Converting to Digital

What steps do I take?

  STATE OF NC

   1.  Have your physicist perform a plan review and submit to Radiation Protection.  Digital units require a new plan, even if placed in the exact location as the previous screen/film unit due to potential increases in patient volume and dose.  Plans are submitted to:

NC Radiation Protection
Attention:  Bonnie Poole  
3825 Barrett Drive  Raleigh, NC  27609
Phone:  (919)571-4141   Fax:  (919)571-4148

   2.  When the plan is approved, a letter of acknowledgement is issued from Radiation Protection.  IT IS IMPORTANT THAT YOU KEEP THIS LETTER FOR REVIEW DURING INSPECTION.  Your vendor is NOT TO INSTALL without this letter of acknowledgement.

   3.  Once the plan is approved and acknowledged,  your vendor may install your unit and give you FDA form 2579 Report of Assembly.  Your unit must be installed according to the acknowledged plan.  Any variations will require that a new plan be submitted to Radiation Protection.  Installation must reflect the room layout acknowledged in the plan.

   4.  After installation, your physicist will need to perform a radiation safety survey.  The safety survey does not have to be submitted to Radiation Protection, but is another important document you will need to maintain for review during inspection.

 

 

ACR/FDA

   1.  Your first point of contact is the ACR.  You will need to contact them at 1-800-227-6440 to apply for accreditation.  You may also visit their website for more information at:  ACR Mammography Accreditation Program

   2.  The following link is to an ACR presentation that describes every step you will follow.  It is posted on the ACR website and is an excellent resource for converting to digital from screen/film OR establishing a new digital facility:

     http://www.acr.org/accreditation/mammography/rsna07presentation.aspx

   3.  If you do not have Powerpoint to view the presentation, the following is a brief summary of the chain of events for a conversion to digital, or establishing a new digital facility:

CONVERTING SCREEN/FILM TO DIGITAL NEW DIGITAL FACILITY
Call the ACR for application materials Call the ACR for entry application materials
Have your physicist perform ALL FDA required equipment evaluation testing Have your physicist perform ALL FDA required equipment evaluation testing
Submit ACR application, fees and PASSING equipment evaluation pass/fail results to the ACR Submit ACR entry application, fees and PASSING equipment evaluation pass/fail results to the ACR
If your MQSA certificate is current, you do not have to wait for ACR response to begin clinical use of the new digital unit. ACR reviews and if passing, notifies the FDA.  FDA issues 6 month provisional certificate which is required before imaging patients.  ACR sends facility full application
Avoid reimbursement issues:  Contact the ACR to ensure receipt of your application.  ACR notifies FDA.  FDA notifies CMS that you are approved for digital. Complete/submit full application to ACR to include phantom and clinical image review
If you still have reimbursement issues, contact CMS at 410-786-7169 If unit passes ACR review, the ACR reports to the FDA.  FDA issues 3 year certificate.
  Avoid reimbursement issues:  Contact the ACR to ensure receipt of your application.  ACR notifies FDA.  FDA notifies CMS that you are approved for digital.
  If you still have reimbursement issues, contact CMS at 410-786-7169

 

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