Radiation-Emitting Products

Notification Protocols When a Facility Moves a Mammography Unit

The following tables are based on information supplied by the MQSA accreditation bodies and State certifying agencies and are to be used to advise a facility when it moves a mammography x-ray unit. This is a general outline and by its very nature cannot address all aspects of a specific move. The facility may contact its accreditation body or certifying agency if it has additional questions.

Scenario 1. A mammography x-ray unit that is on wheels and can be plugged into an ordinary electrical outlet is moved to another room within the same building. The guidance for this Scenario does NOT apply to the situation where the unit is in a truck and is wheeled off to do patients.

ActionABsCAs
ACRARIATXFDAILIASCTX
Notify AB/CA prior to moveNoNoNoNoNoNoNoYesNo
Notify AB/CA within 30 days of moveNoYesYesNoNoNoYesYesNo
Post-Move Pre-Exam test* requiredYes
ACR also recommends checking with MP
YesYesYesYes,
checked at time of inspection
Yes,
checked at time of inspection
Yes,
checked at time of inspection
Yes,
checked at time of inspection
Yes -
also recommend checking with MP
MEE requiredNoNoNoNoNoNoNoNoNo
Change in accreditation/ certification statusNoNoNoNoNoNoNoNoNo
FDA Form 2579 needs to be filed by the installer**NANANANANoNANANANA

*The post-move pre-examination test is described in the Policy Guidance Help System under “Quality Assurance/Equipment/Mobile Units Equipment Quality Control - Question #3.” This post-move pre-examination testing does not have to be performed by a medical physicist.
**The filing of Form 2579 is NOT an MQSA requirement. Under the Diagnostic X-Ray Performance Standards (21 CFR 1020.30(d)(1)), Form 2579 needs to be filed by the installer with the FDA.

Scenario 2. A mammography x-ray unit not meeting the criteria in example #1 is moved to another room within the same building.

ActionABsCAs
ACRARIATXFDAILIASCTX
Notify AB/CA prior to moveNoNoYesYesNoYesYesYesNo
Notify AB/CA within 30 days of moveNoYesNoNoNoNoNoYesNo
Post-Move Pre-Exam test* requiredYes***NoCheck with accreditation bodyNoSame as facility’s ABSame as facility’s ABSame as facility’s ABSame as facility’s ABNo
MEE requiredNo***YesCheck with accreditation bodyYesSame as facility’s ABSame as facility’s ABSame as facility’s ABSame as facility’s ABYes,
checked at time of inspection
Change in accreditation/ certification statusNoNoNoNoNoNoNoNoNo
FDA Form 2579 needs to be filed by the installer**NANANANAYesNANANANA

*The post-move pre-examination test is described in the Policy Guidance Help System under “Quality Assurance/Equipment/Mobile Units Equipment Quality Control - Question #3.” This post-move pre-examination testing does not have to be performed by a medical physicist.
** The filing of Form 2579 is NOT an MQSA requirement. Under the Diagnostic X-Ray Performance Standards (21 CFR 1020.30(d)(1)), Form 2579 needs to be filed by the installer with the FDA.
***The facility needs to check with its medical physicist to determine if disassembly/reassembly has occurred. If it has, the Post-Move Pre-Exam test is to be replaced by an MEE performed by the medical physicist prior to using the unit on patients. The MEE does not have to be sent to the ACR.

Scenario 3. A mammography x-ray unit is moved to another building.

ActionABsCAs
ACRARIATXFDAILIASCTX
Notify AB/CA prior to moveYes
Call ACR for instructions
NoYesYesNoYesYesYesYes
Notify AB/CA within 30 days of moveNoYesNoNoNoNoNoYesNo
Post-Move Pre-Exam test* requiredPossible
Follow ACR’s instructions from initial call above
NoCheck with accreditation bodyNoSame as facility’s ABSame as facility’s ABSame as facility’s ABSame as facility’s ABNo
MEE requiredPossible
Follow ACR’s instructions from initial call above
YesCheck with accreditation bodyYesSame as facility’s ABSame as facility’s ABSame as facility’s ABSame as facility’s ABYes,
checked at time of inspection
Change in accreditation/ certification statusPossible
Status will be determined during initial call
NoPossiblePossibleSame as facility’s ABSame as facility’s ABSame as facility’s ABSame as facility’s ABSame as facility’s AB
FDA Form 2579 needs to be filed by the installer**NANANANAYesNANANANA

*The post-move pre-examination test is described in the Policy Guidance Help System under “Quality Assurance/Equipment/Mobile Units Equipment Quality Control - Question #3.” This post-move pre-examination testing does not have to be performed by a medical physicist.
** The filing of Form 2579 is NOT an MQSA requirement. Under the Diagnostic X-Ray Performance Standards (21 CFR 1020.30(d)(1)), Form 2579 needs to be filed by the installer with the FDA.

Scenario 4. A mammography x-ray unit is moved to a different facility (different MQSA ID number), even if the unit is on wheels and can be plugged into an ordinary electrical outlet.

ActionABsCAs
ACRARIATXFDAILIASCTX
Notify AB/CA prior to moveYesYesYesYesNoYesYesYesYes
Notify AB/CA within 30 days of moveNoYesNoNoNoNoNoYesNo
Post-Move Pre-Exam test* requiredNoNoNoNoNoNoNoNoNo
MEE requiredYesYesYesYesYes,
checked at time of inspection
Yes,
checked at time of inspection
Yes,
checked at time of inspection
Yes,
checked at time of inspection
Yes,
checked at time of inspection
Change in accreditation/ certification statusYes
Unit must go through new accreditation process
Yes
Unit must go through new accreditation process
Yes
Unit must go through new accreditation process
Yes
Unit must go through new accreditation process
YesYesYesYesYes
FDA Form 2579 needs to be filed by the installer**NANANANAYesNANANANA

*The post-move pre-examination test is described in the Policy Guidance Help System under “Quality Assurance/Equipment/Mobile Units Equipment Quality Control - Question #3.” This post-move pre-examination testing does not have to be performed by a medical physicist.
** The filing of Form 2579 is NOT an MQSA requirement. Under the Diagnostic X-Ray Performance Standards (21 CFR 1020.30(d)(1)), Form 2579 needs to be filed by the installer with the FDA.


Legend

  • AB - Accreditation Body
  • ACR - American College of Radiology
  • AR - State of Arkansas
  • CA - Certification Agency
  • FDA - Food and Drug Administration
  • IA - State of Iowa
  • IL - State of Illinois
  • NA - Not Applicable
  • SC - State of South Carolina
  • TX - State of Texas