Mammography under MQSA and ACR Accreditation
Unit 3: Regulation, Accreditation, and the CMMS. Lesson 11 of 60 in CRES Academy.
Mammography is the one modality where the quality control schedule is federal law. Everywhere else a missed test is a finding; here it can close the service.
The law and the program
The MQSA, the Mammography Quality Standards Act, makes the FDA the regulator of every facility that performs mammography. A facility must hold a certificate to operate, be accredited by an approved body such as the ACR, be inspected annually, meet personnel requirements for interpreting physicians, technologists, and medical physicists, have a medical physicist survey every year, and run a written quality control program. Images, reports, and quality control records are retained for the period the law sets, and a patient and her physician must receive results.
The quality control schedule
Daily detector or processor check, and cleanliness Weekly phantom image scored and logged, screen cleanliness, viewing conditions Monthly visual checklist of the unit: paddles, locks, lights, indicators, cables Quarterly repeat analysis, or every 250 patients Semiannual compression force, and the other semiannual tests the program lists Annual full medical physicist survey, or sooner after a major component change
Those intervals are examinable. The mammographer, the technologist who performs the exams, does the daily, weekly, and monthly work; the medical physicist does the annual survey; you make the equipment able to pass both.
The phantom and its score
The ACR test object holds fibers, speck groups, and masses of decreasing size, imaged at the same clinical technique a mammogram is taken with, and its scoring runs from largest to smallest until an object can no longer be seen. The minimum to pass accreditation is four fibers, three speck groups, and three masses, and a score must not fall more than 0.5 from the previous image. A falling score is the single most useful early warning the modality has: stop, and look at detector calibration, target and filter selection, compression, and automatic exposure control before anyone changes technique.
What your service visit must leave behind
After any work on a mammography unit the compliance state has to be restored and proven.
- Compression force: both power and manual modes must reach 25 to 40 lb and hold at least 15 seconds, and 40 lb must never be exceeded in power mode.
- Automatic exposure control: verify constant density across thicknesses after any receptor, detector, or board work.
- Phantom image: take one and score it after any work on the receptor, detector, or beam path, and file it.
- Records: the measurement, the tolerance, pass or fail, and whether a physicist survey is now required because the component you changed was a major one.
Accreditation beyond mammography
The ACR also accredits computed tomography, magnetic resonance, ultrasound, nuclear medicine, and breast tomosynthesis programs, with their own phantoms and submitted images. Those are voluntary in the sense that the law does not compel them, but payers often do, so losing accreditation has the same practical effect as losing a license.
Mammography under MQSA and ACR Accreditation, explained slowly
The one modality where quality control is law
In every other room, a missed quality control test is a finding against the department. In mammography it is a violation of federal law, because the MQSA wrote the quality control program into the statute and gave the FDA the job of inspecting it. That changes your position: on a mammography unit you are not just restoring function, you are restoring a documented compliance state.
What the law requires of the facility
Requirement Detail
Certification a facility may not perform mammography without a certificate
Accreditation by an FDA-approved body, commonly the ACR, with submitted
clinical and phantom images
Annual inspection by an inspector, on site, checking equipment and records
Medical physicist a full survey every year, and after a major component change
survey
Personnel qualification and continuing education requirements for
interpreting physicians, technologists, and physicists
Quality control a written program with assigned tasks at set intervals
Records and results images and reports retained for the period the law sets; results
communicated to the patient as well as the physicianThe quality control schedule, and who does each part
Interval Task Owner
Daily detector or processor check; cleanliness technologist
Weekly phantom image, scored and logged; screen cleanliness; technologist
viewing conditions
Monthly visual checklist: paddles, locks, lights, indicators, technologist
cables, interlocks, cleanliness
Quarterly repeat analysis, or every 250 patients technologist, with you
Semiannual compression force, and the program's other technologist, with you
semiannual tests
Annual full medical physicist survey, or sooner after a medical physicist
major component changeLearn the intervals as intervals; exam items ask which task belongs to which one. Your name appears against the equipment's ability to pass, and against anything the checklist finds broken.
The phantom and its score, step by step
The ACR test object contains fibers, speck groups, and masses in decreasing sizes embedded in tissue-equivalent material.
- Image it at the clinical technique the program specifies, with the same geometry every week.
- Score largest to smallest, counting each object only while it is clearly visible, and stop at the first one you cannot see.
- The minimum to pass accreditation is four fibers, three speck groups, and three masses.
- A score must not fall more than 0.5 from the previous image.
- A drop of more than 0.5 is a stop-and-investigate event, not a technique adjustment: look at detector calibration, target and filter selection, compression, the beam path for dust or a damaged paddle, and processing or display.
The phantom score is the most sensitive early warning the modality has, which is why the weekly image is worth more to you than any annual number.
What your visit must leave behind
- Compression: verify with a scale that both power and manual modes reach 25 to 40 lb and hold at least 15 seconds, and that power mode cannot exceed 40 lb.
- Automatic exposure control: after any detector, receptor, or board work, prove constant density across a range of thicknesses.
- Phantom image: take one and score it after any work in the beam path or on the receptor, and file it with the work order.
- Physicist: decide and document whether the component you replaced was major enough to require a survey before clinical use. Getting this wrong takes the unit out of compliance even though it is working perfectly.
- Records: the measured value, the tolerance, pass or fail, and the return-to-service time, in the CMMS.
Accreditation beyond mammography
The ACR also accredits computed tomography, magnetic resonance, ultrasound, nuclear medicine, and breast tomosynthesis programs, each with its own phantom, image submission, and physicist involvement. Those programs are not compelled by the mammography statute, but payers commonly require accreditation, so in practice losing it closes the service just as effectively. Treat an accreditation phantom scan on any modality the way you treat a mammography phantom: a baseline on file, the same geometry every time, and an investigation when the number moves.
What to memorize
- MQSA is federal law administered by the FDA: certificate, accreditation by an approved body, annual inspection, annual physicist survey, personnel requirements, written quality control.
- Daily detector or processor, weekly phantom, monthly visual checklist, quarterly repeat analysis or every 250 patients, semiannual compression, annual physicist survey.
- Phantom minimum four fibers, three speck groups, three masses; no drop greater than 0.5.
- Compression 25 to 40 lb, held at least 15 seconds, never above 40 lb automatically.