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Information
for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA |
Document issued on January 28, 2003
PrefacePublic CommentComments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. For purposes of this document, additions to the Policy Guidance Help System (PGHS) are shown as highlighted text while deletions are shown by strikethroughs. Note: Questions and answers that are currently in the PGHS and are not being modified are not included in this document. For questions regarding the use or interpretation of this guidance contact Charles Finder at (301) 594-3332 or by email caf@cdrh.fda.gov. Additional CopiesAdditional copies are available from the Internet at: http://www.fda.gov/cdrh/mammography, or through CDRH Facts-On-Demand. You may either send a fax request to (301) 443-8818 to receive a hard copy of the document, or send an e-mail request to GWA@CDRH.FDA.GOV to request hard or electronic copy. Please use the document number (1436) to identify the guidance you are requesting.
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This document is intended to provide guidance. It represents the Agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. |
The Mammography Quality Standards Act was signed into law on October
27, 1992, to establish national quality standards for mammography. The
MQSA required that to provide mammography services legally after October
1, 1994, all facilities, except facilities of the Department of Veterans
Affairs, must be accredited by an approved accreditation body and certified
by the Secretary of Health and Human Services (the Secretary) or by
an approved State certification body. The authority to approve accreditation
bodies, State certification bodies, and to certify facilities was delegated
by the Secretary to the FDA. On October 28, 1997, the FDA published
the MQSA final regulations in the Federal Register. The final
regulations, under which mammography facilities are currently regulated,
became effective April 28, 1999. The FDA compiled all final guidance
related to MQSA into a computerized searchable Policy Guidance Help
System in November 1998. The Policy Guidance Help System is available
on the Internet at: www.fda.gov/cdrh/mammography/robohelp/start.htm
This compliance guidance document serves to update the Policy Guidance
Help System.
Guidance information is periodically updated. Individuals wishing to get automatic notification of such updates may subscribe to our E-mail ListServ by visiting http://list.nih.gov/cgi-bin/wa?SUBED1=mammography_cdrh-l&A=1 and following the directions there.
We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman.
This document is intended to provide guidance to mammography facilities and their personnel. It represents the Food and Drug Administration's (FDA) current thinking on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L. 102-539). The FDA uses mandatory language, such as shall, must, and require, when referring to statutory or regulatory requirements. The FDA uses non-mandatory language, such as should, may, can, and recommend when referring to guidance. It is the responsibility of the facility to read, understand, and follow the final regulations.
Under its own authority, a State may impose more stringent requirements beyond those specified under MQSA and its implementing regulations. A facility may want to check with the State or local authorities regarding their requirements.
Citation:
900.11(a) General. After October 1, 1994, a certificate issued by
FDA is required for lawful operation of all mammography facilities subject
to the provisions of this subpart. To obtain a certificate from FDA,
facilities are required to meet the quality standards in section 900.12
and to be accredited by an approved accreditation body or other entity
as designated by FDA.
Question
11: Our radiology group has two mammography units at the same location.
Can each unit be accredited by a different accreditation body (dual
accreditation)?
Yes,
units located at the same site can be accredited by different accreditation
bodies (dual accreditation). Some of the downsides to dual accreditation
include the increased cost and paperwork associated with dealing with
two accreditation bodies and having to undergo two MQSA inspections
(because each separately accredited unit would be considered a different
MQSA certified facility).
While there are downsides related to dual accreditation, there is at least one situation where a group might decide to have its units dual accredited. For example, suppose a facility already has a film-screen unit accredited by a State accreditation body. The facility then purchases an FFDM unit but the only body that accredits that unit is the ACR. The facility has two options. It can either drop its State accreditation and have both units accredited by ACR (both units are now part of one MQSA certified facility) or proceed with dual accreditation and keep its film-screen unit accredited by the State and have its FFDM unit accredited by the ACR (each unit is now its own MQSA certified facility). In the case of this dual accreditation, FDA would allow these two facilities to be grouped for MQSA inspection billing purposes to reduce the cost.
Question
12: Now that FDA has approved an FFDM accreditation body, do we have
to have our FFDM unit accredited?
If
your State accreditation body or ACR has received FDA approval to accredit
your specific model FFDM unit, then you must have your unit accredited
by one of those bodies. If neither your State accreditation body nor
ACR has received FDA approval to accredit your specific model FFDM unit,
then you must have FDA extend your film-screen certification to cover
your FFDM unit before you can use it clinically.
Question
13: We have been using our FFDM unit under FDA's film-screen certification
extension policy. Now that there is an accreditation body for our model
FFDM unit, what do we need to do to have the unit accredited? We were
keeping our old film-screen-unit just to be eligible for the certification
extension policy. Do we still need to keep this film-screen unit?
Your
facility must follow the accreditation body's procedures for accreditation
of your model FFDM unit. The facility may continue to operate its FFDM
unit under FDA's film-screen certification extension policy while it
applies for and proceeds through the accreditation process. Once you
have started the accreditation process, you no longer are required to
keep your film-screen unit.
Question
14: We have been operating our FFDM unit under FDA's film-screen certification
extension policy by linking our unit with a film-screen facility at
a different location. Now that an accreditation body has been approved
for our FFDM model unit, must we become accredited and certified as
our own independent facility?
Yes.
You must become accredited and certified as your own independent facility.
Once you have received your MQSA provisional certificate, you can sever
your links with the film-screen facility.
Question
15: Which FFDM units can be accredited by which accreditation bodies?
The
General Electric 2000D FFDM unit can be accredited by the American College
of Radiology as of February 15, 2003.
Discussion:
Until an
accreditation bodies
are prepared
body
has been approved
to accredit your
specific model
full field digital mammography (FFDM) unit
units,
FDA has
implemented a
will
continue its
process for extending the certification of an already certified screen-film
facility to include these
specific model
FFDM units. Until otherwise notified by FDA, a facility with an FFDM
unit
(that does not have a have a corresponding approved accreditation body)
will be exempt from the MQSA accreditation requirement but must request
FDA to extend its screen-film certification to cover its FFDM unit.
Requests for FFDM certification extension need to supply all the information
listed in the document MQSA Facility Certification Requirements For
Use Of Full Field Digital Mammography (FFDM) and should be forwarded
to:
Dr. Kish Chakrabarti
Division of Mammography Quality and Radiation Programs
FDA/CDRH/OHIP
1350 Piccard Drive, HFZ-240, Room 230B
Rockville, MD 20850
Phone : 301-594-3332 or 3313
Fax : 301-594-3306
After a decision has been reached, you will receive either a Letter of Acceptance or a Letter of Denial for your FFDM unit(s). If you receive a Letter of Acceptance, your FFDM unit will be added to your certificate and you may begin to use it for clinical examinations. Your facility must maintain its accreditation status for at least one screen-film unit in order to maintain its certification status when utilizing an FFDM unit. Your facility is also subject to an annual onsite MQSA inspection of its FFDM unit at the same time its screen-film unit(s) is/are being inspected.
If you receive a Letter of Denial, we will work with you to resolve the problems preventing your acceptance.
Question 1: Does a facility have to have its FFDM unit accredited?
Until
notified by the FDA, facilities with FFDM units are exempt from MQSA
accreditation requirements. However, you must obtain FDA's extension
of your MQSA screen film certification to cover the FFDM unit before
you can use it clinically.
If
your State accreditation body or ACR has received FDA approval to accredit
your specific model FFDM unit, then you must have your unit accredited
by one of those bodies. If neither your State accreditation body nor
ACR has received FDA approval to accredit your specific model FFDM unit,
then you must have FDA extend your film-screen certification to cover
your FFDM unit before you can use it clinically.
Question 7: Which FFDM units have been approved by FDA?
FDA's Office of Device Evaluation has approved the following FFDM
units for commercial use:
GE Senographe 2000D (approval date: 1/28/00)
Fischer Imaging SensoScan (approval date: 9/25/01)
Lorad Digital Breast Imager (approval date: 3/15/02)
Hologic/Lorad
Selenia FFDM System (approval date: 10/02/02)
Question
9: What will happen when the accreditation bodies start to accredit
FFDM units?
Once
the accreditation bodies begin accrediting your specific model of FFDM
unit, your facility will have to apply to and go through the AB's accreditation
process, similar to what you would have to do for screen film units.
During this transition period, your facility can continue to use the
FFDM unit. Because of the different technologies used by FFDM unit manufacturers,
the accreditation bodies may have to develop different programs for
the different types of units. As a result, it is likely that not all
FFDM unit types will be accredited at the same time. For example, if
an AB implements a program to accredit the GE Senographe 2000D but not
other types of units, then facilities having this GE unit have to get
them accredited. Facilities having other types of FFDM units will not
have to get them accredited until an accreditation process is implemented
for their unit. However, the facility will be able to continue to use
their unit under FDA's FFDM certification extension policy.
Question
9: Which FFDM units can be accredited by which accreditation bodies?
Answer:
The General Electric 2000D FFDM unit can be accredited by the American
College of Radiology as of February 15, 2003.
Question
10: We have been using our FFDM unit under FDA's film-screen certification
extension policy. Now that there is an accreditation body for our model
FFDM unit, what do we need to do to have the unit accredited? We were
keeping our old film-screen-unit just to be eligible for the certification
extension policy. Do we still need to keep this film-screen unit?
Your
facility must follow the accreditation body's procedures for accreditation
of your model FFDM unit. The facility may continue to operate its FFDM
unit under FDA's film-screen certification extension policy while it
applies for and proceeds through the accreditation process. Once you
have started the accreditation process, you no longer are required to
keep your film-screen unit.
Question
11: We have been operating our FFDM unit under FDA's film-screen certification
extension policy by linking our unit with a film-screen facility at
a different location. Now that an accreditation body has been approved
for our FFDM model unit, must we become accredited and certified as
our own independent facility?
Yes.
You must become accredited and certified as your own independent facility.
Once you have received your MQSA provisional certificate, you can sever
your links with the film-screen facility.
Question
12: Our radiology group has two mammography units at the same location.
Can each unit be accredited by a different accreditation body (dual
accreditation)?
Yes,
units located at the same site can be accredited by different accreditation
bodies (dual accreditation). Some of the downsides to dual accreditation
include the increased cost and paperwork associated with dealing with
two accreditation bodies and having to undergo two MQSA inspections
(because each separately accredited unit would be considered a different
MQSA certified facility).
While there are downsides related to dual accreditation, there is at least one situation where a group might decide to have its units dual accredited. For example, suppose a facility already has a film-screen unit accredited by a State accreditation body. The facility then purchases an FFDM unit but the only body that accredits that unit is the ACR. The facility has two options. It can either drop its State accreditation and have both units accredited by ACR (both units are now part of one MQSA certified facility) or proceed with dual accreditation and keep its film-screen unit accredited by the State and have its FFDM unit accredited by the ACR (each unit is now its own MQSA certified facility). In the case of this dual accreditation, FDA would allow these two facilities to be grouped for MQSA inspection billing purposes to reduce the cost.
Citation:
900.11(b)(1)(i)(ii): Application.
(1) Certificates.
(i) In order to
qualify for a certificate, a facility must apply to an FDA-approved
accreditation body, or to another entity designated by FDA. The facility
shall submit to such body or entity the information required in 42 U.S.C.
263b(d)(1).
(ii) Following the agency's
receipt of the accreditation body's decision to accredit a facility,
or an equivalent decision by another entity designated by FDA, the agency
may issue a certificate to the facility, or renew an existing certificate,
if the agency determines that the facility has satisfied the requirements
for certification or recertification.
Question 9: A facility moves or relocates and the address on
its MQSA certificate is no longer correct. Is the MQSA certificate still
valid?
Your MQSA certificate is still valid. However, when a facility
moves or relocates, it must notify its accreditation body. The
facility is reminded that any mammography unit or processor that is
disassembled and reassembled at the same or different location must
have a mammography equipment evaluation. Any failures of a regulatory
requirement found during the mammography equipment evaluation must be
corrected before that piece of equipment is used for patient examinations.
The accreditation body will direct the facility regarding any additional
information and/or testing that it may require. The accreditation body
will then inform FDA or the Certifying State of the facility's new address.
FDA
will no longer issue replacement certificates for address changes. At
the time of the next renewal, FDA-issued MQSA certificates will be issued
with the facility name only. Facilities with State issued MQSA certificates
should check with their State agencies for their policies regarding
replacement of MQSA certificates.
FDA
or the Certifying State will then issue a new MQSA certificate to the
facility reflecting the new address. The facility is reminded that any
mammography unit or processor that is disassembled and reassembled at
the same or different location must have a mammography equipment evaluation.
Any failures of a regulatory requirement found during the mammography
equipment evaluation must be corrected before that piece of equipment
is used for patient examinations.
Until
the new MQSA certificate is received, the facility must prominently
display its original MQSA certificate. The expiration date of the new
MQSA certificate will be the same as the original since the facility
has not been reaccredited or recertified. After the new MQSA certificate
arrives, the original MQSA certificate should not be displayed. The
facility should file or destroy the original MQSA certificate after
it receives the new MQSA certificate.
Citation:
900.2(h) Certificate means the certificate described in section 900.11(a).
Question 4: A facility moves or relocates and the address on
its certificate is no longer correct. Is the MQSA certificate still
valid?
Your MQSA certificate is still valid. However, when a facility
moves or relocates, it must notify its accreditation body. The facility
is reminded that any mammography unit or processor that is disassembled
and reassembled at the same or different location must have a mammography
equipment evaluation. Any failures of a regulatory requirement found
during the mammography equipment evaluation must be corrected before
that piece of equipment is used for patient examinations. The accreditation
body will direct the facility regarding any additional information and/or
testing that it may require. The accreditation body will then inform
FDA or the Certifying State of the facility's new address. FDA
will no longer issue replacement certificates for address changes. At
the time of the next renewal, FDA-issued MQSA certificates will be issued
with the facility name only. Facilities with State issued MQSA certificates
should check with their State agencies for their policies regarding
replacement of MQSA certificates.
FDA
or the Certifying State will then issue a new MQSA certificate to the
facility reflecting the new address.
Until
the new MQSA certificate is received, the facility must prominently
display its original MQSA certificate. The expiration date of the new
MQSA certificate will be the same as the original since the facility
has not been reaccredited or recertified. After the new MQSA certificate
arrives, the original MQSA certificate should not be displayed. The
facility should file or destroy the original MQSA certificate after
it receives the new MQSA certificate.
Citation:
900.2(a) Accreditation body or body means an entity that has been
approved by FDA under section 900.3(d) to accredit mammography facilities.
Discussion:
Currently, the FDA-approved accreditation bodies are:
American College of Radiology (ACR)
State of Arkansas
State of California
State of Iowa
State of Texas
Currently,
the
The
state accreditation bodies may accredit only those facilities that are
located in their respective states.
Related Topics:
General
Requirements for Accreditation and Certification
Citation:
900.2
(bbb) Authorization means obtaining approval from FDA to utilize new
or changed State regulations or procedures during the issuance, maintenance,
and withdrawal of certificates by the certification agency
Citation:
900.2(h) Certificate means the certificate described in section 900.11(a).
Discussion:
After October 1, 1994, all
mammography facilities are required to have an MQSA
a certificate issued by FDA or
the Certifying State
is
required for lawful operation of all
to
legally perform
mammography facilities.
To obtain a an
MQSA
certificate from FDA or
the Certifying State,
facilities are required to be accredited by an approved accreditation
body or other entity, as designated by FDA, and to meet the quality
standards as published in 900.12.
By law, FDA
MQSA
certificates must be prominently displayed in
all patient reception areas
where they can be viewed by mammography patients
examinees.
Question 1: Where does a facility with more than one patient/examinee
reception area display its MQSA
certificate?
FDA
MQSA
certification is facility based. Therefore, if a facility has more than
one patient reception area, it may request an additional MQSA
certificate for each reception area from FDA. All MQSA
certificates issued to a facility will share that facility's unique
6-digit identification number. Contact the FDA MQSA Facility Hotline
at 1-800-838-7715 to request the
additional MQSA
certificates. Facilities
with State issued MQSA certificates should check with their State agencies
for their policies regarding additional MQSA certificates.
Question 2: Can a facility with a large
Spanish-speaking population get a Spanish-language MQSA
certificate?
FDA will issue an additional MQSA
certificate translated into Spanish for those facilities serving a Spanish-speaking
population for each patient reception area. The Spanish-language MQSA
certificate(s) and the English-language MQSA
certificate(s) must both be prominently displayed where they can be
viewed by mammography examinees
patients.
Contact the FDA MQSA Facility Hotline at 1-800-838-7715 to request a
Spanish-language MQSA
certificate. Facilities
with State issued MQSA certificates should check with their State agencies
for their policies regarding additional MQSA certificates.
Question 3: A facility has changed its name but has the same
owner, personnel, and equipment. Is the MQSA
certificate still valid even though the facility name is different?
Your
MQSA certificate is still valid. However, when
When
a facility changes just its name, it must notify its accreditation body
even though it still has the same owner, personnel, and equipment. Once
the facility has complied with the accreditation body's requirements,
the
The
accreditation body will then
inform FDA or
the Certifying State
of the facility's new name. FDA or
the Certifying State
will then issue a new MQSA
certificate to the facility.
Until the new MQSA
certificate is received, the facility must prominently display its original
MQSA
certificate. The expiration date of the new MQSA
certificate will be the same as the original since the facility has
not been reaccredited or recertified. After the new MQSA
certificate arrives, the original MQSA
certificate should not be displayed. The facility should file or destroy
the original MQSA
certificate after it receives the new MQSA
certificate.
Question 4: A facility moves or relocates and the address on
its MQSA
certificate is no longer correct. Is the MQSA
certificate still valid?
Your
MQSA certificate is still valid. However, when
When
a facility moves or relocates, it must notify its accreditation body.
The
facility is reminded that any mammography unit or processor that is
disassembled and reassembled at the same or different location must
have a mammography equipment evaluation. Any failures of a regulatory
requirement found during the mammography equipment evaluation must be
corrected before that piece of equipment is used for patient examinations.
The accreditation body will direct the facility regarding any additional
information and/or testing that it may require. Once
those requirements are satisfied, the
The
accreditation body will then
inform FDA or
the Certifying State
of the facility's new address. FDA
will no longer issue replacement certificates for address changes. At
the time of the next renewal, FDA-issued MQSA certificates will be issued
with the facility name only. Facilities with State issued MQSA certificates
should check with their State agencies for their policies regarding
replacement of MQSA certificates.
FDA
will then issue a new certificate to the facility reflecting the new
address.
Until
the new certificate is received, the facility must prominently display
its original certificate. The expiration date of the new certificate
will be the same as the original since the facility has not been reaccredited
or recertified. After the new certificate arrives, the original certificate
should not be displayed. The facility should file or destroy the original
certificate after it receives the new certificate.
Question 5: What should a facility do if it closes or decides
that it will no longer provide mammography services?
The
facility should contact its accreditation body and inform it that the
facility is no longer practicing mammography. The MQSA certificate should
no longer be displayed. The facility may file or destroy its MQSA certificate.
Before
a facility permanently stops performing mammography, it should do the
following:
1.
Inform its accreditation body that it will no longer be performing mammography;
2. Notify its State radiation control program;
3. Arrange transfer of each patient's medical record (original mammography
films and reports) to the mammography facility where the patient will
be receiving future care, the patient's referring physician or health
care provider, or the patient. This transfer will address the requirement
that the facility maintain the patient's permanent medical record for
a period of not less than 5 years, or not less than 10 years if no additional
mammograms are performed at the facility, or longer if mandated by State
or local law. The facility should make reasonable attempts to inform
its former patients of how they can obtain their mammography records.
Facilities should check with State or local agencies to determine if
their requirements are more stringent. Note: Radiology practices and
other medical facilities that still see patients but have permanently
stopped performing mammography, may choose to keep the patients' medical
records rather than transfer them to another facility (unless the patient
requests such a transfer).
If option 3 is not viable, facilities could store the medical records in a hospital, if appropriate, or make arrangements to warehouse the records. The facility should assure that there is a mechanism to release the films to the appropriate entity when requested and that former patients are made aware of that mechanism. It should be noted that if no one else is willing to accept the records, the facility remains responsible for them. Under MQSA, facilities will not be held responsible for maintenance of examinations performed before October 1, 1994; however, State and local regulations may require otherwise.
Once the facility ceases operation, the MQSA certificate should no longer be displayed. The facility may file or destroy its MQSA certificate.
Due to the fact that some facilities have not followed the above recommendations, FDA has received inquiries from patients complaining that their mammography facility has closed, that they were not informed, and that they cannot find out where or how to gain access to their mammography records. For this reason, FDA requests that a facility that plans to stop performing mammography notify its Certifying Agency of how it intends to fulfill its obligations with respect to medical records. Such information may be sent to:
FDA/CDRH/OHIP/DMQRP
Attention:
Closed Facility Notification of Records Retention
1350 Piccard Drive, HFZ-240
Rockville, MD 20850
Facilities certified by States may send the above information to:
State
of Iowa
Bureau of Radiological Health
Iowa Department of Public Health
401 SW 7th Street, Suite D
Des Moines, IA 50309
515-281-3478
State
of Illinois
Office of Radiation Safety
Department of Nuclear Safety
1035 Outer Park Drive
Springfield, IL 62704
217-785-9974
Question 6: Our facility has several patient waiting areas. Can
I photocopy our facility MQSA
certificate and place copies in each area?
While the Statute requires that the original MQSA
certificate be prominently displayed, the photocopying of the MQSA
certificate so that it may be displayed in additional areas is not prohibited.
However, we recommend that facilities wishing to display their MQSA
certificate in several different areas obtain additional MQSA
certificates (at no charge) by contacting FDA at 1-800-838-7715 or writing
to: FDA MQSA Program, P.O. Box 6057, Columbia, MD 21045-6057.
Facilities with State-issued MQSA certificates should check with their
Certifying
State agencies
for their policies regarding additional MQSA
certificates. Facilities are reminded that, at a minimum, they must
have the original MQSA
certificate displayed even if they choose to display additional copies
of the MQSA
certificate. Mobile facilities must have at least one original MQSA
certificate displayed whenever the mobile unit is performing mammography.
Related Topics:
General
Requirement for Accreditation and Certification
Citation:
900.2(i) Certification means the process of approval of a facility
by FDA or
a certification agency
to provide mammography services.
Related Topics:
General
Requirement for Accreditation and Certification
Citation:
900.2
(zz) Certification agency means a State that has been approved by FDA
under Sec. 900.21 to certify mammography facilities.
Citation:
900.2(o)(1): Direct Supervision means that: During joint interpretation
of mammograms, the supervising interpreting physician reviews, discusses,
and confirms the diagnosis of the physician being supervised and signs
the resulting report before it is entered into the patient's records.
Discussion:
The goal of direct supervision is to provide reasonable assurance that
any mistakes made by the physician being supervised are corrected before
harm is done to the patients.
The supervising interpreting physician does not have to be present when
the physician being supervised makes their
his
or her
initial interpretation. However,
the supervising physician must review and, if necessary, correct the
final interpretation before it is given to the patient.
When the physician being supervised reads previously interpreted mammographic
examinations, these interpretations must still be reviewed, discussed
and confirmed or corrected by a supervising interpreting physician.
This must be done even if the supervised physician's interpretation
agrees with the previous interpretation and/or the interpretation of
the supervising interpreting physician. If mammographic examinations
are being read retrospectively under direct supervision, the usual requirement
that the multireading be done before the patient receives her results
is waived.
When mammographic examinations are read prospectively under direct supervision,
at a minimum, the qualified supervising interpreting physician must
sign the report.
Physicians working to meet one or more of the initial qualifications
are
still considered physicians-in-training
and those
in the requalification process
must continue to read under direct supervision until all initial
qualifications
requirements
have been meet.
Question 2: During annual MQSA inspections, mammography personnel
are sometimes found to not meet one or more of the personnel qualifications.
May this individual (interpreting physician) continue to lawfully provide
mammography services to the facility?
While an individual's qualifications are still under evaluation,
that individual may continue to provide mammography services to the
facility in his or her area. Once it has been determined that an individual
DOES NOT meet one or more of the initial
personnel qualifications (e.g., a "No" answer has been entered
in response to one or more of the initial
qualification questions), that individual may lawfully provide mammography
services to the facility only under the direct supervision of a fully
qualified individual.
The direct supervision must continue until such time as the individual
meets the qualifications, at which time he/she may resume working independently.
Personnel
who fail to meet a continuing requirement must also go under
direct supervision as stated above. However, FDA may allow for a limited
time exception to this rule when the imposition of direct supervision
on the person failing to meet the continuing requirement would
result in the facility having to cease providing mammography services.
Question 4: What does it mean for a physician to be under the
direct supervision of a qualified interpreting physician? Does the supervising
physician have to sit next to the physician being supervised when he
or she reads and interprets the film? Whose name goes on the report,
the supervising physician or the physician being supervised?
The supervising physician need not be present during initial reading
and interpretation. Direct supervision for an interpreting physician
means that during the joint interpretation of mammograms, the supervising
interpreting physician reviews, discusses, and confirms the diagnosis
of the physician being supervised. The physician being supervised should
must
not provide final results to patients or referring physicians without
prior confirmation from the supervising physician. Since each mammography
report must be signed by a qualified interpreting physician, the name
of the supervising interpreting physician must be on the report as the
interpreting physician.
Citation:
900.2(o)(2): Direct Supervision means that: During the performance
of a mammography examination or survey of the facility's equipment and
quality assurance program, the supervisor is present to observe and
correct, as needed, the performance of the individual being supervised
who is performing the examination or conducting the survey.
Question 3: What does it mean to be under the direct supervision
of a qualified medical physicist?
For the physics survey and/or mammography
equipment evaluation, direct supervision means that the supervisor (if
the supervision is done after 4/28/99, the supervising medical physicist
must have qualified under the Master's or higher pathway) is present
to observe and correct, as needed, the performance of the supervisee.
This requires that the supervisor be in the room during the performance
of the individual equipment tests to assure that any mistakes made by
the supervisee are corrected before the test is completed. The supervisor
must review any calculations made from, and any conclusions drawn from
the test results, before those results are provided to the facility.
Furthermore, when conducting a physics survey, the supervisor and supervisee
must jointly review the QC program records. The supervisor does not
have to be present when the supervisee initially reviews the QC program
records. However, the supervisor must review, discuss, confirm, and
if necessary, correct the findings made by the supervisee prior to either
the initial or final survey report being issued.
The goal of direct supervision is to provide reasonable assurance that
any mistakes made by the supervisee are corrected before the QC program
review or tests are completed.
Question 4: During annual MQSA inspections, mammography personnel
are sometimes found to not meet one or more of the personnel qualifications.
May this individual (medical physicist, radiologic technologist) continue
to lawfully provide mammography services to the facility?
While an individual's qualifications are still under evaluation,
that individual may continue to provide mammography services to the
facility in his or her area. Once it has been determined that an individual
DOES NOT meet one or more of the initial
personnel qualifications (e.g., a "No" answer has been entered
in response to one or more of the initial
qualification questions), that individual may lawfully provide mammography
services to the facility only under the direct supervision of a fully
qualified individual. The direct supervision must continue until such
time as the individual meets the qualifications, at which time he/she
may resume working independently.
Personnel
who fail to meet a continuing requirement must also go under
direct supervision as stated above. However, FDA may allow for a limited
time exception to this rule when the imposition of direct supervision
on the person failing to meet the continuing requirement would result
in the facility having to cease providing mammography services.
Question 6: In a radiology training program with a mammography
curriculum, would the facility be in
non-compliance
non-compliant
for letting student technologists show competency in performing mammography
on live patients?
No. As long as the facility is FDA
MQSA
certified, there is nothing in the MQSA or FDA's regulations that will
interfere with training in mammography. Student technologists can receive
classroom and practical training in a variety of ways. Student technologists
who do not yet meet the requirements established under MQSA may perform
actual examinations as part of the training so long as another
technologist who does meet the MQSA requirements is present in the
room to supervise (i.e. direct supervision) and, if necessary, corrects
the student in the conduct of the examination.
Question 8: What are the required minimum qualifications for
the supervisor of an individual who is performing surveys to meet the
initial experience requirement or to requalify after failing to meet
the continuing experience requirement?
The surveys performed to meet the initial experience and requalification
requirements for the medical physicist must be performed under the direct
supervision of a medical physicist who meets all the initial qualification
and continuing qualification requirements (described in 900.12(a)(3)(i)
and (iii)). NOTE: Medical physicists who qualify under the alternative
initial qualification route
(commonly known as the bachelors degree route),
section 900.12(a)(3)(ii), cannot provide supervision of surveys performed
for the purpose of meeting the initial experience requirement or reestablishing
the continuing experience requirement.
Discussion:
Since
the early days of MQSA inspections under the interim rule, FDA has adopted
and used a three-tier system of inspection findings and has assigned
three corresponding non-compliance levels as defined below:
Level 1 (L1). Level 1 is the most serious. It indicates a failure
to meet a key MQSA requirement that may compromise the quality of mammography
services performed at the facility. FDA reviews each L1 finding, and
if confirmed, the facility receives a Warning Letter (WL) requiring
a response from the facility within 15 working days regarding the necessary
corrective action(s).
Level 2 (L2). In the absence of L1 findings, a Level 2 finding
indicates that the facility meets all key MQSA requirements but fails
to meet a significant mammography quality item. An L2 finding usually
requires a response from the facility within 30 days regarding the necessary
corrective action(s).
Level 3 (L3). In the absence of L1 and L2 findings, Level 3 findings
indicate that the facility meets all major MQSA requirements with only
minor problems. While the facility is expected to correct each
non-compliance found in an MQSA inspection as soon as possible regardless
of its level, it is not required to send a written response to FDA concerning
a Level 3 non-compliance. Corrective actions regarding these are usually
checked during the next annual inspection.
Based on inspection experience to date and feedback from the States
and the mammography community, FDA has re-evaluated the finding level
assignments to be implemented under the final rule and is intending:
(1) to implement a new set of finding levels corresponding to new inspection
questions, and (2) to restructure some of the existing finding levels
in order to reflect a more realistic approach.
FDA
has classified each adverse inspection observation into one of three
category levels. A Level 1 observation indicates a failure to meet a
key MQSA requirement that may compromise the quality of mammography
performed at the facility. A Level 2 observation indicates that the
facility meets all key MQSA requirements but fails to meet a significant
mammography quality item. A Level 3 observation indicates that the facility
meets all major MQSA requirements with only minor problems. Adverse
inspection observations are placed into a category level based on FDA's
assessment of how the observation may affect the quality of mammography.
The category level is also used to determine how the facility should
respond to the observation. Identical observations found during two
consecutive inspections are identified as repeats.
Key Words:
Observations
Findings,
Noncompliance, Level 1, Level 2, Level 3
Key Words/Related Topics
Citation:
900.2(z) Mammographic Modality means a technology, within the scope
of 42 U.S.C. 263b, for radiography of the breast. Examples are screen-film
mammography and xeromammography.
Discussion:
Question 1: Are spot compression, magnification, and implant
imaging considered mammographic modalities?
No. A mammographic modality is a technology for radiography of the breast,
such as screen-film mammography, full
field digital mammography,
and xeromammography. Spot compression and magnification are techniques
used with a mammographic modality, but are not to be considered separate
mammographic modalities in and of themselves. Implant imaging represents
an application of a mammographic modality to patients with breast implants.
Question
4: Is Full Field Digital Mammography (FFDM) considered a mammographic
modality?
Yes.
FFDM is a technology for radiography of the breast and, therefore, is
a mammographic modality. Until fairly recently, FFDM was classified
as an investigational use of mammography and thus was exempted from
the MQSA requirements. However, FFDM units produced by a growing number
of manufacturers have now been approved by FDA for commercial distribution.
Such approved units are subject to the MQSA requirements. However, those
FFDM units that are not yet cleared for commercial distribution are
still viewed as investigational units and continue to be exempt from
the MQSA requirements.
Mobile Mammography Unit means a mammography x-ray unit located in a vehicle (truck, van, etc.) that is driven from one location to another to perform mammography. These units may be fixed in a vehicle such as a van or a truck, or may be portable (i.e., can be wheeled-off the van and moved into a site). Mobile units usually go to locations where patients would not normally get mammograms. Note: many stationary facilities have mammography units that are equipped with wheels so they can be easily moved from one room to another. Such units are not considered mobile mammography units.
Citation:
900.2(gg) MQSA means the Mammography Quality Standards Act.
Discussion:
MQSA also includes the
all
Mammography Quality Standards Reauthorization Act
Acts
Citation:
900.2
(aaa) Performance indicators mean the measures used to evaluate the
certification agency's ability to conduct certification, inspection,
and compliance activities.
Citation:
900.2(xx) Traceable to a national standard means an instrument is calibrated
at either the National Institute of Standards and Technology (NIST)
or at a calibration laboratory that participates in a proficiency program
with NIST at least once every 2 years and the results of the proficiency
test conducted within 24 months of calibration show agreement within
+/- 3 percent of the national standard in the mammography energy range.
Discussion
Question
4: If a calibration laboratory met the proficiency test requirement
in the final regulations before April 28, 1999 (the effective date of
the final regulations), will that test "count" after April
28, 1999? Similarly, if an air kerma measuring instrument was calibrated
in accordance with the final regulations before April 28, 1999, will
that calibration "count" after April 28, 1999?
Yes,
to both questions, so long as the permitted maximum time periods are
not exceeded. If the proficiency test or calibration was successfully
completed before April 28, 1999, in accordance with the terms of the
final regulations, the test or calibration will not have to be repeated
simply because the new regulations have become effective. The repetition
of the proficiency test can wait until up to two years after the last
test and the repetition of the calibration can wait until up to two
years after the last calibration or until after the next repair, whichever
comes first.
Question 45:
A physicist utilizes a calibration laboratory after it has been
notified by the National Institute of Standards and Technology (NIST)
that it has failed its latest proficiency test. Can those calibrated
instrument
instruments
calibrated by that laboratory
be used for MQSA evaluations?
No. Instruments calibrated by a laboratory after
the laboratory has been notified that it failed NIST's proficiency test
can
not
cannot
be used for MQSA evaluations.
Discussion:
When used in the context of numerical or time specific MQSA regulatory limits, the word "within" is intended to include the limit itself. For example, the "Kilovoltage peak (kVp) accuracy and reproducibility" requirement states that "The kVp shall be accurate within +/- 5 percent of the indicated or selected kVp.....". This means that if the indicated kVp is 20 and the measured kVp is 19.0, the unit is compliant with this regulation. Similarly, the "Communication of mammography results to the patients" requirement states that "Each facility shall send each patient a summary of the mammography report written in lay terms within 30 days of the mammographic examination. This means that if a facility performs a mammogram on March 1 and sends the lay summary out on March 31, the facility is compliant with this regulation.
Citation: 900.12(b)(8)(ii)(A)(B)(C)(D)(E): Compression Paddle. |
|
(A) | Systems shall be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression paddles for special purposes, including those smaller than the full size of the image receptor (for "spot compression") may be provided. Such compression paddles for special purposes are not subject to the requirements of paragraphs (b)(8)(ii)(D) and (b)(8)(ii)(E) of this section. |
(B) | Except as provided in paragraph (b)(8)(ii)(C) of this section, the compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied. |
(C) | Equipment intended by the manufacturer's design to not be flat and parallel to the breast support table during compression shall meet the manufacturer's design specifications and maintenance requirements. |
(D) | The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor. |
(E) | The chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image. |
Discussion:
Question 7: Who is responsible for performing the compression
paddle deflection test? How often should this test be performed and
by what method?
When
the mammography unit is initially placed in service or if the entire
compression system is replaced, the medical physicist must perform the
compression paddle deflection test as part of the mammography equipment
evaluation. This test should also be performed periodically throughout
the life of the unit or when an old full field compression paddle is
replaced with a new one. Periodic testing and testing of a new full
field compression paddle may be done by a radiologic technologist or
other qualified person but should be performed in consultation with
the medical physicist.
The
regulations do not specify a frequency or designate a specific individual
to perform testing for this requirement; however, the facility is responsible
for ensuring the mammography equipment meets MQSA requirements. FDA
has left both the test procedures and frequency to the discretion of
the facility. Such conformance would be verified under the equipment
evaluation performed by the medical physicist when the equipment is
initially placed in service or when there is a major repair involving
this component. It should also be verified periodically throughout its
useful life.
The
frequency of periodic testing should be established with reference to
the manufacturer's maintenance
specifications and the use considerations (wear and tear) unique to
the facility. If the excessive deflection of the compression paddle
is identified during an
a
mammography
equipment evaluation, it must be repaired before the unit
paddle
is used on patients. If the facility identifies the problem at any other
time, it should be repaired as soon as possible because this problem
may compromise clinical image quality. Manufacturers may specify procedures
and frequency for testing the compression paddles in their maintenance
instructions and adherence to these recommendations should normally
be adequate; however the responsibility for compliance still remains
with the facility.
One acceptable method for performing the compression paddle deflection test is:
Paddles designed not to be flat and parallel to the breast support table during compression should not be evaluated using the procedure described above, but rather must meet the manufacturer's design specifications and maintenance requirements.
Citation: 900.12(b)(7)(i),(ii),(iii): Focal spot selection. |
|
(i) | When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected. |
(ii) | When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material. |
(iii) | When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure. |
Question 1: For x-ray systems with multiple focal spot sizes
and target materials that are automatically selected by the system,
how is it possible for the system to indicate the selected focal spot
or target material before the exposure is taken?
When
focal spot size and/or target material are automatically selected by
the system, the system must show the pre-exposure values that are set
either by the technologist, by the unit, or by default. Once the exposure
has been completed, the system must then display the focal spot size
and/or target material actually used during the exposure.
When
used in the automatic mode the system cannot show before the exposure,
the actual values used during the exposure, but some values must exist
before the exposure can begin. These pre-exposure values are set either
by the technologist, by the unit, or by default.
The unit must indicate these pre-exposure values, either on the unit
or at the operator position, prior to the exposure and then indicate
the actual values used during the exposure, as required in 900.12(b)(7)(iii).
The indication must be clear and legible and can be achieved in any
manner that provides the required information in an unambiguous fashion.
Citation:
900.12(b)(2): General. All radiographic equipment used for mammography
shall be specifically designed for mammography and shall be certified
pursuant to 1010.2 of this chapter as meeting the applicable requirements
of §1020.30 and 1020.31 of this chapter in effect at the date of
manufacture.
Question 1: Are all regulated mammography units in the facility
required to be accredited and, if so, what documentation is necessary
to establish that this has been done?
Yes. The facility should have documentation showing that each unit has
been accredited by the accreditation body or, for new units, showing
that the unit has passed an
a
mammography
equipment evaluation and that the application for accreditation of the
unit has been submitted. There are three cases where the units in use
in the facility may not need to be accredited: 1) the unit is a "loaner"
while repairs to the facility's unit are taking place (limited to 30
days without extenuating documentation such
as written verification from a repair service that repairs will take
longer),
2) the unit is installed in the facility for evaluation prior to purchase
(limited to not more than 90 days), or 3) the unit is an experimental
one installed and used under an Investigational Device Exemption (IDE)
as described in the Safe Medical Devices Act of 1990 or other FDA approved
research protocol. The requirements for accreditation of these units
is dependent on the rules of the facility's accreditation body. Note
that under both 1) and 2) the unit still must have passed an equipment
evaluation and each such unit will be tested by the MQSA inspector,
regardless of its accreditation or ownership status.
Question 2: Is there an exemption or "grandparenting"
for equipment currently in use?
No. The final regulations do not include any "grandparenting"
provisions for using non-conforming
x-ray equipment that
does not meet the regulations
after the effective dates. You should note that not all equipment and/or
equipment quality control requirements become effective on the same
date. Equipment that meets all effective requirements may be used until
any requirements that it does not meet actually go into effect.
Citation: 900.12(b)(4)(i),(ii),(iii): Image receptor sizes. |
|
(i) | Systems using screen-film image receptors shall provide, at a minimum, for operation with image receptors of 18 x 24 centimeters (cm) and 24 x 30 cm. |
(ii) | Systems using screen-film image receptors shall be equipped with moving grids matched to all image receptor sizes provided. |
(iii) | Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptors. |
Question 3: When
doing magnification mammography, can
Can
a facility keep the grid in place but position the cassette on top of
the patient support (to prevent the grid from interfering with the image)
and still
meet the requirement
for doing magnification procedures with the grid removed
intent
of the regulation?
Yes, however, under these conditions the system must still be capable
of providing magnification within the specified
range of
1.4 to 2.0.
A facility meets the requirement if it has a written procedure for (or
can demonstrate that the system has the capability of) conducting mammography
with and without a grid between the image receptor and the x-ray source
and such a practice does not cause the system to fail any other applicable
requirement. A medical physicist may be consulted regarding the appropriateness
of the technique.
Question
6: Our mammography unit has a single image receptor holder that can
accommodate both the 24 X 30 cm and 18 X 24 cm image receptors, but
has only one size grid. Is that acceptable?
No.
Each mammography system must be equipped to allow operation with both
referenced image receptor sizes AND be provided with moving grids matched
to each image receptor size provided with the system. Having a system
equipped with only a single size moving grid, even if the device is
capable of accepting both size cassettes, would not meet the requirements.
Citation:
900.12(b)(5): For any mammography system with a light beam that passes
through the X-ray beam-limiting device, the light shall provide an average
illumination of not less than 160 lux (15 foot candles) at 100 cm or
the maximum source-image receptor distance (SID), whichever is less.
Question 1: Does
FDA have
Are
there
illumination requirements applicable to the collimator light on mammography
x-ray systems? If so, do they apply to all systems?
If the system is equipped with a light source to show the approximate
size of the x-ray field or for positioning of the breast and this light
passes through the x-ray beam-limiting device (collimator), then your
system must have a
effective
April 28, 1999 the above
minimum light output of
160 lux
requirement
is applicable to that system.
The regulation only specifies this requirement if such a collimator-light
field combination is provided. The
requirement is applicable to all such systems in use on that date or
installed on or after that date.
Question 2: Who is responsible for performing the light beam
test? How often should it be tested and by what method?
When
the mammography unit with a light beam that passes through the collimator
is initially placed in service, the medical physicist must perform the
light beam test as part of the mammography equipment evaluation. This
test should also be performed periodically throughout the life of the
unit or when an old bulb is replaced with a new one. Periodic testing
and testing of a new bulb may be done by a radiologic technologist,
repair person, or other qualified person but should be performed in
consultation with the medical physicist.
The frequency of periodic testing should be established with reference to the manufacturer's maintenance specifications and the use considerations (wear and tear) unique to the facility. If the light beam fails during a mammography equipment evaluation, it must be repaired before the light beam is used on patients. If the facility identifies the problem at any other time, it should be repaired as soon as possible.
The
regulations do not specify a frequency or designate a specific individual
to perform testing for the light illuminance requirement. However, the
facility is responsible for ensuring the mammography equipment meets
MQSA requirements. Such conformance would be verified under the equipment
evaluation performed when the equipment is initially placed in service
and should be verified periodically throughout its useful life. The
verification period should be established with reference to the manufacturer's
maintenance specifications and the use considerations (wear and tear)
unique to the facility. Anytime the facility or its personnel become
aware of suspected problems with the equipment through its use or normal
visual checks, the conformance of the equipment should be checked and
repair or replacement should be achieved within the times specified
under 900.12(e)(8)(ii) but always within 30 days of verifying the problem.
Manufacturers may specify procedures and frequency for testing the light
illuminance in their maintenance instructions and adherence to these
recommendations should normally be adequate; however, the responsibility
for compliance still remains with the facility.
Some recommended testing specifications for the average illuminance are found in 21 CFR 1020.31(d)(2)(ii), where it states "The average illuminance shall be based upon the measurements made in the approximate center of each quadrant of the light field." The test must be conducted at the maximal SID or one meter, whichever is less, and should compensate for the ambient light usually present during clinical examinations. Instrumentation used should be appropriate for the purpose. Since this might require special test equipment not usually available in the facility, FDA suggests that the facility add it to the list of items to be examined by the physicist during the annual physics survey.
Citation: 900.12(b)(6)(i),(ii): Magnification. |
|
(i) | Systems used to perform noninterventional problem solving procedures shall have radiographic magnification capability available for use by the operator. |
(ii) | Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0. |
Question 31:
In 900.12(b)(6)(i) what does the phrase "available for use by the
operator" mean?
X-ray
systems used for noninterventional
Noninterventional
problem-solving mammography x-ray
systems
are required to have the capability for magnification "available
for use by the operator," meaning that any necessary magnification
devices must be present with such units to allow operator access to,
and to facilitate the use of, magnification procedures. The decision
on whether to use the magnification still rests with the facility.
Question 2: A facility's x-ray unit has two magnification attachments
that provide a magnification of 1.5 or 2.2, depending on which attachment
is used. Other values specified in the regulation cannot be achieved
using that unit. Must a facility purchase new attachments to cover the
range, and does it mean that magnification at the 2.2 level must be
discontinued?
No. The requirement is that the x-ray unit provide "at least one
magnification value" from
in
the specified
range of
1.4 to 2.0
(in this case, the 1.5 meets
the requirement).
The regulation does not prohibit the presence or use of other
additional
magnification settings.
Question 13:
Must all mammographic units have magnification capabilities?
The requirement to provide magnification capabilities is limited to
those units used to perform noninterventional problem-solving mammography.
The requirement does not apply to units used only for normal screening
procedures. "Noninterventional problem-solving mammography"
means noninvasive mammographic procedures requiring techniques beyond
those used in standard screening of asymptomatic patients.
Citation: 900.12(b)(3)(i),(ii): Motion of tube-image receptor assembly. |
|
(i) | The assembly shall be capable of being fixed in any position where it is designed to operate. Once fixed in any such position, it shall not undergo unintended motion. |
(ii) | The mechanism ensuring compliance with paragraph (b)(3)(i) of this section shall not fail in the event of power interruption. |
Question
3: What motion requirements must the tube-image receptor assembly meet?
There
is no specific range of motion that the assembly must provide. However,
once fixed in any operating position intended by the equipment design,
it must remain fixed in that position, even during power interruption.
Question 34:
How much tube-image receptor assembly motion is acceptable before a
unit would be noncompliant with 900.12(b)(3)(ii)?
The amount of acceptable motion is dependent on the circumstances in
each facility and should be evaluated on an individual basis. The intent
of this regulation is to assure patient safety during power interruptions.
Facilities should evaluate their machines to determine if the amount
of gantry motion during power interruptions is sufficient to allow their
typical patient to fall, be twisted, or be pulled from the position
that they were placed in by the technologist to such an extent that
injury could occur. If such injury could reasonably occur, the regulation
has not been met.
Question 45:
Could you clarify what is meant by the statement that the mechanism
"shall not fail in the event of power interruption"?
This means that if the power to the x-ray system is unexpectedly
terminated during an examination, the tube-image receptor assembly will
not move without operator intervention. This requirement is intended
to provide additional safety for the patient in the event of power interruption
during an examination and to prevent patient injury that might occur
if the assembly moves.
The system must prevent motion until the operator determines that such
motion is acceptable. Depending on the circumstances in each facility,
the time required for the operator to safely remove the patient from
the unit may vary. Therefore, the length of time required for the system
to remain locked in place will also vary. However, removing the patient
from the unit can usually be accomplished in a minute or less. Note:
systems that lack built-in mechanisms to prevent unintended gantry motion
may meet the requirement using external battery backup or mechanical
mechanisms that prevent unintended motion for the amount of time it
takes to remove the patient from the machine.
Question
6: What motion requirements must the tube-image receptor assembly meet?
There
is no specific range of motion that the assembly must provide. However,
once fixed in any operating position intended by the equipment design,
it must remain fixed in that position, even during power interruption.
Question
7: How much tube-image receptor assembly motion is acceptable before
a unit would be noncompliant with 900.12(b)(3)(ii)?
The
amount of acceptable motion depends on the circumstances in each facility
and should be evaluated on an individual basis. The intent of this regulation
is to assure patient safety during power interruptions. Facilities should
evaluate their machines to determine if the amount of gantry motion
during power interruptions is sufficient to allow their typical patient
to fall, be twisted, or be pulled from the position that they were placed
in by the technologist to such an extent that injury could occur. If
such injury could reasonably occur, the regulation has not been met.
Question
8: Our mammography unit has a single image receptor holder that can
accommodate both the 24 X 30 cm and 18 X 24 cm image receptors, but
has only one size grid. Is that acceptable?
No.
Each mammography system must be equipped to allow operation with both
referenced image receptor sizes AND be provided with moving grids matched
to each image receptor size provided with the system. Having a system
equipped with only a single size moving grid, even if the device is
capable of accepting both size cassettes, would not meet the requirements.
Citation:
900.12(b)(1): Regulations published under §1020.30, 1020.31,
and 900.12(e) of this chapter that are relevant to equipment performance
should also be consulted for a more complete understanding of the equipment
performance requirements. (1) Prohibited equipment. Radiographic equipment
designed for general purpose or special nonmammography procedures shall
not be used for mammography. This prohibition includes systems that
have been modified or equipped with special attachments for mammography.
This requirement supercedes the implied acceptance of such systems in
1020.31(f)(3) of this chapter.
Question 1: Must mammography units that are used exclusively
for special interventional purposes (localization, biopsy, specimen
radiography, and/or research) be accredited? Must a facility that performs
mammography only for such special purposes be accredited and certified?
Accreditation of such units is not required at this time. Although these
procedures do involve radiography of the breast, they
currently are excluded from MQSA regulation.
the
current state of knowledge does not permit the development of acceptable
quality standards for these procedures, nor are there mechanisms for
review of the clinical images that result from these procedures.
Therefore, a mammography unit that is used exclusively for special purposes
need not be included in the accreditation application. Similarly, personnel
who are involved only with such special purpose mammography may also
be excluded from the accreditation application.
However, an accredited and certified facility that has a mammography
unit dedicated solely to these special purpose uses must be prepared
to provide the MQSA inspector with proper attestation or
documentation
that such equipment and personnel are used only for these special purposes.
Note that any X-ray units or personnel involved even occasionally in
routine screening or diagnostic mammography must meet the MQSA quality
standards. These units must be included in the accreditation process
and covered under the MQSA
certificate.
Discussion:
Question 1: How does the CMS
(formerly
HCFA)
process relate to the certification and accreditation process?
CMS
(HCFA)
has revised its regulations so that since October 1, 1994, a facility
that meets the MQSA quality standards has been considered as meeting
the CMS
(HCFA)
requirements related to quality. CMS
(HCFA)
also accepts MQSA inspections in lieu of conducting its own inspections.
Thus, as long as a facility has a certificate under MQSA, CMS
(HCFA)
will reimburse it for Medicare covered screening and diagnostic mammography
examinations. CMS
(HCFA)
will not reimburse a
facility
facilities
that do
does
not have an MQSA certificate. The amount and frequency of reimbursement
will still be governed by the CMS
(HCFA)
regulations and facilities will still need to use their CMS
(HCFA)
provider number.
To receive reimbursement from CMS
(HCFA),
the facility must also submit the FDA or Certifying State facility ID
number as it appears on it's
its
certificate to CMS
(HCFA)
with its
and
it's
request for reimbursement.
Key Words:
CMS,
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