Recent Exemptions Granted from N.J.A.C. 7:28

1. Recent Exemptions Granted from N.J.A.C. 7:28

2. X-ray Brachytherapy Exemption • Department approved Xoft, Inc’s X-ray Brachytherapy for use in NJ on January 29, 2008 • Only approved for post lumpectomy radiation therapy treatment • Manufacturer is developing other protocols which would require additional approval

3. Conditions for Approval • Unit is Exempted from most requirements of N.J.A.C. 7:28-14.3 “Therapeutic x-ray systems with energies less than one MeV” • 18 conditional requirements that users of the Xoft system must meet for exemption to be valid • Manufacturer must supply all purchasers with the conditional approval letter

4. Summary of Conditions for Approval • Users must meet the qualifications of personnel of the American College of Radiology 2005 “Practice Guideline for the Performance of High-Dose-Rate Brachytherapy • Each task of the Brachytherapy treatment must be performed under specific levels of supervision • Source geometry must be verified prior to each patient treatment

5. Summary of Conditions for Approval • “Flexi-shield” and portable shielding must be used • Any mis-administrations must be reported to the DEP hotline • An annual report detailing: (a) the total number of patients treated; (b) the total number of fractions delivered and (c) the total number of medical events and equipment malfunctions

6. Extended Role of MPA • Exemption approved July 31, 2007 N.J.A.C 7:28-22.9(b) 1 & 2 • Those seeking the exemption must make application and receive approval from the Bureau • Application must be accompanied by a letter from the certified medical physicist attesting to the MPA’s training and demonstration of competency in the new QC tests • Medical physicist still responsible for supervision, report content and accuracy of results

7. Extended Role of MPA • The qualified medical physicist may delegate QC test item #8- Half-Value Layer contained in Table 5, Medical Physicist’s Fluoroscopic QC Survey, to an MPA who has had documented training in the performance of this test and has made application to and received approval from the Department to perform this test. (N.J.A.C. 7:28-22.9(b)1)

8. Extended Role of MPA • The qualified medical physicist may delegate QC test items #1-10 contained in Table 5, Medical Physicist’s Fluoroscopic QC Survey, for digital fluoroscopic equipment that is not located in a dedicated interventional special procedure suite to an MPA who has had documented training in the performance of these tests and had made application to and received approval from the Department to perform these tests. (N.J.A.C. 7:28-22.9(b)2 )

9. Extended Role of MPA • Once approved, the MPA must receive specific training by the certified medical physicist in the fluoroscopic tests they will perform • Specific tests performed by the MPA must be clearly identified as such in the medical physicist report • Both the medical physicist and assistant must sign the report

10. Quality Assurance Year 6 Updates

11. Reductions in ESE

12. AP Foot ESE and IQ

13. PA Chest ESE and IQ 2001 N.E.X.T. DATA

14. AP Lumbar Spine ESE and IQ 2002 N.E.X.T DATA 388 mR

15. Image Quality Improvements