ACR Mammography Accreditation
- General
- New Mammography Facilities
- Moved Facilities and Units
- New Units at an Accredited Facility
- Equipment Evaluations
- Renewals
- Full Application and/or Accreditation Testing
- Full-Field Digital Mammography (FFDM) Units
- Adverse Accreditation Decisions
- Interim Accreditation and MQSA Certificate Extensions
- Annual Updates
- Validation Film Checks
- Loaner and Demo Units
- Miscellaneous
General FAQ
1.1. How many mammography facilities and units are accredited by the ACR?
1.2. I have questions about my facility's accreditation. Where can I go for help?
1.3. What is the current pass rate for units applying for ACR accreditation in mammography?
1.4. The Entry Application asks for our facility's EIN number. What is it, and where do I find it?
1.1. How many mammography facilities and units are accredited by the ACR?
As of Sept. 1, 2007, 8296 mammography facilities with 12,390 units were accredited by the ACR.
1.2. I have questions about my facility's accreditation. Where can I go for help?
For an immediate response, please call us at the Mammography Accreditation Program Information Line at 800-227-6440. Our phone lines are staffed by experienced mammography technologists with advanced certification in mammography. You may also e-mail us at mamm-accred@acr.org, although our response may not be immediate due to the large volume of e-mail correspondence we receive.
1.3. What is the current pass rate for units applying for ACR accreditation in mammography?
A. In 2006, the first-attempt pass rate for new or renewing units was 90%. This shows that mammography has improved significantly since MQSA went into effect in 1994 (when the pass rate was only 70%). For more information, see "The ACR's Mammography Accreditation Program: Ten Years of Experience Since MQSA" by Destouet, et al.
1.4. The Entry Application asks for our facility's EIN number. What is it, and where do I find it?
A. An Employer Identification Number (EIN, also known as "Federal Tax ID Number") is a 9-digit number that the IRS assigns in the following format: 12-3456789. The IRS uses the number to identify taxpayers who are required to file various business tax returns. You must also use your EIN when filing a CMS (Medicare) claim. EINs are used by employers, sole proprietors, corporations, partnerships, nonprofit organizations, trusts, estates of decedents, government agencies, certain individuals and other business entities. You should ask your business office for your facility's EIN number.
New Mammography Facilities
2.1. When should I notify the ACR that we are opening a new facility?
2.2. When can my new facility start performing mammography?
2.3. How can I obtain a provisional MQSA certificate?
2.1. When should I notify the ACR that we are opening a new facility?
A. You must notify us at least two weeks before you expect to start examining patients so that we may send you the appropriate application materials. Call us at 800-227 6440 for a quick response. You may also download the application package for the new mammography facility.
2.2. When can my new facility start performing mammography?
A. A new mammography facility may perform mammography on patients only after receiving a valid provisional MQSA certificate. The FDA (or state certifying body) will send you a 6-month provisional MQSA certificate within two business days of receiving the ACR notification. Expect to wait a total of four business days from the time you submit all required documentation to the ACR and when you receive the provisional MQSA certificate.
When scheduling your medical physicist’s Equipment Evaluation for your new unit, be sure to allow enough time for any possible corrective action and the accreditation application process described above. The ACR typically recommends scheduling an Equipment Evaluation at least one week prior to performing mammography on patients. You cannot use the unit to examine patients even during “applications” training until you meet the above conditions.
Finally, you should contact your state radiation control agency to determine if they have their own special requirements for operating new equipment that you must meet
2.3. How can I obtain a provisional MQSA certificate?
A. Send to the ACR:
- A completed Mammography Entry Application
- A Survey Agreement signed and dated by your lead interpreting physician and president/CEO
- An MQSA Information Release Authorization signed by your lead interpreting physician
- The appropriate application fee and the results of your Equipment Evaluation (showing all required tests have passed) signed and dated by your medical physicist
The ACR will review your application and Equipment Evaluation and, if complete, transmit the information on your new facility to the FDA within two business days. The FDA (or state certifying body) will send your facility a 6-month provisional MQSA certificate within two business days of receiving the ACR notification. Expect to wait a total of four business days from the time you submit all required documentation to the ACR until you receive the provisional MQSA certificate. You may not legally perform mammography without this certificate.
2.4. We are opening a new site and will be accrediting with the ACR. How and when will I receive a Mammography Quality Control Manual?
A. The ACR will send a new facility applying for accreditation one copy of the 1999 ACR Mammography Quality Control Manual with the testing materials after a complete Entry Application and fee are received and processed. If you would like to start setting up your QC program before you receive the manual, all of the QC forms in the manual are available from the ACR Web site.
2.5. We are opening a new site and will be accrediting with our state accrediting body. Will ACR send me a Mammography Quality Control Manual?
A. No. You may purchase the manual from the ACR. Visit the ACR Web Store for more information.
2.6. My facility is getting a new mobile mammography unit. Does the unit have to have its own MAP ID number?
A. Possibly. The new mobile unit can be added to an already accredited and certified mobile or fixed facility as long as the owner and the Lead Interpreting Physician are the same for both. However, if the owner and/or Lead Interpreting Physician are different, the new mobile unit must apply as a separate facility and obtain unique MAP ID and FDA ID numbers. See "Special Situations" in the Mammography Accreditation Overview for more information.
2.7. We are one facility that is located at two different sites. One of our sites does screening, the other diagnostic imaging. We presently have two ID numbers. Can we consolidate our separate sites under a single accreditation?
A. No. They may not be combined under one accreditation. Because of their separate physical locations and addresses, these two facilities must have their own MAP ID numbers. Mammography equipment physically located at different addresses must be accredited and certified as though they belong to separate facilities even though ownership and/or staffing may be the same.
Moved Facilities and Units
3.1. Our facility will be moving to a new building we are opening at a different address. (The current facility will close.) We will remain under the same ownership, keep the same personnel, and the same equipment. Can we keep our accreditation status when we move?
A. Yes. However, in order to maintain accreditation you must notify the ACR prior to moving your facility to a new address. The ACR will send a Relocation Application to your Lead Interpreting Physician. You are required to submit the completed application and the Equipment Evaluation report conducted by the medical physicist on the relocated mammography unit(s) after the move. These completed materials will let the ACR know if your units still meet all MQSA requirements after the move, and allow both the ACR and the FDA to ensure that essential, time-dependent accreditation and certification notices reach your new location.
3.2. We will be moving one of our accredited mammography units from an existing site to a new facility we are opening at a different address. (The old site will remain open.) Since the new mammography facility is under the same ownership and uses the same radiologists and technologists, do we need our own MQSA certificate prior to examining patients?
A. Yes. Your new facility must be certified separately from the old one. A unit's accreditation does not transfer to a new facility. Furthermore, an MQSA certificate cannot be used to cover two separate physical locations—even temporarily. In order to operate legally, your medical physicist must first perform an Equipment Evaluation that indicates compliance with all MQSA requirements. Second, you must apply for mammography accreditation of this new facility. Upon acceptance of your complete application, the ACR will notify your certifying body (either the FDA or the state) that you have begun the process of accreditation. You may not perform mammography until you receive a 6-month provisional MQSA certificate or an interim notice from your certifying body.
3.3. We will be moving our mammography unit to another existing, certified site affiliated with our facility. Do we have to inform the ACR?
A. Yes. Since this moved unit would be “new” to an existing, separately accredited and certified facility it is considered a “new” unit and must undergo appropriate testing. So that we may provide you with appropriate instructions to accredit this unit, please call the ACR at 800-227-6440 and inform our staff that your facility will be moving your mammography unit to another site and when the move will take place. You may use the unit after your medical physicist has performed an Equipment Evaluation that indicates compliance with all MQSA requirements and you have sent the ACR the appropriate application materials.
3.4. Our facility is remodeling and we are moving our accredited mammography unit to another room in the same building. Please advise me on any ACR requirements regarding post-move accreditation or QC.
A. Since your unit is not moving to another address or facility, the ACR does not require any additional paperwork or accreditation testing. If your unit is disassembled and reassembled as part of this move, the FDA requires your medical physicist to conduct an Equipment Evaluation to ensure that the unit works properly. If the move consists of rolling the unit into a different room (with no disassembly and reassembly) an Equipment Evaluation may not be necessary. You should consult with your medical physicist. In either case, the FDA requires you to perform a phantom image quality test before use on patients per their guidance, "Mobile Units Equipment Quality Control."
New Units at an Accredited Facility
4.1. What does the ACR consider to be a "new" unit?
4.2. When can my facility start using a new unit to examine patients?
4.3. What accreditation testing is required when a facility purchases a new (or previously owned) unit?
4.4. Where can I find the application for accrediting a new unit on the ACR website?
4.1. What does the ACR consider to be a "new" unit?
A. For accreditation purposes, a "new" unit is any mammography unit that is new to the facility. This includes previously owned units, previously accredited units moved from one site to another, and new units replacing previously accredited units.
4.2. When can my facility start using a new unit to examine patients?
A. A facility with a current MQSA certificate may begin examining patients with a new unit only after:
- the medical physicist has provided the facility with the written results of his or her Equipment Evaluation showing that all required tests have passed and
- the facility has sent the complete new unit application (with the Equipment Evaluation results) to the ACR. (The new unit application is not available online. Please call the Mammography Accreditation Department at (800) 227 6440 to request the appropriate application.)
Once approved, the ACR will notify the FDA (or the state certifying body) within two business days that an accreditation application has been accepted for the new unit. These facilities are not required to wait for a response from the ACR to begin clinical use of the new unit since they are operating with a current MQSA certificate. However, the Center for Medicare and Medicaid Services (CMS) will not reimburse for examinations performed on an FFDM unit until the FDA has received notification that your new unit has applied for accreditation. In order to ensure appropriate reimbursement, we recommend that MQSA-certified facilities do the following before using their new FFDM unit to examine patients:
- Fax the application materials with the Equipment Evaluation results to the ACR at 703-648 9176, and
- After three business days, call the ACR at 800-227 6440 to confirm that the new unit information was sent to the FDA.
- Do not submit your mammography claims for 14 days (as recommended by CMS) to ensure that your local payer has the most current MQSA file.
When scheduling your medical physicist's Equipment Evaluation for your new unit be sure to allow enough time for any possible corrective action and the accreditation application process described above. The ACR typically recommends scheduling an Equipment Evaluation at least one week prior to performing mammography on patients. You cannot use the unit to examine patients even during "applications" training until you meet the above conditions.
Finally, you should contact your state radiation control agency to determine if they have their own special requirements for operating new equipment that you must meet.
4.3. What accreditation testing is required when a facility purchases a new (or previously owned) unit?
A. If the facility has over 13 months left on its current accreditation when the new unit is installed, the facility may choose one of two options:
- A facility with other fully accredited units will most likely choose to complete a New Unit Addendum and submit the medical physicist's Equipment Evaluation results along with a reduced fee. Within 45 days of the initial application, the facility must submit a phantom image (with dosimeter), images of a fatty and a dense breast, QC data, and a full medical physicist's Annual Survey report. Once accreditation is approved for that unit, its expiration date will be the same as the expiration dates for the other units at the facility (less than three years), or
- A facility with only one unit will most likely choose to give up its current MQSA certificate and reinstate the facility with the new unit. The facility must submit a New Unit Reinstatement Application for all units at the facility at the full fee and will receive a 6-month provisional MQSA certificate. Once approved, the facility will receive a full 3-year accreditation from the date of approval.
If the facility has less than 13 months left on its accreditation when the new unit is installed, the ACR will instruct the facility to begin early renewal on all units at the usual renewal fee. Facilities should contact the ACR for the appropriate instructions and applications prior to installation of any new units. Once accreditation is approved, all units at the facility will have an expiration date that is three years from the old expiration date.
4.4. Where can I find the application for accrediting a new unit on the ACR website?
A. The new unit application is not available online. Please call the Mammography Accreditation Program at 800-227-6440 for assistance. The application you need depends on the amount of time your facility has left on your MQSA certificate.
Equipment Evaluations
5.1. What is a mammography Equipment Evaluation?
5.2. How should the medical physicist summarize the results of the Equipment Evaluation?
5.4. Who reviews the Equipment Evaluations and what is evaluated?
5.5. Am I required to notify the ACR if we replace the x-ray tube in our mammography unit?
5.1. What is a mammography Equipment Evaluation?
A. Under the FDA's Final Rules for Mammography, the medical physicist is required to perform a Mammography Equipment Evaluation when a new unit or processor is installed, a unit or processor is disassembled and reassembled in the same or a new location, or major components of a mammography unit or processor equipment are changed or repaired. This Equipment Evaluation must determine whether the new or changed equipment meets the applicable MQSA requirements for mammography equipment [section 900.12(b) of the FDA regulations] in addition to the applicable quality assurance requirements for equipment listed in section 900.12(e). All problems must be corrected before the new or changed equipment is put into service for examinations or film processing and before the facility may apply for accreditation of a new mammography unit. All new mammography facilities and all ACR-accredited facilities installing new mammography units must submit a copy of their medical physicist's Equipment Evaluation results with their initial accreditation application and fee to the ACR before the units may be used to examine patients.
5.2. How should the medical physicist summarize the results of the Equipment Evaluation?
A. In order to expedite the application review process for a new unit, the ACR requires the facility to submit only the following two short forms, completed by the medical physicist:
- MQSA Requirements for Mammography Equipment. The medical physicist should complete all applicable sections of the checklist, indicating "Not Applicable" where appropriate. If "Not Applicable" is marked, a reason should be provided.
- Medical Physicist's Mammography QC Test Summary for screen-film or full-field digital mammography as applicable. Because an Equipment Evaluation is performed before a mammography unit is used clinically, a medical physicist is not required to complete the "Evaluation of Site's Technologist QC Program" section of the form at this time. Your medical physicist will need to evaluate your facility's QC program and complete this section of the QC Test Summary as part of the new unit's Annual Survey report submitted to the ACR with the full application and/or testing materials.
The ACR provides these forms with each new facility or new unit application. They can also be downloaded from the ACR Web site at www.acr.org. Click on "ACCREDITATION", and then click on "Mammography"; the forms are located in the "New Mammography Facility Application Package" section. It is important to note that summaries submitted in different formats will delay the ACR's review even if they contain all of the required information.
The medical physicist should provide these summaries to the facility as soon as possible for inclusion with your application to the ACR. (Handwritten or faxed summaries are acceptable.) You do not need to submit the entire Equipment Evaluation report at this time, only the summaries described above. Also, be sure that all requirements pass before submitting the application.
5.3. Must my medical physicist leave a copy of his or her Equipment Evaluation results before he or she leaves my facility after the survey?
A. No. Although some medical physicists may be able to provide you with written, preliminary Equipment Evaluation results before leaving your facility, others may need to take the raw test data and films back to their office for analysis. In this case, your medical physicist must provide you with the written pass/fail Equipment Evaluation summary as soon as possible so that you can include it with your application to the ACR. The medical physicist may fax or e-mail this summary to you.
If this is a new unit at an existing MQSA-certified facility, you may not start using the unit until you have received written Equipment Evaluation results from the medical physicist showing that all items have passed and sent it to the ACR with all required application materials. You may not start using the equipment to examine patients based on a verbal indication from the medical physicist that all items passed.
5.4. Who reviews the Equipment Evaluations and what is evaluated?
A. ACR staff who are experienced mammography technologists with advanced registries in mammography review the medical physicist's pass/fail Equipment Evaluation summary. They check to verify that the Equipment Evaluation was performed no earlier than six months before the date of application, that the medical physicist has evaluated each applicable FDA-required item and that each item has passed. If the medical physicist fails an item, ACR staff will check that the facility has provided appropriate documentation of corrective action (e.g., the medical physicist's re-evaluation, a service ticket, etc.). If the required item was not evaluated by the medical physicist or if the item failed and no corrective action was provided, ACR staff will call and/or contact the facility in writing for the missing information. The application will not be processed until all information is complete.
5.5. Am I required to notify the ACR if we replace the x-ray tube in our mammography unit?
A. No. However, you must have your medical physicist conduct a Mammography Equipment Evaluation (and all applicable tests must pass) before you may use the mammography unit to examine patients.5.6. We recently installed a new processor. Is an Equipment Evaluation by our medical physicist necessary before we start using the unit for mammography?
A. Yes. This is required under the FDA's Final Rules. See FDA's Policy Guidance Help System for specific guidance on appropriate tests.
5.7. FDA regulations require an Equipment Evaluation after a new processor is installed and before it is used to process patient films. Must the facility also submit the results of this Equipment Evaluation to the ACR whenever a new processor is installed and before it is used for mammography?
A. No. Although an Equipment Evaluation must be performed and all items must pass before a new processor is used to develop patient films, a facility does not need to notify the ACR or submit this information for a new or replacement film processor.
Renewals
6.1. Our facility is accredited by the ACR. When should we expect to receive a renewal application?
6.2. Do we have six months to return the renewal application to the ACR?
6.1. Our facility is accredited by the ACR. When should we expect to receive a renewal application?
A. The ACR will send a renewal application by mail to your Lead Interpreting Physician/Supervising Radiologist approximately eight months prior to your ACR accreditation expiration. If you do not receive this application, please call our office so we may follow up on this for you.
6.2. Do we have six months to return the renewal application to the ACR?
A. No. To ensure that there is adequate time to process your application and evaluate images before your MQSA certificate expires, we must receive your completed Renewal Application and fee within 60 days. Facilities should allow at least six months for the reaccreditation process to be completed. For this reason, the ACR sends Renewal Applications to each facility eight months before their accreditation expires. You may not legally perform mammography if your FDA certificate expires.
Full Application and/or Accreditation Testing
Application - General
7.1.1. How long do I have to submit the full application and testing materials to the ACR?
7.1.3. We submitted our testing material three weeks ago. When are we going to receive the results?
7.1.4. Why can't the ACR give facility results over the phone or by fax?
7.1.5. Will the ACR report our facility’s results to anyone else?
Personnel
Testing - Clinical
7.3.5. May we use a model or a volunteer to obtain clinical images to submit accreditation?
7.3.6. Is there any age limit for patients whose images are submitted for accreditation review?
7.3.7. May we send clinical images with a mole marker to the ACR for accreditation review?
7.3.8. May I submit clinical images of male patients for accreditation review?
7.3.10. Must the clinical images we submit for accreditation be performed on 18 x 24 cm film only?
7.3.11. Does the ACR require automatic flashing of films by the mammographic unit?
Testing - Phantom/Dose
7.4.2. When exposing my dosimeter for testing, do I place the acrylic disk on the phantom?
Testing - QC Documentation
7.1.1. How long do I have to submit the full application and testing materials to the ACR?
A. You have 45 calendar days from the date the testing materials are sent to return the completed application and testing materials to the ACR. If you are having a problem meeting this deadline, you should contact the Mammography Accreditation Program Information Line at 800-227-6440 for assistance.
7.1.2. Our facility's accreditation will expire in six months. Since receiving our testing package for renewal, we do not think that we will be able to make the 45-day deadline for submitting the completed application and testing materials. Can we get an extension?
A. No. If you cannot meet the 45-day time limit, the ACR cannot guarantee completion of the accreditation process (this includes reviewing all submitted testing and application materials as well as issuing a final report) before your MQSA certificate expires. Consequently, the ACR does not grant extensions to the 45-day time limit. We recommend that you keep the ACR informed of the reasons for the delay and submit your completed materials as soon as possible.
7.1.3. We submitted our testing material three weeks ago. When are we going to receive the results?
A. The accreditation review process takes approximately 60 days. You should receive your results soon after that.
7.1.4. Why can't the ACR give facility results over the phone or by fax?
A. FDA requires accrediting bodies to report the results of the accreditation process to facilities in writing. Further, the ACR’s Mammography Accreditation Program is a peer-review process; the information we receive is considered privileged and confidential. This includes information received or developed during the accreditation process.
7.1.5. Will the ACR report our facility’s results to anyone else?
A. The ACR will provide this information to your certifying body (either the FDA or the state) only as is required by MQSA.
7.1.6. Will the ACR accept faxed signatures for the application and/or verification of mammography personnel qualifications?
A. Yes, the ACR does accept faxed signatures. These will be considered legally binding.
7.1.7. Will the ACR accept electronic or digital signatures for accreditation applications, medical physicist's reports and/or verification of mammography personnel qualifications?
A. Yes, the ACR accepts electronic or digital signatures. These will be considered legally binding.
7.2.1. Our Lead Interpreting Physician/Supervising Radiologist just left. Do we need to designate a new one?
A. Yes. FDA regulations require each facility to “identify a Lead Interpreting Physician/Supervising Radiologist who shall have the general responsibility of ensuring that the quality assurance program meets all requirements."
7.2.2. We are changing our Lead Interpreting Physician/Supervising Radiologist. Do I need to report this to the ACR?
A. Yes. Your new Lead Interpreting Physician/Supervising Radiologist must complete several forms so that we know that he or she is aware of his or her responsibilities as a Lead Interpreting Physician/Supervising Radiologist. You may download the necessary forms in the “Supervising Radiologist Change Package” from our Web site. Once completed, please mail or fax them to the ACR. (The address and fax number are on the form.)
You may contact the ACR Mammography Accreditation Program Information Line at 800-227-6440 for more assistance.
7.2.3. We have hired several new radiologists, technologists and a medical physicist. Several have also left our facility. (However, our Lead Interpreting Physician/Supervising Radiologist has not changed.) Do we need to report the change in personnel to the ACR?
A. No. The ACR needs only to be notified when your Lead Interpreting Physician/Supervising Radiologist changes. Other personnel changes (i.e. radiologists, technologists, medical physicists) should be reported when your facility renews its accreditation. However, you should be aware that the FDA or state MQSA inspector will verify the qualifications of your new personnel during your next inspection.
7.2.4. Our current radiology group is leaving at the end of this month. We have a new group starting next month. What steps do I need to take for this transition? Currently all correspondence comes to our Lead Interpreting Physician/Supervising Radiologist and I don't want any lost mail.
A. It is important that accredited facilities notify us when they designate a new Lead Interpreting Physician/Supervising Radiologist. You may download the “Supervising Radiologist Change Memorandum” forms from the ACR Web site at www.acr.org. Click on "ACCREDITATION", then "Mammography"; the forms are located in the "Personnel, Testing and QC Forms" section under the “Supervising Radiologist Change Package” heading.
If you prefer, you may call the ACR Mammography Accreditation Program Information Line at 800-227-6440. You will be instructed to submit the following documentation:
- your MAP ID #
- the name of the new Lead Interpreting Physician/Supervising Radiologist
- the name of the previous Lead Interpreting Physician/Supervising Radiologist
- the effective date of change.
We will send the new Lead Interpreting Physician/Supervising Radiologist several forms to complete and sign to establish his or her new responsibility within your facility and to ensure that all accreditation correspondence is sent to the appropriate responsible individual.
7.2.5. I am a medical physicist who, by contract, is able to work at only one facility with a single mammography unit. Is it still possible to meet the FDA requirement for Medical Physicist Continuing Experience of surveying at least 2 mammography facilities and a total of 6 units during 24 months?
A. Yes. The FDA allows medical physicists to count surveys of the same facility and the same mammography unit more than once per year provided that the facility surveys are at least 10 months apart and the unit surveys are at least 60 days apart. See FDA’s Policy Guidance Help System for specific guidance on this topic: FDA's Policy Guidance Help System. For example, you may meet the FDA requirement for continuing experience by surveying your unit three times a year (once every four months). You will then have six surveys in two years and meet the requirements. Keep in mind that each year at least one of the surveys must be a full facility survey (i.e., it must include an evaluation of the technology QC)7.2.6. Can a facility remain ACR accredited if any of the technologists performing mammography are not certified by the ARRT for passing the advanced registry in mammography (e.g., ARRT(M)?
A. The ACR follows MQSA's Final Regulations. MQSA does not require a registered technologist to hold the ARRT's Advanced Registry in Mammography. As long as a licensed or certified technologist becomes and remains qualified he/she may perform mammography independently. Please review the guidance regarding "Radiologic Technologist Overview" in the FDA's Policy Guidance Help System.
7.2.7. After submitting our application for renewal of our accreditation, we received notification from the ACR that one of our radiologists does not have enough continuing experience. We will not be able to pass accreditation without correcting this deficiency first. What does that mean, and how do we do that?
A. In order to be accredited by the ACR, all mammography personnel at your facility must meet FDA requirements for continuing education and continuing experience (as well as initial requirements). If personnel do not meet these requirements, they must requalify. See FDA's Policy Guidance Help System for their detailed requirements on re-establishing qualifications.
7.3.1. The ACR testing instruction say we must submit clinical images for accreditation review that were interpreted as "negative" (BI-RADS® Assessment Category 1). May we submit "benign" images (BI-RADS® Assessment Category 2) or "incomplete" (BI-RADS® Assessment Category 0) cases?
A. Generally, no. The ACR requests "negative" images (BI-RADS® Assessment Category 1: "There is nothing to comment on. The breasts are symmetrical and no masses, architectural disturbances or suspicious calcifications are present.") Do not submit "benign" (BI-RADS® Assessment Category 2) cases or "incomplete" (BI-RADS® Assessment Category 0) cases. If an ACR reviewer finds an abnormality, this will delay the facility's accreditation. FDA requires the accrediting body to return the images to the facility and the ACR requires the facility to follow up as appropriate before the ACR will issue a final report. Occasionally, low-workload facilities may not be able to find "negative" fatty and dense cases for submission during the given time. These facilities should call the ACR for assistance. With prior permission, these facilities may submit "benign" cases (BI-RADS® Assessment Category 2) along with the interpreting physician's report for evaluation.
7.3.2. Can my facility submit images that have benign calcifications or known benign lymph nodules? What about those patients who have had biopsies or known surgeries?
A. In general, no. Images submitted for accreditation review be assessed as "negative" ( BI-RADS® Category 1). The ACR clinical reviewers are radiologists who are currently working in the mammography field. They review these films as if they are films with no history. They do not have old films or patient history information for a complete assessment. If films are submitted and a possible abnormality is seen, the ACR must follow up with the facility. This could delay the facility's accreditation. However, facilities may contact the ACR for assistance if they are unable to find BI-RADS® Category 1 images to submit for accreditation.
7.3.3. Q. Our facility performs only diagnostic mammography and does no screening mammography. We will not be able to submit “negative” cases (BI-RADS® Assessment Category 1) for accreditation review. What should we do?
A. Call the ACR for assistance. With prior permission, you may submit other cases along with the interpreting physician’s report for evaluation.
7.3.4. Q. Our facility provides mammography only to nursing home patients. Because our patients primarily have fatty breasts, it is impossible for us to find a case with dense breasts to submit for accreditation review. What should we do?
A. Call the ACR for assistance. With prior permission, you may submit other cases
7.3.5. May we use a model or a volunteer to obtain clinical images to submit accreditation?
A. No. Any image submitted for accreditation review must be of a patient who needed a mammogram, typically for screening reasons. As with any mammogram, the interpreting physician must have sent a report to the patient's referring physician and a lay letter to the patient.
7.3.6. Is there any age limit for patients whose images are submitted for accreditation review?
A. No, but keep in mind that these images must be from patients who need the mammogram and generally must be interpreted as "negative" (i.e. BI-RADS® Assessment Category 1). These will most likely be from women undergoing screening. The ACR Practice Guideline for the Performance of Screening Mammography states that screening mammography is indicated for asymptomatic women 40 years of age or older.
7.3.7. May we send clinical images with a mole or nipple marker to the ACR for accreditation review?
A. Yes, as long as the mole or nipple is clearly marked in a conventional manner.
7.3.8. May I submit clinical images of male patients for accreditation review?
A. No. The ACR needs to evaluate images from patients that are typically examined by your facility. The vast majority of mammography examinations are of women. Consequently, the ACR will only accept images of women for accreditation review.
7.3.9. After submitting our accreditation testing material, our Lead Interpreting Physician/Supervising Radiologist was notified by the ACR that an abnormality was found on a set of images. Do we need to send another set of images to replace the films that were returned to us?
A. No. When your Lead Interpreting Physician/Supervising Radiologist is notified of an abnormality the ACR reviewers have finished reviewing the images. Therefore, replacement images are not needed. Only the Abnormality Follow-Up Attestation must be returned once your Lead Interpreting Physician/Supervising Radiologist reads and signs it.
However, any decision on your facility's accreditation, including the final report, will be withheld pending receipt of the attestation that appropriate action will be taken. Failure to comply could result in a failure or deficiency for non-compliance. Furthermore, the ACR will randomly review facilities for compliance with this policy. We strongly suggest that all case review and any patient follow-up be documented.
7.3.10. Must the clinical images we submit for accreditation be performed on 18 x 24 cm film only?
A. No. The ACR accepts clinical images on both the 18-by-24 centimeters and 24-by-30 centimeters film sizes. As described in the 1999 ACR Mammography Quality Control Manual, it is important that the appropriate size film be selected to match the size of the breast. ACR clinical image reviewers will evaluate the images accordingly.
7.3.11. Does the ACR require automatic flashing of films by the mammographic unit?
A. No. The FDA requires that the image identification be permanent and legible but does not require a flash ID system to do it. The ACR strongly recommends a flash card since it is the most permanent method for image identification (see 1999 ACR Mammography Quality Control Manual, page 26).
7.3.12. When submitting our clinical images for accreditation, may we remove the patient name and any identifying information for privacy purposes?
A. No. Sections 164.512(b) and (d) of the HIPAA regulations issued by the Department of Health and Human Services (DHHS) (45CFR) allow a mammography facility to release patient information to an MQSA inspector without patient authorization because MQSA inspectors are performing health oversight activities required by law. Because the law requires that each mammography unit be accredited, releasing patient information to the accrediting body is considered part of the health oversight activity. Additional information regarding HIPAA requirements can be found on the DHHS Website at www.hhs.gov/ocr/hipaa/.
FDA requires the ACR to assess the following eight clinical image attributes: positioning, compression, exposure, level, sharpness, noise, artifacts, and exam identification. The mammogram must have a permanent ID label containing at least: the facility name, city, state, zip code, the patient's fist and last name, an additional patient identification number, and the date of the examination. Consequently, the ACR requires facilities to include patient identifying information on images submitted for accreditation review.
7.3.13. Are there any guidelines on an acceptable number of artifacts allowed on clinical images submitted for accreditation?
A. No. The ACR realizes that not all artifacts can be eliminated (for example, it is rare to see a screen-film image with no dust artifacts.) However, artifacts should not be so numerous or severe that they significantly degrade image quality. The Lead Interpreting Physician/Supervising Radiologist should review and approve all images submitted for accreditation.
7.4.1. When we processed our phantom image for accreditation, there were many unexpected artifacts on the image. Can we obtain another dosimeter and retake our phantom image to send in for accreditation?
A. Yes. You may call the ACR at 800-227 6440 and ask for a replacement dosimeter. A replacement fee will be charged, and you will be instructed to return the original dosimeter to the ACR.
7.4.2. When exposing my dosimeter for testing, do I place the acrylic disk on the phantom?
A. Yes, for screen-film systems. You should use the acrylic disk for this image, just as you would when acquiring routine phantom images for quality control purposes. Be sure that the disk does not cover any test objects because this may impair the ACR reviewers' ability to score the phantom image. The 1999 ACR Mammography Quality Control Manual recommends placing the disk in the space between the two largest fibers. Also be sure that the dosimeter does not cover the pink wax block.
Use of the disk will vary for full-field digital mammography systems. You should follow the instructions specific to the manufacturer of your digital unit.
7.5.1. My facility has three screen-film mammography units. May I submit one processor control chart for all three units?
A. Yes, as long as the clinical and phantom images are selected from within the same 30-day time frame and within the time period shown on the processor QC chart. The ACR provides a processor label for each unit undergoing accreditation; therefore you may attach all three labels to one processor form.
7.5.2. The ACR sent our facility a request for additional information stating that our medical physicist did not evaluate the technologist QC of our new mammography unit. When the medical physicist tested the unit, we had just installed it and were not performing the QC. Must the medical physicist still conduct this evaluation?
A. Yes, the FDA requires that the medical physicist evaluate the facility's QC for all mammography units. Because an Equipment Evaluation is performed before a mammography unit is used clinically, the medical physicist is not required to complete the "Evaluation of Site's Technologist QC Program" section of the form during the Equipment Evaluation. However, your medical physicist does need to evaluate your facility's QC program and complete the appropriate section of the QC Test Summary sometime within the 45 days your are provided to obtain the clinical and phantom images. This evaluation must be submitted to the ACR along with the entire Equipment Evaluation report, the full application and/or testing materials.
The medical physicist should check that all required QC tests are done by the QC technologist initially and then at the FDA-mandated frequencies. The ACR does not require the medical physicist to evaluate a certain number of days of QC. The ACR recognizes that, for this first survey, the medical physicist can only evaluate the number of tests that have been performed since the unit was installed. Note that the medical physicist need not evaluate the technologist’s QC program in person; review of the facility’s QC program may be done remotely by mail or fax.
7.5.3. What medical physicist QC documentation is required when a new facility submits the full application to the ACR?
A. Within 45 days of submitting the initial application, the facility must submit the full application to the ACR. In addition, the facility must submit the entire, most recent medical physicist's Annual Survey report. Because this is a new unit, this Annual Survey report will generally include the Equipment Evaluation report. To summarize the results, the following two forms must be completed by the medical physicist and included with the full report:
- MQSA Requirements for Mammography Equipment, and
- Medical Physicist's Mammography QC Test Summary for screen-film or full-field digital mammography, as applicable. It is important to note that the medical physicist must now complete the "Evaluation of Site's Technologist QC Program" section of this form.
The medical physicist should check that all required QC tests are done by the QC technologist initially and then at the FDA-mandated frequencies. The ACR does not require the medical physicist to evaluate a certain number of days of QC. The ACR recognizes that, for this first Annual Survey, the medical physicist can only evaluate the number of tests that have been performed since the unit was installed. If some of the QC tests were evaluated as part of the Annual Survey for another accredited unit at the facility, the medical physicist should attach a copy of that evaluation with the new unit's Annual Survey report. In addition, the medical physicist need not evaluate the technologist's QC program in person. Review of the facility's QC program may also be done remotely by mail or fax.
7.5.4. I am a medical physicist responsible for evaluating two screen-film mammography units at a facility. I conduct the Annual Survey on two different dates during the year. However, I only review the entire facility's technologist QC program once a year. On the "Medical Physicist's Mammography QC Test Summary" form submitted for accreditation, may I complete only the "Evaluation of Site's Technologist QC Program" section of the form on one unit?
A. Yes, as long as you indicate where and when you recorded the results of the technologist QC program evaluation. For example, if you evaluated the technologist's QC for the entire facility during the Jan. 15, 2007 Annual Survey of Unit #1, and you tested Unit #2 on Apr. 15, 2007, indicate "see Jan. 15, 2007 Annual Survey Report for Unit #1" on the "Evaluation of Site's Technologist QC Program" page of Unit #2's Annual Survey Report. Do not indicate "N/A" for these evaluations. Keep in mind, however, that during accreditation, ACR staff looks for a complete Annual Survey Report for each unit that was performed no earlier than 14 months before the date on the full application. Your facility must be sure to send the ACR the reports containing your evaluation of the technologist's QC program with the pass/fail results for each test of this evaluation. Unfortunately, this does not always happen. Consequently, it may be safer to record the pass/fail results for your evaluation of the technologist's QC program on each unit's Annual Survey Report so you can be sure the necessary information is sent to the ACR. If the evaluation was done on a different day from the main equipment tests, note the date of the evaluation on the form.
Full-Field Digital Mammography (FFDM) Units
FDA's Certification Extension Program for FFDM Systems When No Approved Accreditation Program is Available
8.0.5. What inspection costs are associated with CR certification?
8.0.6. How will an inspector inspect a CR unit?
Accreditation and Certification
8.1.1. Will my facility receive a separate MQSA certificate for our FFDM unit?
8.1.7. When exposing my dosimeter for testing, do I place the acrylic disk on the phantom?
8.1.8. May I submit phantom and clinical images to the ACR on a CD?
8.1.9. How should I window and level the phantom image for accreditation?
8.1.11. What background density should be used when printing digital phantom images?
8.1.13. Do the individual TLD chips need to be seen on the digital phantom image?
8.1.15. May I submit my digital accreditation images on 14 X 17 inch laser printer film?
FFDM Quality Control - General
Laser Film Printers
Monitors and Workstations
8.4.1. Do I have to use an FDA-approved review workstation to interpret digital mammograms?
Data Compression
8.5.2. Does it matter if we use lossless and lossy compression for FFDM?
Digitizing Film Mammograms
8.0.1. From an MQSA standpoint, are there any differences between a computed radiography (CR) system and a full-field digital mammography system?
A. No, although the systems have significant physical differences, FDA treats them the same from an MQSA regulatory standpoint. CR systems are considered part of the FFDM mammographic modality. This means that facilities wishing to use a CR system must meet all applicable MQSA requirements, including those specific to FFDM units. (For example, all personnel using a CR system must have completed at least 8 hour of training specific to digital mammography prior to using the new CR system on patients. However, because CR systems are part of the FFDM mammographic modality, personnel who have already obtained 8 hours of training in FFDM do not have to obtain another 9 hours in CR prior to use on patients.)
8.0.2. There currently is no FDA-approved accreditation program for my FFDM system. How may I legally use this system under MQSA if I cannot get it accredited?
A. The FDA will continue its process for extending the certification of an already certified facility to include these specific model FFDM systems, until an accreditation body has been approved to accredit them. A facility with such an FFDM system will be exempt from the MQSA accreditation requirement, unless otherwise notified by FDA, but must request FDA to extend its current certification to cover its unaccredited FFDM system. The facility must contact the FDA directly in order to obtain this exemption. Requests for FFDM certification extension need to include all the information listed in the document "MQSA Facility Certification Requirements For Use Of Full Field Digital Mammography" (see "Full Field Digital Mammography (FFDM) Certification Extension Program" at www.fda.gov/cdrh/mammography/robohelp/START.HTM) and should be forwarded to:
FFDM Certification Extension Program
Division of Mammography Quality and Radiation Programs
FDA/CDRH/OCER
1350 Piccard Drive, HFZ-240
Rockville, MD 20850Phone: (240) 276-3332
Fax: (240) 276-3272
After the FDA has reached a decision on your application, you will receive either a Letter of Acceptance or a Letter of Denial for your FFDM systems. 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 mammography unit in order to maintain its certification status when utilizing an FFDM system. Your facility is also subject to an annual onsite MQSA inspection of its FFDM system at the same time its accredited unit(s) is/are being inspected.
8.0.3. Under the FDA's Certification Extension Program, does a facility wishing to add a CR system to a screen-film unit need to keep accreditation for an existing unit?
A. Yes, your facility will need to maintain accreditation with an FDA-approved accreditation body for at least one unit other than the CR system. This means the facility must either keep accreditation for the screen-film unit, with which the CR system shares the cassette holder, or another screen-film or FFDM unit. Once the FDA approves an accreditation body to accredit CR systems, the facility will have to apply to that accreditation body for accreditation of the CR system. Once the CR system passes accreditation, the facility will not need to maintain the additional accreditation unless it wishes to continue using the other units.
Note that your facility is also required to undergo an annual onsite MQSA inspection of the CR systems during the inspection of its other screen-film and/or FFDM accredited unit(s).
8.0.4. If we have multiple screen-film units and plan to use CR with all of them, must we get approval to extend our accreditation and certification to add CR to all of them?
A. Yes, since FDA grants accreditation and certification extension for the use of a CR system only with a specific mammography unit, the additional units are not covered even if they are the same make and model.
8.0.5. What inspection costs are associated with CR certification?
A. FDA will treat a screen-film unit that is equipped with a CR system as two separate units. Therefore, inspectors will inspect a single physical unit that is used to perform screen-film mammography and CR mammography as two separate units, and the facility will be billed for two units. Once FDA approves an accreditation body to accredit a manufacturer's CR system, a facility may drop the screen-film accreditation for the unit on which they are using CR, thereby reducing their unit inspection and accreditation costs.
8.0.6. How will an inspector inspect a CR unit?
A. Using laptop computers, FDA inspectors will download the records for a mammography unit(s) that uses CR in the same manner as for any other FFDM unit. They will open and examine the applicable inspection procedure screens. If a unit(s) is being used for both screen-film and CR on the same physical unit(s), the inspectors will need to download separate screen-film records as well.
If an inspector determines that CR is being used on a screen-film unit(s) for which there is no certificate extension approval, the inspector will:
- Add a new record for the CR unit(s) into the database (e.g., with the same model, description, and serial number as the screen-film unit(s) but with an image receptor type of CR),
- Mark it a unaccredited (resulting in a Level 1 or 2 inspection observation),
- Answer the mammography equipment evaluation question and all of the applicable questions in the QC records and Survey Report sections accordingly; and,
- Instruct the facility that it should stop using the unit(s) until it applies to FDA for certificate extension on the unit(s) and has received a Letter of Acceptance.
If a facility is performing both screen-film and CR mammography using the same physical unti(s), the inspector will treat the inspection as two separate units and the facility will be billed accordingly.
8.0.7. Where can a facility get more information on the application for use of an FFDM system under the FDA's MQSA Certification Extension Program?
A. Refer to the mammography website at www.fda.gov/cdrh/mammography, the Policy Guidance Help System (PGHS) as follows: Contents (Accreditation and Certification): Keyword (Full Field Digital Mammography (FFDM) Certification Extension Program).
If you have any questions, you may contact the MQSA facility hotline at 800-838-7715 or by e-mail at MQSAhotline@hcmsllc.com.
8.1.1. Will my facility receive a separate MQSA certificate for our FFDM unit?
A. No. MQSA certification is facility-based and not unit-based. The FDA and other MQSA-certifying bodies issue only one MQSA certificate (with a unique ID number) to each facility. This certificate covers any unit, whether it is screen-film or FFDM.
8.1.2. Even though my facility followed all the ACR-recommended guidelines for submitting the accreditation application on our first FFDM unit (including waiting 3 days and calling the ACR to make sure that the unit was transmitted to the FDA), the Centers for Medicare & Medicaid Services (CMS) is denying our facility payment for FFDM. They claim that we are not certified to perform FFDM and are requesting an MQSA certificate that states we are digitally certified
A. A number of practices are experiencing payment problems with the CMS for FFDM services. The FDA does not provide MQSA certificates that specifically state that a facility is certified to perform FFDM. Instead, they send CMS a weekly file containing the most recent approval information. Your payer must look at the current MQSA file to see whether your facility is certified to perform digital mammography.
See CMS Transmittal 33, on the handling of these files and provide a copy to your local payer. You may contact the appropriate CMS headquarter representatives:
- Medicare Carrier for non-payment of the professional component
- Medicare Fiscal Intermediary (FI) for non-payment of the technical component
Please provide them with your facility's 6-digit FDA ID number from your MQSA certificate and your MQSA expiration date.
|
CMS headquarter representative | |||
|
Contact Person |
Phone |
E-mail | |
| Medicare Carrier |
Eric Coulson Wendy Knarr |
410-786-3352 TDY Operator: Dial 711. When relay operator asks for phone number, provide (410) 786-0843 |
wendy.knarr@cms.hhs.gov |
| Medicare FI | Bill Ruiz | 410-786-9283 | william.ruiz@cms.hhs.gov |
If you continue to have problems after contacting the above individuals, please contact the ACR Economics Department for assistance at 800-227-5463.
8.1.3. We plan to use our new Fuji computed radiography (CR) system with an existing accredited mammography unit currently used with screen-film. What do we need to do to accredit this new CR system?
A. Call the ACR at 800-227-6440 for the appropriate accreditation materials.
8.1.4. I heard that if I use both screen-film and CR on the same mammography unit, my facility must accredit that unit as 2 separate units. Is that true?
A. Yes, because the image quality, QC, and personnel requirements are different for screen-film and FFDM, facilities using both screen-film and CR on the same mammography unit(s) must accredit (and test) each unit as 2 separate units.
8.1.5. We perform computed radiography (CR) mammography at our facility and will be replacing our single imaging plate reader with a multi-plate reader. Do we need to notify the ACR, and do we need to go through accreditation again?
A. No. You do not need to notify the ACR when you install a new reader, nor do you need to repeat accreditation. However, you must consult with your medical physicist to ensure that a Mammography Equipment Evaluation is performed and documented. MQSA inspectors will verify that the appropriate testing was performed during their annual inspection.
8.1.6. When I expose the phantom to produce an image to send to the ACR for accreditation, should I use the exposure techniques specified in the manufacturer's QC manual?
A. No. Tthe ACR's accreditation testing instructions specify that the phantom be exposed under routine clinical conditions. The clinical techniques may differ significantly from the QC techniques specified by the manufacturer. Screen-film phantom images submitted for accreditation are produced with clinical techniques typically used for a 4.2 cm compressed breast of average density. The ACR's Committee on Mammography Accreditation has specified that full-field digital mammography images submitted for accreditation should also be produced under clinical conditions. Consequently, it is important that you carefully follow the ACR's testing instructions when producing images for accreditation review.
8.1.7. When exposing my dosimeter for testing, do I place the acrylic disk on the phantom?
A. Use of the disk will vary among full-field digital mammography systems. You should follow the instructions specific to the manufacturer of your digital unit.
8.1.8. May I submit phantom and clinical images to the ACR on a CD?
A. No. ACR reviewers only review hardcopy images at this time. Furthermore, the FDA has only approved the ACR to review hardcopy images. For purposes of transferring films, the FDA requires a facility to be able to “provide the medical institution, physician, health provider, patient, or patient’s representative with hardcopy films of final interpretation quality.” You must print hardcopies of the test images using the laser film printer and film processor (if applicable) normally used for digital mammograms
8.1.9. How should I window and level the phantom image for accreditation?
A. Process the image as typically done for digital mammography. You should window and level the display to best show the test objects without creating excessive noise. Do not zoom or rotate the image.
8.1.10. When printing FFDM phantom images for accreditation, what size should they be? May I magnify or minify the phantom image?
A. Print the digital images without magnification or minification and as close to “true size” as possible. The ACR recommends:
- Printing the phantom images so that it is within 25% of the actual phantom size. Since the accreditation phantom’s outside dimensions are 10.1 x 10.7 cm, the dimensions of the submitted image should be no smaller than 7.6 x 8.0 cm and no greater than 12.6 x 13.4 cm. (See figure.)
- Printing the phantom images on the same size film as would normally be used to print clinical mammograms (usually 18 x 24 cm).
- Not rotating the phantom during exposure or rotate the image when printing. ACR reviewers position digital films for scoring similar to screen-film images.
8.1.11. What background density should be used when printing digital phantom images?
A. Printed images from a digital mammography unit must be of sufficient quality for diagnostic interpretation when sent to another facility for review. This means that clinical mammograms should be of sufficient density and contrast when viewed by other physicians on appropriately bright mammography viewboxes. Hence, the ACR recommends that the background density of the hardcopy phantom images be between 1.60 – 1.90.
8.1.12. The manufacturer of our FFDM unit requires that at least 5 fibers, 4 speck groups, and 4 masses are visible for phantom QC. Does the ACR use the same criteria for accreditation?
A. No. The ACR uses one phantom image criteria (four fibers, three speck groups, and three masses) when reviewing images submitted for accreditation from all manufacturers’ FFDM units as well as those with screen-film. However, the ACR will check the facility’s QC to ensure that they meet their FFDM manufacturer’s QC criteria (as required by FDA).
8.1.13. Do the individual TLD chips need to be seen on the digital phantom image?
A. No. You should window and level the display to best show the test objects without creating excessive noise. Do not focus on windowing and leveling the display to visualize the thermoluminescent dosimeters (TLDs). Although it is not necessary to see the individual, square TLD chips inside the holes of the dosimeter, it is important to see the entire external outline of the dosimeter on the image to ensure that the dosimeter was completely exposed.
8.1.14. When submitting clinical images to accredit my FFDM unit, may I minify them in order to fit multiple images on one sheet of film?
A. No. You must print all clinical images as close to "true size" as possible. Do not magnify or minify them.
8.1.15. May I submit my digital accreditation images on 14 X 17 inch laser printer film?
A. Yes, if this is the same format that you use to provide hardcopies to your patients. Although the ACR prefers smaller format laser printer film, we will accept digital mammography clinical and phantom images submitted on 14 x 17 inch laser printer film. However, the clinical and phantom images themselves must be as close to "true size" as possible (i.e. without magnification or minification).
8.1.16. I’d like to know the ACR’s position on laterality markers and digital mammography. Should facilities use lead laterality (L/R) markers on each image during the exposure, or is it acceptable to place computer generated markers on the image after the exposure using computer annotation?
A. Either is acceptable. The College considers them equivalent. The same potential for error exists whether the computer or lead markers are used. It is the technologist’s responsibility to ensure that the annotation is correct.
8.1.17. On the accreditation final report, the ACR clinical image reviewer suggested that we may not be using the correct algorithm. What is an algorithm?
A. An algorithm is a step-by-step mathematical procedure (i.e. the program) performed by the computer on the workstation. In digital mammography, image processing algorithms allow for manipulation of fine differences in image contrast. Different manufacturers will use different algorithms to process the clinical image for display on the workstation. You should contact your FFDM unit's and/or workstation's manufacturer for further information on their system's algorithm.
8.2.1. The manufacturer of our FFDM unit has a number of different revisions of their QC manual available. Which one should we follow for the medical physicist and technologists QC tests?
A. You should use the most current version of the QC manual for the unit installed at the facility. Note that the correct manual version may depend not only on the FFDM unit but also the software version of the unit. If there are any questions, check with the manufacturer of your FFDM unit.
8.2.2. What tests must the medical physicist perform after a facility installs a new full-field digital mammography (FFDM) unit? What documentation must the medical physicist provide to the facility to send in for ACR accreditation?
A. FDA requires a medical physicist to perform a Mammography Equipment Evaluation whenever a new FFDM unit is installed. This evaluation must determine if the FFDM unit meets the applicable equipment requirements listed in 900.12(b) of the regulations and the quality assurance requirements listed in 900.12(e).
Section (b) of the FDA regulations are fairly specific and the ACR has developed a simple checklist entitled "MQSA Requirements for Mammography" to help medical physicists document this section of the evaluation.
Section (e) of the FDA regulations requires the medical physicist to follow a quality assurance program that is "substantially the same as the quality assurance program recommended by the image receptor manufacturer." This complicates the testing since the tests, frequencies and pass/fail criteria vary across manufacturers, models and QC manual versions. The ACR has tried to simplify the final pass/fail documentation for these tests by developing a simple form entitled "Medical Physicist's Mammography QC Test Summary" for each image receptor manufacturer of FFDM equipment. All of these forms are routinely updated as the manufacturers update their QC manuals and are available on the ACR website on the Mammography Forms Page.
The FDA requires the ACR to collect and review this information as part of accreditation. To summarize – the medical physicist must perform the FDA-required evaluation and tests, and submit the following completed forms to the facility:
- MQSA Requirements for Mammography Equipment
- Medical Physicist's Mammography QC Test Summary – FFDM Unit Manufacturer-Specific
The facility must submit these forms to the ACR with documentation showing that all failures have been corrected before they may use the new FFDM unit to perform exams on patients.
8.2.3. Every time one of the full-field digital mammography (FFDM) manufacturers updates its QC manual, the ACR changes its Medical Physicist's Mammography QC Test Summary form. Is this necessary? How can medical physicists keep informed of the most current summary form to use?
A. Yes, it is necessary. The FDA requires accrediting bodies to evaluate the medical physicist’s Mammography Equipment Evaluation and Annual Survey results based on the most current version of the QC manual for the unit tested at the facility. Consequently, each time an FFDM QC manual is revised by the manufacturer, the ACR has to revise its Medical Physicist's Mammography QC Test Summary form to ensure that the appropriate results are collected and evaluated. The most current ACR forms are available on the ACR website on Mammography Forms Page. Note that the QC form names on the website include the revision date so you may easily determine if you have the latest version.
You are required to submit the summary form that was appropriate to the unit you tested at the time of your survey. If you are testing a new installation, you should probably use the newest summary for the manufacturer of that system. In those cases, please check the ACR website. If you are doing an annual survey on an older piece of equipment, the ACR will accept an older summary form.
The ACR will announce updates to these forms on its Web site.
8.3.1. Does the ACR or the FDA require an FFDM facility to have a laser film printer at the facility? May the facility use the laser printer of a third party to print hard copies?
A. No and yes. Neither the ACR nor the FDA requires an FFDM facility to have an on-site laser film printer. However, for purposes of transferring films, the FDA does require a facility to be able to "provide the medical institution, physician, health provider, patient or patient's representative, with hardcopy films of final interpretation quality." Consequently, the ACR and FDA require FFDM facilities to have access to a compatible laser film printer (either on-site or at a third party). The printer must exist and be tested by a qualified medical physicist according to the FFDM unit manufacturer's recommendations before the facility performs mammography on patients. The facility must also include information and QC data for the laser film printer in its accreditation application as it does for film processors. Furthermore, MQSA inspectors will review the laser film printer QC when they inspect each FFDM unit.
8.3.2. Should I follow the laser printer manufacturer's QC manual when performing QC on the laser printer in order to comply with the FDA regulations?
A. Possibly. It depends on the instructions provided in the FFDM unit manufacturer's QC manual. FDA regulations require the quality assurance program at FFDM facilities to be substantially the same as the quality assurance program recommended by the image receptor manufacturer (i.e., GE, Fischer, Lorad, Siemens, and Fuji). Some FFDM QC manuals provide specific instructions on performing QC of the laser printer used with their systems; others instruct the user to follow the QC manual of the laser printer manufacturer. The following table summarizes the laser printer QC (at the time this question was written). Check with your FFDM manufacturer for the most current instructions.
|
FDA-Required Laser Printer QC Updated October 2005 | ||
|
FFDM Mfr |
Model |
Laser Printer QC |
| General Electric | Senographe 2000D, DS and Essential | Follow the laser printer manufacturer's QC manual |
| Fischer | SenoScan | Follow the laser printer manufacturer's QC manual |
| Fuji | FRCm | Follow the laser printer manufacturer's QC manual |
| Lorad | Selenia | Follow the Lorad Selenia QC Manual |
| Siemens | Mammomat Novation DR | Follow the laser printer manufacturer's QC manual (but conduct QC every day that images are printed) |
8.3.3. During accreditation of my FFDM unit, do I still need to send the ACR a laser printer quality control chart if hard copy printing is done by a third party?
A. Yes. Even though a third party may produce this hardcopy, the facility is responsible for ensuring that the quality of the hardcopy is of final interpretation quality. Evaluating laser printer quality control is part of this assurance. Furthermore, you must follow your FFDM unit's manufacturer recommendations for laser printer QC.
8.3.4. Does a facility with an FFDM unit need to submit quality control data for their laser film printer even if the physicians interpret only from the soft copy?
A. Yes. Because the FDA requires that each facility be able to print hardcopy films of final interpretation quality for purposes of transferring images, we require facilities to submit hardcopy images. The ACR reviews a copy of the laser camera QC as part of accreditation. You must submit at least one calendar month of laser film printer QC data for each printer used for digital mammography even if it is performed by a third party. We recommend you use the QC chart provided in the FFDM unit's or laser film printer's QC manual. Your printer's QC program must be substantially the same as the quality assurance program recommended by the FFDM manufacturer. Finally, the clinical and phantom images must be taken within the same 30-day time frame and must be within the time period shown on the laser film printer QC chart.
8.3.5. Can a facility with an FFDM unit use their MRI laser printer to print their digital mammography images?
A. Possibly. FDA recommends that only printers specifically approved or cleared for FFDM use by FDA's Office of Device Evaluation be used. However, a facility may use other printers. Facilities need to ensure that all printers used by the facility with its FFDM unit comply with a quality assurance program that is substantially the same as that recommended by the FFDM manufacturer and pass the facility's accreditation body's phantom and clinical image review process. See the FDA's Policy Guidance Help System. You should consult with your medical physicist to assist you in making this decision.
8.3.6. We have a digital mammography unit on a mobile van and want to put a laser printer on it. Does my printer need to be approved by FDA for mobile mammography?
A. No, the FDA MQSA regulations do not specifically address laser printers on mobile vans. Even though the FDA recommends that only printers specifically approved or cleared for FFDM use by FDA's Office of Device Evaluation be used, a facility may use other printers. However, facilities must ensure that all printers used by the facility with its FFDM unit comply with a quality assurance program that is substantially the same as that recommended by the FFDM manufacturer and pass the facility's accreditation body's phantom and clinical image review process.
8.3.7. My facility can print hardcopy images for our FFDM unit from three separate workstations. Which one should I use to print images to submit for accreditation?
A. The ACR suggests that you print from the workstation you typically use to print hardcopy images to give to patients. Per FDA guidance, hardcopy images should be of "final interpretation quality", therefore it is important for your radiologist to review and approve these hardcopy images before you submit them for accreditation.
8.3.8. When patients request the release of their mammogram and we print a hardcopy for them may we charge for the hardcopy?
A. You cannot charge them for the first hardcopy version of the mammogram. However, if the patient requests one or more additional hardcopies of the mammogram, the facility may pass the costs of the additional hardcopies on to the patient. Appropriate charges for transfer of mammographic records could include items such as: administrative time costs incurred in logging in the request, retrieving the mammography films and reports, having the patient sign a release, packaging and mailing charges for the materials, and photocopying costs incurred in making copies of reports. See the FDA's Policy Guidance Help System.
8.3.9. When patients or physicians request mammogram hardcopies, may our film room staff print and release FFDM mammograms or must the hardcopy images be printed and released by mammography technologists?
A. FDA does not specify who is responsible for printing or releasing records. However, the FDA does require, for purposes of transferring films, that the facility be able to provide the medical institution, physician, health provider, patient or patient’s representative, with hardcopy films of final interpretation quality. See the FDA's Policy Guidance Help System. The facility should have a system in place to ensure that the printed and transferred hardcopy images are of final interpretation quality. The quality control technologist and lead interpreting physician should ensure the task is performed in accordance with these regulations.
8.4.1. Do I have to use an FDA-approved review workstation to interpret digital mammograms?
A. No. However, the FDA recommends that only monitors specifically cleared for FFDM use by FDA's Office of Device Evaluation (ODE) be used. (See FDA's Policy Guidance Help System.)
8.4.2. We just installed our first FFDM unit. Does our medical physicist also have to test the review workstation along with the new FFDM unit as part of the Mammography Equipment Evaluation? Do we have to submit the review workstation test results for accreditation?
A. Yes and yes.
8.4.3. We have just added a second FFDM unit. Images from this unit are interpreted on our current review workstation. This review workstation was evaluated during the medical physicist's Annual Survey of our old FFDM unit. Does our medical physicist have to retest that review workstation along with the new FFDM unit as part of the Mammography Equipment Evaluation? Do we have to submit the review workstation test results for accreditation?
A. No and yes. If the review workstation was tested previously with another FFDM unit at that site during its Mammography Equipment Evaluation or Annual Survey, the medical physicist does not have to retest the workstation. However, the medical physicist should indicate on the Mammography Equipment Evaluation summary forms sent with the accreditation application when the workstation was tested and the results.
8.4.4. The physician's review workstation is not at the same physical location as the FFDM unit (it is off site). Is the medical physicist still required to test it during Mammography Equipment Evaluations and Annual Surveys of our facility's unit? Does the facility still need to submit QC results on that workstation to the ACR during accreditation?
A. Possibly and yes. There are at least 2 possible situations to consider if the review workstation is not located at the same facility as the FFDM unit:
- If the workstation was tested previously with another FFDM unit (either at the location of the workstation or a sister site), the medical physicist does not have to retest the workstation. However, the medical physicist should indicate on the Mammography Equipment Evaluation summary forms the MAP ID # of the facility where the workstation is located, when the workstation was tested and the results.
- If the workstation is located off-site in an office with no FFDM units and was not tested previously, the medical physicist must include the review workstation in the FFDM unit's Mammography Equipment Evaluation.
In either case, the review workstation testing results must be included in the accreditation application to the ACR.
8.4.5. Our facility uses a third-party review workstation for interpreting our FFDM images (it was not provided by the FFDM unit manufacturer). May I follow the review workstation's QC manual when performing the Mammography Equipment Evaluation tests or QC on the workstation?
A. Possibly. The FDA requires that facilities with FFDM systems comply with a QC program that is substantially the same as that recommended by the image receptor manufacturer (i.e., GE, Fischer, Fuji, Lorad, Siemens). This requirement also applies to review workstations (monitors). However, the FDA allows some flexibility for workstation QC depending on the device’s clearance from the FDA’s Office of Device Evaluation (ODE) for FFDM use. You should check with the workstation manufacturer for their device's FDA clearance status.
- Workstations approved by the FDA's ODE for FFDM - FDA considers the workstation's QC manual to be "substantially the same" as that of the image receptor manufacturer and the facility may follow it for QC
- Workstations not approved by the FDA's ODE for FFDM - the facility must follow the QC manual provided by the image receptor manufacturer (check with the image receptor manufacturer for their required tests)
8.4.6. All clinical images at our new FFDM facility will be printed and interpreted on hardcopy. There is no review workstation for the physician. Do we need to have access to a review workstation and submit the results of its Mammography Equipment Evaluation and QC testing for accreditation?
A. No. However, since this is an unusual situation (most facilities interpret from the softcopy), you must provide a letter signed by your lead interpreting physician stating that all interpretations will be done from hardcopy. Also, please note that any testing required by the manufacturer for the FFDM unit's display is still required since the technologist clinically uses this display when performing the examination.
8.4.7. We just installed a new review workstation. (We have had our FFDM unit for several years.) Does our medical physicist have to conduct a Mammography Equipment Evaluation of this workstation? Do we have to submit the results of this test to the ACR?
A. Yes and no. It is important that your medical physicist conduct a Mammography Equipment Evaluation of your new workstation (and document his results in a report) to ensure that it is operating properly for image interpretation. However, you do not need to send this to the ACR at this time. We will request the results of the entire system's Annual Survey (which must include the review workstation tests) during accreditation renewal.
8.5.1. What is data "compression" and what is the difference between lossless and lossy compression for FFDM images?
A. In digital mammography, data “compression” is a mathematical method used to reduce the size (i.e., number of “bits”) of a digital image file so that less computer storage is necessary and images can be more efficiently transmitted. There are various techniques of accomplishing this, with varying results. “Lossless” compression refers to methods of data compression in which all the original data is preserved and can be completely restored. “Lossy” compression refers to methods in which the original data cannot be completely reconstituted. See the FDA's Policy Guidance Help System.
8.5.2. Does it matter if we use lossless and lossy compression for FFDM?
A. Yes. The FDA permits a facility to store and recreate images for final interpretation from original or lossless compressed files only. Lossy compressed images may not be used for final interpretation or storage.
However, while lossy compression is not allowed for final interpretation, lossy compressed images from previously obtained mammograms may be used for comparison purposes, if the interpreting physician deems the images acceptable. FDA recommends that if lossy compressed images are used for comparison purposes, that only algorithms approved or cleared by FDA’s Office of Device Evaluation for such purposes be used. In addition, FDA recommends that phantom and clinical images produced by lossy compression pass all applicable quality control tests and are of such quality that if they were submitted, they would pass the facility’s accreditation body’s phantom and clinical image review process. Finally, lossy compressed images cannot be used for initial or continuing experience requirements. See the FDA's Policy Guidance Help System.
8.6.1. My facility has a large archive of film images. Can we legally digitize them and discard the old film images to help reduce our storage problem?
A. No. The FDA regulations do not allow this because a digitized film image is not produced through radiography of the breast; under MQSA it is not considered a mammogram and cannot be used for retention or final interpretation. See the FDA's Policy Guidance Help System.
8.6.2. My facility just purchased a FFDM unit and wants to digitize all of our previous film images so they may be more efficiently used for comparison purposes. Is this allowed under MQSA?
A. Yes. The FDA allows digitized or copied images of previously obtained film mammograms to be used for comparison purposes, if the interpreting physician deems that acceptable. However, because such images are not considered mammograms under MQSA, they cannot be counted towards initial or continuing experience requirements for the interpreting physician. See the FDA's Policy Guidance Help System.
Adverse Accreditation Decisions
Reapplying for Accreditation
9.1. What happens if the facility does not pass accreditation during the first attempt?
9.3. May we go back and select mammograms from a previous date to submit during the repeat process?
9.4. What is required for reinstatement?
Appealing an Adverse Accreditation Decision
9.7. My facility failed accreditation. May we appeal the decision? If so, what's involved?
9.1. What happens if the facility does not pass accreditation during the first attempt?
A. If the facility has adequate time remaining on its MQSA certificate it will be given the opportunity to repeat the test that was deficient. If there is not enough time to repeat the tests before the MQSA certificate expires, the facility will have to submit a corrective action plan and reinstate by completing and returning the full application, all testing materials and a reinstatement fee.
If the site repeats (or reinstates) and receives a second deficiency, it fails accreditation. The ACR will notify the FDA (or the state certifying body) of this failure. In order to resume the accreditation process, the facility must reinstate. The following table summarizes these steps:
Proceeding with Accreditation After Accreditation is not Granted
|
Attempt at Accreditation |
Accreditation Result |
Facility Options |
|
1st |
NOT GRANTED 1st Deficiency Facility may continue performing mammography with the unit as long as they have a valid certificate. |
REPEAT not acceptable area(s) REINSTATE by retesting all areas APPEAL decision on original images or WITHDRAW |
|
2nd |
NOT GRANTED 2nd Deficiency = 1st Failure ACR strongly recommends that facility cease performing mammography with the unit |
REINSTATE by retesting all areas APPEAL decision on original images or WITHDRAW |
|
3rd |
NOT GRANTED 3rd Deficiency = 2nd Failure ACR strongly recommends that facility cease performing mammography with the unit |
REINSTATE after participating in Scheduled On-Site Survey, APPEAL decision on original images (may not operate until the appeal is complete) or WITHDRAW |
9.2. We received a deficiency for clinical images and must repeat with new clinical images. Only our dense breast images failed. May we submit just the dense images?
A. No. The entire deficient area must be repeated in order for the reviewers to assess the overall improvement in clinical image quality since the previous deficiency. Consequently, both fatty and dense images must be reacquired and submitted.
9.3. May we go back and select mammograms from a previous date to submit during the repeat process?
A. No. You must select images from a time period after the date you received the final report specifying that you were deficient in the clinical area. This allows the reviewers to assess the overall improvement in clinical image quality since the previous deficiency and to determine if the facility took all their comments into consideration.
9.4. What is required for reinstatement?
A. Reinstating requires the facility to fully document its history and to address all deficiencies noted in previous reports. An appropriate corrective action plan should be designed, approved by the ACR, and implemented. Once all corrective actions are completed, and supporting documentation has been forwarded to the ACR, the facility may receive a 6-month provisional reinstatement certificate from the FDA (or state certifying body) and go through the accreditation process again. If the facility fails again, it will have to participate in a Scheduled On-Site Survey. The Scheduled On-Site Survey is conducted so that an ACR review team (consisting of a radiologist, a medical physicist and an ACR staff mammography technologist) can review the facility's progress and provide on-site training in areas where help may be needed. This process takes time, and the facility is responsible for payment of a base site-visit fee in addition to all travel expenses incurred by the ACR team.
9.5. My facility submitted a plan of corrective action for reinstatement, but this is what we plan on doing to start the reinstatement process, and the actions have not yet been carried out. Is this enough to start the process and get the provisional certificate from the FDA?
A. No. Although the corrective action plan may discuss the problems the facility had in obtaining accreditation and what they plan to do to correct these deficiencies, these plans must be fully carried out and specifically documented to show proof of correction. That is the primary reason for reinstatement. If facilities were to be reinstated based on what they plan to do and without fully implementing the plan, their past problems might remain uncorrected. This could hinder their next testing cycle for accreditation and ultimately prevent them from obtaining accreditation.
9.6. My facility failed accreditation due to positioning. Our corrective action plan stated that the technologist who performed the submitted exam will have additional training. Today we received an incomplete memo indicating that all technologists at our facility have to receive additional training as part of the corrective action. Why is this necessary?
A. The ACR specifies that you send an example of your best quality work during accreditation. If the clinical images do not pass accreditation, the ACR must assume that all mammography performed at your facility (by all technologists) is of equal or lower quality. Consequently, all technologists must receive training in order to address this. Proper patient positioning, is crucial to obtaining consistently high quality mammograms so that your patients receive the best medical care possible.
9.7. My facility failed accreditation. May we appeal the decision? If so, what's involved?
A. Yes. Facilities that receive a deficiency or a failure may appeal the determination in writing within 30 days of the date of the final report. The original films or data must be submitted with a letter describing your reason for appealing. Only those films reviewed for the original determination will be considered during the appeal evaluation. Both fatty and dense cases must be submitted for clinical appeals in order to allow the reviewer to assess the overall clinical performance of the facility. Films will be forwarded to an arbitrator (a reviewer who did not participate in the initial review) with a copy of the previous reviews and the appeal letter written by the facility. No other films or data will be sent to the reviewer for consideration in the evaluation. The arbitrator's determination will be final.
If a unit is denied accreditation after an appeal of a failure (second deficiency), the facility may appeal directly to the FDA. However, such an appeal will stop the ACR application process until the FDA renders a decision. Further, the facility making the appeal may not perform mammography during the FDA appeal process