Medical – Policy Changes

Peter H. Myers, ManagerRadioactive Material Licensing Group

Topics for Discussion

License Renewal Periods Default Financial Assurance Amounts

Mobile Nuclear Medicine Dx Nuclear Medicine Model Procedures

Information Notices

License Renewal Periods

Renewal periods had been: 7 years for higher risk licensees 10 years for lower risk licensees

Renewal periods are now: 10 years for all licensees

Rationale: Assists in managing workload No adverse affect on pubic health & safety Matches NRC renewal period

License Renewal Periods

License Renewal Periods

Default financial assurance amounts

$750K now $850K $150K now $170K $ 75K now $ 85K

Licensees using default financial assurance will be required to increase their financial assurance when renewing their license

Mobile Nuclear Medicine

Full-service, in van

Full-service, in client-site

Limited service, in van

Mobile Nuclear Medicine Full-service, in van

• Possession/use of Dx NucMed material

Mobile Nuclear Medicine Full-service, in van

• Possession/use of Dx NucMed material• Delivery to service’s licensed site

Mobile Nuclear Medicine Full-service, in van

• Possession/use of Dx NucMed material• Delivery to service’s licensed site• Injection/scanning in van at client sites

Mobile Nuclear Medicine Full-service, in van

• Possession/use of Dx NucMed material• Delivery to service’s licensed site• Injection/scanning in van at client sites• Survey/decon before departing client site

Mobile Nuclear Medicine Full-service, in van

• Possession/use of Dx NucMed material• Delivery to service’s licensed site• Injection/scanning in van at client sites• Survey/decon before departing client site• APU supervise each technologist at a

reasonable frequency (e.g., once/month)

Mobile Nuclear Medicine Full-service, in van

• Possession/use of Dx NucMed material• Delivery to service’s licensed site• Injection/scanning in van at client sites• Survey/decon before departing client site• APU supervise each technologist at a

reasonable frequency (e.g., once/month)• Provide actual schedule to Agency when

requested to allow for inspections.

Mobile Nuclear Medicine Full-service, in client-site

• Possession/use of Dx NucMed material

Mobile Nuclear Medicine Full-service, in client-site

• Possession/use of Dx NucMed material• Delivery to service’s licensed site

Mobile Nuclear Medicine Full-service, in client-site

• Possession/use of Dx NucMed material• Delivery to service’s licensed site• Service takes control of client-site

Mobile Nuclear Medicine Full-service, in client-site

• Possession/use of Dx NucMed material• Delivery to service’s licensed site• Service takes control of client-site• Injection/scanning in client sites

Mobile Nuclear Medicine Full-service, in client-site

• Possession/use of Dx NucMed material• Delivery to service’s licensed site• Service takes control of client-site• Injection/scanning in client sites• Survey/decon before departing client site

Mobile Nuclear Medicine Full-service, in client-site

• Possession/use of Dx NucMed material• Delivery to service’s licensed site• Service takes control of client-site• Injection/scanning in client sites• Survey/decon before departing client site• APU supervise each technologist at a

reasonable frequency (e.g., once/month)

Mobile Nuclear Medicine Full-service, in client-site

• Possession/use of Dx NucMed material• Delivery to service’s licensed site• Service takes control of client-site• Injection/scanning in client sites• Survey/decon before departing client site• APU supervise each technologist at a

reasonable frequency (e.g., once/month)• Provide actual schedule to Agency when

requested to allow for inspections.

Mobile Nuclear Medicine Limited-service, in client-site

• Service transports equipment to client

Mobile Nuclear Medicine Limited-service, in client-site

• Service transports equipment to client• Client has own Dx NucMed license

Mobile Nuclear Medicine Limited-service, in client-site

• Service transports equipment to client• Client has own Dx NucMed license• Service does not possess/use material;

Client injects/scans in client site

Diagnostic Nuclear Medicine Model Procedures

• Work Group• Consultants

• Danny Harris, George Janik, Cathy Jones, Chuck Lazarre, Kitz Parker, John Pickett

• DSHS• David Wood, Scott Kee, Pete Myers

Diagnostic Nuclear Medicine Model Procedures

Diagnostic Nuclear Medicine Model Procedures

Information Notices

11/26/06 Release of Patients

01/08/07 IR Cert Exam Cost Increases

02/14/07 Increased Controls

04/13/07 Medical Physicists

07/27/07 Fingerprinting

Information Notices 11/26/07 Release of Patients

• Advise patients alarms may trigger

• Provide patients with licensee’s busi- ness card and information for use by law enforcement/security officials.

Information Notices 01/08/07 IR Cert Exam Costs

• Cost recovery catch-up (12 years ago)

• Was $40; now $60

Information Notices 02/14/07 Increased Controls

• Based on NRC’s 1st year of inspections

• Informs licensees of information and resources available to answer questions

• Documents some common issues identified during inspections.

Information Notices 04/13/07 Medical Physicists

• Based on new Part 35 T&E requirements

• Texas’ Part 35-counterpart expected to be effective 10/01/07• No grandfathering• Get listed on a license now; need:

• LMP (Therapeutic Radiological Physics) &• Certificate of manufacturer’s training, or• Documented Broad-scope RSC approval.

Information Notices 07/27/07 Fingerprinting

• Provided addressees advance notice of impending new requirement.

• Fingerprinting and FBI ID & criminal history check for unescorted access.

Discussion