Radiation-Emitting Products

Facility Certification and Inspection (MQSA)

Certification

Inspections

Note to Mammography Facility Staff: To get a quick response to your questions about MQSA or other concerns, call our MQSA Facility Hotline at 1-800-838-7715, rather than submitting your questions by E-Mail.

The number of MQSA-certified mammography facilities operating in the United States can be found on the Scorecard Statistics page.

Facilities that fail accreditation must cease providing mammography services. However, once the deficiencies leading to failure have been corrected, a facility may apply for reinstatement to resume the accreditation process. FDA uses a state-of-the-art database, which tracks certification, inspections, and accreditation information, that allows it to assess facilities' compliance with MQSA.

For an overview of the MQSA requirements, click on "Requirements" from the options on your left.

For more detailed information about becoming accredited and certified, refer to the Accreditation and Certification section of the Policy Guidance Help System.

For more information on "MQSA Inspections," including Preparing for MQSA Inspections, and "Inspection Fees," click on the appropriate button to your left.

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Certification

States as Certifiers (SAC)

On May 27, 2008, FDA approved the State of Texas (STX) as a Mammography Quality Standards Act (MQSA) Certifying Agency. Subpart C of the MQSA Final Regulations (Title 21, Code of Federal Regulations, Part 900) contains a provision that authorizes FDA to delegate many aspects of the MQSA certification program to qualified states that have applied for and received FDA approval as a certifying agency. Primary responsibilities delegated under the SAC program include :

  • issuance, renewal, denial, suspension, and revocation of certificates to non-federal mammography facilities within the State;
  • annual facility inspections (with the exception of federal facilities); and
  • all compliance actions for any STX MQSA inspection findings.

With this latest approval and on September 1, 2008, the STX joins the FDA and the States of Illinois, Iowa and South Carolina as certifying agencies. If you have any questions, please contact the MQSA facility hotline at 1-800-838-7715. Specific facility questions should be directed to the STX at (512) 834-6688 extension 2245.

SAC approval history: Iowa (August 19, 2004), Illinois (August 19, 2004), South Carolina (April 22, 2005), Texas (May 27, 2008)

State Certifying Agency Contact Information

State of Iowa
Bureau of Radiological Health
Iowa Department of Public Health
321 East 12th Street, 5th Floor
Des Moines, IA 50319
515-281-3478

State of Illinois
Office of Radiation Safety
Division of Registration and Certification
1035 Outer Park Drive
Springfield, IL 62704
217-785-9923

State of South Carolina
Department of Health and Environmental Control
Bureau of Radiological Health
2600 Bull Street
Columbia, SC 29201
803-545-4400

State of Texas
Texas Department of State Health Services
Mammography Certification Program
P.O. Box 149347, Mail Code 2835
Austin, Texas 78714-9347
512-834-6688, Extension 2247

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Inspections

Notice: Possible Incompatibility When Images From Some FFDM Units Are Displayed On Some Third-Party PACS 

FDA has learned that when images from some full-field digital mammography (FFDM) units are displayed on some third-party picture archiving and communication systems (PACS), the image identification information may obscure breast tissue on hard copy images in violation of regulation 21 CFR 900.12(c)(5), or the view and laterality may not always appear near the axillary portion of the breast in either the soft or hard copy images as required by regulation 21 CFR 900.12(c)(5)(iii). This may result in pathology being overlooked or incorrectly localized. This situation is especially important if the images are sent to another facility that is unfamiliar with the configuration of equipment being used at the facility performing the mammogram. Therefore, FDA recommends that all facilities check to ensure that all image-identifying information is correctly displayed on all their soft and hard copy mammography images.

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Clarification of Radiologic Technologist and Medical Physicist Testing of the Initial Power Drive in Units with Computer-Controlled Compression 

We are providing this information for radiologic technologists who conduct quality control (QC) testing, medical physicists who conduct mammography equipment evaluations (MEE) and surveys on mammography units with computer-controlled compression devices, and MQSA inspectors who review the QC records during an MQSA inspection.

The initial power drive on some mammography units (e.g., Siemens Mammomat) is designed with a built-in sensor that terminates the pressure applied to the paddle once the system’s software algorithm determines that additional force will not achieve further thickness reduction. This design is intended to maximize patient comfort while achieving optimum compression. When such a device is pressed against a hard surface (such as a bathroom scale), the sensor, recognizing that very little or no compression has been achieved by the applied force up to that point, terminates the pressure before the maximum force can be achieved. When performing the compression test with such a device, the tester (i.e., radiologic technologist or medical physicist) may have to press the foot pedal more than once to accurately measure the maximum force. Failure to do so may lead the tester to report an artificially low maximum compression force, leading to an inappropriate failure of the initial power drive compression device quality control test.

FDA first because aware of this issue in 2001 in conjunction with a Siemens Mammomat unit. At that time, our evaluation concluded that even though this unit’s compression device had to be tested by pressing the foot pedal more than once to achieve the maximum force, the compression device met the intent of the regulations. Because the issue was isolated to a single unit, our conclusion was not widely disseminated. As there have recently been some inappropriate facility citations related to this issue, we are issuing this clarification.

As specified in the MQSA Final Regulations that became effective after October 28, 2002, the maximum compression force for the initial power drive must be between 25 and 45 pounds. For testing the initial power drive for most devices, the operator presses the foot pedal once until compression ceases, and the scale reading then gives the compression force.

To measure the maximum force in compression devices with computer-controlled initial power drives, the operator may have to press the foot pedal more than once to achieve a maximum force of between 25 and 45 pounds. Most medical physicists and facilities have been using this procedure since this type of compression device was first introduced commercially in the mid-1990’s. FDA has allowed, and will continue to allow, the testing of computer-controlled initial power drive compression devices by pressing the foot pedal more than once to achieve the maximum force.

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Medical Physicist Actions Regarding Instrument Calibration, Dose, and kVp Measurements in a Mammography Unit with a Tungsten (W) Anode and Silver (Ag) or Rhodium (Rh) Filter

This information is intended to aid medical physicists who conduct mammography equipment evaluations (MEE) and surveys on mammography units, accreditation bodies that evaluate facility documentation for accreditation of a new unit, and MQSA inspectors who review the documentation during an MQSA inspection.

With the introduction of mammography units using a Tungsten (W) anode with either a silver (Ag) or Rhodium (Rh) filter (such as Hologic’s Selenia), new issues regarding dose and noninvasive kVp measurements have surfaced. The first issue deals with the regulatory requirement that medical physicists calibrate their air kerma measuring instruments to a National Institute of Standards and Technology (NIST) traceable standard at least once every two years (21 CFR 900.12(e)(12)). The second issue deals with the fact that many of the non-invasive kVp meters and solid state radiation-measuring devices currently in use are not accurate when measuring x-ray beams from a W anode in combination with an Ag or Rh filter.

Calibration issue

The regulations require that all air kerma measuring instruments be calibrated to a NIST-traceable standard, but don’t specify the target-filter combination to be used. Currently, all air kerma measuring instruments are typically calibrated in the mammography kVp range using only one target-filter combination, such as Molybdenum/Molybdenum (Mo/Mo), even if the instrument is used with other combinations such as W/Ag or W/Rh. In addition, NIST currently does not provide calibration standards for W/Ag or W/Rh target-filter combinations in the mammography kVp range. It is well known that the energy response is typically flat in the 20-40 kVp range for ionization chamber-based air kerma measuring instruments. For solid state air kerma measuring instruments, however, the energy response is not flat, and readings from such instruments require appropriate corrections. Means of correction may already be incorporated internally by the instrument or may be obtained from the instrument manufacturer. Consequently, while FDA continues to require that all air kerma measuring instruments be calibrated to a NIST-traceable standard for at least one target-filter combination in the mammography x-ray range, we do not require such calibration with W/Ag or W/Rh beams.

Non-invasive kVp measuring instruments

Some non-invasive kVp measuring instruments give inaccurate kVp readings when used with W/Ag or W/Rh generated x-ray beams. FDA believes that this issue is one that would best be resolved by the kVp instrument manufacturers and the medical physicists. However, until this matter is resolved, FDA suggests the following scenarios:

kVp Measurements

Scenario 1. If you are using a kVp meter that is manufacturer-certified for W/Ag and W/Rh beams and a mammography-calibrated ion chamber, you may accept the measurement results and record them in the medical physicist survey report or mammography equipment evaluation (MEE).

Scenario 2. If your kVp meter is not manufacturer-certified for W/Ag and W/Rh beams and you are using a mammography-calibrated ion chamber, you will need to include a correction factor in your kVp measurements. This correction factor may be obtained from the kVp meter manufacturer or by working with the mammography unit’s service engineer (by comparing the engineer’s manufacturer-approved measurements during machine installation with your noninvasive meter results). You may also use this correction factor when performing mammography equipment evaluations (MEEs) or surveys using this kVp meter/ion chamber combination on other FFDM units of the same manufacturer having W/Ag or W/Rh target-filter combinations.

Scenario 3. If your kVp meter is not manufacturer-certified for W/Ag and W/Rh beams and you are using a separate solid-state probe, you will need to follow Scenario 2 for kVp Measurements.

HVL Assessments

Scenario 1. If you are using an integrated solid state instrument (one that automatically measures kVp, HVL, and dose) that is manufacturer-certified for W/Ag and W/Rh, you may accept the measurement results and record them in the medical physicist survey report or MEE.

Scenario 2. If you are using an integrated solid state instrument that is not manufacturer-certified for W/Ag or W/Rh, you will need to obtain the necessary correction for your kVp reading (as described in Scenario 2 for kVp Measurements). Since such instrument’s HVL and dose values will not be correct, in order to estimate the dose you will need to use the corrected kVp value with a nominal HVL value from the appropriate dose conversion table that is provided in the FFDM manufacturer’s QC manual. You may then enter the estimated results in the MEE or medical physicist survey report. If the estimated dose is above 2.7 milligray (270 mrad), you need to determine the actual HVL with a mammography-calibrated ion chamber and use this HVL value to estimate the dose using the same conversion table provided in the QC manual.

Scenario 3. If your kVp meter is not manufacturer-certified for W/Ag and W/Rh beams and you are using a separate solid-state probe, you will need to follow Scenario 2 for HVL Assessments.

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Use of Cushion Pads While Testing Full-Field Digital Mammography (FFDM) Units

Since FDA has recently received some questions regarding the use of cushion pads during QC testing, we want to take this opportunity to remind everyone that the following Question and Answer (Q&A) regarding this issue is in the Policy Guidance Help System under phantom image testing:

Question 18: We are using an FDA cleared single-use cushion pad when performing mammograms on some of our patients. Do we have to include the pad when performing the phantom and dose QC tests?

Answer: If you are not using a cushion pad for the majority of your patients, you do not have to include the cushion pads when performing the phantom and dose QC tests. However, if you are using a cushion pad for the majority of your patients, you must include the cushion pads when performing the weekly phantom and annual phantom and dose QC tests in order to simulate as closely as possible your typical clinical conditions (21 CFR 900.12(e)(2)). If you routinely use the cushion pad on both the bucky and the compression paddle, you must use 2 layers of the cushion pad when performing the phantom and dose QC tests. When used clinically, the cushion pad is a single-use device. Because of this, QC testing with the cushion pad in place is most appropriate when performing the phantom and dose tests. Therefore, the facility does not have to include the cushion pad when performing other QC tests.

The above Q&A was written before FFDM systems came into widespread use. DMQRP has received questions recently about whether the cushion pad (e.g., MammoPad) must be used when performing QC tests on FFDM units if the facility uses the pad on the majority of its patients. While FDA recommends that tests performed on FFDM units, such as the phantom test, be done under clinical conditions, we can only REQUIRE that the pad be included during the test(s) when the manufacturer’s QC manual specifies a pad to be present during QC testing. As 21 CFR 900.12(e)(6) states that, “…the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer,” the unit manufacturer’s QC manual defines the test conditions for the phantom image and other QC tests.

Page Last Updated: 10/08/2014
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