
, 10 CFR 35.100 Medical uses of byproduct material for uptake and dilution studies.
10 CFR 35.200 Use of radiopharmaceuticals, generator, and reagent kits for imaging and localization studies.
10 CFR 35.300' Use of radiopharmaceuticals for therapy.
L' -10 CFR 35.400 Use of sources for. brachytherapy.
10 CFR 35.500 Use of sealed sources for diagnosis!
l 10 CFR 35.600 Use of a sealed source in'a teletherapy unit.
Applicable license conditions. ,
Authorized uses ofi radioactive materials, excluding broad license.
applications. will. be found iri the' licenses- and license applications.
S)ecific-licenses:will: list the isotopes, physical or chemical forms, and-
~
- tie maximum quantities. The l inspector should physically examine the
[ inventory of radioactive material on hand or examine records of receipt -
and transfer to determine that quantities ~and forms are as authorized.
For medical licenses of broad scope (Type:A. B. C) the maximum quantities are listed (or narrated for Type A) in 10 CFR 33.100. For broad licenses,
~
any chemical or physical form is authorized.-
l The inspector must determine that nuclides are used as authorized.
particularly for human use, that could otherwise become a misadministra- i tion if not used as authorized. For medical facilities or institutions. I
- examine patient log books to dete'rmine that radioactive materials are used l lt in proper chemical form on patients. l
! j
- d. Material Control .
References:
10 CFR 20 Subpart'I -- Storage and Control of Licensed Materials l ;
87100 .- Issue Date: XX/XX/XX w
i
- . Applicable license conditions.
The inspector should examine storage areas in unrestricted and restricted i areas. Such storage areas should -be locked and have limited and controlled access. In general there will be procedures for access i
controls. Additional controls should include logging out radioactive material from storage areas and logging it in after use. This is especially important for medical institutions because of the use of small implant seeds for therapy. In the past, many seeds have been lost because.
of the failure of. controls. The inspector also should determine that radioactive storage devices and source changers are locked when in storage and that storage areas also are locked when not in use.
- e. Area Radiation and Contamination Control.
References:
10 CFR 19.11, 10 CFR 21.6 Posting of notices to workers.
10 CFR 20 Subpart D -- Radiation Dose Limits for Individual Members of the Public.
10 CFR 20 Subpart F -- Surveys and Monitoring 10 CFR 20 Subpart G -- Control of Exposure From External Sources in Restricted Areas
)
10 CFR 20.1901 Caution signs.
10 CFR 20.1902 Posting Requirements. )
10 CFR 20.1903 Exceptions to posting requirements. I 10 CFR 20.1904 Labeling containers.
10 CFR 20.1905 Exemptions to labeling containers.
Applicable license conditions. l The inspector should ensure, during observation and by direct measurement.
that the radiation levels in unrestricted areas are within the limits of l 10 CFR 20.1302(b). The limit is 2 mR in any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />. For this regulation. !
occupancy is not a factor. The inspector may ask the licensee to spot- l check radiation levels in selected areas using the licensee's own i instrumentation. However, readings of radiation levels using the licensee's instruments shall not be considered as valid. The inspector must use his/her own instruments that have been calibrated. source checked prior to leaving the regional _ office and checked upon return to see if the calibration is valid.
By definition, surveys of radioactive materials or radiation areas are supposed to be done before the fact, not after an individual gets exposed.
If practicable, observe how licensees conduct surveys to determine the adequacy of surveys. Also, note the types of instruments used, and l whether they are designed for the type of radiation being measured.
During the physical operations review (facility walkthrough) observe that proper caution signs are being used at access points to areas containing radioactive materials, radiation areas, and those areas containing airborne radioactive materials. Randomly observe labeling on packages or other containers to determine that proper information is recorded such as isotope, quantity, and date of measurement. 10 CFR 20.1903 provides exceptions to posting caution signs, primarily for medical institutions.
Some types of licenses, such as those for teletherapy rooms, radiography i (fixed or permanent facilities), and irradiator operations also require signals or alarms, both visible and audible.
Issue Date: XX/XX/XX 87100
' ^
i
- The inspector should examine these to determine-operability. .In addition.
. during the walkthrough examine.. locations:where notices to workers are posted. These should be located so that~ employees.may examine them on their way to and from work locations,
- f. r Packaaina'and Transoo'tation.
References:
10 CFR Part 71 . Packaging of Radioactive Material?for_ Transport and
-Transportation of. Radioactive Materials Under Certain
- Conditions.
49 CFR Parts Use. Inspection Procedure No. 86740. "Transportatim" 170-199- 1as applicable.
- g. Waste Handlina. Use Inspection Procedure No. 84850.T" Radioactive Waste-Management - Inspection of Waste Generator Requirements of 10 CFR-Part 20.
and 10 CFR Part 61."
- h. Performance Evaluation Factors. Use performance evaluation. factors (PEFs) ;
to assess the potential for degraded safety performance in priority 1. 2.' l and 3. licensees. See Inspection Procedure 87101 for requirements and guidance concerning PEFs. ,
1 02.03 Physical Plant Facilities and Eauioment i General. Most of the following line items are found 1ri license applications and 1 will vary, depending on the type of licensed activity, and may not be all inclusive. ~ These items should be inspected during the facility tour (operations review). Other items may be identified in the regulations and also may be -
repeated in the license application for implementation of the requirements.
References:
10 CFR 20.1003 Unrestricted area (Definitions.)
Radiation area '
High radiation area - . -
10 CFR 20 Subpart I Storage.and Control of Licensed Material- l .
10 CFR 35.632-647 Teletherapy requirements. !
Review and-verify that the equipment and the physical facility promote safe conduct of the licensed activity;. .The facility and equipment should conform to that~ described in the license application and the equipment should be operable.
.-Systems, subsystems, and equipment important to the safe handling of materials and protection of operating personnel and the public should be. (1) examined for operability and:(2) designed to carry out . intended functions.
Examine records of the most recent five-year teletherapy maintenance program.
- Some specific items which may need maintenance. include the following, although these are~nct the only items to be serviced.1
- a. Field-light Cord Reel.
- b. Source drawer solenoids.
l'May'_not be applicable to all types of units.
871001 Issue Date: XX/XX/XX
- c. ' Low air pressure switch.
. d. Air hoses and fittings.
F
- e. Treatment timer.
02.04 Radiation Protection.
a General. Use Inspection Procedure 83822 " Radiation Protection" as applicable.
- b. Medical Licensees -
References:
10 CFR 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
Determine by observinc'. and discussing with the licensee. that a process exists to establish that a patient administered radioactive material is releasable from control under 10 CFR 35.75. Determine that written instructions are provided to released individuals on actions recommended to maintain doses ALARA if doses to other individuals are likely to exceed 0.1 rem. Verify that the licensee is recording (a) the basis for release of patients, when necessary, and (b) that instructions were provided to a breast-feeding woman when. required.
02.05 Radioactive Effluents and Waste Disoosal. Regulatory references and license applications:
,10 CFR 20.1101 Radiation Protection Programs.
10 CFR 20 Subpart D -- Radiation Dose Limits for Individual Members of the Public 10 CFR 20 Subpart K -- Waste Disposal 10 CFR 20.2101 General provisions:(Records).
10 CFR 20.2103 Records of surveys. .
10 CFR 20.2108 Records of waste disposal.
10 CFR 20.2107 Records of dose to individual members of'the public.
10 CFR 20.2110 Form of records.
'10 CFR 30.51 Records.
Review and verify that waste-handling equipment, monitoring equipment. and/or administrative controls are adequate to maintain radioactive effluents within the limits established by the license and other regulatory requirements and are ALARA. Verify that the licensee's air effluents, excluding Radon-222 and its daughters. have not exceeded the constraint limit in 10 CFR 20.1101. If the licensee has exceeded the constraint, verify that the licensee has notified the j NRC as required by 10 CFR 20.2203. If the licensee has notified the NRC that its air effluents have exceeded the constraint limit. review the effectiveness and timeliness of the licensee's corrective actions.
Note, exceeding this constraint limit will not result in a Notice of Violation (NOV). In the case of the constraint rule. an NOV will be issued only if and when (1) a licensee fails to report an actual or estimated dose from airborne effluent releases from a facility that has exceeded the constraint value; or (2) if a licensee fails to institute agreed upon corrective measures intended to prevent further airborne effluents in excess of those which would result in doses exceeding ~the constraint level.
}
Issue Date: XX/XX/XX 87100
Examine the waste release records generated since the last inspection, all annua'l or semiannual reports, all pertinent non-routine event reports, and a random selection .of liquid and . airborne waste release records. . Randomly select
. procedures for both liquid and airborne systems and . verify that.the procedural
( steps are being followed. The verification should be made by whatever means are-available: .i.e., perform an observation of an operation, a review of selected records. etc.
-02.06 . Confirmatory Measurements. Compare / verify 6n a sampling basis survey g results or data that are used by the licensee to show compliance with the regulations.or license conditions. Examples of confirmatory measurements are:
- a. physical surveys, using the region's own instrumentation,
- b. split samples. etc.
02.07 Reauired Scoce of Selected Materials Insoections. The attachments contain standard formats for recording the results of inspections of radiography.:well
. logging, nuclear medicine and teletherapy licensees. Individual topics define the required scope of inspection for NRC inspections of these types of licensees.-
87100-03 INSPECTION GUIDANCE General. All inspections should include a mix of records and procedures review, observations, confirmatory. measurements, and discussions with personnel involved in the " hands on" work.
03.01 Procram Administration
- a. The regulatory requirements related to the organization and administration of the licensed program will be contained in license conditions. The organization should be examined to verify that..the. responsibilities and authorizations of designated individuals comply with ' license conditions. ;
- b. The inspection is a verification of implementation of the recuired program. In the review to verify implementation, the inspector shou'd pay attention to the scope of the programs; frequency of licensee' audits: the use of qualified auditors: procedure for recording and reporting deficiencies to management: methods and completion of follow-up actions ,
by management; and the policy regarding announced and unannounced audits.
- c. No guidance.
- d. In verifying the implementation of the approved or required training ,
program pay attention to completic of requirements related to: initial )
traini ng, periodic retraining, on-the-job training, and tests and 1 examinations of trainees (if applicable).
Inspectors should verify that procedures have been developed to implement I the program, and that the staff has been trained in using these '
procedures. It is not the intent that inspectors routinely review and cite against internal procedures and protocols for the administration of byproduct material for medical use. Only in instances where there has been an event, misadministration, or evidence of a loss of management control is an in-depth review of internal procedures and protocol indicated. In such cases, the review should determine that necessary 87100' Issue Date: XX/XX/XX
1-procedures are in place. and that adequate training or instruction has taken place prior to the administration of byproduct material. Failure to provide adequate procedures, and/or training could be a violation of i
In . those instances where a performance error has resulted in the administration of byproduct material not in accordance with the physician's directions and also involves the failure to follow the
-instructions of the authorized user. or supervising authorized user, the procedures of the Radiation Safety Officer. or to comply with the regulations or licensing conditions. there could be a violation of 10 CFR 35.25(b) for lack of adequate supervision. If however, the event or misadministration was more clearly an isolated human error, e.g.,
distraction due to heavy workload, picking up the wrong container of radiopharmaceutical, etc. then 10 CFR 35.25 should not be cited.
)
10 CFR 35.25 should only be cited in instances where no other regulation I is applicable to the violation. In other words, this regulation should I not be used as a catch-all for poor programmatic management which is not I s)ecific to supervision and training. It -is imperative to determine l w1 ether adequate supervision has been provided the supervised individual 1 has followed instructions, or whether human error has occurred. If i indicated, the appropriate section of 10 CFR 35.25 should then be cited. j
- e. Regulatory requirements related to procedures will be contained in license conditions. It is necessary to verify' that operating and emergency procedures have been developed, are adequate and functional, and have been reviewed and approved by management.
- f. No guidance.
9 No guidance.
03.02 Authorized Materials. Uses. and Users General. Authorized materials, uses, and users are generally described. and I authorized by the license, or as otherwise authorized in 10 CFR 33. I
- a. Receipt and transfer of materials should generally be detailed in procedures sufficient to provide assurance of compliance with regulatory requirements. Specific requirements are set forth in 10 CFR 20.1906. It i is necessary to assure that only authorized persons are involved in the transfer and receipt of materials.
The frequency of inventories is dictated by need or as specifically set forth in certain parts of 10 CFR or in license conditions. License inventories can be used for two purposes: (1) to track the use of material, and (2) to verify that the licensee is only receiving materials authorized in the amounts listed in the license.
- b. No guidance,
- c. No guidance.
- d. Various strategies for control of materials should be in place. These are
[ generally defined by procedures and should ensure that use is limited to authorized users and that secure storage is provided.
L Issue Date: XX/XX/XX 87100
~
'e. No guidance.
4
. f. Specific guidance is set forth in Inspection Procedure 86740.
- g. Specific guidance is set forth in Inspection Procedure 84850.
- h. Follow the guidance on PEFs in Inspection Procedure 87101.
03.03 Physical Plant Facilities and Ecuioment. Descri)tions of the )hysical plant are generally found in the applications for a icense and su) sequent amendments that are usually tied down to a license condition. TM octual or as-built facility should be configured to provide safe working amas separated from unrestricted areas and sufficient access controls to preclude unauthorized entry.
.The facility should include utilities and other services sufficient to cope with emergencies, such as loss of power, loss of contamination control, etc.
Plant equipment is generally described in documents as noted above. Plant equipment should be appropriate to the scope of the licensed program. Processing equipme" associated process control equipment and ventilation and exhaust systems should be sufficient to provide safe use, handling, and storage of the materials in use.
For the five-year maintenance of teletherapy units, critical repairs and maintenance may be recommended by service representatives, but might not be completed by the licensee. Talk to licensee representatives about any needed repairs, and get commitments to comp.c e repairs immediately.
03.04 Radiation Protection.
- a. Specific guidance is set forth in NRC Inspection Procedure 83822.
- b. The inspection of the patient release criteria is to be performance-based.
The inspector should be familiar with the content of Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials." Four distinct objectives must be addressed in establishing compliance with 10 CFR 35.75.
(1) The patient release criteria permits licensees to release individuals from control if the TEDE to any other individual is not likely to exceed 0.5 rem. The quantities of radiopharmaceuticals (dosage) administered to patients for most, if not all, diagnostic studies will deliver less than 0.5 rem to other individuals. The licensee should be familiar with Regulatory Guide 8.39. The inspector should l bring this Regulatory Guide to the attention of appropriate '
individuals if the licensee is not familiar with the Guide. In particular, the licensee should be familiar with the table of activities and dose rates for authorizing patient release and giving instructions. If the licensee is not using the tables in the .
Regulatory Guides as the basis for releasing the patient, the i licensee's practices should be reviewed. )
1 (2) The licensee should be familiar with the requirements in 10 CFR l 35.75(b) to provide instructions to released individuals if the dose i to any other individual is likely to exceed 0.1 rem. In gerieral, the l licensee is required to give instructions, including written '
instructions, on how to maintain doses to other individuals as low as is reasonably achievable. The inspector should determine how the 87100 Issue Date: XX/XX/XX 1
~ ~
^
licensee is demonstrating' compliance with this requirement ? by l reviewing'a sample instruction and/or discussing the content of the
. instructions with a)plicable staff. If the licensee is required by -
i the . rule to provice instructions to a breast-feeding woman, the inspector _ should confirm that the instructions include guidance on
.the interruption or discontinuation of breast-feeding and information
.on the consequences of. failure to follow the guidance.
(3) Verify that the licensee maintains. for three years, a record of the i release if the TEDE has been calculated (1) using' the retained activity rather. than - the activity administered. (2). using an occupancy factor less than 0,25 at 1 meter.'(3) using.the biological or effective half-life, or (4) considering the shielding by tissue.-
- If the licensee is not using these criteria, no' record of the release l is required.
(4) If the TEDE to a breast-feeding child could exceed 0.5 rem if the
- breast-feeding were . continued. verify that the licensee is
! documenting that instructions are being.provided as required by the 10 CFR 35.75(d).
L 03.05 Radioactive Effluents and Waste Discosal. Review the reports and records for obvious mistakes. anomalous measurements, trends, missing, data (compare the recorded data with the requirements)., and verify the accuracy of the data in the report or . record with the licensee if any:of these ' aspects are identified or suspected. ,
' Verify that the licensee's air effluents, excluding Radon-222 and its daughters, have not exceeded the constraint' limit in 10 CFR .20.1101. Information on
-evaluating air. effluents is available in Regulatory Guide 4,20. " Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors'." If the licensee estimated or measured a dose to the i nearest individual member of the public from air emissions greater than 10 mrem.
- per year, the licensee should have notified the NRC (10 CFR 20.2203(a)(2)(iv).
If-the licensee has notified the NRC that its air effluents have-exceeded the constraint limit, the inspector should review the effectiveness and timeliness 4 of the licensee's corrective F.tions, Records of the results of measurements and calculations needed to evaluate the' release of radioactive effluents to the
- - environment are required purst, ant to 10 CFR 20.2103(b)(4), ;
L L 03.06 Confi rmatory Measurements. Confirmatory measurements should be -in-sufficient' scope to verify survey results or data as found in the licensee's
- records. - Examples: radiation levels in an unrestricted area; airflow to process.
or fume hoods; and air samples in process areas.
87100-04 ADDITIONAL REFERENCES Program' Administration .(Section 03.01)
(RG7.1- Administrative Guide for Packaging and Transporting Radioactive Material.
RG 7.7 Administrative Guide for verifying Com311ance With Packaging
' Requirements for Shipments of Radioactive iaterials.
RG 8.2 Administrative Practices in Radiation Monitoring.
RG 8.10- Operating Philosophy for Maintaining Occupational Radiation Exposures
-As low As Is Reasonably Achievable.
~
Issue Date: XX/XX/XX 87100
'..RG 8.13-
_ Instruction Conc'rning e Prenatal Radiation Exposure.
RG 8.15 Acceptable Programs for Res)iratory Protection. .
. RG 8.18 Information Relative to Ensuring That- Occupational Radiation
- Ex)osures at' Medical Institutions Will.. Be - As Low As Reasonably Ac11evable.
RGJ10.1 Compilation of' Reporting Requirements for Persons Subject to NRC l Regulations. I RG 10.3 . Guide for the Preparation of Applications for. a Special . Nuclear
- Material License of Less Than Critical Mass Quantities.
RG 10.5 - Applications for Type A Licenses of Broad Scope. I RG 10.8 Guide for the Preparation of Applications for Medical Programs.
RG 10.9' . Guide for the Preparation of Applications for Licenses for the Use of Gamma Irradiators.
DRAFT RG Guide for the' Preparation of Applications for Licenses in Medical Teletherapy Programs.
Authorized Materials. Uses. and Users (Section 03.02)
.RG 6.1 Leak. Testing Radioactive Brachytherapy Sources.
RG 7.2 . Packaging and Transporting of Radioactively Contaminated Biological Materials.
-RG 7.3 Procedures for Picking 'up and Receiving Packages of Radioactive <
Material. I RG 7.4 Leakage Tests on Packages for. Shipment of Radioactive Materials.
RG .8.21 Health Physics Surveys for Byproduct Material at NRC-Licensed Processing and Manufacturing Plants. l Physica1 I Plant Facilities and Ecuioment. (Section 03.03)
RG 3.2 Efficiency Testing of Air-Cleaning Systems Containing Devices for Removal of Particles.
RG 8.1L Radiation Symbol. ..
l RG 8'. 5 Immediate Evacuation Signal.
Radiation Protection (Section>03.04)
RG 8.3 Film Badge Performance Crit'eria.
RG 8.4 Direct-Reading and Indirect-Reading Pocket' Dosimeters, RG 8.6 Standard Test Procedures =for Geiger-Mueller. Counters.
~
RG 8.7 0ccupational Radiation Exposure Records System; RG 8.9 Acceptable Concepts Models, Equations. Assumptions for a Bioassay Program.
-RG 8.14 Personnel Neutron Dosimeters.
-Acceptable Programs for Respiratory Protection.
RG.-8.20 Applications of Bioassay for -I-125 and I-131.
RG 8.21 Health Physics Surveys for Byproduct ~ Material at NRC-Licensed H Processing and Manufacturing Plants. :
RG 8.23 Health Physics Surveys at Medical Institutions.
RG 8.25. Calibration and Error Limits of Air Sampling Instruments for Total Volume of Air Sampled.
RG 8.28 Audible Alarm Dosimeters.
RG .8.39 Release of. Patients Administered Radioactive Materials i Radioactive Effluents'and Waste Disoosal (Section 03.05) i RG 4.15 Ouality Assurance for- Radiological Monitoring Programs (Normal Operations) - Effluent Streams and the Environment.
87100 Issue Date: XX/XX/XX
R5 4.20 Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors
- . RG 7.1 ' Administrative Guide .~for Packaging and Transporting Radioactive Material.
RG~ 7~.4 Leakage Tests on Packages for Shipment of Radioactive Materials.
Requirements for Shipments of Radioactive Materials.
RG 7.5 -Administrative Guide for Obtaining Exemptions From Certain NRC Requirements Over Radioactive Material Shipments.
i RG 7.7 Administrative Guide for, Verifying Compliance with Packaging.
Appendices:
A. Medical Teletherapy Inspection Field Notes.
B. Nuclear Medicine Inspection Field Notes C. Well Logging Inspection Field Notes F. Commercial Irradiator Inspection Field Notes l G. Medical Broad-Scope Inspection Field Notes ,
H. Radiopharmacy Inspection Field Notes l END 1 i
i I
Issue Date: XX/XX/XX 87100
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,,,,,8 April 15, 1998 MEMORANDUM TO: Richard L. Bangart, Director Office of State Programs e
FROM: Donald A. Cool, Director -,f
- I' Division of Industrial and Medical Nuclear Safety, //NMSS N (/[C /
?S 3$-c
SUBJECT:
REVISED INSPECTION PROCEDURE 87100, 9 LICENSED MATERIAL PROGRAMS q)
D The attached Inspection Procedure (IP) 87100 is being issued for use by the regions. It was revised to remove (strike out) wording dealing with the inspection of industrial / academic licensees and industrial radiography licensees. Both of these inspection programs are covered in separate specific inspection procedures issued since or concurrent with the last revision of IP 87100, issued 02/03/97 (IP 87110-industrial / Academic /Research Programs, issued 02/03/97, and IP 87120-Industrial Radiography Programs, issued 09/02/97). Whenever available, specific inspection procedures are to be used in place of the general IP 87100.
This document is being provided for your information and consideration as to whether Agreement States should be informed of the revision.
Attachment:
As stated.
cc: R. Blough, RI D. Collins, Rll C. Pederson, Rlli R. Scarano, RIV CONTACT: Ronald E. Zelac, NMSS/IMNS (301) 415-6316 i
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