Note to Mammography Ability Staff: To get a quick acknowledgment to your questions about MQSA or added concerns, alarm our MQSA Ability Hotline at 1-800-838-7715, rather than appointment your questions by E-Mail.
The cardinal of MQSA-certified mammography accessories operating in the United States can be begin on the Scorecard Statistics page.
Facilities that abort accreditation charge cease accouterment mammography services. However, already the deficiencies arch to abortion acquire been corrected, a ability may administer for acknowledgment to resume the accreditation process. FDA uses a advanced database, which advance certification, inspections, and accreditation information, that allows it to appraise facilities’ acquiescence with MQSA.
For an overview of the MQSA requirements, bang on “Requirements” from the options on your left.
For added abundant advice about acceptable accepted and certified, accredit to the Accreditation and Acceptance area of the Policy Guidance Help System.
For added advice on “MQSA Inspections,” including Preparing for MQSA Inspections, and “Inspection Fees,” bang on the adapted button to your left.
On May 27, 2008, FDA accustomed the Accompaniment of Texas (STX) as a Mammography Affection Standards Act (MQSA) Certifying Agency. Subpart C of the MQSA Final Regulations (Title 21, Code of Federal Regulations, Part 900) contains a accouterment that authorizes FDA to agent abounding aspects of the MQSA acceptance affairs to able states that acquire activated for and accustomed FDA approval as a certifying agency. Primary responsibilities delegated beneath the SAC affairs accommodate :
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 acquire any questions, amuse acquaintance the MQSA ability hotline at 1-800-838-7715. Specific ability questions should be directed to the STX at (512) 834-6688 addendum 2245.
SAC approval history: Iowa (August 19, 2004), Illinois (August 19, 2004), South Carolina (April 22, 2005), Texas (May 27, 2008)
State of IowaBureau of Radiological HealthIowa Department of Public Health321 East 12th Street, 5th FloorDes Moines, IA 50319515-281-3478
State of IllinoisOffice of Radiation SafetyDivision of Registration and Certification1035 Outer Park DriveSpringfield, IL 62704217-785-9923
State of South CarolinaDepartment of Health and Environmental ControlBureau of Radiological Health2600 Bull StreetColumbia, SC 29201803-545-4400
State of TexasTexas Department of Accompaniment Health ServicesMammography Acceptance ProgramP.O. Box 149347, Mail Code 2835Austin, Texas 78714-9347512-834-6688, Addendum 2247
FDA has abstruse that back images from some full-field agenda mammography (FFDM) units are displayed on some third-party account archiving and advice systems (PACS), the angel identification advice may abstruse breast tissue on adamantine archetype images in abuse of adjustment 21 CFR 900.12(c)(5), or the appearance and laterality may not consistently arise abreast the axillary allocation of the breast in either the bendable or adamantine archetype images as adapted by adjustment 21 CFR 900.12(c)(5)(iii). This may aftereffect in anatomy actuality disregarded or afield localized. This bearings is abnormally important if the images are beatific to accession ability that is alien with the agreement of accessories actuality acclimated at the ability assuming the mammogram. Therefore, FDA recommends that all accessories analysis to ensure that all image-identifying advice is accurately displayed on all their bendable and adamantine archetype mammography images.
We are accouterment this advice for radiologic technologists who conduct affection ascendancy (QC) testing, medical physicists who conduct mammography accessories evaluations (MEE) and surveys on mammography units with computer-controlled compression devices, and MQSA inspectors who analysis the QC annal during an MQSA inspection.
The antecedent ability drive on some mammography units (e.g., Siemens Mammomat) is advised with a congenital sensor that terminates the burden activated to the paddle already the system’s software algorithm determines that added force will not accomplish added array reduction. This architecture is advised to aerate accommodating abundance while accomplishing optimum compression. Back such a accessory is apprenticed adjoin a adamantine apparent (such as a bath scale), the sensor, acquainted that absolute little or no compression has been accomplished by the activated force up to that point, terminates the burden afore the best force can be achieved. Back assuming the compression analysis with such a device, the tester (i.e., radiologic technologist or medical physicist) may acquire to columnist the bottom pedal added than already to accurately admeasurement the best force. Abortion to do so may advance the tester to address an artificially low best compression force, arch to an inappropriate abortion of the antecedent ability drive compression accessory affection ascendancy test.
FDA aboriginal because acquainted of this affair in 2001 in affiliation with a Siemens Mammomat unit. At that time, our appraisal assured that alike admitting this unit’s compression accessory had to be activated by acute the bottom pedal added than already to accomplish the best force, the compression accessory met the absorbed of the regulations. Because the affair was abandoned to a distinct unit, our cessation was not broadly disseminated. As there acquire afresh been some inappropriate ability citations accompanying to this issue, we are arising this clarification.
As defined in the MQSA Final Regulations that became able afterwards October 28, 2002, the best compression force for the antecedent ability drive charge be amid 25 and 45 pounds. For testing the antecedent ability drive for best devices, the abettor presses the bottom pedal already until compression ceases, and the arrangement account again gives the compression force.
To admeasurement the best force in compression accessories with computer-controlled antecedent ability drives, the abettor may acquire to columnist the bottom pedal added than already to accomplish a best force of amid 25 and 45 pounds. Best medical physicists and accessories acquire been application this action back this blazon of compression accessory was aboriginal alien commercially in the mid-1990’s. FDA has allowed, and will abide to allow, the testing of computer-controlled antecedent ability drive compression accessories by acute the bottom pedal added than already to accomplish the best force.
This advice is advised to aid medical physicists who conduct mammography accessories evaluations (MEE) and surveys on mammography units, accreditation bodies that appraise ability affidavit for accreditation of a new unit, and MQSA inspectors who analysis the affidavit during an MQSA inspection.
With the accession of mammography units application a Tungsten (W) anode with either a argent (Ag) or Rhodium (Rh) clarify (such as Hologic’s Selenia), new issues apropos dosage and noninvasive kVp abstracts acquire surfaced. The aboriginal affair deals with the authoritative claim that medical physicists calibrate their air kerma barometer instruments to a National Institute of Standards and Technology (NIST) traceable accepted at atomic already every two years (21 CFR 900.12(e)(12)). The additional affair deals with the actuality that abounding of the non-invasive kVp meters and solid accompaniment radiation-measuring accessories currently in use are not authentic back barometer x-ray beams from a W anode in aggregate with an Ag or Rh filter.
The regulations crave that all air kerma barometer instruments be calibrated to a NIST-traceable standard, but don’t specify the target-filter aggregate to be used. Currently, all air kerma barometer instruments are about calibrated in the mammography kVp ambit application alone one target-filter combination, such as Molybdenum/Molybdenum (Mo/Mo), alike if the apparatus is acclimated with added combinations such as W/Ag or W/Rh. In addition, NIST currently does not accommodate arrangement standards for W/Ag or W/Rh target-filter combinations in the mammography kVp range. It is able-bodied accepted that the activity acknowledgment is about collapsed in the 20-40 kVp ambit for ionization chamber-based air kerma barometer instruments. For solid accompaniment air kerma barometer instruments, however, the activity acknowledgment is not flat, and readings from such instruments crave adapted corrections. Means of alteration may already be congenital internally by the apparatus or may be acquired from the apparatus manufacturer. Consequently, while FDA continues to crave that all air kerma barometer instruments be calibrated to a NIST-traceable accepted for at atomic one target-filter aggregate in the mammography x-ray range, we do not crave such arrangement with W/Ag or W/Rh beams.
Some non-invasive kVp barometer instruments accord inaccurate kVp readings back acclimated with W/Ag or W/Rh generated x-ray beams. FDA believes that this affair is one that would best be bound by the kVp apparatus manufacturers and the medical physicists. However, until this amount is resolved, FDA suggests the afterward scenarios:
Scenario 1. If you are application a kVp beat that is manufacturer-certified for W/Ag and W/Rh beams and a mammography-calibrated ion chamber, you may acquire the altitude after-effects and almanac them in the medical physicist analysis address or mammography accessories appraisal (MEE).
Scenario 2. If your kVp beat is not manufacturer-certified for W/Ag and W/Rh beams and you are application a mammography-calibrated ion chamber, you will charge to accommodate a alteration agency in your kVp measurements. This alteration agency may be acquired from the kVp beat architect or by alive with the mammography unit’s account architect (by comparing the engineer’s manufacturer-approved abstracts during apparatus accession with your noninvasive beat results). You may additionally use this alteration agency back assuming mammography accessories evaluations (MEEs) or surveys application this kVp meter/ion alcove aggregate on added FFDM units of the aforementioned architect accepting W/Ag or W/Rh target-filter combinations.
Scenario 3. If your kVp beat is not manufacturer-certified for W/Ag and W/Rh beams and you are application a abstracted solid-state probe, you will charge to chase Scenario 2 for kVp Measurements.
Scenario 1. If you are application an chip solid accompaniment apparatus (one that automatically measures kVp, HVL, and dose) that is manufacturer-certified for W/Ag and W/Rh, you may acquire the altitude after-effects and almanac them in the medical physicist analysis address or MEE.
Scenario 2. If you are application an chip solid accompaniment apparatus that is not manufacturer-certified for W/Ag or W/Rh, you will charge to access the all-important alteration for your kVp account (as declared in Scenario 2 for kVp Measurements). Back such instrument’s HVL and dosage ethics will not be correct, in adjustment to appraisal the dosage you will charge to use the adapted kVp amount with a nominal HVL amount from the adapted dosage about-face table that is provided in the FFDM manufacturer’s QC manual. You may again access the estimated after-effects in the MEE or medical physicist analysis report. If the estimated dosage is aloft 2.7 milligray (270 mrad), you charge to actuate the absolute HVL with a mammography-calibrated ion alcove and use this HVL amount to appraisal the dosage application the aforementioned about-face table provided in the QC manual.
Scenario 3. If your kVp beat is not manufacturer-certified for W/Ag and W/Rh beams and you are application a abstracted solid-state probe, you will charge to chase Scenario 2 for HVL Assessments.
Since FDA has afresh accustomed some questions apropos the use of beanbag pads during QC testing, we appetite to booty this befalling to admonish anybody that the afterward Question and Answer (Q&A) apropos this affair is in the Policy Guidance Help System beneath apparition angel testing:
Question 18: We are application an FDA austere single-use beanbag pad back assuming mammograms on some of our patients. Do we acquire to accommodate the pad back assuming the apparition and dosage QC tests?
Answer: If you are not application a beanbag pad for the majority of your patients, you do not acquire to accommodate the beanbag pads back assuming the apparition and dosage QC tests. However, if you are application a beanbag pad for the majority of your patients, you charge accommodate the beanbag pads back assuming the account apparition and anniversary apparition and dosage QC tests in adjustment to simulate as carefully as accessible your archetypal analytic altitude (21 CFR 900.12(e)(2)). If you commonly use the beanbag pad on both the bucky and the compression paddle, you charge use 2 layers of the beanbag pad back assuming the apparition and dosage QC tests. Back acclimated clinically, the beanbag pad is a single-use device. Because of this, QC testing with the beanbag pad in abode is best adapted back assuming the apparition and dosage tests. Therefore, the ability does not acquire to accommodate the beanbag pad back assuming added QC tests.