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Mammogram Regulations

A facility that houses any or all of these machines has to be certified by the FDA and adhere to strict regulations

It’s important to understand what your state and federal regulations are as far as diagnostic imaging procedures are concerned. An MRI scan, a CT Scan, and an X-Ray are not just performed in any facility. A facility that houses any or all of these machines has to be certified by the FDA and adhere to strict regulations. The mammogram is not the exception to the rule as it also requires strict regulations.

It’s vital for a center or practice to know these mammogram regulations and to understand if there is any variance from state to state. Some common and unchanging regulations include:

  • Every mammogram has to be certified
  • Certain staff members must meet strict standards
  • Typical X-rays are reviewed for quality and information on radiation dose, which are typically very low.

While it’s important to observe these and other regulations it’s also vital to understand what the state mandates. If you live in a state like California or a state like Michigan the rules may be different in minor or major ways. As a way to provide an example the following is a set of regulations from the state of California with regards to a new and fully certified facility:

  • Notify CDPH, Radiologic Health Branch (RHB) of your intention to perform mammography.
  • Have a medical physicist who has been authorized by RHB perform a complete evaluation of the facility and each mammographic machine(s). Deficiencies found must be corrected.
  • Fax or mail application for State certificates, physicist report(s), including corrective action documentation of deficiencies, and machine registration forms to the RHB.
  • Arrange for an onsite inspection by an RHB inspector.
  • When the inspection and all submissions are approved, you will receive a State certificate for each approved machine valid for up to six months, the time allotted for accreditation review.
  • After passing accreditation review, send/fax RHB a copy of the ACR certificate for each machine. You will receive a new State certificate for each machine issued an ACR certificate, valid until the FDA certificate expiration date.

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The rules mentioned are merely examples of what one state may require when compared to another. Generally states are in fair parity to federal regulations. Most of these rules may represent cumbersome paperwork but they do not make the process worst, they are there to help you with issues that may ultimately determine if your facility is fit or not to perform procedures.

If you have any questions about mammography systems or any other modalities please feel free to give us a call. Our team of experts here at Amber Diagnostics looks forward to answering any questions you may have.


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