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.

Action	ABs				CAs
Action	ACR	AR	IA	TX	FDA	IL	IA	SC	TX
Notify AB/CA prior to move	No	No	No	No	No	No	No	Yes	No
Notify AB/CA within 30 days of move	No	Yes	Yes	No	No	No	Yes	Yes	No
Post-Move Pre-Exam test* required	Yes ACR also recommends checking with MP	Yes	Yes	Yes	Yes, 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 required	No	No	No	No	No	No	No	No	No
Change in accreditation/ certification status	No	No	No	No	No	No	No	No	No
FDA Form 2579 needs to be filed by the installer**	NA	NA	NA	NA	No	NA	NA	NA	NA

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

Action	ABs				CAs
Action	ACR	AR	IA	TX	FDA	IL	IA	SC	TX
Notify AB/CA prior to move	No	No	Yes	Yes	No	Yes	Yes	Yes	No
Notify AB/CA within 30 days of move	No	Yes	No	No	No	No	No	Yes	No
Post-Move Pre-Exam test* required	Yes***	No	Check with accreditation body	No	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB	No
MEE required	No***	Yes	Check with accreditation body	Yes	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB	Yes, checked at time of inspection
Change in accreditation/ certification status	No	No	No	No	No	No	No	No	No
FDA Form 2579 needs to be filed by the installer**	NA	NA	NA	NA	Yes	NA	NA	NA	NA

*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.

Action	ABs				CAs
Action	ACR	AR	IA	TX	FDA	IL	IA	SC	TX
Notify AB/CA prior to move	Yes Call ACR for instructions	No	Yes	Yes	No	Yes	Yes	Yes	Yes
Notify AB/CA within 30 days of move	No	Yes	No	No	No	No	No	Yes	No
Post-Move Pre-Exam test* required	Possible Follow ACR’s instructions from initial call above	No	Check with accreditation body	No	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB	No
MEE required	Possible Follow ACR’s instructions from initial call above	Yes	Check with accreditation body	Yes	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB	Yes, checked at time of inspection
Change in accreditation/ certification status	Possible Status will be determined during initial call	No	Possible	Possible	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB	Same as facility’s AB
FDA Form 2579 needs to be filed by the installer**	NA	NA	NA	NA	Yes	NA	NA	NA	NA

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.

Action	ABs				CAs
Action	ACR	AR	IA	TX	FDA	IL	IA	SC	TX
Notify AB/CA prior to move	Yes	Yes	Yes	Yes	No	Yes	Yes	Yes	Yes
Notify AB/CA within 30 days of move	No	Yes	No	No	No	No	No	Yes	No
Post-Move Pre-Exam test* required	No	No	No	No	No	No	No	No	No
MEE required	Yes	Yes	Yes	Yes	Yes, 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 status	Yes 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	Yes	Yes	Yes	Yes	Yes
FDA Form 2579 needs to be filed by the installer**	NA	NA	NA	NA	Yes	NA	NA	NA	NA

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