United States Nuclear Regulatory Commission - Protecting People and the Environment

Change Notice 02-041

Issue Date: 11/15/2002

NRC INSPECTION MANUAL IIPB

All Files in ZIP Format cn 02-041.zip


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  DELETED: TRANSMITTED:
  Number Date Number Date
1. 2800/029, Rev 2 02/07/02 ---- ----
2. 2800/031 12/14/00 ---- ----
3. 2800/033 04/02/02 2800/033 Rev 1 10/21/02
4. IP 87115 08/28/00 ---- ----
5. IP 87116 08/28/00 ---- ----
6. IP 87118 08/28/00 ---- ----
7. IP 87119 08/28/00 ---- ----
8. ---- ---- IP 87130 10/24/02
9. ---- ---- IP 87131 10/24/02
10. ---- ---- IP 87132 10/24/02
11. ---- ---- IP 87133 10/24/02
12. ---- ---- IP 87134 10/24/02


TRAINING:

No special training requirements have been identified for any documents issued with this change notice.


REMARKS:

TI 2800/029, Revision 2 (Nuclear Medicine Programs) is being replaced by IP 87130, Nuclear Medicine Programs – Written Directive Not Required, and IP 87131, Nuclear Medicine Programs – Written Directive Required. The new IPs incorporate the revised 10 CFR Part 35 and the 7 risk-informed Focus Elements and describes the performance-based approach.

TI 2800/031 (Extremity Exposure Monitoring) is being replaced by IP 87130, Nuclear Medicine Programs – Written Directive Not Required, IP 87131, Nuclear Medicine Programs – Written Directive Required, IP 87132, Brachytherapy Programs, IP 87134, Medical Broad Scope Programs. The new IPs incorporate the revised 10 CFR Part 35 and the 7 risk-informed Focus Elements and describes the performance-based approach.

TI 2800/033, Revision 1 (Revised Materials Inspection Program) has been revised to indicate testing of 5 revised procedures used for inspection of medical licensees during the period of this revised TI. Attachment A (Revised Materials Inspection Program) was further revised to implement conforming changes from the revised inspection procedures. The changes include: (1) removing terms for core and non-core inspections and for misadministrations, (2) inserting topics into the basic inspection process about safety culture awareness and elements that are common to most inspections (e.g., entrance and exit meetings , follow up items, general overview, observations, measurements, special conditions). In addition, Attachment A was revised to: (1) indicate reduction of inspection interval if a temporary job site inspection was not performed, (2) list elements of a "complete" NMED record, and (3) update MCs and IPs from the NRC Inspection Manual that are applicable to IMC 2800.

IP 87115 (Nuclear Medicine Programs) is being replaced by IP 87130, Nuclear Medicine Programs – Written Directive Not Required, and IP 87131, Nuclear Medicine Programs – Written Directive Required. The new IPs incorporate the revised 10 CFR Part 35 and the 7 risk-informed Focus Elements and describes the performance-based approach.

IP 87116 (Medical Teletherapy Programs) is being replaced by IP 87133, Medical Gamma Stereotactic Radiosurgery and Teletherapy Programs. The new inspection procedure incorporates the revised 10 CFR Part 35 and 7 risk-informed Focus Elements and describes the performance-based approach.

IP 87118 (Brachytherapy Programs) is being replaced by IP 87132, Brachytherapy Programs. The new inspection procedure incorporates the revised 10 CFR Part 35 and 7 risk-informed Focus Elements and describes the performance-based approach.

IP 87119 (Medical Broad Scope Programs) is being replace by IP 87134, Medical Broad Scope Programs. The new inspection procedure incorporates the revised 10 CFR Part 35 and 7 risk-informed Focus Elements and describes the performance-based approach.

Note: In each new inspection procedure indicated below, Section 01 (Objectives) is similar to the formerly stated objectives; Section 02 (Requirements) describes 7 risk-informed Focus Elements; and Section 03 (Guidance) describes the performance-based approach to be used by an inspector to assess licensee performance of these elements. An inspector shall develop inspection findings based on direct observation of work activities, interviews with workers, demonstrations by workers performing tasks regulated by NRC, and independent measurements of radiological conditions at the facility, rather than exclusive reliance on a review of the licensee's written procedures and records.

IP 87130 (Nuclear Medicine Programs, Written Directive Not Required) is a new inspection procedure to assess a licensee's implementation of revised 10 CFR Part 35 for use of unsealed byproduct material or uptake, dilution, and excretion studies, and for imaging and localization studies for which a written directive is not required. IP 87130 replaces those portions of Temporary Instruction 2800/029 Revision 2 and IP 87115, Nuclear Medicine Programs, which are being delisted from the NRC Inspection Manual.

IP 87131 (Nuclear Medicine Programs, Written Directive Required) is a new inspection procedure to assess a licensee's implementation of revised 10 CFR Part 35 for I-131 sodium iodide greater than 1.11 Megabecquerels (MBq) (30 microcuries (µCi)) and any therapeutic dosage of unsealed byproduct material for which a written directive is required. IP 87131 replaces those portions of Temporary Instruction 2800/029 Revision 2 and IP 87115, Nuclear Medicine Programs, which are being delisted from the NRC Inspection Manual.

IP 87132 (Brachytherapy Programs) is a new inspection procedure to assess a licensee's implementation of revised 10 CFR Part 35 for medical use of sealed sources containing byproduct material in manual brachytherapy or in a remote afterloader units. IP 87132 replaces IP 87118, Brachytherapy Programs which is being delisted from the NRC Inspection Manual.

IP 87133 (Medical Gamma Sterotactic Radiosurgery and Teletherapy Programs) IP 87133 is a new inspection procedure to assess a licensee's implementation of revised 10 CFR Part 35 for medical use of sealed sources containing byproduct material in gamma stereotactic radiosurgery units and in teletherapy units. IP 87133 replaces IP 87116,Teletherapy Programs, which is being delisted from the NRC Inspection Manual.

IP 87134 (Medical Broad Scope Programs) is a new inspection procedure to assess a licensee's implementation of revised 10 CFR Part 35 for medical broad scope programs which use unsealed and sealed sources of byproduct material for research and development, medical research, diagnosis and therapy. IP 87134 replaces IP 87119, Medical Broad Scope Programs, which is being delisted from the NRC Inspection Manual.

DISTRIBUTION: STANDARD

END

Page Last Reviewed/Updated Thursday, March 29, 2012