MammoComply Mini Moments

Does a change of ownership change a facility's MQSA responsibilities?

What it is

The FDA's MQSA inspection procedures say the owner or operator of a mammography facility is always responsible for the facility's activities under MQSA.

How it works

A change of ownership does not relieve the current owner of that responsibility. If problems found at an inspection continue under new management, the new management must address them, even if they were found while a previous owner ran the facility. Whether the FDA takes enforcement action after an ownership change is decided case by case and depends on factors such as the facility's earlier compliance record.

Why it matters

A buyer inherits open inspection findings. Reviewing the facility's last inspection report during the transaction avoids learning about open items afterward.

What it means to the patient or the client

For the client: when you buy or take over a facility, open inspection findings come with it, so review the last inspection report and any open corrective actions before you close. Under MQSA the current owner answers for the facility.

Does a facility need a new MQSA certificate when it moves?

What it is

When a facility moves, its MQSA certificate is still valid, according to the FDA's inspection procedures.

How it works

The facility must notify its accreditation body, which tells it about any extra information or testing and informs the FDA or the certifying State of the new address. Any mammography unit, processor, or laser printer that is disassembled and reassembled, at the same or a different location, needs a mammography equipment evaluation by a medical physicist, and any failure found must be corrected before the equipment is used on patients. FDA-issued certificates carry only the facility name, so an address change does not need a replacement certificate; facilities with State-issued certificates should ask their State agency.

Why it matters

The certificate follows the facility, but the equipment evaluation follows the equipment. Planning the physicist's visit before reopening avoids patient imaging on untested equipment.

What it means to the patient or the client

For the client: a move does not require a new certificate, but you must notify your accreditation body. Schedule the physicist's equipment evaluation before patients are imaged on any unit that was taken apart and reassembled.

What happens to the MQSA certificate when a facility changes only its name?

What it is

When a facility changes its name but keeps the same owner, personnel, and equipment, its MQSA certificate stays valid, according to the FDA's inspection procedures.

How it works

The facility notifies its accreditation body, which informs the FDA or the certifying State. A new certificate with the new name is issued with the same expiration date, because the facility has not been reaccredited or recertified. Until the new certificate arrives, the facility must prominently display its original certificate, and once the new one arrives it should stop displaying the original.

Why it matters

The accreditation body is the facility's route for name, address, and ownership changes. Telling it promptly keeps the certificate and the public record in step.

What it means to the patient or the client

For the client: tell your accreditation body about a name change, and keep displaying your original certificate until the new one arrives. The new certificate keeps the same expiration date.

What notification rules apply when a mammography unit is moved?

What it is

The FDA's notification protocols describe four scenarios for moving a mammography unit, and the requirements vary by accreditation body and state certifying agency.

How it works

For a wheeled unit moved within the same building, most bodies require no prior notification, the FDA and most states expect notice within 30 days, and post-move testing is required before examinations. For a non-wheeled unit within the same building, several states and the FDA require prior notice, and an equipment evaluation replaces the pre-examination test if the unit was taken apart and reassembled. A move to a different building usually needs prior notification and an equipment evaluation. A move to a facility with a different MQSA ID requires prior notice, a new accreditation process, and an equipment evaluation.

Why it matters

Because the rules differ by accreditation body and state, a facility should confirm with both before the move, not after. The page was current as of March 22, 2018, so check the FDA page for later changes.

What it means to the patient or the client

For the client: confirm the rules with both your accreditation body and your state before you move a unit, not after, because they differ. The FDA page was current as of March 22, 2018, so check it for later changes.

How should a facility prepare for the annual MQSA inspection?

What it is

The FDA's MQSA Insights page describes what facilities can do to help the annual inspection go smoothly.

How it works

Inspectors give at least 5 business days' notice. Facilities should gather and organize their records beforehand, allow about 20 minutes per mammography unit for taking and scoring the phantom image, and keep staff available for questions. The lead interpreting physician, the quality control technologist, the radiology manager, and the facility's MQSA contact should attend the exit interview, which typically lasts 15 to 20 minutes. The inspector provides the final report within 5 business days, and adverse observations must be corrected within the timeframes the report states.

Why it matters

Organized records shorten the inspection and reduce missed items. Having the right people at the exit interview means findings are heard by those who can act on them.

What it means to the patient or the client

For the client: with at least 5 business days' notice, the preparation that matters most is organized records and the right people at the exit interview. Allow about 20 minutes per mammography unit for the phantom image.

What do MQSA inspectors check in mammography reports and patient letters?

What it is

The FDA's MQSA Insights page says inspectors check a sample of mammography reports and the patient lay summary letters.

How it works

Inspectors select at least five mammography reports and check that each has the patient's name and an identifier, the facility's name and location, the date of the examination, the interpreting physician, acceptable assessment category wording, and an acceptable breast density assessment. Patient lay summary letters are checked for the patient's name, the facility address, and the federal breast density notification statement.

Why it matters

These are the items most easily fixed in a template. A report or letter template that carries every required element each time prevents repeat findings.

What it means to the patient or the client

For the client: these are the items most easily fixed in a template, so check that every report and lay letter template carries each element every time. For patients: this is why your letter shows your name, the facility's address, and the breast density statement.

Can owners of several mobile mammography units combine their medical outcomes audit?

What it is

MQSA Alternative Standard 7 lets an owner of several mobile mammography units perform one combined medical outcomes audit, treating the units together as a single facility, instead of a separate audit for each unit.

How it works

The alternative changes the requirement in 21 CFR 900.12(f)(1). The FDA approved it on November 4, 2002 and amended it effective December 3, 2002, with no time limit. Every one of these conditions must be met: each facility is a single mobile unit, the same entity or group administers all the included units, the same lead interpreting physician ensures compliance across them, the same group of radiologists reads the images from all of them, and all of them serve the same patient population.

Why it matters

Mobile programs that meet all five conditions can run one audit instead of several. If any condition stops being true, such as a second reading group, the combined audit no longer fits.

What it means to the patient or the client

For the client: a mobile program that meets all five conditions can run one audit instead of one per unit. If a condition stops being true, such as a second reading group, the program goes back to separate audits.

How is the cancer detection rate defined and calculated under MQSA?

What it is

Under 21 CFR 900.12(f)(1)(ii), cancer detection rate is a ratio per 1,000 patients, based on patients who were first examined with a screening mammogram.

How it works

Among those patients, take the ones who received an assessment of Incomplete: Need additional imaging evaluation, Suspicious, or Highly Suggestive of Malignancy on the screening mammogram or on a later diagnostic mammogram. Count how many of them were diagnosed with breast cancer within 1 year of the date of the initial screening mammogram, and express that number as a ratio per 1,000 patients.

Cancer detection rate = breast cancers diagnosed within 1 year of the initial screening mammogram, per 1,000 screened patients, as defined in 21 CFR 900.12(f)(1)(ii)

Why it matters

The one year follow up is part of the definition, so the rate is not final until that year has passed. Using the same patient base each year keeps the rate comparable over time.

What it means to the patient or the client

For the client: the rate is not final until the one year follow up has passed, so report it with its audit period and use the same patient base each year. The rule sets no target, so compare it with professional benchmarks.

How is the recall rate defined and calculated under MQSA?

What it is

Under 21 CFR 900.12(f)(1)(iii), recall rate is the percentage of screening mammograms given an assessment of Incomplete: Need additional imaging evaluation.

How it works

Count the screening mammograms in the audit period, count how many received that assessment, and divide. The denominator is screening mammograms, not patients and not diagnostic examinations. The rule defines the measure but does not set a target range for it.

Recall rate (%) = screening mammograms assessed Incomplete: Need additional imaging evaluation / all screening mammograms x 100

Why it matters

Recall rate is one of the three measures the audit must determine. Because the rule gives no target, a facility compares its rate with professional benchmarks and keeps the definition stated exactly the same way each year.

What it means to the patient or the client

For the client: count screening mammograms only and define the measure the same way each year. The rule sets no target range, so compare your rate with professional benchmarks and treat a change as a question to look into.

How long must medical outcomes audit records be kept?

What it is

The records and data that show the facility is meeting the audit requirements have a retention rule in 21 CFR 900.12(f)(4).

How it works

They must be kept until the annual inspection that follows the facility's analysis of that information. The requirement covers the records and data behind the audit, not only the final summary.

Why it matters

A facility that analyzes in one year is asked about it at the next inspection. Keeping the supporting data until then lets it show how the numbers were produced.

What it means to the patient or the client

For the client: keep the data behind each audit, not only the summary, until the annual inspection that follows your analysis. That lets you show an inspector how the numbers were produced.

How often must a facility analyze its medical outcomes audit?

What it is

The medical outcomes audit is an analysis the facility repeats on a schedule set in 21 CFR 900.12(f)(2).

How it works

The first audit analysis must be started no later than 12 months after the facility becomes certified, and it is completed within a further 12 months so that diagnostic procedures and data collection can finish. After that, an audit analysis is conducted at least once every 12 months.

Why it matters

The one year outcome window means a year of data is not final on the day the year ends. Facilities that plan the analysis date with that follow up time in mind avoid reporting numbers that later change.

What it means to the patient or the client

For the client: plan the analysis date with the one year follow up in mind, because a year of outcomes is not final the day the year ends. The first analysis can start up to 12 months after certification and has a further 12 months to finish.

What does the audit interpreting physician have to do?

What it is

Each facility must designate at least one interpreting physician to review the medical outcomes audit data (21 CFR 900.12(f)(3)).

How it works

That physician reviews the data at least once every 12 months and records the dates of the audit periods. The physician is responsible for analyzing the results and documenting them, for notifying the other interpreting physicians of their own results and the facility's aggregate results, and, if follow up actions are taken, for documenting the nature of that follow up.

Why it matters

The rule names these duties on one accountable person. A facility that cannot show the dates, the results, the notice to each physician, and any follow up has gaps an inspector can find.

What it means to the patient or the client

For the client: name one accountable physician and keep proof of each duty: the audit dates, the results, the notice to every interpreting physician, and any follow up. For the interpreting physicians: you are owed your own results and the facility's aggregate results.

What three measures must a mammography medical outcomes audit include?

What it is

Each facility must run a medical outcomes audit program that follows up positive mammographic assessments and correlates pathology results with the interpreting physician's findings (21 CFR 900.12(f)).

How it works

The analysis is done for each interpreting physician and for all physicians together, and at a minimum determines three things: positive predictive value (the percent of patients with positive mammograms who are diagnosed with breast cancer within 1 year of the examination), cancer detection rate (breast cancers diagnosed within 1 year per 1,000 patients first examined with screening mammograms who received an assessment of Incomplete, Suspicious, or Highly Suggestive of Malignancy), and recall rate (the percentage of screening mammograms assessed Incomplete: Need additional imaging evaluation).

Why it matters

These are the measures the rule requires. Other measures, such as PPV2, PPV3, or sensitivity, come from professional guidance and are useful, but the regulation sets only these three as the minimum.

What it means to the patient or the client

For the client: these three are the minimum your audit must determine, for each interpreting physician and for the facility together. PPV2, PPV3, and sensitivity are useful additions from professional guidance, not requirements of the rule.

How long must a facility keep its repeat analysis records?

What it is

A repeat analysis is the facility's tracking of why mammograms had to be repeated, done to improve image quality and to reduce radiation from repeats that better technique could have avoided. The written record of that analysis has its own retention rule.

How it works

The facility keeps the written analysis until the next annual inspection is complete and the FDA has found the facility compliant with the quality assurance requirements, or until the test has been done two more times at the required frequency, whichever is longer (21 CFR 900.12(d)(2)). The rule covers the written record, not necessarily the rejected images themselves.

Why it matters

Inspectors ask for the written record. Knowing which records to keep avoids keeping too little, and knowing it covers the record rather than every rejected image avoids storing films that no longer need to be kept.

What it means to the patient or the client

For the client: keep the written repeat analysis until the retention rule is met, not every rejected image. If you are unsure whether an image counts as part of the study, the question is whether the interpreting physician used it to read the study.

How often must a facility do its repeat analysis, and how many patients does it count?

What it is

The FDA's inspection procedures say a facility must track and analyze the reasons mammograms are repeated, so that image quality improves and unnecessary repeats are reduced.

How it works

The analysis is done at least quarterly. The facility counts at least 250 patients: it collects every rejected image from the start of the quarter until 250 patients have been imaged or the quarter ends, whichever comes first. It may keep tracking beyond 250 patients if it analyzes at least quarterly. How repeats are tracked depends on the equipment, for example software on a digital unit or a tally sheet for screen film, and the reasons must be evaluated and any corrective action documented.

Why it matters

Inspectors look for the quarterly analysis, the evaluation, and the documented corrective action. A facility that collects by calendar habit instead of by the 250 patient count can miss the rule.

What it means to the patient or the client

For the client: put the quarterly analysis on the calendar and count patients, not days: collect until 250 patients have been imaged or the quarter ends, whichever comes first. Keep the evaluation and any corrective action in writing for the inspector.

Which rejected mammography images must be kept for the 5 or 10 year retention period?

What it is

Rejected images fall into two groups for retention. The FDA's inspection procedures explain which group an image belongs to.

How it works

A rejected image that the interpreting physician used to read the study is part of the original mammogram and is kept for the same 5 or 10 year period as the rest of the study (21 CFR 900.12(c)(4)(i)), even if a repeat was taken. A rejected image that added no diagnostic information can be counted in the repeat analysis and then discarded. Quality control films that are part of an analysis follow the retention guidance for those films.

Why it matters

The test is use in the interpretation, not the label of reject. A facility that discards every rejected image can destroy part of a patient's original study.

What it means to the patient or the client

For the client: the test is whether the interpreting physician used the image to read the study. If so, it stays with the study for 5 or 10 years; if not, it can be counted in the repeat analysis and then discarded.

How long must a facility keep original mammograms, and how fast must it transfer them on request?

What it is

21 CFR 900.12(c)(4) sets the retention period for the original mammograms and reports, and a deadline for transferring them.

How it works

The facility keeps them in the patient's permanent medical record for the longest of three periods: not less than 5 years, not less than 10 years if no additional mammograms of the patient are performed at the facility, or any period mandated by State or local law. On request by or for the patient, the facility must transfer the original mammograms and copies of the reports within 15 calendar days of receiving the request. The mammograms stay in the modality in which they were produced and cannot be copies of digitized hardcopy originals.

Why it matters

The longest applicable period controls, so a state rule that is longer than the federal period governs. A written process for the 15 day transfer deadline prevents missed requests.

What it means to the patient or the client

For patients: you can ask for your original mammograms and reports to be transferred, and the facility must send them within 15 calendar days of your request. For the practice: keep a written process for that 15 day deadline, and remember that a longer state or local rule controls.

What must a mammography report contain?

What it is

21 CFR 900.12(c)(1) lists what the written mammography report must include for every examination.

How it works

The report includes the patient's name and an additional identifier, the date of the examination, the facility name and location (city, State, ZIP code, and telephone number), the name of the interpreting physician, and an overall final assessment in one of the listed categories (Negative, Benign, Probably Benign, Suspicious, Highly Suggestive of Malignancy, Known Biopsy-Proven Malignancy, or Post-Procedure Mammogram for Marker Placement). When work-up is incomplete, the report uses one of the two Incomplete statements and gives reasons. It also includes an overall breast density assessment and recommendations to the healthcare provider.

Why it matters

The assessment wording is fixed by the rule, so reports should use the exact words in the list. Clinical questions from the referring provider are to be addressed even when the assessment is negative or benign.

What it means to the patient or the client

For patients: the overall assessment in your report uses fixed wording set by the rule, so the same words mean the same thing at any MQSA certified facility. For the client: use the exact assessment words, and answer the referring provider's clinical questions even when the result is negative or benign.