Review

The assigned health physicist will visit before preparing a Hazards Evaluation, which is counter‐signed by the RSO or designate, and returned to the PI. All affected project staff must review and sign the Hazards Evaluation before it is filed in the Radioisotope Journal.

Approval

The RSO approves C‐level CRAs; an information copy is sent to the LCC chairman. The application and hazards evaluation for B‐ and A‐level CRAs are circulated to the appropriate LCC for approval via fax. Any member can request that the committee convene to discuss items of concern. The initial term of an approval is one year. Shortly after the project has begun operation the health physicist will visit to ensure that administrative and technical procedures have been implemented.

Amendments and Renewals

Substantive amendments undergo the same application, review, and approval process that is applied to new applications. Non‐substantive amendments, and renewals of CRAs that have a good safety record, are subject to the same administrative process, but are approved by a single member of the LCC or APRS in the name of the chairman.

Non‐substantive amendments include adding radionuclides or changing inventory limits that do not change the C‐, B‐, or A‐level characterization of the CRA, or adding laboratory procedures that are similar to those already approved. Health Physics will add Quantities of Licensed Material Requiring Labeling QLM quantities to a CRA based on a telephone request.

Renewal period

Projects that do not involve human subjects and that have very good safety and compliance records are usually given a two‐year renewal.

Recovery plan

Projects with significant or repeated safety or non‐compliance violations receive short‐term, provisional renewals and enhanced safety oversight. If significant problems are uncovered during any visit, the PI will be required to meet with the LCC to explain why the problems occurred. The PI and the LCC will develop a recovery plan to correct the problems and to avoid recurrence.

Plan ahead

The administrative process of preparing an application and hazards evaluation for approval can be lengthy. The PI can fax documents to reduce turnaround time. However, committee members will not interrupt their work schedules to accommodate the needs of the PI. It is essential that the work schedule provide adequate time for safety review.

Inspection

During the term of the CRA, Health Physics will conduct periodic surveys and an inspection at the end of the term to assure safety and compliance.

Deficiencies

During the inspection, deficiencies might be uncovered. Deficiencies that are occasionally observed include: incomplete room surveys; lack of on‐the‐job training; incomplete use records; inadequate security of radioactive materials; violations of waste handling; labeling and disposal regulations; evidence of food or beverages in laboratory work areas; or inadequate attention to work rules. Deficiencies must be corrected.  Failure to correct deficiencies, and prevent their reoccurrence, jeopardizes the institutional license.

Suspensions

When necessary, due to overexposure, injury to personnel, survey data that indicate that continued operation poses an unacceptable risk, falsification of records, or multiple or uncorrected deficiencies, the RSO may restrict, modify or terminate the CRA pending review by the appropriate LCC or the APRS.

Moving, modifications, or termination

Project Directors must notify Health Physics at least thirty days before changing laboratory facilities or terminating a project. All radioactive sources must be properly transferred or disposed of.  Rooms, facilities and apparatus used by the project must be decontaminated so when measured by Health Physics, they meet the standards for uncontrolled areas. When surveys have been completed, Health Physics will remove signs from rooms and equipment, take custody of project radiation safety records, and terminate the project, if appropriate. Note that PIs or departments are responsible for costs of decommissioning.